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oms-catalogue 15/07/03 11:32 Page 1<br />

Catal ogue<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

<strong>on</strong> <strong>Pharmaceuticals</strong><br />

2003<br />

World Health Organizati<strong>on</strong>


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

INFORMATION<br />

WORLD HEALTH ORGANIZATION – MARKETING AND DISSEMINATION<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <str<strong>on</strong>g>Products</str<strong>on</strong>g> <strong>on</strong> <strong>Pharmaceuticals</strong> 2003<br />

This informati<strong>on</strong> products catalogue <strong>on</strong> pharmaceuticals provides bibliographic and descriptive<br />

informati<strong>on</strong> <strong>on</strong> over 93 recent WHO publicati<strong>on</strong>s and CD-ROMs relevant to the selecti<strong>on</strong>, use,<br />

quality c<strong>on</strong>trol and quality assurance, safety assessment, regulati<strong>on</strong>, and correct prescribing<br />

of medicines. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> products are an outgrowth of WHO efforts to unite governments,<br />

prescribers, dispensers, c<strong>on</strong>sumers, and the pharmaceutical industry in a search for ways to<br />

assure that safe, effective, and affordable medicines are universally available – and widely used.<br />

Most of this informati<strong>on</strong> stems from l<strong>on</strong>g-standing WHO programmes resp<strong>on</strong>sible for the<br />

internati<strong>on</strong>al standardizati<strong>on</strong> of biological substances, the assignment of generic names, the<br />

development of standards in quality assurance and of quality specificati<strong>on</strong>s, the designati<strong>on</strong><br />

of essential medicines, and the assessment of the abuse potential of psychotropic drugs.<br />

Other informati<strong>on</strong> products provide current scientific informati<strong>on</strong> in the form of fact sheets,<br />

newsletters, teaching and training documents. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> products free of charge are listed<br />

in each secti<strong>on</strong> and relevant URL addresses are given for informati<strong>on</strong> available in electr<strong>on</strong>ic form.<br />

Whatever their individual topic or focus, all informati<strong>on</strong> products participate in the larger<br />

WHO objective of realizing the advantages promised by modern medicines in ways that make<br />

a difference in human health <strong>on</strong> the largest possible scale.<br />

How to order<br />

An order form is c<strong>on</strong>tained in this catalogue <strong>on</strong> page 43. You can also order <strong>on</strong>line at the<br />

following address : http://bookorders.who.int<br />

WHO informati<strong>on</strong> products can be ordered from sales agents (see list at the end of the<br />

catalogue) or directly from WHO. Orders addressed to WHO must be accompanied by payment<br />

in Swiss francs, EURO or US dollars. Payment by credit card is accepted (see order form).<br />

Bank address: UBS SA, Agence de l’OMS, CH-1211 Geneva 27, Switzerland<br />

– Swift <strong>Co</strong>de UBSW CH ZH 12 A<br />

– Swiss franc account no. 279-D3-100-897.0<br />

– US dollar account no. 240-CO-169-920.3<br />

– Euro account no. 240-CO-169-920.1<br />

Email address for direct orders: bookorders@who.int<br />

An alphabetical index of titles is provided at the end.<br />

In developing countries<br />

Developing countries benefit from at least a 30% discount <strong>on</strong> the regular price indicated<br />

in this catalogue for the books published by WHO.<br />

Language editi<strong>on</strong>s<br />

The following abbreviati<strong>on</strong>s are used in bibliographic entries to indicate the availability of<br />

language editi<strong>on</strong>s: Ar = Arabic; C = Chinese; E = English; F = French; G = German; R = Russian;<br />

S = Spanish; E/F = Bilingual editi<strong>on</strong> English/French. An asterisk (*) indicates a language editi<strong>on</strong><br />

in preparati<strong>on</strong>.<br />

Catalogue <strong>on</strong>line<br />

This catalogue can also be c<strong>on</strong>sulted <strong>on</strong> our website at the following address:<br />

http://bookorders.who.int/catalogues. For additi<strong>on</strong>al informati<strong>on</strong> <strong>on</strong> our informati<strong>on</strong><br />

products, please visit our website: http://bookorders.who.int<br />

Tel.: +41 22 791 24 76 Fax: +41 22 791 48 57<br />

Email: publicati<strong>on</strong>s@who.int<br />

Order <strong>on</strong>line: http://bookorders.who.int<br />

WHO Website: www.who.int<br />

World Health Organizati<strong>on</strong><br />

Marketing and Disseminati<strong>on</strong><br />

CH-1211 Geneva 27<br />

Switzerland<br />

MDI.PHA.203


oms-catalogue 15/07/03 11:32 Page 1<br />

CONTENTS<br />

Selecti<strong>on</strong> and Use<br />

Drug Policy<br />

Ec<strong>on</strong>omics and Financing<br />

Supply and Procurement<br />

Quality Assurance and Safety<br />

The Internati<strong>on</strong>al Pharmacopoeia<br />

Drug Prescribing<br />

Legislati<strong>on</strong> and Regulati<strong>on</strong><br />

Publicati<strong>on</strong>s from the South Centre<br />

Ethics and Safety Guidelines<br />

WHO <strong>Co</strong>llaborating Centre<br />

for Internati<strong>on</strong>al Drug M<strong>on</strong>itoring<br />

Medicinal Plants<br />

Traditi<strong>on</strong>al Medicine<br />

Psychotropic Drugs<br />

Periodicals and Subscripti<strong>on</strong>s<br />

Useful Web addresses<br />

Title index<br />

Addresses<br />

Order form<br />

Sales agents<br />

2<br />

5<br />

6<br />

7<br />

8<br />

17<br />

21<br />

25<br />

27<br />

28<br />

30<br />

31<br />

35<br />

36<br />

37<br />

38<br />

39<br />

41<br />

43<br />

45<br />

1


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

SELECTION AND USE<br />

WHO Model Formulary 2002<br />

Available now<br />

<strong>on</strong> CD-ROM<br />

The WHO Model Formulary presents formulary informati<strong>on</strong> <strong>on</strong> over<br />

300 medicines included <strong>on</strong> the WHO Model List of Essential Drugs,<br />

as a reference for nati<strong>on</strong>al and instituti<strong>on</strong>al drugs and therapeutic<br />

committees. It is also a valuable source of independent and unbiased<br />

informati<strong>on</strong> for students and prescribers who are interested<br />

in focusing their prescribing <strong>on</strong> those medicines which are globally<br />

recognized as essential.<br />

This pocket-sized book c<strong>on</strong>tains 27 secti<strong>on</strong>s covering anaesthetics,<br />

analgesics, antiallergics, antidotes, antic<strong>on</strong>vulsants, anti-infective<br />

drugs, antimigraine drugs, antineoplastic and immunosuppressives<br />

drugs and drugs used in palliative care, antiparkins<strong>on</strong> drugs, drugs<br />

affecting the blood, blood products and plasma substitutes, cardiovascular<br />

drugs, dermatological drugs, diagnostics, disinfectants<br />

and antiseptics, diuretics, gastrointestinal drugs, horm<strong>on</strong>es and<br />

c<strong>on</strong>traceptives, immunologicals, muscle relaxants and cholinesterase<br />

inhibitors, ophthalmological preparati<strong>on</strong>s, drugs used in obstetrics,<br />

perit<strong>on</strong>eal dialysis soluti<strong>on</strong>, psychotherapeutic drugs, drugs acting <strong>on</strong><br />

the respiratory tract, soluti<strong>on</strong>s correcting water, electrolyte and<br />

acid-base disturbances, vitamins and minerals. The four successive<br />

annexes include informati<strong>on</strong> <strong>on</strong> drug interacti<strong>on</strong>s, pregnancy,<br />

breast-feeding, renal and liver impairments.<br />

Table of C<strong>on</strong>tents<br />

2<br />

Secti<strong>on</strong> 1: Drugs used in Anaesthesia<br />

Secti<strong>on</strong> 2: Analgesics, antipyretics,<br />

n<strong>on</strong>steroidal anti-inflammatory<br />

drugs, drugs used to treat gout<br />

and disease-modifying<br />

antirheumatic drugs<br />

Secti<strong>on</strong> 3: Antiallergics and drugs used in<br />

anaphylaxis<br />

Secti<strong>on</strong> 4: Antidotes and other substances<br />

used in pois<strong>on</strong>ings<br />

Secti<strong>on</strong> 5: Antic<strong>on</strong>vulsants/antiepileptics<br />

Secti<strong>on</strong> 6: Anti-infective drugs<br />

Secti<strong>on</strong> 7: Antimigraine drugs<br />

Secti<strong>on</strong> 8: Antineoplastic and<br />

immunosuppressive drugs<br />

and drugs used in palliative care<br />

Secti<strong>on</strong> 9: Antiparkins<strong>on</strong> drugs<br />

Secti<strong>on</strong> 10: Drugs affecting the blood<br />

Secti<strong>on</strong> 11: Blood products and plasma<br />

substitutes<br />

Secti<strong>on</strong> 12: Cardiovascular drugs<br />

Secti<strong>on</strong> 13: Dermatological Drugs (topical)<br />

Secti<strong>on</strong> 14: Diagnostics<br />

Secti<strong>on</strong> 15: Disinfectants and Antiseptics<br />

Secti<strong>on</strong> 16: Diuretics<br />

Secti<strong>on</strong> 17: Gastrointestinal drugs<br />

Secti<strong>on</strong> 18: Horm<strong>on</strong>es and other endocrine<br />

drugs and c<strong>on</strong>traceptives<br />

Secti<strong>on</strong> 19: Immunologicals<br />

Secti<strong>on</strong> 20: Muscle relaxants (peripherally<br />

acting) and cholinesterase inhibitors<br />

Secti<strong>on</strong> 21: Ophthalmological preparati<strong>on</strong>s<br />

Secti<strong>on</strong> 22: Drugs used in Obstetrics<br />

Secti<strong>on</strong> 23: Perit<strong>on</strong>eal dialysis soluti<strong>on</strong><br />

Secti<strong>on</strong> 24: Psychotherapeutic drugs<br />

Secti<strong>on</strong> 25: Drugs acting <strong>on</strong> the Respiratory<br />

tract<br />

Secti<strong>on</strong> 26: Soluti<strong>on</strong>s correcting water,<br />

electrolyte and acid-base<br />

disturbances<br />

Secti<strong>on</strong> 27: Vitamins and minerals<br />

Appendix I: Interacti<strong>on</strong>s<br />

Appendix II: Pregnancy<br />

Appendix III: Breast Feeding<br />

Appendix IV: Renal Impairment<br />

Appendix V: Liver impairment<br />

2002 , 500 pages [E]<br />

ISBN 92 4 154559 3<br />

Sw.fr. 40.–/US $36.00<br />

In developing countries: Sw.fr. 20.–<br />

Order no.1150499<br />

CD-ROM, 2003 [E]<br />

ISBN 92 4 154600 X<br />

Sw.fr. 40.–/US $36.00<br />

In developing countries: Sw.fr. 20.–<br />

Order no. 1990019


oms-catalogue 15/07/03 11:32 Page 3<br />

WHO Medicines Bookshelf<br />

CD-ROM<br />

The Selecti<strong>on</strong> and Use<br />

of Essential Medicines<br />

Report of the WHO Expert<br />

<strong>Co</strong>mmittee (including the 12th<br />

Model List of Essential<br />

Medicines)<br />

Handbook <strong>on</strong> Access<br />

to HIV/AIDS-Related<br />

Treatment: A <strong>Co</strong>llecti<strong>on</strong><br />

of <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>, Tools and<br />

Resources for NGOs, CBOs<br />

and PLHA Groups<br />

The WHO Medicines Bookshelf<br />

CD-ROM c<strong>on</strong>tains a selecti<strong>on</strong> of<br />

over 250 publicati<strong>on</strong>s (more than<br />

16 000 pages) in English, French<br />

and Spanish dealing with essential<br />

medicines. The publicati<strong>on</strong>s included<br />

cover the whole field of interest<br />

of WHO's Department of Essential<br />

Drugs and Medicines Policy (EDM),<br />

including access to essential medicines,<br />

rati<strong>on</strong>al use of drugs, nati<strong>on</strong>al<br />

drug policy, quality and safety of<br />

medicines and traditi<strong>on</strong>al medicine.<br />

The CD-ROM also c<strong>on</strong>tains a mirror<br />

of the EDM web site (totalling 315<br />

MB) that can be accessed by clicking<br />

the 'EDM mirror' butt<strong>on</strong> from<br />

the entry screen. This provides the<br />

opportunity for users in developing<br />

countries, who lack a fast Internet<br />

c<strong>on</strong>necti<strong>on</strong>, to browse the site at<br />

their own leisure.<br />

This report presents the recommendati<strong>on</strong>s<br />

of the WHO Expert<br />

<strong>Co</strong>mmittee resp<strong>on</strong>sible for<br />

updating the WHO Model List of<br />

Essential Medicines. The first part<br />

c<strong>on</strong>tains an update <strong>on</strong> the revised<br />

procedures for updating the Model<br />

List and the development of the<br />

WHO Essential Medicines Library.<br />

It c<strong>on</strong>tinues to present a summary<br />

of the <strong>Co</strong>mmittee’s c<strong>on</strong>siderati<strong>on</strong>s<br />

and justificati<strong>on</strong>s for additi<strong>on</strong>s and<br />

changes to the 12th Model List,<br />

including its recommendati<strong>on</strong> to<br />

add ten antiretroviral medicines.<br />

The annexes include the 12th WHO<br />

Model List of Essential Medicines<br />

in its usual presentati<strong>on</strong> and, for<br />

the first time, in the five-level<br />

Anatomical Therapeutic Chemical<br />

(ATC) classificati<strong>on</strong> system.<br />

This handbook is intended to assist<br />

n<strong>on</strong>governmental organizati<strong>on</strong>s,<br />

community-based organizati<strong>on</strong>s<br />

and groups of people living with<br />

HIV/AIDS in finding ways of understanding,<br />

planning and undertaking<br />

work <strong>on</strong> HIV/AIDS-related treatment.<br />

It builds <strong>on</strong> practical skills by using<br />

participatory activities and sharing<br />

experiences; provides a training<br />

resource for NGO support prgrammes,<br />

training organizati<strong>on</strong>s and individuals;<br />

and facilitates <strong>on</strong>going learning about<br />

the treatment work being carried out<br />

by the various groups involved.<br />

Applicable at all levels of experience,<br />

the handbook offers flexibility to<br />

facilitators who need to gear their<br />

work towards specific schedules<br />

or situati<strong>on</strong>s.<br />

3<br />

2002 , CD-ROM [E]<br />

ISBN 92 4 159025 4<br />

Swiss francs 20.–/US $18.00<br />

In developing countries: Sw.fr. 14.–<br />

Order no.0990018<br />

Technical Report Series, No. 914<br />

2002 , vi + 122 pages [E]<br />

ISBN 92 4 120914 3<br />

Swiss francs 23.–/US $20.70<br />

In developing countries: Sw.fr. 16.10<br />

Order no.1110914<br />

Joint United Nati<strong>on</strong>s Programme<br />

<strong>on</strong> HIV/AIDS<br />

2003, 130 pages [E]<br />

ISBN 92 9173 161 7<br />

Swiss francs 15.–/US $13.50<br />

In developing countries: Sw.fr. 7.50<br />

Order no. 1880013


oms-catalogue 15/07/03 11:32 Page 4<br />

SELECTION AND USE<br />

Essential Drugs for Primary<br />

Health Care<br />

A Manual for Health Workers<br />

Third editi<strong>on</strong><br />

The New Emergency Health<br />

Kit 1998<br />

Lists of Drugs and Medical<br />

Supplies for 10,000 People for<br />

Approximately Three M<strong>on</strong>ths<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

4<br />

An illustrated manual designed to help community<br />

health workers learn how to use simple drugs to treat<br />

comm<strong>on</strong> illnesses. Specific to health c<strong>on</strong>diti<strong>on</strong>s in<br />

South-East Asian countries, the book uses simple<br />

explanatory texts and illustrati<strong>on</strong>s to communicate<br />

instructi<strong>on</strong>s for treating illnesses and knowing when<br />

a patient must be referred to a doctor.<br />

Explains how to use standardized packages of<br />

essential drugs, supplies, and equipment to provide<br />

effective medical care under the primitive, demanding<br />

c<strong>on</strong>diti<strong>on</strong>s that follow emergencies or disasters. Both<br />

the c<strong>on</strong>cept and the c<strong>on</strong>tents of the kit, which was<br />

developed by WHO in collaborati<strong>on</strong> with a large<br />

number of internati<strong>on</strong>al and n<strong>on</strong>-governmental<br />

agencies, are designed to expedite the provisi<strong>on</strong> of<br />

supplies in line with priority health needs. Although<br />

primarily addressed to relief agencies, the book also<br />

provides useful informati<strong>on</strong> for nati<strong>on</strong>al authorities<br />

and hospital managers interested in stockpiling drugs<br />

and supplies in advance.<br />

Now in its sec<strong>on</strong>d editi<strong>on</strong>, the book has been significantly<br />

revised to reflect changes in the selecti<strong>on</strong> of<br />

drugs included in the WHO Model List of Essential<br />

Drugs and to bring recommendati<strong>on</strong>s in line with<br />

a new United Nati<strong>on</strong>s list of priority drugs for use<br />

in acute emergencies. New in this editi<strong>on</strong> are WHO<br />

guidelines for drug d<strong>on</strong>ati<strong>on</strong>s and model guidelines<br />

for the internati<strong>on</strong>al provisi<strong>on</strong> of c<strong>on</strong>trolled medicines<br />

for emergency care.<br />

WHO Regi<strong>on</strong>al Office for South-East Asia<br />

SEARO Regi<strong>on</strong>al Health Papers, No. 16<br />

2000, v + 128 pages [E]<br />

ISBN 92 9022 185 2<br />

Swiss francs 10.–/US $9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1583016<br />

