CATHOLIC UNIVERSITY OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

QUANTIFICATION OF EXPIRED DRUGS AT MAKONGORO HEALTH CENTRE

MAIN STORE

NAMES;

1.JOSEPH SAYI KUBAGWA CUHAS/PH/7000883/T/19.

2. WITNESS KISOKA CUHAS/PH/7000984/T/19.

3. LILIAN MALIMI KITOYA CUHAS/PH/7001032/T/19.

4 JANETH AMOS KUZENZA CUHAS/PH/7001934/T/20

5. MWANAIDDI LUMUMBA KISESA CUHAS/PH/7001008/T/19

SUPERVISOR NAME; MR. VICENT MANYANGA.

“Research proposal for partial fulfillment for the award of (Diploma in Pharmaceutical Sciences)

of the Catholic University of Health and Allied Sciences.”

DATE OF SUBMISSION; _______________________

DECLARATION;

WE,

1.JOSEPH SAYI KUBAGWA ____________________

2.WITNESS KISOKA ____________________

3.LILIAN MALIMI KITOYA ____________________

4.JANETH AMOS KUZENZA ____________________

5. MWANAIDDI LUMUMBA KISESA ____________________

Do hereby declare to the CATHOLIC UNIVERSITY OF HEALTH AND ALLIED

SCIENCES that the work presented is original and has not been submitted for any award at

CUHAS

Date; ___________________________

SUPERVISOR NAME; MR. VICENT MANYANGA

Signature; _________________ Date; ____________________

ABBREVIATIONS;

CAG – Comptroller and Auditor General

MSD – Medical Stores Department

FY – Fiscal Year

CUHAS – Catholic University of Health and Allied Sciences

FDA - Food and Drug Administration

LIC – Lower Income Country

LMIC – Lower-Middle Income Country

ICH – International Council for Harmonization of Technical Requirements for Pharmaceuticals

for Human Use.

OPERATIONAL DEFINITIONS;

Expiration date; This reflects to the time period during which the product is known to remain

stable, which means it retains its strength, quality and purity when it is stored according to its

labelled conditions.

Expired drug; this refers to any medication that is past its expiration date, or that is deteriorated,

and discontinued from use, that is considered as wastage.

Push system; This is a chain supply system in which the supplier determines when and what

quantities of items are to be received by the clients,( in this case, the health facilities).

Pull system; This is a supply chain system in which the clients (health facilities) determine when

and what quantity of items they require, and they make orders to the suppliers based on their

consumption rate.
ABSRACT
CHAPTER ONE;

01. INTRODUCTION

1.1 Background Information;

Pharmaceuticals remain a top priority for the Government bodies in both national and

international levels, contributing to a significant rise in the overall healthcare cost. The presence

of medicines and medical supplies in health facilities highly determine the level and quality of

health services provided.

The government dedicates considerable amounts of money for the procurement and logistics of

pharmaceuticals within the health facilities, so as to ensure their constant availability. In

Tanzania, for example, a total of Tsh 2,222 Billion was allocated for the health sector, with Tsh

260 Billion allocated for Pharmaceutical Services. (1)

However, the sufficient availability of pharmaceuticals is greatly threatened by high rates of

expiry of drugs within health facilities. Drug expiries are one of the contributing causes of loss

and wastage of material and financial resources within the health facilities.

According to the CAG’s 2020/2021 report, an existence of expired medicine worth Tsh. 3.49

billion (in the registers for expired medical drugs) has been noticed at the MSD, stocked for 46

Local Government Authorities, in a period ranging from 3 months to 20 years. These expired

medicines pose a potential health threat if they find their way into the market.

Medication wastage at the health facilities is a huge concern due to wastage of potentially useful

medications as well as the costs associated with disposal of those medications. Unused/expired

pharmaceuticals pose a threat to both the health care system and to the environment. Given the
budget constraints in financing the health care system together with the huge amount of wastage

and disposal costs of those unused medications at low- and middle income countries will pose a

huge threat to the health care system and to the total economy in general.

Practically, medications wastage cannot be completely eliminated. However, carefully

examining contributing factors and identifying the most common and expensive medications

involved, is certainly worthwhile, and may help in recognizing the most suitable measures to

reduce medication wastage. Effective communications among health care professionals,

pharmacist training, and adherence to standard practice guidelines might be the most vital

strategies to reduce medication wastage at health facilities.(2) (Ebrahim et al).

