Universal Medical and Business College

Research and Community Office

Extemporaneous Compounding: A Cross-sectional Survey Assessing

the Perceptions and Practices of Pharmacy Professionals in Retail
outlets at Arada sub-city, Addis Ababa, Ethiopia, 2022

Investigators: Nejat Mehdi,

Tigist Tefera
Sosena Eyasu

April, 2022
Addis Ababa, Ethiopia
 Universal Medical and Business College
Research and Community Service Office

Extemporaneous Compounding: A Cross-sectional Survey Assessing

the Perceptions and Practices of Pharmacy Professionals in Retail
outlets at Arada sub-city, Addis Ababa, Ethiopia, 2022

Investigators: Nejat Mehdi,

Tigist Tefera
Sosena Eyasu

Advisor: Mr.Muluken Nigatu

A research proposal submitted to Universal Medical and Business

College, Research and Publication Office in partial fulfillment for the
requirement of the Degree of Pharmacy.

April, 2022Addis Ababa, Ethiopia

 Aknowledgment

We would like to thank our college Universal medical and business

college for giving us this tremendous opportunity, our special thank
would go to our advisor the one and only Mr.muluken,and to our
research methodology instructor Mr. Tadesse A,our student
dean Miss taika adamu.last but not least our families and friends for
being there for us when we need them.

1
Abstract
Background

Extemporaneous compounding is defined as the preparation, mixing, assembling, packaging and

labeling of a medicinal product based on prescription order from licensed prescriber for an
individual patient. Standard of practice state that, when possible, pharmacists should prepare
drug formulation strengths, dosage forms and packages that are not commercially available but
that needed for optimum patient care

Objective

The study will determine the perception and practice of extemporaneous compounding by
pharmacy professionals and its contribution on the individualized patient care practice and its
effect on minimization of drug therapy problem.with the aim of achieving the below specific
objectives.

1,To evaluate the perception of pharmacy professionals in drug retail outlets toward
extemporaneous compounding.

2, To assess the practice of extemporaneous compounding.by pharmacy professionals in drug

retail outlet

3,To assess the reasons for extemporaneous compounding

Method

The study design to be used in this study will be cross sectional descriptive study design.

Work plan

The proposal paper work was done from title selection to paper submission to our advisor Feb
14-Mar27 respectively. The remaining work will be held till July 24 according to the colleges
schedule and will be done by the investigators whom are Nejat mehdi,Tigist tefera and sosena
Eyasu, by the help of our advisor Mr. Muleken

Budget

In order to accomplish thus work 15,560 ETB will be required and it will be covered by only the
investigators.

Key word: compounding,extemporaneous compounding

2
Table of contents
Abstract
Introduction
Literature review
Objectives
Methods
Budget
Workplan
References
Annex

3
1. Introduction

1. Introduction
1.1 Background

Extemporaneous compounding is defined as the preparation, mixing, assembling, packaging and

labeling of a medicinal product based on prescription order from licensed prescriber for an
individual patient. Standard of practice state that, when possible, pharmacists should prepare
drug formulation strengths, dosage forms and packages that are not commercially available but
that needed for optimum patient care(1).

The practice of pharmacy compounding can be traced back to ancient times with compounding
pharmacies existing for thousands of years in some form. The Middle East purportedly has the
first pharmacy in Baghdad in the 1st century A.D.; alchemy and compounding were used.
Compounding pharmacies have been in America since the early 19th century (2).

In many countries nowadays, the activity of compounding practice to the production of medicine
in alternative amount and diversified dosage forms (liquid, semisolid, solid) in community
pharmacy as well as hospital pharmacy (3). The need for these compounded medicines differs
among countries and influenced by availability of suitable dosage forms, and the requirements of
specific patient populations (4). For example, it accounts for approximately 10% of prescriptions
dispensed annually in the United states . Pharmacy is a vital service that helps many people and
serves as an important public health needs for the patients who cannot be treated with the FDA
approved medications(5).

4
1.2 Statement of the problem
There are two main types of medication a physician mainly prescribe which are commercially
available medications and compounding medications.Compounding is the act of creating a
pharmaceutical grade medication when commercially available prescriptions don’t work
effectively to meet the needs of the patient. In some casesa patient may not be able to tolerate the
dosage of formulations of commercially available. In other case a commercially available drug
may not consider the special population needs.6

Pharmacists are considered as scientists that efficiently contribute in the healthcare system. Their
role is related to the protection of the community health. Compounding is very unique attribute
of a pharmacy practice that reflect on the professional status of pharmacists provision for patient
specific health care needed, Therefore the perception and practice of pharmacists on
extemporaneous compounding play a vital role in avoidance and limitation of DTP (Drug
therapy problem) and other health related problems(7).

