Standard Operating Procedures: For Supply Chain Management of Health Products For Amenable To Preventive Chemotherapy

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Standard operating procedures

for supply chain management of health


products for neglected tropical diseases
amenable to preventive chemotherapy
Standard operating procedures
for supply chain management of health
products for neglected tropical diseases
amenable to preventive chemotherapy
Standard operating procedures for supply chain management of health products for neglected tropical diseases
amenable to preventive chemotherapy

ISBN 978-92-4-004958-1 (electronic version)


ISBN 978-92-4-004959-8 (print version)

© World Health Organization 2022


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Cover illustration: WHO/Sam Bradd

■ ■ ■ ■ ii ■ ■ ■ ■ ■ ■ ■
Contents

Acknowledgements vi
Overview viii
Introduction 1
1. Joint Application Package 3
1.1 Purpose and scope of this standard operating procedure 3
1.2 Key considerations 10
1.3 Standard operating procedure 10
1.4 Application process for azithromycin 12
1.5 Standard operating procedure 16
References 17
2. Shipping notification and green light 19
2.1 Purpose and scope of this standard operating procedure 19
2.2 Key considerations 19
2.3 Standard operating procedure 22
References 29
3. Customs clearance and delivery 31
3.1 Purpose and scope of this standard operating procedure 31
3.2 Key considerations 31
3.3 Standard operating procedure 32
3.4 Supplementary information 36
References 36
4. Transport 37
4.1 Purpose and scope of this standard operating procedure 37
4.2 Key considerations 37
4.3 Standard operating procedure 40
5. Inventory management 51
5.1 Purpose and scope of this standard operating procedure 51
5.2 Key considerations 51
5.3 Standard operating procedure 52
6. Storage 57
6.1 Purpose and scope of this standard operating procedure 57
6.2 Key considerations 57
6.3 Standard operating procedure 60

■ ■ ■ ■ ■ ■ iii ■ ■ ■ ■
7. First expiry, first out 69
7.1 Purpose and scope of this standard operating procedure 69
7.2 Key considerations 69
7.3 Standard operating procedure 71
8. Reverse logistics 73
8.1 Purpose and scope of this standard operating procedure 73
8.2 Key considerations 73
8.3 Standard operating procedure 75
Reference 77
9. Removing expired and unserviceable medicines 79
9.1 Purpose and scope of this standard operating procedure 79
9.2 Key considerations 80
9.3 Standard operating procedure 80
10. Waste management 83
10.1 Purpose and scope of this standard operating procedure 83
10.2 Key considerations 84
10.3 Standard operating procedure 84
11. Forecasting and quantification 93
11.1 Purpose and scope of this standard operating procedure 93
11.2 Key considerations 93
11.3 Standard operating procedure 94

Annexes 97
Annex 1. Glossary of key terms and abbreviations 97
Annex 2. Contact list template 102
Annex 3. Action items and greenlight checklist 103
Annex 4. Stock transfer form template 104
Annex 5. Stock card template 105
Annex 6. Physical inventory count form template 106
Annex 7. Stock ledger card template 107
Annex 8. Drug return/transfer form template 108
Annex 9. Job aid for completing the drug return/transfer form 110
Annex 10. Inventory report/register 112
Annex 11. Stock adjustment request form template 113
Annex 12. Pharmaceutical waste and destruction document examples 115

■ ■ ■ ■ iv ■ ■ ■ ■ ■ ■ ■
Tables
Table 1.1. Preventive chemotherapy medicines request forms and management
details 4
Table 1.2. Medicines donated for preventive chemotherapy, by pharmaceutical
company 6
Table 1.3. Trachoma Expert Committee decisions on Zithromax® 14
Table 1.4. Zithromax® application timeline 15
Table 6.1. Summary of logistic information for medicines donated for preventive
chemotherapy 58
Table 10.1. Ordinary waste management documentation and destruction 90
Table 10.2. Pharmaceutical waste management documentation and destruction 91
Table 11.1. Parameters for forecasting quantification of donated medicines for
preventive chemotherapy 95

Figures
Fig. 1. Key supply chain focus areas ix
Fig. 2. Standard operating procedures by number and MDA timeline x
Fig. 1.1. Joint Application Package submission process 7
Fig. 1.2. Application process for donated preventive chemotherapy medicines 9
Fig. 2.1. Example flow chart of air shipping notification and green
light procedure 20
Fig. 4.1. Key steps in transporting medicines to the field 39
Fig. 4.2. Example transportation flow diagram 40
Fig. 6.1. Appropriate carton storage, with description, batch numbers and expiry
dates facing forward 62
Fig. 7.1. Writing the expiry date(s) on each carton of medicine received 70
Fig. 10.1. Stock destruction 88

■ ■ ■ ■ ■ ■ v ■ ■ ■ ■
Acknowledgements

The World Health Organization (WHO) thanks the NTD Supply Chain Forum and all those
who contributed to the preparation of these standard operating procedures.
Writing committee
Ms Cassandra Holloway, Children Without Worms, The Task Force for Global Health,
Decatur (GA), United States of America
Ms Carla Johnson, International Trachoma Initiative, The Task Force for Global Health,
Decatur (GA), United States of America
Ms Penny Smith, United States Agency for International Development, Washington (DC),
United States of America
Dr Afework Tekle, WHO Department of Control of Neglected Tropical Diseases, Geneva,
Switzerland
Mr Modeste Tezembong, WHO Expanded Special Project for Elimination of Neglected
Tropical Diseases, Brazzaville, Congo
Mr Moumine Yaro, International Trachoma Initiative, The Task Force for Global Health,
Decatur (GA), United States of America

Reviewers1
Ms Abimbola Ayoola, Pfizer, Lagos, Nigeria
Dr Christely Badila, Helen Keller International, Conakry, Guinea
Ms Katie Crowley, RTI International, Washington (DC), United States of America
Dr Lamine Diawara, WHO Regional Office for Africa, Brazzaville, Congo
Mr Tim Garner, Centre for Neglected Tropical Diseases, Liverpool School of Tropical
Medicine, Liverpool, United Kingdom
Dr Mawo Fall, RTI International, Maputo, Mozambique
Ms Chantelle Genovezos, Sightsavers, Boston (MA), United States of America
Ms Malika Idouaddi, GlaxoSmithKline, Brentford, United Kingdom of Great Britain and
Northern Ireland
Mr Alex Jones, RTI International, Washington (DC), United States of America

1. The reviewers reviewed different parts of the document to ensure adaptation and quality to the field
experience, which were then shared with the Writing committee for consideration when finalizing the document.
The reviewers were not part of the final approval process for the document.

■ ■ ■ ■ vi ■ ■ ■ ■ ■ ■ ■
Dr Tuan Le Anh, WHO Department of Control of Neglected Tropical Diseases, Geneva,
Switzerland
Ms Lynn Leonard, Johnson & Johnson, New Brunswick (NJ), United States of America
Ms Hilse Lizzette Ruíz, Merck S.A. de C.V, Naucalpan de Juárez, Mexico
Mr Andrew Majewski, NTD Support Center, The Task Force for Global Health, Decatur
(GA), United States of America
Ms Sallay Manah, Children Without Worms, The Task Force for Global Health, Decatur
(GA), United States of America
Mr T.J. Muehlemann, Standard Co., Atlanta (GA), United States of America
Dr Kisito Ogoussan, FHI 360, Washington (DC), United States of America
Mr Benjamin Ongeri, Crown Agents, London, United Kingdom of Great Britain and Northern
Ireland
Ms Tina Patel, Crown Agents, Nairobi, Kenya
Dr Maria Rebollo Polo, WHO Expanded Special Project for Elimination of Neglected
Tropical Diseases, Brazzaville, Congo
Dr Christian Schroeter, Merck Healthcare KGaA, Darmstadt, Germany
Dr Gregory Simon, Management Sciences for Health, Washington (DC), United States of
America
Mr Howard Skarsten, Eisai Manufacturing Ltd, Hatfield, United Kingdom of Great Britain
and Northern Ireland
Dr Aissatou Sougou, WHO Regional Office for Africa, Brazzaville, Congo
Ms Ashley Souza, NTD Support Center, The Task Force for Global Health, Decatur (GA),
United States of America
Ms Mariana Stephens, Children Without Worms, The Task Force for Global Health, Decatur
(GA), United States of America
Mr Valentine Tindi, Kenya Medical Supplies Authority, Nairobi, Kenya
Ms Rocio Villacorta Linaza, Centre for Neglected Tropical Diseases, Liverpool School of
Tropical Medicine, Liverpool, United Kingdom of Great Britain and Northern Ireland
Dr Johannes Waltz, Merck Healthcare KGaA, Darmstadt, Germany
Mr Johan Willems, CBM International, Houston (TX), United States of America
Ms Tijana Williams, GlaxoSmithKline, Brentford, United Kingdom of Great Britain and
Northern Ireland

■ ■ ■ ■ ■ ■ vii ■ ■ ■
Overview

WHO plays a major role in the cycle of supply chain management for donated and/or
procured health products for neglected tropical diseases (NTDs) amenable to preventive
chemotherapy and individual case management.
This first edition describes the standard operating procedures for health products for NTDs
amenable to preventive chemotherapy and the medicines donated to treat them. These
include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin
for trachoma and yaws; diethylcarbamazine citrate for lymphatic filariasis; ivermectin for
onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases;
praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases.
Standard operating procedures for diseases amenable to case management will be
covered in subsequent editions, including the application process for requesting medicines
(Chapter 1). In the meantime, the procedures described in the rest of the document apply
for both case management and preventive chemotherapy NTD health products.
WHO and the NTD Supply Chain Forum prepared this set of standard operating procedures
to reflect key characteristics in the supply chain management of health products including
donated medicines for use in mass drug administration (MDA) at the country level. Health
ministries and national programmes for NTDs are encouraged to adopt and adapt them to
their country context.

The role of the supply chain in MDA


MDA plays a role in the primary prevention of NTDs amenable to preventive chemotherapy
by decreasing transmission rates in populations at risk. The effectiveness of the MDA
strategy depends on epidemiological coverage, which is defined by WHO-recommended
targets for the proportion of the total population ingesting the medicines during MDA.
In order to meet the coverage targets the supply chain must be managed, from planning
and quantifying needs, to moving stock from production sites to patients at the service
delivery point to communities, schools and hospitals, among others, and to retrieving and
accounting for leftover stock, and all steps in between, as outlined in Fig. 1.

Objectives of these standard operating procedures


These standard operating procedures are intended to help strengthen the capacity of
health ministries and national NTD programmes to mainstream and institutionalize efficient
management of the supply chain for NTD medicines. They outline supply chain tasks and
responsibilities before, during and after MDA. They also present key considerations for
optimizing planning and implementation of supply chain activities in the country.

■ ■ ■ ■ viii ■ ■ ■ ■ ■ ■ ■
Overview

These procedures support the realization of the goal set in the WHO 2030 road map for
NTDs: an effective supply chain that ensures timely access to and availability of quality-
assured medicines, products and pharmaceutical supplies at all levels and avoiding, e.g.
stockout, wastage, loss of tablets (1).
Target audience
The procedures are intended for use as a reference document by responsible persons and
key stakeholders of the NTD supply chain, as illustrated below.
Responsible persons and key stakeholders include both organizations and individuals.
Organizations
Health ministries, national NTD programmes, central medical stores, national procurement
and logistics agencies, regional and district medical stores, frontline health facilities,
schools and national educational institutions.
Individuals
National NTD programme staff and stakeholders, medical stores staff at all levels –
pharmacists and warehouse managers, NTD focal persons and MDA supervisors,
community health workers and community drug distributors.

Fig. 1. Key supply chain focus areas

Joint Application Package


submission

Forecastig and Shippimg notification and


quantification green light

Waste Custom clearance and


management delivery
Key supply chain
management
Removing expired and focus areas Transport
unserviceable medicines

Reverse logistics Storage

Inventory management First expiry, first out

■ ■ ■ ■ ■ ■ ix ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Standard operating procedure by number and MDA timeline


The 11 procedures are shown in Fig. 2 in their relevant order before, during and after MDA.

Template for standard operating procedures


For each of the 11 procedures the following template is used.
Task Instruction Responsibility References
The timeframe specific Main job role(s) of those Key points for the Key instructions in this
for the tasks in this part responsible for the specific tasks in this part part of the process, in
of the process specific tasks in this part of process order of activity and/or
of the process as listed in the table

The positions and roles identified under responsibility and the instruction for each task are
illustrative and should be adjusted according to the local context. Chapter numbers for
related procedures and other relevant guidance are listed under references. A glossary
of terms is provided as Annex 1. Sample template forms and document examples are
included as Annexes 2–12. If support is needed to develop templates, please contact
WHO for assistance ([email protected]).

Fig. 2. Standard operating procedures by number and MDA timeline

Before During After


Key Identifying needs and planning Distribution to end-points and Retrieving stock and storing for
activity/task for distribution management of stock next MDA
Persons  National-level actors  Regional-level actors  District-level actors
responsible for  Global-level actors  District-level actors  Regional-level actors
procedure  National-level actors

National 11. Forecasting and


quantification
NTD
programme 2. Shipping
1. Joint notification 3. Customs
Application and green clearance
Package. light and delivery
In-country supply 4. Transport; 6. Storage
chain: central and
7. First expiry, first out
regional medical
stores, first-level 5. Inventory management; 9. Removing expired and unserviceable medicines; 10. Waste management.
health facilities
8. Reverse logistics

■ ■ ■ ■ x ■ ■ ■ ■ ■ ■ ■
Overview

Task Instruction Responsibility References


1 Instruction described in one sentence Main job role(s) Relevant chapters
1.1. Detailed steps required to fulfil the instruction responsible for the for related proce-
1.2. specific instruction dures, guidance and
annexes
1.3.

Dissemination and implementation


These standard operating procedures may be used to inform or supplement existing
national procedures for supply chain management of health commodities. Where such
procedures do not exist or do not address NTD medicines, the current procedures can
be adapted to the country context and the national programme. WHO will add additional
procedures as needed based on country feedback. For information and assistance, please
contact WHO ([email protected]).

References
1. Ending the neglect to attain the Sustainable Development Goals: a road map for neglected
tropical diseases 2021–2030. Geneva: World Health Organization; 2020 (https://www.who.int/
publications/i/item/9789240010352, accessed 18 March 2022).

■ ■ ■ ■ ■ ■ xi ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Illustration: WHO/Sam Bradd

■ ■ ■ ■ xii ■ ■ ■ ■ ■ ■ ■
Introduction

Preventive chemotherapy and individual case management are core strategies to control,
eliminate or eradicate NTDs. Health products (medicines, diagnostics and other supplies)
donated for this purpose underpin the success of NTD programmes. Global coordination
by WHO safeguards access to medicines for countries in which NTDs are endemic to
ensure rational use and reporting, monitoring, evaluation and accountability. Global
coordination also contributes to the achievement of outcome 1.3 of WHO’s Thirteenth
General Programme of Work 2019–2023 (Improved access to essential medicines,
vaccines, diagnostics and devices for primary health care), the NTD road map targets for
2030 (1) and target 3.8 of the Sustainable Development Goals (Achieve universal health
coverage, including access to safe, effective, quality and affordable essential medicines
and vaccines for all).
WHO manages most of the health products for NTDs that are either donated by
pharmaceutical companies or procured by WHO for use by Member States. The main roles
of WHO are to coordinate with and liaise among endemic countries and pharmaceutical
donors and ensure that quantities of requested medicines are appropriate and effectively
and rationally distributed.
WHO plays a major role in the cycle of supply chain management for donated health
products for NTDs amenable to preventive chemotherapy and case management.
It facilitates quantification and forecasting as well as timely review and processing of
requests for medicines. WHO also coordinates logistic arrangements with pharmaceutical
companies and global freight forwarders to ensure that safe, quality-assured health
products are made available easily and equitably and are readily accessible to populations
in need free of charge. Technical assistance is provided to Member States in managing
and monitoring stock balances, minimizing wastage and avoiding expiry of medicines.
Overall, WHO works to improve access to universal health coverage for those affected by
NTDs and supports the global NTD community in the smooth running of the supply chain
management cycle.
The global NTD community, like many other health sectors, faces several challenges
and hindrances in the supply chain management cycle. These include selection of

■ ■ ■ ■ ■ ■ 1 ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

health products, quantification and forecasting, supply planning and procurement to final
delivery and consumption, reporting from primary health care units to national levels, and
compliance with accountability and transparency requirements as a guarantee of the
sustainability of the supply chain for donated health products. As in many areas of health,
most of the issues are related to capacity, financial resources, infrastructure, human
resources and a lack of tools and awareness related to management of essential health
products.
The campaign nature of NTD programmes puts particular stress on supply chain
management systems in countries where NTDs are endemic by requiring large boluses
of medicines, diagnostics and other medical products to be delivered in relatively narrow
timeframes for the purposes of MDA, surveys or other campaign-style events.
Following a consultative assessment exercise with Member States, 11 key supply chain
areas were identified and prioritized and a set of specific standard operating procedures
were developed by members of the NTD Supply Chain Forum.
The procedures are intended to help strengthen the capacity of health ministries and NTD
programmes in mainstreaming and institutionalizing efficient supply chain management for
NTD health products including donated medicines. They outline supply chain tasks and
responsibilities before, during and after MDA and present key considerations for planning
and implementing related activities within countries. They are intended to serve as templates
for countries to adapt to their unique contexts, from national to primary health care unit
levels. The intention is to help health workers improve their skills in handling, delivering
and managing NTD commodities and provide an entry point for managing essential health
products for communicable and noncommunicable disease health programmes.

References
1. Ending the neglect to attain the Sustainable Development Goals: a road map for neglected
tropical diseases 2021–2030. Geneva: World Health Organization; 2020 (https://apps.who.int/
iris/handle/10665/338565, accessed 18 March 2022)

■ ■ ■ ■ 2 ■ ■ ■ ■ ■ ■ ■
1. Joint Application Package

WHO NTD programmes coordinate the donation or/and procurement of health products
for diseases amenable to both preventive chemotherapy and case management.
This chapter describes the procedures for requesting medicines for the preventive
chemotherapy diseases. Most of the requests are consolidated and submitted through the
Joint Application Package; separate forms are used to request medicines for foodborne
trematodiases, taeniasis and cysticercosis, trachoma and yaws. Most of these forms will
be included in the Joint Application Package in due course (see Table 1.1 for details). The
case management diseases have also their own individual medicine request forms and
donation management processes, which are beyond the scope of this chapter. Eventually,
all requests for medicines will be integrated and reflected in subsequent editions of this
document.

1.1 Purpose and scope of this standard operating procedure


This procedure provides technical guidance to national NTD programmes and implementing
partners on preparing and submitting the Joint Application Package to request medicines
for preventive chemotherapy.
The Joint Application Package is a set of four forms:
■ the Joint Request for selected medicines;
■ the Joint Reporting Form;
■ the Epidemiological Reporting Form; and
■ the Annual Workplan (optional).

■ ■ ■ ■ ■ ■ 3 ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Table 1.1. Preventive chemotherapy medicines request forms and management details

Medicine Disease Medicine Review process Donation coordinator


request form
Diethylcarbamazine citrate Lymphatic filariasis JRSM RPRG WHO
(100 mg tablets)
Mebendazole Soil-transmitted JRSM RPRG WHO
(500 mg tablets) helminthiases1
Albendazole Lymphatic filariasis JRSM RPRG WHO
(400 mg tablets)
Soil-transmitted JRSM RPRG WHO
helminthiases
Praziquantel Schistosomiasis JRSM RPRG WHO
(600 mg tablets)
Ivermectin Onchocerciasis JRSM MEC Mectizan®
(3 mg tablets) Donation Program
Lymphatic filariasis in JRSM MEC Mectizan®
co-endemic countries Donation Program
Lymphatic filariasis for triple JRSM MEC Mectizan®
therapy MDA Donation Program
Azithromycin Trachoma TEMF TEC International Trachoma
(250 mg tablets or 1200 mg Initiative
in 30 mL (200 mg/5 mL)
powder for oral suspension)
Azithromycin Yaws Standalone WHO WHO
(500 mg tablets) request form
Triclabendazole Foodborne trematodiases Standalone WHO WHO
(250 mg tablets) request form
Praziquantel Taeniasis and cysticercosis Standalone WHO WHO
(600 mg tablets) or request form
niclosamide
(400 mg tablets)

JRSM: Joint Request for Selected Medicines; MDA: mass drug administration; MEC: Mectizan Expert Committee; RPRG: Regional Programme Review Group;
TEC: Trachoma Expert Committee; TEMF: trachoma elimination monitoring form.

■ ■ ■ ■ 4 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

The Joint Request for selected medicines and the Annual Workplan should be submitted
at least 10 months before the planned date of MDA. The Joint Reporting Form should be
submitted no later than 3 months after completion of the last implementation round in
a reporting year. This early stage of planning for MDA is a required step for countries to
receive their allocations of medicines.
WHO facilitates the supply of many donated medicines for preventive chemotherapy as
part of global efforts to accelerate the expansion of control and elimination of lymphatic
filariasis, onchocerciasis, schistosomiasis and soil-transmitted helminthiases. The
medicines are (in alphabetical order):
■ albendazole for lymphatic filariasis and soil-transmitted helminthiases;
■ azithromycin for yaws;
■ diethylcarbamazine citrate for lymphatic filariasis;
■ ivermectin for onchocerciasis and lymphatic filariasis;
■ mebendazole for soil-transmitted helminthiases;
■ niclosamide or praziquantel for taeniasis and cysticercosis;
■ praziquantel for schistosomiasis; and
■ triclabendazole for foodborne trematodiases;

A joint mechanism and a set of forms facilitate the application process and improve
coordination and integration among NTD programmes. This Excel-based tool is designed
to assist countries in quantifying the number of tablets of each medicine required to
reach the planned target population and districts for the year of request. The output is a
joint request for preventive chemotherapy medicines, which can be printed, signed and
submitted to WHO.
(The donation process for azithromycin for the elimination of trachoma as a public health
problem is similar to that used for the preventive chemotherapy medicines; the separate
application process and timeline are described in section 1.5.1. Further details of the
medicines donated by pharmaceutical companies for preventive chemotherapy are shown
in Table 1.2).

1.1.1 Planning the submission process


■ The set of four forms facilitates the process of applying for the medicines, reporting on
their use and planning for their distribution during MDA.
■ The forms are “joint” because they can be used to apply for, report on and plan for the
distribution of five preventive chemotherapy medicines donated through WHO; they
constitute a Joint Application Package and should be submitted together (Fig. 1.1).
■ To ensure the medicines are delivered on time, the request for preventive chemotherapy
medicines should be submitted 9 months before the planned date(s) of MDA,
regardless of when it is planned.
■ Countries can and should submit their application any time during the year.
– For example, if a country plans to conduct MDA in September 2021, it should
submit the Joint Application Package by January 2021.

■ ■ ■ ■ ■ ■ 5 ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Table 1.2. Medicines donated for preventive chemotherapy, by pharmaceutical company

Company Medicine Quantity donated Disease Commitment Donation


(location) coordinator
Eisai (Japan) Diethylcarba- 2 200 000 000 Lymphatic filariasis Until elimination WHO
mazine citrate tablets total
(100 mg)
Johnson & Johnson Mebendazole 200 000 000 Soil-transmitted Until 2025 WHO
(United States) (500 mg) tablets annually helminthiases1
GlaxoSmithKline Albendazole 600 000 000 Lymphatic filariasis Until elimination WHO
(United Kingdom) (400 mg tablets) tablets annually
400 000 000 Soil-transmitted Until elimination WHO
tablets annually helminthiases1
Merck KGaA Praziquantel 250 000 000 Schistosomiasis1 Unlimited WHO
(Germany) (600 mg) tablets annually
Merck, Sharpe and Ivermectin Unlimited Onchocerciasis Until elimination Mectizan®
Dorne (3 mg) Donation Program
(United States)
Unlimited Lymphatic filariasis Until elimination2 Mectizan®
in co-endemic Donation Program
countries
Up to 100 000 000 Lymphatic filariasis Until 2025 Mectizan®
treatments annually for triple therapy Donation Program
MDA
Pfizer (United States) Azithromycin Unlimited Trachoma 1998–2025 International
(250 mg tablets Trachoma Initiative
or 1200 mg in 30
mL (200 mg/5 mL)
powder for oral
suspension)
Bayer (Germany) Niclosamide Up to a total of Taeniasis and 2020–2024 WHO
(400 mg) 2 800 000 tablets cysticercosis
Praziquantel Up to a total of
(600 mg) 1 339 000 tablets
EMS SA Pharma Azithromycin 153 million tablets Yaws 2019–2023 WHO
(Brazil) (500 mg)

Source: adapted from Fig. 11 of reference (2).


