Learning Module: Drug Supply Management -I | ORHB

Drug Supply
Management -I
Learning Module
Module Code: HLT PRA2-M04- 1217 V1

December 2017

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 Learning Module: Drug Supply Management -I | ORHB

Preface
In response to the critical shortage of Pharmacy professionals in Oromia region, a group of experts
from universities and colleges in Oromia region have developed an Outcome based TVET Model
curriculum for Pharmacy Level II-IV programs in October, 2017 with the leadership of Oromia
Regional Health Bureau.

The outcome based curriculum was developed in reference to the level based 2011 Ethiopian
Occupational standard. The guiding principle in the development of the outcome based curriculum
was to train Pharmacy professionals in focused, time efficient and outcome based approach, and
to fill the existing pharmacy work force shortage in the region with competent professionals.

The key features of the outcome based curriculum include the use of variety of teaching/learning
methods, repeated exposure of trainees to skill laboratories, practical attachment/cooperative
training and the delivery of the training in standardized learning modules (information sheets) and
skill lab manual/checklists (Operation sheets).

This learning module was developed by a diverse group of experts from higher teaching
institutions in Oromia region, experts from Oromia Regional health bureau, OromiaTVET, Oromia
COC agency and professional associations.

This Drug Supply Management- I learning Module covers one unit of competency in the level II
pharmacy program. The learning module covers both theoretical and practical aspects of the
competencies.

Dear Trainee, you are expected to read all information presented in the learning module, attempt
all the self-check questions and perform skill activities as per the skill lab learning guide/checklist.

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ACKNOWLEDGMENT

This Drug Supply Management I learning module and skill lab manual for Retail Pharmacy
assisting Level II Program was developed by experts from Universities and Colleges in Oromia
National Regional State.

Oromia Regional Health Bureau and Oromia TVET Bureau would like to acknowledge the
following individuals and their organization for their dedication, kind participation, and expert
contributions in the development of this training material.

AbayKasa AHMC
AbdiLeggese ORHB
AbdurazakJemal Tura Arsi University
AsratHordofa AA University
BirhanuMotbaynor Haromaya University
DesalegnChilo Mettu University
Dr.WorkuBedada Salale University
EdaoSado Wollega University
ErmiasMergia AHMC
GetuMelesie Ambo University
MamoAbdi ORTETB
MekuriaKebede OOCAA
Mustefa Ahmed Ambo University
ShibiruTesema Jimma University
TeferiGuji Jhpiego
TenaTilki GimbiG.Hospital
TesemmaSileshi Ambo University
ZerihunAyenew ORHB

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 Learning Module: Drug Supply Management -I | ORHB

ABBREVIATIONS

AMC Average Monthly Consumption

DDR Daily Dispensary Registry

DSM-I Drug Supply Management-I

EFMHACA Ethiopian Food, Medicines and Health Care Administration and Control
Authority

FEFO First Expiry First Out

IFRR Internal Facility Report and Requisition

INNs International nonproprietary names

IPLS Integrated Pharmaceutical logistics System

LMIS Logistics Management Information System

PFSA Pharmaceutical Fund and Supply Agency

PVC Polyvinyl chloride

RDF Revolving Drug Fund

RHB Regional Health Bureau

RI Request indicator

RRF Report and Requisition Form

SOP Standard operating procedures

STG Standard Treatment Guideline

VEN Vital Essential Normal

WHO World Health Organization

WoHO Woreda Health Officer

ZHD Zonal Health Department

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TABLE OF CONTENTS
PREFACE ......................................................................................Error! Bookmark not defined.
ACKNOWLEDGMENT................................................................................................................. ii
ABBREVIATIONS ....................................................................................................................... iii
TABLE OF CONTENTS ............................................................................................................... iv
MODULE SYLLABUS ................................................................................................................ 78
1. INTRODUCTION TO DRUG SUPPLY MANAGEMENT ............................................. 1
2. DRUG PROCUREMENT ...................................................................................................... 4
2.1 Introduction .......................................................................................................................................4
2.2 The procurement cycle ....................................................................................................................4
2.2.1 Review drug selection.............................................................................................................5
2.2.2 Drug Quantification.................................................................................................................8
2.2.3 Reconcile needs and funds .................................................................................................. 15
2.2.4 Procurement methods and Purchasing models ............................................................... 15
2.2.5 Locate and select suppliers ................................................................................................. 17
2.2.6 Specify contract terms ......................................................................................................... 18
2.2.7 Monitor order status ............................................................................................................. 19
2.2.8 Receive and check drugs ..................................................................................................... 19
The final steps in procurement cycle are make payment, distributing drugs, and collecting
consumption information. ................................................................................................................... 19
2.3 Key principles of good pharmaceutical Procurement............................................................ 20
3. ORDERING AND RECEIVING OF PHARMACEUTICALS ........................................... 26
3.1 Introduction .................................................................................................................................... 26
3.2 Drugs orderingwithin facility ..................................................................................................... 27
3.3 Receipt of drugs at dispensary.................................................................................................... 29
3.3.1 Discrepancies when receiving drugs ................................................................................ 29
3.3.2 Product recall ......................................................................................................................... 31
3.4 Reporting and requesting from PFSA ..................................................................................... 31
4. DISPENSARY STOCK CONTROL .................................................................................... 36
4.1 Introduction .................................................................................................................................... 36
4.2 Bin card ........................................................................................................................................... 37
4.2.1 Recording Transactions in the Bin Card ......................................................................... 37
5. PHARMACEUTICAL STORE MANAGEMENT .............................................................. 49

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5.1 Introduction to pharmaceutical store management ................................................................ 49

5.2 Receiving Pharmaceuticals at Store .......................................................................................... 50
5.3 Arranging pharmaceuticals in the store .................................................................................... 51
5.3.1 Systems for arranging drugs in store room ..................................................................... 54
5.4 Pharmaceuticals storage conditions .......................................................................................... 55
5.4.1 Temperature of storage conditions.............................................................................. 56
5.4.2 Humidity .............................................................................................................................. 57
5.4.3 Sunlight ................................................................................................................................ 58
5.4.4 Cleanliness of the store ........................................................................................................ 58
5.4.5 Security of store room ......................................................................................................... 60
5.4.6 Vaccine storage and cold chain management ................................................................. 61
6. PHARMACEUTICAL WASTE MANAGEMENT ......................................................... 65
6.1 Introduction .................................................................................................................................... 65
6.2 Types of waste at health facility ............................................................................................. 65
6.2.1 Non-medical waste.............................................................................................................. 65
6.2.2 Health care wastes .............................................................................................................. 66
6.3 Steps for Pharmaceutical waste disposal ............................................................................. 66
6.4 Methods of waste disposal ................................................................................................... 68
6.5. Waste types not to be incinerated ..................................................................................... 69
References ..................................................................................................................................... 75
Annex-1......................................................................................................................................... 76
Annex-2......................................................................................................................................... 77

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1. INTRODUCTION TO DRUG SUPPLY MANAGEMENT

Objective:

At the end of this unit, you will be able to

 Describe Pharmaceutical management cycles

What is a drug?

A drug is defined as:

 Any chemical compound used on or administered to humans or animals as an aid in the

diagnosis, treatment or prevention of disease.
 A substance used recreationally for its effects on the central nervous system.
What is management?
 Management is the act or art of being responsible or in charge and conducting or
supervising something (e.g. a health center pharmacy, business, public undertaking) with
a degree of skill and address.
 Management can also refer to the collective body of those who are responsible for an entity
(e.g. a health center) or who exercise executive, administrative, supervisory and regulatory
control (e.g. board of governors, Primary health care unit- leader).
 Generally management involves: Planning, organizing, Leading, Coordinating and
controlling the activities there to be done.
Drug supply management is an act to ensure the high quality essential drugs are available,
affordable, and used rationally. Medicines are backbone of health care system so that they need
special attention because of the following five reasons:

1. Medicines save lives.

2. Medicines promote trust and participation in health
services.
3. Medicines are costly.
4. Medicines are different from other consumer products, where consumers can select and
use by themselves.

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5. Substantive improvements in the supply and use of medicines through minimizing waste
are possible.

Drug management cycle: -Drug management functions are undertaken in four principal phases,
which are interlinked and are reinforced by appropriate management support systems. The
following figure 1 illustrates the drug management cycle.

From drug selection to drug use, passing through procurement, storage and distribution, a whole
range of management capacities are required and necessitateusing the appropriate tools within a
given legal and policy framework.

Figure-1: Drug supply management cycle

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Now, let us look at each components of drug supply management:

1. Drug Selection: Is the process of determining which types of medicines should be used for
what clinical indications. It is often done by a committee (Drugs and therapeutic committee)
that includes clinicians, pharmacists, policy makers and others.
2.Procurement: - Is the process of buying the selected products in the determined quantities and
quality—for delivery at the right time. It is often done through an international/national tender
whichcontains, among many other things, the exact specifications and quantities desired and
where and when the products are to be delivered. Procurement includes quantification and
inventory managements.
Quantification: - Is the calculation of required quantities of medicines, tests or services
essential to correctly treat patients for a certain period of time—usually one year for the
national leveland one month to a quarter for the district and/or health center level.
InventoryManagement:- Are the processes involved in ensuring that adequate stocks of
products are kept, quality maintained and that programmes and service delivery points have
the products they needavailable and accessible where and when they need them.
3. Distribution: - Involves arrangements for the physical transport of products from central level
tointermediary storage points to the final service delivery points. A particularly
importantelement of this is Logistics Management Information System (LMIS, explained in
unit 2) providing information of how much of each product is needed where and
when.
4. Rational Use: - Refers to the monitoring of the dispensing of medicines and other products,
and whether the dispensing complies with the STG on which Selection, Quantification and
Procurement were done.

Activity-1:Be in one to five groups and discuss the following questions:

1. Define drug and give at least five examples of drug.

2. Why do we worry for drug management?
3. Discuss the four components of drug supply management cycle.

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2. DRUG PROCUREMENT

Objective:

At the end of this unit, you will be able to

- List drugs selection criteria

- Describe pharmaceutical procurement cycles
- Describe pharmaceutical procurement methods
- Describe drugs purchasing models
- Perform stock control

2.1 Introduction
The pharmaceutical procurement system is a major determinantof pharmaceutical availability and
total pharmaceutical costs. In most developing countries, pharmaceutical purchases represent the
single largest health expenditure after personnel costs. Pharmaceuticals also consume the major
share of health-related foreign currency exchange.

As it was defined above, procurement is process of purchasing selected and quantified

products/drugs for use.An effective procurement process ensures the availability of the right drugs
in the right quantities, at reasonable prices and at recognized standards of quality, quality of drugs
received.

2.2 The procurement cycle

The procurement cycle includes most of the decisions andactions that determine the specific
medicine quantitiesobtained, prices paid, and quality of medicines received.Steps in the
procurement cycle are illustrated in the figure 1 below.

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Figure 1: procurement cycle

Dear trainees, now let us discuss eachcomponent of drug procurement cycles in detail.

2.2.1 Review drug selection

Drug selection is a process of deciding the type of drug products needed for the prevalent
diseases.Resources are limited and choices have to be made. A limited list of drugs for
procurement, based on an essential drugs list or drug formulary, defines which drugs will be
regularly purchased, is one of the most effective ways to control drug expenditure.

