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INFORMATION

WORLD HEALTH ORGANIZATION – MARKETING AND DISSEMINATION

Information Products on Pharmaceuticals 2003

This information products catalogue on pharmaceuticals provides bibliographic and descriptiveinformation on over 93 recent WHO publications and CD-ROMs relevant to the selection, use,quality control and quality assurance, safety assessment, regulation, and correct prescribing of medicines. Information products are an outgrowth of WHO efforts to unite governments, prescribers, dispensers, consumers, and the pharmaceutical industry in a search for ways toassure that safe, effective, and affordable medicines are universally available – and widely used.

Most of this information stems from long-standing WHO programmes responsible for the international standardization of biological substances, the assignment of generic names, thedevelopment of standards in quality assurance and of quality specifications, the designation of essential medicines, and the assessment of the abuse potential of psychotropic drugs.

Other information products provide current scientific information in the form of fact sheets,newsletters, teaching and training documents. Information products free of charge are listed in each section and relevant URL addresses are given for information available in electronic form.

Whatever their individual topic or focus, all information products participate in the larger WHO objective of realizing the advantages promised by modern medicines in ways that make a difference in human health on the largest possible scale.

How to orderAn order form is contained in this catalogue on page 43. You can also order online at the following address : http://bookorders.who.int

WHO information products can be ordered from sales agents (see list at the end of the catalogue) or directly from WHO. Orders addressed to WHO must be accompanied by paymentin Swiss francs, EURO or US dollars. Payment by credit card is accepted (see order form).

Bank address: UBS SA, Agence de l’OMS, CH-1211 Geneva 27, Switzerland – Swift Code UBSW CH ZH 12 A– Swiss franc account no. 279-D3-100-897.0– US dollar account no. 240-CO-169-920.3– Euro account no. 240-CO-169-920.1

Email address for direct orders: [email protected]

An alphabetical index of titles is provided at the end.

In developing countriesDeveloping countries benefit from at least a 30% discount on the regular price indicated in this catalogue for the books published by WHO.

Language editionsThe following abbreviations are used in bibliographic entries to indicate the availability of language editions: Ar = Arabic; C = Chinese; E = English; F = French; G = German; R = Russian; S = Spanish; E/F = Bilingual edition English/French. An asterisk (*) indicates a language edition in preparation.

Catalogue onlineThis catalogue can also be consulted on our website at the following address: http://bookorders.who.int/catalogues. For additional information on our information products, please visit our website: http://bookorders.who.int

Tel.: +41 22 791 24 76 Fax: +41 22 791 48 57Email: [email protected] online: http://bookorders.who.intWHO Website: www.who.int

MDI.PHA.203

World Health OrganizationMarketing and DisseminationCH-1211 Geneva 27Switzerland

oms-catalogue 15/07/03 11:32 Page 2

CONTENTS

1

Selection and Use

Drug Policy

Economics and Financing

Supply and Procurement

Quality Assurance and Safety

The International Pharmacopoeia

Drug Prescribing

Legislation and Regulation

Publications from the South Centre

Ethics and Safety Guidelines

WHO Collaborating Centre for International Drug Monitoring

Medicinal Plants

Traditional Medicine

Psychotropic Drugs

Periodicals and Subscriptions

Useful Web addresses

Title index

Addresses

Order form

Sales agents

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5

6

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17

21

25

27

28

30

31

35

36

37

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43

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SELECTION AND USE

2

The WHO Model Formulary presents formulary information on over300 medicines included on the WHO Model List of Essential Drugs,as a reference for national and institutional drugs and therapeutic committees. It is also a valuable source of independent and unbiasedinformation for students and prescribers who are interested in focusing their prescribing on those medicines which are globally recognized as essential.

This pocket-sized book contains 27 sections covering anaesthetics,analgesics, antiallergics, antidotes, anticonvulsants, anti-infectivedrugs, antimigraine drugs, antineoplastic and immunosuppressivesdrugs and drugs used in palliative care, antiparkinson drugs, drugsaffecting the blood, blood products and plasma substitutes, cardio-vascular drugs, dermatological drugs, diagnostics, disinfectants and antiseptics, diuretics, gastrointestinal drugs, hormones and contraceptives, immunologicals, muscle relaxants and cholinesteraseinhibitors, ophthalmological preparations, drugs used in obstetrics,peritoneal dialysis solution, psychotherapeutic drugs, drugs acting onthe respiratory tract, solutions correcting water, electrolyte and acid-base disturbances, vitamins and minerals. The four successiveannexes include information on drug interactions, pregnancy, breast-feeding, renal and liver impairments.

2002 , 500 pages [E] ISBN 92 4 154559 3Sw.fr. 40.–/US $36.00 In developing countries: Sw.fr. 20.– Order no.1150499

WHO Model Formulary 2002

Table of Contents

Section 1: Drugs used in AnaesthesiaSection 2: Analgesics, antipyretics,

nonsteroidal anti-inflammatory drugs, drugs used to treat gout and disease-modifying antirheumatic drugs

Section 3: Antiallergics and drugs used in anaphylaxis

Section 4: Antidotes and other substances used in poisonings

Section 5: Anticonvulsants/antiepilepticsSection 6: Anti-infective drugsSection 7: Antimigraine drugsSection 8: Antineoplastic and

immunosuppressive drugs and drugs used in palliative care

Section 9: Antiparkinson drugsSection 10: Drugs affecting the bloodSection 11: Blood products and plasma

substitutesSection 12: Cardiovascular drugsSection 13: Dermatological Drugs (topical)Section 14: DiagnosticsSection 15: Disinfectants and AntisepticsSection 16: DiureticsSection 17: Gastrointestinal drugsSection 18: Hormones and other endocrine

drugs and contraceptives

Section 19: ImmunologicalsSection 20: Muscle relaxants (peripherally

acting) and cholinesterase inhibitorsSection 21: Ophthalmological preparationsSection 22: Drugs used in ObstetricsSection 23: Peritoneal dialysis solutionSection 24: Psychotherapeutic drugsSection 25: Drugs acting on the Respiratory

tractSection 26: Solutions correcting water,

electrolyte and acid-base disturbances

Section 27: Vitamins and minerals

Appendix I: InteractionsAppendix II: PregnancyAppendix III: Breast FeedingAppendix IV: Renal ImpairmentAppendix V: Liver impairment

Available now on CD-ROM

CD-ROM, 2003 [E] ISBN 92 4 154600 XSw.fr. 40.–/US $36.00 In developing countries: Sw.fr. 20.–Order no. 1990019


3

The WHO Medicines Bookshelf CD-ROM contains a selection ofover 250 publications (more than16 000 pages) in English, Frenchand Spanish dealing with essentialmedicines. The publications includ-ed cover the whole field of interestof WHO's Department of EssentialDrugs and Medicines Policy (EDM),including access to essential medi-cines, rational use of drugs, nation-al drug policy, quality and safety ofmedicines and traditional medicine.

The CD-ROM also contains a mirrorof the EDM web site (totalling 315MB) that can be accessed by click-ing the 'EDM mirror' button fromthe entry screen. This provides theopportunity for users in developingcountries, who lack a fast Internetconnection, to browse the site attheir own leisure.

This report presents the recommen-dations of the WHO ExpertCommittee responsible for updating the WHO Model List ofEssential Medicines. The first partcontains an update on the revisedprocedures for updating the ModelList and the development of theWHO Essential Medicines Library. It continues to present a summaryof the Committee’s considerationsand justifications for additions andchanges to the 12th Model List,including its recommendation toadd ten antiretroviral medicines.The annexes include the 12th WHOModel List of Essential Medicines in its usual presentation and, for the first time, in the five-levelAnatomical Therapeutic Chemical(ATC) classification system.

This handbook is intended to assistnongovernmental organizations, community-based organizations and groups of people living withHIV/AIDS in finding ways of under-standing, planning and undertakingwork on HIV/AIDS-related treatment.It builds on practical skills by using participatory activities and sharingexperiences; provides a trainingresource for NGO support prgrammes,training organizations and individuals;and facilitates ongoing learning aboutthe treatment work being carried outby the various groups involved.

Applicable at all levels of experience,the handbook offers flexibility to facilitators who need to gear theirwork towards specific schedules or situations.

WHO Medicines BookshelfCD-ROM

2002 , CD-ROM [E] ISBN 92 4 159025 4Swiss francs 20.–/US $18.00 In developing countries: Sw.fr. 14.–Order no.0990018

The Selection and Use of Essential Medicines Report of the WHO ExpertCommittee (including the 12thModel List of EssentialMedicines)

Handbook on Access to HIV/AIDS-RelatedTreatment: A Collection of Information, Tools andResources for NGOs, CBOsand PLHA Groups

Technical Report Series, No. 9142002 , vi + 122 pages [E] ISBN 92 4 120914 3Swiss francs 23.–/US $20.70In developing countries: Sw.fr. 16.10Order no.1110914

Joint United Nations Programme on HIV/AIDS2003, 130 pages [E]ISBN 92 9173 161 7Swiss francs 15.–/US $13.50In developing countries: Sw.fr. 7.50Order no. 1880013


SELECTION AND USE

4

An illustrated manual designed to help communityhealth workers learn how to use simple drugs to treatcommon illnesses. Specific to health conditions inSouth-East Asian countries, the book uses simpleexplanatory texts and illustrations to communicateinstructions for treating illnesses and knowing when a patient must be referred to a doctor.

Explains how to use standardized packages of essential drugs, supplies, and equipment to provide effective medical care under the primitive, demanding conditions that follow emergencies or disasters. Boththe concept and the contents of the kit, which wasdeveloped by WHO in collaboration with a large number of international and non-governmental agencies, are designed to expedite the provision ofsupplies in line with priority health needs. Althoughprimarily addressed to relief agencies, the book alsoprovides useful information for national authoritiesand hospital managers interested in stockpiling drugsand supplies in advance.

Now in its second edition, the book has been signifi-cantly revised to reflect changes in the selection ofdrugs included in the WHO Model List of EssentialDrugs and to bring recommendations in line with a new United Nations list of priority drugs for use in acute emergencies. New in this edition are WHOguidelines for drug donations and model guidelinesfor the international provision of controlled medicinesfor emergency care.

Essential Drugs for PrimaryHealth CareA Manual for Health WorkersThird edition

The New Emergency HealthKit 1998Lists of Drugs and MedicalSupplies for 10,000 People forApproximately Three MonthsSecond edition

WHO Regional Office for South-East AsiaSEARO Regional Health Papers, No. 162000, v + 128 pages [E]ISBN 92 9022 185 2Swiss francs 10.–/US $9.00In developing countries: Sw.fr. 7.–Order no. 1583016

1998, vi + 73 pages [E, F]WHO/DAP/98.10Swiss francs 8.–/US $7.20In developing countries: Sw.fr. 5.60Order no. 1931018


DRUG POLICY

5

In this new edition guidelines aregiven on developing a nationaldrug policy - a crucial ingredient in every country's national healthstrategy and an invaluable frame-work to identify national goals andcommitments. This expanded andextensively revised second editiondiscusses key policy components.These include the selection ofessential drugs, affordability,finance and supply, regulation and quality assurance, rational use,research, human resources, moni-toring and evaluation.

Each chapter presents useful advice and references to othersources of more detailed technical information. A valuable resourcefor health professionals, policy-makers and researchers, the publi-cation takes readers through theprocess of planning, developing, implementing and monitoring acomprehensive policy frameworkbased on a country's unique needs,priorities and resources.

Presents and explains a simple yetpowerful new methodology forgathering the data needed toimprove national drug policies.Both the public and private sectorsare addressed. The methodology,which was finalized after extensiveexpert consultations and testing indifferent settings, provides a logicaland systematic tool for identifyingproblems in meeting the mainobjective of a national drug policy:to assure that effective and affordable essential drugs are widely available, of good quality,and wisely used.