1
For treatment of school-aged children.
2
In Yemen and African countries where lymphatic filariasis and onchocerciasis are co-endemic.

■ ■ ■ ■ 6 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

– Countries are responsible for planning their joint application packages to ensure
the medicines arrive in time for MDA; WHO and the pharmaceutical companies
also need significant lead time to ensure the accuracy of applications, to
manufacture and ship the medicines, and then for the medicines to clear
customs in the country. This is why it is essential to submit the application 10
months before the MDA.
■ When submitting in 2021, for example, the application should include information
on planned activities and a request for medicines to be used in year x+1 (i.e. 2022),
together with the report on preventive chemotherapy interventions conducted in
year x-1 (i.e. 2020).
The four forms and their uses are explained below.
■ Joint Request for selected preventive chemotherapy medicines (version 3.1). This
form should be used to request albendazole, diethylcarbamazine citrate, ivermectin,
mebendazole and praziquantel for use in the year after the year of application.
■ For ivermectin, WHO also shares a copy of this form with the Mectizan® Donation
Program, using the JRSM form (see Table 1.1).
■ For triple therapy with ivermectin, diethylcarbamazine citrate and albendazole (IDA),
a separate Joint Request and Joint Reporting Form are not needed. However,
additional documentation for ivermectin donations is needed by the Mectizan®
Donation Program. The application process is summarized in section 1.3.2.

Fig. 1.1. Joint Application Package submission process

Manufacture
Placing
Submission Joint review and
order
shipment

• Joint Reporting Form • Review and • Discussion and • 6−8 months for
for the previous year approval of the consultation manufacturing
request among WHO, and shipping
• Joint Request for manufacturer
selected PC and country
medicines for the
following year • WHO places
order to
• PC Epidemiological manufacturers
Data Reporting Form

If forms need to be
revised

Submission of the
2 weeks 2 weeks 6–8 months
Joint Application Package

Submit anytime 9 months


before the planned MDA date

■ ■ ■ ■ ■ ■ 7 ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ Countries co-endemic for loaiasis should use a specific version of the Joint
Request for selected medicines to request albendazole for interventions against
lymphatic filariasis in non-onchocerciasis endemic areas endemic for loaiasis.
Exception: The Joint Request form cannot be used to apply for azithromycin for
trachoma or triclabendazole for fascioliasis and paragonimiasis; a separate application
process is used (see section 1.5.1).
■ Joint Reporting Form. This form is designed to assist countries in reporting annual
progress on integrated and coordinated distribution of medicines across diseases in
the reporting year in a standardized format.
■ Countries co-endemic with Loa Loa should use a specific version of the Joint
Reporting Form to report on interventions against lymphatic filariasis in non-
onchocerciasis endemic areas endemic for loaiasis.
■ Epidemiological Reporting Form. This form is designed to standardize national
reporting of epidemiological data on lymphatic filariasis, onchocerciasis,
schistosomiasis and soil-transmitted helminthiases. National authorities are
encouraged to complete this form and submit it to WHO annually, together with the
Joint Reporting Form.
■ Annual Workplan. This form provides information on the key preventive chemotherapy
and collateral activities planned by health ministries for lymphatic filariasis,
onchocerciasis, schistosomiasis and soil-transmitted helminthiases in the year of use
of the requested medicines.
Further details of preventive chemotherapy and the Joint Application Package, including
downloads to the latest multilingual versions of the forms, are available on the WHO
website (1).

1.1.2 Completing the forms


The Ministry of Health and its designated officer are responsible for completing the forms,
which should be officially signed by a designated authority to request medicine in the
country and submitted to the WHO country office of the respective country. Typically,
national NTD coordinators, in collaboration with the responsible authority managing
medicine procurements, are the most appropriate people to compile all the required
information for the Joint Application Package. In their absence, programme managers for
each of the targeted diseases should coordinate their respective parts for the joint forms
with the assistance, if available, of the national pharmacy or medical stores, to ensure
inclusion of existing stock in the country. Technical assistance from implementing partners
supporting national programmes is also readily available and is encouraged to assist with
preparing the Joint Application Package.

1.1.3 Approval process


Regional Programme Review Group process
After submission to WHO, the WHO secretariat validates the data, reviews them jointly
with WHO regional offices and headquarters, and provides feedback to countries for
correction. This is one of the most time-consuming periods of the entire process, mainly
because it involves feedback from countries. Once in good order, the completed Joint
Application Package is submitted by WHO to the Regional Programme Review Group for
review and approval. This technical and advisory group of independent experts provides
overall strategic and operational review of national and regional NTD programmes with
the objective of accelerating the control and elimination of targeted NTDs. One of its
mandates is to review applications for medicines submitted by countries to WHO, including
for the following preventive chemotherapy medicines: albendazole, diethylcarbamazine

■ ■ ■ ■ 8 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

citrate, ivermectin, mebendazole and praziquantel. The group meets once annually to
review applications and virtually on an ad hoc basis. The recommendations of the group
are considered in the donation process. For requests for ivermectin for treatment of
onchocerciasis and lymphatic filariasis using triple medicine (IDA) therapy, the review and
approval process is through the Mectizan® Expert Committee outside WHO.

1.1.4 Advantages of the joint forms for national programmes


The Joint Request for selected medicines assists countries to quantify the number of tablets
of the relevant medicines required to reach the planned target populations and districts in
a coordinated and integrated manner against multiple diseases for the year of request.
The output of the tool is a 2-page summary worksheet, which can be printed, signed,
scanned and submitted to WHO together with the full version of the form in order to apply
for the medicines. To expedite the application process, the worksheet should be submitted
to WHO together with soft copies of the Joint Reporting Form and the Epidemiological
Reporting Form. The application process is shown in Fig. 1.2.
Any changes to this process will be communicated and the standard operating procedure
updated accordingly.
case management diseases have also their own individual medicine request forms and
donation management processes, which are beyond the scope of this chapter. Eventually,
all requests for medicines will be integrated and reflected in subsequent editions of this
document.

Fig. 1.2. Application process for donated preventive chemotherapy medicines

World Health
Organization

ORDER

Merck • Joint Request for


GSK Eisai J&J selected PC medicines
KGaA
REVIEW • Joint Reporting Form
• PC Epidemiological
ALB DEC MBD PZQ Data Reporting Form

SHIPMENT

National
programme(s)
MDP ORDER

IVM SHIPMENT

ALB: albendazole; DEC: diethylcarbamazine citrate; GSK: GlaxoSmithKline; IVM: ivermectin; J&J: Johnson & Johnson; MBD: mebendazole; MDP: Mectizan©
Donation Program; PC: preventive chemotherapy; PZQ: praziquantel

■ ■ ■ ■ ■ ■ 9 ■ ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

1.2 Key considerations


The requirements for the Joint Request for selected preventive chemotherapy medicines
are:
■ submission of the completed Joint Report with latest available treatment data for a
calendar year;
■ in-country available inventory of preventive chemotherapy medicines;
■ funding sources availability; and
■ completion with up-to-date status of endemicity for each of the diseases based on
latest available prevalence data submitted through the Epidemiological Data Reporting
Form, if surveys were conducted.

The data collected during this process allow the donation programme to determine the
long-term needs for medicines in a particular country and to evaluate progress towards
elimination. Delays in submitting the annual applications and not adhering to the timelines
can impact the availability of medicines to meet in-country requirements.

1.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.

1.3.1 Preparing and submitting the Joint Application Package (for albendazole,
diethylcarbamazine citrate, ivermectin, mebendazole and praziquantel)

When Who What How


The application to ■ National NTD ■ Updating mapping and 1. Fill in the four forms
request preventive programme country information on with accurate and
chemotherapy manager/national NTDs (e.g. population complete information
medicines should be NTD programme requiring preventive as noted at left.
prepared, filled in and coordinator chemotherapy. 2. Cross-check the
submitted for review ■ Implementing partners This is calculated quantification outputs
and approval at least automatically, but and adjust them
10 months before the ■ Monitoring and countries should
evaluation manager based on the current
planned date of MDA. provide population available balance
Given the amount of ■ Supply chain manager/ data for the stock.
documentation and NTD pharmacist or entire country by
data needed to prepare logistician implementation unit, 3. Verify other funding
the application and status of endemicity, sources of supply in
■ NTD pharmacist and/ the country.
the time required to or logistician number of treatment
identify and gather it, rounds planned
it is recommended to and implemented,
begin preparation at MDA dates,
least 2 months before treatment data, stock
submission to ensure inventory balance,
timely submission to and funding availability,
approval by WHO. assessment reports
(e.g. transmission
assessment survey,
Epidemiological Data
Reporting Form)).
■ Completing the four
forms.
■ Final review and
submission of the filled
in forms.

■ ■ ■ ■ 10 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

Task Instruction Responsibility References


1 Meet with stakeholders to identify and gather ■ NTD programme (1)
needed documentation and data (at least 2 months manager Refer to previous
before submission). ■ Implementing year’s Joint Appli-
1.1. Review previous year pre-approval feedback partners cation Package and
to determine causes for persistent approval WHO feedback
Monitoring
delays.

and evaluation See Chapter 8:


1.2. Develop solutions to prevent repeat delays. manager Reverse logistics
1.3. Discuss and assign responsibilities for gather- ■ Supply chain See Chapter 11:
ing components. manager/NTD Forecasting and
1.4. Schedule a preparatory meeting to serve as pharmacist or quantification
the deadline for gathering the required docu- logistician
mentation.
2 Complete the Joint Reporting Form for the previous ■ NTD programme (1)
year (no later than 3 months after the last imple- manager
mentation round completed in a reporting year). ■ Implementing
The epidemiological data should be submitted in partners
the Epidemiological Reporting Form whenever a
country conducted epidemiological surveys and ■ Monitoring
results are completed. and evaluation
manager
2.1. Convene a meeting with stakeholders to gath-
er all the treatment data from the field.
2.2. Generate the Joint Reporting Form using the
data received from the field and other available
sources..
2.3. Review the final Joint Reporting Form and sub-
mit it for approval.
3 Complete the Joint Request for selected medicines ■ NTD programme See Chapter 5:
(at least 10 months before the planned MDA). manager Inventory manage-
3.1. Convene a meeting with stakeholders to pres- ■ Implementing ment
ent all the required country NTD information partners See Chapter 6:
necessary to complete the request. Storage
■ Monitoring
3.2. Complete the request using the accurate in- and evaluation See Chapter 8:
formation compliant with the local NTD context manager Reverse logistics
and status. (3)
■ Supply chain
3.3. Review the completed request and submit it to manager/NTD See section 3.1.2
WHO country and regional offices for regional pharmacist or Supplementary ap-
review and clearance. If requesting medicines logistician plication process for
for IDA, verify eligibility guidelines. ivermectin for triple
(IDA) therapy
4 Complete the Annual Workplan (at least 10 months ■ NTD programme (1, 4)
before the planned MDA). manager
4.1. Download the Annual Workplan from the ■ Implementing
ESPEN Portal or the WHO website. partners
4.2. Fill in the workplan and share it for review. ■ Monitoring
and evaluation
manager

1.3.2 Supplementary application process for ivermectin for triple (IDA)


therapy
Countries should use the Joint Request for selected medicines form to apply for ivermectin
(1).
Within the time limits recommended by WHO, the application should be submitted to:
■ the NTD department of the WHO regional office together with the supporting
documents; and

■ ■ ■ ■ ■ ■ 11 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ the Mectizan® Donation Program together with:


■ the revised master plan with IDA adopted by the health ministry as a strategy to
eliminate lymphatic filariasis;
■ the Annual Workplan including districts targeted for IDA and the strategy for
implementing IDA with effective coverage and post-intervention monitoring and
evaluation;
■ the epidemiological evidence of eligibility for IDA for each district; and
■ the signed agreement with the Program to receive and distribute ivermectin.

Applications for ivermectin follow the WHO review mechanism for the Joint Application
Package as described above. However, the final decision regarding the number of
implementation units to be approved is made by the Mectizan® Expert Committee
based on the 280 million tablets allocated annually for IDA up until 2025. Members of the
Committee submit recommendations to the Program. Since the expanded donation for
IDA is a special provision to facilitate access to ivermectin and accelerate elimination, all
applications, either initial or re-applications, are discussed among Committee members
who decide whether or not to provide the medicines.
Re-applications for ivermectin to perform a second round of IDA are prioritized. A third
round is conditional upon:
■ successful implementation of the previous donations with high coverage; and
■ data on monitoring and evaluation that justify the need to implement additional MDAs
with IDA.

Full details of the application process for ivermectin for IDA are available in the Guide for
donations of Mectizan® to accelerate the elimination of lymphatic filariasis in countries
where onchocerciasis is not co-endemic (4).

1.4 Application process for azithromycin


Azithromycin is made available for the elimination of trachoma as a public health problem
through donation from a pharmaceutical company, as for the other medicines in this
procedure. Pfizer, through its partner the International Trachoma Initiative (ITI), has a
separate annual application process for all countries applying for azithromycin, with distinct
requirements and timelines.
ITI provides information on the applicant country’s trachoma elimination efforts to the
Trachoma Expert Committee, an independent body of internationally recognized experts
that meets twice a year to review country applications and make evidence-based, consistent
and transparent allocations of the medicine. WHO’s Medical Officer for Trachoma has an
ex officio observer role at meetings of the Trachoma Expert Committee.
The azithromycin application requests information on programme details, including:
■ updated data on district-level trachoma prevalence;
■ current population estimates by district;

■ ■ ■ ■ 12 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

■ treatment distribution data from the previous programme year;


■ the country’s commitment to full implementation of the SAFE strategy (5, 6); and
■ confirmed funding and implementation partners for each district for which azithromycin
is requested.

The application forms a part of the WHO Alliance for GET2020 Trachoma Elimination
Monitoring Form, which facilitates simultaneous reporting to both WHO and ITI on the
previous year’s activities (e.g. the form in 2021 is for activities in 2020). For districts for
which azithromycin is still indicated, the form includes a tab to request azithromycin for the
upcoming year (e.g. application submitted in 2021 is for azithromycin needed in 2022).
Examples of the forms and processes are provided in the Zithromax® management
guide (2).

1.4.1 Key considerations


■ Countries must submit a request each year in their application for every district in which
they plan to treat.
■ Each district where a donation is requested must satisfy the donation criteria during
every application cycle.
■ Applications should be prepared by the national programme manager in close
collaboration with the National Trachoma Task Force. ITI assigns each country
a programme liaison and a supply chain liaison, who work closely with the national
programme to ensure that its needs are addressed.
■ With the information that the national programme provides, the programme liaison
advocates for the country at meetings of the Trachoma Expert Committee.
■ The Trachoma Elimination Monitoring Form (which includes the Zithromax® application)
is pre-populated by ITI with projected district population figures and sent out by WHO.
The national programme should review and make any corrections to the form, which
will update the application tab. Instructions are included in the application package to
make the Zithromax® application process easier.

1.4.2 Approval process


The Trachoma Expert Committee makes district-level recommendations to ITI based on
the data presented for each district, namely:
■ trachoma prevalence;
■ population;
■ number of rounds of MDA already conducted;
■ coverage achieved for each round;
■ schedule for population-based prevalence surveys (baseline, impact and surveillance);
and
■ availability of financial and implementation support for MDA.

■ ■ ■ ■ ■ ■ 13 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Depending on the data presented for each district, the Committee applies one of three
decisions to each district request in the Zithromax® application (Table 1.3). Once the
Committee has reviewed the application for the upcoming year, ITI communicates the
decision to the health ministry and its partners.

1.4.3 Memorandum of understanding


A memorandum of understanding is created to outline the legal obligations of the health
ministry and ITI regarding the donation and management of azithromycin.
The memorandum contains three components:
■ the main agreement detailing the legal obligations to which both ITI and the national
health ministry commit to regarding the donation and management of azithromycin;
■ an addendum detailing the decisions on allocating azithromycin for the upcoming year;
and
■ an addendum detailing what should be reported to Pfizer regarding azithromycin
product quality concerns, at-risk scenarios and adverse events, and how to report
them.

Table 1.3. Trachoma Expert Committee decisions on Zithromax®

1 Approve Zithromax® to be allocated for the upcoming year


2 Approve Zithromax® with contingency:
A. Pending confirmation of available funding, and/or
B. Pending results from population-based prevalence surveys, and/or
C. Pending resolution of a special situation, either:
a. Outside the control of the national programme
b. Requiring intervention by the national programme
3 Does not meet criteria

■ ■ ■ ■ 14 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

A memorandum of understanding is signed by ITI and the health ministry for a period of 3
years. In subsequent years an addendum to the existing 3-year memorandum is sent to the
health ministry detailing the allocation of the medicine for that year.
Once the treatment for any year has been allocated, ITI takes the necessary steps to
ensure the medicine arrives in the country before the scheduled MDA.
Failure to comply with the terms set forth in the memorandum of understanding may result
in the suspension of the azithromycin donation.
The timeline for the Zithromax® application is shown by month and activity in Table 1.4.
Although the Trachoma Expert Committee reviews applications on a set timeline twice per
year (in June and November), under certain circumstances ITI and the Trachoma Expert
Committee accept requests throughout the year as new data or funding become available.
Full details of the application forms and process are available in the Zithromax®
management guide (2).

Table 1.4. Zithromax® application timeline

Month Activity
January WHO sends Zithromax® application to national trachoma programme (or national NTD programme
trachoma focal point for integrated programmes) for the upcoming year
March National trachoma programme submits the application to WHO and ITI
June to November Trachoma Expert Committee decides on allocation of Zithromax®
ITI sends notification to the health ministry of the Committee’s decisions (see Table 1.3) and either enters
into a new memorandum of understanding or updates the current 3-year memorandum with an addendum
1–2 months ITI ships Zithromax® to countries (timing of shipment depends on country’s MDA schedule)
before MDA
March (following Country reports to WHO and ITI on treatments distributed during the past year in the Trachoma Elimination
year) Monitoring Form, which includes the Zithromax® application
Before shipment Countries report to ITI on remaining inventory from the previous year

■ ■ ■ ■ ■ ■ 15 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

1.5 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.

1.5.1 Preparing and submitting the Trachoma Elimination Monitoring Form

When Who What How


Receive application in ■ National trachoma ■ Update trachoma 1. January: receive
January and submit in programme manager prevalence data the Zithromax®
March for the upcoming ■ NTD programme ■ Provide the current application from WHO.
year (i.e. MDA in 2022 trachoma focal point population estimates 2. March: National
submitted in March by district trachoma programme
2021) and report on ■ Implementing partners
Provide treatment submits the
previous year’s SAFE ■ ITI liaison ■
application to WHO
implementation. distribution data
from the previous and ITI.
programme year 3. June to November:
■ Verify country’s receive azithromycin
commitment to full allocation decisions
implementation of the from Trachoma
SAFE strategy Expert Committee
and either enter into
■ Confirm funding a new memorandum
and implementation of understanding or
partners for each update the current
district receiving 3-year memorandum
azithromycin with an addendum.

Task Instruction Responsibility References


1 January: receive the Zithromax® application. ■ ITI programme (7)
liaison and WHO
1.1. WHO sends the pre-populated Zithromax®
application to the national trachoma pro-
gramme manager (or NTD programme tracho-
ma focal point in an integrated programme) for
the upcoming year.
2 March: National trachoma programme manager/ ■ National trachoma
NTD programme trachoma focal point submits programme
the Zithromax® application. manager/NTD
2.1. NTPM/NPM updates trachoma prevalence programme
data. trachoma focal
point
- Steps updated with people or department
responsible for completing the process. ■ Implementing
partners
2.2. National trachoma programme manager/
NTD programme trachoma focal point obtains ■ ITI programme
current population estimates by district. liaison
- Steps updated with people or department ■ Implementing
responsible for completing the process. partners

■ ■ ■ ■ 16 ■ ■ ■ ■ ■ ■ ■
Joint Application Package

Task Instruction Responsibility References


2.3. National trachoma programme manager/
NTD programme trachoma focal point submits
Trachoma Elimination Monitoring Form with the
treatment distribution data from the previous
year.
- Steps updated with people or department
responsible for completing the process.
2.4. Verify the country’s commitment to full imple-
mentation of the SAFE strategy.
- Steps updated with people or department
responsible for completing the process.
2.5. Confirmed funding and implementation part-
ners for each district receiving azithromycin
- Steps updated with people or department
responsible for completing the process.
3 June to November: receive azithromycin ■ National trachoma
allocation decisions from the Trachoma Expert programme
Committee. manager/NTD
3.1. National trachoma programme manager/NTD programme
programme trachoma focal point receives trachoma focal
point
Zithromax® allocation approval.
■ Implementing
3.2. National trachoma programme manager/NTD partners
programme trachoma focal point signs the
3-year memorandum of understanding with ITI
or an addendum to the existing memorandum
that details the allocation of the medicine for
the upcoming year
- Steps updated with people or department
responsible for completing the process.

References
1. Joint Application Package – planning, requesting medicines and reporting. In: WHO/Neglected
tropical diseases [website]. Geneva: World Health Organization; 2021 (https://www.who.int/
teams/control-of-neglected-tropical-diseases/preventive-chemotherapy/joint-application-
package, accessed 18 March 2022).
2. Zithromax® management guide. Decatur (GA): International Trachoma Initiative; 2019 (https://
www.trachoma.org/zithromax-management-guide, accessed 18 March 2022).
3. Apply for Mectizan. In: Mectizan® Donation Program/How the program works [website]. Decatur
(GA): Mectizan Donation Program: 2021 (https://mectizan.org/how/application-process/#,
accessed 18 March 2022).
4. Guide for donations of Mectizan to accelerate the elimination of lymphatic filariasis in countries
where onchocerciasis is not co-endemic [version 1]. Decatur (GA): Mectizan® Donation Program;
2017 (https://mectizan.org/wp-content/uploads/2018/07/Guide-Mectizan-Application-for-IDA-
countries_V1.pdf, accessed 18 March 2022).
5. Report of the Third Meeting of the WHO Alliance for the Global Elimination of Trachoma,
Ouarzazate, Morocco, 19–20 October 1998 Geneva, World Health Organization, 1999
(available at https://apps.who.int/iris/bitstream/handle/10665/65933/WHO_PBD_
GET_99.3.pdf, accessed 18 March 2022).
6. Francis V, Turner V, WHO Programme for the Prevention of Blindness. Achieving community support for
trachoma control: a guide for district health work. Geneva: World Health Organization; 1995 (https://
apps.who.int/iris/bitstream/handle/10665/59567/WHO_PBL_93.36.pdf, accessed 18 March
2022).
7. Expanded Special Project for Elimination of Neglected Tropical Diseases. In: WHO/ESPEN [web
portal]. Brazzaville: WHO Regional Office for Africa; 2021 (https://espen.afro.who.int/, accessed
18 March 2022).