Drug procurement based on an essential drugs list or drug formulary allows the health system to
concentrate resources on the most cost-effective and affordable drugs to treat prevailing health
problems. The selection of drugs based on a national formulary or national list allows for
concentrating on a limited number of products. Larger quantities may encourage competition and
lead to more competitive drug prices. Reducing the number of items also simplifies other supply
management activities and reduces inventory-carrying costs.

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Activity: Be in a pair and answer the following questions:

1. What is essential drug list?
2. Does Ethiopia have its own essential drug lists?
3. What is drug formulary?

Key Factors that should be considered in drug selection include:

o Keeping costs of drugs and dosage forms affordable and cost-effective so as to
optimize the use of financial resources;
o Having drugs available for the treatment of most prevalent diseases, ailments,
sicknesses and the levels of care provided;
o Availability of safe, effective and good-quality drugs.
o National health policy like program pharmaceuticals (free service, exempted
services) and revolving drug fund (RDF) pharmaceuticals.
o Locally manufactured drugs should have get priority.
o Training and experience of available personnel

Generic name: - also known as International nonproprietary names (INNs) are normally
used in identifying selected drugs.The generic name is used in writing prescriptions as well
as in purchasing drugs. The use of the generic name for these purposes has certain
advantages:

– There is easy recognition of the type of drug, especially where many selected
drugs exist in that class (e.g. all benzodiazepines have INNs ending with “ -
zepam”);
– Drugs can be purchased from multiple sources, thus giving the advantage of
buying at a competitive price;
– Product substitution is easy where bio-availability presents a clinical
problem;
– The confusion associated with the use of brand names can be avoided.

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Brand name: - Proprietary medicines are medicines protected by a patent, which are sold
under a tradename given by the manufacturer. A drug can have multiple trade name.

Table 1: - Example generic and brand names

Generic name Brand name

Acetyl salicylic acid Asprin®, Aspro®

Albendazole Zentel®

Amoxcillin+Clavulinic acid Augument®

Benzylpenicillin Megacillin®, Specillin®

Cimetidine Tagamet®

Cotrimoxazole (sulphametoxazole + trimethoprim) Bactrim®, Septrim®

Dexamethasone Dectancyl®, Dexone®

Diazepam Valium®

Doxycycline Doxigram®, Monocline®

Ibuprofen Brufen®

Penytoin Di-Hydan®, Dilantin®

Phenobarbital Gardenal®

Propranolol Inderal®

Salbutamol Ventolin®

Paracetamol Panadol®

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2.2.2 Drug Quantification

Quantification: -is the process of determining/calculating the amount of drugs/ products
needed.The management of the drug supply works best when products are available.Supplies are
more likely to be available if ordered regularly. Supplies should be orderedbased on their use
(consumption). If you order supplies based on consumption, you willhave the supplies you need
when you need them.

Symptoms of poor quantification

 The most commonly encountered symptoms of poor quantification of drug requirements are:

– Chronic and widespread shortages

– Surpluses or overstock
– Inadequate cost-effectiveness:- by failure to use cheaper but equally effective drugs
or dosage forms is a widespread problem
– Irrational adjustments to budgetary constraints: - may lead to irrational order
quantities
– Irrational and ineffective prescribing
There are four drug quantification methods. These are:

1. Consumption method
2. Morbidity method
3. Adjusted consumption method
4. Service level projection budget requirement

However, the first two are the most commonly used methods of drugs quantification in our country.

Consumption Method: uses records of past consumption of individual drugs.

Morbidity Method: estimates the need for specific drugs based on the expected number of
attendance, the incidence of common diseases and the standard treatment patterns for the diseases
considered. Each of the method has its own advantage and disadvantage as detailed in table 2
below:

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Table 2: - Comparison of Quantification Methods

Method Uses Essential Date Limitations

Consumption First choice for Reliable inventory records, Must have accurate
procurement and future Records of supplier lead consumption data can
consumption forecasts time, Projected drug costs perpetuate irrational
use

Morbidity Estimating need in new Data on population and Morbidity data not
programs or disaster patient attendance; Actual or available for an
assistance projected incidence of health diseases; Standard
problems; Standard treatments may not
treatment; Projected drug really be used
costs

Estimation of drug requirements

The estimate of the drug and medical supplies required for a given period is undertaken:

o To avoid shortages (out of stock) and ensure credible health care service,
o To prevent excess stock and avoid waste (loss or mismanagement of financial
resources).
 Factors that influence choice and quantity of drugs include:
 Catchment population which the health institution serves,
 Disease pattern and seasonal variation in disease pattern,
 Monthly (rate of) drug consumption,
 Knowledge of quantity of each dosage form that is regularly consumed,
 Delivery (lead) time,
 Request indicator (re-order level):
 Quantity of drug product that serves as a signal for re-ordering.

The three factors—delivery (lead) time, monthly consumption and request indicator—are
considered as the basis for calculating the appropriate quantity of a particular drug to be
ordered. So let us look these three factors one by one.
Delivery (lead) time: - it is time lag between placing orders and receiving the orders.
It is important to establish how long it takes to have a drug delivered and receipted in

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the store so that the drug does not become out of stock. Delivery time may be days, weeks
or even months due to the following factors:
– Poor road conditions, particularly in the rainy season,
– Poor condition of delivery vehicles,
– Increased work load at the issuing store (e.g. Pharmaceutical Fund and Supply
Agency)
– Stock out of drugs at the central store (Pharmaceutical Fund and Supply
Agency),
– Consumption rate of drugs at Health centers

Monthly consumption: - is obtained by calculating the average consumption over a

period of time (e.g. six months)or dividing the total consumption over the period by the
number of months the a drug was consumed. It is also known as average monthly
consumptions (AMC).

Note: AMC= Total consumption/ Number of months

*According to Ethiopian Integrated Pharmaceutical logistics System(IPLS) 3months

period is used to calculate average monthly consumption
Example 1:Average monthly consumption

 The first method of calculating monthly consumption ;is to add the quantity of drugs in
stock at the beginning of a period (e.g., six months) to the quantity of drugs received
during that same period and then subtract the quantity of drugs remaining at the end of
the period look at the following transaction in X health center.
- March 2017, quantity of paracetamol 1,000 x 500-mg tablet containers in stock =
14
- June 2017, quantity of paracetamol 1,000 x 500-mg tablet containers received =
8
- August 2017, quantity of paracetamol 1,000 x 500-mg tablet containers,
remaining stock= 6

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 Therefore, total quantity of paracetamol 1,000 x 500-mg tablet containers consumed

over a six-month period = 14 + 8 – 6 = 16.

AMC= Total consumption/Number of months

AMC = 16/6

Average monthly consumption to the nearest container = 8/3

Example 2: Average monthly consumption

 A second method of calculating the average monthly consumption is to obtain data on

consumption from the bin card on a monthly basis and then find an average over a period
of time.

April 2000 2 x 1,000 tablets

May 2000 4 x 1,000 tablets

June 2000 2 x 1,000 tablets

July 2000 2 x 1,000 tablets

August 2000 3 x 1,000 tablets

September 2000 3 x 1,000 tablets

16 x 1,000 tablets

Average monthly consumption is 16 x 1,000 tablets = 8/3 containers

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Average monthly consumption of container to the nearest container = 3

Example 3:Monthly consumption

A third method of calculating average monthly consumption is to obtain data on actual

consumption from the daily use record or daily use/cash record.Data of monthly consumption
of paracetamol 500-mg tablets over a six-month period.

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April 2000 2,000 tablets

May 2000 3,100 tablets

June 2000 2,300 tablets

July 2000 2,100 tablets

August 2000 3,100 tablets

September 2000 3,200 tablets

Total six months 15,800 tablets

Average monthly consumption of tablet is15,800/6 = 2633.3 tablets

Each container has 1,000 tablets. Therefore the average monthly consumption of
1,000-tablet tin = 2633.3 = 2.6 tins
1000
Average monthly consumption of paracetamol 500-mg tablets to the nearest
container =3

Request indicator (re-order):- It is also known as safety stock. It is the level of drugs
in stock; it indicates when fresh orders should be made. It is the quantity that is calculated
to last between the period of placing the order and the delivery of the new consignment.

- The stock should never reach “zero level” before a request is made, as there will
be a shortage of stock for some time.
- It is easy to calculate the RI once the monthly consumption is obtained.

For example:

If the delivery time is three months and the monthly total consumption is 2633.3

Then RI is: 2633.3 tablets x 3 months = 7,900 tablets

Since the unit of issue is tins of 1,000 tablets, the above figure must be brought to the
nearest tin, which is 7,900 = 7.90 = approximately 8tins of 1000 tablets

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 This means that when the stock of paracetamol is reduced to 8 tins, a new request
must be made.

= (2 tins x 3 months) + 2 tins

= 8 tins

(c.) RI = 6 tins; current stock balance = 0 tins

In this case an extra quantity must be requested to cover the RI.

Request quantity = 2 tins x 3 months + 1 month consumption (2

tins) + RI (6 tins) quantity

= (2 x 3) + 2 + 6
= 14 tins

In each case above, if previous data show that the number of patients would increase (e.g.
malaria cases due to seasonal variations), then the quantities should be increased
proportionally.

- If the number of patients is expected to double, then the quantity should be

multiplied by 2.
- If the number of patients is expected to drop by half, then the quantity should be
multiplied by 1 / 2 .

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Exercise-1
The following information was extracted from the bin card for paracetamol tablets at the
GudayaBila health center pharmacy. Paracetamol 500 mg tablets; tin or container or box 1, 000
tablets Monthly consumption for proceeding six months is as follows:
4/2017 6 x 1,000 tablets
5/2017 5 x 1,000 tablets
6/2017 4 x 1,000 tablets
7/2017 3 x 1,000 tablets
8/2017 7 x 1,000 tablets
9/2017 4 x 1,000 tablets
Calculate: The total consumptions of paracetamol tablet in boxes of 1000 tablets and average
monthly consumption: Assume that a lead (delivery) time of 3 months. What is safety stock or
reorder indicator. What is AMC according IPLS, which recommends using the last three consecutive months
for AMC calculations?

Home take assignment -1

1. The following information was extracted from the bin card for Amoxicillin capsule
at the GudayaBila health center pharmacy. Amoxicillin 500 mg capsule 50x10 box
was consumed as follow:
- 20 boxes in January, 2017
- 30 boxes in February, 2017
- 20 boxes in March, 2017

Then what is average monthly consumption of 500mg of Amoxicillinin both box and
capsule? If lead time is two weeks, what is safety stock or request indicator?

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2.2.3 Reconcile needs and funds

The need of drugs should be reconciled with funds allocated for drugs purchasing. This can be
done by using:

VEN analysis:

 The VEN system sets priorities for drug selection and drug procurement according to the
potential health impact of individual drugs.
- V (vital) – drugs, which have a potentially of life saving, are categorized as vital. This
category of drugs should be available all the time in the health facilities.E.g. ORS,
Vaccines, Antimalarias etc.
- E (Essential) – dugs, which are effective against less life threatening (common problems),
are categorized as essentialE.g.Certain Antibiotics
- N (Normal uses) – drugs used for minor or self-limiting health problems. E.g. Cough
syrup, antacid

ABC analysis:

 ABC analysis is an extremely powerful tool, with uses in selection, procurement,

management of distribution, and promotion of rational drug use.