How to Develop andImplement a National Drug PolicySecond Edition

Indicators for MonitoringNational Drug PoliciesA Practical ManualSecond edition

2002, 91 pages [E, F, S]ISBN 92 4 154547 XSwiss francs 26.-/US $23.40In developing countries: Sw.fr. 18.20Order no. 1152287

by P. Brudon-Jakobowicz, J.-D.Rainhorn and M.R. Reich2000, x + 216 pages [E, F, S*]WHO/EDM/PAR/99.3Swiss francs 25.–/US $22.50In developing countries: Sw.fr. 17.50Order no. 1932066

WHO Medicines Strategy Framework for Action inEssential Drugs and MedicinesPolicy 2000–2003This strategy evolved from therevised drug strategy originallyadopted by the World HealthAssembly as long ago as 1986. It incorporates four main objectives:to frame and implement nationaldrug policy, to ensure access toessential drugs, to ensure quality,safety and efficacy of all medicines,and to promote rational drug use.2000, viii + 70 pages [E, F]WHO/EDM/2000.1Electronic access:http://www.who.int/medicines/strategy/stmission.shtml#st

WHO Policy Perspectives on MedicinesNo 1. WHO Medicines Strategy

2000-2003

No 2. Traditional Medicine:Growing Needs andPotential

No 3. Globalization, TRIPS andaccess to pharmaceuticals

No 4. The Selection of EssentialMedicines

No 5. Promoting rational use of medicines: core components

No 6. How to develop and implement a national drug policy

Electronic access:http://www.who.int/medicines/organization/ood/ood6pagers.shtml

Free of chargeFor information on availability of these documents, please refer to: www.who.int/medicines


ECONOMICS AND FINANCING

6

Guide to Drug FinancingMechanisms

by J. Dumoulin, M. Kaddar, andG.Velásquez1998, vii + 55 pages [E, F]ISBN 92 9036 068 2Swiss francs 19.–/US $17.10In developing countries: Sw.fr. 13.30Order no. 1150461

A practical guide to the use of economic criteria to analyse acountry’s pharmaceutical sector andidentify ways to improve the drugsupply. Addressed to decision-makers responsible for formulatingdrug policies, the book aims tofacilitate the analysis of expenditureon drugs within the context of a government’s overall economic policies and priorities. With thisgoal in mind, the book explains themany complex economic factorsthat influence the drug supply and identifies the corresponding policyoptions available for introducingchanges in different situations.

Cost-containment Mechanismsfor Essential Medicines, including Antiretrovirals, in ChinaHealth Economics and Drugs EDM Series,No. 132002,27 pages [E]WHO/EDM/PAR/2003.6Electronic access: http://www.who.int/medicines/library/par/who-edm-par-2003-6/CostContainmentEnglish.pdf

Implications of the DOHADeclaration on the TRIPSAgreement and Public HealthThis document considers the implications of the Doha Declaration,and includes discussions on compulsorylicensing and transfer of technology to countries with little or no manufac-turing capacity or insufficient marketdemand.Health Economics and Drugs Series, No. 122002, 68 pages [E, F, S*] WHO/EDM/PAR/2002.3Electronic access: http://www.who.int/medicines/library/par/who-edm-par-2002-3/doha-implications.doc

Network for Monitoring theImpact of Globalization andTRIPS on Access to MedicinesThe last decade has witnessed a sharpacceleration in the processes of economic globalization and a majorincrease in the number, and expansionof the scope, of international tradeagreements. This is a report of a meeting held in 2001 at which WHOinitiated a process to monitor and analyze the impact of trade agree-ments on access to drugs in partner-ship with four WHO collaborating centres in Brazil, Spain, Thailand and the United Kingdom.Health Economics and Drugs Series, No. 112002, 67 pages [E] WHO/EDM/PAR/2002.1Electronic access: http://www.who.int/medicines/library/par/who-edm-par-20021/networktrips.pdf

Public-Private Roles in the Pharmaceutical SectorImplications for Equitable Accessand Rational Drug Use Aimed at policy makers at country,regional and international levels, thisdocument provides a practical guide to how changing public-private roles inthe pharmaceutical sector may affectdrug accessibility and rational use.Health Economics and Drugs Series, No. 51997, 102 pages [E, F, S] WHO/DAP/97.12Electronic access: http://www.who.int/meicines/library/dap/who-dap-97-12/who-dap97-12.htm

Globalization and Access to Drugs Perspectives on the WTO/TRIPSAgreement.The impact of globalization on accessto drugs is of increasing interest, andthis document informs people in thehealth sector with no legal backgroundabout this complex issue.Health Economics and Drugs Series, No. 71998, 98 pages [E, F, S, C, Ar]WHO/DAP/98.9 RevisedElectronic access: http://www.who.int/medicines/library/dap/who-dap-98-9-rev/who-dap-98-9.htm

Health Reform and DrugFinancingSelected Topics This document discusses reform prima-rily from the perspective of certainfinancial aspects of health-publicfinancing, health insurance, usercharges, donor financing and drugdonations, and development loans.Health Economics and Drugs Series, No. 61998, 44 pages [E, F, S] WHO/DAP/98.3Electronic access: http://www.who.int/medicines/library/dap/who-dap-98-3/who-dap-98-3.htm

Free of chargeFor information on availability of these documents,please refer to: www.who.int/medicines


SUPPLY AND PROCUREMENT

7

Operational Principles forGood PharmaceuticalProcurementInteragency guidelinesPharmaceutical procurement is acomplex process and problems arecommon. This document from theInteragency PharmaceuticalProcurement Group sets out fourstrategic objectives and 12 opera-tional principles for good procure-ment, which can be adapted byusers.2000, 24 pages [E, F, S]WHO/EDM/PAR/99.5Electronic access:http://www.who.int/medicines/library/par/who-edm-par-99-5/who-edm-par-99-5.htm

Guidelines for DrugDonations Revised 1999. Second Edition.Interagency GuidelinesThere are many types of drugdonation: rapid response to anemergency, the philanthropic aimsof organizations, and those targeted for use by individualhealth facilities. By describing‘good donation practice’, theseguidelines aim to improve the quality of drug donations.1999, 19 pages [E, F, S] WHO/EDM/PAR/99.4Electronic access:http://www.who.int/medicines/library/par/who-edm-par-99-4/who-edm-par-99-4.htm

This publication is aimed at countries with small procurement agencies and provides practical and simple guidelines for the purchaseof pharmaceutical products. Varioustypes of tender mechanisms aredescribed, as is direct procurement.Emphasis is given to the importanceof pre-qualifying suppliers to ensurepurchase of good quality products.

This book does not cover all aspectsof the drug management cycle, butit does describe the core principlesof procurement and various methods of tendering for drug procurement. It discusses the advantages and disadvantages ofthese methods as well as the tenderprocess itself. Model questionnairesfor prequalification of suppliers,model tender invitations and aninspection checklist for drug receiptsthat can be modified and extendedto meet local requirements areenclosed.

How can unwanted and unusablepharmaceuticals be disposed ofsafely? These guidelines – whichare the result of collaborationbetween 13 international and non-governmental agencies – provideadvice on the safe disposal ofunusable pharmaceuticals in emergencies and in countrieswhere official assistance and advicemay not be available.Electronic access:http://www.who.int/medicines/library/par/who-edm-par-99-2/who-edm-par-99-2.htm

Practical Guidelines on PharmaceuticalProcurement for Countrieswith Small ProcurementAgencies

WHO Regional Office for the Western Pacific2002, 56 pages [E]ISBN 92 9061 014 XSwiss francs 10.–/US$9.00In developing countries: Sw.fr. 7.–Order no. 1520010

Guidelines for SafeDisposal of UnwantedPharmaceuticals in andafter EmergenciesInteragency Guidelines

1999, 31 pages [E, F, S]WHO/EDM/PAR/99.2 Swiss francs 8.–/US $7.20In developing countries: Sw.fr. 5.60Order no. 1930154



QUALITY ASSURANCE AND SAFETY

8

The aim of the INN System has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INNs, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide. This tenth Cumulative List CD-ROM is intended as a reference source for national drug regulatory authorities, the pharmaceutical industry and health professionals. It supersedes the ninth list published in 1996. It contains over 7250 INNs for individual pharmaceutical substances,including about 740 new names proposed since the previous CumulativeList was prepared. It is produced in a multilingual format: English andFrench introductory texts, together with a listing of INNs in Latin, English,French, Russian and Spanish.

Information on Proposed and Recommended InternationalNonproprietary Names (INNs) can also be consulted on the followingwebsite: http://mednet.who.int

2002, CD-ROM [E/F]ISBN 92 4 056019 X Swiss francs 290.–/US $261.00 for individual userIn developing countries: Sw. fr. 100.–Order no. 0990010

2-10 users: Swiss francs 350.–/US $315.00 In developing countries: Swiss francs 175.–, order no. 0991010

11-99 users: Swiss francs 450.–/US $405.00 In developing countries: Swiss francs 225.–, order no. 0992010

100 or more users: Swiss francs 600.–/US $540.00 In developing countries: Swiss francs 300.–, order no. 0993010

Special pricing scheme for multiple users:

CD-ROMInternational Nonproprietary Names (INN) for Pharmaceutical SubstancesList 1-45 of Proposed INNs and List 1-85 of Recommended INNs Cumulative List No.10

International

Nonproprietary Names (INN)

for Pharmaceutical Substances

List 1-45 of Proposed INNs

and List 1-85 of

Recommended INNs

Cumulative List No.10


9

Describes tests for 23 pharmaceuticalsubstances and 58 pharmaceuticaldosage forms, most of which areincluded in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plantmaterials are also included.

Sets out rapid screening testsrequired to verify the identity ofsome 150 pharmaceutical dosageforms in common use. The tests,which are simple and readily appli-cable, make it possible to confirmthe identity of pharmaceutical sub-stances in tablet, capsule, solution,lotion and other forms in thosecases where quality is in doubt. The basic tests may also be appliedto determine whether gross degra-dation has occurred despite highstandards of packaging.

"... describes simple tests of pow-erful use in the primary detectionof degradation, tampering, adulteration, and counterfeiting ...admirably serves its purpose..." – Journal of the Royal Society ofHealth

Presents simplified tests for verify-ing the identify of pharmaceuticalsubstances and detecting grossdegradation. The 321 substancescovered represent the majority ofdrug substances contained in theWHO Model List of Essential Drugsas well as a number of other widelyused drug substances. For each,tests have been devised to serve asa simple and readily applicablemethod of verification of identitywhen a fully equipped laboratory is not available.

"... will serve as a useful compo-nent of the WHO programme for quality assurance in the pharmaceutical supply system..."

– Indian Journal of Hospital Pharmacy

Basic Tests for DrugsPharmaceutical Substances,Medicinal Plant Materials and Dosage Forms

Basic Tests for Pharmaceutical Dosage Forms

Basic Tests for PharmaceuticalSubstances

1991, v + 129 pages [C, E, F, S] ISBN 92 4 154418 X Swiss francs 24.–/US $21.60 In developing countries: Sw.fr. 16.80 Order no. 1150359

1998, iii + 91 pages [E, F, S, R, C]ISBN 92 4 154513 5Swiss francs 26.–/US $23.40In developing countries: Sw.fr. 18.20Order no. 1150462

1986, 210 pages [Ar, C, E, F, S] ISBN 92 4 154204 7 Swiss francs 34.–/US $30.60In developing countries: Sw.fr. 23.80 Order no. 1150245



10

Draws together twenty-two WHOguidelines relevant to the qualityassurance and control of pharma-ceutical products. Most of theseguidelines have appeared as annex-es in various reports of the WHOExpert Committee on Specificationsfor Pharmaceutical Preparations.Others are published here for thefirst time. By making these avail-able in a single reference work, thebook facilitates access to the com-plete body of WHO guidelines andrecommendations issued to assistnational drug regulatory and control authorities, particularly indeveloping countries. Whenviewed together, the collectedguidelines also underscore theneed for a comprehensive systemof quality assurance and illustrateits various technical and administra-tive components in a logical way.