1998, vi + 73 pages [E, F]<br />

WHO/DAP/98.10<br />

Swiss francs 8.–/US $7.20<br />

In developing countries: Sw.fr. 5.60<br />

Order no. 1931018


oms-catalogue 15/07/03 11:32 Page 5<br />

DRUG POLICY<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability<br />

of these documents,<br />

please refer to:<br />

www.who.int/medicines<br />

How to Develop and<br />

Implement a Nati<strong>on</strong>al<br />

Drug Policy<br />

Sec<strong>on</strong>d Editi<strong>on</strong><br />

Indicators for M<strong>on</strong>itoring<br />

Nati<strong>on</strong>al Drug Policies<br />

A Practical Manual<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

WHO Medicines Strategy<br />

Framework for Acti<strong>on</strong> in<br />

Essential Drugs and Medicines<br />

Policy 2000–2003<br />

This strategy evolved from the<br />

revised drug strategy originally<br />

adopted by the World Health<br />

Assembly as l<strong>on</strong>g ago as 1986.<br />

It incorporates four main objectives:<br />

to frame and implement nati<strong>on</strong>al<br />

drug policy, to ensure access to<br />

essential drugs, to ensure quality,<br />

safety and efficacy of all medicines,<br />

and to promote rati<strong>on</strong>al drug use.<br />

2000, viii + 70 pages [E, F]<br />

WHO/EDM/2000.1<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/<br />

strategy/stmissi<strong>on</strong>.shtml#st<br />

In this new editi<strong>on</strong> guidelines are<br />

given <strong>on</strong> developing a nati<strong>on</strong>al<br />

drug policy - a crucial ingredient<br />

in every country's nati<strong>on</strong>al health<br />

strategy and an invaluable framework<br />

to identify nati<strong>on</strong>al goals and<br />

commitments. This expanded and<br />

extensively revised sec<strong>on</strong>d editi<strong>on</strong><br />

discusses key policy comp<strong>on</strong>ents.<br />

These include the selecti<strong>on</strong> of<br />

essential drugs, affordability,<br />

finance and supply, regulati<strong>on</strong><br />

and quality assurance, rati<strong>on</strong>al use,<br />

research, human resources, m<strong>on</strong>itoring<br />

and evaluati<strong>on</strong>.<br />

Each chapter presents useful<br />

advice and references to other<br />

sources of more detailed technical<br />

informati<strong>on</strong>. A valuable resource<br />

for health professi<strong>on</strong>als, policymakers<br />

and researchers, the publicati<strong>on</strong><br />

takes readers through the<br />

process of planning, developing,<br />

implementing and m<strong>on</strong>itoring a<br />

comprehensive policy framework<br />

based <strong>on</strong> a country's unique needs,<br />

priorities and resources.<br />

Presents and explains a simple yet<br />

powerful new methodology for<br />

gathering the data needed to<br />

improve nati<strong>on</strong>al drug policies.<br />

Both the public and private sectors<br />

are addressed. The methodology,<br />

which was finalized after extensive<br />

expert c<strong>on</strong>sultati<strong>on</strong>s and testing in<br />

different settings, provides a logical<br />

and systematic tool for identifying<br />

problems in meeting the main<br />

objective of a nati<strong>on</strong>al drug policy:<br />

to assure that effective and<br />

affordable essential drugs are<br />

widely available, of good quality,<br />

and wisely used.<br />

WHO Policy Perspectives<br />

<strong>on</strong> Medicines<br />

No 1. WHO Medicines Strategy<br />

2000-2003<br />

No 2. Traditi<strong>on</strong>al Medicine:<br />

Growing Needs and<br />

Potential<br />

No 3. Globalizati<strong>on</strong>, TRIPS and<br />

access to pharmaceuticals<br />

No 4. The Selecti<strong>on</strong> of Essential<br />

Medicines<br />

No 5. Promoting rati<strong>on</strong>al use<br />

of medicines: core<br />

comp<strong>on</strong>ents<br />

No 6. How to develop and<br />

implement a nati<strong>on</strong>al<br />

drug policy<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/<br />

organizati<strong>on</strong>/ood/ood6pagers.shtml<br />

5<br />

2002, 91 pages [E, F, S]<br />

ISBN 92 4 154547 X<br />

Swiss francs 26.-/US $23.40<br />

In developing countries: Sw.fr. 18.20<br />

Order no. 1152287<br />

by P. Brud<strong>on</strong>-Jakobowicz,<br />

J.-D.Rainhorn and M.R. Reich<br />

2000, x + 216 pages [E, F, S*]<br />

WHO/EDM/PAR/99.3<br />

Swiss francs 25.–/US $22.50<br />

In developing countries: Sw.fr. 17.50<br />

Order no. 1932066


oms-catalogue 15/07/03 11:32 Page 6<br />

ECONOMICS AND FINANCING<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability of these documents,<br />

please refer to: www.who.int/medicines<br />

6<br />

Guide to Drug Financing<br />

Mechanisms<br />

A practical guide to the use<br />

of ec<strong>on</strong>omic criteria to analyse a<br />

country’s pharmaceutical sector and<br />

identify ways to improve the drug<br />

supply. Addressed to decisi<strong>on</strong>makers<br />

resp<strong>on</strong>sible for formulating<br />

drug policies, the book aims to<br />

facilitate the analysis of expenditure<br />

<strong>on</strong> drugs within the c<strong>on</strong>text of<br />

a government’s overall ec<strong>on</strong>omic<br />

policies and priorities. With this<br />

goal in mind, the book explains the<br />

many complex ec<strong>on</strong>omic factors<br />

that influence the drug supply and<br />

identifies the corresp<strong>on</strong>ding policy<br />

opti<strong>on</strong>s available for introducing<br />

changes in different situati<strong>on</strong>s.<br />

by J. Dumoulin, M. Kaddar, and<br />

G.Velásquez<br />

1998, vii + 55 pages [E, F]<br />

ISBN 92 9036 068 2<br />

Swiss francs 19.–/US $17.10<br />

In developing countries: Sw.fr. 13.30<br />

Order no. 1150461<br />

<strong>Co</strong>st-c<strong>on</strong>tainment Mechanisms<br />

for Essential Medicines,<br />

including Antiretrovirals,<br />

in China<br />

Health Ec<strong>on</strong>omics and Drugs EDM Series,<br />

No. 13<br />

2002,27 pages [E]<br />

WHO/EDM/PAR/2003.6<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/par/who-edm-par-2003-<br />

6/<strong>Co</strong>stC<strong>on</strong>tainmentEnglish.pdf<br />

Implicati<strong>on</strong>s of the DOHA<br />

Declarati<strong>on</strong> <strong>on</strong> the TRIPS<br />

Agreement and Public Health<br />

This document c<strong>on</strong>siders the<br />

implicati<strong>on</strong>s of the Doha Declarati<strong>on</strong>,<br />

and includes discussi<strong>on</strong>s <strong>on</strong> compulsory<br />

licensing and transfer of technology<br />

to countries with little or no manufacturing<br />

capacity or insufficient market<br />

demand.<br />

Health Ec<strong>on</strong>omics and Drugs Series, No. 12<br />

2002, 68 pages [E, F, S*]<br />

WHO/EDM/PAR/2002.3<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/par/who-edm-par-2002-<br />

3/doha-implicati<strong>on</strong>s.doc<br />

Network for M<strong>on</strong>itoring the<br />

Impact of Globalizati<strong>on</strong> and<br />

TRIPS <strong>on</strong> Access to Medicines<br />

The last decade has witnessed a sharp<br />

accelerati<strong>on</strong> in the processes of<br />

ec<strong>on</strong>omic globalizati<strong>on</strong> and a major<br />

increase in the number, and expansi<strong>on</strong><br />

of the scope, of internati<strong>on</strong>al trade<br />

agreements. This is a report of a<br />

meeting held in 2001 at which WHO<br />

initiated a process to m<strong>on</strong>itor and<br />

analyze the impact of trade agreements<br />

<strong>on</strong> access to drugs in partnership<br />

with four WHO collaborating<br />

centres in Brazil, Spain, Thailand<br />

and the United Kingdom.<br />

Health Ec<strong>on</strong>omics and Drugs Series, No. 11<br />

2002, 67 pages [E]<br />

WHO/EDM/PAR/2002.1<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/par/who-edm-par-2002<br />

1/networktrips.pdf<br />

Public-Private Roles<br />

in the Pharmaceutical Sector<br />

Implicati<strong>on</strong>s for Equitable Access<br />

and Rati<strong>on</strong>al Drug Use<br />

Aimed at policy makers at country,<br />

regi<strong>on</strong>al and internati<strong>on</strong>al levels, this<br />

document provides a practical guide<br />

to how changing public-private roles in<br />

the pharmaceutical sector may affect<br />

drug accessibility and rati<strong>on</strong>al use.<br />

Health Ec<strong>on</strong>omics and Drugs Series, No. 5<br />

1997, 102 pages [E, F, S]<br />

WHO/DAP/97.12<br />

Electr<strong>on</strong>ic access: http://www.who.int/me<br />

icines/library/dap/who-dap-97-12/who-dap<br />

97-12.htm<br />

Globalizati<strong>on</strong> and Access<br />

to Drugs<br />

Perspectives <strong>on</strong> the WTO/TRIPS<br />

Agreement.<br />

The impact of globalizati<strong>on</strong> <strong>on</strong> access<br />

to drugs is of increasing interest, and<br />

this document informs people in the<br />

health sector with no legal background<br />

about this complex issue.<br />

Health Ec<strong>on</strong>omics and Drugs Series, No. 7<br />

1998, 98 pages [E, F, S, C, Ar]<br />

WHO/DAP/98.9 Revised<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/dap/who-dap-98-9-<br />

rev/who-dap-98-9.htm<br />

Health Reform and Drug<br />

Financing<br />

Selected Topics<br />

This document discusses reform primarily<br />

from the perspective of certain<br />

financial aspects of health-public<br />

financing, health insurance, user<br />

charges, d<strong>on</strong>or financing and drug<br />

d<strong>on</strong>ati<strong>on</strong>s, and development loans.<br />

Health Ec<strong>on</strong>omics and Drugs Series, No. 6<br />

1998, 44 pages [E, F, S]<br />

WHO/DAP/98.3<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/dap/who-dap-98-3/<br />

who-dap-98-3.htm


oms-catalogue 15/07/03 11:32 Page 7<br />

SUPPLY AND PROCUREMENT<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability<br />

of these documents,<br />

please refer to:<br />

www.who.int/medicines<br />

Practical Guidelines<br />

<strong>on</strong> Pharmaceutical<br />

Procurement for <strong>Co</strong>untries<br />

with Small Procurement<br />

Agencies<br />

This publicati<strong>on</strong> is aimed at<br />

countries with small procurement<br />

agencies and provides practical and<br />

simple guidelines for the purchase<br />

of pharmaceutical products. Various<br />

types of tender mechanisms are<br />

described, as is direct procurement.<br />

Emphasis is given to the importance<br />

of pre-qualifying suppliers to ensure<br />

purchase of good quality products.<br />

This book does not cover all aspects<br />

of the drug management cycle, but<br />

it does describe the core principles<br />

of procurement and various<br />

methods of tendering for drug<br />

procurement. It discusses the<br />

advantages and disadvantages of<br />

these methods as well as the tender<br />

process itself. Model questi<strong>on</strong>naires<br />

for prequalificati<strong>on</strong> of suppliers,<br />

model tender invitati<strong>on</strong>s and an<br />

inspecti<strong>on</strong> checklist for drug receipts<br />

that can be modified and extended<br />

to meet local requirements are<br />

enclosed.<br />

Guidelines for Safe<br />

Disposal of Unwanted<br />

<strong>Pharmaceuticals</strong> in and<br />

after Emergencies<br />

Interagency Guidelines<br />

How can unwanted and unusable<br />

pharmaceuticals be disposed of<br />

safely? These guidelines – which<br />

are the result of collaborati<strong>on</strong><br />

between 13 internati<strong>on</strong>al and n<strong>on</strong>governmental<br />

agencies – provide<br />

advice <strong>on</strong> the safe disposal of<br />

unusable pharmaceuticals in<br />

emergencies and in countries<br />

where official assistance and advice<br />

may not be available.<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/<br />

medicines/library/par/who-edmpar-99-2/who-edm-par-99-2.htm<br />

Operati<strong>on</strong>al Principles for<br />

Good Pharmaceutical<br />

Procurement<br />

Interagency guidelines<br />

Pharmaceutical procurement is a<br />

complex process and problems are<br />

comm<strong>on</strong>. This document from the<br />

Interagency Pharmaceutical<br />

Procurement Group sets out four<br />

strategic objectives and 12 operati<strong>on</strong>al<br />

principles for good procurement,<br />

which can be adapted by<br />

users.<br />

2000, 24 pages [E, F, S]<br />

WHO/EDM/PAR/99.5<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/library/<br />

par/who-edm-par-99-5/who-edm-par-<br />

99-5.htm<br />

Guidelines for Drug<br />

D<strong>on</strong>ati<strong>on</strong>s<br />

Revised 1999. Sec<strong>on</strong>d Editi<strong>on</strong>.<br />

Interagency Guidelines<br />

There are many types of drug<br />

d<strong>on</strong>ati<strong>on</strong>: rapid resp<strong>on</strong>se to an<br />

emergency, the philanthropic aims<br />

of organizati<strong>on</strong>s, and those<br />

targeted for use by individual<br />

health facilities. By describing<br />

‘good d<strong>on</strong>ati<strong>on</strong> practice’, these<br />

guidelines aim to improve the<br />

quality of drug d<strong>on</strong>ati<strong>on</strong>s.<br />

1999, 19 pages [E, F, S]<br />

WHO/EDM/PAR/99.4<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/library/<br />

par/who-edm-par-99-4/who-edm-par-99-<br />

4.htm<br />

7<br />

WHO Regi<strong>on</strong>al Office<br />

for the Western Pacific<br />

2002, 56 pages [E]<br />

ISBN 92 9061 014 X<br />

Swiss francs 10.–/US$9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1520010<br />

1999, 31 pages [E, F, S]<br />

WHO/EDM/PAR/99.2<br />

Swiss francs 8.–/US $7.20<br />

In developing countries: Sw.fr. 5.60<br />

Order no. 1930154


oms-catalogue 15/07/03 11:32 Page 8<br />

QUALITY ASSURANCE AND SAFETY<br />

Internati<strong>on</strong>al<br />

N<strong>on</strong>proprietary Names (INN)<br />

for Pharmaceutical Substances<br />

List 1-45 of Proposed INNs<br />

and List 1-85 of<br />

Recommended INNs<br />

Cumulative List No.10<br />

CD-ROM<br />

Internati<strong>on</strong>al<br />

N<strong>on</strong>proprietary Names (INN)<br />

for Pharmaceutical<br />

Substances<br />

List 1-45 of Proposed INNs<br />

and List 1-85 of Recommended INNs<br />

Cumulative List No.10<br />

8<br />

The aim of the INN System has been to provide health professi<strong>on</strong>als<br />

with a unique and universally available designated name to identify<br />

each pharmaceutical substance. The existence of an internati<strong>on</strong>al<br />

nomenclature for pharmaceutical substances, in the form of INNs,<br />

is important for the clear identificati<strong>on</strong>, safe prescripti<strong>on</strong> and dispensing<br />

of medicines to patients, and for communicati<strong>on</strong> and exchange of<br />

informati<strong>on</strong> am<strong>on</strong>g health professi<strong>on</strong>als and scientists worldwide.<br />

This tenth Cumulative List CD-ROM is intended as a reference source<br />

for nati<strong>on</strong>al drug regulatory authorities, the pharmaceutical industry<br />

and health professi<strong>on</strong>als. It supersedes the ninth list published in 1996.<br />

It c<strong>on</strong>tains over 7250 INNs for individual pharmaceutical substances,<br />

including about 740 new names proposed since the previous Cumulative<br />

List was prepared. It is produced in a multilingual format: English and<br />

French introductory texts, together with a listing of INNs in Latin, English,<br />

French, Russian and Spanish.<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> Proposed and Recommended Internati<strong>on</strong>al<br />

N<strong>on</strong>proprietary Names (INNs) can also be c<strong>on</strong>sulted <strong>on</strong> the following<br />

website:<br />

http://mednet.who.int<br />

Special pricing scheme<br />

for multiple users:<br />

2-10 users: Swiss francs 350.–/US $315.00<br />

In developing countries: Swiss francs 175.–, order no. 0991010<br />

11-99 users: Swiss francs 450.–/US $405.00<br />

In developing countries: Swiss francs 225.–, order no. 0992010<br />

100 or more users: Swiss francs 600.–/US $540.00<br />

In developing countries: Swiss francs 300.–, order no. 0993010<br />

2002, CD-ROM [E/F]<br />

ISBN 92 4 056019 X<br />

Swiss francs 290.–/US $261.00 for individual user<br />

In developing countries: Sw. fr. 100.–<br />

Order no. 0990010


oms-catalogue 15/07/03 11:33 Page 9<br />

Basic Tests for Drugs<br />

Pharmaceutical Substances,<br />

Medicinal Plant Materials<br />

and Dosage Forms<br />

Basic Tests<br />

for Pharmaceutical<br />

Dosage Forms<br />

Basic Tests<br />

for Pharmaceutical<br />

Substances<br />

Describes tests for 23 pharmaceutical<br />

substances and 58 pharmaceutical<br />

dosage forms, most of which are<br />

included in the WHO Model List<br />

of Essential Drugs. Basic tests for<br />

c<strong>on</strong>firming the identity of four<br />

comm<strong>on</strong>ly used medicinal plant<br />

materials are also included.<br />

Sets out rapid screening tests<br />

required to verify the identity of<br />

some 150 pharmaceutical dosage<br />

forms in comm<strong>on</strong> use. The tests,<br />

which are simple and readily applicable,<br />

make it possible to c<strong>on</strong>firm<br />

the identity of pharmaceutical substances<br />

in tablet, capsule, soluti<strong>on</strong>,<br />

loti<strong>on</strong> and other forms in those<br />

cases where quality is in doubt.<br />

The basic tests may also be applied<br />

to determine whether gross degradati<strong>on</strong><br />

has occurred despite high<br />

standards of packaging.<br />

"... describes simple tests of powerful<br />

use in the primary detecti<strong>on</strong><br />

of degradati<strong>on</strong>, tampering,<br />

adulterati<strong>on</strong>, and counterfeiting ...<br />

admirably serves its purpose..."<br />

– Journal of the Royal Society of<br />

Health<br />

Presents simplified tests for verifying<br />

the identify of pharmaceutical<br />

substances and detecting gross<br />

degradati<strong>on</strong>. The 321 substances<br />

covered represent the majority of<br />

drug substances c<strong>on</strong>tained in the<br />

WHO Model List of Essential Drugs<br />

as well as a number of other widely<br />

used drug substances. For each,<br />

tests have been devised to serve as<br />

a simple and readily applicable<br />

method of verificati<strong>on</strong> of identity<br />

when a fully equipped laboratory<br />

is not available.<br />

"... will serve as a useful comp<strong>on</strong>ent<br />

of the WHO programme<br />

for quality assurance in the<br />

pharmaceutical supply system..."<br />

– Indian Journal of Hospital Pharmacy<br />

9<br />

1998, iii + 91 pages [E, F, S, R, C]<br />

ISBN 92 4 154513 5<br />

Swiss francs 26.–/US $23.40<br />

In developing countries: Sw.fr. 18.20<br />

Order no. 1150462<br />

1991, v + 129 pages [C, E, F, S]<br />

ISBN 92 4 154418 X<br />

Swiss francs 24.–/US $21.60<br />

In developing countries: Sw.fr. 16.80<br />

Order no. 1150359<br />

1986, 210 pages [Ar, C, E, F, S]<br />

ISBN 92 4 154204 7<br />

Swiss francs 34.–/US $30.60<br />

In developing countries: Sw.fr. 23.80<br />

Order no. 1150245


oms-catalogue 15/07/03 11:33 Page 10<br />

QUALITY ASSURANCE AND SAFETY<br />

Quality Assurance of<br />

<strong>Pharmaceuticals</strong><br />

A <strong>Co</strong>mpendium of Guidelines<br />

and Related Materials<br />

Volume 1<br />

Quality Assurance of<br />

<strong>Pharmaceuticals</strong><br />

A <strong>Co</strong>mpendium of Guidelines<br />

and Related Materials<br />

Volume 2: Good Manufacturing<br />

Practices and Inspecti<strong>on</strong><br />

Quality C<strong>on</strong>trol Methods<br />

for Medicinal Plant<br />

Materials<br />

10<br />

Draws together twenty-two WHO<br />

guidelines relevant to the quality<br />

assurance and c<strong>on</strong>trol of pharmaceutical<br />

products. Most of these<br />

guidelines have appeared as annexes<br />

in various reports of the WHO<br />

Expert <strong>Co</strong>mmittee <strong>on</strong> Specificati<strong>on</strong>s<br />

for Pharmaceutical Preparati<strong>on</strong>s.<br />

Others are published here for the<br />

first time. By making these available<br />

in a single reference work, the<br />

book facilitates access to the complete<br />

body of WHO guidelines and<br />

recommendati<strong>on</strong>s issued to assist<br />

nati<strong>on</strong>al drug regulatory and<br />

c<strong>on</strong>trol authorities, particularly in<br />

developing countries. When<br />

viewed together, the collected<br />

guidelines also underscore the<br />

need for a comprehensive system<br />

of quality assurance and illustrate<br />

its various technical and administrative<br />

comp<strong>on</strong>ents in a logical way.<br />

Draws together twelve WHO<br />

guidelines related to good manufacturing<br />

practives (GMP) and to<br />

the inspecti<strong>on</strong> of pharmaceutical<br />

manufacturers and distributi<strong>on</strong><br />

channels. Most of these guidelines<br />

have appeared as annexes in<br />

various reports of the WHO Expert<br />

<strong>Co</strong>mmitee <strong>on</strong> Specificati<strong>on</strong>s for<br />

