MeTA - Quality of medicines

The quality of medicines is another important factor that concerns MeTA. Counterfeit medicines are a big problem in developing countries. Some may not contain enough active ingredients to have any effect on the patient and some may even be harmful. The quality of medicines can also be affected by poor storage or medicines being out of date. Regulatory authorities are needed to ensure implementation of good manufacturing practices, combat substandard products, inspect distribution channels (checking, for example, that out-of-date medicines are not on sale) and monitor new information on serious adverse effects of pharmaceutical products.

Resources in this key list are concerned with improving the regulation of medicines.

We will add to this key list over time and would welcome suggestions or additions. Please send these to: sourceassistant@hi-uk.org

Selected resources

Books, reports, etc

2009 FIP global pharmacy workforce report

WULIJI, Tana
Ed
2009

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"Without access to and appropriate use of quality medicines, health systems lose their ability to meet health care needs. The pharmacy workforce crisis threatens the ability of many countries to deliver health services, however little information or studies have been published in this area. The International Pharmaceutical Federation (FIP) has sought to address this crisis by gathering global baseline data on pharmacy workforce and developing evidence-based background papers to serve as an advocacy tool at country, regional and global levels"

A model quality assurance system for procurement agencies : recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products

WORLD HEALTH ORGANIZATION (WHO)
2007

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This report is intended to assist organisations purchasing pharmaceutical products, vaccines or other health sector goods, or who are otherwise involved in the prequalification, purchasing, storage and distribution of such products. It addresses the general requirement for the quality assurance system that needs to be in place at all procurement agencies and sets out recommendations that these agencies should implement when evaluating product needs, assessing the products offered and the manufacturing and supply arrangements. It also describes principles of purchasing pharmaceutical products, how to receive and store them; good distribution practices; and monitoring and reassessment of products and contracted-out activities. This document was previously published as Annex 6 of the 40th Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (Technical report 937, 2006).

A model quality assurance system for procurement agencies : recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products

WORLD HEALTH ORGANIZATION (WHO)
2007

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The long-term goal of these recommendations is the design and implementation of a uniform and harmonised system that will ensure procurement of pharmaceutical products of defined quality for supply to patients, based on a mutually recognised process of prequalification of products and manufacturers by means of product dossier evaluation and inspection of manufacturing sites. This document was previously published as Annex 6 of the WHO Technical Report Series No. 937, 2006

Anti-corruption in the health sector : preventing drug diversion through supply chain management

VIAN, Taryn
October 2006

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This case-based brief describes how the President’s Emergency Plan for AIDS Relief (the US PEPFAR initiative) and the related Supply Chain Management System (SCMS) Project are working to increase transparency and provide a secure, high-quality supply of HIV/AIDS drugs to developing countries in Africa and Asia. Drug supply is an essential component of health care systems, accounting for 10-30 percent of health care costs. Drugs can be expensive, and willingness to pay for drugs is high, creating the danger that employees will divert drugs for re-packaging and sale in the grey market, or for personal use

Counterfeit drugs kill

INTERNATIONAL MEDICAL PRODUCTS ANTI-COUNTERFEITING TASKFORCE (IMPACT)
May 2008

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This leaflet describes how counterfeit medicines may endanger people's health because their quality is unpredictable. It also considers the challenges faced in combating counterfeit medicines and the role of the IMPACT coalition

Effective drug regulation : what can countries do?

WONDEMAGEGNEHU, Eshetu
1999

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This paper presents an overview of the development of drug regulation and the rationale for drug regulation. It also reviews the drug regulation situation in selected countries, examines key contributing factors to observed drug regulation weaknesses, and identifies the measures that must be taken to improve drug regulation

Ensuring the quality of vaccine at country level : guidelines for health staff

WORLD HEALTH ORGANISATION (WHO). Department of Vaccines and Biologicals
UNITED NATIONS CHILDREN'S FUND (UNICEF). Supply Division
et al
2002

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These guidelines were prepared for countries procuring their vaccines through UNICEF, and are aimed at programme and regulatory authority personnel at country level, UNICEF and WHO country staff, and all who handle, store and use vaccines. They describe the procedures necessary for ensuring vaccine quality from production to administration, and address identified problems with shipping, receiving, quality control, release, storage, distribution and administration

Ghana national drug policy

Ministry of Health, Ghana
2004

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This policy includes the following sections: a situational analysis of drug selection; drug procurement, storage and distribution; drug financing; quality assurance; local manufacture of pharmaceutical and traditional medicinal products; rational drug use; global trade and pharmaceuticals; emerging diseases and pharmaceuticals; human resource development for drug management; traditional medicinal products; research and development; and implementation of the policy

Guide to good storage practices for pharmaceuticals - Annex 9

WORLD HEALTH ORGANIZATION (WHO)
2003

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This guide describes the special measures considered appropriate for the storage and transportation of pharmaceuticals. These may be adapted to meet individual needs where necessary, provided that the desired standards of quality are still achieved. The guidelines are applicable not only to manufacturers of medicinal products but also to pharmaceutical importers, contractors and wholesalers, and community and hospital pharmacies. They have been prepared in close collaboration with the International Pharmaceutical Federation (FIP)