• Class A item (10 to 20% of items, 75 to 80% percent of expenditures are mostly high-
volume, fast moving drugs.

• Class B item are usually 10 to 20% of items and 15 to 20% of expenditures

• Class C items often represent 60 to 80% of the items but only about 5 to 10% of
expenditures, these are the low – volume, slow moving items. Thus, Class C is a good place
to look for items that might not be needed in stock at all times.

2.2.4 Procurement methods and Purchasing models

There are four types of procurement methods used to purchase drugs. These are open tender,
restricted tender, competitive negotiation & direct procurement. They vary with respect to their
effect on price, delivery times, and work load of the procurement office.

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The procurement method chosen should:

 Obtain the lowest possible purchase price for high quality products
 Ensure suppliers’ reliability, in terms of both quality and service
 Maintain transparency in the process and minimize the opportunity for illicit influences on
procurement decisions
 Achieve these objectives with the least possible professional and clerical staff time and
within the shortest possible time.

Table3:- Advantages and disadvantages of procurement methods

Procurement method Advantages Disadvantages

Open tender Many bids, some with low prices High workload required in
evaluating bids and selected
New supplies can be identified
suppliers

Restricted tender Fewer bids, prequalified suppliers, Fewer bids, more limited options

Quality easier to ensure A system for prequalification of

suppliers must be in place

Competitive Suppliers generally well known, less Generally higher prices

negotiation evaluation work

Direct procurement Easy and quick High prices

 These methods are used combined with the standard purchasing models – annual,
scheduled, or perpetual review – given the right sort of procurement contract.

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The three purchasing models are described below:

Annual purchasing – Products/drugs are purchased once a year

• Main reasons to use annual purchasing are: -easier to manage and usually lower unit price
when we purchase in bulk.

• It has the following disadvantages when used as a sole means of drug purchasing:

 Consumption change—Shortage or surplus

 High inventory holding cost

 More space for storage if not spaced in delivery

 May be difficult to cope up with funds at once

Scheduled purchasing - a periodic review model in which orders are placed at prescribed
intervals. For example purchase from Pharmaceutical Fund and Supply Agency(PFSA)every two
months.

Perpetual purchasing- Drugs are purchased when the stock reaches reorder quantity or safety
stock.

2.2.5 Locate and select suppliers

The selection of suppliers has a profound impact on the quality and cost of drugs acquired.
Inadequate safeguards in supplier selection may result in the purchase of drugs that are ineffective,
unsafe or even deadly.

Hidden costs resulting from late deliveries, complete default on confirmed orders, losses due to
poor packaging, or short expiry dates are common problems with unreliable suppliers that may
raise the actual drug cost to several times the original contract cost.

Pre- and post-qualification procedures help to eliminate substandard suppliers, if properly

managed.

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Pre-qualification is the procedure of evaluating supplier capacity and reputation before bids are
solicited for specific products.

Post-qualification evaluates the suppliers after bids have been received. If there are numerous
offers from unknown suppliers there may be long delays in awarding contracts, as it will be
necessary to validate suppliers’ capacity to supply good-quality products.

 In addition to using pre- or post-qualification procedures, successful procurement offices

ensure continued good supplier performance through a formal monitoring system which tracks:
o lead time
o compliance with contract terms
o partial shipments, quality of drugs
o remaining shelf-life
o Compliance with packaging and labeling instructions, etc.

 There are three ways of locating qualified suppliers:

1. Direct inquiries: Direct inquiries to suppliers are the quickest means of attracting an offer.
2. Public Tender: Can be publicized through local newspaper notices, international notices, and
direct mailings to known suppliers to attract a large number of bidders.
3. Contacts with International Agencies: may be one of the most effective ways for a
procurement office with little international experience to identify potential suppliers WHO, the
World Bank, or the United Nations Children’s Fund may be able to help establish
communications with companies, trade associations, and procurement agencies.

2.2.6 Specify contract terms

A contract for provision of goods or services is a legally binding document between a purchaser
and seller for a specified period of time.

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Preparing an effective drug procurement contract is a specialized function requiring a great deal
of care. Critical details include:-

 The specification of the drug

 The quality standards required
 The type of packing
 The price and payment terms and
 The last day of shipment

2.2.7 Monitor order status

The procurement office is responsible for monitoring performance and compliance with contract
terms by the suppliers. The office must actively track suppliers’ lead time, delivery status,
compliance with contract pricing and terms, shelf life, and packaging of product

2.2.8 Receive and check drugs

Procurement proceduresshould include all assurances that the drugspurchased are of high quality,
according to international standards.

Four components make up an effective quality assurance system:

 Selecting reliable suppliers of quality drugs;

 Using existing mechanisms, such as the WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in International Commerce;

 Establishing a programme of product defect reporting; and

 Performing targeted quality control testing.

The final steps in procurement cycle are make payment, distributing drugs, and collecting
consumption information.

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2.3 Key principles of good pharmaceutical Procurement

1. Procurement by generic Name: important for fair competition, specify quality standards,
2. Limitation of procurement by essential drug list, Formulary & treatment guidelines
 Avoid generic (Brand) duplications

 Select safe, effective, cost- effective drugs

3. Procurement in bulk
- Concentrate purchases on limited list to increase quality, reduce price
- Specify divided deliveries
4. Formal Suppliers Qualification & monitoring
- Use formal suppliers qualification based on drug quality, service reliability
- Approve suppliers before tendering (prequalification) or after (post qualification).
- Use a formal monitoring system to ensure continued supplier qualification.
5. Sole- source commitment
- All contracted drugs are procured from winning supplier.
- Enter into no separate deals with non-contracted suppliers.
- Adjust for expected program growth & changing disease pattern
6. Order quantities based on reliable Estimate at Actual need.
- Develop reliable consumption records & morbidity data.
7. Reliable payment & Good financial management
- Develop mechanisms for prompt, reliable payment
- Prompt payment may bring down drugs prices as much as bulk discounts.
- Financial mechanisms that establish separate drug accounts
8. Transparency & written procedure
- Develop & follow written procedures for all procurement actions
9. Separation of key functions
- Separate key functions that require different expertise
- Functions that involve d/t committees, units, or individuals,
10. Product quality Assurance program
- Establish & maintain a formal system for product quality assurance

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- Include quality assurance product certification, inspection of shipments, targeted

laboratory testing, and reporting of suspect products.
11. Annual Audit with published results
- Conduct an annual audit to assess Compliance with procurement procedures,
promptness of payment, & related factors.
12. Regular reporting procurement performance

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Summary

In this unit, you have learned the following:

Drug management supply is an act to ensure the high quality essential drugs are available,
affordable, and used rationally

Drug management functions are undertaken in four principal phases, which are interlinked and are
reinforced by appropriate management support systems.

- Drug Selection: Is the process of determining which types of medicines should be used for
what clinical indications
- Procurement: - Is the process of buying the selected products in the determined quantities and
quality—for delivery at the right time.
- Distribution: - Involves arrangements for the physical transport of products from central level
to intermediary storage points to the final service delivery points.
- Rational Use: - Refers to the monitoring of the dispensing of medicines and other products
 Drugs procurement cycles
 Generic name: - also known as International nonproprietary names (INNs) are
normally used in identifying selected drugs.
 Brand name: - Proprietary medicines are medicines protected by a patent, which are sold
under a trade name given by the manufacturer.
 Quantification: - is the process of determining/calculating the amount of drugs/ products
needed.

Symptoms of poor quantification

– Chronic and widespread shortages

– Surpluses or overstock
– Inadequate cost-effectiveness:- by failure to use cheaper but equally effective drugs
or dosage forms is a widespread problem
– Irrational adjustments to budgetary constraints: - may lead to irrational order
quantities
– Irrational and ineffective prescribing

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- Delivery (lead) time: - it is time lag between placing orders and receiving the orders.
- AMC= Total consumption/ Number of months
- VEN and ABC analysis:
- There are four methods of drug procurement:

o Open tender,

o Restricted tender,

o Competitive negotiation &

o Direct procurement.

- Drugs purchasing models:

o Annual purchasing
o Scheduled purchasing
o Perpetual purchasing
- Key principles of good pharmaceutical purchasing

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 Learning Module: Drug Supply Management -I | ORHB

Self-check

Part I: True or False

1. Medicines are backbone of health care system so that they need special
management(True/False).
2. Procurement is the process of buying the selected products in the determined quantities and
quality—for delivery at the right time(True/False).
3. Quantification is process of determining amount of products needed (True/False).
4. Generic name is the same as international nonproprietary names (INNs )
(True/False).
5. Drugs purchasing should be done by using brand names(True/False).
6. Request indicator (re-order) is also known as safet y stock, used as an alarming
indication for re-order (True/False).
7. ABC analysis is an extremely powerful tool, with uses in selection, procurement, management
of distribution, and promotion of rational drug use(True/False).
8. Orders are placed whenever stock falls to specific level in scheduled
purchasing(True/False).
9. The simplest and most practical period for which to calculate average monthly consumption
is three months (True/False).
10. Selection of combination of drug products has advantages over single
compounds(True/False).

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Part II: Multiple Choose Questions:

1. All are phases of drug supply management except:

A. Drug selection C. Drug Procurement
B. Drug Quantification D. Drug use
2. Drugs which have a potentially of life saving, are categorized as:
A. Vital C. Normal
B. Essential
3. Which statement is true about procurement methods? (multiple answer is possible)
A. In Open tenders, prices are usually highest
B. In restricted tender, the lead time is shortest
C. In competitive negotiation, the work load is high
D. In direct procurement, prices are usually highest
E. All are true
4. Good pharmaceutical procurement practices include all except:
A. Procure by generic name. C. Procure in bulk. E. All
B. Procure from winning suppliers. D. Order quantities arbitrarily.
5. Which statement is true about annual purchasing model?
A. Less storage space is needed. C. Make better use of limited drug budget
B. Less inventory holding cost. D. Drug purchase prices per unit are usually lower.

Part III: Short answer questions

1. Lists symptoms of poor quantification of drug

2. What is the difference between RDF and Program pharmaceuticals?
3. Discuss procurement cycles.

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3. ORDERING AND RECEIVING OF PHARMACEUTICALS

Objective:

At the end of this unit, you will be able to

- To identify different stock requisition and receiving formats

- Use IFRR to request stock for dispensary
- To identify stock receiving steps
- To enter dispensary stock in to stock records (bin card)
3.1 Introduction

Logistics management information system (LMIS) is the system of records and reports that you
use to collect, organize, and present logistics data gathered across all levels of the system. Most
importantly, LMIS enables you to collect the data needed to make informed decisions that will
ultimately improve customer services.

Activity: What are the three essential logistics data and three logistics data records?