Draws together twelve WHOguidelines related to good manu-facturing practives (GMP) and tothe inspection of pharmaceuticalmanufacturers and distributionchannels. Most of these guidelineshave appeared as annexes in various reports of the WHO ExpertCommitee on Specifications forPharmaceutical Preparations. Bymaking these available in a singlereference work, the book facilitatesaccess to the complete body ofWHO guidelines and recommenda-tions aimed at ensuring the pharmaceutical products are manufactured in compliance withinternationally accepted standardsfor quality and safety.

A collection of recommended test pro-cedures for assessing the identity, puri-ty, and content of medicinal plantmaterials. Intended to assist nationallaboratories engaged in drug qualitycontrol, the manual responds to thegrowing use of medicinal plants, thespecial quality problems they pose, andthe corresponding need for interna-tional guidance on reliable methods for quality control. Recommended procedures – whether involving visualinspection or the use of thin-layerchromatography for the qualitativedetermination of impurities – shouldalso prove useful to the pharmaceuticalindustry and pharmacists working withthese materials.

Quality Assurance ofPharmaceuticalsA Compendium of Guidelinesand Related MaterialsVolume 1

Quality Assurance ofPharmaceuticalsA Compendium of Guidelinesand Related MaterialsVolume 2: Good ManufacturingPractices and Inspection

Quality Control Methodsfor Medicinal PlantMaterials

1998, viii + 115 pages [E]ISBN 92 4 154510 0Swiss francs 35.–/US $31.50In developing countries: Sw.fr. 24.50Order no. 1150451

1999, v + 198 pages [E, F*, R]ISBN 92 4 154526 7Swiss francs 62.–/US $55.80In developing countries: Sw.fr. 43.40Order no. 1152452

1997, vi + 238 pages [E, F, R]ISBN 92 4 154504 6Swiss francs 50.–/US $45.00In developing countries: Sw.fr. 35.–Order no. 1150452


11

This report presents the recommendations of an international group of experts convened by the WorldHealth Organization to consider matters concerningthe quality assurance of pharmaceuticals and specifications for drug substances and dosage forms.This committee reviews and adopts guidelines thathave been prepared reflecting consensus obtainedduring a large international consultative process. Of particular relevance to drug regulatory authoritiesand pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests forpharmaceutical substances and dosage forms, as well as quality control of reference materials, goodmanufacturing practices (GMP), stability studies,inspection, hazard analysis, procurement, storage andother aspects of quality assurance of pharmaceuticals,and regulatory issues.

The report is complemented by a number of annexes,including recommendations on the risk of transmittinganimal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharma-ceutical products, a model certificate for GMP andguidance on a GMP inspection report. The finalannexes provide guidance on the application ofHazard Analysis and Critical Control Point (HACCP)method to pharmaceuticals, good storage practicesand a procedure for assessing acceptability of pharmaceutical products for purchase by agencies of the United Nations.

Sets out a series of twelve international guidelines andother recommendations intended to assist nationaldrug regulatory authorities and manufacturers in the quality assurance of pharmaceutical products. The report also responds to the need to extend previ-ously issued WHO guidelines for good manufacturing practices (GMP) to cover several special circumstancesas well as guidance for inspectorates.

List of adopted guidelines:

Quality Control Laboratory related: • Guideline on "Good Practices for National

Pharmaceutical Control Laboratories" (with Model Test Report and List of equipment for pharmaceutical control laboratories appended)

• Model Certificate of Analysis • Considerations for requesting analysis of drug

samples• List of International Chemical Reference Substances• List of International Infrared Reference Spectra

GMP (updates and reviews)• GMP in pharmaceutical production

(essential elements)• GMP for sterile pharmaceutical products

(updated text)

Inspection related: • Guidelines on Pre-approval inspection• WHO quality systems requirements for national

GMP inspectorates

• Guidance on "comparative products" for equivalence assessment of interchangeable multisource (generic) products

• General Aspects of Packaging

• Guidelines on the use of INN for Pharmaceutical Substances

WHO Expert Committee on Specificationsfor Pharmaceutical PreparationsThirty-seventh Report

Technical Report Series, No. 9082002 , viii + 136 pages [E] ISBN 92 4 120908 9Swiss francs 25.–/US $22.50In developing countries: Sw.fr. 17.50Order no.1110908

WHO Expert Committee on Specificationsfor Pharmaceutical Preparations Thirty-sixth Report

Technical Report Series, No. 9022002, 215 pages [E, F*, S] ISBN 92 4 120902 XSwiss francs 42.–/US $37.80In developing countries: Sw.fr. 29.40Order no. 1100902



12

This report presents the recommen-dations of a WHO Expert Committeecommissioned to coordinate activities leading to the adoption of international requirements for theproduction and control of vaccinesand other biologicals and the estab-lishment of international biologicalreference materials. The report startswith a discussion of general issuesbrought to the Committee’s attentionand provides information on the status and development of reference materials for various antibodies, antigens, blood products and relatedsubstances, cytokines, growth factors,and endocrinological substances. The second part of the report, of particular relevance to manufacturersand national control authorities, con-tains an addendum to recommenda-tions for the production and controlof oral poliomyelitis vaccine, recommendations for production and quality control of inactivatedpoliomyelitis vaccine, and guidelinesfor live attenuated Japaneseencephalitis vaccine.

This report presents the recommen-dations of a WHO Expert Committeecommissioned to coordinate activitiesleading to the adoption of interna-tional requirements for the produc-tion and control of vaccines andother biologicals and the establish-ment of international biological reference materials.

The report starts with a discussion of general issues brought to theCommittee’s attention and providesinformation on the status and development of reference materialsfor various antibodies, antigens,blood products and related substances, cytokines, growth factors, and endocrinological substances.

The second part of the report, of particular relevance to manufacturersand national control authorities, contains recommendations for the production and control of oral poliomyelitis vaccine, an amendment to the requirements for meningococcal polysaccharide vaccine, and a decision-tree for setting priorities in the developmentof reference materials. Also includedare guidelines for the preparation,characterization, and establishmentof standards and reference reagentsfor biological substances.

Presents the recommendations of aWHO expert committee commis-sioned to coordinate a range ofresearch and other activities need-ed to assure the purity, potency,safety, and stability of biologicalproducts used in medicine. Issuesinclude progress in the establish-ment of cytokine standards, effortsto harmonize technical require-ments for vaccine production andlicensing, the implications for vaccine requirements of theAgreement on Technical Barriers toTrade of WTO, and safety questionsarising from the detection by verysensitive polymerase-chain-reac-tion-based methods of low levelsof reverse transcriptase activity inlive viral vaccines prepared in chicken cells.

WHO Expert Committee onBiological StandardizationForty-eighth Report

Technical Report Series, No. 8891999, vi + 111 pages [E, F, S]ISBN 92 4 120889 9Swiss francs 23.–/US $20.70In developing countries: Sw.fr. 16.10Order no. 1100889

Technical Report Series, No. 9042001 , vi + 108 pages [E] ISBN 92 4 120904 6Swiss francs 35.–/US $31.50In developing countries: Sw.fr. 24.50Order no.1100904

IN PREPARATIONTechnical Report Series, No. 9102002 , vi + 104 pages [E] ISBN 92 4 120910 0Swiss francs 20.–/US $18.00In developing countries: Sw.fr.14.–Order no.1100910

WHO Expert Committee onBiological StandardizationFifty-first Report

WHO Expert Committee onBiological StandardizationFiftieth Report


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Explains the system of internationalnonproprietary names (INNs)administered by WHO to ensurethat each pharmaceutical sub-stance or active pharmaceuticalingredient is identified by a uniquename that is universally recognizedand universally accessible as publicproperty. This system of "generic"names was introduced by WHO in1950 as a mechanism for ensuringthe clear identification of medicinaldrugs, promoting their safe prescribing and dispensing, and facilitating international scientificcommunications.

Guidelines on the Use of InternationalNonproprietary Names(INNs) for PharmaceuticalSubstances

1997, iii + 36 pages [E]WHO/PHARM S/NOM 1570Swiss francs 15.–/US $13.50In developing countries: Sw.fr. 10.50Order no. 1930120


The Guidelines for ATC classification and DDD assign-ment (version 2002) describes the structure of theAnatomical Therapeutic Chemical (ATC) classificationsystem and the main principles and procedures forassigning ATC codes for medicines. The concept of theDefined Daily Dose (DDD) is explained as well as princi-ples and procedures for assigning DDDs for medicines.Different uses of the ATC/DDD methodology aredescribed. The book includes all ATC headings down tothe ATC 4th level assigned by the WHO CollaboratingCentre in Oslo. Comments regarding specific ATC andDDD assignments are included for most of the ATC levels. The comments describe particular issues thathave been discussed and resolved by consensus of theWHO International Working Group for Drug StatisticsMethodology during deliberation while establishingATC/DDDs. Guidelines on how to assign DDDs forcombination products are added under the respectiveATC levels.

ATC Index with DDDsThis ATC Index with DDDs (version 2002) includes allmedicines with a final ATC code and a final DDDassigned at the time of issuing. The list includes non-proprietary drug names and no brand names. The index comprises two lists:

• List A: This list is sorted according to ATC code, and gives the complete ATC classification, i.e. all ATC levels. All final DDDs, which are established for single substances, are included in this list. DDDs for combination products are not included.

• List B: The alphabetical index, sorted according to nonproprietary drug names, should be used to look up the ATC code for a substance. This list includes ATC 5th levels only.

Guidelines for ATCClassification and DDD Assignment5th Edition


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The Guidelines for ATC Classification and DDD Assignment and the ATC Indexwith DDDs are updated annually (in January). To order, please contact:WHO Collaborating Centre for Drug Statistics MethodologyP.O. Box 183, Kalbakken, N-0903 Oslo, NorwayEmail: [email protected]: +47 22 16 98 11 – Fax +47 22 16 98 18Both publications are available in English, Spanish and German versionsPrice for the set: US $90.00Separate edition: US $50.00


15

This CD-ROM is intended to support the creation oftraining courses on Good Manufacturing Practices(GMP), particularly courses for inspectors of manufac-turing facilities which produce medicines or pharma-ceutical starting materials. The CD-ROM may also beuseful as a self-study guide for the inspectors them-selves, or anyone else interested in the manufactureof quality medicines. The content of the CD-ROM isbased on a modular training course designed by staffof the World Health Organization in collaborationwith a team of international experts in the subject.Details of the project that produced this course are to be found on the CD-ROM itself (in two formats -Microsoft Word and Adobe Acrobat, in the files'IntroAckn.doc' and 'IntroAckn.pdf' respectively, in the'Project' folder). There are twenty modules in thecourse. Fourteen of these cover Basic Principles ofGMP, five cover the GMP Inspection Process, and thefinal module covers setting up and running a trainingcourse on GMP. The CD-ROM contains a set of theMicrosoft PowerPoint presentations, together withhandouts and other supporting material (these latteragain in both Word and Acrobat formats), togetherwith utilities for viewing or printing these. The CD-ROM also contains a software tool (installed by run-ning 'Setup') to help trainers modify the course tobetter fit local conditions and regulations. This con-tains the full text of the presentations in a searchabledatabase, together with examples of speaker's notes,and action-setting and note-taking facilities, andoptions for printing these. The tool also providesaccess to an introductory video on GMP, which lasts18 minutes and has been optimised for viewing on-screen.

The Supplementary Training Modules on GoodManufacturing Practices (GMP) are a product of theWHO/EDM Strengthening of PharmaceuticalManufacturing Inspection (SPMI) Project. The aims of the project were to strengthen pharmaceutical manufacturing inspectorates by promoting the use of the previously developed training package entitled:WHO Basic Training Modules on GMP, through the setting up of international workshops using the materials, and by undertaking global distributions of the Basic Training Modules CD-ROM, issued in April 2001. The SPMI project concluded at the end of March 2003.