■ ■ ■ ■ ■ ■ 17 ■ ■ ■
■ ■ ■ ■ 18 ■ ■ ■ ■ ■ ■ ■
2. Shipping notification and
green light

2.1 Purpose and scope of this standard operating procedure


The shipping notification and green light procedure, together with the list of key contacts,
is the first step in the country receiving the donated medicines and is a critical aspect of
supply chain management.
This procedure describes the process pertaining to notification by the donor of the
shipment of medicines into the country, from the donor’s production plant or warehouse
to the country’s port of entry or central medical store/warehouse. It outlines the contact
list required for all shipping documents and the “green light approval” for shipping the
medicines, which is only required by some countries. An example of a green light country is
one that requires an import permit, container inspection or additional lead-time to prepare
for the shipment. For an example flow chart of the process, see Fig. 2.1.

2.2 Key considerations


Preparation before a shipment arrives reduces the time for delivering the medicines to the
central medical store/warehouse. The availability of the in-country cleared document(s)
when the shipment arrives facilitates customs clearance; space and personnel to offload
the shipment are also essential for timely receipt of the medicines at the central medical
store/warehouse. See Chapter 3 for additional information.
This procedure should be followed in order to:
■ streamline the timeline for transportation by delivering medicines to the country’s port
of entry or central medical store/warehouse to ensure timely distribution of medicines
for MDA;
■ prevent overstock at the central medical store/warehouse;
■ prevent delay due to insufficient staff availability for offloading medicines arriving at the
central medical store/warehouse;
■ decrease cost due to delays for both the donor and the country (see glossary (Annex
1) for definition of terms):

■ ■ ■ ■ ■ ■ 19 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ ocean freight – demurrage shipping line/port storage and demurrage charges/


detention shipping line/detention inland carrier (using sea freight versus ocean freight).
air freight – airport storage charges/detention inland carrier.

(Example for donor cost due to delays for both ocean and air (storage charges
before departure).

The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.
Planning. A successful green light process for shipping donated medicines to recipient
countries includes the following factors.
Distribution plan
■ A distribution plan defines the timing for the donor to start the shipping process,
according to the planned month of MDA. The national programme coordinator or WHO
must communicate the expected time for delivery of medicines in the country, taking
into account the time it takes to clear and transport medicines to communities.
Budget
■ Funding to clear shipments from customs and secure truck rental for transportation
to the central medical store and any fees associated with the freight, if not already
accessible, through existing WHO or government medical supply systems.
■ Example: Funding must be allocated for clearing, transporting and storing donated
azithromycin, which does not fall under the WHO supply chain mechanism.

Fig. 2.1. Flow chart of the process

Provide shipping Receive answers for


START notification and green each question on
light request green light checklist

Proceed with Is the answer Access the


the shipment and request “Yes” to all answers that are “No” before
shipping documents questions? proceeding with
shipment

Request shipping
Book flight and issue
Final green light Lead time − waiver document including
airway bill
draft airway bill

Flight departure END

Source: International Trachoma Initiative

■ ■ ■ ■ 20 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light

Responsible authority
Identify who decides on import permits for medicines or duty-free waivers, especially

when medicines will be arriving in the country at different times. Verify that the noted
authority has the power to prioritize.
Identify the signature authority at the finance ministry, health ministry, pharmaceutical

authority, customs bureau and any others.


Security
Some medicines have a high value for other needs (livestock, other target audiences);

ensuring that they can be safely stored at the customs warehouse and during
transportation and storage at the central medical store/warehouse without damage or
theft is crucial to conducting MDA with good coverage and achieving elimination and
control goals. Safety of medicines must be ensured at all levels, from receipt into the
country to the community.
Documentation
Identify in advance all the administrative procedures for receiving and clearing the

donated medicines.
Inform the donor in advance about country requirements and needed documentation.

Ensure systems are in place to monitor the shipping process at every step – correctly

verified and completed documents should accompany the shipment.


Environmental conditions
Medicines transported from the customs warehouse to the central medical store in

unpredictable weather (e.g. warm or dry season versus wet season). It is essential to
ensure that the transport mechanisms used are adequate to preserve stocks from
damage or deterioration and to ensure their arrival in a condition that is considered
intact and undamaged.

■ ■ ■ ■ ■ ■ 21 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

2.3 Standard operating procedure


2.3.1 Shipping notification

When Who What How


■ Prompted by order ■ National NTD ■ Notification 1. Donor provides
receipt; may include programme, donor, of shipment shipping notification
multiple shipments WHO, national transportation and to WHO/national
per year. programme steps taken to programme.
■ Takes into coordinator, supply streamline its receipt. coordinator and
consideration planned chain manager of ■ Allows countries to Consignee.
MDA dates, lead-time, central medical store/ prepare for receipt of 2. WHO/national
transit, customs warehouse. medicines in-country. programme
clearance, in-country ■ Donor initiates the ■ Donor initiates process coordinator confirms
transportation and shipping notification by email to the contact list.
time for dispatching to countries including Consignee stating 3. WHO/national
medicines to last NTD programme that the shipment is programme
miles. of health ministry, packed. coordinator provides
donor, WHO, green light to proceed
national programme ■ Consignee must
confirm that the with booking.
coordinator and
supply chain manager shipment can proceed
of central medical to booking.
store/warehouse.

Task Instruction Responsibility References


1 Provide shipping notification to ■ Donors send ■ Refer to country contact list (health
countries. email notification ministry, national programme
1.1. Provide the shipping notifica- to recipient coordinator/WHO)
tion in the timeline indicated countries, Refer to country application for
by the NTD programme of health ministry, donated medicines for:
health ministry. WHO/national
programme - lymphatic filariasis, schistosomiasis,
coordinator to soil-transmitted helminthiases and
inform them about onchocerciasis (1);
the upcoming - trachoma (2)
shipment of
medicines.

■ ■ ■ ■ 22 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light

Task Instruction Responsibility References


2 Prepare for shipment departure ■ Donor emails Provide shipping notification to coun-
from production sites/logistics national tries.
centre. programme ■ Pre-alert/final documents
2.1. Prepare the shipment. coordinator/WHO
informing them - Limited shipping documents
2.2. Plan and execute the book- of the impending available and shipment booked or
ing. shipment in in the process of being booked.
the shipping ■ Shipping notification
notification email
- Limited shipping documents
with detailed
available and shipment in the
information on
process of being booked.
quantities.
■ Shipping advice
- All shipping documents provided,
and shipment booked..
■ Other
- Refer to shipping documents
provided by donor, which may
include:
1. Invoices
2. Bill of lading or airway bill (if
available)
3. Bill of lading (available after ship
sails from the port of origin
4. Packing list
5. Certificate of origin
6. Certificate of analysis
7. Certificate for exemption of customs
duties (WHO)
8. Certificate of donation
3 Prepare for shipment arrival. ■ WHO/national ■ WHO/national programme
programme coordinator to verify with donor if
coordinator timelines are appropriate for both
■ Supply chain ocean and air shipments.
manager of the ■ WHO/national programme
central medical coordinator to ensure paperwork
store/warehouse is ready to receive and clear the
shipment from customs.
■ Supply chain manager to ensure
central medical store has planned the
arrival of the shipment and made all
resources available: trucks, labour to
unload trucks, storage space.

■ ■ ■ ■ ■ ■ 23 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


4 Request of the tax-and-duty-free ■ WHO/national
waivers. programme
WHO/national programme coordinator
coordinator requesting additional ■ [Country to outline
unessential documents can delay prerequisites
receipt of the shipment. Docu- for obtaining all
ments outside of the standard administrative
shipping package may need 3 documents for
months to generate. clearing the
Providing the donor with the shipment.]
information on the country-specif- ■ Health ministry/
ic requirements and their timeline national
in advance can help them better programme
coordinate the shipment arriving coordinator/WHO
after the receipt of the in-country to determine
clearance document(s). Pre- the timeline for
venting the shipment from being obtaining each
delayed in clearance is vital for document and
timely delivery. resources to be
4.1. WHO/national programme allocated.
coordinator request the
creation of the tax-and-duty-
free waivers from the finance
ministry or other appropriate
government body.
4.2. [This section should clearly
list below the country’s doc-
umentation requirement(s)
for the clearance of the
medicines through customs
and the process for obtaining
them.]
Examples may include:
- Approval from the finance
ministry.
- Health ministry stamped copies
of original shipping documents
provided by the donor:
- invoices
- packing list
- certificate of origin
- certificate of donation
- certificate of analysis
5 Notify supply chain manager ■ NTD logistics
Include in the notification: officer
■ amount of treatments; ■ WHO/national
■ shipment size (volume, number programme
of pallets and boxes); coordinator

■ anticipated date of shipment in ■ Central medical


the port; and store supply chain
experts can be
■ expected date and time of vital in identifying
delivery to the central medical bottlenecks within
store. the donation
supply chain.
Use of their
knowledge is key
when updating
this standard
operating
procedure.

■ ■ ■ ■ 24 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light

Task Instruction Responsibility References


6 Prepare central medical store/ ■ Supply chain ■ See Chapter 5: Inventory
warehouse: manager to Management
6.1. Verify storage capacity. prepare central ■ See Chapter 6: Storage
medical store/
6.2. Coordinate personnel for warehouse for ■ Substantial charges from the inland
reception of shipment. the receipt of the carrier can occur if space is not
medicines. available for the medicines when they
arrive.
■ Steps for verifying
space will be ■ Tracking is available for selected
available for the medicines:
shipment when it - Country summary online view (3)
arrives.
- Country page subscription form (4)
Steps for
- Country Zithromax® tracking (5)

coordinating
personnel to
offload shipment.
Paid labourers
or current staff,
rented equipment
of offloading,
other.

2.3.2 Contact list

When Who What How


Prompted by order ■ NTD programme of The contact list is the Before each shipment,
receipt; may include mul- health ministry first step in getting things donor will request
tiple shipments per year. set up with the donor’s updated contact
Donor
shipping service and information.

Updated contact list


WHO, national getting the pro forma
to be provided by Donor sends the first

programme

health ministry/national invoice.


draft of the contact
programme coordinator/ coordinator
■ Donor provides NTD list to the recipient
WHO to donor before ■ Supply chain manager programme of health country for updates.
shipment is packed. of the central medical ministry, WHO,
National programme
store/warehouse.

national programme
coordinators use
coordinator with a
the draft contact list
draft list of contacts
to update the list of
based on the previous
people to be informed
delivery to which they
about the upcoming
are invited to make
shipment.
changes or make
additions, if necessary. ■ Clear correspondence
on the date of
This process allows
feedback is essential

the recipient country


to prevent the need for
to provide the list of
constant email request
people to be informed
for updates.
about the evolution
or the routing of the See Chapter 3: Customs
shipment. clearance and delivery
■ WHO/national
programme
coordinator provides
the up-to-date
contact list to ship the
medicines.

■ ■ ■ ■ ■ ■ 25 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


1 Donor sends first draft of contact list for updat- ■ WHO/national ■ Initial contact list
ing. programme is drafted based
1.1. In the initial email announcing the shipment, coordinator to on the contact
donor requests WHO/national programme update contact list from previous
coordinator to update the contact list list and return shipments (see
updated file to template in
donor to initiate Annex 2)
the order.
■ This process
allows the
recipient country
to provide the list
of people to be
informed about
the evolution or
the routing of the
shipment.

2 WHO/national programme coordinator receives ■ WHO/national ■ WHO/national


and updates the contact list. programme programme
coordinator coordinator to use
to ensure all the contact list
stakeholder received from the
contacts are donor for updates.
included and up
to-date.
■ WHO/national
programme
coordinator
receives the
contact list of
the impending
shipment
and takes the
appropriate
actions to provide
the approval.
3 WHO/national programme coordinator responds ■ WHO/national ■ WHO/national
to the contact list request. programme programme
3.1. WHO/national programme coordinator emails coordinator coordinator
the updated contact list back to the donor.. to ensure the to contact all
accuracy of stakeholders to
the contact update contacts
information before that should be
submitting to the informed about
donor. the shipment.
■ WHO/national ■ The contact list
programme may include the
coordinator following:
to respond to 1. Donee of record
the contact list
request within 2. Consignee
2 weeks of its (organization or
receipt. person to whom
the product is
■ If for some reason officially sent or
WHO/ national delivered)
programme
coordinator 3. Consign to/
cannot return delivery to
the updated 4. National
contact list, they programme
will explain the coordinator
reasons for the 5. Importer of record
delay and provide
anticipated date 6. Routing/notify
of approval.

■ ■ ■ ■ 26 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light

Task Instruction Responsibility References


7. Point of contact
at the “deliver to”
address (physical
address to which
the shipment
should be
delivered)
8. Person
responsible
for customs
clearance
9. Anyone else who
should be notified
of the upcoming
shipment

2.3.3 Green light

When Who What How


Prompted by order ■ NTD programme ■ Consignee, WHO/ ■ This process allows
receipt; may include mul- of health ministry, national programme the recipient country
tiple shipments per year. donor, WHO, coordinator provides to provide the required
The green light checklist national programme the approval to ship documents, inspection
may be sent to the Con- coordinator, supply the medicines to the or other action to
signee/WHO/national chain manager of the donor, called a “green receive the medicines
programme coordinator central medical store/ light”. in the country.
by donor before starting warehouse.
the order process and ■ Donor requests
before booking freight.
green light from
The green light request Consignee, NTD
may be requested by the programme of health
donor at the same time ministry, or WHO/
as sending the shipping national programme
notification, and the coordinator.
contact list request.
National programme
coordinator/WHO to pro-
vide green light before
donor proceeds booking
freight.

■ ■ ■ ■ ■ ■ 27 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


4 Assess the green light requirement. ■ NTD drug ■ For lymphatic
4.1. NTD drug application programmes assess the application filariasis,
requirement of a green light based on their programmes, schistosomiasis
programme guidelines. WHO/national and soil-
programme transmitted
4.2. National programme coordinators should email coordinator. helminthiases,
the Director of the Mectizan® Donation Pro- contact WHO:
gram ([email protected]) to request PC_JointForms@
additional information of the requirements of a who.int
green light for their country.
■ For
onchocerciasis,
contact the
Mectizan®
Donation Program
Director (currently
Dr Yao Sodahlon:
ysodahlon@
taskforce.org)
or mectizan@
mectizan.org
■ For trachoma,
contact the
International
Trachoma
Initiative: www.
trachoma.org/
contact-us
5 Green light request. ■ NTD drug ■ See action items
5.1. Donor emails the green light request to WHO/ application and greenlight
national programme coordinator. The notifica- programmes, checklist in Annex
tion can include the following documents: WHO/national 3: the national
programme programme
1. Invoices coordinator coordinator/
2. Draft airway bill* (if available) ■ A green light is WHO/ consignee
3. Packing list a confirmation must answer
message from “YES” to all
4. Certificate of origin questions before
the national
5. Certificate of analysis programme giving green light.
6. Certificate for exemption of customs duties coordinator/
(WHO) WHO to the
7. Certificate of donation donor stating that
the country is
ready to receive
* The bill of lading is not available until after the ship leaves the port the shipment of
of origin. medicines. WHO
or the national
programme
coordinator
must confirm
the needed
preparations have
been completed
before sending a
green light note.
■ Health ministry/
national
programme
coordinator/WHO
to assign staff
responsible for
assessing each of
the five questions
on the green light
checklist.

■ ■ ■ ■ 28 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light

Task Instruction Responsibility References


6 Freight booking.
6.1. Donor books shipment and places it on a
transport (air or sea).
6.2. Issuing shipping documents.
6.3. Donor couriers shipping documents to nation-
al programme coordinator/WHO.

References
1. Joint Application Package – planning, requesting medicines and reporting. In: WHO/Neglected
tropical diseases [website]. Geneva: World Health Organization; 2021 (https://www.who.int/
teams/control-of-neglected-tropical-diseases/preventive-chemotherapy/joint-application-
package, accessed 18 March 2022).
2. The International Trachoma Initiative manages Pfizer’s donation of the antibiotic needed to treat
trachoma. In: International Trachoma Initiative [website]. Decatur (GA): International Trachoma
Initiative; 2021 (https://www.trachoma.org/fighting-trachoma-zithromax, accessed 18 March
2022).
3. Country summary [online view]. In: NTDeliver Supply Chain Information System [website].
(https://www.ntdeliver.com/country, accessed 18 March 2022).
4. Country page subscription form. In: NTDeliver Supply Chain Information System [website].
(https://www.ntdeliver.com/subscribers/new, accessed 18 March 2022).
5. Country Zithromax® tracking. In: GET2020 [online database]. Decatur (GA): International
Trachoma Initiative; 2021 (https://www.trachomadata.org/supply-chain/subscription, accessed
18 March 2022).

■ ■ ■ ■ ■ ■ 29 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ ■ ■ ■ 30 ■ ■ ■ ■ ■ ■ ■
3. Customs clearance and
delivery

3.1 Purpose and scope of this standard operating procedure


Customs clearance and delivery are the final steps in receiving medicines into the country.
This procedure outlines the key processes for the donors and recipients of the medicines.
Customs clearance is the first process. It involves releasing the medicines from the point
of entry to the recipient.
Delivery is the second process. It involves moving the medicines from the point (after their
release) to the central medical store/warehouse. This procedure should be followed in
order to:
■ streamline the transport of medicines, from the donor’s factory or production
warehouse to the country’s central medical store, to enable timely MDA;
■ avoid delays due to lack of staff availability for offloading medicines delivered to the
central medical store; and
■ reduce costs to the donor and the recipient country, including:
■ sea freight costs: shipping company container rental, port storage and demurrage
charges as well as the costs of holding by the shipping company or by the
continental carrier, and
■ air freight costs: airport storage and detention costs by the continental carrier.

3.2 Key considerations


■ The positions identified, their roles and the steps to be taken in this procedure are
illustrative and should be adjusted according to the prevailing context in each country.
■ For landlocked countries, maritime cargoes may require clearance at both the seaport
and the land border. Factor in the additional time required for multiple clearance.

■ ■ ■ ■ ■ ■ 31 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

3.3 Standard operating procedure


3.3.1 Shipping notification

When Who What How


Before the shipment of ■ WHO ■ WHO/national 1. WHO/national
medicines arrives at the ■ National programme programme programme
port/border; typically as coordinator provides coordinator should
coordinator
soon as the pharmaceu- the country-required initiate the process of
tical donor has initiated ■ Donor freight documentationa obtaining the required
the shipment (weeks to forwarder or WHO/ to the donor’s or documentation
months ahead of arrival, national programme WHO’s forwarder for as soon all the
depending on shipment coordinator freight the clearance of the documents necessary
mode). forwarder (the medicines for the shipment from
“forwarder”) the pharmaceutical
a
The procedure for obtaining the
■ Supply chain manager required documentation for clear- donor are received
of the central medical ance of medicines in a country is and should identify
described in Chapter 2 Shipping
store or warehouse notification and green light. and gather the
required documents,
signatures and
approvals in the
country.

Task Instruction Responsibility References


1 WHO/national programme coordinator provides ■ WHO See Chapter 2:
the required country documentation* to the do- ■ National Shipping notification
nor’s or WHO’s forwarder for the clearance of the programme and green light
medicines. coordinator
1.1. Identify the document requirements for your
Forwarder
country, which may include:

- tax exemption waiver


- import permits
- medicine distribution plan
- marketing authorization
- approval from the federal finance ministry
- Health ministry stamped copies of docu-
ments such as invoice, packing list, ship-
ping slip, certificate of origin, certificate of
donation or certificate of analysis.
1.2. Forwarder may also approach customs
services to confirm required documentation
and enquire about additional requirements or
process changes in the country.
- tax exemption waiver
- import permits.
2 Documents, in particular tax exemption waivers
and import permits, may be required from different
channels, depending on the contents and value of
the cargo. It is important to know the appropriate
channel(s) for your country ahead of time to avoid
clearance delays while pursuing approvals.

■ ■ ■ ■ 32 ■ ■ ■ ■ ■ ■ ■
Customs clearance and delivery

3.3.2 When the cargo arrives at the point of entry or border

When Who What How


Upon arrival, and within ■ WHO ■ Customs clearance is 1. Inform all relevant
2 days to 2 weeks after ■ National programme carried out parties
arrival
coordinator 2. Set timetable
■ Forwarder 3. Submit required
■ Supply chain manager signed/sealed
or designee documents

Task Instruction Responsibility References


1 Forwarder informs the relevant parties of the ■ Forwarder See Chapter 2:
shipment’s arrival. ■ WHO Shipping notification
1.1. Forwarder informs WHO/national programme and green light
National
coordinator of the shipment’s arrival and

programme
provides a forecast timetable for customs
coordinator
clearance and delivery to the central medical
store by email or telephone.
1.2. WHO/national programme coordinator pro-
vides the above information to the supply chain
manager, central medical store operations
manager or NTD programme pharmacist, as
designated in the country.
2 Forwarder completes customs clearance. ■ Forwarder See Chapter
2.1. Forwarder ensures all required documents are ■ Supply chain 5: Inventory
submitted, with appropriate signatures/seals manager or management
as required by the customs regulations. designee
2.2. Forwarder communicates the arrival time at
the central medical store to WHO/national
programme coordinator and supply chain
manager or designee.
2.3. Supply chain manager or designee verifies to
the NTD programme pharmacist, and WHO/
national programme coordinator, that the
necessary space is available at the central
medical store and that staff will be available to
offload the cargo upon arrival.

■ ■ ■ ■ ■ ■ 33 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

3.3.3 After customs clearance: delivery to the central medical store/


warehouse

When Who What How


After the cargo clears ■ Forwarder ■ The medicines are 1. Provide clear
customs ■ Supply chain manager delivered to the central guidelines for the
or designee depot or warehouse delivery of medicines
and received to the central medical
store/warehouse.
2. Ensure clear
processes are in place
for the receipt and
confirmation of the
medicines.

Task Instruction Responsibility References


1 Supply chain manager or designee provides ■ Forwarder See Chapter 4:
clear instructions for the delivery of the medi- ■ Supply chain Transport
cines to the central medical store/warehouse manager or
1.1. Forwarder clears the cargo and informs WHO designee
and national programme coordinator of the
Central medical
planned arrival time at the central medical

store/warehouse
store/warehouse.
manager
1.2. Supply chain manager or designee provides
the forwarder with the central medical store/
warehouse details, including the exact route
and instructions on the offloading process:
- Forwarder transports the cargo to the
central medical store/warehouse.
- Central medical store/warehouse manag-
er receives the medicines and supervises
the offloading.
- Central medical store/warehouse manag-
er oversees the transfer of the medicines
to facility pallets and shelves.
- This section should contain the complete
process of offloading each medicine; sol-
id, chewable, powder or liquid formulations
may require different processes.
2 Supply chain manager or designee prepares the ■ Supply chain See Chapter
depot or warehouse to receive the medicines. manager or 5: Inventory
2.1. Central medical store/warehouse manager designee Management
confirms there is sufficient space for the new ■ Central medical See Chapter 6:
cargo and personnel to handle the offloading store/warehouse Storage
and storage. manager See Chapter 7: First
expiry first out

3 Medicines are delivered to the central medical ■ Forwarder See Chapter 4:


store/warehouse ■ Supply chain Transport
3.1. Forwarder transports the cargo to the central manager or
medical store/warehouse in its original con- designee
tainer.
■ National
3.2. Supply chain manager or designee provides programme
personnel to offload trucks into the central coordinator
medical store/warehouse.