The three essential data items those are required to run a logistics system andmust be
captured by the LMIS are:

1. Stock on Hand: Quantities of usable stock available at a particular point in time.

2. Consumption Data: The quantity of pharmaceuticals used during the reporting period.
3. Losses/Adjustments: Losses are the quantities of products removed from your stock
for anything other than in the provision of services to patients or issuing to another
facility (e.g. expiry, lost, theft, or damage) and are recorded as negative (-) numbers.
Adjustments are quantities of a product received from any source other than PFSA, or
issued to anyone other than your health facility. An adjustment may also be a correction
due to an error in mathematics. An adjustment may be a negative (-) or positive (+)
number.

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From a logistics point of view, only three things can happen to supplies/pharmaceuticals in a
pipeline—they can be stored, moved (in transit), or consumed (used).

– Stock keeping records. Holds information about products in storage. E.g. Bin cards,
Stock cards, inventory control cards..
– Transaction records. Holds information about products being moved. E.g. Internal
Facility Report and Requisition Form(IFRR), Report and Resupply Form (RRF)
– Consumption records. Holds information about products being consumed or
used.E.g. Daily dispensing registry(DDR)

Therefore, a well-designed logistics management information system will include records

and forms that collect and report the three essential data items as they relate to these three
activities.

To prevent stock out of pharmaceuticals or drugs in the health the drug should be timely ordered
and received. In our country, Ethiopia, different formats are being in use for the supply/order and
receiving within facilities and outside facilities from pharmaceutical fund and supply agency. In
thisunit, you will see different formats used in the health facility.

3.2 Drugs orderingwithin facility

Drugs that are ordered for use in the health institutions must be approved for use in that institution.
The drugs should also be relevant to the pattern of endemic diseases as well as the type of services
being provided.

It is advisable to request drugs on a regular basis to prevent shortages. If drugs are not always
available, patients may lose confidence in the health service being given and will be discouraged
from visiting it. It is important to make requests on a regular basis, as drugs will only be delivered
when requested. The delivery time should be taken into consideration in ensuring that drugs are
not in short supply.The head of the health center and a representative of the health committee
should endorse the stores requisition/delivery (issue) form.

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When issuing pharmaceuticals to a unit within a health Centre or hospital, the Internal
Facility Report and Resupply Form (IFRR) is used to maintain a record of the products thatare
issued and received. The Internal Facility Report and Resupply Form(see Annex-1)should bekept
in the respective dispensing units and completed when a service provider is scheduledto come for
re-supply.

Note the following while receiving:

 The consignment must come with two copies of the stores internal facility report
and requisition forms (IFRR)
 Check that the quantity issued actually corresponds to the quantity indicated on IFRR
 Check off each drug after checking.
 Take note of the unit price of each drug and compare it to the previous unit price.
 Check that all original boxes, tins or bottles are unopened and are in good condition.
 Check the labels and ensure that there are no expired drugs being received.
 Any drugs already expired or soon to expire that cannot be consumed before
expiration ordrugs not in good condition should be returned for destruction or
redistribution to othercenters.
 Sign two copies of the stores IFRR if the above procedure has been completed.
 Return one copy of the signed stores requisition/delivery (issue) form to the medical
stores, and place another copy in the “drug order” file.
 Place drugs with shorter expiration dates in front of the shelf so that they can be
reached and used first.
 Remember to record the new stock on the respective stock (bin) cards and
appropriate forms.

Assignment: Write information/data that should be entered into IFRR while filling?

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3.3 Receipt of drugs at dispensary

Note the following points while receiving drugs at dispensary:

• Check that the quantity issued actually corresponds to the quantity indicated on the stores
requisition/delivery (issue) form.

• Check off each drug after checking.

• Take note of the unit price of each drug and compare it to the previous unit price.

• Check that all original boxes, tins or bottles are unopened and are in good condition.

• Check the labels and ensure that there are no expired drugs being received.

• Any drugs already expired or soon to expire that cannot be consumed before expiration or
drugs not in good condition should be returned for destruction or redistribution to other
centers.

• Return one copy of the signed stores requisition/delivery (issue) form to the medical stores,
and place another copy in the “drug order” file.

• Place drugs with shorter expiration dates in front of the shelf so that they can be reached
and used first.

3.3.1 Discrepancies when receiving drugs

• Where there is a difference in the quantities of drugs issued and the quantities actually
received, request the delivery team to give an immediate explanation and make the
necessary correction on the stores requisition/delivery (issue) form. If there are broken
bottles or leaking packages, hand these over to the delivery team along with an internal
drug return (IDR) form.

• Discrepancies should always be recorded in the Remarks column on the stores

requisition/delivery (issue) form.

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Transfer voucher or internal drug return (IDR) form

The transfer voucher effects the movement of the following items to the medical store:

 Expiring drugs, Damaged or spoiled drugs,

 Drugs soon to expire,

 Excess stock resulting from wrong RI or low consumption.

The following rules should be kept in mind:

• It is important that drugs are not allowed to expire in the health center because of changes
in disease pattern or for any other reasons.

• Items that can be used elsewhere should be transferred immediately using an IDR form to
the medical stores for subsequent redistribution.

• Expired or spoiled items should be transferred immediately using the IDR form to the
medical stores for destruction.

Table 4: Example of Transfer Voucher or Internal Drug Return Form

Unit of Expiry Unit

Item description issue issue date Quantity price Amount Remarks
Normal saline 500 ml 500 ml 9/04 10 800 8,000 Leaking
Aspirin 500 mg 1,000 tab 7/04 2,000 10 20,000 Soon to expire
Bipenicillin 1 MU 1 vial 4/04 2 180 360 Broken
Mebendazole 100 mg 1,000 tab 6/04 610 30 18,300 Expired
Chloroquine 100mg 1,000 tab 1/04 3,000 10 30,000 Over quantity
ANC card Piece - 5 150 750 Misprint
Povidone iodine 100 ml 12/04 2 1,000 2,000 Not supplied
TOTAL 79,410

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3.3.2 Product recall

Recall means firm’s removal of marketed pharmaceutical product that EFMHACA considersbeing
unsafe,inefficacious and poor quality. Recall doesn’t not include market withdrawal or
returnedproducts.

Steps of Recall Procedure

The procedure is divided into six steps, which are set out below

1. Receipt of Pharmaceutical Product Problem Report

- Notification to EFMHACA
2. Initiation of Recall and Information required for Assessment
3. Assessment of Recall. The classification, level and strategy of recall are determined
depending on the potential hazardof the defective product and the extent of product
distribution.
4. Communication
Letters and press release (if required) are dispatched to relevant firms for notifying on the
recall.
5. Progress of Recall and Report
Progress reports and a final report are submitted EFMHACA.
6. Evaluation of the Recall
The effectiveness of the recall is monitored by EFMHACA

3.4 Reporting and requesting from PFSA

A stores requisition/delivery (issue) form should accompany any supply made from the

PFSA. Health centers normally receive their drug supplies from central, regional PFSA. In

some cases they may purchase drugs from other sources private sources.

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 Supplies are issued on the basis of request made to the PFSA by the health

centreon an approved stores requisition report and requisition form (RRF)(see

Annex-2).

 The request should not be excessive and should preferably ask for quantities

that can be used in between delivery times.

 The quantity of drugs requested is made in the appropriate column of the form

and is sent to the medical store from which drugs are supplied.

 The request is made on the basis of approved delivery time, time frame or in

emergency.

 The quantities of drugs delivered or issued from the medical stores should be

entered in the appropriate column of the form.

The records of requisition and receipt of drugs from the medical store are kept in the

health centre in an approved manner.

The delivery note from the PFSA should indicate what has been supplied as indicated

in the stores RRF.

RRF has the column for both requested and reported drugs see the RRF table below.

RRF mostly used for program pharmaceuticals, which are given to the patients free of

charges. E.g. Anti-malaria drugs, TB, ART drugs…

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The RRF has 3 copies. Copies are distributed and kept during the process as follows:
* Hospital or Health Centre completes 3 copies of the RRF
* Sends 1 copy to PFSA
* Sends 1 copy to administrative body (RHB/ZHD or WoHO)
* Keep one copy with them

Guided practice:

Observation and practice how to fill RRF& IFRR at a health facility. Course
instructor will provide sample of drug requisition and receiving form from the
health care facility.

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Summary

In this chapter you have learned:

LMIS is the system of records and reports that you use to collect, organize, and present logistics
data gathered across all levels of the system.

Three essential data items are required to run a logistics system are:

o Stock on Hand: Quantities of usable stock available at a particular point in time.

o Consumption Data: The quantity of pharmaceuticals used during the reporting period.
o Losses/Adjustments:

The three basic stock records in drug supply management are:

o Stock keeping records. Holds information about products in storage. E.g. Bin cards, Stock
cards, inventory control cards.
o Transaction records. Holds information about products being moved. E.g. Internal Facility
Report and Requisition Form(IFRR), Report and Resupply Form (RRF)
o Consumption records. Holds information about products being consumed or used. E.g.
Daily dispensing registry(DDR)
- Reporting and requesting from pharmaceutical fund and supply agency
- RRF used for requesting and reporting pharmaceuticals from PFSA
- The RRF filled in 3 copies.
- IFRR is use for requesting and reporting of pharmaceuticals from store to different
service delivery points within health care facilities
- Procedures of receiving drugs at dispensary

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Self-check

Part I: True/False

1. LMIS enables you to collect the data needed to make informed decisions that will ultimately
improve customer services (True/False).
2. Losses are the quantities of products removed from your stockfor anything other than in the
provision of services to patients or issuing to anotherfacility (True/False).
3. The RRF should be filled by 3 copies (True/False).
4. IFRR should be filled by two copies (True/False).

Part II: Multiple choice questions

5. Stock keeping records includes:

A. Bin cards C. Inventory control cards.
B. Stock cards, D. All
6. Transaction records include:
A. IFRR C. IRV
B. RRF D. All
7. Consumption records.
A. Holds information about products being consumed or used.
B. Holds information about products in storage
C. Holds information about products being moved
D. None

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4. DISPENSARY STOCK CONTROL

Objective:

At the end of this chapter you will be able to:

- To identify dispensary stock records and documentation

- To identify dispensary stock levels (min-max stock levels) and
- To investigate dispensary stock discrepancies
- To identify procedures and formats used for product recall and return forms

4.1 Introduction
Dispensary is a service delivery point, where pharmaceuticals or drugs are dispensed to patients.
Within a health facility it could be out patient pharmacy, wards, MCH unit, ART clinic laboratory
units. For all these services delivery points, drugs are obtained from the central pharmacy store of
the facility. They should be managed properly in order to minimize pharmaceutical wastes through
loses, thus there should be strong inventory control systems in the health care facilities.

The purpose of an inventory control system is to inform personnel when and how much of a
pharmaceuticals to order and to maintain an appropriate stock level to meet the needs of patients.

