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Essential Drugs Monitor No. 028-029 (2000)
(2000; 36 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentEditorial - Antimicrobial resistance: A global threat
View the documentNewsdesk
View the documentAntimicrobial resistance
View the documentLetters to the editor
View the documentNational drug policy
View the documentNewsdesk
View the documentAccess
View the documentDRUG INFORMATION
View the documentResearch
View the documentCourses & meetings
View the documentNetscan
View the documentPublished lately
View the documentTraditional medicine
View the documentWorld trade

Published lately


The Department of Essential Drugs and Medicines Policy cannot supply the publications reviewed on these pages unless stated otherwise.

Please write to the address given at the end of each item.

Intellectual Property Rights, the WTO and Developing Countries. The TRIPS Agreement and Policy Options, C.M. Correa, 2000, 254 p.

The structure of international trade is being fundamentally altered by the various agreements which the World Trade Organization polices. This book cuts through the sometimes daunting technicalities of one of the most important of these agreements, that dealing with intellectual property rights. The publication clearly explains what the Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) is about and its main provisions.

The author is particularly concerned to explore the Agreement’s implications for developing countries. These relate to the future of local research and development, access to advanced technology, commercial exploitation of their natural resources and welfare effects. The book uses Latin American and Caribbean experience to illustrate the problems that have arisen with implementing TRIPS.

Throughout, Correa indicates concrete options available at national level to implement the TRIPS Agreement’s provisions in a manner consistent with development objectives and public policy concerns. (See also page 36).

Available from: Zed Books, 7 Cynthia Street, London N1 9JF, UK. Price: £16.95, plus £2.50 postage and packing.

Handbook on Antimicrobial Therapy, (revised edition), The Medical Letter on Drugs and Therapeutics, 1998, 205 p.

This comprehensive handbook on antibacterials, antifungal and antiviral drugs includes first-choice and alternative drugs for every indication, doses and adverse effects. In addition there are chapters on the safety of antimicrobial drugs in pregnancy, advice for travellers and drugs for HIV infections. The non profit publication also includes price lists for commonly used oral antibacterial drugs.

Available from: The Medical Letter on Drugs and Therapeutics, 1000 Main Street, New Rochelle, N.Y. 10801-7537, USA. Fax: + 1 914 632 1733. Price 1 - 9 copies US$ 14 each, 10 - 99 copies US$ [11.20 each, 100+ copies US$ 8.40 each. Special rates are available for subscribers to the journal, The Medical Letter on Drugs and Therapeutics.

Operational Principles for Good Pharmaceutical Procurement, Interagency Guidelines, World Health Organization, WHO/EDM/PAR/99.5, 2000, 24 p.

Pharmaceutical procurement is a complex process and problems are common. This document from the Interagency Pharmaceutical Procurement Group sets out four strategic objectives and 12 operational principles for good procurement. These will be reproduced in full in EDM-30.

Available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

Référentiel pour l’harmonisation des procédures d’enregistrement des médicaments essentiels génériques dans les pays de la zone franc et pays associés, (Pharmaceutical Sector Collaboration between CFA and Associated Countries), World Health Organization, WHO/EDM/DAP/99.2, 1999, 25 p.

This guide on harmonization of registration procedures is intended to facilitate the introduction of essential drugs on to the markets of Communauté financière africaine (CFA) and associated countries, and thus improve the availability and affordability of pharmaceuticals. The guidelines, adopted at a seminar in Ouagadougou in February 1999, cover generic drug registration and marketing authorisation.

Available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

HIV Testing: A Practical Approach, Healthlink Worldwide, 1999, 48 p.

HIV testing is an essential part of all HIV prevention and care programmes, to ensure safe blood supplies and determine HIV status. And appropriate counselling, education, care and follow-up support are an essential part of any HIV testing programme.

HIV testing: a practical approach provides clear information for policy-makers, planners, and health personnel involved in counselling and HIV testing. An update of the 1994 publication, Practical issues in HIV testing, it reflects recent developments, and lessons learned over the last six years. Topics covered include: considerations before beginning an HIV testing programme; technical aspects of testing, testing individuals and surveillance; and implementing blood screening programmes.

In addition, the publication provides examples of programmes in Africa, Asia and Latin America, and experiences from people who have had HIV tests. A useful resource list and detailed technical information on the characteristics of some of the most commonly used tests are also given.

Available from: Healthlink Worldwide, Cityside, 40 Adler Street, London E1 1EE, UK. E-mail: publications@healthlink.org.uk Price: £7.50/US$ 15. Single copies are free of charge to indigenous organizations in developing countries.

Counterfeit and Substandard Drugs in Myanmar and Viet Nam, World Health Organization, EDM Research Series No. 29, WHO/EDM/QSM/99.3, 1999, 55 p.

This report presents the results of two studies, done in Myanmar and Viet Nam, to obtain independent information on the counterfeit drugs problem, and so help to develop measures against counterfeiting. The research study involved collecting background information on the status of drug regulation and also samples of 500 products, which were subjected to laboratory quality testing. Two hundred and fourteen of these were selected for investigation, with a portion of each sent to the drug regulatory authorities in the manufacturing country for analysis.