Factors that may affect the perception and practice of pharmacists towards extemporaneous
compounding includes Experience of the pharmacist, Knowledge of preparation, the premise of
compounding area, Quality of the available ingredients, fear of inappropriate preparation, under
dose preparation and poor patient compliance.Although application of quality standard
extemporaneous compounding is still a major concern for regulatory agencies since poor quality
compounding practice can result in life threatening contamination in products that don’t possess
the required strength,quality and purity.8

Only a few studies have attempt to evaluate variable aspects of pharmacy compounding such as
the compounding practices and beliefs of pharmacists. Although this studies have reported
valuable information, there remains a need to thoroughly assess this professional practice .9

1.3 significance of the study

The study will determine the perception and practice of extemporaneous compounding by
pharmacy professionals in community pharmacy and its contribution on the individualized
patient care practice and its effect on minimization of drug therapy problem.furthermore in
knowing how pharmacy professionals perceive extemporaneous compounding and its practice,it

5
States a stepping stone for researchers and others concerned bodies to be able to identify the
strength and limitation in this area and therefore to provide a solution.

2. Literature review

2.1introduction
Extemporaneous compounding is the preparation of a therapeutic product for an individual patient in
response to an identified need. It is a practical way to have medicines supplied when there is no other
option. For example, compounding may be useful for patients with dysphagia who are unable to swallow
solid medications whole, when an appropriate dose or dosage form is not commercially available, when
patients require an individualised dose, or when medicines must be delivered via nasogastric or
gastrostomy tubes.10

2.2. Practice of extemporaneous compounding

In 2018 a research done in Indonesia showed that Compounding personnel at Primary Health Care
Centers in Banyumas Regency, Central Java, Indonesia consist of 59 personnel consisting of pharmacist
(40.68%), pharmaceutical technicians (10.17%), compounding personnel having health educational
background (22.03%) and those from non-health educational background (27.12%). Most of the
compounding personnel are women (74.58%) while the rest of 25.42% is men. Mostly, compounding
personnel working at the Primary Health Care Centers (35.60%) are in their productive age; they are
between 20 to 30 years old. Most of their educational background are undergraduates (S1); they are 27
persons (45.76%). Commonly, the prescribers were general practitioners (79.75%), midwives (15.08%),
dentists (2%), and nurses (3.17%). Children (97.67%) are the patients who are mostly prescribed at
Primary Health Care Centers. The pediatric patients were dominated by 0–5 years-old children (74.33%)
while adult patients were only 2.33%. The most common prescription is one extemporaneous
compounding per prescription sheet as much as 97.58%. The form of extemporaneous compounding is
mostly 96.42% oral; it consisted of 88.36% puyer (crushed tablet) and 8.06% suspension.11

In 2017 a research done in Europe showed that Nine studies were identified and evaluated in which
extemporaneous products prepared by pharmacist could be identified. Most of the studies record that
prevalence of extemporaneous compounding practice is very low (less than 5%). Prescribing of
compounded medicines occurs more frequently in paediatrics and for special patients’ need. The major
types of extemporaneous compounding products were dermatological dosage forms and followed by oral
solutions and oral suspensions. Reasons for providing compounding practice were to make a customised
products that not available commercially and to provide full pharmaceutical care to patients. Issues about
the stability of compounded products, accuracy in dose strength and lack of standardised protocol in
extemporaneous compounding need to be addressed.12

6
Nine studies were identified and evaluated in which extemporaneous products prepared by pharmacist
could be identified. Most of thestudies record that prevalence of extemporaneous compounding practice is
very low (less than 5%). Prescribing of compounded medicines occurs more frequently in paediatrics and
for special patients’ need. The major types of extemporaneous compounding products were
dermatological dosage forms and followed by oral solutions and oral suspensions. Reasons for providing
compounding practice were to make a customised products that not available commercially and to
provide full pharmaceutical care to patients. Issues about the stability of compounded products, accuracy
in dose strength and lack of standardised protocol in extemporaneous compounding need to be
addressed.13

A study done in Queensland reveals 382 (36%) pharmacists and 455 (51%) students completed the
survey. Most pharmacists (96%) reported compounding a product in the 12 months prior to the survey,
particularly semi‐solids (89%) and liquids (64%) for external use. Most pharmacies (> 96%) owned basic
compounding equipment, such as a slab and spatula, mortar and pestle, and cylindrical/conical measures.
Half of the pharmacies used mechanical rather than electronic balances. Students expressed greater
confidence in their ability to use basic compounding equipment and to perform basic compounding tasks
as they progressed through the 4‐year degree course. Pharmacists' views on students' ability to compound
basic products at the end of their degree were generally similar to the proportion of final ‐year students
who reported they could confidently complete the task.14

The study done on arizona pharmacists show thst the reasons for which Arizona pharmacists do not
participate in compounding, and the beliefs of Arizona pharmacists regarding contemporary
compounding issues. Pharmacists licensed and residing in Arizona were mailed a postcard containing a
brief description of the project and the URL to a 20-item online survey. Reminder postcards were mailed
four weeks after the initial mailing, and the online survey was open to participants for two months. The
usable response rate was 8.1% (412/5112). Respondents reported approximately 8.1% of all prescriptions
and/or medication orders are compounded by a pharmacist with the most frequent aspect of compounding
performed being reconstitution and/or flavoring of commercially available, nonsterile products. The most
prevalent reason for not compounding was "not recieivng requests" (40%). "Preparation of alternate
dosage forms" was the most beneficial aspect of compounding reported (93). The most cited educational
method for teaching compounding was as "part of a required course with hands on experience" (76%) and
94% of respondents were taught by this method. Ninety-five percent of respondents agreed that
compounding is an important part of the pharmacy profession. Overall, pharmacy compounding is fairly
prevalent within Arizona and most respondents are supportive of compounding practices.15