Pharmaceutical Preparati<strong>on</strong>s. By<br />

making these available in a single<br />

reference work, the book facilitates<br />

access to the complete body of<br />

WHO guidelines and recommendati<strong>on</strong>s<br />

aimed at ensuring the<br />

pharmaceutical products are<br />

manufactured in compliance with<br />

internati<strong>on</strong>ally accepted standards<br />

for quality and safety.<br />

A collecti<strong>on</strong> of recommended test procedures<br />

for assessing the identity, purity,<br />

and c<strong>on</strong>tent of medicinal plant<br />

materials. Intended to assist nati<strong>on</strong>al<br />

laboratories engaged in drug quality<br />

c<strong>on</strong>trol, the manual resp<strong>on</strong>ds to the<br />

growing use of medicinal plants, the<br />

special quality problems they pose, and<br />

the corresp<strong>on</strong>ding need for internati<strong>on</strong>al<br />

guidance <strong>on</strong> reliable methods<br />

for quality c<strong>on</strong>trol. Recommended<br />

procedures – whether involving visual<br />

inspecti<strong>on</strong> or the use of thin-layer<br />

chromatography for the qualitative<br />

determinati<strong>on</strong> of impurities – should<br />

also prove useful to the pharmaceutical<br />

industry and pharmacists working with<br />

these materials.<br />

1997, vi + 238 pages [E, F, R]<br />

ISBN 92 4 154504 6<br />

Swiss francs 50.–/US $45.00<br />

In developing countries: Sw.fr. 35.–<br />

Order no. 1150452<br />

1999, v + 198 pages [E, F*, R]<br />

ISBN 92 4 154526 7<br />

Swiss francs 62.–/US $55.80<br />

In developing countries: Sw.fr. 43.40<br />

Order no. 1152452<br />

1998, viii + 115 pages [E]<br />

ISBN 92 4 154510 0<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no. 1150451


oms-catalogue 15/07/03 11:33 Page 11<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong> Specificati<strong>on</strong>s<br />

for Pharmaceutical Preparati<strong>on</strong>s<br />

Thirty-seventh Report<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong> Specificati<strong>on</strong>s<br />

for Pharmaceutical Preparati<strong>on</strong>s<br />

Thirty-sixth Report<br />

This report presents the recommendati<strong>on</strong>s of an<br />

internati<strong>on</strong>al group of experts c<strong>on</strong>vened by the World<br />

Health Organizati<strong>on</strong> to c<strong>on</strong>sider matters c<strong>on</strong>cerning<br />

the quality assurance of pharmaceuticals and<br />

specificati<strong>on</strong>s for drug substances and dosage forms.<br />

This committee reviews and adopts guidelines that<br />

have been prepared reflecting c<strong>on</strong>sensus obtained<br />

during a large internati<strong>on</strong>al c<strong>on</strong>sultative process.<br />

Of particular relevance to drug regulatory authorities<br />

and pharmaceutical manufacturers, the report<br />

discusses activities related to the development of<br />

The Internati<strong>on</strong>al Pharmacopoeia and basic tests for<br />

pharmaceutical substances and dosage forms,<br />

as well as quality c<strong>on</strong>trol of reference materials, good<br />

manufacturing practices (GMP), stability studies,<br />

inspecti<strong>on</strong>, hazard analysis, procurement, storage and<br />

other aspects of quality assurance of pharmaceuticals,<br />

and regulatory issues.<br />

The report is complemented by a number of annexes,<br />

including recommendati<strong>on</strong>s <strong>on</strong> the risk of transmitting<br />

animal sp<strong>on</strong>giform encephalopathy agents via<br />

medicinal products, guidelines <strong>on</strong> GMP for pharmaceutical<br />

products, a model certificate for GMP and<br />

guidance <strong>on</strong> a GMP inspecti<strong>on</strong> report. The final<br />

annexes provide guidance <strong>on</strong> the applicati<strong>on</strong> of<br />

Hazard Analysis and Critical C<strong>on</strong>trol Point (HACCP)<br />

method to pharmaceuticals, good storage practices<br />

and a procedure for assessing acceptability of<br />

pharmaceutical products for purchase by agencies<br />

of the United Nati<strong>on</strong>s.<br />

Technical Report Series, No. 908<br />

2002 , viii + 136 pages [E]<br />

ISBN 92 4 120908 9<br />

Swiss francs 25.–/US $22.50<br />

In developing countries: Sw.fr. 17.50<br />

Order no.1110908<br />

Sets out a series of twelve internati<strong>on</strong>al guidelines and<br />

other recommendati<strong>on</strong>s intended to assist nati<strong>on</strong>al<br />

drug regulatory authorities and manufacturers in<br />

the quality assurance of pharmaceutical products.<br />

The report also resp<strong>on</strong>ds to the need to extend previously<br />

issued WHO guidelines for good manufacturing<br />

practices (GMP) to cover several special circumstances<br />

as well as guidance for inspectorates.<br />

List of adopted guidelines:<br />

Quality C<strong>on</strong>trol Laboratory related:<br />

• Guideline <strong>on</strong> "Good Practices for Nati<strong>on</strong>al<br />

Pharmaceutical C<strong>on</strong>trol Laboratories"<br />

(with Model Test Report and List of equipment<br />

for pharmaceutical c<strong>on</strong>trol laboratories appended)<br />

• Model Certificate of Analysis<br />

• C<strong>on</strong>siderati<strong>on</strong>s for requesting analysis of drug<br />

samples<br />

• List of Internati<strong>on</strong>al Chemical Reference Substances<br />

• List of Internati<strong>on</strong>al Infrared Reference Spectra<br />

GMP (updates and reviews)<br />

• GMP in pharmaceutical producti<strong>on</strong><br />

(essential elements)<br />

• GMP for sterile pharmaceutical products<br />

(updated text)<br />

Inspecti<strong>on</strong> related:<br />

• Guidelines <strong>on</strong> Pre-approval inspecti<strong>on</strong><br />

• WHO quality systems requirements for nati<strong>on</strong>al<br />

GMP inspectorates<br />

• Guidance <strong>on</strong> "comparative products" for<br />

equivalence assessment of interchangeable<br />

multisource (generic) products<br />

• General Aspects of Packaging<br />

• Guidelines <strong>on</strong> the use of INN for Pharmaceutical<br />

Substances<br />

Technical Report Series, No. 902<br />

2002, 215 pages [E, F*, S]<br />

ISBN 92 4 120902 X<br />

Swiss francs 42.–/US $37.80<br />

In developing countries: Sw.fr. 29.40<br />

Order no. 1100902<br />

11


oms-catalogue 15/07/03 11:33 Page 12<br />

QUALITY ASSURANCE AND SAFETY<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong><br />

Biological Standardizati<strong>on</strong><br />

Fifty-first Report<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong><br />

Biological Standardizati<strong>on</strong><br />

Fiftieth Report<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong><br />

Biological Standardizati<strong>on</strong><br />

Forty-eighth Report<br />

12<br />

This report presents the recommendati<strong>on</strong>s<br />

of a WHO Expert <strong>Co</strong>mmittee<br />

commissi<strong>on</strong>ed to coordinate<br />

activities leading to the adopti<strong>on</strong> of<br />

internati<strong>on</strong>al requirements for the<br />

producti<strong>on</strong> and c<strong>on</strong>trol of vaccines<br />

and other biologicals and the establishment<br />

of internati<strong>on</strong>al biological<br />

reference materials. The report starts<br />

with a discussi<strong>on</strong> of general issues<br />

brought to the <strong>Co</strong>mmittee’s attenti<strong>on</strong><br />

and provides informati<strong>on</strong> <strong>on</strong> the<br />

status and development of reference<br />

materials for various antibodies,<br />

antigens, blood products and related<br />

substances, cytokines, growth factors,<br />

and endocrinological substances.<br />

The sec<strong>on</strong>d part of the report, of<br />

particular relevance to manufacturers<br />

and nati<strong>on</strong>al c<strong>on</strong>trol authorities, c<strong>on</strong>tains<br />

an addendum to recommendati<strong>on</strong>s<br />

for the producti<strong>on</strong> and c<strong>on</strong>trol<br />

of oral poliomyelitis vaccine,<br />

recommendati<strong>on</strong>s for producti<strong>on</strong><br />

and quality c<strong>on</strong>trol of inactivated<br />

poliomyelitis vaccine, and guidelines<br />

for live attenuated Japanese<br />

encephalitis vaccine.<br />

This report presents the recommendati<strong>on</strong>s<br />

of a WHO Expert <strong>Co</strong>mmittee<br />

commissi<strong>on</strong>ed to coordinate activities<br />

leading to the adopti<strong>on</strong> of internati<strong>on</strong>al<br />

requirements for the producti<strong>on</strong><br />

and c<strong>on</strong>trol of vaccines and<br />

other biologicals and the establishment<br />

of internati<strong>on</strong>al biological<br />

reference materials.<br />

The report starts with a discussi<strong>on</strong><br />

of general issues brought to the<br />

<strong>Co</strong>mmittee’s attenti<strong>on</strong> and provides<br />

informati<strong>on</strong> <strong>on</strong> the status and<br />

development of reference materials<br />

for various antibodies, antigens,<br />

blood products and related<br />

substances, cytokines, growth<br />

factors, and endocrinological<br />

substances.<br />

The sec<strong>on</strong>d part of the report, of<br />

particular relevance to manufacturers<br />

and nati<strong>on</strong>al c<strong>on</strong>trol authorities,<br />

c<strong>on</strong>tains recommendati<strong>on</strong>s<br />

for the producti<strong>on</strong> and c<strong>on</strong>trol<br />

of oral poliomyelitis vaccine, an<br />

amendment to the requirements for<br />

meningococcal polysaccharide<br />

vaccine, and a decisi<strong>on</strong>-tree for<br />

setting priorities in the development<br />

of reference materials. Also included<br />

are guidelines for the preparati<strong>on</strong>,<br />

characterizati<strong>on</strong>, and establishment<br />

of standards and reference reagents<br />

for biological substances.<br />

Presents the recommendati<strong>on</strong>s of a<br />

WHO expert committee commissi<strong>on</strong>ed<br />

to coordinate a range of<br />

research and other activities needed<br />

to assure the purity, potency,<br />

safety, and stability of biological<br />

products used in medicine. Issues<br />

include progress in the establishment<br />

of cytokine standards, efforts<br />

to harm<strong>on</strong>ize technical requirements<br />

for vaccine producti<strong>on</strong> and<br />

licensing, the implicati<strong>on</strong>s for<br />

vaccine requirements of the<br />

Agreement <strong>on</strong> Technical Barriers to<br />

Trade of WTO, and safety questi<strong>on</strong>s<br />

arising from the detecti<strong>on</strong> by very<br />

sensitive polymerase-chain-reacti<strong>on</strong>-based<br />

methods of low levels<br />

of reverse transcriptase activity in<br />

live viral vaccines prepared in<br />

chicken cells.<br />

IN PREPARATION<br />

Technical Report Series, No. 910<br />

2002 , vi + 104 pages [E]<br />

ISBN 92 4 120910 0<br />

Swiss francs 20.–/US $18.00<br />

In developing countries: Sw.fr.14.–<br />

Order no.1100910<br />

Technical Report Series, No. 904<br />

2001 , vi + 108 pages [E]<br />

ISBN 92 4 120904 6<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no.1100904<br />

Technical Report Series, No. 889<br />

1999, vi + 111 pages [E, F, S]<br />

ISBN 92 4 120889 9<br />

Swiss francs 23.–/US $20.70<br />

In developing countries: Sw.fr. 16.10<br />

Order no. 1100889


oms-catalogue 15/07/03 11:33 Page 13<br />

Guidelines <strong>on</strong> the Use<br />

of Internati<strong>on</strong>al<br />

N<strong>on</strong>proprietary Names<br />

(INNs) for Pharmaceutical<br />

Substances<br />

Explains the system of internati<strong>on</strong>al<br />

n<strong>on</strong>proprietary names (INNs)<br />

administered by WHO to ensure<br />

that each pharmaceutical substance<br />

or active pharmaceutical<br />

ingredient is identified by a unique<br />

name that is universally recognized<br />

and universally accessible as public<br />

property. This system of "generic"<br />

names was introduced by WHO in<br />

1950 as a mechanism for ensuring<br />

the clear identificati<strong>on</strong> of medicinal<br />

drugs, promoting their safe<br />

prescribing and dispensing, and<br />

facilitating internati<strong>on</strong>al scientific<br />

communicati<strong>on</strong>s.<br />

13<br />

1997, iii + 36 pages [E]<br />

WHO/PHARM S/NOM 1570<br />

Swiss francs 15.–/US $13.50<br />

In developing countries: Sw.fr. 10.50<br />

Order no. 1930120


oms-catalogue 15/07/03 11:33 Page 14<br />

QUALITY ASSURANCE AND SAFETY<br />

Guidelines for ATC<br />

Classificati<strong>on</strong><br />

and DDD Assignment<br />

5th Editi<strong>on</strong><br />

The Guidelines for ATC classificati<strong>on</strong> and DDD assignment<br />

(versi<strong>on</strong> 2002) describes the structure of the<br />

Anatomical Therapeutic Chemical (ATC) classificati<strong>on</strong><br />

system and the main principles and procedures for<br />

assigning ATC codes for medicines. The c<strong>on</strong>cept of the<br />

Defined Daily Dose (DDD) is explained as well as principles<br />

and procedures for assigning DDDs for medicines.<br />

Different uses of the ATC/DDD methodology are<br />

described. The book includes all ATC headings down to<br />

the ATC 4th level assigned by the WHO <strong>Co</strong>llaborating<br />

Centre in Oslo. <strong>Co</strong>mments regarding specific ATC and<br />

DDD assignments are included for most of the ATC<br />

levels. The comments describe particular issues that<br />

have been discussed and resolved by c<strong>on</strong>sensus of the<br />

WHO Internati<strong>on</strong>al Working Group for Drug Statistics<br />

Methodology during deliberati<strong>on</strong> while establishing<br />

ATC/DDDs. Guidelines <strong>on</strong> how to assign DDDs for<br />

combinati<strong>on</strong> products are added under the respective<br />

ATC levels.<br />

14<br />

ATC Index with DDDs<br />

This ATC Index with DDDs (versi<strong>on</strong> 2002) includes all<br />

medicines with a final ATC code and a final DDD<br />

assigned at the time of issuing. The list includes n<strong>on</strong>proprietary<br />

drug names and no brand names.<br />

The index comprises two lists:<br />

• List A: This list is sorted according to ATC code, and<br />

gives the complete ATC classificati<strong>on</strong>, i.e. all ATC<br />

levels. All final DDDs, which are established for<br />

single substances, are included in this list. DDDs<br />

for combinati<strong>on</strong> products are not included.<br />

• List B: The alphabetical index, sorted according to<br />

n<strong>on</strong>proprietary drug names, should be used to look<br />

up the ATC code for a substance. This list includes<br />

ATC 5th levels <strong>on</strong>ly.<br />

The Guidelines for ATC Classificati<strong>on</strong> and DDD Assignment and the ATC Index<br />

with DDDs are updated annually (in January).<br />

To order, please c<strong>on</strong>tact:<br />

WHO <strong>Co</strong>llaborating Centre for Drug Statistics Methodology<br />

P.O. Box 183, Kalbakken, N-0903 Oslo, Norway<br />

Email: whocc@nmd.no<br />

Tel: +47 22 16 98 11 – Fax +47 22 16 98 18<br />

Both publicati<strong>on</strong>s are available in English, Spanish and German versi<strong>on</strong>s<br />

Price for the set: US $90.00<br />

Separate editi<strong>on</strong>: US $50.00


oms-catalogue 15/07/03 11:33 Page 15<br />

CD-ROM <strong>on</strong> WHO Basic Training<br />

Modules <strong>on</strong> GMP<br />

A resource and study pack for trainers<br />

CD-ROM <strong>on</strong> WHO Supplementary Training<br />

Modules <strong>on</strong> GMP: Validati<strong>on</strong>, Water, and<br />

Air Handling Systems<br />

This CD-ROM is intended to support the creati<strong>on</strong> of<br />

training courses <strong>on</strong> Good Manufacturing Practices<br />

(GMP), particularly courses for inspectors of manufacturing<br />

facilities which produce medicines or pharmaceutical<br />

starting materials. The CD-ROM may also be<br />

useful as a self-study guide for the inspectors themselves,<br />

or any<strong>on</strong>e else interested in the manufacture<br />

of quality medicines. The c<strong>on</strong>tent of the CD-ROM is<br />

based <strong>on</strong> a modular training course designed by staff<br />

of the World Health Organizati<strong>on</strong> in collaborati<strong>on</strong><br />

with a team of internati<strong>on</strong>al experts in the subject.<br />

Details of the project that produced this course are<br />

to be found <strong>on</strong> the CD-ROM itself (in two formats -<br />

Microsoft Word and Adobe Acrobat, in the files<br />

'IntroAckn.doc' and 'IntroAckn.pdf' respectively, in the<br />

'Project' folder). There are twenty modules in the<br />

course. Fourteen of these cover Basic Principles of<br />

GMP, five cover the GMP Inspecti<strong>on</strong> Process, and the<br />

final module covers setting up and running a training<br />

course <strong>on</strong> GMP. The CD-ROM c<strong>on</strong>tains a set of the<br />

Microsoft PowerPoint presentati<strong>on</strong>s, together with<br />

handouts and other supporting material (these latter<br />

again in both Word and Acrobat formats), together<br />

with utilities for viewing or printing these. The CD-<br />

ROM also c<strong>on</strong>tains a software tool (installed by running<br />

'Setup') to help trainers modify the course to<br />

better fit local c<strong>on</strong>diti<strong>on</strong>s and regulati<strong>on</strong>s. This c<strong>on</strong>tains<br />

the full text of the presentati<strong>on</strong>s in a searchable<br />

database, together with examples of speaker's notes,<br />

and acti<strong>on</strong>-setting and note-taking facilities, and<br />

opti<strong>on</strong>s for printing these. The tool also provides<br />

access to an introductory video <strong>on</strong> GMP, which lasts<br />

18 minutes and has been optimised for viewing<br />

<strong>on</strong>-screen.<br />

The Supplementary Training Modules <strong>on</strong> Good<br />

Manufacturing Practices (GMP) are a product of the<br />

WHO/EDM Strengthening of Pharmaceutical<br />

Manufacturing Inspecti<strong>on</strong> (SPMI) Project. The aims<br />

of the project were to strengthen pharmaceutical<br />

manufacturing inspectorates by promoting the use<br />

of the previously developed training package entitled:<br />

WHO Basic Training Modules <strong>on</strong> GMP, through the<br />

setting up of internati<strong>on</strong>al workshops using the<br />

materials, and by undertaking global distributi<strong>on</strong>s<br />

of the Basic Training Modules CD-ROM, issued in<br />

April 2001. The SPMI project c<strong>on</strong>cluded at the end<br />

of March 2003.<br />

In resp<strong>on</strong>se to the many requests that were received<br />

back from individuals who had either attended a<br />

workshop or who had used the CD-ROM, three<br />

supplementary modules were developed <strong>on</strong> topics that<br />

had been specifically asked for, namely:<br />

• Validati<strong>on</strong> (including Cleaning, Process,<br />

and QC-related Validati<strong>on</strong>)<br />

• Water for Pharmaceutical Use, and<br />

• Air Handling Systems.<br />

The materials, which comprise PowerPoint slide<br />

presentati<strong>on</strong>s, tutorial notes, group sessi<strong>on</strong> exercises,<br />

and questi<strong>on</strong> and answer papers, are intended to<br />

support the creati<strong>on</strong> of training courses primarily<br />

for government compliance officers who inspect<br />

manufacturing facilities that produce medicines or<br />

pharmaceutical starting materials. The training<br />

package may also be useful as a self-study guide<br />

for these inspectors, or any<strong>on</strong>e else interested in the<br />

manufacture of quality medicines.<br />

15<br />

2001, CD-ROM [E]<br />

WHO/EDM/QSM/2000.7<br />

Available Free of Charge<br />

Order no. 1990012<br />

2003, CD-ROM [E]<br />

WHO/EDM/QSM/2002.5<br />

Available Free of Charge<br />

Order No. 1992012


oms-catalogue 15/07/03 11:33 Page 16<br />

QUALITY ASSURANCE AND SAFETY<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability of these documents,<br />

please refer to: www.who.int/medicines<br />

16<br />

The Use of <strong>Co</strong>mm<strong>on</strong> Stems in the Selecti<strong>on</strong><br />

of Internati<strong>on</strong>al N<strong>on</strong>proprietary Names<br />

(INN) for Pharmaceutical Substances<br />

2003<br />

Lists comm<strong>on</strong> stems for internati<strong>on</strong>al n<strong>on</strong>proprietary<br />

names (INN) for pharmaceutical substances for which<br />

chemical or pharmacological categories have been<br />

established. These stems and their definiti<strong>on</strong>s are<br />

intended to guide the selecti<strong>on</strong> of new INNs (generic<br />

names) for substances that bel<strong>on</strong>g to an established<br />

series of related compounds. The list aims to encourage<br />

c<strong>on</strong>sistency in the designati<strong>on</strong> of generic drug names<br />

while also protecting the principle that INNs are public<br />

property. Produced as a working document, the list is<br />

of interest to manufacturers engaged in research and<br />

development, trademark officers, and nati<strong>on</strong>al regulatory<br />

authorities.<br />

2003, 137 pp, WHO/EDM/QSM/2003.2<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/<br />

library/qsm/stemdoc2002.pdf<br />

Internati<strong>on</strong>al N<strong>on</strong>proprietary Names (INN)<br />

for Pharmaceutical Substances: Names of<br />

Radicals and Groups<br />

<strong>Co</strong>mprehensive List April 2002<br />

Provides a comprehensive list of names for radicals and<br />

groups used in the WHO system for assigning internati<strong>on</strong>al<br />

n<strong>on</strong>proprietary names (INNs) for pharmaceutical<br />

substances. Names for radicals and groups arise from<br />

the need to provide modified names for the salts or<br />

esters of substances already identified by an INN. In<br />

view of the complex compositi<strong>on</strong> of many radicals and<br />

groups, use of chemical nomenclature is inc<strong>on</strong>venient<br />

and shorter n<strong>on</strong>proprietary names are thus selected.<br />

The list also includes reference to two-word INNs.<br />

2003, 38 pages, WHO/EDM/QSM/2003.1<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/<br />

library/qsm/radicaldoc2002.pdf<br />

The Importance of Pharmacovigilance<br />

Safety M<strong>on</strong>itoring of Medicinal <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

