Standard Operating Procedures: For Supply Chain Management of Health Products For Amenable To Preventive Chemotherapy
Standard Operating Procedures: For Supply Chain Management of Health Products For Amenable To Preventive Chemotherapy
Standard Operating Procedures: For Supply Chain Management of Health Products For Amenable To Preventive Chemotherapy
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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
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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
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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
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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.
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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
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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.
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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.
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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]).
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Overview
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).
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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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
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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)
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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.
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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
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.
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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).
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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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.
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
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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).
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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.
World Health
Organization
ORDER
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
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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.
1.3.1 Preparing and submitting the Joint Application Package (for albendazole,
diethylcarbamazine citrate, ivermectin, mebendazole and praziquantel)
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Joint Application Package
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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).
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Joint Application Package
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).
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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.
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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).
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
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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Joint Application Package
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).
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2. Shipping notification and
green light
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Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
(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.
Request shipping
Book flight and issue
Final green light Lead time − waiver document including
airway bill
draft airway bill
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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
■
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
■
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
■ ■ ■ ■ 22 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light
■ ■ ■ ■ ■ ■ 23 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 24 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light
coordinating
personnel to
offload shipment.
Paid labourers
or current staff,
rented equipment
of offloading,
other.
programme
■
■ ■ ■ ■ ■ ■ 25 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 26 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light
■ ■ ■ ■ ■ ■ 27 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 28 ■ ■ ■ ■ ■ ■ ■
Shipping notification and green light
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
■ ■ ■ ■ ■ ■ 31 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 32 ■ ■ ■ ■ ■ ■ ■
Customs clearance and delivery
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
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
■ ■ ■ ■ 34 ■ ■ ■ ■ ■ ■ ■
Customs clearance and delivery
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
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
■ ■ ■ ■ ■ ■ 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
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
Central
warehouse
Note: If no regional medical store exists the flow would go directly to the districts.
■ ■ ■ ■ 40 ■ ■ ■ ■ ■ ■ ■
Transport
■ ■ ■ ■ ■ ■ 41 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 42 ■ ■ ■ ■ ■ ■ ■
Transport
■ ■ ■ ■ ■ ■ 43 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 44 ■ ■ ■ ■ ■ ■ ■
Transport
■ ■ ■ ■ ■ ■ 45 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 46 ■ ■ ■ ■ ■ ■ ■
Transport
■ ■ ■ ■ ■ ■ 47 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 48 ■ ■ ■ ■ ■ ■ ■
Transport
■ ■ ■ ■ ■ ■ 49 ■ ■ ■
■ ■ ■ ■ 50 ■ ■ ■ ■ ■ ■ ■
5. Inventory management
■ ■ ■ ■ ■ ■ 51 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ Follow procedure in
Before MDA. pharmacist
Chapter 7 First expiry
■ ■
■ ■ ■ ■ 52 ■ ■ ■ ■ ■ ■ ■
Inventory management
■ ■ ■ ■ ■ ■ 53 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 54 ■ ■ ■ ■ ■ ■ ■
Inventory management
■ ■ ■ ■ ■ ■ 55 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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
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.
■
■ a cooling system;
■ power maintenance;
■ a storage structure; and
■ a daily log of conditions.
Management/storage of other NTD supplies.
■
procedure.
■ ■ ■ ■ ■ ■ 59 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 60 ■ ■ ■ ■ ■ ■ ■
Storage
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
■ ■ ■ ■ ■ ■ 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”
■ ■ ■ ■ 62 ■ ■ ■ ■ ■ ■ ■
Storage
■ ■ ■ ■ ■ ■ 63 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 64 ■ ■ ■ ■ ■ ■ ■
Storage
■ ■ ■ ■ ■ ■ 65 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 66 ■ ■ ■ ■ ■ ■ ■
Storage
■ ■ ■ ■ ■ ■ 67 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■
■ ■
■ ■
■ ■
■ 68 ■
■ ■
■ ■
■ ■
■ ■
■ ■
■ ■
Storage
■ ■ ■ ■ ■ ■ 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)
■ ■ ■ ■ 70 ■ ■ ■ ■ ■ ■ ■
First expiry, first out
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
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
■ ■ ■ ■ ■ ■ 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
■ ■ ■ ■ ■ ■ 75 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 76 ■ ■ ■ ■ ■ ■ ■
Reverse logistics
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
■ ■ ■ ■ ■ ■ 79 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 80 ■ ■ ■ ■ ■ ■ ■
Removing expired and unserviceable medicines
■ ■ ■ ■ ■ ■ 81 ■ ■ ■
■ ■ ■ ■ 82 ■ ■ ■ ■ ■ ■ ■
10. Waste management
■ ■ ■ ■ ■ ■ 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.
■ ■ ■ ■ 84 ■ ■ ■ ■ ■ ■ ■
Waste management
■ ■ ■ ■ ■ ■ 85 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 86 ■ ■ ■ ■ ■ ■ ■
Waste management
■ ■ ■ ■ ■ ■ 87 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 88 ■ ■ ■ ■ ■ ■ ■
Waste management
■ ■ ■ ■ ■ ■ 89 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 90 ■ ■ ■ ■ ■ ■ ■
Waste management
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)
■ ■ ■ ■ ■ ■ 91 ■ ■ ■
■ ■ ■ ■ 92 ■ ■ ■ ■ ■ ■ ■
11. Forecasting and quantification
■ ■ ■ ■ ■ ■ 93 ■ ■ ■
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.
managers
■
■ ■ ■ ■ 94 ■ ■ ■ ■ ■ ■ ■
Forecasting and quantification
Table 11.1. Parameters for forecasting quantification of donated medicines for preventive
chemotherapy
■ ■ ■ ■ ■ ■ 95 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
■ ■ ■ ■ 96 ■ ■ ■ ■ ■ ■ ■
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.
■ ■ ■ ■ ■ ■ 97 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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.
■ ■ ■ ■ 98 ■ ■ ■ ■ ■ ■ ■
Annexes
■ ■ ■ ■ ■ ■ 99 ■ ■ ■
Standard operating procedures for supply chain management of health products for NTDs amenable to preventive chemotherapy
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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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.
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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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Performed by Department
Signature
Your signature
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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
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.
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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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Origin: ___________________
Destination: ___________________
2.
3.
4.
5.
6.
7.
8.
9.
10.
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Department: ___________________
Requested by: ___________________ Approved by: ___________________
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