■ ■ ■ ■ 34 ■ ■ ■ ■ ■ ■ ■
Customs clearance and delivery

Task Instruction Responsibility References


3.3. Supply chain manager or designee checks
to verify that the seal on the container is not
broken. If the seal is broken:
- ask the driver to write down the broken
seal on the delivery voucher; and
- when possible, take a picture of the broken
seal so that there is a time stamp and to
create visual proof.
- A broken seal may indicate that some
medicines have been removed from
the cargo.
4 Delivery is received and confirmed. ■ Forwarder
4.1. Supply chain manager or designee conducts a ■ Supply chain
physical inventory of all the medicines received manager or
and confirms that all pallets and boxes are designee
present and in good condition, in accordance
National
with the shipping documents. If medicines are

programme
not in good condition, or if they are missing,
coordinator
complete the following:
- If pallets are damaged, open all damaged
boxes on the pallet and verify medicines
are in good condition. Good condition
would include that the bottles are not dam-
aged, and seals on bottles not broken.
- Report on the delivery note any unus-
able medicines due to damage and
keep a copy of the record.
- If possible, take pictures of all dam-
aged goods so that there is a time
stamp and visual proof of the damage.
- If pallets are missing, have the driver note
any missing pallets and the batch or lot
number of medicine(s) associated with
that pallet on the proof of delivery form..
- The shipping slip (packing list) and in-
voice contain the lot or batch number.
• If possible, take pictures of each
received pallet to help confirm the
missing pallet(s).
• Report the damaged or missing medi-
cines to the forwarder and request that
they file a formal report.
4.2. The national programme coordinator is
responsible for requesting replacement med-
icines per the requirements of the NTD drug
application.
4.3. The central medical store manager prepares
and submits official reports to the supplier
within 10 days.
4.4. Supply chain manager or designee signs the
delivery order from the forwarder and ensures
that the driver signs the central medical store
supervisor’s copy of the delivery order.
4.5. The copy of the proof of delivery form provided
to the supply chain manager must be clear
and readable. A legible copy of this document
will allow the country to receive a replacement
cargo for missing or damaged medicines.
4.6. Forwarder provides the delivery to the donor
and WHO/national programme coordinator.

■ ■ ■ ■ ■ ■ 35 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

3.4 Supplementary information


The NTD Supply Chain Forum developed NTDeliver (www.ntdeliver.com), an online
supply chain information portal which centralizes information from a variety of sources to
improve the monitoring and evaluation of the supply chain for donated medicines. The
goal of NTDeliver is to increase the visibility of the NTD supply chain from the issuance of
orders to the delivery of shipments. With this knowledge, countries and partners can better
coordinate their internal supply chains.
To enhance timely access to information, recipient countries can track available shipments
through:
■ country summaries (1), which allow tracking of many of NTD medicines shipments in
real-time and is accessible on a computer, smartphone or tablet; and
■ a country page subscription form (2), which allows subscribers to select a country that
they would like to receive email notifications. Also, NTDeliver provides a weekly update
to the subscriber.
Shipments available for tracking include those for:
■ lymphatic filariasis
■ albendazole donated by GlaxoSmithKline through WHO
■ diethylcarbamazine citrate donated by Eisai through WHO
■ schistosomiasis
■ praziquantel donated by Merck KGaA through WHO
■ soil-transmitted helminthiases
■ albendazole donated by GlaxoSmithKline through WHO
■ mebendazole donated by Johnson & Johnson through WHO
■ trachoma
■ azithromycin donated by Pfizer through the International Trachoma Initiative.
Ivermectin is not tracked through NTDeliver. Please refer to the Mectizan® Donation
Program (https://mectizan.org/).

References
1. Country summary [online view]. In: NTDeliver Supply Chain Information System [website].
(https://www.ntdeliver.com/country, accessed 18 March 2022).
2. Country page subscription form. In: NTDeliver Supply Chain Information System [website].
(https://www.ntdeliver.com/subscribers/new, accessed 18 March 2022).

■ ■ ■ ■ 36 ■ ■ ■ ■ ■ ■ ■
4. Transport

4.1 Purpose and scope of this standard operating procedure


This standard operating procedure covers the transport of medicines from central medical
stores to regions/states/provinces, or from regions to district-level distribution points. The
key steps are illustrated in Fig. 4.1.
Transporting medicines from customs clearance to distribution points involves many
steps and time, usually by road, but in some countries also by plane. Ensuring that the
correct medicines in their correct quantities reach each post requires careful planning and
processes; recovering excess medicines from one location to meet the needs in another
location, perhaps across the country, can be very costly and significantly delay scheduling
of MDA. It is essential to know ahead of time where the medicines are needed, and how
much are needed and when they are needed, well ahead of the date of transport.

4.2 Key considerations


Planning. Successful transfer of medicines includes the following significant factors.
Distribution plan
■ A distribution plan that defines the circuit and stages of distribution from the central to
district level.
Budget
■ Funding to secure truck rental, drivers’ per diems or security, if not already accessible,
through existing government medical supply systems.
■ Example: The national NTD control programme allocates funding to the national
supply pharmacy for medicines at regional supply pharmacies. At the regional
level, a transport line is allocated to districts for removal and routing at service
delivery points.

■ ■ ■ ■ ■ ■ 37 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Responsible authority
■ Identify who decides which regions or districts receive which medicines, especially
when they will be arriving in-country at different times. Verify that the noted authority
has the power to prioritize.
■ Identify the signature authority at the receiving end.
Security
■ Some medicines have a high value for other needs (livestock, other target audiences);
ensuring that they can be safely transported without damage or theft is crucial to
conducting MDA with good coverage and achieving elimination and control goals.
Safety of medicines must be ensured at all levels, from receipt into the country to the
community.
Documentation
■ Tracking of electronic stock-keeping units is highly valuable for supply chain
management from central to district levels; however, paper-based systems are
adequate if managed appropriately with detailed processes and signed forms returned
to their origin for filing (closing the loop).
■ Ensure the country has appropriate forms to document the transport process.
■ Ensure systems are in place to monitor stocks at every step; correctly filled out
documents should accompany the delivery at every stage.
Environmental conditions
■ Medicines travelling in unpredictable weather (e.g. warm or dry season versus
wet season) or on bad roads can be easily damaged. It is essential to ensure that
the transport mechanisms used are adequate to preserve stocks from damage
or deterioration and to ensure their arrival in a condition that is considered intact or
undamaged. For further information, see Chapter 9 for clarification.

■ ■ ■ ■ 38 ■ ■ ■ ■ ■ ■ ■
Transport

Fig 4.1. Key steps transporting medicines

Source: reproduced with permission from Management Sciences for Health [Figure 25-3: Transporting pharmaceuticals safely. In: MDS3: Managing
access to medicines and health technologies. Arlington (VA): Management Sciences for Health; 2012 (https://www.msh.org/resources/mds-3-
managing-access-to-medicines-and-health-technologies)].

■ ■ ■ ■ ■ ■ 39 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

4.3 Standard operating procedure


The procedure has two stages: transport from central level to regions/states/provinces
(3.4.1) and transport from regions to districts (3.4.2). Use of these steps for development
of standard operating procedures can be independent or combined depending on the
supply chain’s specific need. The timeframe for transport planning is usually 2–4 weeks
before the MDA. An example transportation flow diagram is provided in Fig. 4.2. The
positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.

Fig 4.2. Example transportation flow diagram

Central
warehouse

Regional Regional Regional


medical store medical store medical store

District District District District District

Note: If no regional medical store exists the flow would go directly to the districts.

■ ■ ■ ■ 40 ■ ■ ■ ■ ■ ■ ■
Transport

4.3.1 Transport from central level to regions/states/provinces(or to districts


if no regional facility)

When Who What How


Upon request of regional ■ WHO/Consignee ■ To transport donated/ 1. Prepare for transport
level (usually 2–4 weeks ■ NTD programme procured drug shipment from central
ahead of MDA) materials from central level
■ Implementing partners to regional sites
After MDA if stocks are (if supporting costs) 2. Assemble cartons/
returned to central level ■ To allocate and boxes for each
■ Central pharmacy disseminate correct regional medical store
■ Central medical stores amounts of medicines 3. Prepare issue/
■ State medical store to regional/district receiving voucher for
level distribution points each regional medical
■ Regional medical
stores store and waybills for
total cartons for each
■ Drivers destination
■ Truck loaders/ 4. Inspect/count sealed/
unloaders complete cartons and
Level of authority count the number of
required bottles in the open
■ Signature authority
cartons
to assign specific 5. Load trucks
quantities of 6. Unload trucks
medicines to regions
7. Regional medical
■ Signature authority to store receipt of
remove medicines, shipment(s) and
either to release them documentation
to field sites or for
destruction 8. Delivery confirmation.

Task Instruction Responsibility References


1 Prepare for shipment transport from central ■ Central medical See Chapter 6:
level. store’s point Storage
1.1. Liaise with the NTD programme and regularly of contact in See Chapter 11:
check when medicines are due at regional coordination with: Forecasting and
level(s) is accurate with the drug distribution ■ NTD quantification
schedule. programme
1.1.1. Have consignee and regional focal ■ WHO/
points’ contact information on hand. consignee
1.2. Confirm regional repository is aware of the ■ Implementing
planned delivery and that space is available. partners
1.2.1. Identify calendar restrictions for deliv- ■ District health
ery (e.g. deliveries not accepted on office’s point of
weekends). contact
1.3. Create a quantity and distribution schedule ■ Regional
in coordination with the NTDP to ensure safe, medical store’s
efficient transport; share with the regional point of contact
medical store.
■ Drivers
1.3.1. This should include approximate travel
times for each regional medical store ■ Truck loaders/
delivery, factoring in appropriate rest unloaders
stops, avoidance of night driving and
poor road conditions.

■ ■ ■ ■ ■ ■ 41 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


1.4. Obtain necessary approval from the district
NTD coordinator or district health office for the
distribution plan, transportation budget and
secure funding.
1.4.1. Consider providing drivers with mobile
airtime for reporting incidents en route;
if drivers do not have mobile phones,
consider providing a temporary phone
with camera.
1.4.2. Ensure driver is paid to return signed
forms to central medical store or state
medical store for confirmation of deliv-
ery.
1.5. Ensure transport vehicles meet acceptable
standards for transfer of medicines (e.g.
working condition, appropriate cover from
weather).
1.6. Determine the total number of cartons/boxes
to be delivered to each regional medical store
and prepare waybills.
1.7. Ensure vouchers are prepared for each region-
al medical store designee.
1.8. Ensure that transport to regional medical store
is arranged for the necessary date(s). E.g.,
if trucks are not available for use by central
medical , how will transport be provided?
1.9. Central medical store to notify regional med-
ical store that the truck is being prepared for
transport in advance.
1.9.1. Ensure staff are available to load/un-
load truck(s).
1.10.Prepare for transport security from theft,
weather or other risks.
1.11. Identify/confirm who will have access to the
stock during transport (if locked in truck)
2 Assemble cartons/boxes for each regional ■ Central medical See Chapter 7: First
medical store. store’s point expiry first out
2.1. Reassemble cartons with stock based on of contact in See Chapter 10:
quantity needs identified in distribution coordination with: Waste management
schedule. ■ Regional
2.2. Fill voids in cartons with packing material to medical store’s
avoid damage. point of contact
2.3. If feasible, label each carton by destination ■ District health
of regional medical store for secondary office’s point of
verification. contact
2.4. Ensure oldest and previously opened stock is
included first (per the “FEFO” method).
2.5. Any damaged/expired stock should be docu-
mented and removed.
3 Prepare issue/receiving voucher for each ■ Regional medical
regional medical store and waybills for total store’s point
cartons for each destination. of contact in
3.1. Mark clearly how many bottles of each med- coordination with:
icine type are going to each regional medical ■ Central
store. If possible, also include the distribution medical store’s
posts earmarked by each carton. point of contact
■ Driver

■ ■ ■ ■ 42 ■ ■ ■ ■ ■ ■ ■
Transport

Task Instruction Responsibility References


4 Inspect/count sealed/complete cartons and ■ Regional See Chapter
count the number of bottles in the open cartons. medical store in 5: Inventory
4.1. Ensure tally sheets or other appropriate inven- coordination with: management
tory management forms are in place before ■ Central
loading onto trucks. medical store’s
4.2. Central medical store and driver confirm point of contact
against prepared vouchers and waybills and ■ Drivers
sign both.

5 Load trucks. ■ Regional medical


5.1. Load trucks systematically, using store’s point
“first in, last out” procedure. of contact in
coordination with:
5.2. Use loading straps to prevent physical dam-
age. ■ Drivers
5.3. Secure vehicle doors against theft and weath- ■ Truck loaders
er. Confirm who has access.
5.4. Ensure routing provides sufficient time for rest,
safety (avoid driving at night, bad roads).
5.5. Any shipment delivery longer than 1 day should
be secured and visually inspected at every
overnight stop and each morning, with appro-
priate documentation.
6 Unload trucks. ■ Regional See Chapter 6:
6.1. Upon arrival, unload per the distribution sched- medical store in Storage
ule and first in last out policy. coordination with: See Chapter 10:
6.2. Driver to present voucher and waybill to ■ Drivers Waste management
recipient at each regional medical store driver, ■ Truck Unload
including title, name, signature and date (dd/
mm/yyyy).
6.3. Regional medical store point of contact to
inspect/count sealed and unsealed cartons
and sign prepared voucher and waybill.
6.4. Any damaged/expired stock should be docu-
mented and removed.
7 Regional medical store receipt of shipment(s) ■ Regional medical See Chapter 10:
and documentation. store’s point Waste management
7.1. If documentation is incomplete or missing, the of contact in
regional medical store should not accept the coordination with:
shipment; contact the central medical store ■ Central
point of contact for guidance. medical store’s
7.2. If documentation does not match quantities point of contact
received: ■ Drivers
7.2.1. Accept delivery and prepare a supply
discrepancy report to record the short-
age or excess received. Give a copy
to the driver to submit to the central
medical store point of contact.
7.3. In case of excess supply, return the excess
goods and invoice to driver, and request a new
invoice for quantity accepted.
7.4. Notify NTD programme point of contact and
district health office that quantities were
received.
7.5. Any damaged/expired stock should be docu-
mented and removed.

■ ■ ■ ■ ■ ■ 43 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


8 Delivery confirmation. ■ Regional
8.1. Driver to receive and file with central medical medical store in
store a copy of the signed receiving as a coordination with:
record of delivery and date (dd/mm/yyyy).. ■ NTD
programme
■ WHO/
consignee
■ Regional
medical store’s
point of contact
■ Drivers

4.3.2 Transport from regions to districts


(Including transport from districts after MDA to regional/central level for final storage or
destruction)

When Who What How


Upon request of district ■ WHO/consignee ■ To transport donated/ 4. Prepare for shipment
level (usually 2–4 weeks ■ NTD programme procured medicines transport from regional
ahead of MDA) and/or diagnostic or district level, or after
■ District health office materials MDA to long-term
After MDA or after
disease-specific ■ Implementing partners ■ To allocate and storage and/or waste
assessment if stocks (if supporting costs) disseminate correct destruction
are returned to central/ ■ Regional medical store amounts of medicines 5. Assemble cartons/
regional level or for and/or diagnostics boxes for each
■ Drivers
destruction to district level distribution point
■ Truck loaders/ distribution points
unloaders 6. Prepare issue/
receiving voucher for
Level of authority each regional medical
required store for total cartons
■ Signature authority for each destination
to assign specific 7. Inspect and count
quantities of sealed cartons/count
medicines to districts/ the number of bottles
distribution points in the open cartons
■ Signature authority to 8. Load trucks/unload
remove medicines, trucks
either to release
medicines to field sites 9. Temporary storage or
or for destruction destruction
10.District receipt of
shipment(s) and
documentation
11.Delivery confirmation.

■ ■ ■ ■ 44 ■ ■ ■ ■ ■ ■ ■
Transport

Task Instruction Responsibility References


1 Planning/coordination district to prepare for the ■ Regional medical See Chapter 6:
district depot. store/district Storage
1.1. 5 days before the start of the MDA, the district health office’s
health office must ensure the medicines are point of contact
implemented at the district level. coordinate with:
1.2. The NTD programme must ensure that the dis- ■ NTD
trict depot manager is informed of the planned community
delivery and that the depot has storage space. programme
1.3. The NTD programme must build on the MDA’s ■ Implementing
micro-planning to develop a district distribution partners
plan. ■ Drivers
1.4. The NTD programme must share the distribu- ■ Truck loaders/
tion plan with the district depot manager and unloaders
inform them about the timing of the transition.
1.5. Depot manager must establish the bill of lading
by district
1.5.1. This plan should include approximate
travel times for each district-level de-
livery, taking into account appropriate
downtime to rest, the need to avoid
night driving and the use of the usual
taxiways.
1.5.2. Obtain the necessary NTD programme
approval for the distribution plan and
transportation budget
2 Assemble cartons/boxes for each distribution ■ Regional medical See Chapter 7: First
point. store/district expiry first out
2.1. Reassemble cartons with stock based on health office’s See Chapter 10:
each district’s quantity needs, identified in the point of contact Waste management
distribution schedule. coordinate with: :
2.2. Fill voids in cartons with packing material to ■ NTD
avoid damage. community
programme
2.3. If feasible, label each carton by district destina-
tion for secondary verification.
2.4. Ensure oldest and previously opened stock is
included first.
2.5. Any damaged/expired stock should be docu-
mented and removed.
3 Prepare issue/receiving voucher for each ■ Regional medical
regional medical store for total cartons for each store/district
destination. health office’s
3.1. Clearly mark how many bottles of each medi- point of contact
cine type are going to each district. coordinate with:
■ NTD
community
programme
■ Drivers
4 Inspect/count sealed cartons and count the ■ Regional medical See Chapter 5:
number of bottles in the open cartons. store/district Inventory
4.1. Ensure tally sheets or other appropriate inven- health office’s management
tory management forms are in place before point of contact
loading onto trucks. coordinate with: :
4.2. Regional medical store and driver confirm ■ NTD
against prepared vouchers and waybills and community
sign both. programme
■ Drivers

■ ■ ■ ■ ■ ■ 45 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


5 Load trucks. ■ Regional medical
5.1. Load trucks systematically, using “first in, last store/district
out”. health office’s
point of contact
5.2. Using loading straps to prevent physical dam- coordinate with:
age.
■ NTD
5.3. Secure vehicle doors against theft and weath- community
er. Confirm who has access. programme
5.4. Ensure routing provides sufficient time for rest, ■ Drivers
safety (avoid driving at night, bad roads).
■ Truck loaders
5.5. Any shipment delivery taking longer than 1 day
should be secured and visually inspected at
every overnight stop and morning, with appro-
priate documentation.
6 Unload trucks and temporarily store or destroy. ■ District point See Chapter 6:
6.1. Upon arrival, unload per the distribution of contact in Storage
schedule and follow the first expiry, first out coordination with: See Chapter 7: First
approach. ■ Regional expiry first out
6.2. Driver to present voucher and waybill to recip- medical store’s See Chapter 10:
ient at each district level, including title, name, point of contact Waste management
signature and date (dd/mm/yyyy). ■ Drivers
6.3. District point of contact to inspect/count ■ Truck
sealed and unsealed cartons and sign pre- unloaders
pared voucher.
6.4. District level should have designated storage
for medicines until MDA.
6.5. Any damaged/expired stock should be docu-
mented and removed.
7 District receipt of shipment(s) and documen- ■ District point
tation. of contact in
7.1. If documentation is incomplete or missing, coordination with:
district level should not accept the shipment; ■ Regional
contact regional medical store point of contact medical store’s
for assistance. point of contact
7.2. If documentation does not match quantities ■ Drivers
received:
7.2.1. Accept delivery and prepare a supply
discrepancy report to record the short-
age or excess received. Give a copy
to the driver to submit to the regional
medical store point of contact.
7.3. In case of excess supply, return the excess
goods and invoice to driver, and request a new
invoice for quantity accepted.
7.4. Notify NTD community programme point of
contact and district health office that quantities
were received at district level.
8 Delivery confirmation. ■ District point
8.1. Driver to receive and file with regional medical of contact in
store a copy of the signed receiving as a coordination with:
record of delivery and date (dd/mm/yyyy). ■ Regional
medical store’s
point of contact
■ NTD
community
programme
■ Drivers

■ ■ ■ ■ 46 ■ ■ ■ ■ ■ ■ ■
Transport

4.3.3 Transport from districts to care delivery points


(Including transport from districts after MDA to regional/central level for final storage or
destruction)

When Who What How


Upon request of district ■ WHO/consignee ■ To transport donated/ 1. Prepare for shipment
level (usually 2–4 weeks ■ NTD community procured medicines transport from regional
ahead of MDA) programme and/or diagnostic or district level, or after
materials MDA to long-term
After MDA or after District health office
disease-specific

■ To allocate and storage and/or waste
assessment if stocks ■ Implementing partners disseminate correct destruction
are returned to central/ (if supporting costs) amounts of medicines 2. Assemble cartons/
regional level or for ■ Regional medical store and/or diagnostics boxes for each
destruction to district level distribution point
■ Drivers
distribution points 3. Prepare issue/
■ Truck loaders/
unloaders receiving voucher for
each regional medical
store for total cartons
Level of authority for each destination
required 4. Inspect and count
■ Signature authority sealed cartons/count
to assign specific the number of bottles
quantities of in the open cartons
medicines to districts/ 5. Load trucks/unload
distribution points trucks
■ Signature authority to 6. Temporary storage or
remove medicines, destruction
either to release them
to field sites or for 7. District receipt of
destruction shipment(s) and
documentation
8. Delivery confirmation .

Task Instruction Responsibility References


1 Prepare for shipment transport from regional or ■ Regional medical See Chapter 6:
district level, or after MDA for long-term storage store/district Storage
and/or waste destruction. health office’s See Chapter 11:
1.1. Have NTD community programme distribu- point of contact Forecasting and
tion point of contact and implementers’ (if coordinate with: quantification
required) contacts information on hand. ■ NTD
1.2. Liaise with the NTD community programme community
and regularly check when medicines are due programme
to distribution points level(s). ■ Implementing
1.3. Confirm district repository is aware of the partners
planned delivery and that space is available. ■ Drivers
1.4. Create a quantity and distribution schedule ■ Truck loaders/
in coordination with the NTD community unloaders
programme to ensure safe, efficient transport;
share with the regional medical store and the
district-level point of contact.
1.4.1. This should include approximate travel
times for each district level delivery,
factoring in appropriate rest stops,
avoidance of night driving and poor
road conditions.