1.2 Problem Statement;

There is a significantly large amount of medicines that expire within health facilities, and they

greatly contribute to loss of resources / resource wastage, as they are considered as assets.

Expiries of medicines in health facilities contribute to insufficiency of medicines, leading to the

decrease of quality of healthcare given in those facilities. The current situation regarding the

extent of drug expiries in health facilities is not clearly known, which is why it is necessary to

conduct studies which will enlight decision makers, regarding the expiries of drugs, so that

relevant action may be taken.

 1.3 Rationale of the Study;

This study will aim at identifying the groups of drugs that most commonly end up expired, and

the quantities of such expired drugs that are accumulated in the facility’s main store, throughout

the year 2019/2020, as this information will help in identifying what drugs are most susceptible

to expiration.

1.4 Research Question;

What medicines / groups of medicines are mostly reported expired from various departments in

the main store, with their respective quantities, at Makongoro Health Centre

1.5 Research Objective;

1.5.1 Broad Objective;

To determine the current situation of drug expiries present at Makongoro Health Centre main

store.

1.5.2 Specific Objectives;

 To determine the quantities of expired drugs for the year 2019/2020.

 To determine the therapeutic groups of the expired drugs for the year 2019/2020
CHAPTER TWO

2.0 LITERATURE REVIEW;

2.1 EXPIRED DRUGS OVERVIEW;

An expiration date is defined based on a drug that is stored under “ideal manufacturer-suggested

conditions of temperature, humidity, light exposure, and packaging integrity.” (ICH,2002). The

expiry date specified by the manufacturer of a drug means that a drug should meet the applicable

standard of identity, purity, strength and quality at the time of use, provided that it is kept under

storage conditions indicated by the manufacturer (Farrugia, 2005) (03).

2.2 EXPIRATION QUALIFICATIONS;

According to the US Food and Drug Administration (FDA), drug manufacturers are required to

label their products with expiration dates, based on real time or estimated testing data. Most

products are released to the market with expiration dates of 1 to 5 years from their date of

manufacture ( Lyon et al, 2006).

In case of drugs stored in temporary, provisional warehouses as in emergency settings, however,

it is very hard to rely on the quoted expiry date. This initial expiration date may later be extended

based on further stability testing (Lyon et al, 2006).

In low, or low- and- middle- income countries (LICs/LMICs), such as Tanzania, it should be

possible to extend the useful lives of medications that pass tests for efficacy and safety, as this

will help save both money and the environment, through Shelf Life Extension Programs(SLEP),

therefore, the printed expiry dates may not necessarily represent the ultimate shelf life (Kamba et

al, 2007). (03).

 2.3 PREVALENCE OF DRUG EXPIRIES;

A cross-sectional survey of six public and 32 private medicine outlets in Kampala and Entebbe

municipality was conducted using semi-structured questionnaires (Nakyanzi et al., 2010).

Results showed that drugs and medicines prone to expiry include those used for vertical

programmes, donated drugs, and those with a slow turnover. Even essential medicines expired in

the supply chain. The Ministry of Health of Uganda introduced the ‘Pull’ system of drug supply

in 2003 to overcome the problems of drug availability and expiries. This system requires the

health units to determine the types and quantities of medicines and medical supplies they need

(Tumwine et al., 2010:557- 558). Records of 27 essential medicines and 11 medical supplies in

Kilembe Hospital, western Uganda were reviewed over two periods in a ‘Push’ (2000 - 2001)

and ‘Pull’ system (2004 - 2005). Results showed that there was higher volume and number of

expired drugs and medical supplies in the 2001-2002 period compared to the 2004-2005 period

(Tumwine et al., 2010:559). Large quantities of expired drugs and medical supplies were found

in most district level facilities (Tumwine et al., 2010:558). Expired drugs were worth USD1,584

(25 items) in 2000/2001 and USD1,307 (13 items) in 2004/2005 (Tumwine et al., 2010:560).

The key informants felt that abrupt changes of policies caused expiry of drugs: “There are

sometimes abrupt changes in policies, for example, the changes in antimalarial policy whereby

the first line drugs were changed from chloroquine and Fansidar to artemether-lumefantrine yet

there were already large supplies of the former. These could lead to expiry of the drugs in stock”

(Tumwine et al., 2010:560). Now when drugs are received, they are stored according to FIFO

and First-Expiry First-Out (FEFO) principles (Tumwine et al., 2010:562).(03).