2.3. Determinant of extemporaneous compounding

A research done in Jordan revealed that 223 (51.7%) of the surveyed pharmacies practiced
extemporaneous compounding. The main reason for not providing extemporaneous compounding
services was lack of prescription orders for compounded preparations (53.8%). The second reason was

7
lack of the equipment and supplies necessary for compounding (24.4%). Extemporaneous compounding
prescriptions were mainly issued by dermatologists (98.2%); dermatological indication was the most
common of all extemporaneous compounded prescriptions. The main reason for requesting compounded
medications was the lack of a commercially available product (87.9%). The vast majority of the
compounded dosage forms were creams (99.6) and ointments (91.5), followed by solutions (23.3%). Only
5 (2.2%) of the studied compounding pharmacies prepared sterile products. The major sources for
compounding protocols were the physician order (94.2%), and 'in-house' protocols (44.8%). However, the
main resource for estimating compounded medications expiration date was information based on
pharmacist's experience (57.8%) and the physician's order (53.4%). 16

A study done in Indonesia showed that Among the 425 pharmacists who were contacted, 305 agreed to
participate in the survey, giving a response rate of 71%. Overall, 286 (94.08%) pharmacists provided
compounding services. Compounded prescriptions accounted for 155 (11.55%) of the 1342 total
prescriptions dispensed per month. About 265 (40.4%) pharmacists reported that their aim to provide full
pharmaceutical care to patients was one of the most important reasons for providing compounding
service. About one-third of compounded prescriptions, 208 (30.1%), were general practitioners, while the
remaining were specialized physicians. The three most commonly prescribed dosage forms were powder
(32.1%), capsule (25.3%), and syrup (21.9%). The most frequent drug compounded was paracetamol
(28.1%), chlorpheniramine maleate (11.4%), and ambroxol (10.6%). Regarding the pharmacists’
perception to control the quality of compounded products, most of the pharmacists answered that they
feel confident in the quality of compounding because of the guideline provided (80.26%), documenting
all procedure in compounding (73%), and the availability of special room for compounding (56.58%).17

A study done in Yogyakarta Indonesia showed Attitude, SN, and perception of control of the TPB
components accounted for 58.6% of the variance in the prescribing intentions. The model was statistically
significant (p< 0.001). Attitude had the strongest impact on intentions. The additional variable of past
behavior increased 61.9% to the explained variance in intentions (p< 0.001). Participants’ beliefs in the
benefit of compounding prescription were the strongest predictor of the decision to prescribe.18

A study done in Palastine showed Of the 260 community pharmacists who were contacted, 212 agreed to
participate in the survey, giving a response rate of 81.5%. Overall, 153 (72.2%) of respondent
pharmacists provided compounding services. Compounded prescriptions accounted for 1973 (1.55%) of
126 840 prescriptions dispensed in a typical month. Among the compounders, 112 (73.2%) pharmacists
reported that their goal in providing full pharmaceutical care to their patients was the most important
motivator. The most frequently reported reason for not providing compounding was ‘I do not receive
prescriptions that require compounding’ by 43 out of 59 (72.9%) pharmacists. A total of 179 out of 220
physicians consented to participate in this study giving a response rate of 81.4%. The majority of
physicians (142, 79.3%) did not prescribe compounded medicines. The most important reason for their
decision to prescribe compounded medicines was the unavailability of the required dosage forms. The
most commonly cited reason for not prescribing them was a lack of trust in the quality of the compounded
formulations.19

8
Pharmacists providing specialized compounding reported that compared with their prior routine practice,
they used a greater variety of ingredients and dosage forms for more clinical conditions, used different
equipment and processes, and had upgraded facilities for handling compounded products. Patient and
physician interactions were more involved and in the case of physicians, more collaborative compared
with routine dispensing. Participants reported feeling more empowered in their roles, with improved
professional satisfaction.Specialized compounding may also be an avenue for reprofessionalization. The
organization of compounding as a specialized service should be considered in proposed changes to
compounding regulations and practice standards.20

2.3 pattern,perception and evaluation of extemporaneous compounding

Response rate was 60%; 75.2% were females and 24.8% were males. 28.2% of respondents compounded
1-5 prescriptions weekly that comprised 3-5% of total prescriptions; most prescriptions
weredermatological preparations; major reasons for compounding were product (53%), pediatric strength
42% and official preparations 41%; Major prescribers were dermatologist; Pharmacist who often
compound prescriptions; appreciable number of respondents rated standard of equipments and quality of
ingredients as high, respectively; 25% and 15.8% of respondents indicated that lack of ingredients and
lack of time limited their immediate extemporaneous dispensing; Factors that greatly inhibit
compounding were lack of equipments, lack of practice in compounding and time constrains; 49.6% of
respondents stated that demand for compounding greatly decreased over the pat few years; 52.2% of the
respondents thought that, extemporaneous compounding will be decreased in the future; 54.0% of
respondents felt that their skill in compounding were increased since graduation; most respondents had
high confidence and professional satisfaction in extemporaneous compounding; 54% of respondents felt
that their training was inadequate and emphasis should be placed in training 31,7%; 71.2% agreed for
periodical assessment of pharmacists in compounding; overall respondents felt that a refreshing course in
extemporaneous compounding is useful.21