This document presents a critical examinati<strong>on</strong> of the<br />

strengths and weaknesses of present systems of safety<br />

m<strong>on</strong>itoring in order to increase their impact, and provides<br />

an overview of the challenges facing pharmacovigilance<br />

in the future.<br />

2002, 48 pages<br />

ISBN 92 4 159015 7<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/library/<br />

qsm/ip_booklet.pdf<br />

<strong>Pharmaceuticals</strong>: Restricti<strong>on</strong>s<br />

in Use and Availability<br />

2003, 26 pages [E]<br />

WHO/EDM/QSM/2003.5<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/library/<br />

qsm/who-edm-qsm-99-2/who_edm_qsm_992.htm<br />

Safety of Medicines<br />

A Guide to Detecting and Reporting Adverse<br />

Drug Reacti<strong>on</strong>s<br />

2002, 18 pages [E]<br />

WHO/EDM/QSM/2002.2<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/library/<br />

qsm/who-edm-qsm-2002-2/esd_safety.pdf<br />

Medical <str<strong>on</strong>g>Products</str<strong>on</strong>g> and the Internet<br />

A Guide to Finding Reliable <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

As the medical informati<strong>on</strong> and the number of medical<br />

products for sale <strong>on</strong> the Internet increases rapidly, WHO<br />

has produced this guide to finding reliable medical<br />

informati<strong>on</strong> <strong>on</strong> the Net.<br />

1999, 16 pages<br />

WHO/EDM/QSM/99.4<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/library/qsm/<br />

who-edm-qsm-99-4/who-edm-qsm-99-4.htm<br />

<strong>Co</strong>unterfeit Drugs<br />

Guidelines for the Development of Measures<br />

to <strong>Co</strong>mbat <strong>Co</strong>unterfeit Drugs<br />

In the recent past, the unregulated proliferati<strong>on</strong> of pharmaceutical<br />

industries and products has brought with it<br />

many problems. These guidelines provide an overview<br />

of the problem of counterfeiting and the c<strong>on</strong>tributing<br />

factors.<br />

1999, 60 pages [E, F]<br />

WHO/EDM/QSM/99.1<br />

Electr<strong>on</strong>ic access: http://www.who.int/medicines/library/qsm/<br />

who-edm-qsm-99-1/who-edm-qsm-99-1.htm<br />

Safety M<strong>on</strong>itoring of Medicinal <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

Guidelines for setting up and running a<br />

Pharmacovigilance Centre<br />

This booklet aims to provide practical guidelines<br />

and informati<strong>on</strong> for the setting up of new<br />

Pharmacovigilance Centres. It discusses practical<br />

aspects of how to run a pharmacovigilance centre<br />

at the technical level and provides many realistic<br />

recommendati<strong>on</strong>s.<br />

2000, 24 pages<br />

ISBN 91 630 9004 X<br />

Electr<strong>on</strong>ic access:http://www.who-umc.org/pdfs/guidelines.pdf


oms-catalogue 15/07/03 11:33 Page 17<br />

INTERNATIONAL PHARMACOPOEIA<br />

Now<br />

Available<br />

The Internati<strong>on</strong>al<br />

Pharmacopoeia<br />

Third Editi<strong>on</strong><br />

Volume 5: Tests and General Requirements for Dosage Forms.<br />

Quality Specificati<strong>on</strong>s for Pharmaceutical Substances<br />

and Dosage Forms.<br />

Presents an historical account of the Pharmacopoeia and describes<br />

methods and procedures for the quality c<strong>on</strong>trol of pharmaceutical<br />

substances and dosage forms, including a special secti<strong>on</strong> <strong>on</strong> quality<br />

c<strong>on</strong>trol of anti-malarials.<br />

C<strong>on</strong>tents<br />

Preface. History. Acknowledgements. General Notices.<br />

Abbreviati<strong>on</strong>s and symbols. Tests, methods, and general requirements.<br />

M<strong>on</strong>ographs for pharmaceutical substances. M<strong>on</strong>ographs for tablets.<br />

M<strong>on</strong>ographs for antimalarial drugs. List of reagents, test soluti<strong>on</strong>s, and<br />

volumetric soluti<strong>on</strong>s. Amendements and corrigenda to Volumes 1, 2, 3, and 4.<br />

Supplementary informati<strong>on</strong>. Index. Tests, methods, and general requirements.<br />

General requirements for dosage forms<br />

Ophthalmic preparati<strong>on</strong>s. Requirements for specific types of ophthalmic<br />

preparati<strong>on</strong>s. Suppositories.<br />

Tests for dosage forms<br />

Disintegrati<strong>on</strong> test for suppositories. Dissoluti<strong>on</strong> test for solid oral dosage<br />

forms. Test for extractable volume for parenteral preparati<strong>on</strong>s. Microbial purity<br />

of pharmaceutical preparati<strong>on</strong>s. Test for bacterial endotoxins. Test for sterility<br />

of n<strong>on</strong>-injectable preparati<strong>on</strong>s. Visual inspecti<strong>on</strong> of particulate matter injectable<br />

preparati<strong>on</strong>s.<br />

17<br />

M<strong>on</strong>ographs for pharmaceutical<br />

substances (Latin names)<br />

Albendazolum. Alcur<strong>on</strong>ii chioridum.<br />

Amoxicillinum trihydricum. Atenololum.<br />

Benznidazolum. Benzoylis peroxidum cum<br />

aqua. Captoprilum. Chlorali hydras.<br />

Chloramphenicoli natrii succinas.<br />

Ciclosporinum. Ciprofloxacini<br />

hydrochlo-ridum. Ciprofloxacinum.<br />

Clindamycini phosphas.<br />

Dacarbazinum. Diethyltoluamidum.<br />

Dinitrogeniioxidum. Dithranolum.<br />

Erythromycini lacto bi<strong>on</strong>as. Etoposidum.<br />

Heparinum calcicum. Heparinum<br />

natricum. Idoxuridinum. Isosorbidi dinitras<br />

dilutus. Ketoc<strong>on</strong>azolum. Levamisoli<br />

hydrochloridum. DL-Methi<strong>on</strong>inum.<br />

Methylrosanilinii chloridum. Metr<strong>on</strong>idazoli<br />

benzoas. Nifedipinum. N<strong>on</strong>oxinolum 9.<br />

Oxygenium. Prednisol<strong>on</strong>i natrii phosphas.<br />

Protamini sulfas. Retinolum densatum<br />

oleosum. Selenii disulfidum.<br />

Sulfadiazinum argentum. Tropicamidum.<br />

M<strong>on</strong>ographs for tablets<br />

(Latin names)<br />

Allopurinoli compressi. Carbamazepini<br />

compressi. <strong>Co</strong>deini phosphatis compressi.<br />

<strong>Co</strong>lchicini compressi. Dexamethas<strong>on</strong>i compressi.<br />

Diloxanidi furoatis compressi.<br />

Doxycyclini hyclatis compressi.<br />

Erythromycini ethylsuccinatis compressi.<br />

Erythromycini stearatis compressi.<br />

Ethambutoli hydrochoridi compressi.<br />

Ibuprofeni compressi. Indometacini compressi.<br />

Is<strong>on</strong>iazidi compressi. Morphini<br />

sulfatis compressi.Pethidini hydroch1oridi<br />

compressi. Phenobarbitali compressi.<br />

Phenytoini natrici compressi. Praziquanteli<br />

compressi. Prednisol<strong>on</strong>i compressi. Pyranteli<br />

emb<strong>on</strong>atis compressi<br />

M<strong>on</strong>ographs for antimalarial drugs<br />

(Latin names)<br />

Artemetherum. Artemetheri capsulae.<br />

Artemetheri compressi.Artemetheri injectio.<br />

Artemisininum. Artemisinini capsulae.<br />

Artemisinini compressi. Artemotilum.<br />

Artemotili injectio. Artenimolum. Artenimoli<br />

compressi. Artesunatum. Artesunati compressi.<br />

Mefloquini hydrochloridum.<br />

Proguanili hydrochloridum.<br />

Supplementary informati<strong>on</strong><br />

Annotated references. List of available<br />

Intemati<strong>on</strong>al Chemical Reference Substances,<br />

list of available Intemati<strong>on</strong>al Infrared<br />

Reference Spectra. General guidelines for<br />

the establishment, maintenance, and distributi<strong>on</strong><br />

of chemical reference substances<br />

VOLUME 5<br />

2003, 389 pages [E, F*, S*]<br />

ISBN 92 4 154536 4<br />

Swiss francs 95.-/US $85.50<br />

In developing countries: Sw.fr. 66.50<br />

Order no. 1155091<br />

New: Volume 5


oms-catalogue 15/07/03 11:33 Page 18<br />

INTERNATIONAL PHARMACOPOEIA<br />

The Internati<strong>on</strong>al<br />

Pharmacopoeia<br />

Third Editi<strong>on</strong><br />

Volume 1: General<br />

Methods of Analysis<br />

The Internati<strong>on</strong>al<br />

Pharmacopoeia<br />

Third Editi<strong>on</strong><br />

Volume 2: Quality Specificati<strong>on</strong>s<br />

18<br />

Describes methods and procedures<br />

for the quality c<strong>on</strong>trol of pharmaceutical<br />

substances and dosage forms.<br />

“... a very useful laboratory aid...”<br />

— Internati<strong>on</strong>al Journal of Crude Drug<br />

Research<br />

C<strong>on</strong>tents<br />

Preface. General notices. Units of<br />

measurement<br />

Physical methods<br />

Measurement of mass. Determinati<strong>on</strong><br />

of melting temperature, melting<br />

range, c<strong>on</strong>gealing point, boiling<br />

point, and boiling range.<br />

Determinati<strong>on</strong> of mass density<br />

and relative density. Determinati<strong>on</strong> of<br />

optical rotati<strong>on</strong> and specific rotati<strong>on</strong>.<br />

Determinati<strong>on</strong> of refractive index.<br />

Spectrophotometry in the visible and<br />

ultraviolet regi<strong>on</strong>s.Spectrophotometry<br />

in the infrared regi<strong>on</strong>. Atomic absorpti<strong>on</strong><br />

spectrophotometry. Fluorescence<br />

spectrophotometry. Turbidimetry and<br />

nephelometry. <strong>Co</strong>lour of liquids.<br />

Radiopharmaceuticals. Powder fineness<br />

and sieves.<br />

Physiochemical methods<br />

Chromatography. Determinati<strong>on</strong> of<br />

pH. Electrophoresis. Phase solubility<br />

analysis.<br />

Chemical methods<br />

General identificati<strong>on</strong> tests. Limit test<br />

for chlorides. Limit test for sulfates.<br />

Limit test for heavy metals. Limit test<br />

for ir<strong>on</strong>. Limit test for arsenic.<br />

Sulfated ash. Oxygen flask method.<br />

<strong>Co</strong>mplexometric titrati<strong>on</strong>s.<br />

N<strong>on</strong>-aqueous titrati<strong>on</strong>. Nitrite titrati<strong>on</strong>.<br />

Determinati<strong>on</strong> of water by the<br />

Karl Fischer method. Determinati<strong>on</strong><br />

of methoxyl. Determinati<strong>on</strong> of nitrogen.<br />

Determinati<strong>on</strong> of iodine value.<br />

Determinati<strong>on</strong> of peroxides in fixed<br />

oils. Determinati<strong>on</strong> of sap<strong>on</strong>ificati<strong>on</strong><br />

value. Determinati<strong>on</strong> of unsap<strong>on</strong>ifiable<br />

matter. Determinati<strong>on</strong> of acid<br />

value.<br />

Biological methods<br />

Microbiological assay of antibiotics.<br />

Sterility testing of antibiotics. Undue<br />

toxicity. Test for pyrogens. Test for<br />

histamine-like substances (vasodepressor<br />

substances).<br />

Methods for pharmacognosy<br />

Determinati<strong>on</strong> of ash and acidinsoluble<br />

ash.<br />

Miscellaneous<br />

Internati<strong>on</strong>al chemical reference<br />

substances. Names, symbols, and<br />

relative atomic masses of elements.<br />

List of reagents, test soluti<strong>on</strong>s, and<br />

volumetric soluti<strong>on</strong>s. Index.<br />

C<strong>on</strong>tains quality specificati<strong>on</strong>s<br />

for 126 pharmaceutical substances<br />

included in the WHO Model List of<br />

Essential Drugs. The specificati<strong>on</strong>s<br />

are especially suited to quality<br />

c<strong>on</strong>trol in developing countries.<br />

“... deserves due internati<strong>on</strong>al<br />

recogniti<strong>on</strong> as a basis for<br />

standardising drug quality c<strong>on</strong>trol<br />

procedures...”<br />

— The Pharmaceutical Journal<br />

C<strong>on</strong>tents<br />

Preface.General notices.M<strong>on</strong>ographs.<br />

List of reagents, test soluti<strong>on</strong>s, and<br />

volumetric soluti<strong>on</strong>s. Index.<br />

The Internati<strong>on</strong>al<br />

Pharmacopoeia<br />

Third Editi<strong>on</strong><br />

Volume 3: Quality Specificati<strong>on</strong><br />

Presents quality specificati<strong>on</strong>s for 157<br />

widely used pharmaceutical sustances.<br />

In keeping with the overall purpose of<br />

the Internati<strong>on</strong>al Pharmacopoeia, the<br />

m<strong>on</strong>ographs are based <strong>on</strong> sound,<br />

classical chemical methods appropriate<br />

for use in small and medium-sized<br />

laboratories.<br />

“... helps enhance the applicability<br />

of the Pharmacopoeia to a large<br />

range of laboratory settings...”<br />

— Journal of Pharmacy Technology<br />

C<strong>on</strong>tents<br />

Preface. Acknowledgements.<br />

M<strong>on</strong>ographs. List of reagents, test<br />

soluti<strong>on</strong>s, and volumetric soluti<strong>on</strong>s.<br />

Amendements and corrigenda to<br />

Vols. 1 and 2. Index.<br />

Volume 1<br />

1979, 223 pages [E, F, S]<br />

ISBN 92 4 154150 4<br />

Swiss francs 24.–/US $21.60<br />

In developing countries: Sw.fr.16.80<br />

Order no. 1151091<br />

Volume 2<br />

1981, 342 pages [E, F, S]<br />

ISBN 92 4 154151 2<br />

Swiss francs 36.–/US $32.40<br />

In developing countries: Sw.fr. 25.20<br />

Order no. 1152091<br />

Volume 3<br />

1988, 407 pages [E, F, R, S]<br />

ISBN 92 4 154215 2<br />

Swiss francs 64.–/US $57.60<br />

In developing countries: Sw.fr. 44.80<br />

Order no. 1153091<br />

“global drug quality c<strong>on</strong>trol”


oms-catalogue 15/07/03 11:34 Page 19<br />

The Internati<strong>on</strong>al Pharmacopoeia<br />

Third Editi<strong>on</strong><br />

Volume 4: Tests, Methods,<br />

and General Requirements;<br />

Quality Specificati<strong>on</strong>s for Pharmaceutical<br />

Substances, Excipients, and Dosage<br />

Forms<br />

Provides a collecti<strong>on</strong> of recommended quality<br />

specificati<strong>on</strong>s and methods of analysis for<br />

selected pharmaceutical products, excipients,<br />

and dosage forms.<br />

C<strong>on</strong>tents<br />

Preface. Acknowledgements. General Notices.<br />

Abbreviati<strong>on</strong>s and symbols. Tests, methods,<br />

and general requirements. M<strong>on</strong>ographs for<br />

pharmaceutical substances. M<strong>on</strong>ographs for<br />

excipients. M<strong>on</strong>ographs for dosage forms.<br />

List of reagents, test soluti<strong>on</strong>s, and volumetric<br />

soluti<strong>on</strong>s. Amendements and corrigenda to<br />

Volumes 1, 2, and 3. Index.Tests, methods,<br />

and general requirements. Test for sterility,<br />

Methods of sterilizati<strong>on</strong>, Atomic emissi<strong>on</strong> and<br />

absorpti<strong>on</strong> spectrometry.<br />

General requirements for substances<br />

Hydroxyl value<br />

General requirements for dosage forms<br />

Tablets, capsules, parenteral preparati<strong>on</strong>s,<br />

disintegrati<strong>on</strong> test for tablets and capsules.<br />

Topical semi-solid dosage forms. Uniformity<br />

of c<strong>on</strong>tent for single-dose preparati<strong>on</strong>s.<br />

Uniformity of mass for single-dose preparati<strong>on</strong>s.<br />

The Internati<strong>on</strong>al<br />

Pharmacopoeia<br />

CD-ROM<br />

Now available<br />

This multilingual CD-ROM c<strong>on</strong>tains all<br />

5 volumes of the Internati<strong>on</strong>al Pharmacopoeia<br />

in English and volumes 1-4 in French and<br />

Spanish.<br />

The user-friendly interface allows searches<br />

to be c<strong>on</strong>ducted by volume, m<strong>on</strong>ograph<br />

(substances,m<strong>on</strong>ographs for excipients,<br />

m<strong>on</strong>ographs for dosage forms), general<br />

methods or reagents.<br />

19<br />

Volume 4<br />

1994, xv + 343 pages [E, F, S]<br />

ISBN 92 4 154462 7<br />

Swiss francs 85.–/US $76.50<br />

In developing countries: Sw.fr. 59.50<br />

Order no. 1154091<br />

CD-ROM [E/F/S]<br />

2003<br />

ISBN 92 4 056021 1<br />

Swiss francs 150.–/US $135.00<br />

In developing countries: Sw.fr. 105.–<br />

Order no. 0990020


oms-catalogue 15/07/03 11:34 Page 20<br />

INTERNATIONAL PHARMACOPOEIA<br />

The Internati<strong>on</strong>al Pharmacopoeia<br />

“your benchmark to global drug quality c<strong>on</strong>trol”<br />

30%<br />

DISCOUNT<br />

Special price offer for 5 volumes:<br />

Swiss francs 212.80 / US $191.00<br />

In developing countries Swiss francs 148.–<br />

CD-ROM<br />

ALSO<br />

AVAILABLE<br />

Order Form<br />

MDI.PHS.203<br />

20<br />

Please send me copies of The Internati<strong>on</strong>al Pharmacopoeia, special price offer for 5 volumes at the price<br />

of Swiss francs 212.80 / US $191.00; in developing countries Swiss francs 148.–<br />

Please send me The Internati<strong>on</strong>al Pharmacopoeia :<br />

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

copies of volume 2 at the price of Swiss francs 36.– / in developing countries Swiss francs 25.20 (order no. 1152091)<br />

copies of volume 3 at the price of Swiss francs 64.– / in developing countries Swiss francs 44.80 (order no. 1153091)<br />

copies of volume 4 at the price of Swiss francs 85.– / in developing countries Swiss francs 59.50 (order no. 1154091)<br />

copies of volume 5 at the price of Swiss francs 95.– / in developing countries Swiss francs 66.50 (order no. 1155091)<br />

copies of Internati<strong>on</strong>al Pharmacopoeia CD-ROM at the price of Swiss francs 150.– /in developing countries<br />