 2.4 THREAT POSED BY EXPIRED DRUGS;

In some low- and middle-income countries, the national stores and public-sector health facilities

contain large stocks of pharmaceuticals that are past their expiry dates. In low-income countries

like Uganda, many such stockpiles are the result of donations. If not adequately monitored or

regulated, expired pharmaceuticals may be repackaged and sold as counterfeits or be dumped

without any thought of the potential environmental damage (Kamba et al)

The rates of pharmaceutical expiry in the supply chain need to be reduced and the disposal of

expired pharmaceuticals needs to be made both timely and safe. Many low- and middle-income

countries need to: (i) strengthen public systems for medicines’ management, to improve

inventory control and the reliability of procurement forecasts; (ii) reduce stress on central

medical stores, through liberalization and reimbursement schemes; (iii) strengthen the regulation

of drug donations; (iv) explore the salvage of officially expired pharmaceuticals, through re-

analysis and possible shelf-life extension; (v) strengthen the enforcement of regulations on safe

drug disposal; (vi) invest in an infrastructure for such disposal, perhaps based on ultra-high-

temperature incinerators; and (vii) include user accountability for expired pharmaceuticals within

the routine accountability regimes followed by the public health sector (04).
CHAPTER THREE

3.0 METHODOLOGY;

3.1 STUDY AREA;

The study was conducted at Makongoro Health Centre, in Mwanza, Tanzania, specifically at the

facility’s main store. Makongoro Health Centre is a primary level health facility located at

Ilemela district, in Mwanza region.

3.2 STUDY DESIGN AND PROJECT DURATION;

The study was facility-based, with a cross-sectional design, and involved analytical data

collection, by reviewing documents from the main store at Makongoro Health Centre, regarding

the nature (therapeutic group), and the quantity of the expired drugs recorded between the years

2018 to 2021. It was conducted from May to June, 2022.

3.3 STUDY POPULATION;

This study’s population included the facility’s Main Store, which is the main storage and

handling area where all medicine in the facilty’s dispensing units originate from, and is the

storage area for all the expired drugs in the facility.

3.4 SELECTION CRITERIA;

3.4.1 INCLUSION CRITERIA;

All suspensory ledgers with necessary data on expired drugs in the main store, for the years

2018 to 2021, were used in this study.

 3.4.2 EXCLUSION CRITERIA;

All ledgers and suspensory ledgers with no data regarding expired drugs were excluded from the

study.

All suspensory ledgers lacking data on expired drugs for the years 2018 to 2021 were excluded

from this study.

3.5 SAMPLE SIZE AND SAMPLING PROCEDURE;

The minimum sample size included in the study was obtained using the (Yamane 1967) formula,

with the equation below:

N
n= 2 Where;
1+ N (e)

n- is the sample size

N- is the population

e- is the level of precision

The study included a total population of 1 unit (Main store), and the level of precision of 0.05.

From this, a sample size of 0.99 (1) unit was obtained. Simple Random sampling was used in

obtaining the data.

3.6 DATA COLLECTION PROCEDURES;

In the study, data was collected directly from the Main store at Makongoro Health Centre, by

manual searching of data on expiries from the unit’s suspensory ledger (documents review).

Variables in the study included names of drugs, their therapeutic groups, their unit of issue and

the quantities of the drugs that have been recorded as expired, for the years 2018 to 2021.
 3.7 DATA ANALYSIS PROCEDURES AND STATISTICAL ANALYSIS;

The data collected during this study was presented in tables, for easy interpretation. Also, pie

charts and graphs will be used to show the data trend, aiding in data analysis.

3.8 ETHICAL CONSIDERATION;

The study did not require any ethical clearance, as it did not involve getting into direct contact

with a patient, and it did not contain any procedures that attempted to breach confidentiality.

Also, the study mainly focused on data collection for the establishment of educational data, and

not for criticizing the staff’s activities.

3.9 STUDY LIMITATIONS;

The study was limited to only the Main store at Makongoro Health Centre, where expired drugs

are handled, and data was collected for expiries in 2018 to 2021, and this does not reflect the

situation of the entire society (only facility-based.)

