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: email@example.com
Books, reports, etc
"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"
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).
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
This is a detailed manual giving a step by step approach to undertaking pharmacovigilance of antiretroviral medicines
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
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
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
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)
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
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
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
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
"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"
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
This report assesses the quality of antiretroviral medicines obtained at accredited public and private sector antiretroviral procurement and treatment sites in selected African countries. The aim is to help with the development of appropriate quality assurance strategies for antiretrovirals
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
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
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
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
This is a summary of a study that gathered clinical evidence comparing generic and brand-name used in cardiovascular disease and assessed the the perspectives of editors on this issue
This article suggests that many pharmaceutical companies and governments are reluctant to publicise the problem of counterfeit medicines to health staff and the public. It recommends mandatory reporting to governmental authorities, which should have a legal duty to investigate, issue appropriate public warnings, and share information across borders