A study done in Indonesia showed The drugs used in extemporaneous compounding were 49 types, and
the mostly used were chlorpheniramin maleate (22.54%), dexamethasone (18.20%), glycerol guaiacolate
(15.36%), amoxicillin (9.15%) and paracetamol (7.47%). Number of drugs used in each extemporaneous
compounding was various; one to six drugs per-compounding with its average 2.86 drugs per-prescription
of extemporaneous compounding. Generic drugs were mostly used in extemporaneous compounding with
percentage 93.88%, while percentage of antibiotic use was low; it was 11.36%. Based on conformity with
national formulary in Indonesia, the proper used drug in extemporaneous compounding was 71.43 %,
while based on conformity with WHO Model List Essential Medicines, it was 46.96 %. 22

A study done in Europe peninsula showed a list of the most commonly prescribed extemporaneously
compounded products to include: drug indication, generic name, dosage form, stability dating, dose
regimen, route of administration, and age group. A database was constructed and each compounded
prescription was allocated to a therapeutic category based on the American Hospital Formulary Service.
Data was obtained from a total of 555 prescriptions, available from 113 entries. The most frequently
prescribed therapeutic categories were gastrointestinal agents, skin and mucous membrane agents, and
anti-infective agents, accounting for 41%, 26%, and 14% of all prescriptions, respectively. Community
pharmacies accounted for 54%, 76%, and 27% of prescriptions in the gastrointestinal, skin care, and anti-
infective agents' individual categories, respectively. Hospital pharmacies accounted for 46%, 24%, and
73%, of prescriptions in the gastrointestinal, skin care, and anti-infective agents' individual categories,

9
respectively. Prescriptions containing lidocaine along with other active ingredients, mainly
gastrointestinal cocktail and magic mouthwash, were the most commonly filled prescriptions in the
gastrointestinal category.23

A study done in new England Four articles met inclusion criteria. The 2012-2013 fungal infections
outbreak was attributed to 3 lots of preservative-free methylprednisolone acetate, which comprised
17,675 vials distributed to 76 facilities across 23 states. Median incubation period (from time of last
injection to initial diagnosis) was 47 days, ranging from 0 to 249 days. According to the FDA, a total of
30 recalls regarding compounded products were issued by pharmacies during March through December
2013.24

A study done in England In September 2012, a single case report sparked an investigation into a
nationwide outbreak of fungal meningitis due to contaminated injectable drugs. The source of the
contamination, New England Compounding Center (NECC), was in violation of several state and federal
laws and had a history of such violations. The regulation of compounding pharmacies has historically
been left to the states, while manufacturing fell under the jurisdiction of the Food and Drug
Administration. However, as more compounders took part in large-scale interstate distribution of drugs,
the current state-based regulatory system became less equipped to provide oversight. The lack of a clear
definition of "compounding pharmacy" further obscures proper oversight and regulation. Congress and
several states have taken steps to build safeguards against large-scale compounding by increasing
inspections, adopting stricter licensing requirements, and enacting the Drug Quality and Security Act of
2013.25

The study done in khartoum found that Fifty-four questionnaires were completed (78.6%), 61.1% males
and 38.9% females; 33.3% of respondents dispensed 1-5 prescription weekly; For 70.4% of respondents
extemporaneous prescriptions made up >1%-5% of total prescriptions; Productsprescribed were mainly
dermatological preparations; The main reasons for prescribing were product not commercially available
and physician’s preference; 92.6% stated that prescriber were very often dermatologist; 22.2% and 20.0%
rated standard of the equipments and quality of the ingredients as high, respectively; 33.3% cited that lack
of ingredients often limit extemporaneous dispensing; 44.5% and 40.8% had high confidence and
satisfaction in extemporaneous compounding, respectively; 59.5% and 53.7% felt that undergraduate
training was adequate and their skills increased since graduation, respectively; 81.4% and felt that
refreshing courses would be useful; 77.8% agreed for periodical assessment ofpharmacists; 40.8% and
40.7% believed that extemporaneous dispensing had greatly decreased in the few past years and will
decrease in the future, respectively; 66.7% and 5% agreed that extemporaneous compounding should be
undertaken by all pharmacists and decline for all, respectively; 48.2% supported specialist pharmacies. 26

Most respondents were pharmacists (62.7%) and frst-degree holders (48.3%). The majority of them had
experience in administering (57.7%), preparing (38%), prescribing (21%), and repackaging and labeling
(14%) compounded medications. Commonly they request compounded medications when prepackaged
products (77.7%) and needed dosage regimens (72.3%) were not available in the market. However, most
of them believed that compounded medications might lack quality (49%) and had poor patient

10
compliance (40.7%). Moreover, they fear that inappropriate preparation processes (75%) and under-dose
administration (59%) of compounded medication might contribute to the development and prevalence of
antimicrobial resistance.27

