NTA Level 5 • Semester 1 • PST05101

Quality Assurance in Procurement of Medicines and Medical

Medicines and Medical Supplies Management • Source Session/Topic 11

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Session 11: Quality Assurance in Procurement of Medicines and Medical

Supplies

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List sources of medicines and medical supplies for procurement

• Explain the quality assurance in procurement of medicines and medical

supplies

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Sources of Medicines And Medical Supplies For Procurement (35

minutes)

|Activity: Buzzing (5minutes) |

| |

|ASK students to pair up and buzz on the following question for 3 |

|minutes |

| |

|What are the Sources of medicines and medical supplies for procurement?|

| |

|ALLOW few pairs to respond on the question and let other pairs add on |

|points not mentioned WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

The following are the Sources of medicines and medical supplies for

procurement:

They could be primary or secondary sources:

• Primary sources

o Manufacturers

o Industries

• Secondary sources

o Distributors

o Agencies

o Others eg individuals or private pharmacy

These are examples of common Sources of medicines and medical supplies

for procurement;

• Medical Stores Department (MSD)

• Private pharmacies

• Donors (Non Governmental Organization-NGOs) ie Bilateral Aid programs

eg. DANIDA,USAID, JICA

• United Nation Organizations (United Nations International Children’s

Emergency Fund-UNICEF, UNDP)

• World Health Organization (WHO)

• At the global level, United Nations agencies such as UNICEF, United

Nations Population Fund, and United Nations Development Programme have

long functioned as pooled procurement systems serving their country

programs

• In recent years, a number of new global procurement mechanisms have

emerged, such as the Stop TB Global Drug Facility, the U.S. President’s

Plan for Emergency AIDS Relief (PEPFAR)–funded Supply Chain Management

System (SCMS), and the Global Fund to Fight AIDS, Tuberculosis and

Malaria’s voluntary pooled procurement system

STEP 3: Quality Assurance in Procurement of Medicines and Medical

Supplies (40 minutes)

|Activity: Small Group Discussion ( 15 minutes) |

| |

|DIVIDE students into manageable groups |

| |

|ASK students to discuss in groups on the following question: |

| |

|What is quality assurance in procurement of medicines and medical |

|supplies? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW each groups to present |

| |

|CLARIFY and SUMMARIZE by using the contents below |

Quality assurance in procurement of medicines and medical supplies:

• The purpose of quality assurance in pharmaceutical supply systems is to

help ensure that each medicine procured and that reach a patient is safe,

effective, and of acceptable quality.

• A comprehensive quality assurance program includes both technical and

managerial activities, spanning the entire supply process from

pharmaceutical selection to patient use.

• For the purposes of primary health care, the most important

characteristics of a pharmaceutical product are identity, purity,

strength, potency, uniformity of dosage form, bioavailability, and

stability.

• Pharmaceutical quality is affected by starting materials, manufacturing

process, packaging, transportation and storage conditions, and other

factors; these influences may be cumulative.

• If a pharmaceutical product does not meet established quality standards,

passes its expiration date, or has been degraded by storage conditions,

the possible consequences are;

o Lack of therapeutic effect, leading to prolonged illness or death

o Toxic and adverse reactions

o Waste of limited financial resources

o Loss of credibility of the health care delivery system

• A comprehensive quality assurance program must ensure the following;

o Pharmaceuticals selected have been shown to be safe and efficacious

for their intended use, are presented in an appropriate dosage

form, and have the longest possible shelf life

o Suppliers with acceptable quality standards are selected

o Pharmaceuticals received from commercial suppliers and donors meet

specified quality standards at the time of delivery

o Packaging meets contract and usage requirements

o Repackaging activities and dispensing practices maintain quality

o Storage and transportation conditions do not compromise product

quality

o Product quality concerns reported by prescribers, dispensers, and

consumers are properly cataloged and addressed

o Product recall procedures are implemented to remove defective

products

STEP 4: Critical Elements in Quality Assurance for Pharmaceutical

Procurement

(20 minutes)

|Activity: Small Group Discussion ( 15 minutes) |

| |

|DIVIDE students into manageable groups |

| |

|ASK students to discuss in groups on the following question: |

| |

|What are the critical elements for quality assurance for pharmaceutical|

|procurement? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW each groups to present |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Product selection: products with longer shelf life (for example, powders

for reconstitution rather than oral suspensions), avoidance of products

with bioavailability problems, when possible

• Product certification: supplier prequalification, recent GMP inspection

reports from national drug authorities, formal supplier-monitoring

system, limitation of purchases from new suppliers to non-critical

products

• Product certification: GMP certificate from drug regulatory authority

(prequalification), certificate of pharmaceutical products (WHO-type) for

all new products, new suppliers batch certificate (WHO-type) for problem

drugs only

• Contract specifications: acceptable pharmacopeial standards, language,

labelling requirements, minimum shelf life, packaging standards

• Inspection of shipments: physical inspection of all shipments, sampling

for analysis of suspect products

• Targeted laboratory testing: therapeutically critical drugs, drugs with

known bioavailability problems, new suppliers, suppliers with quality

difficulties in the past

• Product problem reporting system: system for reporting suspect or problem

products

STEP 4: Key Points (10 minutes)

• The purpose of quality assurance in pharmaceutical supply systems is to

help ensure that each medicine procured and that reach patients is safe,

effective and of acceptable quality

• A poor-quality medicine is one that does not meet specifications. The use

of poor-quality products may have undesirable clinical and economic

effects, as well as affect the credibility of the health delivery system.

Clinical effects can include prolonged illness or death or adverse

reactions. On the economic side, limited financial resources may be

wasted on poor-quality medicines

• In the procurement of medicines and medical supplies it is very important

to assure quality for the betterment of health of communities and

national at large

• For pharmaceutical procurement organizations, pharmaceutical quality is

assessed as the product’s compliance with specifications concerning

identity, purity, strength, potency, and other characteristics.

Uniformity of the dosage form, bioavailability, and stability are

important characteristics that are also considered in the specifications.

STEP 5: Evaluation (10 minutes)

• What are the sources of medicines and medical supplies for

procurement?

• What is the quality assurance in procurement of medicines and

medical supplies?

References

MSH and WHO (2012) Managing Access to Medicines and Health Technology,

3rd Edition. Kumarian Press

World Health Organization (WHO), Regional Office for Africa

Brazzaville 2004, Management of Drugs at Health Centre Level Training

Manual.

United Republic of Tanzania Ministry of Health and Social Welfare,

Strategy for Development and Implementation of an Integrated Logistics

System for Essential Health Commodities: Government Printers, Dar es

Salaam

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