In response to the many requests that were receivedback from individuals who had either attended a workshop or who had used the CD-ROM, three supplementary modules were developed on topics thathad been specifically asked for, namely:

• Validation (including Cleaning, Process, and QC-related Validation)

• Water for Pharmaceutical Use, and

• Air Handling Systems.

The materials, which comprise PowerPoint slide presentations, tutorial notes, group session exercises,and question and answer papers, are intended to support the creation of training courses primarily for government compliance officers who inspect manufacturing facilities that produce medicines or pharmaceutical starting materials. The training package may also be useful as a self-study guide for these inspectors, or anyone else interested in themanufacture of quality medicines.

CD-ROM on WHO Basic Training Modules on GMPA resource and study pack for trainers

2001, CD-ROM [E]WHO/EDM/QSM/2000.7Available Free of ChargeOrder no. 1990012

2003, CD-ROM [E]WHO/EDM/QSM/2002.5Available Free of ChargeOrder No. 1992012

CD-ROM on WHO Supplementary TrainingModules on GMP: Validation, Water, andAir Handling Systems



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Pharmaceuticals: Restrictions in Use and Availability2003, 26 pages [E]WHO/EDM/QSM/2003.5Electronic access: http://www.who.int/medicines/library/qsm/who-edm-qsm-99-2/who_edm_qsm_992.htm

Safety of MedicinesA Guide to Detecting and Reporting AdverseDrug Reactions2002, 18 pages [E]WHO/EDM/QSM/2002.2Electronic access: http://www.who.int/medicines/library/qsm/who-edm-qsm-2002-2/esd_safety.pdf

Medical Products and the Internet A Guide to Finding Reliable InformationAs the medical information and the number of medicalproducts for sale on the Internet increases rapidly, WHOhas produced this guide to finding reliable medicalinformation on the Net.1999, 16 pages WHO/EDM/QSM/99.4Electronic access: http://www.who.int/medicines/library/qsm/who-edm-qsm-99-4/who-edm-qsm-99-4.htm

Counterfeit DrugsGuidelines for the Development of Measures to Combat Counterfeit DrugsIn the recent past, the unregulated proliferation of phar-maceutical industries and products has brought with itmany problems. These guidelines provide an overviewof the problem of counterfeiting and the contributingfactors.1999, 60 pages [E, F]WHO/EDM/QSM/99.1Electronic access: http://www.who.int/medicines/library/qsm/who-edm-qsm-99-1/who-edm-qsm-99-1.htm

Safety Monitoring of Medicinal ProductsGuidelines for setting up and running aPharmacovigilance CentreThis booklet aims to provide practical guidelines and information for the setting up of newPharmacovigilance Centres. It discusses practicalaspects of how to run a pharmacovigilance centre at the technical level and provides many realistic recommendations.2000, 24 pagesISBN 91 630 9004 XElectronic access:http://www.who-umc.org/pdfs/guidelines.pdf


The Use of Common Stems in the Selectionof International Nonproprietary Names(INN) for Pharmaceutical Substances2003Lists common stems for international nonproprietarynames (INN) for pharmaceutical substances for whichchemical or pharmacological categories have beenestablished. These stems and their definitions areintended to guide the selection of new INNs (genericnames) for substances that belong to an establishedseries of related compounds. The list aims to encourageconsistency in the designation of generic drug nameswhile also protecting the principle that INNs are publicproperty. Produced as a working document, the list isof interest to manufacturers engaged in research anddevelopment, trademark officers, and national regula-tory authorities.2003, 137 pp, WHO/EDM/QSM/2003.2Electronic access: http://www.who.int/medicines/library/qsm/stemdoc2002.pdf

International Nonproprietary Names (INN)for Pharmaceutical Substances: Names ofRadicals and GroupsComprehensive List April 2002Provides a comprehensive list of names for radicals andgroups used in the WHO system for assigning interna-tional nonproprietary names (INNs) for pharmaceuticalsubstances. Names for radicals and groups arise fromthe need to provide modified names for the salts oresters of substances already identified by an INN. Inview of the complex composition of many radicals andgroups, use of chemical nomenclature is inconvenientand shorter nonproprietary names are thus selected.The list also includes reference to two-word INNs.2003, 38 pages, WHO/EDM/QSM/2003.1Electronic access: http://www.who.int/medicines/library/qsm/radicaldoc2002.pdf

The Importance of PharmacovigilanceSafety Monitoring of Medicinal ProductsThis document presents a critical examination of thestrengths and weaknesses of present systems of safetymonitoring in order to increase their impact, and pro-vides an overview of the challenges facing pharma-covigilance in the future.2002, 48 pagesISBN 92 4 159015 7Electronic access: http://www.who.int/medicines/library/qsm/ip_booklet.pdf



Presents an historical account of the Pharmacopoeia and describes methods and procedures for the quality control of pharmaceutical substances and dosage forms, including a special section on quality control of anti-malarials.

ContentsPreface. History. Acknowledgements. General Notices. Abbreviations and symbols. Tests, methods, and general requirements. Monographs for pharmaceutical substances. Monographs for tablets. Monographs for antimalarial drugs. List of reagents, test solutions, and

volumetric solutions. Amendements and corrigenda to Volumes 1, 2, 3, and 4.Supplementary information. Index. Tests, methods, and general requirements.

General requirements for dosage formsOphthalmic preparations. Requirements for specific types of ophthalmic preparations. Suppositories.

Tests for dosage formsDisintegration test for suppositories. Dissolution test for solid oral dosageforms. Test for extractable volume for parenteral preparations. Microbial purityof pharmaceutical preparations. Test for bacterial endotoxins. Test for sterility of non-injectable preparations. Visual inspection of particulate matter injectablepreparations.

Monographs for pharmaceutical substances (Latin names)Albendazolum. Alcuronii chioridum.Amoxicillinum trihydricum. Atenololum.Benznidazolum. Benzoylis peroxidum cumaqua. Captoprilum. Chlorali hydras.Chloramphenicoli natrii succinas.Ciclosporinum. Ciprofloxacini hydrochlo-ridum. Ciprofloxacinum.Clindamycini phosphas. Dacarbazinum. Diethyltoluamidum.Dinitrogeniioxidum. Dithranolum.Erythromycini lacto bionas. Etoposidum.Heparinum calcicum. Heparinumnatricum. Idoxuridinum. Isosorbidi dinitrasdilutus. Ketoconazolum. Levamisolihydrochloridum. DL-Methioninum.Methylrosanilinii chloridum. Metronidazolibenzoas. Nifedipinum. Nonoxinolum 9.Oxygenium. Prednisoloni natrii phosphas. Protamini sulfas. Retinolum densatumoleosum. Selenii disulfidum.Sulfadiazinum argentum. Tropicamidum.

Monographs for tablets (Latin names)Allopurinoli compressi. Carbamazepinicompressi. Codeini phosphatis compressi.Colchicini compressi. Dexamethasoni com-pressi. Diloxanidi furoatis compressi.Doxycyclini hyclatis compressi.Erythromycini ethylsuccinatis compressi.Erythromycini stearatis compressi.Ethambutoli hydrochoridi compressi.Ibuprofeni compressi. Indometacini com-pressi. Isoniazidi compressi. Morphini sulfatis compressi.Pethidini hydroch1oridicompressi. Phenobarbitali compressi.Phenytoini natrici compressi. Praziquantelicompressi. Prednisoloni compressi. Pyranteliembonatis compressi

Monographs for antimalarial drugs(Latin names)Artemetherum. Artemetheri capsulae.Artemetheri compressi.Artemetheri injectio.Artemisininum. Artemisinini capsulae.

Artemisinini compressi. Artemotilum.Artemotili injectio. Artenimolum. Artenimolicompressi. Artesunatum. Artesunati com-pressi. Mefloquini hydrochloridum.Proguanili hydrochloridum.

Supplementary informationAnnotated references. List of availableIntemational Chemical Reference Substances,list of available Intemational InfraredReference Spectra. General guidelines forthe establishment, maintenance, and distri-bution of chemical reference substances

NowAvailable

17

VOLUME 52003, 389 pages [E, F*, S*] ISBN 92 4 154536 4 Swiss francs 95.-/US $85.50In developing countries: Sw.fr. 66.50Order no. 1155091

New: Volume 5

INTERNATIONAL PHARMACOPOEIA

Third EditionVolume 5: Tests and General Requirements for Dosage Forms.Quality Specifications for Pharmaceutical Substances and Dosage Forms.


“global drug quality control”

The International PharmacopoeiaThird EditionVolume 1: GeneralMethods of Analysis

Describes methods and proceduresfor the quality control of pharmaceu-tical substances and dosage forms.

“... a very useful laboratory aid...”— International Journal of Crude DrugResearch

ContentsPreface. General notices. Units ofmeasurement

Physical methodsMeasurement of mass. Determinationof melting temperature, melting range, congealing point, boilingpoint, and boiling range.Determination of mass density and relative density. Determination ofoptical rotation and specific rotation.Determination of refractive index.Spectrophotometry in the visible andultraviolet regions.Spectrophotometryin the infrared region. Atomic absorp-tion spectrophotometry. Fluorescencespectrophotometry. Turbidimetry andnephelometry. Colour of liquids.Radiopharmaceuticals. Powder fine-ness and sieves.

Physiochemical methodsChromatography. Determination ofpH. Electrophoresis. Phase solubilityanalysis.

Chemical methodsGeneral identification tests. Limit testfor chlorides. Limit test for sulfates.Limit test for heavy metals. Limit testfor iron. Limit test for arsenic.Sulfated ash. Oxygen flask method.Complexometric titrations.

Non-aqueous titration. Nitrite titra-tion. Determination of water by theKarl Fischer method. Determinationof methoxyl. Determination of nitro-gen. Determination of iodine value.Determination of peroxides in fixedoils. Determination of saponificationvalue. Determination of unsaponifi-able matter. Determination of acidvalue.

Biological methodsMicrobiological assay of antibiotics.Sterility testing of antibiotics. Unduetoxicity. Test for pyrogens. Test forhistamine-like substances (vaso-depressor substances).

Methods for pharmacognosyDetermination of ash and acid-insoluble ash.

MiscellaneousInternational chemical referencesubstances. Names, symbols, andrelative atomic masses of elements.List of reagents, test solutions, andvolumetric solutions. Index.

The InternationalPharmacopoeiaThird EditionVolume 2: Quality Specifications

Contains quality specificationsfor 126 pharmaceutical substancesincluded in the WHO Model List ofEssential Drugs. The specificationsare especially suited to qualitycontrol in developing countries.

“... deserves due internationalrecognition as a basis for standardising drug quality controlprocedures...” — The Pharmaceutical Journal

ContentsPreface.General notices.Monographs.List of reagents, test solutions, and volumetric solutions. Index.

The InternationalPharmacopoeiaThird EditionVolume 3: Quality Specification

Presents quality specifications for 157widely used pharmaceutical sustances.In keeping with the overall purpose ofthe International Pharmacopoeia, themonographs are based on sound, classical chemical methods appropriatefor use in small and medium-sized laboratories.

“... helps enhance the applicabilityof the Pharmacopoeia to a largerange of laboratory settings...” — Journal of Pharmacy Technology

ContentsPreface. Acknowledgements. Monographs. List of reagents, test solutions, and volumetric solutions.Amendements and corrigenda to Vols. 1 and 2. Index.

Volume 11979, 223 pages [E, F, S] ISBN 92 4 154150 4 Swiss francs 24.–/US $21.60 In developing countries: Sw.fr.16.80 Order no. 1151091

Volume 21981, 342 pages [E, F, S] ISBN 92 4 154151 2 Swiss francs 36.–/US $32.40 In developing countries: Sw.fr. 25.20 Order no. 1152091

Volume 31988, 407 pages [E, F, R, S] ISBN 92 4 154215 2 Swiss francs 64.–/US $57.60 In developing countries: Sw.fr. 44.80 Order no. 1153091


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The International PharmacopoeiaThird Edition Volume 4: Tests, Methods, and General Requirements; Quality Specifications for PharmaceuticalSubstances, Excipients, and DosageForms

Provides a collection of recommended quality specifications and methods of analysis forselected pharmaceutical products, excipients,and dosage forms.

