WHO Expert Committee on Specifications for Pharmaceutical Preparations, 35th Report, Technical Report Series No. 885, 1999, 156 p.

This publication provides a progress report on a number of WHO activities which support a comprehensive approach to the quality assurance of pharmaceutical products. Although the report has global relevance, it is of particular importance in countries attempting to establish or strengthen a regulatory framework for pharmaceutical products.

The report has two parts. The first provides a brief summary of several ongoing activities coordinated by WHO. The second, most extensive section, consists of nine annexes. The first two provide updated lists of available international Chemical Reference Substances and International Infrared Reference Spectra. The remaining annexes set out international guidelines and recommendations covering a range of activities central to pharmaceutical quality control and regulation. There are revised general guidelines for the establishment, maintenance and distribution of chemical reference substances, and two annexes supplement WHO guidelines for good manufacturing practices. The report also discusses the inspection of drug distribution channels, and presents a framework for promoting good pharmacy practices in community and hospital pharmacy settings.

The most extensive guidelines, on national drug regulatory legislation, establish guiding principles for small drug regulatory authorities. General advice on drafting national legislation and defining the scope of marketing authorisation procedures is followed by an example of a legislative scheme. These guidelines will be particularly useful to small national drug regulatory authorities with limited resources. The report concludes with information on developing training programmes for inspecting and examining counterfeit pharmaceuticals.

Available from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.35, US$31.50, and in developing countries Sw.fr.24.50.

Guidance Modules on Antiretroviral Treatments, World Health Organization, UNAIDS, WHO/ASD/98.1, 1998.

Optimism has been generated by the recent development of new antiretrovirals, particularly triple combination therapies, including a protease inhibitor. These drugs offer hope of a longer and better life to people living with HIV/AIDS.

In response to requests for information about these treatments, and for policy and technical guidance from health professionals and governments, WHO, in collaboration with UNAIDS, has published a set of nine guidance modules.

The modules cover the following topics: introduction to antiretroviral treatments; introducing antiretroviral treatments into national health systems -economic considerations; antiretroviral treatments -planning and integration into health services; safe and effective use of antiretrovirals; laboratory requirements for the safe and effective use of antiretrovirals; the use of antiretroviral drugs to reduce mother to child transmission of HIV; treatments following exposure to HIV; antiretrovirals: regulation, distribution and control; ethical and social issues relating to antiretroviral treatments.

Available, in English and French, from: World Health Organization, Distribution and Sales. Price: Sw.fr. 28, US$25.20, and in developing countries Sw.fr. 19.60. Single copies are available free of charge to those in developing countries from: World Health Organization, HIV/AIDS/STI, 1211 Geneva 27, Switzerland.

Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs, World Health Organization, WHO/EDM/QSM/99.1, 1999, 60 p.

Concern about the quality of drugs is as old as drugs themselves. As early as the fourth century BC people were warned about the dangers of adulterated medicines, and despite all the advances made over the years this concern has not disappeared. In the recent past the unregulated proliferation of pharmaceutical industries and products has brought with it many problems. Counterfeiting is just one example.

These guidelines provide an overview of the problem and the factors contributing to counterfeiting drugs. They also outline the steps to be followed in developing national strategies, and specific measures for combating the growing problem of counterfeit drugs. Approaches to country studies, inspection and testing of suspected counterfeit drugs and staff training are also covered.

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

Quality Control Methods for Medicinal Plant Materials, World Health Organization, 1998, 115 p.

Plant materials are used throughout developing and developed countries as home remedies, over-the-counter drug products and raw materials for the pharmaceutical market. They represent a substantial proportion of the global drug market. It is therefore essential to establish internationally recognised guidelines for assessing the quality of medicinal plant materials. This manual describes a series of tests for such assessment. It includes procedures which will support the development of national standards based on local market conditions, with due regard to existing national legislation, and national and regional norms. The tests are designed primarily for use in national drug quality control laboratories in developing countries and complement those described in the International Pharmacopoeia.

In addition to the test methods, the manual includes suggestions on general limits for contaminants to use as a basis for establishing national limits.