The compounding pharmacists in this study had a mean age of 30.6 (±3.1) years and nine of the thirteen
participants were men. Ten participants believed that the compounding practice in their respective sites
followed the principles of good compounding practice. More than half of the participants did not believe
that ABHR products were used rationally in health facilities. They argued that users did not have enough
awareness when and how to use sanitizers. Most of the interviewees reported that compounding personnel
had no formal training on ABHR solution production. Study participants suggested incentive mechanisms
and reimbursements for experts involved in the compounding of ABHR .28

Out of the 13 public hospitals observed in the study, 11 facilities had dedicated premises for
compounding of ABHR solution. Seven facilities determined the concentration of ethanol in ABHR
solution using alcoholmeters. Only one health facility had a titration kit and performed a strength test for
the hydrogen peroxide raw material. Thermal and chemical disinfection processes were practiced for
cleaning of recycled dispensing bottles only in 3 and 2 hospitals, respectively. Most of the hospitals (11
facilities) had standard operating procedures (SOPs) for production, but the majority lack SOPs for
beyond-use-date assignment (11 facilities), premise and equipment cleaning (12 facilities), and
disinfection of recycled bottles (12 facilities).29

In this study, most extemporaneous pediatric oral formulations were chemically, physically, and
microbiologically stable and retained more than 90% of the initial content. Very few studies did not
include either a physical stability test or a microbiological stability test.30

11
3. Objectives

3.1General objective

To assess perceptions and practice of community pharmacists towards extemporaneous

compounding in Arada sub city Addis Ababa, Ethiopia, 2022

3.2 Specific Objectives

 To assess the perceptions of community pharmacists towards extemporaneous
compounding in Arada sub city Addis Ababa, Ethiopia, 2022
 To assess the practice of community pharmacists towards extemporaneous compounding
in Arada sub city Addis Ababa, Ethiopia, 2022
 To identify factors associated with perceptions and practice of community pharmacists
towards extemporaneous compounding in Arada sub city Addis Ababa, Ethiopia, 2022

12
4. Methods
4.1. Study setting
The study will be carried out in community pharmacies found in Arada sub city Addis Ababa,
Ethiopia. There are nearly 50 pharmacies in the sub city.

4.2. Study period

This study will be conducted between May and June, 2022 in Arada sub city, Addis Ababa.
Ethiopia.

4.3. Study Design

Facility based semi-structured cross-sectional study design will be employed: A predesigned
questionnaire will be used to collect the relevant information pertaining to the study variables.

4.4. Population

4.4.1Source population
The source populations for the study will be all drug retail outlets in Arada sub city Addis
Ababa, Ethiopia.

4.4.2 Study population

The study population will be community pharmacies in Arada sub city Addis Ababa,
Ethiopia.

4.5 Eligibility criteria

4.5.1 Inclusion criteria

All pharmacy professionals working in community pharmacies in Arada sub city Addis Ababa,
Ethiopia who will agree to involve in the research.

4.5.2 Exclusion criteria

Pharmacy professionals working at community pharmacies who will not be present during the
data collection time and those who will not agree to involve in the research will be excluded.

13
4.6. Sample Size and Sampling Technique
Purposive sampling will be employed for the study. All pharmacy professionals working in
Arada sub city community pharmacies will be included in the study to assess the perceptions and
practice towards extemporaneous compounding. Therefore, a total of about 200 participants will
be included.

4.7. Study Variables

4.7.1 Dependent variable

 Attitudes towards extemporaneous compounding

 Practice of extemporaneous compounding

4.7.2 Independent variable

Age, gender, qualification, total work experience, extemporaneous compounding experience

4.8. Data collection

A semi-structured questionnaire will be used to collect data. Students will be asked to confirm
their willingness to participate on the written consent form; afterwards they will be given the
questionnaire. The questionnaire will be self-administered. In the end, the questionnaires will be
gathered and checked for completeness.

4.9. Data Quality Assurance

Semi-structured questionnaire will be prepared in English Pre-test of the questionnaire will be
done on 5% of sample size in similar study participants which is not to be included in study
before the actual data collection to see the accuracy of responses and to estimate time needed.
Every day, the collected data will be reviewed and checked for completeness and consistency of
the response.

4.10. Data Analysis

The data will be entered into EPI-data V. 4. 2 and analyzed using Statistical Package for IBM
social sciences (SPSS) version 23. Descriptive statistics will be used for analyses of general
characteristics of participants. Categorical variables will be described by frequencies and
percentages, and continuous variables will be described by means and standard deviations.

14
4.11. Ethical approval
Ethical approval will be obtained from UMBC Research and Publication Office. Participants of
the study will also be asked for consent before participating in the study. During the consent
process, they will be provided with information regarding the purpose of the study and will be
assured about the confidentiality of the information obtained in the course of the study by not
using personal identifiers and analyzing data in aggregates.

4.12. Dissemination of Result

The findings of this study will be sent to the department of Pharmacy and other bodies to whom
the study finding is found to be beneficial. The study result will also be published in reputable
journal.