 A well designed and well operated inventory control system helps to prevent shortages,
oversupply, and expiry of pharmaceuticals.
To help maintain adequate stock levels, the maximum months of stock, minimum months of stock
and an emergency order point have been established for each health facility in the system.
 The maximum months of stock is the largest amount of each pharmaceutical a facility
should hold at any one time. If a facility has more than the maximum, it is overstocked and
risks having stocks expire before they are used.
 The minimum months of stock is the level of stock at which actions to replenish inventory
should occur under normal conditions.
 The emergency order point is the level where the risk of stocking out is likely, and an
emergency order should be placed immediately.
 In current Ethiopian integrated pharmaceutical logistics systems (IPLS) all facilities are
required to report on a fixed schedule

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 Health centers and hospitals are required to report and order every two months to
PFSA
 Health centers and hospitals calculate their own order quantities, ordering
sufficientquantities of all pharmaceuticals to bring stock levels up to the maximum
level.
 Health posts report data monthly to their affiliated Health Centre
 Health center calculates the re-supply quantities that are needed to bring health
poststocks up to the maximum level.
 If the stock on hand for any product at a facility falls below a set emergency order
pointbefore the end of the reporting period, an emergency order should be placed.

4.2 Bin card

Bin card is one of the commonly used stock records keeping records are used in the dispensary:

The Bin Card is used at all health facilities (Health Post, Health Centre and Hospital); It services
as body guard for a drug. It means that holds information about drugs quantity and expiry date,
where there a drug there is bin card.

 Bin Cards are used to account for products held in storage, including their receipt and issue.
 In the IPLS valuable information used to make re-supply decisions is recorded on the Bin Card
and Stock Record Card; data from these records are used in reporting, calculating reorder
quantities and for monitoring stock levels.
 It is essential that personnel responsible for the storage of pharmaceuticals maintain up-to-date
and accurate Bin Cards.
 One Bin Card should be maintained for each pack size, form or presentation of
pharmaceuticals.
 The Bin Card should be kept with the product in the storage area.

Bin card is a body guard of a drug. It holds information about drugs quantity
(transaction) and expiry date.
4.2.1 Recording Transactions in the Bin Card

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Sample of Bin Card

Name of Health Facility: - ___________________________________
Product Name, Strength and Dosage Form: - ____________________________
Unit of Issue: - ______________________________

Doc. No. Received Quantity

(Receivin from or Received Issued Loss/ Balance Batch Expiry
g Adj.

Remarks
Issued to No. Date
or
Date

Issuing)
Date

Completed by: Health staff in charge of pharmaceuticals (Health Extension Worker, Pharmacy
Store manager and Dispensing Units like wards heads, laboratory head…)

Purpose:

- To record pharmaceuticals received

- To record pharmaceuticals issued
- To record changes in stock balances
- To track supplies moved through non-routine methods (e.g., local purchase, transfers)
- To track losses/adjustments
- To record expiry dates

When to Perform:

 When pharmaceuticals are received or issued

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 When pharmaceuticals are transferred to another facility

 When pharmaceuticals are transferred in from another facility
 When pharmaceuticals are removed from the storage area for reasons other than for use in
health services (e.g., for demonstrations, expiration, damage)
 At the end of the month when physical counts are conducted at the Health Post; every other
month at the Health Centers and Hospitals

Steps in Recording Transactions in the Bin Card

1. Complete one Bin Card for each pharmaceutical you manage

For example, each of the following should have a separate Bin Card:

Amoxicillin 250 mg capsule

Amoxicillin 500 mg capsule

2. Enter only one transaction on each line.

If Opening a new Bin Card, then continue with Step 3
If entering a transaction, then Skip to Step 10

Steps 3 – 10: Opening a new Bin Card

3. Name of Health Facility: Write the name of the health facility where the product is being
managed.
4. Product Name, Strength and Dosage Form: Enter the name, pack size, form or presentation
of the pharmaceutical.
Example: Acetaminophen 500 mg Tabs
Doxycycline 100 mg capsules
5. Unit of Issue: Write the individual unit for the particular pharmaceuticals.
Example: bottle, tablet, tube, piece

N.B: The unit recorded at the top of the Bin Card is the same unit that is used to record transactions
on the card

6. Maximum Stock Level:

 For health centers and hospitals, the maximum has been set at 4 months of stock.

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 For Health Post: 2 months of stock

7. Emergency Order Point:
 For health centers and hospitals, the Emergency Order Point has been set at 0.5 months (=
2 weeks of stock).
 For Health Post: 0.25 months of stock (=1week of stock)
8. Average Monthly Consumption (AMC): Take 3 months average of monthly Internal Issues
from the Bin Card.
9. Record the opening balance at the time the Bin Card is opened.
 If this is the first line of a new Bin Card for an existing product, write the date, write
“Balance Brought Forward” under the received column, and record the ending balance
from the old Bin Card under the balance column.
 If this is the first line of a new Bin Card for a new product, conduct a physical count
and record the results of the physical inventory on the first line of the Bin Card.
If you do not have a transaction to record, you are finished with this part of the task. If
you have a transaction to record, continue with Step 11 below.
10. Date: Enter the date of the transaction
11. Document No. (Receiving or Issuing): Write the pre-printed number from the issue or receipt
voucher that was used to document the receipt or issue of the pharmaceuticals.
Example: 736529
12. Received From or Issued To:
 If receiving products, enter the name of the facility from which the item was received.
 If issuing at a health post, write “dispensed to patients”.
 If issuing within a health center or hospital, or if issuing from a health center to a health
post, write the name of the dispensing unit or health post to which the pharmaceuticals are
being issued.
 If a physical count was conducted, write “Physical Count”.
 If a positive adjustment (such as a transfer in) is being recorded, note from what facility
products are being received.

13. Quantity/Received: Enter the exact amount of the product received on the date recorded.

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 The quantity should be written in terms of units of issue, the units noted at the top of
the card, for example, bottles.
 Stock transferred from one facility to another should be recorded as an adjustment (see
Step 16 for information on entering adjustments). Therefore, the only quantities entered
in the Quantity/Received column should be those quantities received from the health
center (at the health post) or from PFSA (at the health center or hospital).
14. Quantity/Issued: Record the number of units issued as indicated: At the health post, write the
total quantity of the product that was given to clients during the day. At the health center and
hospital, write the quantity of the product each time the product is issued to dispensing unit
and health post.
15. Quantity/Loss/Adj.: Enter the exact amount of losses or adjustments to the inventory on this
date. Explain any losses or adjustments in the “Remarks” column (see Step 20).
 Losses are quantities removed from your stock for anything other than issuing to
patients or another unit in the facility (e.g. expired, lost, stolen, or damaged). Losses
are recorded as (-) negative numbers.
 Adjustments are quantities of a pharmaceuticals received from any source other than
the regular source, that is, health center (for health posts) or PFSA (for health centers
and hospitals), or issued to anyone other than within your facility.

Always use a (+) sign to indicate positive adjustments, and a (-) sign to indicate negative
adjustments. Adjustments may also be made to correct mathematical mistakes previously made in
recording. Be sure to indicate if the adjustment was negative or positive and note the reason for
the adjustment in the “Remarks” column

16. Quantity/Balance:
If receiving products: Add the “Quantity Received” to the Balance from the previous
row and then enter the new balance.
If issuing products: Subtract the “Quantity Issued” from the Balance from the previous
row and then enter the new balance.
If recording a loss or adjustment: Add (if +ve adjustment) or subtract (if –ve
adjustment) the loss or adjustment quantity to the Balance from the previous row and
then enter the new Balance.

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The Balance should show only the quantities of usable stock. Any unusable stock should have
been removed from inventory and an adjustment made on the Bin Card.

17. Batch Number:

 At the health post: Leave this column blank.
 At the health center or hospital: Write the batch number of the pharmaceuticals received
or issued.
 If the pharmaceuticals received or issued have more than one batch number, use a
separate row for each batch number and indicate the quantity received or issued for
each batch number.
18. Expiry Date:
 At the health post: Leave this column blank.
 At the health center or hospital: Write the expiry date of the pharmaceuticals received
or issued.
 If the pharmaceuticals received or issued have more than one expiry date, use a separate
row for each expiry date and indicate the quantity received or issued for each expiry
date. Each expiry date should match with the corresponding batch number.
19. Remarks: Provide a brief explanation for any loss/adjustment or add any other comments as
needed

Examples: Damaged product

Purchase from local pharmacy

Correction of math error

20. If you have filled the last line of the front of the Bin Card…. Turn to the back of the card
and write “Balance Brought Forward” in the “Received From” column and carry the balance
from the front of the card and write it in the “Balance” column of the back of the card.
If you have filled the last line of the back of the Bin Card…You will need to start a new
Bin Card. Go to Step 3.
21. Keep the Bin Card close to where pharmaceuticals are being stored and issued.

The task is complete when:

 A separate Bin Card has been completed for each pharmaceuticals managed in the store.

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 The Name of Health Facility, Product Name, Strength and Dosage Form, and Unit ofIssues
have been written at the top of the Bin Card.
 Each transaction is recorded on the Bin Card as it occurs.
 The Bin Card is kept close to where the pharmaceuticals are stored and issued.

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Casescenario-1

Instruction: - Fill in the Bin Card with the following information:

 The Bin Card is being used at GudayaBila Health Center.

 Bin Card for ciprofloxacin 500 mg tablets
 The Bin Card is started on 2 Ebla 2007.
 The unit of issue is boxes.
 The last balance from the previous Bin Card is 1000 boxes, which have a batch number
of0712309 and an expiry date of July 7/2018.
 2 Ebla 2007 Issued 50 boxes to the dispensary with a batch number of 0712309 and an
expiration date of 7/2018
 15 Ebla 2007 Received 1000 boxes from PFSA with a batch number of 1012409 and an
expiration date of 10/2018.
 18 Ebla 2007 transferred 400 boxes to ArjoGudetu health center with a batch number of
1012409 and an expiration date of 10/2018.
 22 Ebla 2007 Issued 170 boxes to the dispensary with a batch number of 0712309 and an
expiration date of 7/2018.
 28 Ebla 2007, Stock assessment indicated 110 boxes to be damaged with a batch number
of 1012409 and an expiration date of 10/2018 and were declared unusable

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Summary

In this unit, you have learned

 The maximum months of stock is the largest amount of each pharmaceutical a facility
should hold at any one time.
 The minimum months of stock is the level of stock at which actions to replenish inventory
should occur under normal conditions.
 The emergency order point is the level where the risk of stocking out is likely, and an
emergency order should be placed immediately.
 Bin card is one of the commonly used stock records keeping records are used in the
dispensary:
 Components of bin card that should be filled and updated:
o Name of Health Facility o Document No. (Receiving or
o Product Name, Strength and Issuing)
Dosage Form o Received From or Issued To
o Unit of Issue o Quantity/Received
o Maximum Stock Level o Quantity/Issued
o Emergency Order Point o Quantity/Loss/Adjustment
o Average Monthly o Quantity/Balance
Consumption (AMC) o Batch Number
o Date o Expiry Date
o Remarks

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 Learning Module: Drug Supply Management -I | ORHB

Self-check

1. Enter the following transactions on the bin card and calculate average monthly
consumption of niverapine.
- In January 2017, GudayaBila received from the PFSA of Nekemte branch 60
tins of a new item in the store called Niverapine 60 mg tablets wit h invoice
number of 005867.
- During January, two tins of 500 tablets were issued to the dispensing area
(ART pharmacy).
- In February, five tins were issued to ART pharmacy, and
- In the next two successive months, six and seven tins were issued to ART
pharmacy respectively.
- Finally during the last four months, six, eight, nine and ten tins were issued to
ART pharmacy, respectively.
Bin Card

Name of Health Facility: - ___________________________________

Product Name, Strength and Dosage Form: - ____________________________
Unit of Issue: - ______________________________

Doc. No. Received Quantity

Dat (Receiving from or Received Issue Loss/Adj. Balanc Batch Expiry Remark
e d e s
or Issuing) Issued to No. Date

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5. PHARMACEUTICAL STORE MANAGEMENT

Objective:

At the end of this chapter you will be able to:

- Recognize the essential elements of current good storage practices

- Identify storage conditions
- Use Standard operating procedures (SOPs) for pharmaceuticals storage
- Arrange and handlemedicines, vaccines and biological products in refrigerator

5.1 Introduction to pharmaceutical store management

Pharmaceuticals/drugs are stored at every facility in the pipeline of pharmaceuticals supply chain
management; almost everyone working in the supply chain is responsible for product storage.
Storage ensures the physical integrity and safety of products and their packaging,throughout the
various storage facilities, until they are dispensed to clients. An important goal in storageof health
products is the correct staging of health products to ensure that orders can be filled and distributed.