Available from: World Health Organization, Distribution and Sales, 1211 Geneva 27. Switzerland. Price: Sw.fr.35. US$31.50, and in developing countries Sw.fr.24.50.

Promoting Appropriate Drug Use in Cameroon, A. Groom, K. Hedlund, DAP Research Series No. 28, World Health Organization, WHO/DAP/98.14, 1999, 58 p.

In Cameroon, the Cameroon Baptist Convention, a missionary health care provider, employs a variety of educational, supervisory and regulatory strategies to promote appropriate drug use in its 17 health facilities. There is, however, considerable variation between facilities in the strategies employed. Not all receive the same type or the same degree of training or supervision. This is the report of a research study to identify which of the strategies most directly correlated with prescribing and dispensing behaviour.

Research was conducted over three months in 1997, and identified some characteristics of effective supervision and training to promote rational drug use. Specifically, on-site supervision and regular supervision by doctors were more effective than other methods. The report states that training prescribing personnel for at least six weeks and dispensing personnel for at least one week also correlated with more appropriate drug use. A minimum six weeks’ training seemed particularly effective in influencing complex prescribing behaviour, such as antibiotic prescription, the report concludes.

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

Three new books have been published by Ecuador’s Ministry of Public Health:

Guiá del Sistema Descentralizado del Manejo de Medicamentos en las Areas de Salud, 2nd ed., Ministerio de Salud Publica, Dirección General de Salud, Dirección Nacional de Control Sanitario, 1999, 114 p.

This is the second edition of a guide published by Ecuador’s Ministry of Public Health to promote efficient drug treatment through the provision of good-quality, low-cost drugs. Its 10 chapters deal with such topics as the evaluation of pharmaceutical needs, drug procurement, storage, distribution, and the rational use of drugs.

Guiá para el Manejo de los Medicamentos en Unidades Operativas del Ministerio de Salud Publica, Ministerio de Salud Publica, Dirección General de Salud, Dirección Nacional de Farmacia y Control Sanitario, 1998, 65 p.

This guide to drug management is intended for auxiliary health personnel. The topics covered include drug prescribing, procurement; distribution and storage; and the physical aspects of the premises, including security issues. The publication also contains three annexes. The first deals with storage of the drugs most used for outpatients, and the other two list psychotropic and narcotic drugs.

Buenos Prácticas de Prescripción, 3rd ed., M. Lalama, R. Teran, Publicación de la Representación OPS/OMS en el Ecuador, 1998, 66 p.

This is the third edition of a guide to good prescribing practices for medical students, published jointly by the Pan American Health Organization and WHO. It is based on the experience of professors at the Central University of Ecuador and on WHO recommendations. As pointed out in the introduction, when students begin their practical work with patients they generally do not know how to make rational drug choices, how to write a prescription correctly. or how to monitor the results of treatment. They are also uncertain what information patients require about their treatment. The publication aims to help students overcome these problems. It includes sections on pharmacoepidemiology, drug education, choice of drugs, and assessment of rational drug prescribing. There is also a useful bibliography.

For further information contact: Ministry of Public Health, Juan Larrea 446, between Checa and Riófrio, Quito, Ecuador.

Guidelines for Drug Donations, 2nd ed., Interagency Guidelines, World Health Organization, WHO/EDM/PAR/99.4, 1999, 19 p.

There are many types of drug donation. Some are a rapid response to an acute emergency or form a component of development aid. Others represent the philanthropic aims of large corporations. Yet others are small and targeted for use by individual health facilities. But all too often, drug donations are inappropriate and cause disposal problems for their recipients.

By describing “good donation practice”, these guidelines aim to improve the quality of drug donations. As a basis for national or institutional guidelines, they can be adapted and implemented by governments and organizations dealing with this type of assistance.

First issued in 1996, the guidelines have since been revised, following an extensive review of experiences with their use. This second edition begins with a discussion of the need for guidelines and goes on to present four core principles and 12 guidelines for drug donations covering such issues as selection of drugs, quality assurance, and presentation and packaging. Exceptions to the general guidelines are also given, to take account of specific drug donation situations. The guidelines conclude with suggestions on other ways in which donors can provide assistance and advice on how recipients can implement a drug donations policy.