■ ■ ■ ■ ■ ■ 47 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


1.5. Obtain necessary approval from the district
NTD coordinator or district health office for the
distribution plan and transportation budget.
1.5.1. Consider providing drivers with mobile
airtime for reporting incidents in route;
if drivers do not have mobile phones,
consider providing a temporary phone
with camera.
1.5.2. Ensure driver is paid to return signed
forms to regional medical store or state
medical store confirmation of delivery.
1.6. Ensure transport vehicles meet acceptable
standards for transfer of medicines (e.g.
working condition, appropriate cover from
weather).
1.7. Determine the total number of cartons/boxes
to be delivered to each distribution point.
1.8. Ensure vouchers are prepared for each district
level designee.
1.9. Ensure that transport to districts is arranged for
the necessary date(s). If trucks are not availa-
ble for use by regional medical store, how will
transport be provided?
1.10.Ensure staff are available to load/unload
truck(s).
1.11. Prepare for transport security from theft,
weather or other risks.
1.12.Identify/confirm who will have access to the
stock during transport (if locked in truck).
2 Assemble cartons/boxes for each distribution ■ Regional medical See Chapter 7: First
point. store/district expiry first out
2.1. Reassemble cartons with stock based on health office’s See Chapter 10:
each district’s quantity needs, identified in the point of contact Waste management
distribution schedule. coordinate with::
2.2. Fill voids in cartons with packing material to ■ NTD
avoid damage. community
programme
2.3. If feasible, label each carton by district desti-
nation for secondary verification.
2.4. Ensure oldest and previously opened stock is
included first.
2.5. Any damaged/expired stock should be docu-
mented and removed.
3 Prepare issue/receiving voucher for each ■ Regional medical
regional medical store for total cartons for each store/district
destination. health office’s
3.1. Mark clearly how many bottles of each medi- point of contact
cine type are going to each district.. coordinate with:
■ NTD
community
programme
■ Drivers
4 Inspect/count sealed cartons and count the ■ Regional medical See Chapter 5:
number of bottles in the open cartons store/district Inventory
4.1. Ensure tally sheets or other appropriate inven- health office’s management
tory management forms are in place before point of contact
loading onto trucks. coordinate with: :
4.2. Regional medical store and driver confirm ■ NTD
against prepared vouchers and waybills and community
sign both. programme
■ Drivers

■ ■ ■ ■ 48 ■ ■ ■ ■ ■ ■ ■
Transport

Task Instruction Responsibility References


5 Load trucks. ■ Regional medical
5.1. Load trucks systematically, using first in, last store/district
out approach. health office’s
point of contact to
5.2. Using loading straps to prevent physical dam- coordinate with::
age.
■ NTD
5.3. Secure vehicle doors against theft and weath- community
er. Confirm who has access. programme
5.4. Ensure routing provides sufficient time for rest, ■ Drivers
safety (avoid driving at night, bad roads).
■ Truck loaders
5.5. Any shipment delivery taking greater than 1
day should be secured and visually inspected
at every overnight stop and morning, with
appropriate documentation.
6 Unload trucks and temporary storage or ■ District point See Chapter 6:
destruction of contact in Storage
6.1. Upon arrival, unload per the distribution sched- coordination with: See Chapter 7: First
ule and follow the first in, first out approach. ■ Regional expiry first out
6.2. Driver to present voucher and waybill to recip- medical store’s See Chapter 10:
ient at each district level, including title, name, point of contact Waste management
signature and date (dd/mm/yyyy). ■ Drivers
6.3. District POC to inspect/count sealed and ■ Truck
unsealed cartons and sign prepared voucher. unloaders
6.4. District level should have designated storage
for drugs until MDA.
6.5. Any damaged/expired stock should be docu-
mented and removed
7 District receipt of shipment(s) and documen- ■ District point
tation. of contact in
7.1. If documentation is incomplete or missing, coordination with:
district level should not accept the shipment; ■ Regional
contact regional medical store point of contact medical store’s
for assistance. point of contact
7.2. If documentation does not match quantities ■ Drivers
received:
7.2.1. Accept delivery and prepare a supply
discrepancy report to record the short-
age or excess received. Give a copy
to the driver to submit to the regional
medical store point of contact.
7.3. In case of excess supply, return the excess
goods and invoice to driver, and request a new
invoice for quantity accepted.
7.4. Notify NTD community programme point of
contact and district health office that quantities
were received at district level.
8 Delivery confirmation. ■ District point
8.1. Driver to receive and file with regional medical of contact in
store a copy of the signed receiving as a coordination with:
record of delivery and date (dd/mm/yyyy). ■ Regional
medical store’s
point of contact
■ NTD
community
programme
■ Drivers

■ ■ ■ ■ ■ ■ 49 ■ ■ ■
■ ■ ■ ■ 50 ■ ■ ■ ■ ■ ■ ■
5. Inventory management

5.1 Purpose and scope of this standard operating procedure


The purpose of managing inventories of donated NTD medicines is to:.
■ minimize the total cost of inventory by balancing the costs of carrying and ordering
stock;
■ ensure that information on stock levels in the health system is readily available in all
locations;
■ facilitate adequate inventory for distribution to affected populations;
■ avoid stockouts;
■ ensure proper record-keeping;
■ minimize losses, damage and misuse; and
■ ensure accountability to pharmaceutical donors.
Inventory management is performed whenever stock is received, stored, transferred, near
expiration or disposed of. It involves physical inspection, counting and maintaining records
of stock.

5.2 Key considerations


The tasks and responsibilities in this procedure are relevant for:
■ the national NTD programme;
■ the supply chain, warehouse/stores and pharmacy staff at all levels of the health
system; and
■ NTD focal persons and supervisors of school and community drug distributors. The
positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.

■ ■ ■ ■ ■ ■ 51 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

The national NTD programme should:


■ regularly contact all sites where donated medicines are stored for inventory updates;
■ encourage sites to conduct their own regular inventories of donated medicines
alongside other health commodities and to create alert systems for expiring stock; and
■ report the results of physical inventory to all stakeholders including implementing
partners, national supply chain department, WHO, pharmaceutical donors or any other
actor involved in MDA.

5.3 Standard operating procedure


5.3.1 Before and during MDA

When Who What How


■ Whenever stock is Responsible persons for Physical inspection, ■ Inspect and count
received, stored, stores management at counting and stock received
issued or transferred, each level of the health maintenance of stock ■ Store donated
near expiration or system, including: records. medicines separately
disposed of. ■ supply chain manager

■ Follow procedure in
Before MDA. pharmacist
Chapter 7 First expiry
■ ■

■ pharmacist technician first out


■ warehouse or stores ■ Use transfer forms
supervisor to record stock
■ NTD programme staff movements (see
Annex 4 for template)
■ transporter
■ NTD programme
coordinator
■ Health ministry

Task Instruction Responsibility References


1 Receiving donated medicines. ■ Supply chain See Chapter 3:
1.1. Before receiving stock, ensure that there is suf- manager Customs clearance
ficient storage space and consider shelving. ■ Pharmacist or See Chapter 4:
1.2. Ensure that the area is clean, clear and pre- technician Transport
pared for receiving and storing stock. ■ Warehouse or See Chapter 6:
1.3. Inspect and count stock received, updating the stores’ supervisor Storage
stock card and eLMIS system (where such a ■ NTD programme See Chapter 7: First
system is in use) accordingly. coordinator expiry first out
1.4. Inspect stock for any damage and check expiry ■ Transporter See Chapter 8:
dates. (driver) Reverse logistics
1.5. If required, follow the appropriate procedure for See Chapter 9:
damaged and/or expired stock. Removing expired
1.6. Complete a transfer form upon receipt of stock and unserviceable
at each level. This form should be signed, dat- medicines
ed, and a copy returned to the origin location. See Chapter 10:
Waste management
2 Storing. ■ Supply chain See Chapter 6:
2.1. Physically separate the donated medicines manager Storage
from the nationally procured medicines. ■ Pharmacist or See Chapter 7: First
2.2. Create a unique stock card and a unique technician expiry first out
stock code in the eLMIS (where such system ■ Warehouse or See Chapter 8:
is in use) to ensure that donated medicines stores’ supervisor Reverse Logistics
are distinguishable from nationally procured
medicines.
2.3. Attach a separate stock card to each stack of
medicines in the warehouse/stores.

■ ■ ■ ■ 52 ■ ■ ■ ■ ■ ■ ■
Inventory management

Task Instruction Responsibility References


3 Issuing. ■ Supply chain See Chapter 4:
3.1 Follow the first expiry, first out policy at all manager Transport
levels. ■ Pharmacist or See Chapter 7: First
3.2. Only open one carton at a time to issue bottles technician expiry first out
at the community level. ■ Warehouse or
3.3. Do not break cartons into single bottles except stores supervisor
when issuing to school and community drug ■ Transporter
distributors. (driver)
3.4. Update the stock card immediately after issu- ■ NTD programme
ing medicines (i.e. record keeping). coordinator
4 Transferring. ■ Supply chain See Chapter 4:
4.1. The transfer form should be used when issuing manager Transport
donated medicines, from one storage facility ■ Warehouse or See Chapter 7: First
to another or to school or community drug stores supervisor expiry first out
distribution teams. Annex 4: Stock
■ Transporter
4.2. If there is no eLMIS system, two copies of the (driver) transfer form
form should be used to record each transac- template
NTD programme
tion:

coordinator See Chapter 8:


■ one copy goes to the destination with the Reverse logistics
School or
carrier (i.e. the person responsible for

distribution centre See Chapter 9:


transportation); and Removing expired
point of contact
■ one copy is kept in the location of origin and unserviceable
for record-keeping. ■ District health medicines
officer
■ Both copies of the form should have the See Chapter 10:
same serial number. Waste management
4.3. The first part of the form records the origin,
destination and name of the person trans-
porting the shipment along with the quantity
issued.
4.4. This part should be filled in at the origin
location and signed by both the carrier and the
issuer.
4.5. The second part of the form should be filled in
at the destination and signed for by the carrier
and the receiver.
4.6. Any damaged quantity in the shipment should
be recorded on the form and the relevant staff
informed, including NTD programme staff.
4.7. Follow relevant procedures for removing ex-
pired and unserviceable medicines (Chapter
9) and waste management (Chapter 10).
4.8. All levels of the health system, including school
and community drug distribution teams,
should use the same form when receiving
medicines.
4.9. Transfer forms should be kept safely on file
for the length of time mandated by the health
ministry/donor

■ ■ ■ ■ ■ ■ 53 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

5.3.2 After MDA

When Who What How


■ After each MDA Responsible persons for 1. Plan ■ Check actual physical
■ Before applying for stores management at 2. Organize stock against the stock
each level of the health card balances.
and requesting a new 3. Count
system, including:
consignment. For ■ Identify quantities
■ supply chain manager, 4. Reorganize
example, immediately of usable stock for
before submitting ■ pharmacist, 5. Update distribution.
the annual Joint ■ pharmacist technician, 6. Action ■ Detect and separate
Application Package/ damaged and/or
warehouse or stores
Trachoma Elimination

supervisor, expired stock.


Monitoring Form
NTD programme staff,
Whenever a regular

physical inventory ■ transporter


of other health
commodities is
conducted.
■ Any time when alerted
to damage, loss and/
or theft.
■ When requested by the
donor.

Task Instruction Responsibility References


1 Plan physical inventory. ■ Supply chain See Chapter 6:
1.1. Set specific dates and times to conduct physi- manager Storage
cal inventories. At a minimum, before and after ■ Warehouse or See Chapter 7: First
each MDA, and whenever a regular physical stores supervisor expiry first out
inventory of other health commodities at the See Chapter 8:
storage site is conducted. Reverse logistics
1.2. Avoid busy times, as receiving and issuing
stock must be paused for the duration of the
counting process.
1.3. Identify at least two people (wherever possi-
ble) to conduct the count and reconciliation.
1.4. Ensure that there are no conflicts of interest.
For example, the person in charge of the
inventory should not participate but should be
available on site to show the inventories
2 Organize stock. ■ Supply chain See Chapter 6:
2.1. Group bottles according to their expiry date. manager Storage
2.2. Arrange the medicines by expiry date, older ■ Warehouse or See Chapter 7: First
medicines at the front and newer at the back. store supervisor expiry first out
2.3. Opened bottles should be kept separate from See Chapter 8:
closed bottles. Reverse logistics
■ Any reconstituted oral solutions (e.g. pedi- See Chapter 9:
atric oral solution of azithromycin) should Removing expired
not be saved in the inventory but disposed and unserviceable
of immediately medicines
■ Any chewable tablets (i.e. mebendazole) See Chapter 10:
once opened have a shelf life of only 1-2 Waste management
months, so should not be stored for the
next MDA.
2.4. Separate damaged and/or expired medicines
from usable stock. Follow the procedures for
removing expired and unserviceable med-
icines (Chapter 9) and waste management
(Chapter 10)

■ ■ ■ ■ 54 ■ ■ ■ ■ ■ ■ ■
Inventory management

Task Instruction Responsibility References


3 Count stock. ■ Supply chain See Chapter 6:
3.1. One person should count while the other manager Storage
person records. ■ Warehouse or See Chapter 7: First
3.2. Use a different coloured pen to highlight the stores supervisor expiry first out
physical inventory quantities on the stock card. ■ NTD programme See Chapter 9:
3.3. Count one location at a time and record sepa- manager Removing expired
rately by expiry date group. and unserviceable
medicines
3.4. Count the number of bottles per expiry date
group.
3.5. Mark the expiry date clearly, in large, dark
numbers on the front of each carton. Separate
any damaged or expired medicines, recording
the amount in the losses/adjustments column
on the stock card and provide a brief explana-
tion for the expiry or damage.
3.6. Count the number of sealed/complete cartons
first, then multiply this by the number of bottles
in a carton; this will give you the total number
of bottles.
3.7. Count the number of unopened bottles in
open cartons.
3.8. Count the number of open bottles and divide
the total count of by two; this will give you the
estimated equivalent number of the full bottles.
3.9. Do not mix or consolidate open bottles into a
single bottle.
3.10.On the physical inventory form (from the
donor) record:
■ quantity of opened bottles
■ quantity of unopened bottles
■ expired and/or damaged product
3.11. Record quantities in the lowest unit denomina-
tion, and not by bottles.
3.12.Obtain sign-off on the final physical inventory
report by the pharmacist/pharmacist techni-
cian or other relevant member of staff.
3.13.Set up an alert system for expiry dates of
stock-on-hand; this should include alerts at 6
months, 3 months and 30 days.
3.14 .Notify the NTD programme manager via SMS
of any stock expiry alerts, providing medicine
and quantities expiring.
4 Reorganize stock. ■ Supply chain See Chapter 6:
4.1. Reorganize the stock according to the expira- manager Storage
tion dates and complying with the first expiry ■ Warehouse or See Chapter 7: First
first out (FEFO) policy. stores supervisor expiry first out
4.2. If open stock is allowed for use, ensure that it is
issued first during the next MDA campaign.
4.3. Complete the process as quickly as possible to
allow normal operations to resume.

■ ■ ■ ■ ■ ■ 55 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


5 Update stock card. ■ Supply chain Annex 5 Stock card
5.1. Once counting is finished, reconcile the total manager template
number of bottles counted with the quantities ■ Warehouse or Annex 6 Physical
recorded on the stock card. stores supervisor inventory count form
5.2. Use a different coloured pen to highlight the template
physical inventory stock quantity on the stock See Chapter 9:
card. Removing expired
5.3. If there are any differences, add or subtract the and unserviceable
number of bottles on the stock card under the medicines
loss/adjustment column. Clearly record the
date, quantity difference and write “Physical
inventory”.
5.4. Keep records of all stock cards for donated
medicines.
5.5. Transfer stock cards that are older than 2 years
to the national NTD programme.
6 Action. ■ Supply chain See Chapter 8:
6.1. Share physical inventory reports on donated manager Reverse logistics
medicines with the national NTD programme ■ Warehouse or See Chapter 9:
and national supply chain department where stores supervisor Removing expired
relevant. If the physical inventory differs from and unserviceable
NTD programme
the stock card balance, report the reasons for medicines

manager
the discrepancy. See Chapter 10:
6.2. Include actions resulting from physical invento- Waste management
ry in budget planning. This may cover reverse
logistics and waste management.

■ ■ ■ ■ 56 ■ ■ ■ ■ ■ ■ ■
6. Storage

6.1 Purpose and scope of this standard operating procedure


Proper storage ensures the safety and high quality of medicines until their distribution to
populations at risk through MDA. The procedure for proper storage conditions including
monitoring storage ambient conditions must be observed to maintain the quality of the
medicines until they exit the storage or warehouse. The main objectives of proper storage
are to:
■ receive donated/procured medicines and/or diagnostic shipments;
■ safely store medicines and/or diagnostics until required by field distribution teams;
■ allocate and disseminate correct amounts of medicines and/or diagnostics to
distribution points; and
■ receive and serve as a repository for remaining usable medicines and/or diagnostics
after MDA or for disease-specific assessment.

6.2 Key considerations


A strong central or regional medical storage relationship with the NTD programme should
be in place for management, operations, documentation and communication. To guide
the amount of space in cubic metres required for different quantities of medicines, please
refer to Table 6.1.

Management
■ Government-owned or private franchise.
■ Level of the warehouse central, regional, district or subdistrict levels.
■ Access, security and safety conditions of the storage/warehouse.

■ ■ ■ ■ ■ ■ 57 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Table 6.1. Summary of logistic information for medicines donated for preventive chemotherapy

Medicine No. of No. of tablets/ No. of No. of Size of Height Net Gross
tablets/ shipper per shippers/ tablets/ pallet of pallet weight weight of
bottle case (carton pallet pallet width/ (cm) of pallet pallet (kg)
box) length (cm) (kg)
Albendazole 200 200 x 30 bottles 52 312 000 120 x 100 120 392 410
(400 mg tablets) (6000 tablets)
Mebendazole 150 150 x 20 bottles 135 405 000 120 x 80 115 381
(500 mg tablets) (3000 tablets)
Praziquantel 1000 1000 x 9 bottles 30 270 000 121 x 81 122 426 429
(600 mg tablets) (9000 tablets)
Diethylcarba- 1000 1000 x 12 bottles 84 1 008 000 Min. 110 x 127 322 340-350
mazine citrate (12 000 tablets)a 110 Max
(100 mg tablets) 120 x 120
Ivermectin (3 mg 500 500 x 96 bottles 25b 1 195 000c 120 x100 115 127.9 153
tablets) for full shippers
Triclabendazol 4 1200 tablets 18 21 600 120 x 80 89 88 ~ 121
(250 mg tablets) (320 paper
boxes;
4 tablets/box)
Azithromycin 3 3 tablets x 60 132 23 760 120 x 80 160 138 144
(500 mg tablets) packs
for yaws
Praziquantel 1000 (1000 x 10)/ 21 210 000 120 x 80 103 ~ 400
(600 mg tablets) carton box
from Bayer
Niclosamide 4 720 tablets/ 32 23 040 120 x 80 985 75 90
(400 mg tablets) shipper
(4 x 15 x 180)
Azithromycin 500 500 x 24 54 648 000 120 x 100 80 359 379
(250 mg tablets) (12 000 tablets)
for trachoma

a
Shipping carton box (containing 1000 tablets/bottle x 12 bottles) of size 32 (L) x 25 (W) x 16 (W) cm and weight of 3.36 kg.
b
25 cartons (normally 24 full cartons with 96 bottles each; the last carton could be uncompleted, in this case, 86 bottles).
c
Assuming 2390 units = 1 195 000 tablets is the largest pallet.

■ ■ ■ ■ 58 ■ ■ ■ ■ ■ ■ ■
Storage

Operations
Adequate storage procedure and system.

Visual inspection and physical inventory frequency.


Lot quality assurance sampling implementation and frequency, where available.


Adequate storage conditions, observation and monitoring, including:


■ a cooling system;
■ power maintenance;
■ a storage structure; and
■ a daily log of conditions.
Management/storage of other NTD supplies.

Storage operation protocol including:


■ first expiry first out; and


■ waste/damage prevention and management.

Documentation and communications


Forms and logbooks adapted to needs and properly used.

Documentation processes for receipt/removal.


Proper protocol for documentation.


Electronic logistics information management system (eLMIS) and communication


procedure.

■ ■ ■ ■ ■ ■ 59 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

6.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.
6.3.1 Central storage of medicines before MDA

When Who What How


■ Central level ■ Central NTD supply ■ To receive and store ■ Prepare sufficient
--> When providing chain manager NTD medicines initially space and confirm
green light to ship ■ National NTD arriving in country until arrival date to ensure
medicines to the programme manager needed for MDA access to storage
country until To accurately allocate Receive shipment(s)
1 month before MDA ■ Consignee/forward ■ ■

clearing agent appropriate medicines and documentation


and quantities to ■ Stack new inventory
regions for distribution
■ Monitor storage
ambient conditions

Task Instruction Responsibility References


1 Prepare sufficient space and confirm arrival date ■ Central NTD See Chapter 3:
to ensure access to storage. supply chain Customs clearance
1.1. Prepare storage space and proper conditions manager See Chapter 4:
for shipment arrival. ■ NTD programme Transport
1.2. Ensure necessary tools, including registers and manager See Chapter
stock cards are on hand. ■ Consignee/ 5: Inventory
1.3. Ensure tally sheets or other appropriate inven- forward clearing management and
tory management forms are in place. agent Chapter 7 First
expiry first out
1.4. Have consignee contact information on hand
(with consignee previously designated)
1.5. Liaise with the NTD programme and regularly
check delivery status and when medicines
are due.
1.6. Ensure that transport to central medial store is
arranged for the necessary date(s).
1.7. Ensure staff are available to unload the truck(s)
and store stock.
1.8. Identify/confirm who will have access to the
stock.
2 Inspect/count sealed/complete cartons ■ Central NTD See Chapter 3:
received. supply chain Customs clearance
2.1. Receive shipment(s) and documentation. manager See Chapter
2.2. Verify and identify the quantity of each product 5: Inventory
received against documentation. management
2.3. Visual inspection and physical count of ... See Chapter 10:
sealed/complete cartons: Waste management
■ physically count sealed/complete cartons;
and
■ physically count the number of bottles in
the open cartons.
2.4. Document and remove any damaged, expired
stock upon arrival
2.5. Do not combine open bottle stocks into one
bottle; keep them in separate bottles and
label the carton accordingly regarding expiry
date(s).
2.6. Create a delivery confirmation note and send it
to the NTD programme/central medical store
manager.

■ ■ ■ ■ 60 ■ ■ ■ ■ ■ ■ ■
Storage

Task Instruction Responsibility References


3 Receive shipment(s) and documentation. ■ Central NTD See Chapter 3:
3.1. Sign voucher and waybill, returning a copy to supply chain Customs clearance
the clearing agent. manager See Chapter 4:
3.2. If documentation is incomplete or missing, do ■ Transporter Transport
not accept the shipment; contact the consign- ■ NTD programme See Chapter
ee for assistance. manager 5: Inventory
3.3. If documentation does not match quantities management
■ Consignee/
received: forward clearing
■ accept the delivery and prepare a supply agent
discrepancy report to record the shortage
or excess received; give a copy to the
driver to submit to the supplier/shipper.
■ In case of excess supply, return the
excess goods and invoice to the driver,
and request a new invoice for the quantity
accepted.
3.4. Notify consignee
4 Create a delivery confirmation note and send to ■ Central NTD See Chapter 3:
the NTD programme. supply chain Customs clearance
4.1. Document quantities received (e.g. pharmacy manager See Chapter 4:
log; transfer forms/signed acknowledgment of ■ Transporter Transport
receipt or report of the transaction by deliver- See Chapter 5:
NTD programme
ing and receiving parties).

manager Inventory
4.2. Ensure NTD programme is notified if stock management
Consignee/
quantities do not match documentation

forward clearing
(whether too much or too little).
agent

5 Implement lot quality assurance protocol, if ■ Central NTD


applicable supply chain
5.1. Ensure protocol is in place for lot testing if manager
country pharmacovigilance policy and person-
nel are in place.
5.2. Document quality assurance activities and
prepare report for WHO and/or national NTD
programme.
6 Stack new inventory (see Fig. 6.1). ■ Central NTD See Chapter 5:
6.1. Sort according to national policy, then by batch supply chain Inventory
and expiry date, moving older drugs already in manager management
stock to the front of storage rack. See Chapter 7: First
6.1. 1. If storing open cartons (leftover from expiry first out
previous MDA), reorganize the cartons
to ensure oldest stock is at the front.
6.2. Mark the date received, expiry date and initials
of the person making the notation clearly in
large, dark numbers on the front of each car-
ton/box and ensure markings all face forward.
6.3. Ensure as much as possible that NTD medi-
cines are kept cool, dry, away from direct light
and at an appropriate height for access and
avoiding damage.
6.4. Fill in stock and bin cards.
7 Monitoring storage ambient condition ■ Central NTD See Chapter 5:
7.1. Daily monitoring should be conducted to supply chain Inventory
maintain temperature control, security and to manager management
ensure boxes remain appropriately stacked.
7.2. Log monitoring results on an appropriate form

■ ■ ■ ■ ■ ■ 61 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Fig. 6.1. Appropriate carton storage, with description, batch numbers and expiry dates facing
forward “Keep temperature at 0–25 °C and relative humidity at 45–75% (personnel to measure twice weekly)”
“Medicines stacked a minimum of …” “Stack height no more than 2.5 metres”

Source: Illustration by Cassandra Holloway

■ ■ ■ ■ 62 ■ ■ ■ ■ ■ ■ ■
Storage

6.3.2 Central storage of medicines after MDA (2 weeks to 1 month after


MDA)

When Who What How


■ Central level ■ Central NTD supply ■ To receive and ■ Prepare sufficient
--> 1 month after chain manager store leftover NTD space and confirm
MDA ■ Regional/district/ medicines after MDA arrival date to ensure
■ Regional/district level peripheral health until needed for next access to storage
--> 2 weeks to 1 facility NTD drug MDA ■ Receive shipment(s)
month after MDA manager and documentation
■ Peripheral health ■ National NTD manager ■ Stack new inventory
facility ■ Monitor storage
--> 2 weeks to 1 ambient conditions
month after MDA

Task Instruction Responsibility References


1 Prepare sufficient space and confirm arrival date ■ Central NTD See Chapter 4:
from the regional/district level to ensure access supply chain Transport
to storage. manager See Chapter
1.1. Prepare appropriate storage space and proper ■ NTD programme 5: Inventory
conditions for shipment arrival (see Fig. 6.1). manager management
1.2. Ensure transport to central medical store ■ Regional/district See Chapter 6:
is arranged with national NTD programme supply chain Storage and
manager and regional/district supply chain manager Table 6.1
manager.
1.3. Prepare a receiving voucher from each region-
al/district medical store for total cartons from
each destination.
2 Receive shipment(s) and documentation and ■ Central NTD See Chapter 4:
stack received inventory. supply chain Transport
2.1. Receives shipment(s) and documentation. manager See Chapter 5:
2.2. Inspect/count the number of sealed cartons ■ Transporter Inventory
(after MDA) and the number of sealed bottles management
■ NTD programme
in open cartons (after MDA)/number of open manager See Chapter 6:
bottles in open cartons (after MDA). Storage
2.2.1. Any leftover bottles should be marked See Chapter 7: First
“opened dd/mm/yyyy” with initials. expiry first out
2.3. Verify and identify the quantity of each product See Chapter 8:
received against the receiving voucher from Reverse logistics
the regional/district medical store. See Chapter 9:
2.4. If the documentation does not match the Removing expired
quantities received from the regional/district and unserviceable
medical store medicines
■ Accept the delivery and prepare a supply See Chapter 10:
discrepancy report to record the shortage Waste management
or excess received to the NTD programme
and regional/district medical store as
applicable.
2.5. Document and remove any damaged, expired
stock upon arrival.
2.6. Reorganize and stack cartons/boxes.
2.7. Create a delivery confirmation note for the
NTD programme, including all quantities
by category (sealed, opened, damaged,
expired).
2.8. Submit the delivery confirmation note and the
supply discrepancy report (as needed) to the
NTD programme

■ ■ ■ ■ ■ ■ 63 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


3 Storage condition maintenance and monitoring. ■ Central NTD See Chapter 6:
3.1. Daily monitoring of storage temperature, se- supply chain Storage
curity, and proper storage of stacked boxes. manager
3.2. Log monitoring results on an appropriate form.