5. Budget Breakdown
Table 1: Budget breakdown for the study

Item Quantity Unit Cost Total Cost

(ETB) (ETB)

15
 Paper 4 360 1440
Translation 3 200 600
Transportation 3 1000 3000
Printing 2952 4 11808
Writing materials 36 10 360
Miscellaneous 1 500 500

6. Work Plan
Table 2: The study will be carried out according to the following plan.

S. Activities Responsible March April May June July

N person

1 Proposal preparation/devt PI 3-27

2 Proposal submision PI 01-15

4 Data collection PI 09-31

16
 5 Experimental work 09-31

6 Data entry and analysis PI & Advisor 01-05

7 Write up PI 06-26
7 Submission of the final PI 27 03
report

7. Reference
1,Gubara O.A et al. Attitudes and opinions of hospital pharmacists towards extemporaneous
compounding and related issues in Khartoum city. Wo Jou Pharm Res. 2018;7(8):2-3.
Availalable from: https://journals.indexcopernicos.com

2,Uzondu Al et al. Prescription pattern of anxiolytic drugs used in orthopaedic patients. Jou
Pharm All Scie. 2013;10(2):2-4. Available from: https://impactfactor.org

3,Dias F, Marinho M et al. Cellulose and its derivative used in the pharmaceutical compounding
practice. Edition 1. Minas Genais: InTech;2013. Available from:
http://creativecommons.org/licenses/by/3.0

4,Lau Et et al. Compounding practices in Queensland. Jpharm Prac Res. 2021;43(1):19-24.

Available from: https://doi.org/10.3390/pharmacy8010027

17
5,Roark AM, Anksons H et al. Long-term results of an analytical assessment of student
compounded preparations. Ame Jou Pharm Edu. 2014;78(9)1-6. Doi: 10.5688/ajpe789164

6, Custom Formulations for Your Unique Medication Needs.The Compounding Pharmacy of

America.2022Available from: https://compoundingrxusa.com/what-is-compounding/

7,Angeliki siamidi et al. Pharmaceutical Compounding: Recent advances, reasons learned and
future perspective. Glo Dru The. 2017;2(2):1-3 Available from: https://www.oatext.com

8,Hatim S etal.Analysis of Factors that Affect the Decision of Pharmacy to Perform

Compounding Results Using Stepwise Logistic Regression
Analysis.BMC.2019/11.vol19(1).https//Doi:10.1186/s12913-019-4684-y.

9,Kimberly AB Cauthon et al. Compounding practices and belief of Arizona Pharmascists.Int J

Pharm Compd. 2013;17(2):154-6. Available at https://doi.org/10.1186/512913-022-07649-4

10. James R Falconer.Extemporaneously compounded medicines.AP.2017/02/01/.40(1):5–8. DOI

10.18773/austprescr.2017.001

11. Marchaban Marchaban.The extemporaneous compounding at primary health care centers:

Characteristic and personnel.GJH.2018.vol10(9).112.

12.Chairun Wiedyaningsih etal.Extemporaneous compounding practice by pharmacists: a systematic

review.IJPP.2017.vol9(i2).42-46.

13.SUSI ARI KRISTINAet al.EXTEMPORANEOUS COMPOUNDING PRACTICE BY

PHARMACISTS: A SYSTEMATIC REVIEW.Int J Pharm Pharm Sci.2017:9(2);42-46

14. Esther TL Lau etal.Compounding practices in Queensland: experiences and perceptions of

pharmacists and pharmacy students.Journal of Pharmacy Practice and Research.JPPR.2013.vol43(I 1).19-
24.espace.library.uq.edu.au

15.Kimberly A B Cauthon et al.Compounding practices and beliefs of Arizona pharmacists.Int J Pharm

Compd. Mar-Apr 2013;17(2)

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16.AlKhatib HS.Prevalence, determinants, and characteristics of extemporaneous compounding in
Jordanian pharmacies.Europe public medical center. Epmc.219/11/08.19(1):816DOI: 10.1186/s12913-
019-4684-y

17.Susi Ari Kristina.Profile and determinants of compounding services among pharmacists in

Indonesia.AJP.2018.12(03).

18.Chairun WiedyResearch etal.THE USE OF THE THEORY OF PLANNED BEHAVIOR TO

PREDICT FACTORS INFLUENCING PHYSICIANS'DECISION TO PRESCRIBE
EXTEMPORANEOUS COMPOUNDING DOSAGE FORM FOR PEDIATRIC OUTPATIENTS.Asian
Journal of Pharmaceutical and Clinical Research.AJPCR.2016.v9(i4).288-291.

19.Abdel Naser Zaid etal. Determinants and frequency of pharmaceutical compounding in pharmacy
practice in Palestine.Ijpp. 2012/02.2022.Volume 20, Issue 1, Pages 9–14, https://doi.org/10.1111/j.2042-
7174.2011.00157.x

20.Jennifer Anne.Characterizing specialized compounding in community pharmacies.RSAP.may-june

2012;8(3):240-252

21.Gubara O. Aet al.ATTITUDES AND OPINION OF HOSPITAL PHARMACISTS TOWARDS

EXTEMPORANEOUS COMPOUNDING AND RELATED ISSUES IN KHARTOUM CITY: PART
II.WJPR.2018;7(8).

22.Indri Hapsari etal.Prescribing Pattern of Extemporaneous Compounding in Primary Health Care

Centers.GJHS.2018/11.v10(I 12).104.DOI:10.5539/gjhs.v10n12p104.