Regardless of storage facility size—from a small health center to a central warehouse—the main
operational activities for storage are very similar. How complex these activities become will vary
based on the volume of products to be managed and storage facility size; as well as particular
requirements, such as cold storage.

 Drugs need to be stored in a specially designed secure area or space of a building in order to:
 Avoid contamination or deterioration,
 Avoid disfiguration of labels,
 Maintain integrity of packaging and so guarantee quality and potency of drugs during
shelf life,
 Prevent or reduce pilferage, theft or losses,
 Prevent infestation of pests.

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5.2 Receiving Pharmaceuticals at Store

When you receive Drugs or other pharmaceuticals: -

1. Ensure there is sufficient storage space.

2. Prepare and clean the areas used for
receiving and storing the products.
3. Inspect packages for damaged or expired

If products are damaged or expired, then

1. Separate the damaged or expired stock from the usable stock.

2. If damage or expiry is discovered while the delivery truck is still at your site,
refuse to accept the products and note the problem(s) on the delivery note.
3. If damage or expiry is discovered after the delivery truck has departed, follow
your facility’s procedures for handling damaged or expired stock

If products are not damaged or expired, then

1. Count the number of units for each product received and compares to issue
voucher.

2. Record the date and quantity received on bin card.

3. Ensure the expiry date is visibly marked on every package or unit.

4. Arrange products in the storage area to facilitate the first-to-expire, first-

out (FEFO) procedure. (See section on stock rotation.)

Remember: Model 19 is used for received products while model 22 is used for issuing
products.

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5.3 Arranging pharmaceuticals in the store

 If you are using pallets (more likely in a central facility than a health center), stack
cartons on pallets:
• at least 10 cm off the floor;
• at least 30 cm away from the walls and other stacks; no more than 2.5 m high
(general rule).

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For all storage:

• Follow the manufacturer’s or shipper’s directions when stacking, and follow labels for
storage conditions.
• Place liquid products on the lower shelves or on bottom of stacks.
• Store products that require cold storage in appropriate temperature controlled zones.
• Store attractive and controlled products in appropriate security zones.
• Separate damaged or expired products from the usable stock without delay, and dispose
of using established disposal procedures.
• Always store all commodities in a manner that facilitates FEFO (“First Expiry First Out”)
rule for stock management.

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• Arrange cartons so arrows point up and

identification labels, expiry dates, and
manufacturing dates are visible.

• If this is not possible, write the product

name and expiry date clearly on the visible
side

• When issuing products, it is

important to follow the FEFO
policy.

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 Following FEFO minimizes wastage from product expiry.

– Always issue products that will expire first, ensuring they are not too close to or
past their expiration date. The shelf life remaining must be sufficient for the
product to be used before the expiry date.

– To facilitate FEFO, place products that will expire first in front of products with a
later expiry date.

– Write expiry dates on bin cards, so stocks can be sent to facilities at least 6
months before they expire.

5.3.1 Systems for arranging drugs in store room

Medical stores must have a system for classifying or organizing medicines, and must ensure that
all employees know the system being used.

Some common systems for arranging medicines include: -

- Alphabetical order by generic name: Often seen in both large and small facilities. When
using this system, the labeling must be changed when the Essential Medicines List.
- Therapeutic or pharmacologic category: Most useful in small storerooms or dispensaries
where the storekeeper is very knowledgeable about pharmacology.
- Dosage form: Medicines come in different forms, such as tablets, syrups, injectables, and
external use products such as ointments and creams.
- System level: Items for different levels of the health care system are kept together.
- Frequency of use: Frequently used products that move quickly or often through
the store should be placed in the front of the room or closest to the staging area. This
system should be used in combination with another system.
- Random bin: Identifies a specific storage space or cell with a code that corresponds to
its aisle, shelf, and position on the shelf. This system requires computer automation.
- Commodity coding: Each item has its own article and location code. This system
has the greatest flexibility, but it is also the most abstract form of arrangement.

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5.4 Pharmaceuticals storage conditions

Storage conditions of all the pharmaceuticals (drugs, laboratory reagents and chemicals
and medical supplies) should be maintained according to manufacturer’s recommendation
to keep their quality.

Within store room the quality of pharmaceuticals can be affected by the following four
conditions depicted in the figure below.

Maintain Quality
• Inside the storage area …

• …what can affect the quality of the medicines?

Cleanliness Temperature

Humidity Direct Light

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5.4.1 Temperature of storage conditions

The following terms are commonly used in storage of pharmaceuticals (drugs, vaccines,
laboratory reagents). Therefore, you are expected to differentiate and use in your store
management.

Store frozen: Some products, such as certain vaccines, need to be transported within a
cold chain and stored at –20°C (4°F). Frozen storage is normally for longer-term storage at
higher- level facilities like PFSA central medical store.

Store at 2°–8°C (36°–46°F):Some products are very heat sensitive but must not be
frozen. These are usually kept inthe first and second part of the refrigerator (never the
freezer).This temperature is appropriate for storing vaccines for a short period of time.

Keep cool: Store between 8°–15°C (45°–59°F).

Store at room temperature: Store at 15° –25°C (59° –77° F).

Store at ambient temperature:

- Store at the surrounding temperature. This term is not widely used due to
significant variation in ambient temperatures.
- It means “room temperature” or normal storage conditions, which means
storage in a dry, clean, well-ventilated area at room temperatures between 15° to
25°C (59°–77°F) or up to 30°C, depending on climatic conditions.

 Remember that heat or high temperature will affect many products. It melts ointments
and creams and causes other products to become useless. It is important to have
thermometers in various parts of the storeroom to monitor temperature
 Monitoring temperature. Consistently monitor the temperature of the different areas
within the storeroom.

– Keep thermometers in various places for monitoring

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– Keep the storeroom well ventilated (see section on humidity). For better ventilation,
store boxes on pallets and leave room between rows of stacked boxes (see section on
arranging products).
– Keep direct sunlight out of the storeroom

 But, even if you do not

have thermometers,
you can still monitor
the heat. If you feel hot,
your products are
probably hot, too

5.4.2 Humidity
Humidity of the store can affect certain pharmaceutical. Thus, when product labeled as
“protect from moisture,” store the product in a space with no more than 60% relative
humidity.

In humid climate, dehumidifiers are useful for preventing moisture damage.If the store room has
no dehumidifier, use ventilating fans, expose the area to the light or peon the windows if possible.

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Ventilation: Open the windows or air vents of the storeroom to allow air circulation.
Ensure all windows have screens to keep out insects and birds, and either have
bars or are not open wide enough for anyone to climb in. Put boxes on pallets
and ensure there is space between pallets and the walls of the storeroom

Packaging: Secure all lids. Never open a new container unless necessary.

Circulation: Use a fan to circulate fresh (outside) air. In bigger storerooms you may need
a ceiling fan.

5.4.3 Sunlight

 Some health products are photosensitive and will be damaged if exposed to light. These
include: -

- Multiple vitamins,
- Furosemide,
58 - Chloropheniraminemaleate,
- Hydrocortisone,
- latex products (such as male condoms), and
- X-ray film.
 To protect products from sunlight
- Shade the windows or use curtains, if they are in direct sunlight.
- Keep products in cartons.
- Do not store or pack products in sunlight.
- Use opaque plastic or dark glass bottles for products that require them.
- Maintain trees on the premises around the facility to help provide shade, but check
them regularly to ensure that there aren’t any branches that can damage the facilities.

5.4.4 Cleanliness of the store

Keep clean your store as dirty materials attract different pests which can damage the
quality of stored pharmaceuticals. Some common pests are rats, roaches, ants and

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wasps. Spilled items may attract pests. Clean spills and remove broken containers
immediately.

To protect against pests follow the following guidelines:

– Inside the storage facility:

 Regular cleaning to prevent conditions that favor pests.
 Do not store or leave food in the storage facility.
 Keeping the interior as dry as possible.
 Paint or varnish woods.
 Regular inspection for evidence of pests
- Outside the storage facility:
o Regularly inspect and clean the outside premises specially areas where
garbage is stored.
o Check for rodent burrows.
o Using mercury vapor lighting where possible, and locate lighting away
from the building to minimize the attraction of pests.

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5.4.5 Security of store room

Pharmaceuticals are expensive so that they can be lost through theft. Follow the
following procedures to keep the security of your store.

General rule to protect against theft:

- Use double doors and double locks on entrance

- Use burglar bars on window
- Control entry to the pharmacy
- Set rules for staff who handle suppliers to be equally accountable for their
actions
- Maintain good control of stock cards and registries to detect theft.

Outside the facility

- During transport:
o Verify documents E.g. DIC (delivery invoice cards)or GRV Goods
receiving voucher(Model 19)
o Use packing seals
o Use strong boxes
- In outpatient departments and health centers
o Set maximum dispensing quantities
o Record individual prescriptions
o Allow only pharmacy personnel to dispense

Protection against fire:

- Availability of standard fire extinguishers in every storage facility and inspecting them
every 2-3 months to ensure pressures are maintained and the extinguisher is ready for use.
- Service of fire extinguishers at least every 12 months.
- Placing smoke detectors and checking them every 2-3 months.
- Prohibiting smoking in the storage.
- Conducting fire drills every 6 months.
- Emergency exits should be clearly marked and checked
regularly for accessibility and any blockage.

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- Display of fire protection signs at appropriate places.