Guidelines to health care equipment donations

HEIMANN, Peter
Ed
March 2000

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These guidelines seek to improve the process of equipment donation to the mutual benefit of both donors and recipients and have been created to help develop national or institutional guidelines. Such guidelines are necessary because many developing countries are increasingly dependent on donor assistance to meet the equipment needs of their health care systems, but because not all important parameters are taken into consideration, donations sometimes do not achieve their intended objectives, and could even constitute an added burden to the recipient health care system

Indicators for monitoring national drug policies : a practical manual

BRUDON, Pascale
RAINHORN, Jean-Daniel
REICH, Michael R
1999

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This manual has been developed to evaluate the performance of pharmaceutical sectors, to monitor progress in the implementation of national drug policies or to assess the effects of changes on drug policy objectives. It contains a comprehensive set of simple, objective and reliable indicators which can be adapted to fit national contexts

Keeping it real : combating the spread of fake drugs in poor countries

HARRIS, Julian
STEVENS, Philip
MORRIS, Julian
May 2009

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This paper is about substances that are sold as medicines yet are not what they purport to be. Some of these substances are deliberately mislabeled, i.e. counterfeit. Others may have been inadvertently mislabelled or the pills contaminated during manufacture. Others may originally have been exactly as they claim, but due to poor storage have degraded and are consequently substandard. The paper is composed of four parts. The first looks at the scope of the problem in less developed countries; the second examines the health impacts of fake medicines; the third section considers the main causes of the problem; and the final section offers some possible solutions

Medicines : corruption and pharmaceuticals

WORLD HEALTH ORGANIZATION (WHO)
December 2009

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This fact sheet gives a brief overview of the key facts regarding corruption in the pharmaceutical supply chain. It focuses on unethical practices in the medicines supply chain, factors contributing to pharmaceutical corruption, the impact of corruption, and the response of the WHO

Processes and issues for improving access to medicines : the evidence base for domestic production and greater access to medicines

GUIMIER Jean-Marc Guimier
LEE, Evan
GRUPPER, Michel
2004

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This study addresses the question of whether access to medicines can be improved in sub-Saharan Africa by producing them locally. For this production to be sustainable, it must be both economically viable while meeting quality standards, and result in the improvement of access along one or more of the following dimensions: geographical accessibility, physical availability, affordability and acceptability

Public and private sector approaches to improving pharmaceutical quality in Bangladesh

KOSTERMANS, Kees
et al
March 2008

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"Low-cost high-quality drugs benefit society and helps provide pharmaceutical companies a competitive edge. This study presents the issues that must be considered to achieve these common objectives in Bangladesh and explores options that the Government and the local industry could pursue. "Previous efforts to improve the drug quality in Bangladesh focused, without much success, on stricter regulation of the public market. This paper addresses this issue from a more private sector approach. The existing quality and price of pharmaceuticals are analysed and alternative mechanisms are explored to improve the quality and cost competitiveness of Bangladesh’s pharmaceuticals domestically and internationally"

Safety of medicines : a guide to detecting and reporting adverse drug reactions|Why health professionals need to take action

LEPAKHIN, V.K.
et al
2002

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This guide raises awareness about the magnitude of the drug safety problem and seeks to convince health professionals that reporting adverse reactions is their moral and professional obligation. The ultimate goal of the guide is to reduce drug morbidity and drug mortality by early detection of drug safety problems in patients and improving selection and rational use of drugs by health professionals

Survey of the quality of selected antimalarial medicines circulating in Madagascar, Senegal, and Uganda

UNITED STATES PHARMACOPEIA DRUG AND INFORMATION PROGRAM
November 2009

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This report focuses on three of 10 sub-Saharan countries that were covered by a study examining the quality of key antimalarial medicines. A total of 491 samples of anti-malarial medicines (both artemisinin-based combination therapy and sulfadoxine-pyrimethamine products) were collected from the public sector, the regulated private sector and the informal market in these three countries. The study revealed a high failure rate among sampled antimalarials in all three countries, based both on Minilab and full-compendial or quality control laboratory testing

The quality of anti-malarials : a study in selected African countries

MAPONGA, Charles
ONDARI, Clive
May 2003

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This was a pilot study to assess the quality of anti-malarials in selected African countries, and to determine whether the quality of these products was related to the level of the distribution chain at which the samples were collected. The data from this study indicate significant problems of substandard anti-malarial products circulating within the drug distribution chains in the African region. It therefore recommends that quality surveillance systems be set up within drug regulatory authorities in the region and that support be given to manufacturers to improve compliance with good manufacturing practices

Serials

Safe medicines project - phase II : the Zambian case study

AFRICA FIGHTING MALARIA
March 2009

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This bulletin reports on the results of a study in which a range of antimalarial drugs were procured from private pharmacies, shops and kiosks within the urban and peri-urban areas of Lusaka, Zambia and tested to measure the active pharmaceutical ingredient content against internationally acceptable standards

Journal articles

Antimalarial drug quality in the most severely malarious parts of Africa - a six country study

BATE, Roger
et al
May 2008

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This article describes research conducted on a range of antimalarial drugs, procured from private pharmacies in urban and peri-urban areas in the major cities of six African countries which were subjected to semi-quantitative thin-layer chromatography (TLC) and dissolution testing to measure active pharmaceutical ingredient content against internationally acceptable standards

Websites