Swiss francs 105.– (order no. 0990020)<br />

Name<br />

Address<br />

Postal code City <strong>Co</strong>untry<br />

Tel. Fax Email<br />

Payment enclosed<br />

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Visa American Express Diners Club Eurocard/Access/Mastercard<br />

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Expiry date: Date of order: Signature:<br />

Please return or fax this order to:<br />

WHO - Marketing & Disseminati<strong>on</strong><br />

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Tel. +41 22 791 24 76 Fax +41 22 791 48 57<br />

Email: bookorders@who.int<br />

Order <strong>on</strong>line at: http//:bookorders.who.int<br />

For customers in the USA, please return or fax this order to:<br />

WHO Publicati<strong>on</strong>s Center USA<br />

49 Sheridan Avenue<br />

Albany NY 12210, USA<br />

Tel. +518 436-9686 Fax +518 436 7433<br />

Email: qcorp@compuserve.com


oms-catalogue 15/07/03 11:34 Page 21<br />

DRUG PRESCRIBING<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability<br />

of these documents,<br />

please refer to:<br />

www.who.int/medicines<br />

Adherence to L<strong>on</strong>g-term<br />

Therapies<br />

Evidence for Acti<strong>on</strong><br />

Adherence to therapies is a primary<br />

determinant of treatment success.<br />

Poor adherence attenuates optimum<br />

clinical benefits and therefore<br />

reduces the overall effectiveness of<br />

health systems.<br />

"Medicines will not work if you do<br />

not take them". Medicines will<br />

not be effective if patients do not<br />

follow prescribed treatment, yet in<br />

developed countries <strong>on</strong>ly 50% of<br />

patients who suffer from chr<strong>on</strong>ic<br />

diseases adhere to treatment recommendati<strong>on</strong>s.<br />

In developing countries,<br />

when taken together with poor<br />

access to health care, lack of appropriate<br />

diagnosis and limited access<br />

to medicines, poor adherence is<br />

threatening to render futile any<br />

effort to tackle chr<strong>on</strong>ic c<strong>on</strong>diti<strong>on</strong>s,<br />

such as diabetes, depressi<strong>on</strong> and<br />

HIV/AIDS.<br />

This report is based <strong>on</strong> an exhaustive<br />

review of the published literature<br />

<strong>on</strong> the definiti<strong>on</strong>s, measurements,<br />

epidemiology, ec<strong>on</strong>omics and<br />

interventi<strong>on</strong>s applied to nine chr<strong>on</strong>ic<br />

c<strong>on</strong>diti<strong>on</strong>s and their risk factors.<br />

These are asthma, cancer (palliative<br />

care), depressi<strong>on</strong>, diabetes, epilepsy,<br />

HIV/AIDS, hypertensi<strong>on</strong>, tobacco<br />

smoking and tuberculosis.<br />

Intended for clinical practiti<strong>on</strong>ers,<br />

health managers and policy-makers,<br />

this report provides a c<strong>on</strong>cise<br />

summary of the c<strong>on</strong>sequences of<br />

poor adherence for health and<br />

ec<strong>on</strong>omics.<br />

Guide to Good Prescribing<br />

A Practical Manual<br />

A spiral-bound training manual<br />

offering a step-by-step guide<br />

to the process of rati<strong>on</strong>al, resp<strong>on</strong>sible<br />

prescribing. Addressed to<br />

undergraduate medical students<br />

who are about to enter the<br />

clinical phase of their studies,<br />

the manual aims to help students<br />

acquire the skills and c<strong>on</strong>fidence<br />

needed to exercise independent<br />

judgement and make their own<br />

decisi<strong>on</strong>s about which drugs or<br />

n<strong>on</strong>-drug treatments are best<br />

for each individual patient.<br />

Throughout, numerous practical<br />

exercises and examples of patients<br />

and their complaints are used to<br />

help tie advice to the realities of<br />

a doctor’s daily practice.<br />

Teacher’s Guide to Good<br />

Prescribing<br />

This is a compani<strong>on</strong> volume to the<br />

Guide to Good Prescribing. Its target<br />

audience is university teachers<br />

who wish to use the Guide for<br />

teaching undergraduate medical<br />

students.<br />

2001, 106 pages<br />

WHO/EDM/PAR/2001.2<br />

Electr<strong>on</strong>ic access: http://www.who.int/<br />

medicines/library/par/teachers<br />

_guide.pdf<br />

21<br />

2003, 212 pages [E]<br />

ISBN 92 4 154599 2<br />

Swiss francs: 30.–/US $27.00<br />

In developing countries: Sw.fr. 15.–<br />

Order no. 1150526<br />

by T.P.G.M. de Vries, R.H. Henning,<br />

H.V. Hogerzeil and D.A. Fresle<br />

1995, ii + 108 pages [E, F, S, C, G, P]<br />

WHO/DAP/94.11<br />

Swiss francs 15.–/US $13.50<br />

In developing countries: Sw.fr. 10.50<br />

Order no. 1930074


oms-catalogue 15/07/03 11:34 Page 22<br />

DRUG PRESCRIBING<br />

WHO Model Prescribing <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>:<br />

Drugs Used in Parasitic Diseases<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

WHO Model Prescribing <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>:<br />

Drugs Used in Sexually Transmitted<br />

Diseases and HIV Infecti<strong>on</strong><br />

22<br />

The sec<strong>on</strong>d revised editi<strong>on</strong> of model prescribing<br />

informati<strong>on</strong> for some 37 essential drugs used for<br />

the preventi<strong>on</strong> and treatment of protozoal and<br />

helminthic infecti<strong>on</strong>s. The secti<strong>on</strong>s <strong>on</strong> malaria, African<br />

trypanosomiasis, cestode infecti<strong>on</strong>s, schistosomiasis, and<br />

<strong>on</strong>chocerciasis have been extensively revised in the light<br />

of new developments in the treatment of these<br />

diseases.<br />

The book is organized according to diseases, moving<br />

from amoebiasis and giardiasis to intestinal, liver, and<br />

lung flukes. Each disease or group of diseases is first<br />

introduced with c<strong>on</strong>cise informati<strong>on</strong> about its causes,<br />

mode of transmissi<strong>on</strong>, clinical features, and geographical<br />

prevalence, followed by general advice <strong>on</strong> preventi<strong>on</strong><br />

and treatment. Prescribing informati<strong>on</strong> is then<br />

provided for first-choice and alternative therapeutic and<br />

prophylactic drugs. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> includes uses, dosage<br />

and administrati<strong>on</strong>, c<strong>on</strong>traindicati<strong>on</strong>s and precauti<strong>on</strong>s,<br />

use in pregnancy, adverse effects, drug interacti<strong>on</strong>s,<br />

and advice <strong>on</strong> storage.<br />

From reviews of the first editi<strong>on</strong>:<br />

"... a mine of admirably c<strong>on</strong>cise and accurately<br />

compiled data ... will be of enormous value..."<br />

– Transacti<strong>on</strong>s of the Royal Society of Tropical Medicine<br />

and Hygiene<br />

A practical guide to the use of drugs in the management<br />

of sexually transmitted diseases and diseases<br />

associated with HIV infecti<strong>on</strong>. Addressed to clinicians,<br />

especially in developing countries, the book aims to<br />

guide the selecti<strong>on</strong> and prescribing of drugs in line<br />

with the latest knowledge about efficacy, safety, and<br />

costs. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> resp<strong>on</strong>ds to both the dramatic<br />

global increase in the incidence of these diseases<br />

and the spread of resistance to readily available<br />

antimicrobials.<br />

1995, 146 pages [E, F, S]<br />

ISBN 92 4 140104 4<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no. 1152343<br />

1995, 97 pages [E, F, S]<br />

ISBN 92 4 140105 2<br />

Swiss francs 25.–/US $22.50<br />

In developing countries: Sw.fr. 17.50<br />

Order no. 1150429


oms-catalogue 15/07/03 11:34 Page 23<br />

WHO Model Prescribing<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>: Drugs Used<br />

in Skin Diseases<br />

WHO Model Prescribing<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>: Drugs Used<br />

in Bacterial Infecti<strong>on</strong>s<br />

Guide to Chemotherapy<br />

and Chemoprophylaxis<br />

in Bacterial Infecti<strong>on</strong>s<br />

Sec<strong>on</strong>d Editi<strong>on</strong><br />

Provides model prescribing informati<strong>on</strong><br />

for essential drugs used in<br />

the treatment of skin diseases.<br />

Emphasis is placed <strong>on</strong> skin diseases<br />

comm<strong>on</strong>ly found in developing<br />

countries, since rural communities<br />

in these areas c<strong>on</strong>tinue to experience<br />

c<strong>on</strong>siderable disability, disfigurement,<br />

and distress caused by<br />

curable or c<strong>on</strong>trollable diseases.<br />

Some rare but life-threatening<br />

disorders, such as pemphigus, are<br />

also briefly discussed.<br />

Provides model prescribing informati<strong>on</strong><br />

for essential drugs used<br />

in the treatment of bacterial<br />

infecti<strong>on</strong>s. This new volume<br />

includes drugs used for treating<br />

respiratory, gastrointestinal, urinary,<br />

perioral, dental and cardiovascular<br />

infecti<strong>on</strong>s, as well as septicaemia<br />

and infecti<strong>on</strong>s of the skin, soft<br />

tissues, b<strong>on</strong>es and joints, sexually<br />

transmitted diseases, and other<br />

comm<strong>on</strong>ly encountered bacterial<br />

infecti<strong>on</strong>s. It also covers prophylaxis<br />

against rheumatic fever, meningitis,<br />

and bacterial infecti<strong>on</strong> during<br />

surgery.<br />

This guide aims to provide a comprehensive<br />

yet simplified approach<br />

to the rati<strong>on</strong>al use of antibiotics<br />

and to help the physician select<br />

therapeutic programmes that<br />

are both safe and effective. This<br />

sec<strong>on</strong>d editi<strong>on</strong> updates a number<br />

of recommendati<strong>on</strong>s as a result of<br />

new developments and emergence<br />

of resistance in bacterial infecti<strong>on</strong>s.<br />

23<br />

1997, iv + 126 pages [E, F, S, R]<br />

ISBN 92 4 140106 0<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no. 1150450<br />

2001, iv + 126 pages [E]<br />

ISBN 92 4 140107 9<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no. 1150483<br />

WHO Regi<strong>on</strong>al office for the Eastern<br />

Mediterranean<br />

Eastern Mediterranean Series, No. 4<br />

1997, 134 pages [E]<br />

ISBN 92 9021 225 X<br />

Swiss francs 10.–/US $9.00<br />

In developing countries: Sw.fr. 7.00<br />

Order no. 1442004


oms-catalogue 15/07/03 11:34 Page 24<br />

DRUG PRESCRIBING<br />

Antimicrobial Resistance<br />

in the Americas<br />

Magnitude and C<strong>on</strong>tainment<br />

of the Problem<br />

Drugs for the Elderly<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

Vitamin A Supplements<br />

A Guide to their Use in the<br />

Treatment and Preventi<strong>on</strong><br />

of Vitamin A Deficiency and<br />

Xerophthalmia<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

24<br />

This book makes a valuable c<strong>on</strong>tributi<strong>on</strong><br />

to the surveillance of resistance<br />

to antibiotics. The text offers<br />

noteworthy articles grouped under<br />

two major categories: m<strong>on</strong>itoring<br />

bacterial resistance to antimicrobial<br />

drugs, and factors determining the<br />

use of antimicrobials. The goal of<br />

this work is to increase awareness<br />

of the problem, to promote surveillance<br />

activities, and to find the best<br />

ways to apply preventive measures,<br />

so that antibiotics are used judiciously<br />

with both humans and<br />

animals.<br />

The sec<strong>on</strong>d revised editi<strong>on</strong> of a<br />

popular practical guide to the prescribing<br />

of drugs for the elderly.<br />

Designed to promote a more<br />

rati<strong>on</strong>al use of drugs, the book<br />

emphasizes the many physical and<br />

mental c<strong>on</strong>diti<strong>on</strong>s associated with<br />

aging that must be c<strong>on</strong>sidered<br />

when evaluating symptoms and<br />

selecting the most appropriate<br />

drug, dose, and formulati<strong>on</strong>.<br />

Provides c<strong>on</strong>cise, authoritative<br />

advice <strong>on</strong> the use of high-dose<br />

vitamin A supplements for the<br />

c<strong>on</strong>trol of vitamin A deficiency and<br />

the emergency treatment of<br />

xerophthalmia and other c<strong>on</strong>diti<strong>on</strong>s<br />

in high-risk groups. Now in its<br />

sec<strong>on</strong>d editi<strong>on</strong>, the guide has been<br />

updated to reflect the latest<br />

scientific knowledge, particularly<br />

c<strong>on</strong>cerning the safety and effectiveness<br />

of different dose schedules<br />

in different age and populati<strong>on</strong><br />

groups.<br />

Pan American Health Organizati<strong>on</strong><br />

by R. Salvatierra-G<strong>on</strong>zález and<br />

Y. Benguigui<br />

2001, 269 pages [E]<br />

ISBN 92 75 32319 5<br />

Swiss francs: 50.–/ US $ 45.00<br />

In developing countries: Sw.fr. 35.–<br />

Order no. 1630121<br />

WHO Regi<strong>on</strong>al office for Europe<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

European Series, No. 71<br />

1997, x + 145 pages [E]<br />

ISBN 92 890 1335 4<br />

Swiss francs 32.–/US $28.80<br />

In developing countries: Sw.fr. 22.40<br />

Order no. 1310071<br />

1997, vi + 28 pages [E, F, S]<br />

ISBN 92 4 154506 2<br />

Swiss francs 14.–/US $12.60<br />

In developing countries: Sw.fr. 9.80<br />

Order no. 1152303


oms-catalogue 15/07/03 11:34 Page 25<br />

LEGISLATION AND REGULATION<br />

Internati<strong>on</strong>al Travel<br />

and Health 2003<br />

Situati<strong>on</strong> as <strong>on</strong> 1 January 2003<br />

Effective Drug Regulati<strong>on</strong><br />

A Multicountry Study<br />

Guidelines for the<br />

Regulatory Assessment<br />

of Medicinal <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

for Use in Self-medicati<strong>on</strong><br />

This editi<strong>on</strong> of Internati<strong>on</strong>al<br />

travel and health was completely<br />

redesigned in 2002 to reflect better<br />

knowledge about the risks to<br />

which travellers are exposed and<br />

the precauti<strong>on</strong>s needed to protect<br />

their health.<br />

The book offers guidance <strong>on</strong> the<br />

full range of health risks likely to<br />

be encountered at specific destinati<strong>on</strong>s<br />

and associated with different<br />

types of travel - from business,<br />

humanitarian and leisure travel to<br />

backpacking and adventure tours.<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> is intended to help the<br />

medical professi<strong>on</strong> be fully alert to<br />

potential risks and provide appropriate<br />

advice, whether c<strong>on</strong>cerning<br />

recommended vaccinati<strong>on</strong>s, protecti<strong>on</strong><br />

against insects and other disease<br />

vectors, or safety in different<br />

envir<strong>on</strong>mental settings. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

<strong>on</strong> infectious diseases of potential<br />

risk for travellers has also been<br />

greatly expanded. Additi<strong>on</strong>al chapters<br />

describe vaccine-preventable<br />

diseases, vaccines for routine and<br />

selective use, and selecti<strong>on</strong> criteria,<br />

and offer detailed guidance<br />

<strong>on</strong> malaria, the most important<br />

infectious disease threat for<br />

travellers.<br />

Drugs play a crucial role in saving<br />

lives, restoring health, and preventing<br />

diseases and epidemics. But<br />

they need to be safe, efficacious,<br />

of good quality, and used rati<strong>on</strong>ally.<br />

This means that their producti<strong>on</strong>,<br />

import/export, storage, supply and<br />

distributi<strong>on</strong> should be subject to<br />

government c<strong>on</strong>trol through prescribed<br />

norms and standards and<br />

an effective regulatory system.<br />

Substandard and counterfeit drugs<br />

proliferate primarily in an envir<strong>on</strong>ment<br />

where drug regulati<strong>on</strong> has<br />

proved ineffective.<br />

This publicati<strong>on</strong> presents a<br />

synthesis of studies <strong>on</strong> drug<br />

regulati<strong>on</strong> carried out in 10<br />

countries: Australia, Cuba, Cyprus,<br />

Est<strong>on</strong>ia, Malaysia, the Netherlands,<br />

Tunisia, Uganda, Venezuela, and<br />

Zimbabwe in 1998-1999. It gives<br />

an overview of the development of<br />

drug regulati<strong>on</strong> in these countries<br />

as well as the resources available<br />

and the strategies applied in drug<br />

regulati<strong>on</strong> implementati<strong>on</strong> at the<br />

time the studies were c<strong>on</strong>ducted.<br />

An analysis of the strengths and<br />

weaknesses in drug regulati<strong>on</strong> in<br />

these countries is also provided.<br />

Presents guidelines for determining<br />

when medicinal products, sold <strong>on</strong><br />

prescripti<strong>on</strong> <strong>on</strong>ly, can be reclassified<br />

for n<strong>on</strong>-prescripti<strong>on</strong>, or over-thecounter,<br />

sale. Noting that self-medicati<strong>on</strong><br />

plays an important role in<br />

the health care system, the booklet<br />

sets out criteria and methods<br />

intended to help drug regulatory<br />

authorities decide when a product<br />

is suitably safe and effective for<br />

self-medicati<strong>on</strong>.<br />

25<br />

2002, vii + 85 pages [E, F]<br />

ISBN 92 4 158028 3<br />

Swiss francs 25.–/US $22.50<br />

In developing countries: Sw.fr. 17.50<br />

Order no. 1180003<br />

by S. Ratanawijitrasin and<br />

E. W<strong>on</strong>demagegnehu<br />

2002, ix + 189 pages [E]<br />

ISBN 92 4 156206 4<br />

Swiss francs 20.–/US $18.00<br />

In developing countries: Sw.fr. 14.–<br />

Order no. 1150503<br />

2000, 31 pages [E]<br />

WHO/EDM/QSM/00.1<br />

Swiss francs 10.–/US $9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1930175


oms-catalogue 15/07/03 11:34 Page 26<br />

LEGISLATION AND REGULATION<br />

Marketing Authorizati<strong>on</strong><br />

of Pharmaceutical <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

with Special Reference<br />

to Multisource (Generic)<br />

<str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

A Manual for a Drug<br />

Regulatory Authority<br />

26<br />

A detailed guide to the establishement<br />

of a system for the marketing<br />

authorizati<strong>on</strong> of multisource (generic)<br />

pharmaceutical products. Addressed<br />

to drug regulatory authorities, the<br />

guidelines are intended for use in<br />

countries that do not presently have<br />

a fully functi<strong>on</strong>al system of premarket<br />

evaluati<strong>on</strong> and market authorizati<strong>on</strong>,<br />

and want to establish such a system,<br />

giving priority to the assessment and<br />

authorizati<strong>on</strong> of generic drugs.<br />

Regulatory Support Series, No. 5<br />

1999, v + 213 pages [E]<br />

WHO/DMP/RGS/98.5<br />

Swiss francs 40.–/US $36.00<br />

In developing countries: Sw.fr. 28.–<br />

Order no. 1930169


oms-catalogue 15/07/03 11:35 Page 27<br />

PUBLICATIONS FROM THE SOUTH CENTRE<br />

Publicati<strong>on</strong>s from<br />

The South Centre<br />

The South Centre is an intergovernmental organizati<strong>on</strong><br />

based in Geneva. (For details about the South Centre visit<br />

its website www.southcentre.org ) It undertakes policyoriented<br />

analytical work <strong>on</strong> issues of comm<strong>on</strong> interest to<br />

the countries and peoples of the South. The Centre functi<strong>on</strong>s<br />

essentially as an intellectually aut<strong>on</strong>omous think-tank.<br />

While the Centre is very small and has very limited financial<br />

resources at its disposal, its strength is based <strong>on</strong> networking<br />

with instituti<strong>on</strong>s and experts in the South. Its political and<br />

substantive relevance and importance stems from its mandate<br />

to promote South solidarity and c<strong>on</strong>sciousness; to promote<br />

various types of South-South cooperati<strong>on</strong> and acti<strong>on</strong>,<br />

links, networking and informati<strong>on</strong> exchange; to c<strong>on</strong>tribute<br />

to efforts to coordinate participati<strong>on</strong> by developing countries<br />

in internati<strong>on</strong>al forums dealing with South-South and<br />

North-South matters and to foster c<strong>on</strong>vergent views and<br />

approaches am<strong>on</strong>g countries of the South – with respect<br />

to global ec<strong>on</strong>omic, political and strategic issues related<br />

to development, sovereignty, security and in general<br />

governance and directi<strong>on</strong> of the internati<strong>on</strong>al system.<br />