- Use of sand to extinguish fires where there are no fire extinguishers.
Placing the sand bucket near the door

5.4.6 Vaccine storage and cold chain management

- The potency of vaccines, sera, test kits, and many other items depends on cold
storage. Vaccine, in particular, must be kept at precisely controlled temperatures
from the point of manufacture to the point of administration. Also daily
temperature record should be maintained properly.
- The “cold chain” is a system of transporting and storing vaccines, medicines and
laboratory reagents within a recommendedtemperature range of +2 to +8 degrees
Celsius (°C).
- For the cold chain management of vaccines, medicines and laboratory reagents
we use different types of refrigerators and freezers. So let us look some of their
types.
Refrigerators and freezers

- Refrigerators that open on the top are more efficient than vertical ones, because hot
air rises while cold air falls.
- The coldest part of vertical refrigerators is at the bottom
- Store products that are sensitive to freezing or very low temperatures on the
upper shelves.
- Always have enough frozen icepacks to transport items requiring cold storage in
cold boxes and/or vaccine carriers. Use only icepacks filled with water. Do not
use icepacks prefilled with other liquids, which are usually blue or green.
- When ordering cold chain equipment, larger facilities should reassess the needs for
icepacks and icepack freezer space.
-
- If there is enough space, place a few plastic
bottles of water in the refrigerator. This will
help maintain the temperature for a longer
period of time if the power is cut off.
- Place refrigerators and freezers with
space between and about an arm’s 61
length
away from the wall. This will increase the
air circulation.
 Learning Module: Drug Supply Management -I | ORHB

Storage of vaccines:
- All vaccines and diluents must be stored in the refrigerator for short term
between 2°C and 8°C in a pharmacy that issues to the end- user or clinics.
- For long terms storage -20°C is preferred only for BCG, OPV and measles.
- Do not freeze other vaccines.
- Domestic refrigerator, ice lined refrigerator are used for short term storage and
deep freezer for long term storage.

Table 5: Potency& temperature for storage vaccines

Vaccine Temperatu Potency Remarks

re maintained

Oral Polio (OPV) -20°C 1year Avoid repeated thawing

4°C to 8°C 3 months Keep on ice while using

Bacillus Calmettle 4°C to 8°C 1 years Reconstituted vaccine, if not used

Guerine (BCG) within four hours must be discarded

DiphtheriaPertussis 4°C to 8°C 2 years Must not be frozen

Tetanus (DPT)

Diphtheria, 4°C to 8°C 2 years Must not be frozen

Tetanus (DT)

Measles 0°C to 2°C 2 years Should be used immediately after

reconstitution

Typhoid (TAB) 4°C to 8°C 8 months Must not be frozen

Tetanus Toxoid 4°C to 8°C 8 months Must not be frozen. Unused portion
(TT) must be discarded

Hepatitis B 4°C to 8°C 4 years Must not be frozen

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Summary

In this unit, you have learned:

 Drugs need to be stored in a specially designed secure area to:

 Avoid contamination
 Avoid disfiguration of labels,
 Maintain integrity of packaging and so guarantee quality,
 Prevent or reduce pilferage, theft or losses,
 Prevent infestation of pests.

 Differentiated model 19 and model 22

 Principles arranging pharmaceuticals using shelves and pallet
 Some common systems for arranging medicines include
- Alphabetical order by generic - System level
name - Frequency of use
- Therapeutic or pharmacologic - Random bin
category - Commodity coding
- Dosage form
 Conditions that affect quality of drugs include:
- Temperature - Humidity
- Cleanliness - Direct sunlight
 The “cold chain” is a system of transporting and storing vaccines, medicines and
laboratory reagents within a recommendedtemperature range of +2 to +8 degrees
Celsius (°C).

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Self-check

1. Why drugs or pharmaceuticals need to be stored securely?

2. Discuss steps that should be followed while receiving pharmaceuticals at store?
3. Lists systems of arranging pharmaceuticals in store
4. Differentiate the following term temperature related terms that we use in store:
- Store frozen and Keep cool
5. Define cold chain and describe how vaccines should be stored

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6. PHARMACEUTICAL WASTE MANAGEMENT

Objectives

By the end of this unit, you will be able to

 To describe principles of pharmaceutical waste disposal

 Outline the procedures for identification and disposal of pharmaceutical wastes
 To segregate, record and report pharmaceutical wastes

6.1 Introduction

Pharmaceutical products become unusable if failed to with required quality standards (might be
manufactured with poor quality) or expired or damaged during transport, storage and handling.
Proper management of unusable pharmaceutical products has several objectives.The main
objective of which is to prevent harm of people from the reuse or resale of expired, damaged or
recalled health care goods as well as harm from sharps.

Another important objective is to protect environment which can be harmed by inappropriate

disposal of drug products or substances contained in certain health care facility.

Disposal of unusable health care goods must be carried out in complete transparency towards
the health authorities, public information must be handled carefully as it may be politicized and
sensationalized.

6.2 Types of waste at health facility

6.2.1 Non-medical waste

These types of waste include: compost leaves, sticks, weeds, and trimmings from shrubs and
trees, if feasible. Designate a separate area for composting.

Cardboard cartons: If possible, recycle cardboard; otherwise, treat like ordinary

rubbish.

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Ordinary rubbish: Where municipal solid waste facilities exist, dispose of

ordinary rubbish in the municipal dump. Otherwise, burn or bury it.
Human waste: Use pit latrines or other toileting facilities to dispose of all human
wastes
6.2.2 Health care wastes

Sharps waste: Single-use disposable needles, needles from auto-disable syringes, scalpel
blades, disposable trocars, sharp instruments requiring disposal, and sharps waste from
laboratory procedure

Other hazardous medical waste: Waste contaminated with blood, body fluids, human
tissue; compounds such as mercury; pressurized containers; and wastes with high
heavy metal content.
Pharmaceuticals: Expired, damaged, or otherwise unusable medicines, chemical, reagents and
items contaminated by or containing medical substance

6.3 Steps for Pharmaceutical waste disposal

Disposal – Steps and Methods

A series of steps need to be taken when disposing of unwanted pharmaceuticals:

Step 1- Decision: The hospital, district or regional pharmacist or organizations with

pharmaceutical programs decide when action needs to be initiated, because of an accumulation of
unwanted pharmaceuticals which are unfit for human consumption and for veterinary treatment.

Step 2 –Approval: Approval and sanctioning of disposal of pharmaceuticals must be sought

from the appropriate authority. This authority will differ from country to country and may
be the department responsible for pharmaceutical management within the ministry of health,
the drug regulatory authority, or the regional or local health authority (pharmaceutical officer).
FMHACA/Regional regulatory wing is the responsible body in Ethiopian context.

Step 3- Planning:-Planning, in terms of funding, necessary expertise, human resources,

professional time, space, equipment, material and available disposal options will be required.
This is essential before practical steps can be taken to start disposal.

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Step 4 -Forming work teams: -Work should be conducted by teams consisting of supervising
pharmacists and general medical workers, who are preferably pharmaceutical technicians or
experienced pharmaceutical warehouse personnel. The size of each team, and the ratio of experts
to workers, will be determined by the volume and composition of the stockpiles, and working
conditions at the sites.

Step 5 -Health and safety of work teams:-All workers should wear appropriate protective equipment
including overalls and boots at all times, and gloves, masks and caps when appropriate. Masks
should be worn when tablets or capsules are being crushed as part of the disposal technique and when
there is a risk of powders being liberated. Particular care is required when handling anti-neoplastic

Step 6 –Sorting:-The objective of sorting is to separate the pharmaceuticals into separate categories
for which different disposal methods are required. The separation should be made into those that
can be safely used and returned to the pharmaceutical supply system and those that require disposal
by different methods. For example, controlled drugs (e.g. narcotics), anti-neoplastic drugs and
antibiotics all require special methods of disposal. Substantial investment in human resources
may be required for identifying and separating pharmaceuticals.

Step 7:- Disposal:-Disposal options vary considerably with situations and the ideal solution may
not be feasible. As result using the simplest,safe stand most practical alternatives is important.

Note the following points during disposal of pharmaceutical:

1. Controlled substances (e.g. narcotics and psychotropic) require tight security and control
measures. In some countries, scavenging of material from landfills is a frequent problem,
and disposed drugs may be recovered and sold by the scavengers. Measures are therefore
necessary to prevent diversion during sorting, and pilfering of drugs from land fill.
2. All workers should wear appropriate protectiveequipment including over all sand boots at
all times, and gloves, masks and capsule when appropriate .Masks should be worn when
tablets or capsules are being crushed as part of the disposal technique
(forexample,inertization)andwhenthereisariskofpowdersliberation.Particularcareisrequire
d when handling anti -neoplastic.

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6.4 Methods of waste disposal

Burial pits and encapsulation are suitable in locations without shallow groundwater and for
small volumes of waste.

Burial pits: The bottom of the pit should be 1.5 m above the groundwater level, 3–5 m deep,
and lined with a substance of low permeability, such as clay. Surround the opening with
a mound to keep run-off water from entering the hole, and build a fence around the area.
Periodically, cover waste layers with 10–15 cm of soil.

Encapsulation: Cement-lined pits or high-density plastic containers or drums are filled to

75% capacity with health care waste. The container is then filled with plastic foam, sand,
cement, or clay to immobilize the waste. The encapsulated waste is then disposed of in a
landfill or left in place if the container is constructed in the ground.

Incineration: Medium- and high-temperature incineration devices require a capital

investment and an operations and maintenance budget. They operate on fuel, wood, or other
combustible material and produce solid ashes and gases. Pollutants are emitted to varying
degrees. The ash is toxic and must be buried in a protected pit. Combustible waste is reduced
to incombustible waste with a decreased volume

The high temperatures kill microorganisms medium-temperature incinerators, commonly

a double- chamber design or pyrolytic incinerator, operate at a medium-temperature
combustion process (800 °–1,000 °C).

High-temperature incinerators, recommended by WHO, treat health care waste at a

temperature >1,000°C.When operated by staff trained in correct use and maintenance,
incineration in a device like this one— completely destroys needles and syringes n kills
microorganisms reduces the volume of waste generates less air pollution than low-
temperature burning.Note: Incinerate pharmaceuticals only if absolutely necessary.

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Low-temperature burning: Burning devices not exceeding 400° C include single-

chamber brick hearths, drum burners, and burning pits. They burn
incompletely and do not fully destroy waste.

They may not kill microorganisms. Given these shortcomings,

- low-temperature
- Burning should be used only as a short-term solution.

Burn andbury: Pit burning is a low-cost but relatively ineffective means of waste disposal. A
fence should surround the pit to prevent children, animals, and others from coming into
contact with the waste. The pit location should avoid walking paths (high-traffic areas). The
fire, usually started with a petroleum-based fuel and allowed to burn, should be supervised by
designated staff and located down-wind of the facility and residential areas. The low-
temperature fire emits pollutants, and the ash and remaining material should be covered with
10–15 cm of dirt.

Othermethods: In addition to the common methods, other methods are used in some settings,
including needle removal/ needle destruction, melting syringes, steam sterilization
(autoclaving and hydroclaving), and microwaving (with shredding).

Managing health care waste is a comprehensive program that requires support at all levels
of the health care system. Staff involved in health care waste management must be given
training and support.

6.5. Waste types not to be incinerated

Pressurized gas containers.

Large amounts of reactive chemical waste.
Silver salts and photographic or radiographic wastes
Waste with high mercury or cadmium content, such as broken thermometers,
used batteries, and lead-lined wooden panels.
Sealed ampoules or ampoules containing heavy metals

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Pharmaceutical disposal.It is very important to dispose of pharmaceuticals properly

because there can be very negative consequences to improper disposal. Improper disposal
can result in—

Contaminated water supplies

The diversion and resale of expired or inactive medicines
Improperly incinerated products, which can release toxic pollutants into the air.