ContentsPreface. Acknowledgements. General Notices.Abbreviations and symbols. Tests, methods,and general requirements. Monographs forpharmaceutical substances. Monographs forexcipients. Monographs for dosage forms. List of reagents, test solutions, and volumetricsolutions. Amendements and corrigenda toVolumes 1, 2, and 3. Index.Tests, methods,and general requirements. Test for sterility,Methods of sterilization, Atomic emission andabsorption spectrometry.

General requirements for substances Hydroxyl value

General requirements for dosage forms Tablets, capsules, parenteral preparations, disintegration test for tablets and capsules.Topical semi-solid dosage forms. Uniformity of content for single-dose preparations.Uniformity of mass for single-dose prepara-tions.

Volume 41994, xv + 343 pages [E, F, S] ISBN 92 4 154462 7 Swiss francs 85.–/US $76.50 In developing countries: Sw.fr. 59.50 Order no. 1154091

The InternationalPharmacopoeiaCD-ROM

19

CD-ROM [E/F/S]2003ISBN 92 4 056021 1Swiss francs 150.–/US $135.00In developing countries: Sw.fr. 105.–Order no. 0990020

This multilingual CD-ROM contains all 5 volumes of the International Pharmacopoeiain English and volumes 1-4 in French andSpanish.

The user-friendly interface allows searches to be conducted by volume, monograph (substances,monographs for excipients, monographs for dosage forms), general methods or reagents.

Now available


20Please send me The International Pharmacopoeia :

copies of volume 1 at the price of Swiss francs 24.– / in developing countries Swiss francs 16.80 (order no. 1151091)





copies of International Pharmacopoeia CD-ROM at the price of Swiss francs 150.– /in developing countries

Swiss francs 105.– (order no. 0990020)

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Please return or fax this order to: WHO - Marketing & Dissemination1211 Geneva - 27 SwitzerlandTel. +41 22 791 24 76 Fax +41 22 791 48 57Email: [email protected] online at: http//:bookorders.who.int

For customers in the USA, please return or fax this order to:WHO Publications Center USA49 Sheridan AvenueAlbany NY 12210, USATel. +518 436-9686 Fax +518 436 7433Email: [email protected]

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“your benchmark to global drug quality control”


CD-ROMALSO

AVAILABLE


DRUG PRESCRIBING

21

A spiral-bound training manualoffering a step-by-step guide to the process of rational, respon-sible prescribing. Addressed toundergraduate medical studentswho are about to enter the clinical phase of their studies, the manual aims to help studentsacquire the skills and confidenceneeded to exercise independentjudgement and make their owndecisions about which drugs ornon-drug treatments are best for each individual patient.Throughout, numerous practicalexercises and examples of patientsand their complaints are used tohelp tie advice to the realities of a doctor’s daily practice.

Teacher’s Guide to GoodPrescribingThis is a companion volume to theGuide to Good Prescribing. Its tar-get audience is university teacherswho wish to use the Guide forteaching undergraduate medicalstudents.2001, 106 pagesWHO/EDM/PAR/2001.2Electronic access: http://www.who.int/medicines/library/par/teachers_guide.pdf

Guide to Good PrescribingA Practical Manual

by T.P.G.M. de Vries, R.H. Henning,H.V. Hogerzeil and D.A. Fresle1995, ii + 108 pages [E, F, S, C, G, P]WHO/DAP/94.11Swiss francs 15.–/US $13.50In developing countries: Sw.fr. 10.50Order no. 1930074

Adherence to Long-termTherapiesEvidence for Action

Adherence to therapies is a primarydeterminant of treatment success.Poor adherence attenuates optimumclinical benefits and thereforereduces the overall effectiveness ofhealth systems.

"Medicines will not work if you donot take them". Medicines will not be effective if patients do notfollow prescribed treatment, yet in developed countries only 50% ofpatients who suffer from chronic diseases adhere to treatment recom-mendations. In developing countries,when taken together with pooraccess to health care, lack of appro-priate diagnosis and limited accessto medicines, poor adherence isthreatening to render futile anyeffort to tackle chronic conditions,such as diabetes, depression andHIV/AIDS.

This report is based on an exhaustivereview of the published literature on the definitions, measurements, epidemiology, economics and interventions applied to nine chronicconditions and their risk factors.These are asthma, cancer (palliativecare), depression, diabetes, epilepsy,HIV/AIDS, hypertension, tobaccosmoking and tuberculosis.

Intended for clinical practitioners,health managers and policy-makers,this report provides a concise summary of the consequences ofpoor adherence for health and economics.

2003, 212 pages [E]ISBN 92 4 154599 2Swiss francs: 30.–/US $27.00In developing countries: Sw.fr. 15.–Order no. 1150526



DRUG PRESCRIBING

22

The second revised edition of model prescribing information for some 37 essential drugs used for the prevention and treatment of protozoal and helminthic infections. The sections on malaria, African trypanosomiasis, cestode infections, schistosomiasis, andonchocerciasis have been extensively revised in the lightof new developments in the treatment of these diseases.

The book is organized according to diseases, movingfrom amoebiasis and giardiasis to intestinal, liver, andlung flukes. Each disease or group of diseases is firstintroduced with concise information about its causes,mode of transmission, clinical features, and geographi-cal prevalence, followed by general advice on preven-tion and treatment. Prescribing information is then provided for first-choice and alternative therapeutic andprophylactic drugs. Information includes uses, dosageand administration, contraindications and precautions,use in pregnancy, adverse effects, drug interactions, and advice on storage.

From reviews of the first edition:"... a mine of admirably concise and accurately compiled data ... will be of enormous value..."

– Transactions of the Royal Society of Tropical Medicine and Hygiene

A practical guide to the use of drugs in the manage-ment of sexually transmitted diseases and diseasesassociated with HIV infection. Addressed to clinicians,especially in developing countries, the book aims toguide the selection and prescribing of drugs in linewith the latest knowledge about efficacy, safety, andcosts. Information responds to both the dramaticglobal increase in the incidence of these diseases and the spread of resistance to readily available antimicrobials.

WHO Model Prescribing Information: Drugs Used in Parasitic DiseasesSecond edition

1995, 146 pages [E, F, S]ISBN 92 4 140104 4Swiss francs 35.–/US $31.50In developing countries: Sw.fr. 24.50Order no. 1152343

WHO Model Prescribing Information:Drugs Used in Sexually TransmittedDiseases and HIV Infection

1995, 97 pages [E, F, S]ISBN 92 4 140105 2Swiss francs 25.–/US $22.50In developing countries: Sw.fr. 17.50Order no. 1150429


23

Provides model prescribing infor-mation for essential drugs used inthe treatment of skin diseases.Emphasis is placed on skin diseasescommonly found in developingcountries, since rural communitiesin these areas continue to experi-ence considerable disability, disfig-urement, and distress caused bycurable or controllable diseases.Some rare but life-threatening disorders, such as pemphigus, arealso briefly discussed.

Provides model prescribing infor-mation for essential drugs used in the treatment of bacterial infections. This new volumeincludes drugs used for treatingrespiratory, gastrointestinal, urinary,perioral, dental and cardiovascularinfections, as well as septicaemiaand infections of the skin, soft tissues, bones and joints, sexuallytransmitted diseases, and othercommonly encountered bacterialinfections. It also covers prophylaxisagainst rheumatic fever, meningitis,and bacterial infection during surgery.

This guide aims to provide a com-prehensive yet simplified approachto the rational use of antibioticsand to help the physician selecttherapeutic programmes that are both safe and effective. This second edition updates a numberof recommendations as a result ofnew developments and emergenceof resistance in bacterial infections.

WHO Model PrescribingInformation: Drugs Used in Skin Diseases

1997, iv + 126 pages [E, F, S, R]ISBN 92 4 140106 0Swiss francs 35.–/US $31.50In developing countries: Sw.fr. 24.50Order no. 1150450

WHO Model PrescribingInformation: Drugs Used in Bacterial Infections

2001, iv + 126 pages [E]ISBN 92 4 140107 9Swiss francs 35.–/US $31.50In developing countries: Sw.fr. 24.50Order no. 1150483

Guide to Chemotherapyand Chemoprophylaxis in Bacterial InfectionsSecond Edition

WHO Regional office for the EasternMediterraneanEastern Mediterranean Series, No. 41997, 134 pages [E]ISBN 92 9021 225 XSwiss francs 10.–/US $9.00In developing countries: Sw.fr. 7.00Order no. 1442004


DRUG PRESCRIBING

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This book makes a valuable contri-bution to the surveillance of resist-ance to antibiotics. The text offersnoteworthy articles grouped undertwo major categories: monitoringbacterial resistance to antimicrobialdrugs, and factors determining theuse of antimicrobials. The goal ofthis work is to increase awarenessof the problem, to promote surveil-lance activities, and to find the bestways to apply preventive measures,so that antibiotics are used judi-ciously with both humans and animals.

The second revised edition of apopular practical guide to the pre-scribing of drugs for the elderly.Designed to promote a morerational use of drugs, the bookemphasizes the many physical andmental conditions associated withaging that must be consideredwhen evaluating symptoms andselecting the most appropriatedrug, dose, and formulation.

Provides concise, authoritativeadvice on the use of high-dosevitamin A supplements for the control of vitamin A deficiency andthe emergency treatment ofxerophthalmia and other conditionsin high-risk groups. Now in its second edition, the guide has beenupdated to reflect the latest scientific knowledge, particularly concerning the safety and effec-tiveness of different dose schedulesin different age and populationgroups.

Antimicrobial Resistance in the AmericasMagnitude and Containmentof the Problem

Drugs for the ElderlySecond edition

Vitamin A SupplementsA Guide to their Use in theTreatment and Prevention of Vitamin A Deficiency andXerophthalmiaSecond edition

WHO Regional office for EuropeWHO Regional Publications,European Series, No. 711997, x + 145 pages [E]ISBN 92 890 1335 4Swiss francs 32.–/US $28.80In developing countries: Sw.fr. 22.40Order no. 1310071

Pan American Health Organizationby R. Salvatierra-González and Y. Benguigui2001, 269 pages [E]ISBN 92 75 32319 5Swiss francs: 50.–/ US $ 45.00 In developing countries: Sw.fr. 35.–Order no. 1630121

1997, vi + 28 pages [E, F, S]ISBN 92 4 154506 2Swiss francs 14.–/US $12.60In developing countries: Sw.fr. 9.80Order no. 1152303


LEGISLATION AND REGULATION

25

This edition of International travel and health was completelyredesigned in 2002 to reflect betterknowledge about the risks towhich travellers are exposed andthe precautions needed to protecttheir health.

The book offers guidance on thefull range of health risks likely tobe encountered at specific destina-tions and associated with differenttypes of travel - from business,humanitarian and leisure travel tobackpacking and adventure tours.Information is intended to help themedical profession be fully alert topotential risks and provide appro-priate advice, whether concerningrecommended vaccinations, protec-tion against insects and other dis-ease vectors, or safety in differentenvironmental settings. Informationon infectious diseases of potentialrisk for travellers has also beengreatly expanded. Additional chap-ters describe vaccine-preventablediseases, vaccines for routine andselective use, and selection criteria,and offer detailed guidance on malaria, the most important infectious disease threat for travellers.

Drugs play a crucial role in savinglives, restoring health, and prevent-ing diseases and epidemics. Butthey need to be safe, efficacious,of good quality, and used rationally.This means that their production,import/export, storage, supply anddistribution should be subject togovernment control through pre-scribed norms and standards andan effective regulatory system.Substandard and counterfeit drugsproliferate primarily in an environ-ment where drug regulation hasproved ineffective.