6.3.3 Regional/district/peripheral health facility storage before MDA

When Who What How


1 month to 2 weeks from ■ Regional/district/ ■ To receive and store ■ Prepare sufficient
MDA date, upon receipt peripheral health NTD medicines initially space and confirm
of new medicines facility level arriving at regional/ arrival date to ensure
programme district/peripheral access to storage
coordinator or health facilities before ■ Receive shipment(s)
designee MDA and documentation
■ Regional/district/ ■ To accurately allocate ■ Stack new inventory
peripheral health appropriate medicines
facility supply chain and quantities to ■ Monitor storage
manager/logistician distribution points ambient conditions
■ Regional/district/
peripheral health
facility pharmacist
■ Central national NTD
supply chain manager
■ National NTD manager

Task Instruction Responsibility References


1 Prepare sufficient space and confirm arrival date ■ Regional/district/ Section 6.3.4
to ensure access to storage. peripheral health Regional/district/
1.1. Prepare for shipment arrival (from central level facility NTD supply peripheral health
or field level as applicable) and ensure proper chain manager or facility level storage
conditions for shipment arrival are in place. designee See Chapter 4:
See Fig. 6.1. ■ NTD programme Transport
1.2. Ensure appropriate space and pallets are manager See Chapter 5:
available and necessary tools and registers/ ■ Central NTD Inventory
stock cards are on hand. supply chain management
1.3. Ensure tally sheets or other appropriate inven- manager Section 3.1 Central
tory management forms are in place. storage before MDA
1.4. Have NTD country programme contact infor-
mation on hand.
1.5. Liaise with the NTD programme and regularly
check delivery status.
1.6. Ensure that transport to the regional medical
store is coordinated with the district health
office or NTD community programme.
1.7. Ensure staff are available to unload the truck(s)
and store stock.
1.8. Identify/confirm who will have access to the
stock.
1.9. Prepare receiving voucher for each regional/
district medical store for total cartons from
each destination.

■ ■ ■ ■ 64 ■ ■ ■ ■ ■ ■ ■
Storage

Task Instruction Responsibility References


2 Inspect/count sealed/complete cartons ■ Regional/district/ See Chapter 5:
received . peripheral health Inventory
2.1. Receives shipment(s) and documentation. facility NTD supply management
chain manager See Chapter 10:
2.2. Visual inspection and physical count of
sealed/complete cartons. Waste management
■ Physically count sealed/complete cartons. See Chapter 6:
Storage before MDA
■ Physically count the number of bottles in
the open cartons.
2.3. Verify and identify the quantity of each product
received against the transport documentation.
2.4. Document and remove any damaged, expired
stock upon arrival.
2.5. Do not combine open bottle stocks into one
bottle; keep them in separate bottles and
label the carton accordingly regarding expiry
date(s).
3 Receive shipment(s) and documentation. ■ Regional/district/ See Chapter 4:
3.1 Sign the receiving voucher and return a copy peripheral health Transport
to the central medical store (confirm the trans- facility NTD supply See Chapter
porter is contracted to do this). chain manager 5: Inventory
■ If the documentation is incomplete or ■ Transporter management
missing, contact the field logistician, dis- ■ NTD programme See Chapter 6:
trict health office or NTD community pro- manager Storage before MDA
gramme point of contact for assistance.
■ If the documentation does not match the
quantities received:
- Accept delivery and prepare a supply
discrepancy report to record the
revised totals.
3.2. SMS the NTD programme manager with final
counts received to ensure quick confirmation
in case medicines can be used in other loca-
tions within the same MDA period.
3.3. Create a delivery confirmation note and send
to the NTD Programme.
4 Stack new inventory (see Fig. 6.1). ■ Regional/district/ See Chapter
4.1. Sort according to type of medicine, then batch peripheral health 5: Inventory
and expiry date, moving older bottles already facility NTD supply management
in stock to the front of the storage rack. chain manager See Chapter 7: First
■ If storing open bottles leftover from MDA, expiry first out
ensure they are marked “opened dd/ See Chapter 6:
mmm/yyyy” with initials. Storage before MDA
■ Ensure that open bottles are issued first for
upcoming MDA.
4.2. If not already marked, mark the expiry date
clearly, with large, dark numbers on the front of
each carton/box and ensure markings all face
forward.
4.3. Ensure (as much as possible) medicines are
kept cool, dry, away from direct sunlight and at
an appropriate height for access and avoiding
damage.
4.4. Fill in stock and bin cards as applicable.

■ ■ ■ ■ ■ ■ 65 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


5 Storage conditions maintenance and monitor- ■ Regional/district/ See Chapter
ing. peripheral health 5: Inventory
5.1. Daily monitoring of storage temperature, facility NTD supply management
security, and proper storage of stacked boxes. chain manager See Chapter 6:
5.2. Monitoring of temperature on an appropriate Storage before MDA
form. Recorded temperature monitoring data
should be available for review. The equipment
used for monitoring should be checked at suit-
able predetermined intervals and the results of
such checks should be recorded and retained.
Equipment used for monitoring should also be
calibrated at defined intervals.

6.3.4 Regional/district/peripheral health facility level storage after MDA


(1 month – 2 weeks after MDA)

When Who What How


2 weeks to 1 month after ■ Regional/district/ ■ To receive and store ■ Prepare sufficient
MDA date peripheral health NTD medicines space and confirm
facility level leftover after MDA until arrival date to ensure
programme needed for next MDA access to storage
coordinator or ■ Receive shipment(s)
designee and documentation
■ Regional/district/ ■ Stack new inventory
peripheral health
facility supply chain ■ Monitor storage
manager/logistician ambient conditions
■ Regional/district/
peripheral health
facility pharmacist
■ Central national NTD
supply chain manager

Task Instruction Responsibility References


1 Prepare sufficient space and confirm arrival date ■ Regional/district/ Section 6.3.3:
to ensure access to storage. peripheral health Regional/ district/
1.1. Prepare for shipment arrival (from field level as facility NTD supply peripheral health
applicable) and ensure proper conditions are chain manager or facility level storage
in place. designee before MDA
1.2. Ensure necessary tools, including registers, ■ NTD programme See Chapter 4:
stock cards, tally sheets or other appropriate manager Transport
inventory management forms, are in place. See Chapter 5:
1.3. Liaise with the NTD programme and regularly Inventory
check delivery status and when medicines are management
due.
1.4. Ensure that transport to central medical store
is arranged for the necessary date(s).
1.5. Ensure staff are available to unload the truck(s)
and store stock.
1.6. Identify/confirm who will have access to the
stock.
1.7. (if regional medical store) Prepare receiving
voucher from each district medical store for
total cartons from each destination.

■ ■ ■ ■ 66 ■ ■ ■ ■ ■ ■ ■
Storage

Task Instruction Responsibility References


2 Receive shipment(s) and documentation and ■ Regional/district/ Section 6.3.3:
stack new inventory. peripheral health Regional/district/
2.1. Receives shipment(s) and documentation. facility NTD supply peripheral health
chain manager facility level storage
2.2. Conduct a visual inspection and physical before MDA
count of sealed/complete cartons (physically
count sealed/complete cartons; physically See Chapter 5:
count the number of bottles in the open car- Inventory
tons). Management
2.3. Create a delivery confirmation note and send it See Chapter 7: First
to the NTD programme/central medical store expiry first out
manager. See Chapter 9:
2.4. Sort according to type of medicine, then batch Removing expired
and expiry date, moving older bottles already and unserviceable
in stock to the front of the storage rack. medicines
■ If not already marked, mark the expiry See Chapter 10:
date clearly, with large, dark numbers on Waste management
the front of each carton/box and ensure
markings all face forward.
■ Any leftover bottles should be marked
“opened dd/mmm/yyyy” with initials.
2.5. Ensure (as much as possible) medicines are
kept cool, dry, away from direct sunlight and at
an appropriate height for access and avoiding
damage.
2.6. Fill in stock and bin cards as applicable.
2.7. Ensure that the open bottles are issued first
during the next round of MDA.
2.8. If medicines will remain in regional/district/
peripheral health facility storage until the next
MDA, send a final tally with expiry dates to
NTD programme point of contact for use in
preparing the Joint Reporting Form and the
Joint Request for selected medicines.
2.9. If medicines will be transported elsewhere or
destroyed, notify the NTD community pro-
gramme point of contact as soon as possible,
with details on drugs and quantities.
3 Storage conditions maintenance and monitor- ■ Regional/district/ 6.3.3 Regional/
ing. peripheral health district/peripheral
3.1. Daily monitoring of storage temperature, se- facility NTD supply health facility
curity, and proper storage of stacked boxes. chain manager storage before MDA
3.2. Log monitoring results on an appropriate form. See Chapter 5:
Inventory
management

■ ■ ■ ■ ■ ■ 67 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy


■ ■
■ ■
■ ■
■ 68 ■
■ ■
■ ■
■ ■
■ ■
■ ■
■ ■
Storage

7. First expiry, first out

7.1 Purpose and scope of this standard operating procedure


This procedure explains the process of minimizing the risk of wastage due to expiry, by
ensuring that stock with the earliest expiry date is used first. Stock is organized according
to expiry date; stock that will expire first is issued first, regardless of receipt into the medical
stores or health facility. The “E” refers to the expiry date of the product, which is set by the
manufacturer. First expiry first out (FEFO) is a best practice for stock management and is
part of good storage practice and inventory management.

7.2 Key considerations


Warehouse management systems. Warehouse management systems should be used
or introduced where possible to facilitate FEFO, whether electronic or paper-based. On
receipt of stock, the batch/lot numbers, expiry dates and shelf/rack location should be
captured in such systems and indicated on the shelves/rack where the product is stored.
The store pharmacist/supply chain manager should set up an alert system and conduct
regular checks to identify stock nearing expiry and to notify relevant stakeholders such as
the NTD programme. Bottles and cartons should have their batch/lot number and expiry
date clearly marked on each carton (see Fig. 7.1) and stock ledger cards (see Annex 7
for template).
Maximizing labour resources and productivity, and minimizing stock wastage due to
expiry. The FEFO method can save labour costs and time, reducing issues related to expiry
dates at the time of stock distribution. With such a process in place, the NTD programme
can better manage stock levels and avoid wastages through expiry, thereby maximize the
acceptable remaining shelf-life of stock-on-hand and increase overall resource productivity
and benefits to local target populations. Physical inventory checks and monitoring of
stock expiry dates are still required.
Stewardship of donated medicines. The FEFO method has the benefit of demonstrating
effective programme stewardship of donated NTD medicines, reducing reported numbers
of expired and wasted stock on the Joint Reporting Form (see Chapter 1) and decreasing
additional stock needs due to more accurate reporting of available stock (see Chapter
11), ensuring greater confidence in the relationship between pharmaceutical donors and
recipients.

■ ■ ■ ■ ■ ■ 69 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Fig. 7.1. Writing the expiry date(s) on each carton of medicine received (dd/mm/yyyy)

Source: Illustration by Cassandra Holloway

■ ■ ■ ■ 70 ■ ■ ■ ■ ■ ■ ■
First expiry, first out

7.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.
7.3.1 At all times, at all levels

When Who What How


■ Whenever medicines ■ Store pharmacist ■ Prioritize distribution ■ Clearly mark expiry
are received into the ■ Pharmacy technician of soon-to-expire dates and keep
storage facility medicines records on inventory
■ Medical store supply
■ Whenever medicines chain managers at ■ Minimize wastage ■ Conduct routine
are to be transferred all levels (central, of medicines due to checks and keep
between storage regional, district, point expire stock organized by
facilities of care) expiry date
■ Before MDA ■ Check remaining shelf-
■ After MDA and on life policies and issue
receipt of leftover notifications of stock
stock with expiry dates less
than 6 months

Task Instruction Responsibility References


1 Clearly mark expiry dates and keep records on ■ Store pharmacist See Chapter 5:
inventory (Fig. 7.1) ■ Pharmacy Inventory
1.1. On receipt of new or leftover stock, mark technician management
expiry dates with a black marker on the outside See Chapter 6:
Medical store
of each carton, making sure that the dates are Storage

supply chain
visible at a distance. See Chapter 8:
managers at all
1.2. In the case of single unopened bottles, write levels (central, Reverse logistics
the expiry date in large letters on the bottle. regional, district,
1.3. Any opened bottles should be marked “opened point of care)
dd/mm/yyyy” with initials as well as the expiry
date in a different colour marker.
1.4. Record inventory details such as batch/lot
number, expiry dates and quantities on stock
forms and warehouse systems (e.g. stock
ledger card, warehouse management system).
1.5. Confirm and document the acceptable
remaining shelf-life for medicines. Follow the
country policy at the time of receipt of stock.
2 Keep stock organized by expiry date at all times ■ Store pharmacist Stock ledger card
2.1. Place bottles or cartons of each medicine so ■ Pharmacy (Annex 7)
that the stock first to expire is stacked in front technician Warehouse
of or on top of the stock of the same medicine Management
Medical store
that will expire later. Where several products System (where

supply chain
that have the same expiry date, follow same available)
managers at all
the principle: place stock that has the earliest See Chapter
levels (central,
expiry date first for picking/issuing. 5: Inventory
regional, district,
2.2. Conduct routine checks and reorder each time point of care) management
additional stock is received. See Chapter 6:
Storage

■ ■ ■ ■ ■ ■ 71 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


3 Expiry date notifications and issuing stock. ■ Store pharmacist Stock ledger card
3.1. Use the stock ledger card or the warehouse ■ Pharmacy (Annex 7)
management system where available to rou- technician Warehouse
tinely check the expiry dates of stock-on-hand management
Medical store
and to confirm that the batch/lot number of the system (where

supply chain
stock picked is based on first expiry, first out. available)
managers at all
3.2. Routinely share quantities of stock-on-hand levels (central, See Chapter 6:
and expiry dates with the NTD programme. regional, district, Storage
3.3. Issue monthly notifications of products with point of care) See Chapter 5:
expiry dates of < 6 months. NTD programme Inventory
manager management
3.4. Any expired medicine must be documented
and transferred for proper disposal as soon as See Chapter
possible per national policy. 9: Removing
3.5. Notify the NTD programme of all expired medi- unserviceable and
cines, by name and quantity. expired medicines
See Chapter 10:
Waste management

■ ■ ■ ■ 72 ■ ■ ■ ■ ■ ■ ■
8. Reverse logistics

8.1 Purpose and scope of this standard operating procedure


This procedure guides countries through the process of reverse logistics for NTD
medicines, including return and transfer of medicines from downstream to upstream of the
supply chain system. Arranging reverse logistics is as important as distribution planning
and should be developed as a part of MDA. This procedure mainly applies to unused NTD
diagnostics.
Objectives
■ To ensure integrity of the national supply chain for donated and procured medicines.
■ To prevent theft and commercialization of medicines.
■ To avoid wasting resources in countries by procuring or requesting too much or too
little for MDA needs, whether from WHO, procurement agencies or other purveyors.
Expected results
■ No diversion of medicines from designated repositories before or after MDA.
■ No expired medicines.
■ No wasted medicines.
■ Appropriately stored medicines for use in the next round of MDA.
■ Unusable medicines directed for disposal according to national policy.

8.2 Key considerations


To ensure that leftover medicines are properly managed and to prevent loss of stock, the
national NTD programme coordinator(s) or assignee(s) should take the following into
consideration.

■ ■ ■ ■ ■ ■ 73 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ Ensure adequate budget to support reverse logistics (per diems, transportation, fuel,
etc.) as part of MDA planning including:
■ developing strategies to motivate community drug distributors, teachers or health
facility workers (as applicable) to round up and consolidate leftover medicines
after MDA. These responsible parties are not always compensated for travel
when returning medicines, which decreases their motivation to do so.
■ Ensure that all unused medicines are returned to the final designated repository no
more than one month after completion of MDA campaigns. This entails:
■ planning a specific timeline for each stage of return;
■ identifying people to conduct the inventory at each stage and aggregating the
leftover stock at each designated level; at least two people should jointly conduct
the inventory; and
■ planning for follow-up of identified gaps in leftover returns so that all medicines
are reconciled or reported.
■ Develop a plan and identify those responsible for executing, finalizing and submitting
reconciliations of open and closed bottles, storage/reuse versus destruction to the
central medical store or central pharmacy (see procedures for transport (Chapter
4), inventory management (Chapter 5), Storage (Chapter 6), first expiry first out
(Chapter 7) and waste management (Chapter 10) for recommended steps at each
stage).
■ Report open and closed bottle stocks stored for future use on the Joint Reporting
Form after MDA (Chapter 1) and forecasting and quantification (Chapter 11).
■ For azithromycin tablets or pediatric oral solution, also report stocks to the
International Trachoma Initiative (ITI).
■ Any reconstituted oral solutions should not be saved in the inventory but disposed
of immediately.
■ For chewable tablets (i.e. mebendazole) the shelf-life is only 1–2 months after
opening, so they should not be stored for the following year’s MDA.
■ Sort and dispose of expired and damaged medicines according to government
guidelines and document this process (see procedure for waste management in
Chapter 10). Share the documentation with the national NTD programme coordinator
or assignee to ensure their inclusion in the Joint Reporting Form. The positions
identified, their roles and the steps to be taken in this procedure are illustrative and
should be adjusted according to the prevailing context in each country.

■ ■ ■ ■ 74 ■ ■ ■ ■ ■ ■ ■
Reverse logistics

8.3 Standard operating procedure


The overarching steps in the reverse logistics process may vary by country context. The
positions and responsibilities below illustrate typical steps taken at each stage of reverse
logistics, from MDA level to central medical storage. It is recognized that some countries
may opt to keep leftover medicines at regional or district levels; if so, the subsequent points
on the timeline can then be disregarded. This procedure can and should be adapted to the
specific context of each country. Sample template forms are included in Annexes 8 and 9.
Other forms and documentation needed for effective reverse logistics are shown in bold in
the instructions. For assistance in developing document templates, please contact WHO.

When Who What How


Immediately after MDA ■ Community drug ■ Returns leftover, ■ Complete the drug
distributors/teachers/ damaged and expired return/transfer form
health facility staff, as medicines to a according to the job
applicable to MDA previously designated aid (Annexes 8 and 9)
context facility/district medical
■ District medical store store (as applicable in
manager country).
1–2 weeks after MDA ■ District NTD ■ Confirms total ■ Complete the drug
(if medicines are to move coordinator or treatment numbers return/transfer form
to higher level storage assignee against received according to the job
facilities) ■ Regional/district medicines. aid (Annexes 8 and 9)
medical store ■ Notes any
manager discrepancies and/
or missing stock for
follow up and sends
report to regional
or national NTD
coordinator (as
appropriate in country
context).
■ Takes custody of
returned medicines
and keeps records of
quantities received
from each district (and
implementation unit if
available).
■ Makes note of data
gaps and reports
them to national NTD
coordinator for follow
up.
1–2 weeks after MDA ■ District NTD ■ Confirms receipt of ■ Complete the drug
(if medicines are to move coordinator or returned medicines return/transfer form
to higher level storage assignee from all districts. according to the job
facilities) ■ Regional/district ■ Returns all Stage 2 aid (Annexes 8 and 9)
medical store collected medicines
manager to central storage
■ Central medical store after consultation
with National NTD
Coordinator.
■ Takes custody of
returned medicines.

■ ■ ■ ■ ■ ■ 75 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


1 Stage 1: Collection at designated facility or storage ■ Community drug Drug return/transfer
nearest to MDA point (typically district level, but distributors/ form (Annex 8)
may be subdistrict, depending on number of imple- teachers/health Job aid for
mentation units in area) facility staff as completing drug
1.1. Plan to complete this task immediately after applicable to MDA return/transfer form
MDA. context (Annex 9)
1.2. Damaged, expired or otherwise unusable ■ Transporter (as See Chapter 5:
medicines should be clearly labelled and applicable) Inventory
packaged separately. Batch numbers (located ■ District medical management
on bottle or packaging) should also be provid- store manager See Chapter 6:
ed if available. Storage
■ District NTD
1.3. Collect empty bottles and deface labels (using coordinator See Chapter 7: First
a dark marker or lighter) for destruction per expiry first out
country waste management policy.
See Chapter 10:
1.4. Count open bottles/containers separately from Waste management
unopened (sealed) bottle/containers.
1.5. Provide a count of total treatment numbers and
drug stock balance record or drug return/
transfer forms to district NTD coordinator
along with the leftover medicines.
1.6. District store or health facility contact keeps
temporary custody of returned medicines
and keeps records of quantities received,
including batch numbers.
1.7. If this is a formal storage facility where MDA
medicines will remain, updates stock ledger
and prepares stock status report of avail-
able quantities, expiry dates, waste for NTD
programme. Medicines are then boxed and
stored.
2 Stage 2: Collection of aggregated bundles from all ■ District medical Drug return/transfer
Stage 1 facilities at regional store (if medicines are store manager form (Annex 8)
to move to higher level storage facilities) ■ District NTD See Chapter 5:
2.1. Plan to complete this task within 1–2 weeks coordinator or Inventory
after MDA. assignee management
2.2. Confirm total treatment numbers against ■ Regional/ See Chapter 6:
received medicines. provincial medical Storage
2.3. Note any discrepancies and/or missing stock store See Chapter 7: First
for follow-up and send report to regional or ■ Transporter (as expiry first out
national NTD coordinator (as appropriate in applicable)
country context).
2.4. Return all Stage 1 collected medicines to the
regional medical store after consultation with
the national NTD coordinator.
2.5. Take custody of returned medicines and keep
records of quantities received from each
district (and implementation unit if available).
2.6. Make note of data gaps and report them to the
national NTD coordinator for follow up.
2.7. Collate the quantity returned with the batch
numbers clearly stated.
2.8. Update the stock ledger and also prepare the
stock status report

■ ■ ■ ■ 76 ■ ■ ■ ■ ■ ■ ■
Reverse logistics

Task Instruction Responsibility References


3 Stage 3: All leftover medicines after MDA returned ■ Regional NTD (1)
to central medical store for next MDA coordinator or See Chapter 5:
3.1. Plan to complete this task within 1–3 weeks designee Inventory
after MDA. ■ Central medical Management
3.2. Confirm receipt of returned medicines from store See Chapter 6:
all districts. ■ Transporter (as Storage
3.3. Return all Stage 2 collected medicines to the applicable) See Chapter 7: First
central medical store after consultation with expiry first out
the national NTD coordinator. See Chapter 10:
3.4. Central medical store takes custody of re- Waste Management
turned medicines.
3.5. Verify numbers of damaged, expired medicines
against reports; separate those for destruc-
tion.
3.6. Group opened bottles by medicine type and
ensure open bottles are properly labelled as
open, marked “opened dd/mm/yyyy” with
initials as well as the expiry date in a different
colour marker.
3.6.1. Follow national policies regarding future
use of opened bottles.
3.6.2. Any reconstituted oral solutions should
not be saved in the inventory but dis-
posed of immediately.
3.6.3. For chewable tablets (i.e. mebendazole)
the shelf-life is only 1–2 months after
opening, so they should not be stored
for the next year’s MDA.
3.7. Store remaining, usable medicines for the next
MDA.
3.8. Update the stock ledger, including batch
numbers, and also prepare the stock status
report.