The scope of Centre’s work and activities ranges over a<br />

broad spectrum. Am<strong>on</strong>g other things, it has d<strong>on</strong>e work <strong>on</strong><br />

South-South cooperati<strong>on</strong>, UN reform, financing and development,<br />

sustainable development, intellectual property, and<br />

internati<strong>on</strong>al trade, and has produced policy papers and<br />

publicati<strong>on</strong>s <strong>on</strong> the occasi<strong>on</strong> of major UN c<strong>on</strong>ferences,<br />

most recently those held in M<strong>on</strong>terrey <strong>on</strong> financing<br />

for development and in Johannesburg <strong>on</strong> sustainable<br />

development. An area where the Centre has been able to<br />

undertake more systematic and sustained activity thanks<br />

to the availability of project funding has to do with WTO,<br />

trade and development.<br />

While the Centre has not as yet initiated a work programme<br />

<strong>on</strong> health-related matters, it has worked in close<br />

c<strong>on</strong>tact with WHO, especially its Department of Essential<br />

Drugs and Medicines Policy, and has issued a number of<br />

relevant publicati<strong>on</strong>s, including joint publicati<strong>on</strong>s with<br />

WHO, most recently a study entitled Protecti<strong>on</strong> and<br />

Promoti<strong>on</strong> of Traditi<strong>on</strong>al Medicine: Implicati<strong>on</strong>s for Public<br />

Health in Developing <strong>Co</strong>untries. The Centre plans, as its<br />

resources and staffing expand, to initiate systematic work<br />

<strong>on</strong> health-related issues from a South perspective.<br />

27<br />

C<strong>on</strong>tact address: South Centre, BP 228, 17-19<br />

Chemin du Champ d’Anier, 1211 Geneva 19, Switzerland.<br />

Tel 41-22-7918050, Fax 41-22-7988531,<br />

Email: south@southcentre.org


oms-catalogue 15/07/03 11:35 Page 28<br />

ETHICS AND SAFETY GUIDELINES<br />

Assessing New Vaccines<br />

for Nati<strong>on</strong>al Immunizati<strong>on</strong><br />

Programmes<br />

A Framework to Assist<br />

Decisi<strong>on</strong>-makers<br />

Guidelines for Preparing <strong>Co</strong>re<br />

Clinical-Safety <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

<strong>on</strong> Drugs<br />

Sec<strong>on</strong>d editi<strong>on</strong><br />

Including New Proposals for<br />

Investigator’s Brochures<br />

Report of CIOMS, Working<br />

Groups III (Revised) and V (New)<br />

Biomedical Research Ethics:<br />

Updating Internati<strong>on</strong>al<br />

Guidelines<br />

A C<strong>on</strong>sultati<strong>on</strong><br />

28<br />

This book aims to help policy<br />

analysts and decisi<strong>on</strong>-makers<br />

when c<strong>on</strong>sidering the additi<strong>on</strong><br />

of new vaccines to nati<strong>on</strong>al<br />

immunizati<strong>on</strong> programmes. It<br />

reflects the growing internati<strong>on</strong>al<br />

c<strong>on</strong>cerns that all children of the<br />

world should have access to<br />

life-saving vaccines wherever they<br />

happen to live, and provides a<br />

set of questi<strong>on</strong>s to work through<br />

the technical issues for adding<br />

a new vaccine to the nati<strong>on</strong>al<br />

immunizati<strong>on</strong> schedule.<br />

A revised and expanded editi<strong>on</strong><br />

of the first internati<strong>on</strong>ally-agreed<br />

guidelines covering the minimum<br />

drug safety informati<strong>on</strong> that should<br />

be communicated by manufacturers<br />

to physicians and other prescribers.<br />

Originally published as the<br />

CIOMS Working Group III report,<br />

the "<strong>Co</strong>re Safety <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g>"<br />

specified in the guidelines has been<br />

widely endorsed as a standard for<br />

the preparati<strong>on</strong> of all official<br />

nati<strong>on</strong>al data sheets, package<br />

inserts, product labels, and other<br />

official statements issued by<br />

manufacturers.<br />

The Guidelines, first issued in 1982<br />

and then revised in 1993, are being<br />

updated and expanded to address a<br />

number of new and especially challenging<br />

ethical issues. These include issues<br />

raised by internati<strong>on</strong>al collaborative<br />

trials of drugs in developing countries,<br />

especially expansive drugs, and the use<br />

of placebo c<strong>on</strong>trols in randomized<br />

clinical trials. Others arise from the<br />

complexity of research in human<br />

genetics, including stem-cell research,<br />

and in reproductive biology.<br />

WHO Regi<strong>on</strong>al Office for the<br />

Western Pacific<br />

2000, v + 32 pages [E]<br />

ISBN 92 9061 154 5<br />

Swiss francs 10.–/US$9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1520015<br />

CIOMS, 1999, 98 pages [E]<br />

ISBN 92 9036 070 4<br />

Swiss francs 15.–/US $13.50<br />

In developing countries: Sw.fr. 10.50<br />

Order no. 1840021<br />

Edited by R.J. Levine and<br />

S. Gorovitz with J. Gallagher<br />

CIOMS, 2000, viii + 295 pages [E]<br />

ISBN 92 9036 073 9<br />

Swiss francs 30.–/US $27.00<br />

In developing countries: Sw.fr. 21.00<br />

Order no. 1840023


oms-catalogue 15/07/03 11:36 Page 29<br />

Benefit-Risk Balance for<br />

Marketed Drugs: Evaluating<br />

Safety Signals<br />

Report of CIOMS, Working<br />

Group IV<br />

Adverse Drug Reacti<strong>on</strong><br />

Terms: Definiti<strong>on</strong>s<br />

Respiratory Disorders,<br />

Skin Disorders<br />

Presents and explains a standardized<br />

methodology for reassessing the<br />

established benefit-risk relati<strong>on</strong>ship of<br />

a marketed drug when a new safety<br />

problem arises. Addressed to drug<br />

manufacturers and regulatory<br />

authorities, the book resp<strong>on</strong>ds to the<br />

absence of any standard, systematic<br />

procedure for assessing newly detected<br />

hazards, balancing risks against<br />

benefits, and reporting the results.<br />

The recommended approach, which<br />

reflects the c<strong>on</strong>sensus reached by 24<br />

representatives of industry and<br />

government regulatory authorities,<br />

includes detailed advice <strong>on</strong> c<strong>on</strong>cepts<br />

and procedures for determining the<br />

magnitude of the safety problem and<br />

deciding <strong>on</strong> the appropriate acti<strong>on</strong>,<br />

whether involving a routine change<br />

in product informati<strong>on</strong> or immediate<br />

withdrawal of the drug from the<br />

market. The use of a standard<br />

reporting form, presented here for<br />

the first time, forms a central part<br />

of the recommended procedure.<br />

Provides c<strong>on</strong>cise definiti<strong>on</strong>s for<br />

twenty-six terms frequently used<br />

when reporting respiratory and<br />

skin disorders that may be caused<br />

by adverse reacti<strong>on</strong>s to drugs.<br />

Addressed to drug regulatory<br />

authorities and the drug safety<br />

units of pharmaceutical companies,<br />

the book resp<strong>on</strong>ds to the problems<br />

created when sp<strong>on</strong>taneous reports<br />

of adverse drug reacti<strong>on</strong>s use<br />

imprecise, incorrect, or inc<strong>on</strong>sistent<br />

terms. With these problems in<br />

mind, the book sets out precise<br />

definiti<strong>on</strong>s of terms, and minimum<br />

requirements for their use, for the<br />

most important respiratory and skin<br />

disorders that may be caused by<br />

drugs. The book is part of an <strong>on</strong>going<br />

project to develop an internati<strong>on</strong>ally<br />

agreed terminology for<br />

the designati<strong>on</strong>, reporting, validati<strong>on</strong>,<br />

and coding of adverse drug<br />

reacti<strong>on</strong>s, giving priority to the<br />

most severe disorders that may<br />

be caused by drugs.<br />

29<br />

CIOMS, 1998, 160 pages [E]<br />

ISBN 92 9036 068 2<br />

Sw.fr. 15.–/US $13.50<br />

In developing countries: Sw.fr. 10.50<br />

Order no. 1840020<br />

CIOMS, 1996, 28 pages [E]<br />

ISBN 92 9036 064 X<br />

Swiss francs 10.–/US $9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1840019


oms-catalogue 15/07/03 11:36 Page 30<br />

WHO COLLABORATING CENTRE FOR<br />

INTERNATIONAL DRUG MONITORING<br />

The WHO<br />

<strong>Co</strong>llaborating Centre<br />

for Internati<strong>on</strong>al Drug M<strong>on</strong>itoring<br />

30<br />

This WHO <strong>Co</strong>llaborating Centre is situated in Uppsala<br />

Sweden and known throughout the world as the<br />

Uppsala M<strong>on</strong>itoring Centre.<br />

The UMC supports WHO's leadership in the field<br />

of world health by providing excellence<br />

• in the science and c<strong>on</strong>cepts of all aspects of<br />

pharmacovigilance<br />

• to prevent harm to humans from the effects<br />

of medicines<br />

• to gather and share objective intelligence and<br />

opini<strong>on</strong> in the field of drug safety through open<br />

and transparent means of communicati<strong>on</strong><br />

• to support the promoti<strong>on</strong> of the rati<strong>on</strong>al use of<br />

drugs, and the achievement of improved<br />

patient therapy and public health<br />

• in global educati<strong>on</strong> and communicati<strong>on</strong>s in benefit,<br />

harm, effectiveness and risk in medical therapy<br />

It achieves this by<br />

• developing leading-edge systems and science for<br />

the identificati<strong>on</strong> and communicati<strong>on</strong> of safety<br />

hazards in drugs and other substances used in<br />

medicine<br />

• carrying out research pushing forward the ethical,<br />

intellectual and scientific boundaries of theory and<br />

practice in pharmacovigilance<br />

• pursuing active collaborati<strong>on</strong> and communicati<strong>on</strong><br />

with all stakeholders<br />

• pursuing the goal of a single, global database<br />

for drug safety data<br />

And in particular it aims to<br />

• ensure that effective, timely internati<strong>on</strong>al collective<br />

effort will never miss a signal of a potential hazard<br />

• ensure that all stakeholders evaluate and learn<br />

from decisi<strong>on</strong>s and acti<strong>on</strong>s through positive<br />

impact-assessment, follow-up and debate<br />

• encourage the growth of pharmacovigilance<br />

activities around the world, in particular the<br />

establishment of new Nati<strong>on</strong>al Centres<br />

• promote existing Nati<strong>on</strong>al Centres and other stake<br />

holders in the field<br />

• to c<strong>on</strong>tribute actively to the global visi<strong>on</strong> of the<br />

WHO Programme<br />

• to use and share available informati<strong>on</strong> openly<br />

and transparently<br />

• to sp<strong>on</strong>sor and support others in their<br />

pharmacovigilance activities<br />

• to exploit fully the resources of the UMC<br />

• stimulate the development of coherent, harm<strong>on</strong>ised<br />

systems worldwide for pharmacovigilance, through<br />

educati<strong>on</strong>, training, promoting and participating in<br />

internati<strong>on</strong>al forums, the promoti<strong>on</strong> of best practice<br />

and the publicati<strong>on</strong> of guidelines<br />

• maintain and develop useful products, services and<br />

tools in pursuit of the visi<strong>on</strong> and goals of the WHO<br />

Programme and the UMC.<br />

Some key publicati<strong>on</strong>s of the Uppsala<br />

M<strong>on</strong>itoring Centre are:<br />

• Viewpoint – Watching for Safer Medicines<br />

• Guidelines for setting up and running<br />

a Pharmacovigilance Centre<br />

• Pharmacovigilance in Focus<br />

• Uppsala Reports<br />

• <strong>Co</strong>mmunicating Drug Safety <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> -<br />

The Erice Declarati<strong>on</strong><br />

• Dialogue in Pharmacovigilance - more effective<br />

communicati<strong>on</strong><br />

• Expecting the Worst –Anticipating, preventing and<br />

managing medicinal product crises<br />

• Guidelines for Herbal ATC classificati<strong>on</strong><br />

• Nati<strong>on</strong>al Pharmacovigilance Systems<br />

• The WHO Adverse Reacti<strong>on</strong> Terminology<br />

• The WHO Drug Dicti<strong>on</strong>ary<br />

For further informati<strong>on</strong> and publicati<strong>on</strong> orders,<br />

please c<strong>on</strong>tact:<br />

WHO <strong>Co</strong>llaborating Centre for Internati<strong>on</strong>al<br />

Drug M<strong>on</strong>itoring<br />

Stora Torget 3<br />

S-753 20 Uppsala, Sweden<br />

Tel: +46-18-656060<br />

Fax: +46-18656080<br />

Email: info@who-umc.org<br />

web site: www.who-umc.org


oms-catalogue 15/07/03 11:36 Page 31<br />

MEDICINAL PLANTS<br />

Guidelines for the<br />

Appropriate Use<br />

of Herbal Medicines<br />

Research Guidelines for<br />

Evaluating the Safety and<br />

Efficacy of Herbal<br />

Medicines<br />

Some Traditi<strong>on</strong>al Herbal<br />

Medicines, Some Mycotoxins,<br />

Naphthalene and Styrene<br />

Reports the findings and recommendati<strong>on</strong>s<br />

of a working group<br />

c<strong>on</strong>vened to prepare guidelines<br />

for the use of herbal medicines<br />

in Western Pacific countries.<br />

Addressed to nati<strong>on</strong>al health<br />

authorities, the report resp<strong>on</strong>ds to<br />

the widespread use of herbal medicines<br />

in this part of the world and<br />

the corresp<strong>on</strong>ding need for mechanisms<br />

to ensure that these products<br />

are safe and effective, yet remain<br />

broadly accessible. With this need in<br />

mind, the report sets out a comprehensive<br />

framework for developing<br />

nati<strong>on</strong>al policies designed to c<strong>on</strong>trol<br />

the safety, efficacy, and quality of<br />

herbal medicines, manufacturing<br />

practices, product registrati<strong>on</strong>,<br />

and labelling, marketing, and trade.<br />

Sets out detailed guidelines for<br />

c<strong>on</strong>ducting scientific research <strong>on</strong><br />

the safety and efficacy of herbal<br />

medicines. The guidelines, which<br />

reflect the c<strong>on</strong>sensus reached by<br />

17 experts in pharmacology,<br />

biochemistry, and traditi<strong>on</strong>al<br />

medicine, resp<strong>on</strong>d to the need to<br />

assure the safety of widely-used<br />

herbal medicines while also<br />

facilitating the search for new<br />

pharmaceutical products. Specific<br />

research criteria are covered<br />

together with general principles<br />

of investigati<strong>on</strong>, including ethical<br />

c<strong>on</strong>cerns.<br />

Traditi<strong>on</strong>al herbal medicines<br />

encompass an extremely diverse<br />

group of preparati<strong>on</strong>s that originate<br />

from many different cultures.<br />

In recent years, such products have<br />

become widely available commercially<br />

in developed countries, where<br />

mixtures prepared from medicinal<br />

plants have been marketed or uses<br />

that were never c<strong>on</strong>templated in the<br />

traditi<strong>on</strong>al healing systems from<br />

which they emerged.<br />

This m<strong>on</strong>ograph evaluates the<br />

carcinogenic risks to humans posed<br />

by the use of some traditi<strong>on</strong>al<br />

herbal medicines, Fum<strong>on</strong>isin B1,<br />

and the industrial organic chemicals<br />

naphthalene and styrene, and<br />

provides an update of the data <strong>on</strong><br />

the carcinogenicity of aflatoxins.<br />

An Annex to the volume describes<br />

fungal sources and formati<strong>on</strong> of<br />

aflatoxins in foods and feeds, and<br />

discusses practical strategies for<br />

reducti<strong>on</strong> of aflatoxin levels.<br />

31<br />

WHO Regi<strong>on</strong>al Office for the Western Pacific<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s, Western Pacific<br />

Series, No. 23<br />

1998, vi + 79 pages [E]<br />

ISBN 92 9061 124 3<br />

Swiss francs 7.50/US $6.70<br />

In developing countries: Sw.fr. 5.20<br />

Order no. 1510023<br />

WHO Regi<strong>on</strong>al Office<br />

for the Western Pacific<br />

1993, v + 86 pages [E]<br />

ISBN 92 9061 110 3<br />

Swiss francs 7.50/US $6.70<br />

In developing countries: Sw.fr. 5.20<br />

Order no. 1520003<br />

Internati<strong>on</strong>al Agency<br />

for Research <strong>on</strong> Cancer<br />

IARC M<strong>on</strong>ographs <strong>on</strong> the Evaluati<strong>on</strong><br />

of Carcinogenic Risks to Humans,<br />

Volume 82<br />

2002, 500 pages [E]<br />

ISBN 92 832 1282 7<br />

Swiss francs 55.-/US $49.50<br />

In developing countries: Sw.fr. 38.50<br />

Order no.1720082


oms-catalogue 15/07/03 11:36 Page 32<br />

MEDICINAL PLANTS<br />

Medicinal Plants in China<br />

Medicinal Plants in Viet Nam<br />

Medicinal Plants<br />

in the Republic of Korea<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> 150 comm<strong>on</strong>ly<br />

used Medicinal Plants<br />

32<br />

Catalogues the 150 species of<br />

medicinal plants most comm<strong>on</strong>ly<br />

used in traditi<strong>on</strong>al Chinese<br />

medicine. Each plant species is first<br />

documented by a full colour photograph<br />

taken under natural c<strong>on</strong>diti<strong>on</strong>s<br />

during the flowering or<br />

fruiting seas<strong>on</strong>. Where relevant,<br />

a sec<strong>on</strong>d photograph illustrates the<br />

plant parts from which the crude<br />

drug is extracted. Explanatory notes<br />

for each species cover botanical<br />

name and syn<strong>on</strong>yms, Chinese<br />

name, English name, parts used,<br />

descripti<strong>on</strong> of the plant, its habitat,<br />

and geographical distributi<strong>on</strong>, and<br />

clinical indicati<strong>on</strong>s and dosage.<br />

Some of the syndromes and clinical<br />

signs are described in traditi<strong>on</strong>al<br />

Chinese medical terminology.<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> indicati<strong>on</strong>s and<br />

dosage is in keeping with theories<br />

for the prescripti<strong>on</strong> of medicinal<br />

plants taken from traditi<strong>on</strong>al<br />

Chinese pharmacology.<br />

Catalogues the 200 species of<br />

medicinal plants most comm<strong>on</strong>ly<br />

used in traditi<strong>on</strong>al Vietnamese<br />

medicine. The book, which has<br />

been translated from the original<br />

Vietnamese, was produced in an<br />

effort to communicate knowledge<br />

about herbal medicine that has<br />

accumulated over thousands of<br />

years, has been c<strong>on</strong>firmed through<br />

both empirical experience and<br />

scientific evaluati<strong>on</strong>, and yet has<br />

rarely been published outside the<br />

Vietnamese literature. The book<br />

also resp<strong>on</strong>ds to increasing respect<br />

for the value of medicinal plants as<br />

a source of efficacious and inexpensive<br />

new drugs that offer an<br />

important alternative to chemically<br />

synthesized medicines.<br />

Presents c<strong>on</strong>cise m<strong>on</strong>ographs,<br />

accompanied by full-colour photographs,<br />

for the 150 plant species<br />

most comm<strong>on</strong>ly used for medicinal<br />

purposes in the Republic of Korea.<br />

In view of the country's l<strong>on</strong>g and<br />

successful history in the use of traditi<strong>on</strong>al<br />

medicines, the book aims<br />

to provide written and visual documentati<strong>on</strong><br />

of important plants and<br />

summarize their uses to treat<br />

ailments, protect against disease,<br />

or promote health.<br />

WHO Regi<strong>on</strong>al office for the Western<br />

Pacific<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

Western Pacific Series, No. 2<br />

1989, 327 pages,<br />

151 colour plates[E]<br />

ISBN 92 9061 102 2<br />

Swiss francs 50.–/US $45.00<br />

In developing countries: Sw.fr. 35.–<br />

Order no. 1510002<br />

WHO Regi<strong>on</strong>al office for the Western Pacific<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