Available, free of charge, in English (French and Spanish in preparation), from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies. Interagency Guidelines, World Health Organization, WHO/EDM/PAR/99.2, 1999,31 p.

Large quantities of pharmaceuticals are donated as part of humanitarian assistance during conflicts and following natural disasters. They are often urgently needed and contribute to saving lives. But some arrive past their expiry date, are inappropriate to needs or are unrecognisable because they are labelled in a foreign language. Also, due to the confusion that often surrounds an emergency, donated pharmaceuticals with a long shelf-life may be mismanaged owing to lack of storage space and staff, or to disruption of the pharmaceutical management system. The result is an accumulation of unwanted and unusable pharmaceuticals. How can they be disposed of safely?

These guidelines provide advice on the safe disposal of unusable pharmaceuticals in emergencies, and in countries where official assistance and advice may not be available. They are the result of collaboration between 13 international and non governmental agencies. Aimed at ministries, health authorities, environmental and waste management authorities, and experts at ministerial, regional and local levels, the guidelines describe a number of methods involving minimal risks to public health and the environment. These methods include landfill, encapsulation, inertization, discharge to a sewer and incineration. All are suitable for use by countries with limited resources and equipment, and whenever disposal of pharmaceuticals is a potential problem.

Available in English, (French and Spanish in preparation), from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.8, US$7.20, and in developing countries Sw.fr.5.6. (Single copies are available free of charge for those in developing countries, from the Department of Essential Drugs and Medicines Policy).

The New Emergency Health Kit 98. Lists of Drugs and Medical Supplies for 10,000 People for Approximately Three Months, 2nd ed., Interagency Guidelines, World Health Organization, WHO/DAP/98.10, 1998, 73 p.

The difficult and demanding conditions in the aftermath of large scale emergencies and disasters pose particular problems in the provision of health care. This book, now in its second edition and significantly revised, explains how to use standardised packages of essential drugs, supplies and equipment under such circumstances. Both the concept and the contents of the kit, which was developed by WHO in collaboration with a large number of international and nongovernmental agencies, are designed to expedite the provision of supplies in line with priority health needs. Although primarily addressed to relief agencies, the book also provides useful information for national authorities and hospital managers interested in stockpiling drugs and supplies in advance.

A complete emergency kit contains two separate sets of drugs and supplies. The first set consists of 10 identical packages of basic units containing drugs and supplies intended for use by community health workers located in remote areas. The second, or supplementary kit, contains drugs, renewable supplies and equipment needed by doctors working in first or second referral health facilities.

The book provides background information on the development of the kit, a detailed description of its contents, comments on the selection of items, treatment guidelines for prescribers, and some useful checklists for suppliers and prescribers. New in this edition are interagency guidelines for drug donations and model guidelines for the international provision of controlled medicines for emergency care.

Available in English, (French, Russian and Spanish in preparation), from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.8, US$7.20, and in developing countries Sw.fr.5.60. (Single copies are available free of charge for those in developing countries, from the Department of Essential Drugs and Medicines Policy).

WHO Monographs on Selected Medicinal Plants, Volume 1, World Health Organization, 1999, 289 p.

WHO monographs on selected medicinal plants

In publishing 28 monographs WHO aims to encourage standardised scientific approaches to ensuring the safety, quality and efficacy of medicinal plants and their products. The monographs are also intended to promote international harmonisation in the quality control and use of herbal medicines, and to serve as models for the development of national formularies. Plants were selected for inclusion on the basis of their widespread use, particularly in countries that rely heavily on medicinal plants to meet primary health care needs.

Each monograph is in two parts. The first gives pharmacopoeial summaries for quality assurance, botanical features, distribution, identity tests, purity requirements, chemical assays and active or major chemical constituents. The second lists dosage forms and medicinal uses categorised as: uses supported by clinical data; uses described in pharmacopoeias and in traditional systems of medicine; and uses described in folk medicine, but not yet supported by experimental or clinical data.