The report shows that the prevalence of substandard drugs is generally a much greater problem than counterfeit drugs in both countries. Products which had passed laboratory tests were sometimes found to be counterfeit (deliberately mislabelled products, for example). The report concludes that laboratory tests alone are insufficient to determine whether a product is counterfeit. Any investigation requires adequate resources, planning, and undercover work, and must be undertaken in collaboration with drug regulatory authorities and manufacturers.

Available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

Narcotic and Psychotropic Drugs. Achieving Balance in National Opioids Control Policy. Guidelines for Assessment, World Health Organization, WHO/EDM/QSM/2000.4, 2000, 37 p.

WHO estimates that by the year 2020 approximately 70% of the annual 20 million new cancer cases will occur in developing countries, where most patients are diagnosed in the late stages of the disease. It is at this time that pain is most prevalent. But cancer pain is frequently untreated and, even when it is, relief is often inadequate. While health worker training and increased access to palliative care services can help, the publication focuses on solving the problem of inadequate availability and use of pain medications, particularly opioid analgesics, in developing countries.

The authors state that opioid analgesics, such as codeine and morphine are “absolutely necessary” for the management of cancer pain and that for moderate to severe pain there is no substitute for opioids in the therapeutic group of morphine. But, because of their potential for abuse, opioids are classified as narcotic drugs.

The International Narcotics Control Board, WHO and national governments report that opioids are not sufficiently available for medical purposes. Reasons for this include the low priority of pain care in health systems, greatly exaggerated fears of addiction, overly restrictive national drug control policies and problems in procurement, manufacture and distribution of opioids. The publication presents guidelines for governments to determine whether their national drug control policies have the legal and administrative framework to ensure medical availability of opioid analgesics, as recommended by the International Narcotics Control Board.

Available, free of charge from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

Beyond Our Means? The Cost of Treating HIV/AIDS in the Developing World, The Panos Institute, 2000, 59 p.

This report looks at the controversial and complex issues surrounding access to HIV/AIDS treatments in developing countries. It states that at least 12 million people in the developing world are in urgent need of the antiretroviral drugs which can suppress HIV and indefinitely postpone symptoms of AIDS. But the vast majority of these people live in the world’s poorest countries, and while providing such treatment is theoretically possible, it is highly improbable in the foreseeable future, according to the authors.

A number of factors lie behind this failure to provide full treatment to those in need. These vary from country to country, but, according to the publication, include lack of political will, unhelpful economic policies (such as taxing medical products), lack of relevant information and lack of appropriate distribution mechanisms. The authors believe two other factors are critical. The first is weak health care systems - poor infrastructures, inadequate facilities, including lack of hospital beds, laboratories and trained staff. The second factor is a combination of the high cost of antiretroviral and other drugs, and disputes over patenting and licensing rights for these products.

The publication provides an overview of the issues surrounding access to treatment for AIDS, in order to encourage informed debate, further research and considered action. It is intended primarily for policy-makers, AIDS organizations and medical personnel.

Available from: The Panos AIDS Programme, 9 White Lion Street, London N1 9PD, UK. Tel: + 44 20 7278 1111, fax: 44 20 7278 0345. Available on the Panos Web site: www.panos.org.uk Price: £5/US$10. Copies are available, free of charge, to resource-poor NGOs in developing countries.

Integrating Public Health Concerns into Patent Legislation in Developing Countries, C. Correa, South Centre, 2000, 124 p.

This publication presents options for the design and implementation of public-health sensitive patent policies in developing countries. It is particularly concerned with the TRIPS Agreement
(Trade-Related Aspects of Intellectual Property Rights) which covers protection of pharmaceutical products and processes. World Trade Organization member countries are obliged to comply with the minimum standards of the Agreement. But, the author points out, they also have considerable room to develop their own patent and other intellectual property laws in response to the characteristics of their legal systems and development needs. Topics covered include patentability requirements, special cases in pharmaceuticals, disclosure, exceptions to exclusive rights and compulsory licensing.

The publication is primarily intended for policy-makers, particularly ministries of health and government lawyers responsible for drafting TRIPS compliant national legislation. For further details see page 36.

Available, free of charge, from: South Centre, Case Postale 228, 1211 Geneva 19, Switzerland. Also available on the South Centre Web site at: www.southcentre.org/publications/publichealth/toc.htm

Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication, World Health Organization, WHO/EDM/QSM/00.1, 2000, 32 p.

Reclassification of medicinal products from sale on prescription only to non prescription
(over-the-counter) sale is increasingly common. Drug regulatory and health authorities have to consider the types of medicinal products for which reclassification is appropriate, safe and rational in the interest of public health.

The Guidelines suggest criteria and methods which drug regulatory agencies can use to determine the suitability of medicinal products for use in self-medication. They are also intended for marketing authorisation holders applying for the classification of a prescription product to be changed to non prescription sale. Guidance is given on documentation for new active substances, never marketed as prescription medicines, to accompany applications for self-medication marketing authorisation.