Western Pacific Series, No. 3<br />

1990, 410 pages, 200 colour plates [E]<br />

ISBN 92 9061 101 4<br />

Swiss francs 45.–/US $40.50<br />

In developing countries: Sw.fr. 31.50<br />

Order no. 1510003<br />

<strong>Co</strong>mpiled by Natural <str<strong>on</strong>g>Products</str<strong>on</strong>g> Research<br />

Institute, Seoul Nati<strong>on</strong>al University<br />

WHO Regi<strong>on</strong>al office for the Western Pacific<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

Western Pacific Series, No. 21<br />

1998, ix + 316 pages, 150 colour plates [E]<br />

ISBN 92 9061 120 0<br />

Swiss francs 42.–/US $37.80<br />

In developing countries: Sw.fr. 29.40<br />

Order no. 1510021


oms-catalogue 15/07/03 11:36 Page 33<br />

Medicinal Plants in the<br />

South Pacific<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> 102 comm<strong>on</strong>ly<br />

used Medicinal Plants in the<br />

South Pacific<br />

General Guidelines<br />

for Methodologies <strong>on</strong><br />

Research and Evaluati<strong>on</strong><br />

of Traditi<strong>on</strong>al Medicine<br />

Describes the informati<strong>on</strong> available,<br />

from both traditi<strong>on</strong>al medical texts<br />

and recent scientific studies, for<br />

102 medicinal plants used in the<br />

South Pacific Islands. Plants from<br />

this part of the world represent an<br />

especially diverse flora and include<br />

several species currently undergoing<br />

scientific investigati<strong>on</strong>.<br />

Addressed to ethnobotanists,<br />

phyto-chemists, and pharmacologists,<br />

the book aims to document<br />

traditi<strong>on</strong>al clinical uses and bring<br />

these to the attenti<strong>on</strong> of the<br />

internati<strong>on</strong>al scientific community.<br />

WHO has developed these general<br />

guidelines in resp<strong>on</strong>se to the questi<strong>on</strong>:<br />

what types of academic<br />

research approaches and methods<br />

can be used to evaluate the safety<br />

and efficacy of traditi<strong>on</strong>al medicine?<br />

The guidelines presented in this<br />

document c<strong>on</strong>sist of secti<strong>on</strong>s <strong>on</strong><br />

herbal medicines, <strong>on</strong> traditi<strong>on</strong>al procedure-based<br />

therapies, <strong>on</strong> clinical<br />

research, and related issues including<br />

ethics, educati<strong>on</strong> and training,<br />

and surveillance systems.<br />

The specific objectives of the guidelines<br />

are to harm<strong>on</strong>ize the use of<br />

certain accepted and important<br />

terms in traditi<strong>on</strong>al medicine; summarize<br />

key issues for developing<br />

methodologies for research and<br />

evaluati<strong>on</strong> of traditi<strong>on</strong>al medicine;<br />

improve the quality and value of<br />

research in traditi<strong>on</strong>al medicine; and<br />

provide appropriate evaluati<strong>on</strong><br />

methods to facilitate the development<br />

of regulati<strong>on</strong> and registrati<strong>on</strong><br />

in traditi<strong>on</strong>al medicine<br />

33<br />

WHO Regi<strong>on</strong>al office<br />

for the Western Pacific<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

Western Pacific Series, No. 19<br />

1998, xvii + 254 pages, 102 colour plates [E]<br />

ISBN 92 906 1119 7<br />

Swiss francs 33.–/US $29.70<br />

In developing countries: Sw.fr. 23.10<br />

Order no. 1510019<br />

2001, vi + 71 pages [E, F*]<br />

WHO/EDM/TRM/2000.1<br />

Swiss francs 19.–/US $17.10<br />

In developing countries: Sw.fr. 13.30<br />

Order no. 1930184


oms-catalogue 15/07/03 11:36 Page 34<br />

MEDICINAL PLANTS<br />

WHO M<strong>on</strong>ographs <strong>on</strong> Selected<br />

Medicinal Plants, Volume 1<br />

WHO M<strong>on</strong>ographs <strong>on</strong> Selected<br />

Medicinal Plants, Volume 2<br />

WHO M<strong>on</strong>ographs <strong>on</strong> Selected<br />

Medicinal Plants, Volume 3<br />

IN PREPARATION<br />

34<br />

This book c<strong>on</strong>tains 28 m<strong>on</strong>ographs<br />

<strong>on</strong> widely used medicinal plants,<br />

selected for inclusi<strong>on</strong> <strong>on</strong> the basis<br />

of scientific evidence for both safety<br />

and efficacy. Each m<strong>on</strong>ograph<br />

c<strong>on</strong>tains two parts, the first of<br />

which provides pharmacopoeial<br />

summaries for quality assurance<br />

purposes, including botanical features,<br />

identity tests, purity requirements,<br />

chemical assays and major<br />

chemical c<strong>on</strong>stituents. The sec<strong>on</strong>d<br />

part, drawing <strong>on</strong> an extensive<br />

review of scientific research,<br />

describes the clinical applicati<strong>on</strong>s<br />

of the plant material, with detailed<br />

pharmacological informati<strong>on</strong> and<br />

secti<strong>on</strong>s <strong>on</strong> c<strong>on</strong>traindicati<strong>on</strong>s,<br />

adverse effects and dosage.<br />

The m<strong>on</strong>ographs are intended to<br />

promote internati<strong>on</strong>al harm<strong>on</strong>izati<strong>on</strong><br />

in the quality c<strong>on</strong>trol and use<br />

of herbal medicines and to serve<br />

as models for the development<br />

of nati<strong>on</strong>al formularies.<br />

Volume 2 of the WHO M<strong>on</strong>ographs <strong>on</strong><br />

Selected Medicinal Plants provides an<br />

additi<strong>on</strong>al collecti<strong>on</strong> of 30 m<strong>on</strong>ographs<br />

covering the quality c<strong>on</strong>trol and traditi<strong>on</strong>al<br />

and clinical uses of selected<br />

medicinal plants reviewed by 120<br />

experts in more than 50 countries.<br />

It follows the same format as Volume 1<br />

with the additi<strong>on</strong> of two cumulative<br />

indexes in order to facilitate referencing.<br />

One lists the m<strong>on</strong>ographs in<br />

alphabetical order by plant name and<br />

the other according to the plant material<br />

of interest. Volume 2 also includes<br />

general technical notices that provide<br />

descripti<strong>on</strong>s of each secti<strong>on</strong>.<br />

Provides an additi<strong>on</strong>al collecti<strong>on</strong><br />

of 31 m<strong>on</strong>ographs.<br />

Medicinal Plants covered in volume 1<br />

Bulbus Allii Cepae. Bulbus Allii Sativi.<br />

Aloe. Aloe Vera Gel. Radix Astragali.<br />

Fructus Bruceae. Radix Bupleuri.<br />

Herba Centellae. Flos Chamomillae.<br />

<strong>Co</strong>rtex Cinnamomi. Rhizoma<br />

<strong>Co</strong>ptidis. Rhizoma Curcumae L<strong>on</strong>gae.<br />

Radix Echinaceae. Herba Echinaceae<br />

Purpureae. Herba Ephedrae. Folium<br />

Ginkgo. Radix Ginseng. Radix<br />

Glycyrrhizae. Radix Pae<strong>on</strong>iae. Semen<br />

Plantaginis. Radix Platycodi. Radix<br />

Rauwolfiae. Rhizoma Rhei. Folium<br />

Sennae. Fructus Sennae. Herba<br />

Thymi. Radix Valerianae. Rhizoma<br />

Zingiberis.<br />

Medicinal Plants covered in volume 2<br />

Radix Althaeae.<br />

Herba Andrographidis.<br />

Radix Angelicae Sinensis. Flos<br />

Calendulae. Flos Caryophylli.<br />

Rhizoma Cimicifugae. Folium<br />

cum Flore Crataegi. Radix<br />

Eleutherococci. Aetheroleum<br />

Eucalypti. Folium Eucalypti.<br />

<strong>Co</strong>rtex Frangulae. Folium et<br />

<strong>Co</strong>rtex Hamamelidis.<br />

Semen Hippocastani.<br />

Herba Hyperici. Aetheroleum<br />

Melaleucae. Folium Melissae.<br />

Aetheroleum Menthae<br />

Piperitae. Folium Menthae<br />

Piperitae. Folium Ocimi sancti.<br />

Oleum Oenotherae Biennis.<br />

Rhizoma Piperis Methystici.<br />

<strong>Co</strong>rtex Pruni Africaniae.<br />

<strong>Co</strong>rtex Rhamni Purshianiae.<br />

Flos Sambuci. Radix senegae.<br />

Fructus serenoae Repentis.<br />

Fructus silybi Mariae.<br />

Herba Tanaceti Parthenii.<br />

Radix Urticae. Folium Uvae Ursi.<br />

Medicinal Plants covered in volume 3<br />

Fructus Ammi Majoris. Fructus<br />

Ammi Visnagae. Fructus Anethi.<br />

Aetheroleum Anisi. Fructus Anisi.<br />

Semen Armeniacae. Flos Arnicae.<br />

Folium Azadirachti.Oleum<br />

Azadirachti. Flos Carthami.<br />

Stigma Croci. Fructus Foeniculi.<br />

Radix Gentianae Luteae. Radix<br />

Gentianae Scabrae. Gummi<br />

Gugguli. Radix Harpagophyti.<br />

Rhizoma Hydrastis.<br />

Radix Ipecacuanhae.<br />

Aetheroleum Lavandulae.<br />

Flos Lavandulae. Strobilus Lupuli.<br />

Gummi Myrrha. Herba Passiflorae.<br />

Testa Plantaginis.Radix Rehmanniae.<br />

Fructus Schisandrae. Radix<br />

Scutellariae. Radix cum Herba<br />

Taraxaci. Semen Trig<strong>on</strong>ellae<br />

Foenugraeci. <strong>Co</strong>rtex Uncariae.<br />

Fructus Zizyphi.<br />

1999, v + 289 pages [E]<br />

ISBN 92 4 154517 8<br />

Swiss francs 92.–/US $82.80<br />

In developing countries: Sw.fr. 64.40<br />

Order no. 1150460<br />

2002, v + 357 pages [E]<br />

ISBN 92 4 154537 2<br />

Swiss francs 100.–/US $90.00<br />

In developing countries: Sw.fr. 70.–<br />

Order no. 1152460<br />

IN PREPARATION 2004<br />

Order no. 1153460


oms-catalogue 15/07/03 11:36 Page 35<br />

TRADITIONAL MEDICINE<br />

Regulatory Situati<strong>on</strong><br />

of Herbal Medicines<br />

A Worldwide Review<br />

The increasing demand for medicinal<br />

plants and the products derived<br />

from them has led to c<strong>on</strong>cerns<br />

over their safety and efficacy.<br />

The evaluati<strong>on</strong> of herbal medicines<br />

and the use of registrati<strong>on</strong> and<br />

regulati<strong>on</strong> to ensure their safety<br />

and efficacy present important<br />

challenges.<br />

This document describes experiences<br />

from 52 countries in<br />

formulating policies <strong>on</strong> herbal<br />

medicines and introducing<br />

measures for their regulati<strong>on</strong><br />

and registrati<strong>on</strong>.<br />

1998, 45 pages [ E, F, S]<br />

WHO/TRM/98.1<br />

Swiss francs 14.–/US $12.60<br />

In developing countries: Sw.fr. 9.80<br />

Order no. 1930193<br />

Traditi<strong>on</strong>al Medicine in Asia<br />

This unique book provides a<br />

comprehensive picture of the vivid<br />

kaleidoscope of traditi<strong>on</strong>al<br />

medicine in Asia presented by 34<br />

eminent authors from 15 countries,<br />

bel<strong>on</strong>ging to the different systems<br />

like Ayurveda and Chinese<br />

Traditi<strong>on</strong>al Medicine.<br />

Important emerging areas such as<br />

harm<strong>on</strong>izati<strong>on</strong> of the traditi<strong>on</strong>al<br />

systems with modern medicine and<br />

the growing role of these systems<br />

in the health care structure of<br />

countries are also dealt with.<br />

Legislati<strong>on</strong> and regulati<strong>on</strong> of these<br />

systems and practiti<strong>on</strong>ers, an area<br />

of growing c<strong>on</strong>cern, the need for<br />

good preclinical toxicology studies<br />

and scientific clinical evaluati<strong>on</strong> of<br />

the products and medicinal plants<br />

used for therapy are exhaustingly<br />

dealt with. The vital issue of protecti<strong>on</strong><br />

of traditi<strong>on</strong>al systems of<br />

medicine and patenting of medicinal<br />

plants is discussed in detail.<br />

The book is replete with suggesti<strong>on</strong>s<br />

and ideas aimed at making<br />

traditi<strong>on</strong>al systems more effectively<br />

and more widely used for health<br />

care. The book also covers the prevailing<br />

situati<strong>on</strong> regarding the use<br />

and other aspects of traditi<strong>on</strong>al<br />

medicine in the 10 Member countries<br />

of the South-East Asia Regi<strong>on</strong><br />

of the World Health Organizati<strong>on</strong>.<br />

Edited by R.R. Chaudhury and Ut<strong>on</strong> M. Rafei<br />

WHO Regi<strong>on</strong>al Office for South-East Asia<br />

WHO Regi<strong>on</strong>al Publicati<strong>on</strong>s,<br />

South-East Asia Series, No. 39<br />

2002, vii + 309 pages [E]<br />

ISBN 92 9022 224 7<br />

Swiss francs 20.–/US $18.00<br />

In developing countries: Sw.fr. 14.–<br />

Order no. 1560039<br />

Legal Status of<br />

Traditi<strong>on</strong>al Medicine and<br />

<strong>Co</strong>mplementary/Alternative<br />

Medicine<br />

A Worldwide Review<br />

Various types of traditi<strong>on</strong>al medicine<br />

and other medical practices referred<br />

to as complementary or alternative<br />

medicine are increasingly used in<br />

both developing and developed<br />

countries. In order to promote safe<br />

and appropriate use of these<br />

medicines and practices, as well as<br />

to ensure the quality of service and<br />

practiti<strong>on</strong>ers, nati<strong>on</strong>al regulati<strong>on</strong>s are<br />

vital. Establishing nati<strong>on</strong>al policies<br />

<strong>on</strong> traditi<strong>on</strong>al medicine, and/or<br />

complementary/alternative medicine<br />

and their medical practices, should<br />

therefore include creati<strong>on</strong> of legal<br />

frameworks.<br />

This review summarizes the legal<br />

status of several major practices in<br />

traditi<strong>on</strong>al medicine and complementary/alternative<br />

medicine in 123<br />

coutries. It includes data <strong>on</strong>: the use<br />

of traditi<strong>on</strong>al and complementary/<br />

alternative medicine; the regulatory<br />

situati<strong>on</strong> of traditi<strong>on</strong>al and<br />

complementary/alternative remedies<br />

and practiti<strong>on</strong>ers; health insurance<br />

coverage of traditi<strong>on</strong>al and<br />

complementary/alternative<br />

medicine; educati<strong>on</strong> and training of<br />

practiti<strong>on</strong>ers of traditi<strong>on</strong>al and complementary/alternative<br />

medicine.<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> provided in this review<br />

will be useful not <strong>on</strong>ly to policy<br />

makers,but also to researchers,<br />

universities, the public, insurance<br />

companies and pharmaceutical<br />

industries.<br />

2001, ix + 189 pages [E, R]<br />

ISBN 92 4 154548 8<br />

Swiss francs 35.–/US $31.50<br />

In developing countries: Sw.fr. 24.50<br />

Order no. 1930190<br />

35


oms-catalogue 15/07/03 11:36 Page 36<br />

TRADITIONAL MEDICINE<br />

PSYCHOTROPIC DRUGS<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability<br />

of these documents,<br />

please refer to:<br />

www.who.int/medicines<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability<br />

of these documents,<br />

please refer to:<br />

www.who.int/medicines<br />

36<br />

WHO Traditi<strong>on</strong>al Medicine<br />

Strategy : 2002-2005<br />

WHO has developed this strategy<br />

for traditi<strong>on</strong>al medicine to enable<br />

this form of health care to better<br />

c<strong>on</strong>tribute to health security.<br />

It focuses <strong>on</strong> working with WHO<br />

Member States to define the role<br />

of traditi<strong>on</strong>al medicine in nati<strong>on</strong>al<br />

health care strategies, supporting<br />

the development of clinical<br />

research into the safety and efficacy<br />

of traditi<strong>on</strong>al medicines, and<br />

advocating the rati<strong>on</strong>al use of<br />

tradti<strong>on</strong>al medicine.<br />

2002, 61 pages<br />

WHO/EDM/TRM/2002.1<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/library/tr<br />

m/trm_strat_eng.pdf<br />

WHO Expert <strong>Co</strong>mmittee <strong>on</strong><br />

Drug Dependence<br />

Thirty-third Report<br />

This report presents the<br />

recommendati<strong>on</strong>s of a WHO<br />

Expert <strong>Co</strong>mmittee resp<strong>on</strong>sible<br />

for reviewing informati<strong>on</strong> <strong>on</strong><br />

dependence-producing drugs to<br />

assess the need for their internati<strong>on</strong>al<br />

c<strong>on</strong>trol. The first part of the<br />

report c<strong>on</strong>tains a descripti<strong>on</strong><br />

of the procedure for the review of<br />

dependence-producing substances.<br />

This is followed by a critical review<br />

of five psychoactive substances<br />

(amfepram<strong>on</strong>e, amineptine,<br />

buprenorphine, delta-9-tetrahydrocannabinol<br />

and tramadol). The<br />

report also discusses the substances<br />

that were pre-reviewed by the<br />

<strong>Co</strong>mmittee, four of which (ketamine,<br />

zopicl<strong>on</strong>e, butorphanol and<br />

khat) were recommended for<br />

critical review at a future meeting.<br />

The final secti<strong>on</strong> discusses the<br />

problems of the terminology used<br />

in reporting abuse-related adverse<br />

drug reacti<strong>on</strong>s and describes how<br />

c<strong>on</strong>fusi<strong>on</strong> affects the reporting of<br />

adverse effects using the example<br />

of the selective serot<strong>on</strong>in reuptake<br />

inhibitors.<br />

Guidelines for the WHO<br />

Review of Dependenceproducing<br />

Psychoactive<br />

Substances for<br />

Internati<strong>on</strong>al C<strong>on</strong>trol<br />

2000, 22 pages [E, F]<br />

WHO/EDM/QSM/2000.5<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/library/<br />

qsm/who-edm-qsm-2000-5/who-edmqsm-2000-5en.htm<br />

Narcotic and Psychotropic<br />

Drugs<br />

Achieving Balance in Nati<strong>on</strong>al<br />

Opioids C<strong>on</strong>trol Policy.<br />

Guidelines for Assessment<br />

The publicati<strong>on</strong> presents guidelines<br />

for governments to determine<br />

whether their nati<strong>on</strong>al drug c<strong>on</strong>trol<br />

policies have the legal and<br />

administrative framework to ensure<br />

medical availability of opioid<br />

analgesics, as recommended by<br />

the Internati<strong>on</strong>al Narcotics C<strong>on</strong>trol<br />

Board.<br />

2000, 37 pages [E, F]<br />

WHO/EDM/QSM/2000.4<br />

Electr<strong>on</strong>ic access:<br />

http://www.who.int/medicines/library/q<br />

sm/who-edm-qsm-2000-4/who-edmqsm-2000-4.htm<br />

Technical Report Series, No. 915<br />

2002 , 30 pages [E]<br />

ISBN 92 4 120915 1<br />

Swiss francs 14.–/US $12.60<br />

In developing countries: Sw.fr. 9.80<br />

Order no.1100915


oms-catalogue 15/07/03 11:36 Page 37<br />

PERIODICALS AND SUBSCRIPTIONS<br />

The WHO <strong>Pharmaceuticals</strong> and Biologicals<br />

Subscripti<strong>on</strong> Package<br />

A yearly service offering automatic and immediate delivery of all<br />

WHO publicati<strong>on</strong>s dealing with pharmaceuticals, pharmacy and<br />

biologicals.<br />

Introduced as a c<strong>on</strong>venience for customers, the WHO<br />

<strong>Pharmaceuticals</strong> and Biologicals Subscripti<strong>on</strong> Package includes subscripti<strong>on</strong>s<br />

to the following periodicals: WHO Drug <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

and the Essential Drugs M<strong>on</strong>itor. The subscripti<strong>on</strong> also covers new<br />

reports of the WHO Expert <strong>Co</strong>mmittees <strong>on</strong> biological standardizati<strong>on</strong>,<br />

specificati<strong>on</strong>s for pharmaceutical preparati<strong>on</strong>s, and drug<br />

dependence, plus all books relevant to drug research and<br />

development, manufacturing, prescribing, essential drugs,<br />

pharmacy, and internati<strong>on</strong>al regulati<strong>on</strong> and quality c<strong>on</strong>trol.<br />