The monographs also include an extensive review of available data on experimental and clinical pharmacology, followed by information on contraindications, warnings, precautions, adverse reactions and dosage.

Available in English, (French in preparation), from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.64.40, US$58.40, and in developing countries Sw.fr.45.40.

WHO Model Prescribing Information. Drugs used in the Treatment of Streptococcal Pharyngitis and Prevention of Rheumatic Fever, World Health Organization, WHO/EDM/PAR/99.1, 1999, 18 p.

Rheumatic fever and rheumatic heart disease were widely prevalent in countries throughout the world at the beginning of the second half of the twentieth century. However, during the ensuing decades the disease’s major impact has been centred in developing countries. Yet rheumatic fever and rheumatic heart disease are theoretically preventable. If group A beta-haemolytic streptococcal infections of the upper respiratory tract are prevented or are effectively treated, neither initial nor recurrent attacks of rheumatic fever occur.

This document outlines currently accepted and effective methods for management of group A streptococcol upper respiratory tract infections. It describes the drugs, doses and dosage regimens for the treatment of streptococcal pharyngitis and prevention of rheumatic fever.

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

Pharmaceuticals: Restrictions in Use and Availability, World Health Organization, WHO/EDM/QSM/99.2, 1999, 53 p.

This document presents information on new national regulatory decisions and on voluntary withdrawal of products by manufacturers on grounds of safety that were reported to WHO between mid-1993 and early 1999.

Products are listed alphabetically within sections, with international nonproprietary names used wherever possible. Each product entry includes, where available, the Chemical Abstracts Service registry number; synonyms including other generic names and chemical name; the effective date on which the regulation came into force; a summary of regulatory measures taken by governments; brief explanatory comments where necessary; and legal and bibliographic references. While the information given is not exhaustive, either in terms of products or regulatory measures, the document covers regulatory actions taken by a total of 26 governments on 98 products.

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

Responsibility for Drug-Induced Injury, 2nd ed., G. Dukes, M. Mildred, B. Swartz, eds., 1998, 537 p.

The publication brings together standards for allocating responsibility for safety and liability for injury. Now in its second edition, it is a reference for lawyers, judges and medical arbiters who have to define and interpret legal and ethical rules. It is also targeted at the people and institutions to whom these rules apply, such as hospitals, physicians, pharmacists and pharmaceutical companies. Where disputes arise between parties involved in the supply and use of pharmaceuticals, the book is a comprehensive and neutral source of information for all concerned. Such disputes are quite common, with more than a quarter of all malpractice suits brought against physicians or other health professionals revolving around drug injury.

The book documents the general medical and legal background to drug safety and injury; and sets out the duties and liability of the parties concerned. Eight chapters provide in-depth guidance on special issues including drug injury to the unborn child, vaccines, liability in alternative medicine and existing compensation schemes.

Available from: IOS Press, Van Diemenstraat 94, 1013 CN Amsterdam, the Netherlands. Fax: + 13 20 620 3419; e-mail: order@iospress.nl (Information on distributors in other countries available from this address). Price: NLG260/£79/DM232/US$125.

Basic Tests for Drugs. Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms, World Health Organization, 1998, 91 p.

BASIC TESTS FOR DRUGS

This manual provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabelled, substandard or counterfeit products when the labelling or physical attributes are questionable. Intended for use in developing countries, where resources and specialised skills may be scarce, all tests rely on a limited range of easily available reagents and equipment. They need not be performed in a fully equipped laboratory or by those with specialised training in pharmacy or chemistry.

The publication describes tests for 23 pharmaceutical substances, 58 pharmaceutical dosage forms and four commonly used plant materials. As stressed in the text, the tests are intended as primary screening tools to confirm identity and may need to be followed by a full pharmacopoeial analysis in cases of adverse test results.

Available in English, (French and Spanish in preparation), from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.26, US$23.40, and in developing countries Sw.fr.18.20.

Guidelines on Basic Training and Safety in Acupuncture, World Health Organization, WHO/EDM/TRM/99.1, 1999, 23 p.