This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus,Estonia, Malaysia, the Netherlands,Tunisia, Uganda, Venezuela, andZimbabwe in 1998-1999. It givesan overview of the development ofdrug regulation in these countriesas well as the resources availableand the strategies applied in drugregulation implementation at thetime the studies were conducted.An analysis of the strengths and weaknesses in drug regulation inthese countries is also provided.

Presents guidelines for determiningwhen medicinal products, sold onprescription only, can be reclassifiedfor non-prescription, or over-the-counter, sale. Noting that self-med-ication plays an important role inthe health care system, the bookletsets out criteria and methodsintended to help drug regulatoryauthorities decide when a productis suitably safe and effective forself-medication.

International Travel and Health 2003Situation as on 1 January 2003

2002, vii + 85 pages [E, F]ISBN 92 4 158028 3Swiss francs 25.–/US $22.50In developing countries: Sw.fr. 17.50Order no. 1180003

Effective Drug RegulationA Multicountry Study

by S. Ratanawijitrasin andE. Wondemagegnehu2002, ix + 189 pages [E]ISBN 92 4 156206 4Swiss francs 20.–/US $18.00In developing countries: Sw.fr. 14.–Order no. 1150503

Guidelines for theRegulatory Assessment of Medicinal Products for Use in Self-medication

2000, 31 pages [E]WHO/EDM/QSM/00.1Swiss francs 10.–/US $9.00In developing countries: Sw.fr. 7.–Order no. 1930175


LEGISLATION AND REGULATION

26

A detailed guide to the establishe-ment of a system for the marketingauthorization of multisource (generic)pharmaceutical products. Addressedto drug regulatory authorities, theguidelines are intended for use incountries that do not presently have a fully functional system of premarketevaluation and market authorization,and want to establish such a system,giving priority to the assessment andauthorization of generic drugs.

Marketing Authorization of Pharmaceutical Productswith Special Reference to Multisource (Generic)ProductsA Manual for a DrugRegulatory Authority

Regulatory Support Series, No. 51999, v + 213 pages [E]WHO/DMP/RGS/98.5Swiss francs 40.–/US $36.00In developing countries: Sw.fr. 28.–Order no. 1930169


PUBLICATIONS FROM THE SOUTH CENTRE

27

Publications fromThe South CentreThe South Centre is an intergovernmental organizationbased in Geneva. (For details about the South Centre visitits website www.southcentre.org ) It undertakes policy-oriented analytical work on issues of common interest tothe countries and peoples of the South. The Centre func-tions essentially as an intellectually autonomous think-tank.

While the Centre is very small and has very limited financialresources at its disposal, its strength is based on networkingwith institutions and experts in the South. Its political andsubstantive relevance and importance stems from its man-date to promote South solidarity and consciousness; to pro-mote various types of South-South cooperation and action,links, networking and information exchange; to contributeto efforts to coordinate participation by developing coun-tries in international forums dealing with South-South andNorth-South matters and to foster convergent views andapproaches among countries of the South – with respect to global economic, political and strategic issues related to development, sovereignty, security and in general governance and direction of the international system.

The scope of Centre’s work and activities ranges over abroad spectrum. Among other things, it has done work onSouth-South cooperation, UN reform, financing and devel-opment, sustainable development, intellectual property, andinternational trade, and has produced policy papers andpublications on the occasion of major UN conferences,most recently those held in Monterrey on financing for development and in Johannesburg on sustainable development. An area where the Centre has been able toundertake more systematic and sustained activity thanks to the availability of project funding has to do with WTO,trade and development.

While the Centre has not as yet initiated a work pro-gramme on health-related matters, it has worked in closecontact with WHO, especially its Department of EssentialDrugs and Medicines Policy, and has issued a number ofrelevant publications, including joint publications withWHO, most recently a study entitled Protection andPromotion of Traditional Medicine: Implications for PublicHealth in Developing Countries. The Centre plans, as itsresources and staffing expand, to initiate systematic workon health-related issues from a South perspective.

Contact address: South Centre, BP 228, 17-19 Chemin du Champ d’Anier, 1211 Geneva 19, Switzerland. Tel 41-22-7918050, Fax 41-22-7988531, Email: [email protected]


ETHICS AND SAFETY GUIDELINES

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This book aims to help policyanalysts and decision-makerswhen considering the addition of new vaccines to nationalimmunization programmes. Itreflects the growing international concerns that all children of theworld should have access to life-saving vaccines wherever theyhappen to live, and provides a set of questions to work through the technical issues for adding a new vaccine to the national immunization schedule.

A revised and expanded edition of the first internationally-agreedguidelines covering the minimumdrug safety information that shouldbe communicated by manufactur-ers to physicians and other pre-scribers. Originally published as theCIOMS Working Group III report,the "Core Safety Information"specified in the guidelines has beenwidely endorsed as a standard forthe preparation of all officialnational data sheets, packageinserts, product labels, and otherofficial statements issued by manufacturers.

The Guidelines, first issued in 1982and then revised in 1993, are beingupdated and expanded to address anumber of new and especially challeng-ing ethical issues. These include issuesraised by international collaborative trials of drugs in developing countries,especially expansive drugs, and the useof placebo controls in randomized clinical trials. Others arise from thecomplexity of research in human genetics, including stem-cell research,and in reproductive biology.

Edited by R.J. Levine andS. Gorovitz with J. GallagherCIOMS, 2000, viii + 295 pages [E]ISBN 92 9036 073 9Swiss francs 30.–/US $27.00In developing countries: Sw.fr. 21.00Order no. 1840023

CIOMS, 1999, 98 pages [E]ISBN 92 9036 070 4Swiss francs 15.–/US $13.50In developing countries: Sw.fr. 10.50Order no. 1840021

WHO Regional Office for the Western Pacific 2000, v + 32 pages [E]ISBN 92 9061 154 5Swiss francs 10.–/US$9.00In developing countries: Sw.fr. 7.–Order no. 1520015

Assessing New Vaccines for National ImmunizationProgrammesA Framework to AssistDecision-makers

Guidelines for Preparing CoreClinical-Safety Informationon DrugsSecond editionIncluding New Proposals forInvestigator’s BrochuresReport of CIOMS, WorkingGroups III (Revised) and V (New)

Biomedical Research Ethics:Updating InternationalGuidelinesA Consultation


29

Presents and explains a standardizedmethodology for reassessing theestablished benefit-risk relationship ofa marketed drug when a new safetyproblem arises. Addressed to drugmanufacturers and regulatory authorities, the book responds to theabsence of any standard, systematicprocedure for assessing newly detect-ed hazards, balancing risks againstbenefits, and reporting the results.The recommended approach, whichreflects the consensus reached by 24representatives of industry and government regulatory authorities,includes detailed advice on conceptsand procedures for determining themagnitude of the safety problem anddeciding on the appropriate action,whether involving a routine changein product information or immediatewithdrawal of the drug from themarket. The use of a standard reporting form, presented here forthe first time, forms a central part of the recommended procedure.

Provides concise definitions fortwenty-six terms frequently usedwhen reporting respiratory and skin disorders that may be caused by adverse reactions to drugs.Addressed to drug regulatoryauthorities and the drug safetyunits of pharmaceutical companies,the book responds to the problemscreated when spontaneous reportsof adverse drug reactions useimprecise, incorrect, or inconsistentterms. With these problems inmind, the book sets out precisedefinitions of terms, and minimumrequirements for their use, for themost important respiratory and skindisorders that may be caused bydrugs. The book is part of an on-going project to develop an inter-nationally agreed terminology forthe designation, reporting, valida-tion, and coding of adverse drugreactions, giving priority to themost severe disorders that may be caused by drugs.

Benefit-Risk Balance forMarketed Drugs: EvaluatingSafety SignalsReport of CIOMS, WorkingGroup IV

Adverse Drug ReactionTerms: DefinitionsRespiratory Disorders, Skin Disorders

CIOMS, 1996, 28 pages [E]ISBN 92 9036 064 XSwiss francs 10.–/US $9.00In developing countries: Sw.fr. 7.–Order no. 1840019

CIOMS, 1998, 160 pages [E]ISBN 92 9036 068 2Sw.fr. 15.–/US $13.50In developing countries: Sw.fr. 10.50Order no. 1840020


30

This WHO Collaborating Centre is situated in UppsalaSweden and known throughout the world as theUppsala Monitoring Centre.

The UMC supports WHO's leadership in the field of world health by providing excellence

• in the science and concepts of all aspects of pharmacovigilance

• to prevent harm to humans from the effects of medicines

• to gather and share objective intelligence and opinion in the field of drug safety through open and transparent means of communication

• to support the promotion of the rational use of drugs, and the achievement of improved patient therapy and public health

• in global education and communications in benefit, harm, effectiveness and risk in medical therapy

It achieves this by • developing leading-edge systems and science for

the identification and communication of safety hazards in drugs and other substances used in medicine

• carrying out research pushing forward the ethical, intellectual and scientific boundaries of theory and practice in pharmacovigilance

• pursuing active collaboration and communication with all stakeholders

• pursuing the goal of a single, global database for drug safety data

And in particular it aims to • ensure that effective, timely international collective

effort will never miss a signal of a potential hazard

• ensure that all stakeholders evaluate and learn from decisions and actions through positive impact-assessment, follow-up and debate

• encourage the growth of pharmacovigilance activities around the world, in particular the establishment of new National Centres

• promote existing National Centres and other stakeholders in the field

• to contribute actively to the global vision of the WHO Programme

• to use and share available information openly and transparently

• to sponsor and support others in their pharmacovigilance activities

• to exploit fully the resources of the UMC

• stimulate the development of coherent, harmonised systems worldwide for pharmacovigilance, through education, training, promoting and participating in international forums, the promotion of best practiceand the publication of guidelines

• maintain and develop useful products, services and tools in pursuit of the vision and goals of the WHO Programme and the UMC.

Some key publications of the UppsalaMonitoring Centre are:• Viewpoint – Watching for Safer Medicines• Guidelines for setting up and running

a Pharmacovigilance Centre

• Pharmacovigilance in Focus

• Uppsala Reports

• Communicating Drug Safety Information -The Erice Declaration

• Dialogue in Pharmacovigilance - more effective communication

• Expecting the Worst –Anticipating, preventing and managing medicinal product crises

• Guidelines for Herbal ATC classification

• National Pharmacovigilance Systems

• The WHO Adverse Reaction Terminology

• The WHO Drug Dictionary

The WHOCollaborating Centre for International Drug Monitoring

WHO COLLABORATING CENTRE FORINTERNATIONAL DRUG MONITORING

For further information and publication orders,please contact:WHO Collaborating Centre for International Drug MonitoringStora Torget 3S-753 20 Uppsala, SwedenTel: +46-18-656060Fax: +46-18656080Email: [email protected] site: www.who-umc.org


31

Reports the findings and recom-mendations of a working groupconvened to prepare guidelines for the use of herbal medicines in Western Pacific countries.Addressed to national healthauthorities, the report responds tothe widespread use of herbal medi-cines in this part of the world andthe corresponding need for mecha-nisms to ensure that these productsare safe and effective, yet remainbroadly accessible. With this need inmind, the report sets out a compre-hensive framework for developingnational policies designed to controlthe safety, efficacy, and quality ofherbal medicines, manufacturingpractices, product registration, and labelling, marketing, and trade.

Sets out detailed guidelines forconducting scientific research onthe safety and efficacy of herbalmedicines. The guidelines, whichreflect the consensus reached by17 experts in pharmacology, biochemistry, and traditional medicine, respond to the need toassure the safety of widely-usedherbal medicines while also facilitating the search for newpharmaceutical products. Specificresearch criteria are coveredtogether with general principles of investigation, including ethical concerns.