23.Sherr Z, Karara AH.Evaluation of the most frequently prescribed extemporaneously compounded

medications in a rural setting: a case study from the Delmarva Peninsula.International Journal of
Pharmaceutical Compounding.IJPC. 2014/11/01,
v18(i6).p462-468.https://europepmc.org/article/med/25906622

24.Qureshi N etal.Sterile compounding: clinical, legal, and regulatory implications for patient
safety.Journal of Managed Care & Specialty Pharmacy.JMCSP.2014/12/01.vol 20(I 12).p1183-
1191.DOI: 10.18553/jmcp.2014.20.12.1183.

25.Teshome BF etal.How gaps in regulation of compounding pharmacy set the stage for a multistate
fungal meningitis outbreak.journal of the American pharmacy association.
JAPA.2014/07/01.vol54(i4):p441-445.DOI: 10.1331/japha.2014.14011

19
26Othman A. Gubaraet al.EXTEMPORANEOUS COMPOUNDING: ATTITUDES OF COMMUNITY
PHARMACISTS AT KHARTOUM CITY.WJPR.2016;5(6):119-140

27.Desta Assefaet al.Investigating the knowledge, perception, and practice of healthcare practitioners
toward rational use of compounded medications and its contribution to antimicrobial resistance: a cross-
sectional study.BMC Health Services Research.2022:22(243)

28.Assefa Mulu Baye et al.Perspectives of compounding pharmacists on alcohol-based hand sanitizer

production and utilization for COVID-19 prevention in Addis Ababa, Ethiopia: A descriptive
phenomenology study.PLoS One.april 29 2021:https://doi.org/10.1371/journal.pone.0250020

29.Muluken Nigatu Selam et al. J Pharm Policy Pract. Adequacy of alcohol-based handrub solution
production practice in response to COVID-19 in public hospitals found in Addis Ababa, Ethiopia: a
multicentered cross-sectional study.jppp.2021;14(39)

30.Anteneh Belayneh et al. A Systematic Review of the Stability of Extemporaneous Pediatric Oral
Formulations.ScientificWorldJournal. 2021.

31,https://en.m.wikipedia.org/wiki/Arada_(district_of_Addis_Ababa)

Universal Medical College

Pharmacy Department

Introduction:
Attached herewith is a self-administered questionnaire developed to assess the attitudes and
practice of pharmacy professionals towards extemporaneous compounding in Arada sub city,
Addis Ababa, Ethiopia, 2022. This study is conducted by the candidates Nejat Mehdi,
Tigist Tefera, and Sosena Eyasu for the partial fulfillment of the requirements for the degree of
Bachelor of Science in pharmacy at Universal Medical and Business College.

Your participation is purely voluntary and information you provide will be kept completely
confidential. Your name will never be written and aggregate responses from different
respondents are identified only by codes.

20
 Your honest response to the questions is of paramount importance for the successful completion
of the study. There is no Right or Wrong answer and you can have clarification for any doubt
regarding the questions. If you have any questions or comment in the meantime, please feel free
to contact the investigator Nejat Mehdi (Tel: 0979478156).

Are you willing to respond to the questions? Yes  No 

Annex-1
Data collection tool

SECTION-I: SOCIO DEMOGRAPHIC AND GENERAL DATA

SN Characteristics Possible response
1 Age in years __________________
2 Sex  Female  Male

3 Marital Status  Never married Divorced/separated

 Living with partner Widow/widower
 Married
4 Qualification Diploma Second degree
First Degree (BSc)  Other: _________
5 Training modality you attended pharmacy  Regular  Weekend
education  Night
6 Did you attend diploma/level program of pharmacy  Yes  No
before you begin degree program?
7 Work place  Private Pharmacy  Hospital pharmacy
 Kenema pharmacy  Other, ________
8 Total work experiences (in years) ___________________________
9 Did you receive formal training on the Yes No

21
 extemporaneous compounding other than the under
graduate training
10 Do you friend/relative who has practiced Yes No
extemporaneous compounding?
11 Have you practiced extemporaneous compounding Yes No
in the work place?
12 How long did you engage in compounding service
at your work place if you have experience? (in
years)

SECTION-II. ATTITUDE
Please indicate your agreement or disagreement with the following statements by encircling ONE number on
the provided scales: 1= Strongly Disagree; 2= Disagree; 3=Neutral; 4= Agree; 5= Strongly Agree.
SN Item Your Level of Agreement
I believe the extemporaneous compounding service is an outdated and
1 1 2 3 4 5
traditional pharmacy service
I prefer not to engage in compounding extemporaneous preparations as
2 1 2 3 4 5
it is time consuming
I prefer not to engage in compounding extemporaneous preparations as
3 1 2 3 4 5
there is exposure to chemical hazards
I believe pharmacy professionals should be periodically assessed to
4 1 2 3 4 5
determine their competence in extemporaneous compounding
I believe the undergraduate training has enough practical session to
5 1 2 3 4 5
equip students with the skill of extemporaneous compounding
I believe compounding extemporaneous preparations requires specific
6 training in addition to the practical session of the undergraduate 1 2 3 4 5
training
I believe the equipment used for compounding extemporaneous
7 1 2 3 4 5
preparations are easily available in the local market
I think pharmaceutical grade chemicals and ingredients required for
8 compounding extemporaneous preparations are easily available from 1 2 3 4 5
the local market
I believe compounding extemporaneous preparations is an important
9 service to provide pharmaceutical products which is not available in 1 2 3 4 5
the commercial market
I believe the practice of compounding extemporaneous preparations are
10 1 2 3 4 5
difficult because of lack of reference books/literatures
I believe the extemporaneous compounding service enhances the
11 1 2 3 4 5
acceptability of pharmacy professionals by the patients/public
I believe prescribers have confidence on the quality of the
12 1 2 3 4 5
extemporaneously compounded products by pharmacy professionals