CHAPTER FOUR;
4.0 RESULTS;
4.1; GENERAL INFORMATION;
During the research, data was collected from one (1) suspensory ledger, whereas the required
data included a total of 82 entries of expired drugs, for the years 2018, 2019, 2020, 2021 and
2022. The entries included items of solid dosage forms (Tablets), semi-solid dosage forms
(Ointments), liquid dosage forms (Injections), gaseous dosage forms (inhalations), and liquid
preparations for external use. Below is a summary of the statistical data acquired from the study;
YEAR. NO; THERAPEUTIC QUANTITY
GROUP. EXPIRED.
01; ANTI PSYCHOTICS 1000 Tabs

02; ANTIVIRAL 14,275 Tabs

03; SUPPLEMENTS 1,000 Tabs

04; ANTI MALARIALS 578 TabS

05; ISOTONIC FLUIDS 4 Units

06; ANTI ANXIETY 1 Unit

07; ANTI SPASMODIC 16 Units

08; ANALGESICS 19 Units

09; ANAESTHETICS 5 Units

10; ANTI NEOPLASTICS 7 Units

11; DISINFECTANTS 1 Unit

12; ANTIBIOTICS 102 Tabs

13; CORTICOSTEROIDS 100 Tabs

14; ANTI TB 672 Tabs

15; BRONCHODILATORS 8 Units

16; ANTISEPTICS 2 Units

YEAR. NO; THERAPEUTIC QUANTITY
GROUP. EXPIRED.
2019 01; ANTI MALARIALS 384 Tabs

02; ORAL 20 Tabs

CONTRACEPTIVES
03; ANTIVIRALS 240 Tabs

04; NSAIDs 715 Tabs

05; OPTHALMIC 1 Unit

STEROIDS
06; ANTIBIOTICS 1470 Tabs

07; ANGIOTENSIN 440 Tabs

RECEPTOR
BLOCKERS
08; DIURETICS 7300 Tabs
73 Units

YEAR. NO; THERAPEUTIC QUANTITY

GROUP. EXPIRED.
2020 01; ANTIFUNGALS 51 Units
2 Units
02; ISOTONIC FLUIDS 1 Units

03; FLUID/ELECTROLYTE 460 Tabs

REPLENISHERS

04; ANTISEPTICS 20 Units

05; ANTIVIRAL 1427 Tabs

06; ANTIBIOTICS 17000 Units

07; NSAIDs 24 Units

08; PROSTAGLANDINS 48 Tabs

YEAR. NO; THERAPEUTIC QUANTITY
GROUP. EXPIRED.
2021 01; SUPPLEMENTS 4080 Tabs

02; ANAESTHETICS 2 Units

03; ANTIVIRALS 26,486 Tabs

04; ISOTONIC FLUIDS 46 Units

05; DIURETICS 900 Tabs

1 Unit
06; ANTI-DIABETICS 2600 Tabs
10 Units
07; ANTI-ANXIETY 8 Units

08; NSAIDs 124 Tabs

7 Units
09; ANTI-TB 3770 Tabs

10; ANTISEPTIC 20 Units

11; ANTIBIOTICS 32 Units

12; G.I AGENTS & 385 Tabs

LAXATIVES
13; CALCIUM CHANNEL 1320 Tabs
BLOCKERS
14; SEDATIVE 90 Tabs
HYPNOTICS 8 Units
15; PROTON PUMP 5400 Tabs
INHIBITORS
16; NARCOTIC 25 Units
ANALGESICS
 QUANTITY EXPIRED.
1600
1400
1200
1000
800
1,427
600
1,000 1,000
400
578 672
200
0 4 1 16 19 5 7 1 102 100 8 2
CS AL TS LS D S T Y I C C S CS CS T S CS DS T B R S CS
O TI V IR E N R IA LU I
XIE O D
E SI E TI S TI A N
OTI O I
T I T O PTI
H I M A F N M G H A CT BI ER AN LA SE
S YC A NT PLE AL NIC T IA P AS N AL E ST OPL FE TI ST DI TI
P P M S A A E N N O O N
TI SU TI OT
O AN TI AN T I N SI A IC H A
AN AN DI RT NC
AN IS N C O O
A BR

QUANTITY EXPIRED.