Guidelines for theAppropriate Use of Herbal Medicines

Research Guidelines forEvaluating the Safety andEfficacy of HerbalMedicines

WHO Regional Officefor the Western Pacific1993, v + 86 pages [E]ISBN 92 9061 110 3Swiss francs 7.50/US $6.70In developing countries: Sw.fr. 5.20Order no. 1520003

WHO Regional Office for the Western PacificWHO Regional Publications, Western PacificSeries, No. 231998, vi + 79 pages [E]ISBN 92 9061 124 3Swiss francs 7.50/US $6.70In developing countries: Sw.fr. 5.20Order no. 1510023

MEDICINAL PLANTS

Some Traditional HerbalMedicines, Some Mycotoxins,Naphthalene and Styrene

Traditional herbal medicines encompass an extremely diversegroup of preparations that originatefrom many different cultures. In recent years, such products havebecome widely available commer-cially in developed countries, wheremixtures prepared from medicinalplants have been marketed or usesthat were never contemplated in thetraditional healing systems fromwhich they emerged.

This monograph evaluates the carcinogenic risks to humans posedby the use of some traditionalherbal medicines, Fumonisin B1, and the industrial organic chemicalsnaphthalene and styrene, and provides an update of the data onthe carcinogenicity of aflatoxins. An Annex to the volume describesfungal sources and formation ofaflatoxins in foods and feeds, anddiscusses practical strategies forreduction of aflatoxin levels.

International Agencyfor Research on Cancer IARC Monographs on the Evaluation of Carcinogenic Risks to Humans,Volume 822002, 500 pages [E] ISBN 92 832 1282 7 Swiss francs 55.-/US $49.50 In developing countries: Sw.fr. 38.50 Order no.1720082


MEDICINAL PLANTS

32

Catalogues the 200 species ofmedicinal plants most commonlyused in traditional Vietnamesemedicine. The book, which hasbeen translated from the originalVietnamese, was produced in aneffort to communicate knowledgeabout herbal medicine that hasaccumulated over thousands ofyears, has been confirmed throughboth empirical experience and scientific evaluation, and yet hasrarely been published outside theVietnamese literature. The bookalso responds to increasing respectfor the value of medicinal plants asa source of efficacious and inex-pensive new drugs that offer animportant alternative to chemicallysynthesized medicines.

Catalogues the 150 species ofmedicinal plants most commonlyused in traditional Chinese medicine. Each plant species is first documented by a full colour photo-graph taken under natural condi-tions during the flowering or fruiting season. Where relevant, a second photograph illustrates theplant parts from which the crudedrug is extracted. Explanatory notesfor each species cover botanicalname and synonyms, Chinesename, English name, parts used,description of the plant, its habitat,and geographical distribution, andclinical indications and dosage.Some of the syndromes and clinicalsigns are described in traditionalChinese medical terminology.Information on indications anddosage is in keeping with theoriesfor the prescription of medicinalplants taken from traditionalChinese pharmacology.

Presents concise monographs,accompanied by full-colour photo-graphs, for the 150 plant speciesmost commonly used for medicinalpurposes in the Republic of Korea.In view of the country's long andsuccessful history in the use of tra-ditional medicines, the book aimsto provide written and visual docu-mentation of important plants andsummarize their uses to treat ailments, protect against disease,or promote health.

Medicinal Plants in Viet NamMedicinal Plants in China Medicinal Plants in the Republic of KoreaInformation on 150 commonlyused Medicinal Plants

Compiled by Natural Products ResearchInstitute, Seoul National UniversityWHO Regional office for the Western PacificWHO Regional Publications, Western Pacific Series, No. 211998, ix + 316 pages, 150 colour plates [E]ISBN 92 9061 120 0Swiss francs 42.–/US $37.80In developing countries: Sw.fr. 29.40Order no. 1510021

WHO Regional office for the WesternPacificWHO Regional Publications,Western Pacific Series, No. 21989, 327 pages, 151 colour plates[E]ISBN 92 9061 102 2Swiss francs 50.–/US $45.00In developing countries: Sw.fr. 35.–Order no. 1510002

WHO Regional office for the Western PacificWHO Regional Publications,Western Pacific Series, No. 31990, 410 pages, 200 colour plates [E]ISBN 92 9061 101 4Swiss francs 45.–/US $40.50In developing countries: Sw.fr. 31.50Order no. 1510003


33

Describes the information available,from both traditional medical textsand recent scientific studies, for102 medicinal plants used in theSouth Pacific Islands. Plants fromthis part of the world represent anespecially diverse flora and includeseveral species currently undergo-ing scientific investigation.Addressed to ethnobotanists,phyto-chemists, and pharmacolo-gists, the book aims to documenttraditional clinical uses and bringthese to the attention of the international scientific community.

Medicinal Plants in theSouth PacificInformation on 102 commonlyused Medicinal Plants in theSouth Pacific

WHO Regional office for the Western Pacific WHO Regional Publications,Western Pacific Series, No. 191998, xvii + 254 pages, 102 colour plates [E]ISBN 92 906 1119 7Swiss francs 33.–/US $29.70In developing countries: Sw.fr. 23.10Order no. 1510019

General Guidelines for Methodologies onResearch and Evaluation of Traditional Medicine

WHO has developed these generalguidelines in response to the ques-tion: what types of academicresearch approaches and methodscan be used to evaluate the safetyand efficacy of traditional medicine?The guidelines presented in thisdocument consist of sections onherbal medicines, on traditional pro-cedure-based therapies, on clinicalresearch, and related issues includ-ing ethics, education and training,and surveillance systems.

The specific objectives of the guide-lines are to harmonize the use ofcertain accepted and importantterms in traditional medicine; sum-marize key issues for developingmethodologies for research andevaluation of traditional medicine;improve the quality and value ofresearch in traditional medicine; andprovide appropriate evaluationmethods to facilitate the develop-ment of regulation and registrationin traditional medicine

2001, vi + 71 pages [E, F*]WHO/EDM/TRM/2000.1Swiss francs 19.–/US $17.10In developing countries: Sw.fr. 13.30Order no. 1930184


MEDICINAL PLANTS

34

Volume 2 of the WHO Monographs onSelected Medicinal Plants provides anadditional collection of 30 monographscovering the quality control and tradi-tional and clinical uses of selectedmedicinal plants reviewed by 120experts in more than 50 countries.

It follows the same format as Volume 1with the addition of two cumulativeindexes in order to facilitate referenc-ing. One lists the monographs inalphabetical order by plant name andthe other according to the plant mate-rial of interest. Volume 2 also includesgeneral technical notices that providedescriptions of each section.

2002, v + 357 pages [E]ISBN 92 4 154537 2Swiss francs 100.–/US $90.00In developing countries: Sw.fr. 70.–Order no. 1152460

WHO Monographs on SelectedMedicinal Plants, Volume 2

Medicinal Plants covered in volume 2Radix Althaeae. Herba Andrographidis. Radix Angelicae Sinensis. FlosCalendulae. Flos Caryophylli.Rhizoma Cimicifugae. Foliumcum Flore Crataegi. RadixEleutherococci. AetheroleumEucalypti. Folium Eucalypti.Cortex Frangulae. Folium etCortex Hamamelidis. Semen Hippocastani. Herba Hyperici. AetheroleumMelaleucae. Folium Melissae.Aetheroleum MenthaePiperitae. Folium MenthaePiperitae. Folium Ocimi sancti.Oleum Oenotherae Biennis.Rhizoma Piperis Methystici.Cortex Pruni Africaniae. Cortex Rhamni Purshianiae. Flos Sambuci. Radix senegae.Fructus serenoae Repentis.Fructus silybi Mariae. Herba Tanaceti Parthenii. Radix Urticae. Folium Uvae Ursi.

WHO Monographs on SelectedMedicinal Plants, Volume 3 IN PREPARATION

IN PREPARATION 2004Order no. 1153460

Medicinal Plants covered in volume 3Fructus Ammi Majoris. FructusAmmi Visnagae. Fructus Anethi.Aetheroleum Anisi. Fructus Anisi.Semen Armeniacae. Flos Arnicae.Folium Azadirachti.OleumAzadirachti. Flos Carthami. Stigma Croci. Fructus Foeniculi.Radix Gentianae Luteae. RadixGentianae Scabrae. GummiGugguli. Radix Harpagophyti.Rhizoma Hydrastis. Radix Ipecacuanhae. Aetheroleum Lavandulae.Flos Lavandulae. Strobilus Lupuli.Gummi Myrrha. Herba Passiflorae.Testa Plantaginis.Radix Rehmanniae.Fructus Schisandrae. RadixScutellariae. Radix cum HerbaTaraxaci. Semen TrigonellaeFoenugraeci. Cortex Uncariae.Fructus Zizyphi.

This book contains 28 monographson widely used medicinal plants,selected for inclusion on the basis of scientific evidence for both safetyand efficacy. Each monograph contains two parts, the first ofwhich provides pharmacopoeialsummaries for quality assurance purposes, including botanical fea-tures, identity tests, purity require-ments, chemical assays and majorchemical constituents. The secondpart, drawing on an extensivereview of scientific research,describes the clinical applications of the plant material, with detailedpharmacological information andsections on contraindications,adverse effects and dosage.

The monographs are intended topromote international harmoniza-tion in the quality control and use of herbal medicines and to serve as models for the development of national formularies.

WHO Monographs on SelectedMedicinal Plants, Volume 1

1999, v + 289 pages [E]ISBN 92 4 154517 8Swiss francs 92.–/US $82.80In developing countries: Sw.fr. 64.40Order no. 1150460

Provides an additional collection of 31 monographs.

Medicinal Plants covered in volume 1Bulbus Allii Cepae. Bulbus Allii Sativi.Aloe. Aloe Vera Gel. Radix Astragali.Fructus Bruceae. Radix Bupleuri.Herba Centellae. Flos Chamomillae.Cortex Cinnamomi. RhizomaCoptidis. Rhizoma Curcumae Longae. Radix Echinaceae. Herba EchinaceaePurpureae. Herba Ephedrae. FoliumGinkgo. Radix Ginseng. RadixGlycyrrhizae. Radix Paeoniae. SemenPlantaginis. Radix Platycodi. RadixRauwolfiae. Rhizoma Rhei. FoliumSennae. Fructus Sennae. HerbaThymi. Radix Valerianae. RhizomaZingiberis.


TRADITIONAL MEDICINE

35

The increasing demand for medici-nal plants and the products derivedfrom them has led to concerns over their safety and efficacy. The evaluation of herbal medicines and the use of registration and regulation to ensure their safetyand efficacy present importantchallenges.

This document describes experi-ences from 52 countries in formulating policies on herbal medicines and introducing measures for their regulation and registration.

This unique book provides a comprehensive picture of the vividkaleidoscope of traditional medicine in Asia presented by 34 eminent authors from 15 countries,belonging to the different systemslike Ayurveda and ChineseTraditional Medicine.

Important emerging areas such asharmonization of the traditionalsystems with modern medicine andthe growing role of these systemsin the health care structure ofcountries are also dealt with.Legislation and regulation of thesesystems and practitioners, an areaof growing concern, the need forgood preclinical toxicology studiesand scientific clinical evaluation ofthe products and medicinal plantsused for therapy are exhaustinglydealt with. The vital issue of pro-tection of traditional systems ofmedicine and patenting of medici-nal plants is discussed in detail.

The book is replete with sugges-tions and ideas aimed at makingtraditional systems more effectivelyand more widely used for healthcare. The book also covers the pre-vailing situation regarding the useand other aspects of traditionalmedicine in the 10 Member coun-tries of the South-East Asia Regionof the World Health Organization.

Regulatory Situation of Herbal MedicinesA Worldwide Review

Traditional Medicine in Asia

1998, 45 pages [ E, F, S]WHO/TRM/98.1Swiss francs 14.–/US $12.60In developing countries: Sw.fr. 9.80Order no. 1930193

Edited by R.R. Chaudhury and Uton M. RafeiWHO Regional Office for South-East AsiaWHO Regional Publications, South-East Asia Series, No. 392002, vii + 309 pages [E] ISBN 92 9022 224 7Swiss francs 20.–/US $18.00In developing countries: Sw.fr. 14.–Order no. 1560039

Various types of traditional medicineand other medical practices referredto as complementary or alternativemedicine are increasingly used inboth developing and developedcountries. In order to promote safeand appropriate use of these medicines and practices, as well as to ensure the quality of service andpractitioners, national regulations arevital. Establishing national policies on traditional medicine, and/or complementary/alternative medicineand their medical practices, should therefore include creation of legal frameworks.