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 I believe patients have confidence on the quality of the
13 1 2 3 4 5
extemporaneously compounded products by pharmacy professionals
I believe the extemporaneous compounding is a well-practiced service
14 1 2 3 4 5
in the country
I believe there are enough skilled persons in the country to perform the
15 1 2 3 4 5
extemporaneous compounding service
I think ensuring the quality of extemporaneous compounded products
16 1 2 3 4 5
is a challenging task
I believe extemporaneous compounded products have low cost than
17 1 2 3 4 5
commercially available similar products
18 I have doubts on the quality of extemporaneous compounded products 1 2 3 4 5
19 I have no trust in safety and efficacy of compounded medications 1 2 3 4 5
I prefer the extemporaneous compounded products than commercially 5
available ones if both are possible options 1 2 3 4

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SECTION-III. PRACTICE
S,N Item Response
o
1 Is there a compounding service at your facility  Yes  No
What are challenges/barriers for the compounding service at your  Unavailability of pharmaceutical
facility? (more than one answer is possible) grade chemicals/ingredients in the
local market
 Chemicals/ingredients in the local
market are expensive
 Lack of references/books
 Lack of adequate equipment
 Exposure to chemicals hazard
2  Lack of adequate and appropriate
premise
 Lack of adequate training in this
area
 Pharmacy professionals lack
interest for the service
 Insufficient payment for the
service
 Other, specify ____________
3 What are opportunities for the compounding service at your  Availability of adequate
23
 facility? (more than one answer is possible) pharmacy professionals
 Availability of experienced or
trained pharmacy professionals in
this area
 Availability of adequate
equipment
 Presence of premise for the
service
 Availability of references/books
 Other, specify ____________
If your response for question 1 is ‘YES’, please respond to the following questions
4 How long do you engage in compounding practice? (in years) ____________
Reasons for providing a compounding service? (more than one  I want to provide full
answer is possible) pharmaceutical care to my patients
 Compounding is a factor that
reinforces trust between patients
and pharmacists
 I enjoy compounding
 Compounding is an intellectually
stimulating part of pharmacy
practice
 Compounding helps in
individualization of therapy
5
 Compounding is a profitable duty
 Compounded medications are less
expensive
 Ministry of Health (MOH)
encourages compounding
 Ethiopian Pharmaceutical
association (EPA) encourages
compounding
 I have received training
 Other, specify
__________________
How frequent you are using pharmaceutical grade chemicals and  Always  Often
6 ingredients for compounding?  Some times  Rarely
 Never
Purified/distilled water is used for compounding  Always  Often
7  Some times  Rarely
 Never

24
 Are there adequate equipments for compounding practice at your
8  Yes  No
facility?
I am concerned about quality of compounded product  Always  Often
9  Some times  Rarely
 Never
I am concerned about stability of compounded product  Always  Often
10  Some times  Rarely
 Never
I am concerned about safety of compounded product  Always  Often
11  Some times  Rarely
 Never
12 Have you ever recalled the compounded product after dispensed?  Yes  No
Have you ever received patient compliant about the safety of
13  Yes  No
dispensed preparations?
Have you ever received patient compliant about the efficacy of
14  Yes  No
dispensed preparations?
Have you ever received patient compliant about the
15  Yes  No
quality/stability of dispensed preparations??
Do you wash your hands before starting the compounding  Always  Often
16 activity?  Some times  Rarely
 Never
Do you wash your hands after the compounding activity is over?  Always  Often
17  Some times  Rarely
 Never
Do you clean the compounding bench/table when you move to the  Always  Often
18 next prescription/compounding of different preparation?  Some times  Rarely
 Never
Do you prepare anticipated products before the receipt of  Always  Often
19 prescriptions?  Some times  Rarely
 Never
The average period/time ℞ containing one active/drug ____________ minutes
required for preparation ℞ containing two actives/drugs ____________ minutes
20
℞ containing three
____________ minutes
actives/drugs
The average period/time assigned as beyond use date (BUD) for
21 ____________ days
the compounded product
22 Where do you get information about the compounding practice?  From internet
(more than one answer is possible)  From reference books
 From colleagues
 From MOH guideline

25
  Other, specify
__________________

ASSURRANCE OF PRINICIPAL INVESTIGATOR

The undersigned agrees to accept responsibility for the scientific ethical and technical conduct of the
research project and for provision of required progress reports as per terms and conditions of the
Universal Medical and Business College Research and Community Service Office.

26
Name of the principal investigators:_______________________________________________

Date: ____________________________________ Signature: __________________________

APPROVAL OF THE ADVISOR

Name of advisor: _______________________________

Date: ____________________________________ Signature: __________________________

27