References
1. Zithromax® management guide. Decatur (GA): International Trachoma Initiative; 2019 (https://
www.trachoma.org/zithromax-management-guide, accessed 18 March 2022).

■ ■ ■ ■ ■ ■ 77 ■ ■ ■
■ ■ ■ ■ 78 ■ ■ ■ ■ ■ ■ ■
9. Removing expired and
unserviceable medicines

9.1 Purpose and scope of this standard operating procedure


This procedure covers expired or unserviceable medicines that are stored at any level of
the health system. It involves removing stock from the medical stores/health facilities where
medicines are stored and updating inventory records for stores/facilities and the national
NTD programme. It is part of inventory management of stock in country to assure quality of
products used in NTD treatments such as MDA.
Expired medicines include any medicine that has passed the manufacturer’s expiry date
listed on the label. These medicines are not suitable for distribution to any population
requiring treatment.
Unserviceable medicines include:
■ damaged stock (e.g. water damaged, contaminated, broken, exposed to prolonged
temperature variations);
■ stock whose shelf-life is considered too short for distribution in the next scheduled
MDA, including
■ leftover reconstituted paediatric oral solution of azithromycin,
■ opened bottles of chewable mebendazole and
■ new medicines that will expire during MDA
■ missing medicines (e.g. lost/theft) from the physical inventory; and
■ opened bottles recovered from theft, due to the loss of quality control.

■ ■ ■ ■ ■ ■ 79 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

9.2 Key considerations


Generally, stock is managed through periodic inventory management, which may
be conducted monthly, quarterly and annually (see related procedure for inventory
management in Chapter 5).
For medicines used in preventive chemotherapy, this procedure should help to:
■ confirm inventory for use in MDA;
■ eliminate use of expired medicines during MDA;
■ reduce storage costs; and
■ verify available stock before and after MDA for use in forecasting and quantifying next
year’s request for medicines.
Appropriate inventory tools and reports include:
■ stock inventory reports/registers as applicable;
■ stock cards; and
■ stock adjustment request forms.
Accurate reporting of stock to the NTD programme is essential to upstream communication
to WHO, donors and implementing partners and to properly plan upcoming and subsequent
MDAs.

9.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.
9.3.1 At any time before, during and after MDA

When Who What How


■ At least 30 days (i.e. ■ Warehouse clerk(s) ■ Identification of expired 1. Immediately separate
one calendar month) ■ Storekeeper/ or unserviceable stock affected stock from
before MDA supervisor ■ Complete the Stock usable stock
■ Maximum 21 days (i.e. ■ Distribution pharmacist Adjustment Request 2. Communicate to NTD
within one calendar Form programme
month) of MDA ■ NTD focal person
■ Reporting to the NTD 3. Update store and
■ Periodically at central, programme stock inventory
regional and district records e.g. stock
medical stores and card
health facilities where
medicines are stored

■ ■ ■ ■ 80 ■ ■ ■ ■ ■ ■ ■
Removing expired and unserviceable medicines

Task Instruction Responsibility References


1 Review physical inventory and reports ■ Warehouse clerk See Chapter 5:
1.1. Review the most recent physical stock and ■ Storekeeper Inventory
inventory records to identify any expired or Management
Pharmacist
unserviceable stock and quantities. See Chapter 6:

■ If the last inventory record is more than 90 Storage


days old, conduct a new physical invento- Inventory report/
ry to update the record. register (Annex 10)
1.2. Goods in/out processes (e.g. receiving, Stock adjustment
picking and packing stock) should not happen request form
while conducting a physical inventory (see Annex 11 for
template)
Stock card (see
Annex 5 for
template)
2 Report and separate expired and unserviceable ■ Warehouse clerk See Chapter 5:
stock ■ Storekeeper Inventory
2.1. Upon identification of expired or unserviceable Management
Pharmacist
stock, the warehouse clerk completes a stock See Chapter 10:

adjustment request form and submits it to the Waste Management


distribution pharmacist for endorsement. Annex 11: Stock
2.2. Upon review and approval, the distribution adjustment request
pharmacist completes a stock adjustment. form
2.3. The warehouse clerk separates expired or Annex 5: Stock card
unserviceable stock from usable stock.
2.4. The warehouse clerk removes expired or
unserviceable stock to a separate location for
storage, pending safe and proper disposal.
■ Where space is limited, expired or unser-
viceable stock should be clearly labelled
and placed inside a clearly labelled,
sealed carton to avoid it being distributed
during or after MDA.
2.5. The warehouse clerk updates the stock card:
■ Remove approved expired and unservice-
able quantities from the appropriate stock
card.
■ For expired stock, write “EXP” and the
reference number of the stock adjustment
request form in the remarks column.
■ For damaged/unserviceable stock write
“DAM” and the reference number of the
Stock adjustment request form and
the nature of the damage in the remarks
column.
■ For missing stock write “MIS” and the
reference number of the stock adjustment
Request form in the remark’s column.
2.6. Follow national guidelines for waste manage-
ment of medicines.
3 Report to the NTD programme. ■ Stores in-charge Refer to NTD
3.1. Report the quantities of unserviceable med- ■ Pharmacist programme report
icines with details and rationale for expiry or
NTD focal person
unserviceability to the NTD programme.

■ ■ ■ ■ ■ ■ 81 ■ ■ ■
■ ■ ■ ■ 82 ■ ■ ■ ■ ■ ■ ■
10. Waste management

10.1 Purpose and scope of this standard operating procedure


This procedure covers the process of disposing of expired and unserviceable medicines as
well as guidance on disposal methods for empty bottles. It should be read in conjunction
with the procedures for reverse logistics (Chapter 8) and for removing expired and
unserviceable medicines (Chapter 9).
Waste management helps prevent dispensing of expired and unserviceable medicines
to the communities we serve. It is essential to avoid diversion of unusable medicines for
commercialization or illegal markets.
Medicines that have expired or are unserviceable should NOT be administered under any
circumstances; they should be destroyed and reported to WHO via the Joint Reporting
Form (and to ITI for azithromycin products).
Expired and unserviceable medicines include:
■ all tablets or paediatric oral solutions of medicines that have expired;
■ all damaged bottles of medicines (e.g. punctured or leaking bottle);
■ all open bottles of chewable or reconstituted medicines or paediatric oral solutions that
remain after completion of the MDA campaign; and
■ all medicines in bottles without any expiry date or with a label that is illegible.
If donated medicines meet any of the conditions above, the national NTD programme
manager and the NTD pharmacist at the relevant storage level should be notified
immediately. Identified field personnel should follow the necessary steps in this standard
operating procedure for the destruction of medicines under the direction of the national
NTD programme manager or their assignee.

■ ■ ■ ■ ■ ■ 83 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

MDA campaigns do not produce infectious waste; however, there are two types of waste
relevant to NTDs and MDA:
■ ordinary waste, including empty bottles and packaging materials, gloves, masks,
cups and spoons used during MDA; and
■ pharmaceutical waste, including expired or unserviceable (e.g. damaged,
contaminated) medicines. These medicines are termed “unusable drugs” and should
be treated in accordance with the country’s governmental directives on pharmaceutical
waste management.

10.2 Key considerations


10.2.1 Cooperation
Disposal of pharmaceutical waste usually requires cooperation among different departments
or agencies, ministries and levels of the government within a country. Depending on the
country, the authority in charge of managing pharmaceutical waste may be the Department
of Pharmacy within the Ministry of Health, the Drug Regulatory Authority, a regional or local
authority, or the Ministry of Environment. The NTD programme should identify the authorized
regulatory body and appropriate stakeholders. Once identified, these stakeholders and
authorities should identify and implement the correct procedures for safe management of
NTD pharmaceutical waste.
Lack of awareness of the consequences of irresponsible waste management for NTD
medicines, as well as lack of training for community health workers including MDA supervisors
and community drug distributors on the correct procedures, can lead to serious health
consequences. Stakeholders should therefore ensure that expired and unserviceable
medicines are kept away from unauthorized groups or individuals and returned to a safe
location for proper disposal.
Keeping expired and unserviceable NTD medicines in storage facilities, even if separated
from usable medicines, can lead to unqualified dispensing of unusable medicines. It also
allows expired and unserviceable medicines to occupy vital storage space that could be used
for other medicines/commodities.
Secure removal of expired and unserviceable medicines from storage facilities helps the
national NTD programme to mitigate the risk of unusable medicines being dispensed to the
target population. It also avoids jeopardizing public health and the reputation of the national
NTD programme.

10.2.2 Integrated waste management


In many situations, MDAs occur in conjunction with other health interventions such as child
health days or vaccination campaigns. In these situations, the management of waste from the
respective programmes should be coordinated equally as planning of implementation of the
service distribution. This will help to reduce costs and lower risks of waste being improperly
disposed of.

10.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.

■ ■ ■ ■ 84 ■ ■ ■ ■ ■ ■ ■
Waste management

10.3.1 Before and after MDA – national level

When Who What How


■ During the planning ■ National NTD ■ Disposal of unusable ■ Planning and training
stages for MDA programme manager NTD medicines and ■ Disposal of unusable
■ After MDA ■ MDA supervisors packaging at the NTD medicines and
national level packaging
■ Central/regional
medical stores ■ Reporting of disposed
manager NTD waste
■ NTD pharmacist
■ National health
waste management
coordinator

Task Instruction Responsibility References


1 Planning and training ■ NTD programme See national health
1.1. Review the Joint Application Package for manager/ waste management
required reporting on leftover, expired and coordinator policy
wasted stocks. ■ NTD pharmacist See Chapter 1: Joint
1.2. Review the national health waste management Application Package
■ Central/regional
policy for requirements. medical stores See Chapter 4:
■ Determine the policy’s applicability to manager Transport
NTD medicines and packaging.. See Chapter 5:
1.3. Develop an NTD waste management plan, Inventory
including WHO reporting requirements. management
■ Identify persons responsible to execute, See Chapter 8:
finalize and submit reconciliations of open Reverse logistics
bottle stocks as well as closed bottles, See Chapter 9:
storage/reuse versus destruction to the Removing expired
central medical store or central pharmacy. and unserviceable
At least two people should jointly conduct medicines
the physical inventory and verify counts.
■ If NTD waste will be destroyed at regional
level, coordinate with regional medical
stores to develop and employ the NTD
waste management plan.
1.4. Ensure there is an adequate budget to support
reverse logistics and waste management (per
diems, transportation, fuel, etc.) as part of
MDA planning.
1.5. Develop strategies to motivate community drug
Distributors, teachers or health facility workers
(as applicable) to round up and consolidate
leftover as well as unusable drugs after MDA.
1.6. Plan a specific timeline for each stage of
return.
1.7. Communicate the NTD waste management
plan to NTD coordinators, focal persons, MDA
supervisors, pharmacists, medical stores
managers and other relevant stakeholders as
required.
1.8. Ensure all persons responsible for generating,
handling or transporting contaminated waste
are trained. Training should occur as a compo-
nent of the MDA training.

■ ■ ■ ■ ■ ■ 85 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


2 Disposal of unusable drugs and packaging. ■ NTD programme See Chapter 1: Joint
2.1. Ensure that all unusable drugs are disposed of manager/ Application Package
no more than one month after completion of coordinator See Chapter 4:
MDA campaigns. . ■ NTD pharmacist Transport
■ In some countries, this activity is done ■ Central/regional See Chapter 5:
through a well-established committee or medical stores Inventory
team composed of different sectors and manager management
several representatives from the health See Chapter 6:
National
sector. In such circumstances, the already

health waste Storage


existing mechanism should be used,
management See Chapter 7: First
adapted to include the NTD programme
coordinator expiry first out
or focal points.
(where existing)
■ Employ the developed NTD waste See Chapter 8:
management plan, ensuring each stage is Reverse logistics
followed as documented. See Chapter 9:
■ Dispose of expired and damaged medi- Removing expired
cines according to government guidelines and unserviceable
and document the process. medicines
2.2. Any reconstituted oral solutions of a medicine See Chapter 11:
should not be saved in the inventory but Forecasting and
disposed of immediately. quantification
2.3. For chewable tablets (i.e. mebendazole), the
shelf-life is only 1–2 months after opening, so
they should not be stored for the next year’s
MDA but should be disposed of.
3 Reporting of disposed NTD waste. ■ NTD programme See Chapter 1: Joint
3.1. Report the disposal of damaged, expired manager/ Application Package
or otherwise unusable stocks on the Joint coordinator See Chapter 8:
Reporting Form. Reverse logistics
3.2. For azithromycin tablets or paediatric oral See Chapter 9:
solution, also report damaged, expired or Removing expired
otherwise unusable stocks to the International and unserviceable
Trachoma Initiative. medicines
3.3. Follow up on any identified gaps in returns of (1)
leftover medicine, so all medicines (whether
usable or not) are reconciled or reported on
the Joint Reporting Form.

10.3.2 After MDA – community level

When Who What How


Immediately after MDA Community drug Return waste to Return ordinary and
distributors/teachers/ designated supervisor, pharmaceutical waste
health facility staff (as health facility, district
applicable to MDA medical stores
context)

■ ■ ■ ■ 86 ■ ■ ■ ■ ■ ■ ■
Waste management

Task Instruction Responsibility References


1 Return ordinary and pharmaceutical waste. ■ Community drug See Chapter 8:
1.1. Ordinary and pharmaceutical waste is returned distributors Reverse logistics
to a previously designated health facility or ■ Teachers/ health See Chapter 9:
district medical stores (as applicable in the facility staff (as Removing expired
country): applicable to MDA and unserviceable
■ label expired and unserviceable medi- context) medicines
cines; National health
■ record information on the quantity waste management
returned, batch/lot number, reason for policy
unusable condition, etc.; Fig. 10.1 examples
■ package expired and unserviceable med- A and B
icines and store separately from usable
leftover stock

10.3.3 After MDA – supervisor level

When Who What How


■ Within 2 weeks after ■ MDA supervisor or ■ Collect waste from all ■ Gather and separate
MDA assignee MDA implementation usable leftover stock
■ NTD focal person units in area of and unusable stock
responsibility (waste)
■ Prepare for disposal ■ Prepare for return and
■ Return to designated disposal
level ■ Return all collected
waste to designated
waste repository

Task Instruction Responsibility References


1 Gather and separate usable leftover stock and ■ MDA supervisor or See Chapter
unusable stock (waste). assignee 5: Inventory
1.1. Take possession of ordinary and pharmaceuti- ■ NTD focal person Management
cal waste from all MDA implementation units See Chapter 8:
1.2. Centralize all waste from distribution sites Reverse logistics
within their area of responsibility. Fig. 10.1 examples
1.3. Separate empty bottles and unusable stock A and B
from usable leftover stock
1.4. Conduct a physical inventory of this waste
2 Prepare for return and disposal. ■ MDA supervisor or See national health
2.1. Oversee defacing of bottles, as per country assignee waste management
health waste management policy. If permitted ■ NTD focal person policy
by the policy, empty, defaced bottles may then Fig. 10.1 example B
be preserved at district facility level for per-
sonal use with instructions to thoroughly wash
inside of bottle with soap and water.
2.2. Aggregate quantities, conditions, and reports
of unusable stock for return and disposal.
2.3. Consult with NTD focal person for designated
area on the next step. If facilities available and
permitted by the policy, dispose at site follow-
ing authorized methods.
2.4. Send report to the district or regional level (as
applicable in the country) for disposal inciner-
ation no more than seven days after the MDA
is completed in the area of responsibility.

■ ■ ■ ■ ■ ■ 87 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Fig. 10.1. Stock destruction

Example A: Destruction options


Example A: Destruction options

Example B: Defacing labels


Example B: Defacing labels

Source: Illustrations and photographs by Cassandra Holloway

■ ■ ■ ■ 88 ■ ■ ■ ■ ■ ■ ■
Waste management

Task Instruction Responsibility References


3 Return all collected waste to district or regional ■ MDA supervisor or See national health
medical store or other designated waste repos- assignee waste management
itory. policy
3.1. Steps to be identified per country health waste See Chapter 8:
management policy and NTD waste manage- Reverse logistics
ment plan.

10.3.4 After MDA – district/regional level

When Who What How


Within one month after ■ District or regional/ Gather all quantities ■ Collate unusable
MDA provincial medical of expired and stock from district and
stores or assignee unserviceable stock subdistrict levels
■ NTD focal person returned after MDA and ■ Return all collected
prepare for disposal or waste to designated
transfer waste repository
■ Record information
on standard forms
and report to relevant
stakeholders

Task Instruction Responsibility References


7 Collate unusable stock from district and sub-dis- ■ District or regional/ Annex 12 document
trict levels. provincial medical examples
7.1. Ensure that district-level NTD waste has been store or assignee Chapter 8:
collected and brought to the regional level for ■ Regional NTD See national health
disposal or transfer to central level (as appli- focal person waste management
cable in the country) as outlined in the NTD policy
waste management plan.
See NTD waste
7.2. Record all quantities and batch/lot numbers management plan
of each NTD medicine marked for disposal,
along with reasons for disposal; verify that all Fig. 10.1 example B
bottles have been appropriately defaced.
7.3. Keep stock for disposal separate from usable
stock, and ensure it is clearly marked.
7.4. If the waste is to be destroyed at district level,
the regional NTD focal person should receive
the report that the MDA waste has been de-
stroyed or defaced and that no further action is
needed.
8 Prepare for return and disposal. ■ District or Section 10.3.5:
8.1. Initiate process for disposal as outlined in the regional/ Handling ordinary
NTD waste management plan. provincial medical and pharmaceutical
store or assignee waste
8.2. Follow guidelines on disposal methods and
document all quantities destroyed or defaced.
8.3. If waste is to be transferred to central level,
document all quantities to be transferred and
prepare a report for the national NTD coordi-
nator.

■ ■ ■ ■ ■ ■ 89 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


9 Record information on standard forms and ■ Regional NTD Annex 12 document
report to relevant stakeholders. focal person examples
9.1. If the waste is to be destroyed at regional-lev-
el, prepare a report that the MDA waste has
been destroyed or defaced and that no further
action is needed.
9.2. Submit report to the national NTD programme
for recording on the Joint Request Form.

10.3.5 Handling ordinary and pharmaceutical waste: guidance on disposal


methods
Managing empty bottles. All empty bottles of medicines should be defaced with a permanent
marker and washed thoroughly, if the national health waste management policy agrees to let
the community keep and reuse empty bottles (Table 10.1).
One of the following waste disposal methods should be used to dispose of the damaged/
expired medicines, adhering to the national waste management policy (Table 10.2).

Table 10.1. Ordinary waste management documentation and destruction

Priority scale Action Guidance


First Disposal Follow the health ministry and/or national environmental regulations for disposal of pharmaceutical
containers where available. This may include incineration in a “burn and bury” pit or incinerator
burning at 800–1000 °C (see Fig. 10.1, example A photographs).
Incineration with medium-to-high temperature burning disposal method for MDA waste. This
is especially important for NTD medicines that may have health and environmental concerns if
not disposed of properly. This option may not be available locally, but it may be possible to return
waste to an offsite facility that uses incineration (burning at ≥ 800–1000 °C).
Incineration at a local cement kiln, if available. A cement kiln can use small amounts of waste
(5%) as fuel. These incinerators reach similar temperature ranges.
Drum or pit-burning low-temperature burning, while not ideal, can provide some level of proper
incineration while reducing the environmental and health hazards of NTD MDA waste products.
To use this method, collect trash and put it in a barrel-shaped furnace or pit, and set it on fire.
Ensure that it is placed downwind of work and residential areas and away from any water source.
The combustible part of the trash will burn (< 400 °C), and the remainder will melt. Generally,
low-temperature burning is not recommended for several reasons: plastics and pharmaceuticals
release toxic gases when they are burned, releasing contaminants into the air. Therefore, drum or
pit burning should be the last option for NTD programme waste.
Designated staff should supervise the fire. After the fire is out, cover the ash and remaining
material with soil, as described above, to prepare for the next burn and bury. Never remove or
move ash in a burn-and-bury pit.
Second Reuse Preserve the bottles for personal use after they are properly cleaned and defaced using a lighter
or permanent marker. The NTD drug label is pressure-sensitive and cannot easily be peeled off
(see Fig. 10.1, example B photographs).
Third Recycle If the bottles are not reused, send them to a recycling facility, where available in the country.

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Waste management

Table 10.2. Pharmaceutical waste management documentation and destruction

Priority scale Disposal method Method


First Disposal As outlined in Table 10.1.

Second Manufacturer- Add water to the product to wet it down to render unusable, then incinerate as
recommended described in Table 10.1 example A.
disposal method
Third WHO guideline For solid tablets, suitable methods are:
■ waste encapsulation in a concrete, non-reactive steel or plastic container and
burial; and
■ medium or high temperature incineration (cement kiln incinerator; see Table 10.1
and Fig. 10.1 example A)

For paediatric oral solution or other liquified medicines:


■ dilute with water, leave to stand for several weeks and then discharge to sewer.

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11. Forecasting and quantification

11.1 Purpose and scope of this standard operating procedure


This procedure explains the annual process for accurately estimating the quantities of
preventive chemotherapy medicines required to reach the planned target population and
coverage in the country, for the year of request. It covers the preventive chemotherapy
medicines that are part of WHO’s global NTD medicine donation programme for endemic
countries.
Quantification is the first step in the forecasting process.

11.2 Key considerations


This exercise should be done by the national NTD programme and submitted to the WHO
regional office. The WHO regional office and WHO headquarters then review and finalize
the forecast. The forecasted information is communicated by WHO headquarters to the
donating pharmaceutical companies to help with their production plans.
Accurate and timely forecasts are critical to the provision of donated medicines for NTDs
amenable to preventive chemotherapy. Short-term forecasts are requested by WHO from
country programmes to accommodate the planning, production and shipping time for the
donating pharmaceutical companies to meet the annual need for production. This forecast
is submitted during the annual request for medicines in the Joint Application Package for
the following year showing the forecasts for the next 2 years.
It is the responsibility of the NTD programme to:
■ collect and analyse the epidemiological data;
■ secure commitments for government and/or donor funding, resources and
implementing partner support;

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

■ check eligibility for donated medicines and obtain accurate stock-on-hand data, as
well as plan to procure medicines where required; and
■ ensure technical and programmatic capacity to distribute the medicine in the country.
The forecast quantification of the number of tablets is determined according to the
parameters shown in Table 11.1.