Available from: World Health Organization, Marketing and Dissemination, 1211 Geneva 27, Switzerland. Price: Sw.fr.10, US$ 9, and in developing countries Sw.fr.7.

Updates on new formularies, treatment guidelines, essential drugs lists, drug bulletins and newsletters

The Department of Essential Drugs and Medicines Policy produces a global index of formularies, therapeutic guides and essential drugs lists, which is available free of charge.
(Please note that we are unable to supply copies of the publications themselves. Requests should be addressed direct to the countries concerned). Some recent additions are:

♦ India, Himachal Pradesh: List of Essential Drugs. 1999. Department of Health and Family Welfare, Government of Himachal Pradesh. Drugs by generic name, divided into 29 therapeutic groups.

♦ Médecins Sans Frontières: Essential Drugs: Practical Guidelines. New editions of this useful manual for doctors, pharmacists, nurses and medical auxiliaries are available. A first edition in Portuguese, and second editions in English and Spanish, will soon be followed by a second edition in Arabic.

♦ Nepal: Standard Treatment Schedules for Health Posts and Sub-Health Posts, 3rd ed., 1999. Ministry of Health. Now available in English and Nepali. Includes principles of appropriate prescribing and dispensing, and advice for patients.

♦ Russia: Formulary 2000 (Russian Formulary System). 2000. Health of Men Foundation, Moscow. Guidelines for doctors on drug use. Approved and recommended by the Russian Federation Ministry of Health. In Russian.

♦ South Africa: Treatment Guidelines from South Africa’s Department of Health include:

- National Guideline on Management and Control of Asthma in Children at Primary Level. 1999.

- National Guideline on Primary Prevention and Prophylaxis of Rheumatic Fever and Rheumatic Heart for Health Professionals at Primary Level. 1999.

- Hypertension: National Programme for Control and Management at Primary Level. 1998.

- Diabetes: National Programme for Control and Management of Diabetes Type 2 at Primary Level. 1998.

♦ South-East Asia: Essential Drugs for Primary Health Care, 3rd edition. 2000. WHO Regional Office for South-East Asia. The manual provides community health workers and auxiliary health personnel with guidelines on the use of 34 essential drugs. It also advises on treatment and referral requirements for 22 common medical problems.

♦ Zimbabwe: EDLIZ. 4th Essential Drugs List and Standard Treatment Guidelines. 2000. Ministry of Health and Child Welfare. Fewer drugs on the list
(from 600 down to 250) and updated advice for Zimbabwe’s health workers.

Drug bulletins and newsletters

♦Introducing Essential Drugs in Brief. Anyone involved in national drug policy implementation who wants a quick update on the latest WHO activities carried out with and for countries should subscribe to the bulletin, Essential Drugs in Brief. The bulletin, which will be published twice a year, shares information on the latest country support provided or coordinated by EDM’s extended Drug Action Programme team through country, regional and Headquarters’ offices.

♦ And a new look for the WHO Pharmaceuticals Newsletter, which has been redesigned and has had some content changes. Articles will be restricted to subjects more directly related to drug quality assurance and safety. Some more general information, such as new developments, guidelines, and regulations of a general nature, will be published only in the quarterly journal WHO Drug Information. The WHO Collaborating Centre is now providing the Safety of Medicines section for International Drug Monitoring. The Centre’s Adverse Reactions Newsletter is being discontinued.

♦ With WHO support the Delhi Society for the Promotion of Rational Use of Drugs
(DSPRUD) launched its Medical Newsletter in July 1999, to help health care professionals update existing knowledge about drug therapy. Distributed free of charge to doctors, the Newsletter contains a digest of various published articles, which include drug reactions, news and review articles.

♦ WHO/EDM is also supporting Spectrum, India-WHO Essential Drugs Programme Newsletter, which covers the activities of the Delhi Society for the Promotion of Rational Drug Use and the Essential Drugs Programme.

Practical Pharmacy packs. Complete sets of Practical Pharmacy are now available to developing countries, free of charge, while stocks last. This newsletter for health workers of all levels includes easy-to-read information on basic aspects and skills of pharmacy work. Contact: Echo International Health Services Ltd, Ullswater Crescent, Coulsdon, Surrey CR5 2HR, UK. Tel: + 44 20 8660 2220, fax: + 44 20 8668 0751.

Globalization, Patents and Drugs: An Annotated Bibliography, 2nd ed., World Health Organization, Health Economics and Drugs, EDM Series No.10, EDM/PAR/01.1, 2001, 52 p.

The impact of globalisation and trade agreements on access to drugs is an increasingly important issue. This annotated bibliography is intended for those in the health sector with no particular legal background, who want an overview of the issues and arguments involved. It directs readers to key reports, books and articles from technical and scientific journals, subdivided into general articles and country specific studies. The document concludes with a section on useful Web sites.

Available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.


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