This review summarizes the legal status of several major practices intraditional medicine and complemen-tary/alternative medicine in 123coutries. It includes data on: the useof traditional and complementary/alternative medicine; the regulatorysituation of traditional and complementary/alternative remedies and practitioners; health insurance coverage of traditional and complementary/alternative medicine; education and training of practitioners of traditional and com-plementary/alternative medicine.Information provided in this reviewwill be useful not only to policy makers,but also to researchers, universities, the public, insurancecompanies and pharmaceuticalindustries.

Legal Status of Traditional Medicine andComplementary/AlternativeMedicineA Worldwide Review

2001, ix + 189 pages [E, R]ISBN 92 4 154548 8 Swiss francs 35.–/US $31.50 In developing countries: Sw.fr. 24.50 Order no. 1930190


36

This report presents the recommendations of a WHO Expert Committee responsible for reviewing information on dependence-producing drugs toassess the need for their interna-tional control. The first part of thereport contains a description of the procedure for the review ofdependence-producing substances.This is followed by a critical reviewof five psychoactive substances(amfepramone, amineptine,buprenorphine, delta-9-tetrahydro-cannabinol and tramadol). Thereport also discusses the substancesthat were pre-reviewed by theCommittee, four of which (keta-mine, zopiclone, butorphanol andkhat) were recommended for critical review at a future meeting. The final section discusses theproblems of the terminology usedin reporting abuse-related adversedrug reactions and describes howconfusion affects the reporting ofadverse effects using the exampleof the selective serotonin reuptakeinhibitors.


Guidelines for the WHOReview of Dependence-producing PsychoactiveSubstances forInternational Control2000, 22 pages [E, F]WHO/EDM/QSM/2000.5Electronic access:http://www.who.int/medicines/library/qsm/who-edm-qsm-2000-5/who-edm-qsm-2000-5en.htm

Narcotic and PsychotropicDrugs Achieving Balance in NationalOpioids Control Policy.Guidelines for AssessmentThe publication presents guidelinesfor governments to determinewhether their national drug controlpolicies have the legal and administrative framework to ensure medical availability of opioid analgesics, as recommended by the International Narcotics ControlBoard.2000, 37 pages [E, F]WHO/EDM/QSM/2000.4Electronic access:http://www.who.int/medicines/library/qsm/who-edm-qsm-2000-4/who-edm-qsm-2000-4.htm

WHO Expert Committee onDrug DependenceThirty-third Report

Technical Report Series, No. 9152002 , 30 pages [E] ISBN 92 4 120915 1Swiss francs 14.–/US $12.60In developing countries: Sw.fr. 9.80Order no.1100915

WHO Traditional MedicineStrategy : 2002-2005WHO has developed this strategyfor traditional medicine to enablethis form of health care to bettercontribute to health security. It focuses on working with WHOMember States to define the roleof traditional medicine in nationalhealth care strategies, supportingthe development of clinicalresearch into the safety and effica-cy of traditional medicines, andadvocating the rational use of tradtional medicine.2002, 61 pagesWHO/EDM/TRM/2002.1Electronic access:http://www.who.int/medicines/library/trm/trm_strat_eng.pdf


PSYCHOTROPIC DRUGSTRADITIONAL MEDICINE


PERIODICALS AND SUBSCRIPTIONS

37

The WHO Pharmaceuticals and BiologicalsSubscription PackageA yearly service offering automatic and immediate delivery of allWHO publications dealing with pharmaceuticals, pharmacy and biologicals.

Introduced as a convenience for customers, the WHOPharmaceuticals and Biologicals Subscription Package includes sub-scriptions to the following periodicals: WHO Drug Informationand the Essential Drugs Monitor. The subscription also covers newreports of the WHO Expert Committees on biological standardiza-tion, specifications for pharmaceutical preparations, and drugdependence, plus all books relevant to drug research and development, manufacturing, prescribing, essential drugs, pharmacy, and international regulation and quality control.The WHO Pharmaceuticals and Biologicals Subscription Package2003 subscription rate:Sw.fr. 240–/US $192.00(includes handling charges and postage via surface mail)

WHO Drug Information

WHO Drug Information communicates pharmaceutical informationthat is either developed and issued by WHO or transmitted to WHOby research and regulatory agencies throughout the world. The jour-nal also includes regular presentation of changes in the WHO ModelList of Essential Drugs and newly proposed and recommendedInternational Nonproprietary Names (INN) for PharmaceuticalSubstances.Published quarterly in issues of approximately 50–60 pages each2003: Vol. 17ISSN 1010-9609Languages: available in English only2003 subscription rate:Sw.fr. 75.–/US $60.00 (includes handling charges and postage via surface mail)


PERIODICALS AND SUBSCRIPTIONS WEB ADDRESSES

38

Essential Drugs in BriefThe purpose of Essential drugs inbrief is to share information on thelatest country support provided orcoordinated by the extended DrugAction Programme team (country,regional and HQ offices). It is aninformal instrument aiming to share our experiences with colleagues within and outsideWHO, who are active in the imple-mentation of national drug policiesat national and regional levels.2003, 3 issues per yearContact: [email protected]

Additional information and updatesare available at the following WHO web sites:

Medicines web site:http://www.who.int/medicinesThe public web site of the WHO/EDMEssential Drugs and Medicines PolicyDepartment

The Pharmaceutical Information andDocumentation Centre web site:http://www.who.int/medicines/information/infdoccentre.shtmlEmail: [email protected]

Mednet web site:http://mednet.who.intThe Essential Drugs and Medicinesextranet for focussed pharmaceuticalinformation exchange

The Essential Drug Monitor web site:http://www.who.int/medicines/information/infmonitor.shtml

WHO Drug Information web site:http://www.who.int/druginformation

WHO PharmaceuticalsNewsletterThe aim of this Newsletter is to dis-seminate information on the safetyand efficacy of pharmaceuticalproducts, based on informationreceived from our network of"drug information officers" andother sources such as specializedbulletins and journals, as well aspartners in WHO. Also containsinformation on adverse drug reactions.2003, 4 volumes each yearContact: [email protected]

Essential Drugs MonitorThe Essential Drugs Monitor is pro-duced and distributed by the WHODepartment of Essential Drugs andMedicines Policy. It is published inChinese, English, French, Spanishand Russian, and has a global read-ership of some 300,000 to whom it is free of charge. The Monitor carries news of developments innational drug policies, therapeuticguidelines, current pharmaceuticalissues, educational strategies andoperational research.2003, 2 issues per yearContact: The Editor, Essential DrugsMonitor, WHO, 1211 Geneva 27,SwitzerlandEmail: [email protected]



TITLE INDEX

39

Adverse drug reaction terms: definition, 29Antimicrobial resistance in the Americas, 24Assessing new vaccines for national immunization

programmes, 28Basic tests for drugs, 9Basic tests for pharmaceutical dosage forms, 9Basic tests for pharmaceutical substances, 9Benefit-risk balance for marketed drugs: evaluating

safety signals, 29Biomedical research ethics: updating international

guidelines, 28Cost-containment mechanisms for essential medicines,

including antiretrovirals, in China, 6Counterfeit drugs, 16Drugs for the elderly, 24Eastern Mediterranean series

No. 4: Guide to chemotherapy and chemoprophylaxis in bacterial infections, 23

Effective drug regulation, 25Essential drugs in brief, 38European series

No. 71: Drugs for the elderly, 24Globalization and access to drugs, 6Guide to chemotherapy and chemoprophylaxis

in bacterial infections, 23Guide to drug financing mechanisms, 6Guide to good prescribing, 21Guidelines for ATC classification and DDD assignment, 14Guidelines for drug donations, 7Guidelines for preparing core clinical-safety

information on drugs, 28Guidelines for safe disposal of unwanted

pharmaceuticals in and after emergencies, 7Guidelines for the appropriate use of herbal medicines, 31Guidelines for the regulatory assessment

of medicinal products for use in self-medication, 25Guidelines for the WHO review of dependence-producing

psychoactive substances for international control, 36Guidelines on the use of international nonproprietary

names (INNs) for pharmaceutical substances, 13Handbook on access to HIV/AIDS-related treatment, 3Health reform and drug financing, 6How to develop and implement a national drug policy, 5Implications of the DOHA declaration on the TRIPS

agreement and public health, 6Importance of pharmacovigilance, 16Indicators for monitoring national drug policies, 5International nonproprietary names (INN)

for pharmaceutical substances CD-ROM, 8International nonproprietary names (INN) for pharmaceutical

substances: names of radicals and groups, 16International pharmacopoeia, 17-20International travel and health 2003, 25Legal status of traditional medicine

and complementary/alternative medicine, 35Marketing authorization of pharmaceutical products with

special reference to multisource (Generic) products, 26

Medicinal plants in China, 32Medicinal plants in the Republic of Korea, 32Medicinal plants in the South Pacific, 33Medicinal plants in Viet Nam, 32Narcotic and psychotropic drugs, 36Network for monitoring the impact of globalization

and TRIPS on access to medicines, 6New emergency health kit 1998, 4Operational principles for good pharmaceutical

procurement, 7Pharmaceutical restrictions in use and availability, 16Practical guidelines on pharmaceutical procurement

for countries with small procurement agencies, 7Publications from the South Centre, 27Public-private roles in the pharmaceutical sector, 6Quality assurance of pharmaceuticals, 10Quality control methods for medicinal plant materials, 10Regulatory situation of herbal medicines, 35Research guidelines for evaluating the safety

and efficacy of herbal medicines, 31SEARO Regional Health Papers

No.16: Essential drugs for primary health care, 4Safety monitoring of medicinal products, 16Safety of medicines, 16Selection and use of essential medicines, 3South-East Asia series

No. 39: Traditional medicine in Asia, 35Teacher’s guide to good prescribing, 21Technical report series

No. 889: WHO expert committee on biological standardization (48th report), 12No. 902: WHO expert committee on specifications for pharmaceutical preparations (36th report), 11No. 904: WHO expert committee on biological standardization (50th report), 12No. 908: WHO expert committee on specifications for pharmaceutical preparations (37th report), 11No. 910: WHO expert committee on biological standardization (51st report), 12No. 914: Selection and use of essential medicines, 3No. 915: WHO expert committee on drug dependence (33rd report), 36

Traditional medicine in Asia, 35Use of common stems in the selection

of international nonproprietary names (INN) for phamaceutical substances, 16

Vitamin A supplements, 24Western Pacific series

No. 3: Medicinal plants in China, 32No. 2: Medicinal plants in Viet Nam, 32No. 19: Medicinal plants in the South Pacific, 33No. 21: Medicinal plants in the Republic of Korea, 32No. 23: Guidelines for the appropriate use of herbal medicines, 31

WHO basic training modules on GMP CD-ROM, 15WHO Collaborating centre for international

drug monitoring, 30

Cont. page 40


TITLE INDEX

40

WHO drug information, 37WHO expert committee on biological standardization, 12WHO expert committee on drug dependence, 36WHO expert committee on specifications

for pharmaceutical preparations, 11WHO medicines bookshelf CD-ROM, 3WHO medicines strategy, 5WHO model formulary 2002, 2WHO model prescribing information: drugs used

in bacterial infections, 23WHO model prescribing information: drugs used

in parasitic diseases, 22WHO model prescribing information: drugs used

in sexually transmitted diseases and HIV infection, 22WHO model prescribing information: drugs

used in skin diseases, 23WHO monographs on selected medicinal plants, 33-34WHO pharmaceuticals and biologicals

subscription package, 37WHO pharmaceuticals newsletter, 38WHO policy perspectives on medicines, 5WHO traditional medicine strategy, 36


41

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