11.3 Standard operating procedure


The positions identified, their roles and the steps to be taken in this procedure are illustrative
and should be adjusted according to the prevailing context in each country.
11.3.1 Complete the Joint Request for selected medicines: not less than 12
months before MDA

When Who What How


Not less than 12 months ■ NTD programme ■ Data collection and 1. Contact relevant
before MDA manager analysis stakeholders to
■ Disease-specific ■ Forecasting and provide data for
managers quantification analysis

■ Logistics manager ■ Submission of 2. Download and


accurate, complete complete the
Joint Request signed requirements of the
by health ministry Joint Request
3. Sign and submit the
Joint Request to WHO
headquarters and the
WHO regional office

Task Instruction Responsibility References


1 Gather all the data needed to enter into the Joint ■ NTD programme See Demographic
Request, as outlined in Table 11.1. manager information
1.1. Request required data from all disease-spe- ■ Logistics managerDisease mapping
cific program managers and implementing data
NTD implementing
partners. Data to include (but not necessarily

partners National (e)LMIS (or


limited to): equivalent system
Disease-specific
Current endemicity level of the imple- which records

managers

mentation units using results of recent the inventory of


epidemiological survey (e.g. mapping ■ WHO national NTD preventive
surveys, transmission assessment survey programme chemotherapy
results, impact assessment survey) coordinator medicines in
■ Number of rounds of MDA required for country)
each disease for control/elimination Other drug sources,
targets, according to disease-specific if available in country
epidemiology Contact information
■ Target population and dosage needs by for WHO regional
age office
1.2. Request stock-on-hand data from the central See Chapter 1: Joint
medical stores and all other subnational Application Package
medical stores where NTD preventive chemo- See Chapter 5:
therapy medicines are stored. Inventory data Inventory
of medicines remaining should be recorded management
in the (e)LMIS and/or obtained from all levels
from NTD focal points See Chapter 8:
Reverse logistics
1.3. Call a meeting with relevant stakeholders to
review data

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Forecasting and quantification

Table 11.1. Parameters for forecasting quantification of donated medicines for preventive
chemotherapy

Parameter Source(s) Use


1. Current endemicity level of the Country report using Epidemiological This epidemiological information may
implementation units using results Reporting Form indicate that part of the country would
of recent epidemiological survey Formal and informal publications and interrupt or expand MDA in the following
(e.g. mapping surveys, transmission survey reports or presentations year. Estimate the number of people
assessment survey results, impact eligible for MDA based on up-to-date
assessment survey) population data and disease prevalence
by district or implementation unit.
2. Check if there is a plan to procure or Other donor information or government Subtract the committed amount from
receive medicine donations from other procurement plan the forecast or indicate the amount and
sources source so that it will not be considered
in the donor’s pharmaceutical donation
plan.
3. Information on commitment from the Amount of committed funding (domestic Information on commitment indicates
funding or implementing partners in or donor support) that part of the country would continue,
support of the country Country agreement with donor expand or interrupt MDA in the following
year.
Official memorandum of understanding
or informal donor information on
predicted funding for the next 2 years
4. Information on the country’s capacity Data from previous implementation Information on capacity indicates that
to distribute the medicine (technically Availability of human resources and part of the country would continue,
and/or financially) infrastructure of the country (e.g. NTD expand or interrupt MDA in the following
programme, implementing partner year.
support)
5. Number of rounds of MDA required for Guidelines on preventive chemotherapy According to disease prevalence, the
each disease for control or elimination and transmission control frequency of yearly MDA and the total
according to disease-specific number of rounds of MDA may differ
epidemiology (e.g. schistosomiasis, soil-transmitted
helminthiases, trachoma).
6. Consider the target population and Guidelines on preventive chemotherapy The average amount of medicine
estimate needs based on the dosage and transmission control must be calculated to quantify the
needs by age total requirement. For example, the
average amount of medicine for
diethylcarbamazine citrate is 2.5 tablets
and for albendazole and mebendazole is
1 tablet.
7. Total number of tablets estimated to Population requiring preventive This will provide the upper limit of a
be needed in the country chemotherapy based on above donation. If it is discordant from the
multiplied by the number of tablets in an country request, the country should
average dose. request an update in the WHO PCT
databank.
Demographic data (population numbers
and growth, demographic trends) at the
implementation unit level

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Task Instruction Responsibility References


2 Complete annual forecasting and quantification ■ NTD programme See quantification
for country demand. manager result/report
2.1. Download appropriate Joint Request form (Mi- ■ Logistics manager See Chapter 1: Joint
crosoft Excel template) from the WHO website Application Package
that corresponds to your local language and
NTD endemicity
2.2. Fill in the form with recent epidemiological and
up-to-date stock data for the country
2.3. Produce the annual forecast of the quantity of
medicine needed for each disease, in collabo-
ration with the disease focal points at the WHO
regional office
2.4. Complete the consignee information on the
shipment tab
2.5. Obtain signature from appropriate health min-
istry representative and date the form
3 Submit the completed, signed form to WHO ■ NTD programme See Chapter 1: Joint
headquarters, the WHO regional office and cc manager Application Package
the WHO country representative. ■ WHO national See Chapter 6:
3.1. Ensure the Joint Request includes the Joint programme Storage
Reporting Form and the Epidemiological Data coordinator
Reporting Form
3.2. Ensure the Consignee and the central med-
ical store are aware of the submission and
prepared to receive the medicines when they
arrive.
4 Maintain and update records for future submis- ■ NTD programme See Chapter 1: Joint
sions. manager Application Package
4.1. Store the (2–3 year) forecasts locally and
update annually as part of the Joint Application
Package submission process

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Annex 1. Glossary of key terms
and abbreviations

This glossary provides brief definitions of terms and abbreviations used in the document;
they may have different meanings in other contexts.
annual workplan
Form that provides information on key preventive chemotherapy and collateral activities by
health ministries for planning purposes (see Joint Application Package).
batch number, control number or lot number
Any distinctive combination of letters, numbers or symbols, or any combination of them,
from which the complete history of production, processing, packaging, handling and
distribution of a batch or lot of medical product or other material can be determined (1).
This number is available on the packing list, invoice and pallet.
DAM (“damaged medicines”)
Example notation for recording damaged or unserviceable stock on the stock card.
delivery confirmation note
Document that accompanies a shipment of goods and provides a list of the products and
quantity of the goods included in the delivery.
demurrage
Daily fees assessed on containers inside a port until the consignment is cleared through
customs and received by the consignee. The shipment has a limited amount of free time,
calculated in days, before these fees are imposed. This free time depends on the shipping
company and the port of entry (in the United States, for example, there is a 4-day fee
exemption for dry containers and 2 free days for refrigerated containers).
detention inland carrier
Hourly fee assessed on the amount of time a driver has to wait for unloading of cargo at a
warehouse. The shipment has a limited amount of free time in hours before assessment of
charges. Free time depends on the shipping line and the port of entry.
detention shipping line
Daily fees assessed on containers outside a port until the inland carrier returns the
container to the shipping line. The shipment has a limited amount of free time in days before
assessment of charges. Free time depends on the shipping line and the port of entry.

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drug aggregation
Process of gathering leftover medicines from the same level (e.g. from multiple distribution
points for mass drug administration), bundling them together with an aggregated count and
then transferring that bundle to the next stage in the process of the returning medicines.
drug distribution schedule
Schedule containing the plan for transporting medicines based on the quantities required
by region and district.
drug return process
Movement of medicines from the distribution point (lowest level) to the long-term storage
or destruction point (highest level).
drug transfer
Movement of medicines between facilities at the same level (e.g. between distribution
points during mass drug administration).
eLMIS
Electronic logistics management information system used to manage government supply
chain systems in a country.
Epidemiological Reporting Form
Form to assist countries in reporting epidemiological information including coordinated
distribution of medicines (see Joint Application Package).
EXP (“expired medicines”)
Example notation for recording expired stock on the stock card.
first expiry, first out
Method used to organize stock including medicines by expiry date and issue stock with
the earliest expiry date regardless of the date of receipt. This process differs from first in,
first out because leftover medicines may be returned from the field and stored for future
mass drug administration; they may have newer expiry dates than recently received or
transferred stock. Expiry date is the driving factor, not the date of receipt.
first in, first out
Method used to ensure stock that enters medical stores or pharmacies first is also sold
first. It does not take into account the age of the product or how long it has been in a
country. For neglected tropical diseases, first expiry, first out is the standard approach.
Example: if a storage facility (at any level) receives a shipment of albendazole on 1
April with an expiry date of September 2023, that stock should be stored BEHIND
the leftover albendazole that arrived from the field on 30 June and expires in
September 2022. The 30 June stock arrived later but expires earlier. The later-
expiring stock should ALWAYS be stored in front of the earlier-expiring stock of the
same product.
first in, last out
Procedure whereby the last order is loaded first, the second to last loaded next and so on,
with the first to be delivered now being located at the back of the truck.
inventory management
Process of ordering, storing and using inventory, as well as warehousing and processing
of such items.
invoice
Time-stamped commercial document that itemizes and records a transaction.

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Annexes

Joint Application Package


WHO-led system through which countries request medicines donated by pharmaceutical
companies for treatment of neglected tropical diseases amenable to preventive
chemotherapy. It is a set of four forms: the Joint Request for selected medicines, the Joint
Reporting Form, the Epidemiological Reporting Form, and the Annual Workplan.
Joint Reporting Form
Form to assist countries in reporting annual progress on integrated and coordinated
distribution of medicines across diseases in the reporting year in a standardized format
(see Joint Application Package).
Joint Request for Selected Medicines
Form to assist countries in applying for albendazole, diethylcarbamazine citrate,
mebendazole, ivermectin and praziquantel for use in the year after the year of application
(see Joint Application Package).
mass drug administration (MDA)
Distribution of medicines to the entire population of a given administrative setting (for
instance, state, region, province, district, subdistrict or village). In this document, the terms
mass drug administration and preventive chemotherapy are used interchangeably.
MIS (“missing medicines”)
Example notation for recording medicines missing from stock.
neglected tropical diseases (NTDs)
A diverse set of 20 diseases and disease groups that disproportionately affect populations
living in poverty, predominantly in tropical and subtropical areas. They impose a
devastating human, social and economic burden on more than 1 billion people worldwide.
They include Buruli ulcer; Chagas disease; dengue and chikungunya; dracunculiasis;
echinococcosis; foodborne trematodiases; human African trypanosomiasis; leishmaniasis;
leprosy; lymphatic filariasis; mycetoma, chromoblastomycosis and other deep mycoses;
onchocerciasis; rabies; scabies and other ectoparasitoses; schistosomiasis; snakebite
envenoming; soil-transmitted helminthiases; taeniasis and cysticercosis; trachoma; and
yaws.
open bottles
Contents of bottles that have not been fully used at the end of mass drug administration.
Each medicine will have a different shelf-life once opened and should be considered on a
case-by-case basis following the manufacturer’s recommendations and the opening date
clearly marked on the bottle/container.
periodic inventory
Monthly, quarterly, biannual or annual inventory stock counts as may be the standard
practice at specific warehouse levels in the country.
physical inventory
Process of counting stock and reconciling records of stock.
physical inventory form
Form to record results of stock count reconciliation, discrepancies in quantities and
reasons.
preventive chemotherapy
Large-scale use of medicines, either alone or in combination, in public health interventions.
Mass drug administration is one form of preventive chemotherapy; other forms could
be limited to specific population groups such as school-aged children and women of
childbearing age. In this document, the terms preventive chemotherapy and mass drug
administration are used interchangeably.

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proof of delivery
Document signed by the recipient to confirm that the shipment was delivered in good
condition.
receiving voucher
Transactional document that provides a permanent record of medicines received from
central or regional medical stores.
record-keeping
Physical inventory is accounted for on two important forms: stock cards and transfer
forms. Storage facilities should use both forms to record current stock and the history of
all transactions or adjustments (i.e. receiving, issuing, distributing and physical inventory
reconciliation).
reverse logistics
Process of returning usable surplus supplies including medicines and/or expired or
damaged supplies from lower levels to the next level within the supply chain to facilitate
redistribution to places where medicines are needed or need to be disposed of if damaged
and/or expired.
SAFE strategy
Surgery, antibiotics, facial cleanliness and environmental improvement to eliminate
trachoma as a public health problem.
shelf-life
Length of time for which a material may be stored while retaining its properties of use.
stock card
Card to specifically record receipts, issues and adjustments for medicines stored in a
particular location and generally to keep track of inventories of medicines while in storage.
stock ledger card
Also known as a “bin card”, a card to keep a record all receipts and issues of stocks from
the pharmacy stock/store department.
supply discrepancy report
Tool to report shipping or packaging discrepancies attributable to the responsibility of
the shipper (including US Government sources and contractors/manufacturers/vendors)
and to provide appropriate responses and resolution, including financial action when
appropriate. The purpose of the supply discrepancy report exchange is to determine the
cause of such discrepancies, effect corrective action and prevent recurrence.
Trachoma Elimination Monitoring Form
Form designed by the International Trachoma Initiative to assist countries in applying for
azithromycin (Zithromax®) and for monitoring progress towards elimination of trachoma as
a public health problem.
transfer form
Form to record the details of stock movements from one location to another.
transmission assessment survey
Survey designed to measure whether evaluation units have lowered the prevalence of
filarial infection to a level where recrudescence is unlikely to occur, even in the absence of
mass drug administration interventions.

■ ■ ■ ■ 100 ■ ■ ■ ■ ■ ■ ■
Annexes

waybill
Document prepared by the carrier of a shipment of goods that contains details of the
shipment, route and charges.

References
1. Code of Federal Regulations, Title 21. Washington (DC): United States Food & Drug Administration;
2018 (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3, accessed
17 May 2021).

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Annex 2. Contact list template

[Medicine name] contact sheet


Pharmaceutical contacts for shipment:
Add appropriate names as relevant. Confirm contacts with WHO.
Proforma information:
Add appropriate names as relevant. Confirm contacts with WHO.
Contact/delivery information:
Consign to/deliver to:
Importer of record:
Routing/notify:

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Annexes

Annex 3. Action items and


greenlight checklist

Action Responsible
1. Review contact list for accuracy and
completeness.
2. Confirm that shipping documentation
requirements are correct.
3. Review green light checklist items A, B
and C. Answer “Yes” when ready.

Medicine shipment green light checklist Responsible Yes/No


A. Communication Are the customs agents
aware of the shipment
and its quantity?
B. Customs duty waiver Has the customs duty
waiver been prepared?
C. Customs clearance and Are funds available to
handling costs pay customs clearance
and handling costs for
the inbound shipment?
D. Warehouse space Does the central medical
store have space to
receive the shipment?
E. Distribution Is the country prepared
to distribute the
medicines?

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Annex 4. Stock transfer form


template

■ ■ ■ ■ 104 ■ ■ ■ ■ ■ ■ ■
Annexes

Annex 5. Stock card template

NAME OF MEDICINE: STOCK CARD

Storage location: Storage unit:

Date (dd/ Transfer Origin/ Quantity Quantity Losses/ Quantity Remarks Signature
mm/yyyy) form serial destina- received issued adjust- on hand of the
no. tion (bottles) (bottles) ments (bottles) store in‐
(bottles) charge

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Annex 6. Physical inventory


count form template

SAMPLE PHYSICAL INVENTORY COUNT FORM

SAMPLE PHYSICAL INVENTORY COUNT FORM


Sheet No. Date

Performed by Department

Inventory No. Item description Purchase price Quantity Location

Signature

Your signature

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Annexes

Annex 7. Stock ledger card


template

Source:Procurement and management of supplies and equipment. In: Kaur M, Hall S. Medical supplies and
equipment for primary health care. Surrey (UK): ECHO International Health Services Ltd; 2001:13–28 (https://
www.who.int/management/resources/procurement/MedicalSuppliesforPHC(2)Procurement&Management.
pdf, accessed 18 March 2022).

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Annex 8. Drug return/transfer


form template

Text in red is illustrative.

Step Responsible Data point


1. State/region/district where transfer
originates
2. District/MDA distribution point where
transfer originates
3. Receiving facility: Receiving facility:
Write the name of the facility where the FLHF/LGA/State central medical store
medicines are to be returned/transferred
at this stage.
4. Medicines returning/transferring facility: Medicines returning/transferring
Write the name of the facility that is facility:
returning or transferring the medicines. e.g. public health center Ibeto,
Kontagora District store or central
medical store
For each medicine being returned or transferred:
5. Item description, strength and dosage Item description and dosage form:
form Zithromax tablet 250 mg
Write the name and description of the
medicine
6. Unit: Unit:
Write the smallest unit of measurement for Tablet, cap, bottle, tube, etc.
the medicine.
7. Batch no: Batch no:
Write the batch number of the medicines EPA22221
being returned/transferred.
8. Expiry date: Expiry date:
Write the expiry date of the medicines December 2024 or 12/2024
being returned/transferred.

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Annexes

Step Responsible Data point


9. Quantity returned/transferred: Quantity returned/transferred:
Write the quantity of medicines being 600 tabs, caps, tubes or bottles
returned/transferred.
10. Reason for return/transfer: Reason for return/transfer:
Write the reason why the product is being Damaged, expired, unused or
returned. redistribution
11. Items return/transfer officer: Items return/transfer officer:
The person who is returning/transferring Mohammad Amin, MA,
the medicines writes his/her name and 080xxxxxxxxxxx, 16/11/2019
signature, mobile number and date.
12. Items return/transfer approving officer: Items return/transfer approving
The person who approves the return/ officer:
transfer writes his/her name, signature, Moses Jacob, MJ, 083xxxxxxxxxxxx,
mobile number and date. 16/11/2019
13. Transporter: Transporter:
The driver transporting the medicines writes Nathan Yao, NY, 060xxxxxxxxxxxx,
his/her name, signature, mobile number, 16/11/15, BDG 114 XY
date and vehicle registration number.
14. Receiving facility: Receiving facility:
The person who receives the returned/ Amy Ido, AI, 090xxxxxxxxxxxx,
transferred medicines writes his/her name, 17/11/15
signature, mobile number and date.
15. Receiving witness: Receiving witness:
The person who witnesses receipt of the Jasmin Riota, JR, 089xxxxxxxxxxxx,
returned/transferred medicines writes his/ 19/11/15
her name, signature, mobile number and
date.
16. Remarks: Remarks:
Written by the receiving officer to e.g. complete, incomplete, unlabelled,
acknowledge the quantity and condition of improperly packaged
the returned medicines.

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Annex 9. Job aid for completing


the drug return/transfer form

This job aid can be used to complete the form for returning or transferring NTD medicines
from one level to another.
The form is a transaction record that should be completed in quadruplicate (four copies).
Once this activity is completed, the copies are distributed as follows:
■ white copy to the receiving facility;
■ yellow copy to the returning/transferring facility;
■ green copy to the transporter; and
■ blue copy to remain at the returning/transferring facility.

Job aid
Task: Completing the NTD medicines return/transfer form.
Completed by:
■ the officer at the community/MDA distribution level who is returning or
transferring the medicines;
■ the officer approving the return or transfer of the medicines;
■ the person responsible for transporting the medicines;
■ the person receiving the medicines; and
■ the person witnessing the transaction.
Purpose:
To track the return or transfer of NTD medicines.
When to perform:
Each time NTD medicines are returned or transferred from any level.
Materials/tools needed:
Blank NTD medicines return/transfer form, calculator, metre ruler and pen.

■ ■ ■ ■ 110 ■ ■ ■ ■ ■ ■ ■
Annexes

This task is completed when:


■ the names of the state, district or health facility to which the medicines were sent and
the facility returning or transferring the medicines have been completed;
■ the returned or transferred medicine is fully described by batch number, expiry date,
the quantity returned/transferred recorded and the reason(s) for the transaction stated;
■ the person returning or transferring the medicines signs the form;
■ the transporter signs the form;
■ the approving officer signs the form;
■ the witness to the transaction signs the form;
■ the receiving officer signs the form; and
■ a signed copy of the form is sent back to the facility that returned or transferred the
medicines.

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Annex 10. Inventory report/


register

Source: Procurement and management of supplies and equipment. In: Kaur M, Hall S. Medical supplies
and equipment for primary health care. Surrey (UK): ECHO International Health Services Ltd; 2001:13–28
(https://cdn-auth-cms.who.int/media/docs/default-source/ntds/neglected-tropical-diseases-non-disease-
specific/medical-supplies-and-equipment-for-primary-health-care--echo.pdf, accessed 03 January 2023).

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Annexes

Annex 11. Stock adjustment


request form template

Form serial no. ___________________

Date (dd/mm/yyyy): ___________________

Origin: ___________________

Destination: ___________________

Name and address of the person responsible:

Stock adjustment list:

No Stock Type of Original Reduced Remarks


code stock quantity quantity
1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

Department: ___________________


Requested by: ___________________ Approved by: ___________________

Signature: ___________________ Signature: ___________________

Name: ___________________ Name: ___________________

Date (dd/mm/yyyy): ___________________ Date (dd/mm/yyyy): ___________________

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Annex 12. Pharmaceutical waste


and destruction document
examples
A12.1. Pharmaceutical waste for disposal or destruction – com-
munity drug distributor register
(To accompany waste materials collected for disposal or destruction)

MDA site Waste storage type


(e.g. plastic bag)
Name of Receipt by health
community drug post focal point
distributor/health signature and date
worker (dd/mm/yyyy)
Date
(dd/mm/yyyy)

Item name Packaging Expiry date No./qty Comment


type returned
(Example): Bottle 21/12/2020 5 Bottles cleaned
500 tablet according to proper
albendazole bottle guidelines and kept
by community health
workers

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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

A12.2. Pharmaceutical waste for disposal/destruction – health


post register

Health post site Waste storage type


(e.g. plastic bag)
Name of focal point Receipt by district
post focal point
signature and date
(dd/mm/yyyy)
Date
(dd/mm/yyyy)

Item name Packaging Expiry date No./qty Comment


type returned
(Example) Spoiled Bottle 21/12/2020 215 tablets
albendazole tablet

■ ■ ■ ■ 116 ■ ■ ■ ■ ■ ■ ■
Annexes

A12.3. Pharmaceutical waste for disposal or destruction – district


health facility register

District health Waste storage type


facility (e.g. plastic bag)
Name of focal point Receipt by regional
health facility
signature and date
(dd/mm/yyyy)
Date
(dd/mm/yyyy)

Item name Packaging Expiry date No./qty Format Comment


type returned and date
disposed
of (dd/mm/
yyyy)
(Example) Spoiled Bottle 21/12/2020 215 tablets Sent to
albendazole tablet regional
health
facility

■ ■ ■ ■ ■ ■ 117 ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy

A12.4. Pharmaceutical waste for disposal or destruction –


regional health facility register

Regional health Waste storage type


facility (e.g. plastic bag)
Name of focal point Receipt by national
health facility
signature and date
(dd/mm/yyyy)
Date Pharmacist
(dd/mm/yyyy) supervising
destruction of
waste

Item name Packaging Expiry date No./qty Format Comment


type (dd/mm/ returned and date
yyyy) disposed
of (dd/mm/
yyyy)
(Example) Spoiled bottle 21/12/2020 215 tablets Incinerated Incinerated
albendazole tablet (21/1/2021) at XXXX
cement
factory
furnace

■ ■ ■ ■ 118 ■ ■ ■ ■ ■ ■ ■
Annexes

A12.5. Pharmaceutical waste for disposal or destruction –


national health facility register

National health Waste Storage Type


facility (e.g. plastic bag)
Name of focal point Receipt by National
Health Facility
Signature and Date
Date Pharmacist
(dd/mm/yyyy) supervising
destruction of
waste:

District Item name Packaging Expiry date No./qty Format Comment


type (dd/mm/ returned and date
yyyy) disposed of
(dd/mm/yyyy)
(Example) Bottle 21/12/2020 170 tablets Incinerated
Expired (12/01/2021)
albendazole
tablet

■ ■ ■ ■ ■ ■ 119 ■ ■

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