 Particular attention must be given to disposal of the following categories of pharmaceuticals—

controlled substances, such as:
o narcotics and psychotropic medicines
o anti-infective drugs
o antineoplastics
o cytotoxic
o anti-cancer drugs, toxic drugs
o antiseptics and disinfectants

Proper use of safety boxes

 Safety boxes or sharps containers are puncture- and water-resistant, impermeable
containers. When used correctly, they reduce the risk of skin-puncture injuries that
may spread disease.
 Do not recap syringes before disposal.
 Place the syringe and needle in the sharps box immediately after use.
 Keep the sharps box where the injections are given.
 Do not overfill the sharps containers (about 3/4 full).

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 When 3/4 full, close box tab completely to cover the opening and tape it shut.
 Store the box in a safe and secure
 location until ready for final disposal.
 n Do not empty and refill sharps boxes. Fill once and
 discard immediately.
 See annex 2 for more information about waste disposal.
Table 6: Different disposal methods base on drug types

Category Disposal Methods Comments

Solids Landfill No more than 1% of
Semi- Waste encapsulation the daily
solids Powd Waste inertization municipal waste should be
ers Medium and high temperature incineration disposed of daily in an untreated
(cement kiln incinerator) form (non- immobilized) to a
landfill.
Liquids Sewer Antineoplastics not to sewer.
High temperature incineration (cement
kiln incinerator)
Crush ampoules and flush diluted fluid to
Ampoules Antineoplastics not to sewer.
sewer
Anti-infective Waste encapsulation Liquid antibiotics may be diluted
drugs Waste inertization with water, left to stand for several
Medium and high temperature incineration weeks and discharged to a sewer.
(cement kiln incinerator)
Controlled Waste encapsulation Not to landfill unless encapsulated
drugs Waste inertization
Medium and high temperature
incineration (cement kiln
incinerator)
Aerosol Landfill Not to be burnt: may explode.
canisters Waste encapsulation
Disinfectants Use No undiluted disinfectants to
To sewer or fast-flowing watercourse: sewers or water courses.
small quantities of diluted disinfectants Maximum 50 liters per day diluted
(max. 50 liters per day under to sewer or fast-flowing
supervision) watercourse. No disinfectants at
all to slow moving or stagnant

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watercourses.

PVC plastic, Landfill Not for burning in open containers

Glass
Paper, Recycle, burn, landfill
cardboard

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 Learning Module: Drug Supply Management -I | ORHB

Summary

In this unit, you have learned:

 Types of waste at health facility

o Non-medical waste or Garden rubbish

 Cardboard cartons
 Ordinary rubbish
 Human waste:

o Health care wastes

o Pharmaceutical wastes
o Sharp material wastes
o Other hazardous medical waste:
 Steps in pharmaceutical waste disposal
 Methods of waste disposal
o Burial pits:
o Encapsulation:
o Incineration
o Low-temperature burning
o Burn and bury
o Other methods
 Waste types not to be incinerated

Pressurized gas containers.

Large amounts of reactive chemical waste.
Silver salts and photographic or radiographic wastes. nHalogenated plastics such as
polyvinyl chloride (PVC).
Waste with high mercury or cadmium content, such as broken thermometers,
used batteries, and lead-lined wooden panels.
Sealed ampoules or ampoules containing heavy metals

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 Learning Module: Drug Supply Management -I | ORHB

Self-check

1. Write types of waste at health care facilities

2. Describe steps used in pharmaceutical waste disposal
3. List method of waste disposal

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 Learning Module: Drug Supply Management -I | ORHB

References

1. Management Sciences for Health (2012). MDS-3: Managing Access to Medicines and
HealthTechnologies. Arlington, VA: Management Sciences for Health.
2. John Snow Inc./DELIVER (2004). The Logistics Handbook: A Practical Guide for Supply
ChainManagers in Family Planning and Health Programs. Arlington, Va.: John Snow
Inc./DELIVER,for the U.S. Agency for International Development (USAID).
3. USAID | DELIVER PROJECT,Task Order 1 (2011). The Logistics Handbook: A Practical
Guide for the Supply Chain Management of Health Commodities. Arlington, Va.: USAID |
DELIVER PROJECT, Task Order 1. Second edition.

4. John Snow, Inc./DELIVER in collaboration with the World Health Organization. Guidelines
for the Storage of Essential Medicines and Other Health Commodities. 2003. Arlington, Va.:
John Snow, Inc./DELIVER, for the U.S. Agency for International Development.
5. FMHACA (2011).Medicines Waste Management and Disposal Directive. Addis Ababa,
Ethiopia.

6. PFSA (2015). Standard Operating Procedures (SOP) Manual For The Integrated
Pharmaceuticals Logistics System in Health Facilities of Ethiopia, First Edition. Addis Ababa,
Ethiopia.
7. AnsTimmermans and Anu Sharma (2006). UNHCR drugmanagement manual. Geneva.
8. Drug store management & rational drug use (2010). State Institute of Health & Family
Welfare,Rajasthan, India.
9. FMHACA (2015). Guide lines for good storage practices, good distribution practices, and
pharmaceutical product recall, first edition, Addis Ababa, Ethiopia.
10. WHO (2010).WHO good distribution practices for pharmaceutical products. WHO Technical
Report Series, No. 957, Geneva.
11. WHO Training manual (2004). Management of drugs at health center level. Brazzaville.
12. Amhara National Regional State Health Bureau (2012). Auditable Pharmaceutical
Transactions and Services (APTS): A Guide for Implementation. Bahirdar, Ethiopia.

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Annex-1
Internal Facility Report and Resupply Form
Name of Dispensing Unit:___________________Reporting Period From:___________To:_________________

Maximum Level (ML):_______

COMPLETED BY UNIT COMPLETED BY STORE

Quantity
Calculated Maximum
Ser Beginning Loss/ Ending
Consumption Quantity
Needed to Quantity to be
Balance Quantity Adjustment Balance Reach Max. Supplied
. Item Received E = A+B+/-C-D F =E * 2
G=F–C
No.
A B C D E F G H
1
2
3
4
5
6
7
8
9
10
11
Remarks :
Completed by (Name, Date and Signature) : Completed by (Name, Date and Signature) :

Approved by (Name, Date and Signature) :

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 Learning Module: Drug Supply Management -I | ORHB

Annex-2
Report and Requisition Form (RRF)

Health Region Zone Woreda:

Facility: : :
Reporting period From (month/day/year) to (month/day/year)
Maximum Stock Level:4 Mos:Emergency Order Point: 0.5 Mos
Report Part Requisition Part

Quantit Losses/ Calculate

Ending Days Maximu Quantity Quantity
Beginning y d
Product Adjustme Balanc Out Of m Stock needed to
Product Unit of Balance Receiv Consump Ordered
No. Descriptio nts e Stock Quantity reach
Code Issue ed tion
n Max

E F G
A B C D =A+B = 120*E H= G-D
+/- C – D /(60 – F)
1
2
3
4
5
Products with shelf life <6 months (S/No, Quantity and Expiry date): Remarks:

Completed by: Signature: Date:

Verified by: Signature: Date:
Approved Signature : Date :
by :

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 Learning Module: Drug Supply Management -I | ORHB

MODULE SYLLABUS

Module title:-Drug Supply Management I

Module code: PRA2 M3 1017

Nominal duration: 80 hours (two weeks) Theory 50 hrs. Practice 30 hrs.

Module Description: This module aims to provide the learners with the knowledge, skills and
right attitudes for maintaining a dispensary stock control system, according to standard operating
procedures in compliance with statutory and legal requirements.

Unit of Competencies

 Assist in Dispensary Stock Control

Module Objective

By the end of this module, you will be able to

- Apply pharmaceutical procurement procedure

- Perform ordering and receiving dispensary stock
- Perform drug storage tasks
- Perform dispensary stock control

Teaching/learning methods

 Interactive presentation
 Group work
 Guided practices at health facilities
 Case studies

Teaching/learning materials
- Students learning module DSM-I
- LCD projector
- Power point slides
- IFRR formats and Bin cards

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 Learning Module: Drug Supply Management -I | ORHB

- Bin cards/stock record system

- SOP for storage
- Medicines Vaccines, Biological products
- Refrigerator
- Dispensary room
- Daily Dispensary Registry
- Expiry register form
- Recall and return forms

Methods of assessment
- Quizzes
- Tests
- Objective written exam
- Written exercises
- Assignments(group and individual)
- Written test/oral questioning on underpinning knowledge
- Oral questioning
- Structured observation
- Case based exam
- Short answer
- Structured feed back
- Observation

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 Learning Module: Drug Supply Management -I | ORHB

Module Schedule
Week Learning Activity Required
Reading /
Assignment

Week Day one

one
Interactive presentation (2 hours )
- To describe Pharmaceutical management cycles
- Lists principles of Good pharmaceutical procurement practices
Group Activity (2 hours)
 Discuss drug supply management cycles
Interactive presentation (2 hours )
 Describe pharmaceutical procurement methods
 Describe drugs purchasing models
Independent study(2 hours)
Day two
Group Activity (4) hours
 Discussion pharmaceutical procurement methods& purchasing
models
Interactive presentationand discussion(2 hours)
 List drugs selection criteria
Interactive presentation (2 hours)

 Describe morbidity and consumption methods to quantify

pharmaceuticals needs for health facilities
Day three
Group Activity (4 hours)

 Determine drug quantity using morbidity methods for health

facilities
Group Activity (4 hours)

 Determine drug quantity using consumption methods for health

facilities
Dayfour
Interactive presentation and discussion ( 2hours)
 Perform stock control
Independent reading ( 2hours)

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 Learning Module: Drug Supply Management -I | ORHB

Perform stock control

Skill Lab (4 hours)

 Perform stock control

Day five
Interactivepresentation(2 hours)

 To identify steps in dispensary stock ordering

 To identify stock receiving steps
Skill Lab (4 hours)

 Use IFRR to request stock for dispensary

 Arrange stocks on shelve
Guided practice and group activity (2 hours)
- To enter dispensary stock in to stock records (bin card)
Day six
Guided practice and group activity (2 hours)
- To enter dispensary stock in to stock records (bin card)
Interactive presentation(2hours)
- Recognize the essential elements of current good storage practices
- Identify storage conditions
Skill Lab (4 hours)

Week 2 
Observe storage conditions

Use Standard operating procedures (SOPs) for pharmaceuticals
storage
Day one
Skill Lab (4 hours)


Arrange medicines, vaccines and biological products in refrigerator

To identify dispensary stock records and documentation
- To enter dispensary stock in to stock records (bin card)
Group Activity and discussion (4hours)
- To identify dispensary stock levels (min-max stock levels)
Day two
Guided practice and group activity (4 hours)
- To investigate dispensary stock discrepancies
Guided practice and discussion (4)
- To identify procedures and formats used for product recall and return
forms.

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 Learning Module: Drug Supply Management -I | ORHB

- Bin card exercise

Day three
Interactive presentation and group discussion (2 hours)
- To describe principles of pharmaceutical waste disposal.
- Outline the procedures for identification and disposal of
pharmaceutical
- Wastes
Independent study (2hrs)
Skill Lab (4 hours)
- To segregate, record and report pharmaceutical wastes
- To enter dispensary stock in to stock records (bin card)
- Independent study
- To enter dispensary stock in to stock records (bin card)
- IFRR format
- Filling recall and returned stocks on bin cards
- Exam

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