Acupuncture is an important element of traditional Chinese medicine. First used more than 2500 years ago, over the past two decades the practice of acupuncture has spread worldwide.

WHO has paid particular attention to supporting research on acupuncture and its proper application. More than 50 international experts were involved in preparing these guidelines on basic safety and training in acupuncture. The publication is intended for all practitioners, and provides standards for safety in the clinical practice of acupuncture. Their purpose is to minimise the risk of infection and accidents, to alert acupuncturists to contraindications, and to advise on managing complications.

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

Symptom Relief in Terminal Illness, World Health Organization, 1998, 109 p.

Tens of millions of people die from incurable disease every year, most of them in developing countries. While it is unlikely that this situation will change significantly in the short term, there is much that can be done to relieve the suffering that is an inevitable feature of such disease.

Even a minor complaint such as a cough or a hiccup, which may be little more than an irritation to the healthy individual, can give rise to considerable and unnecessary discomfort in the terminally ill patient. More serious problems, both physical and mental, cause proportionally greater distress. This publication outlines the likely causes of a wide range of these secondary symptoms and provides comprehensive guidance on their management. Many of the approaches discussed are drug-based, but non drug measures, which are often simple to implement and can provide substantial relief, are also described. The additional support that can be provided by family members and by appropriate counselling is emphasised, particularly in the context of psychological problems, such as anxiety and depression.

Complementing WHO’s Guidelines on the Management of Cancer Pain, this book is aimed at health professionals at all levels who are concerned with the care and comfort of patients with terminal illnesses.

Available in English, (French and Spanish in preparation), from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.25, US$22.50, and in developing countries Sw.fr. 17.50.

Guide to Drug Financing Mechanisms, J. Dumoulin, M. Kaddar, G. Velasquez, World Health Organization, 1998, 55 p.

Drugs are an essential element in health services the world over, yet half the world’s population lacks regular access to necessary drugs. Ensuring that safe and effective drugs are accessible to those who need them is a responsibility of governments, but many factors -economic, legal, cultural and political - influence drug accessibility. While touching on all of these issues, this book focuses on economic influences on the pharmaceutical sector. It looks in detail at drug selection, procurement, distribution and prescribing from an economic perspective. The authors describe different approaches to each of these elements, listing the benefits and disadvantages in differing situations.

In many places drug supply is a haphazard process that reduces the effectiveness of health services and does little to improve health, but is very expensive. The publication urges those involved in national drug supply systems to take a dispassionate look at the way supply is financed and organized. In the light of the policies and strategies described in the book, they should ensure that the system reflects the most rational approach for their particular situation.

Available from World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.19, US$17.10, and in developing countries Sw.fr.13.30.

Pharmaceuticals in the Americas, World Health Organization, WHO/HTP/EDM/99.1, 1999, 32 p.

This document provides an overview of the pharmaceutical situation in the Americas, with the focus on access to drugs, financing policies, and regulation and registration. This is followed by a brief analysis of the drug situation in more than 30 countries in the region.

Available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland. WHO/DAP/98.13

Interventions to Improve Antimalarial Use, M. Gomes and L. Pang, eds., Supplement No. 1 to Volume 76, 1998, of the Bulletin of the World Health Organization, 1998, 73 p.

This is a report of a Task Force on Improved Use of Antimalarials, set up in 1993 by the WHO Special Programme for Research and Training in Tropical Diseases. Its work was to identify and test ways to rationalise and improve the home treatment of malaria using existing oral antimalarials. Research interventions were implemented in six South-East Asian countries which had the highest rates of antimalarial multidrug resistance in the world. The Task Force provided a forum for identifying problem areas and testing the effect of small but potentially important changes in drug delivery in the private sector.

The report covers several approaches tested in Cambodia, China, the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam. These included subsidies for certain drug combinations, improved packaging of doses, health education interventions, use of a pharmacological marker to measure adherence, and assessment of drug quality. The report concludes that user friendly packaging of drugs, which included simple and clear patient information, produced the best results.

Available from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.20, US$18, and in developing countries Sw.fr.14.