The WHO <strong>Pharmaceuticals</strong> and Biologicals Subscripti<strong>on</strong> Package<br />

2003 subscripti<strong>on</strong> rate:<br />

Sw.fr. 240–/US $192.00<br />

(includes handling charges and postage via surface mail)<br />

WHO Drug <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

WHO Drug <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> communicates pharmaceutical informati<strong>on</strong><br />

that is either developed and issued by WHO or transmitted to WHO<br />

by research and regulatory agencies throughout the world. The journal<br />

also includes regular presentati<strong>on</strong> of changes in the WHO Model<br />

List of Essential Drugs and newly proposed and recommended<br />

Internati<strong>on</strong>al N<strong>on</strong>proprietary Names (INN) for Pharmaceutical<br />

Substances.<br />

Published quarterly in issues of approximately 50–60 pages each<br />

2003: Vol. 17<br />

ISSN 1010-9609<br />

Languages: available in English <strong>on</strong>ly<br />

2003 subscripti<strong>on</strong> rate:<br />

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37


oms-catalogue 15/07/03 11:36 Page 38<br />

PERIODICALS AND SUBSCRIPTIONS<br />

WEB ADDRESSES<br />

Free of charge<br />

For informati<strong>on</strong> <strong>on</strong> availability of these documents,<br />

please refer to: www.who.int/medicines<br />

38<br />

WHO <strong>Pharmaceuticals</strong><br />

Newsletter<br />

The aim of this Newsletter is to disseminate<br />

informati<strong>on</strong> <strong>on</strong> the safety<br />

and efficacy of pharmaceutical<br />

products, based <strong>on</strong> informati<strong>on</strong><br />

received from our network of<br />

"drug informati<strong>on</strong> officers" and<br />

other sources such as specialized<br />

bulletins and journals, as well as<br />

partners in WHO. Also c<strong>on</strong>tains<br />

informati<strong>on</strong> <strong>on</strong> adverse drug<br />

reacti<strong>on</strong>s.<br />

2003, 4 volumes each year<br />

C<strong>on</strong>tact: QSM@who.int<br />

Essential Drugs M<strong>on</strong>itor<br />

The Essential Drugs M<strong>on</strong>itor is produced<br />

and distributed by the WHO<br />

Department of Essential Drugs and<br />

Medicines Policy. It is published in<br />

Chinese, English, French, Spanish<br />

and Russian, and has a global readership<br />

of some 300,000 to whom<br />

it is free of charge. The M<strong>on</strong>itor<br />

carries news of developments in<br />

nati<strong>on</strong>al drug policies, therapeutic<br />

guidelines, current pharmaceutical<br />

issues, educati<strong>on</strong>al strategies and<br />

operati<strong>on</strong>al research.<br />

2003, 2 issues per year<br />

C<strong>on</strong>tact: The Editor, Essential Drugs<br />

M<strong>on</strong>itor, WHO, 1211 Geneva 27,<br />

Switzerland<br />

Email: medmail@who.int<br />

Essential Drugs in Brief<br />

The purpose of Essential drugs in<br />

brief is to share informati<strong>on</strong> <strong>on</strong> the<br />

latest country support provided or<br />

coordinated by the extended Drug<br />

Acti<strong>on</strong> Programme team (country,<br />

regi<strong>on</strong>al and HQ offices). It is an<br />

informal instrument aiming<br />

to share our experiences with<br />

colleagues within and outside<br />

WHO, who are active in the implementati<strong>on</strong><br />

of nati<strong>on</strong>al drug policies<br />

at nati<strong>on</strong>al and regi<strong>on</strong>al levels.<br />

2003, 3 issues per year<br />

C<strong>on</strong>tact: dap@who.int<br />

Additi<strong>on</strong>al informati<strong>on</strong> and updates<br />

are available at the following<br />

WHO web sites:<br />

Medicines web site:<br />

http://www.who.int/medicines<br />

The public web site of the WHO/EDM<br />

Essential Drugs and Medicines Policy<br />

Department<br />

The Pharmaceutical <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> and<br />

Documentati<strong>on</strong> Centre web site:<br />

http://www.who.int/medicines/<br />

informati<strong>on</strong>/infdoccentre.shtml<br />

Email: edmdoccentre@who.int<br />

Mednet web site:<br />

http://mednet.who.int<br />

The Essential Drugs and Medicines<br />

extranet for focussed pharmaceutical<br />

informati<strong>on</strong> exchange<br />

The Essential Drug M<strong>on</strong>itor web site:<br />

http://www.who.int/medicines/<br />

informati<strong>on</strong>/infm<strong>on</strong>itor.shtml<br />

WHO Drug <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> web site:<br />

http://www.who.int/druginformati<strong>on</strong>


oms-catalogue 15/07/03 11:36 Page 39<br />

TITLE INDEX<br />

Adverse drug reacti<strong>on</strong> terms: definiti<strong>on</strong>, 29<br />

Antimicrobial resistance in the Americas, 24<br />

Assessing new vaccines for nati<strong>on</strong>al immunizati<strong>on</strong><br />

programmes, 28<br />

Basic tests for drugs, 9<br />

Basic tests for pharmaceutical dosage forms, 9<br />

Basic tests for pharmaceutical substances, 9<br />

Benefit-risk balance for marketed drugs: evaluating<br />

safety signals, 29<br />

Biomedical research ethics: updating internati<strong>on</strong>al<br />

guidelines, 28<br />

<strong>Co</strong>st-c<strong>on</strong>tainment mechanisms for essential medicines,<br />

including antiretrovirals, in China, 6<br />

<strong>Co</strong>unterfeit drugs, 16<br />

Drugs for the elderly, 24<br />

Eastern Mediterranean series<br />

No. 4: Guide to chemotherapy and chemoprophylaxis<br />

in bacterial infecti<strong>on</strong>s, 23<br />

Effective drug regulati<strong>on</strong>, 25<br />

Essential drugs in brief, 38<br />

European series<br />

No. 71: Drugs for the elderly, 24<br />

Globalizati<strong>on</strong> and access to drugs, 6<br />

Guide to chemotherapy and chemoprophylaxis<br />

in bacterial infecti<strong>on</strong>s, 23<br />

Guide to drug financing mechanisms, 6<br />

Guide to good prescribing, 21<br />

Guidelines for ATC classificati<strong>on</strong> and DDD assignment, 14<br />

Guidelines for drug d<strong>on</strong>ati<strong>on</strong>s, 7<br />

Guidelines for preparing core clinical-safety<br />

informati<strong>on</strong> <strong>on</strong> drugs, 28<br />

Guidelines for safe disposal of unwanted<br />

pharmaceuticals in and after emergencies, 7<br />

Guidelines for the appropriate use of herbal medicines, 31<br />

Guidelines for the regulatory assessment<br />

of medicinal products for use in self-medicati<strong>on</strong>, 25<br />

Guidelines for the WHO review of dependence-producing<br />

psychoactive substances for internati<strong>on</strong>al c<strong>on</strong>trol, 36<br />

Guidelines <strong>on</strong> the use of internati<strong>on</strong>al n<strong>on</strong>proprietary<br />

names (INNs) for pharmaceutical substances, 13<br />

Handbook <strong>on</strong> access to HIV/AIDS-related treatment, 3<br />

Health reform and drug financing, 6<br />

How to develop and implement a nati<strong>on</strong>al drug policy, 5<br />

Implicati<strong>on</strong>s of the DOHA declarati<strong>on</strong> <strong>on</strong> the TRIPS<br />

agreement and public health, 6<br />

Importance of pharmacovigilance, 16<br />

Indicators for m<strong>on</strong>itoring nati<strong>on</strong>al drug policies, 5<br />

Internati<strong>on</strong>al n<strong>on</strong>proprietary names (INN)<br />

for pharmaceutical substances CD-ROM, 8<br />

Internati<strong>on</strong>al n<strong>on</strong>proprietary names (INN) for pharmaceutical<br />

substances: names of radicals and groups, 16<br />

Internati<strong>on</strong>al pharmacopoeia, 17-20<br />

Internati<strong>on</strong>al travel and health 2003, 25<br />

Legal status of traditi<strong>on</strong>al medicine<br />

and complementary/alternative medicine, 35<br />

Marketing authorizati<strong>on</strong> of pharmaceutical products with<br />

special reference to multisource (Generic) products, 26<br />

Medicinal plants in China, 32<br />

Medicinal plants in the Republic of Korea, 32<br />

Medicinal plants in the South Pacific, 33<br />

Medicinal plants in Viet Nam, 32<br />

Narcotic and psychotropic drugs, 36<br />

Network for m<strong>on</strong>itoring the impact of globalizati<strong>on</strong><br />

and TRIPS <strong>on</strong> access to medicines, 6<br />

New emergency health kit 1998, 4<br />

Operati<strong>on</strong>al principles for good pharmaceutical<br />

procurement, 7<br />

Pharmaceutical restricti<strong>on</strong>s in use and availability, 16<br />

Practical guidelines <strong>on</strong> pharmaceutical procurement<br />

for countries with small procurement agencies, 7<br />

Publicati<strong>on</strong>s from the South Centre, 27<br />

Public-private roles in the pharmaceutical sector, 6<br />

Quality assurance of pharmaceuticals, 10<br />

Quality c<strong>on</strong>trol methods for medicinal plant materials, 10<br />

Regulatory situati<strong>on</strong> of herbal medicines, 35<br />

Research guidelines for evaluating the safety<br />

and efficacy of herbal medicines, 31<br />

SEARO Regi<strong>on</strong>al Health Papers<br />

No.16: Essential drugs for primary health care, 4<br />

Safety m<strong>on</strong>itoring of medicinal products, 16<br />

Safety of medicines, 16<br />

Selecti<strong>on</strong> and use of essential medicines, 3<br />

South-East Asia series<br />

No. 39: Traditi<strong>on</strong>al medicine in Asia, 35<br />

Teacher’s guide to good prescribing, 21<br />

Technical report series<br />

No. 889: WHO expert committee <strong>on</strong> biological<br />

standardizati<strong>on</strong> (48th report), 12<br />

No. 902: WHO expert committee <strong>on</strong> specificati<strong>on</strong>s<br />

for pharmaceutical preparati<strong>on</strong>s (36th report), 11<br />

No. 904: WHO expert committee <strong>on</strong> biological<br />

standardizati<strong>on</strong> (50th report), 12<br />

No. 908: WHO expert committee <strong>on</strong> specificati<strong>on</strong>s<br />

for pharmaceutical preparati<strong>on</strong>s (37th report), 11<br />

No. 910: WHO expert committee <strong>on</strong> biological<br />

standardizati<strong>on</strong> (51st report), 12<br />

No. 914: Selecti<strong>on</strong> and use of essential medicines, 3<br />

No. 915: WHO expert committee <strong>on</strong> drug<br />

dependence (33rd report), 36<br />

Traditi<strong>on</strong>al medicine in Asia, 35<br />

Use of comm<strong>on</strong> stems in the selecti<strong>on</strong><br />

of internati<strong>on</strong>al n<strong>on</strong>proprietary names (INN)<br />

for phamaceutical substances, 16<br />

Vitamin A supplements, 24<br />

Western Pacific series<br />

No. 3: Medicinal plants in China, 32<br />

No. 2: Medicinal plants in Viet Nam, 32<br />

No. 19: Medicinal plants in the South Pacific, 33<br />

No. 21: Medicinal plants in the Republic of Korea, 32<br />

No. 23: Guidelines for the appropriate use<br />

of herbal medicines, 31<br />

WHO basic training modules <strong>on</strong> GMP CD-ROM, 15<br />

WHO <strong>Co</strong>llaborating centre for internati<strong>on</strong>al<br />

drug m<strong>on</strong>itoring, 30<br />

C<strong>on</strong>t. page 40<br />

39


oms-catalogue 15/07/03 11:36 Page 40<br />

TITLE INDEX<br />

WHO drug informati<strong>on</strong>, 37<br />

WHO expert committee <strong>on</strong> biological standardizati<strong>on</strong>, 12<br />

WHO expert committee <strong>on</strong> drug dependence, 36<br />

WHO expert committee <strong>on</strong> specificati<strong>on</strong>s<br />

for pharmaceutical preparati<strong>on</strong>s, 11<br />

WHO medicines bookshelf CD-ROM, 3<br />

WHO medicines strategy, 5<br />

WHO model formulary 2002, 2<br />

WHO model prescribing informati<strong>on</strong>: drugs used<br />

in bacterial infecti<strong>on</strong>s, 23<br />

WHO model prescribing informati<strong>on</strong>: drugs used<br />

in parasitic diseases, 22<br />

WHO model prescribing informati<strong>on</strong>: drugs used<br />

in sexually transmitted diseases and HIV infecti<strong>on</strong>, 22<br />

WHO model prescribing informati<strong>on</strong>: drugs<br />

used in skin diseases, 23<br />

WHO m<strong>on</strong>ographs <strong>on</strong> selected medicinal plants, 33-34<br />

WHO pharmaceuticals and biologicals<br />

subscripti<strong>on</strong> package, 37<br />

WHO pharmaceuticals newsletter, 38<br />

WHO policy perspectives <strong>on</strong> medicines, 5<br />

WHO traditi<strong>on</strong>al medicine strategy, 36<br />

40


oms-catalogue 15/07/03 11:36 Page 41<br />

ADDRESSES<br />

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Geneva, Switzerland (Headquarters)<br />

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<strong>Co</strong>uncil for Internati<strong>on</strong>al Organizati<strong>on</strong>s<br />

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C.I.O.M.S.<br />

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41


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99235 43, Email: alexhorn1@aol.com<br />

GREECE: G.C. Eleftheroudakis S.A.,<br />

Librairie internati<strong>on</strong>ale, 17 Panepistimiou,<br />

105-64 Athens, Tel: (30 1) 331 41 80 ,<br />

Fax: (30 1) 323 98 21<br />

INDIA: WHO Regi<strong>on</strong>al Office for South-<br />

East Asia, World Health House,<br />

Indraprastha Estate, Mahatma Gandhi<br />

Road, New Delhi 110002 ,Tel: (91 11)<br />

331 7804, Fax: (91 11) 331 8607,<br />

Email: Publicati<strong>on</strong>s@whosea.org<br />

ISRAEL: Yozmot <strong>Ltd</strong>, P.O. Box 56055, Tel<br />

Aviv 61560, Tel: (972) 3 528 48 51, Fax:<br />

(972) 3 528 53 97, Email: books@yozmot.com<br />

ITALY: Edizi<strong>on</strong>i Minerva Medica, <strong>Co</strong>rso<br />

Bramante 83-85, 10126 Turin<br />

Tel: (39 011) 67 8282, Fax: (39 011) 67<br />

45 02, Email: journals.dept@minervamedica.it<br />

JAPAN: Maruzen <strong>Co</strong>. <strong>Ltd</strong>., P.O. Box<br />

5050, Tokyo Internati<strong>on</strong>al, 100-31,<br />

Tel: (81 3) 3272 7211, Fax: (81 3) 3274<br />

3238, Email: K_iwata@maruzen.co.jp<br />

JORDAN: Jordan Book Centre <strong>Co</strong>. <strong>Ltd</strong>,<br />

P.O. Box 301 Al-Jubeiha, Amman<br />

11941,Tel: 5151 882, Fax: 5152 016,<br />

E.mail: jbc@go.com.jo<br />

Global Development Forum, PO Box<br />

941488, Amman 11194,<br />

Tel: 6465 61 24, Fax: 6465 61 23,<br />

Email: gdf@index.com.jo<br />

KENYA: Text Book Center <strong>Ltd</strong>, P:O. Box<br />

47540, Nairobi, Tel: (254) 233 03 42,<br />

Fax: (254) 233 81 10<br />

MEXICO: Librería Internaci<strong>on</strong>al de C.V.,<br />

Av. S<strong>on</strong>ora 206, 06100-Mexico, D.F.,<br />

Tel: (52 5) 265 11 65, Fax: (52 5) 265 11<br />

64, Email: libinter@compuserve.com.mx<br />

NETHERLANDS: De Lindeboom<br />

Internati<strong>on</strong>ale Publicaties b.v., P.O. Box<br />

202, NL-7480 AE Haaksbergen,<br />

Tel: (31) 53 574 00 04, Fax: (31) 53 572<br />

92 96, Email: books@delindeboom.com<br />

NEW ZEALAND: Medical Books (New<br />

Zealand), <strong>Ltd</strong>, 8 Park Avenue, P.O. Box<br />

8565, Sym<strong>on</strong>ds Street, Auckland 3,<br />

Tel: (64 9) 373 3773, Fax: (64 9) 373<br />

3282<br />

NIGERIA: Mr G. Obiaga, 28 Onitsha<br />

Road, P.O. Box 370, Nnewi, Anambra<br />

State, Tel/Fax:(234) 46 460 273<br />

NORWAY: Academic Book Center, PO<br />

Box 2728, St Hanshaugen, 0131 Oslo,<br />

Tel: (47 22) 99 48 40, Fax: (47 22) 20 89<br />

71, Email: abc@fribokhandel.no<br />

PERU: Euroamerican Bussiness SA, Ca.<br />

las Beg<strong>on</strong>ias No. 183, Dept. 202, Urb.<br />

J.C. Mariategui, Lima 35,Tel: (51 1)<br />

725 9152, Fax: (51 1) 283 0129,<br />

Email: euroamerican@terra.com.pe<br />

POLAND: Ars Pol<strong>on</strong>a, ul. Krakowskie<br />

Przedmiescie 7, 00-950 Warszawa,<br />

Tel: (48 ) 22 826 12 01, Fax: (48) 22 826 47<br />

63, Email: books119@arspol<strong>on</strong>a.com.pl<br />

PORTUGAL: Livraria Rodrigues, 188 Rua da<br />

Ouro, 1100 Lisboa,<br />

Tel: (351 21) 342 48 57,<br />

Fax: (351 21) 343 13 02 ; Prata & Rodrigues<br />

Publicaçoes, <strong>Ltd</strong>a, Estrada da Luz, 90-11º H,<br />

1600-160 Lisboa,Tel: (351 21) 722 35 28/29,<br />

Fax: (351 21) 722 35 31, Email:<br />

ip263692@ip.pt; LUSODOC, Documentação<br />

Técnico-Cientifica <strong>Ltd</strong>a, Rua Cruzado<br />

Osberno 3,5°, Dt°, 1900 Lisboa,<br />

Tel: (351) 21 815 3312, Fax: (351) 21 813<br />

0641, Email: postmaster@lusodoc.pt<br />

SINGAPORE: Select Books, 19 Tanglin Road,<br />

03-15 Tanglin Shopping Center, Singapore<br />

247909, Tel: (65) 732 15 15, Fax: (65) 736<br />

08 55, Email:info@selectbooks.com.sg<br />

SOUTH AFRICA: Democratic Nursing<br />

Organisati<strong>on</strong> of South Africa (DENOSA), P.O.<br />

Box 1280, 605 Church street, Pretoria (T)<br />

0001, Tel: (27 12) 343 2315, Fax: (27 12)<br />

344 0750; Email: info@denosa.org.za<br />

SPAIN: Librería Díaz de Santos, Lagasca, 95,<br />

P.O. Box 6050, 28006 Madrid, Tel: (34 91)<br />

781 94 80, Fax: (34 91) 575 55 63;<br />

Email:librerias@diazdesantos.es<br />

SWEDEN: Akademibokhandeln, Mäster<br />

Samuelsgatan 28, Box 7634, 103 94<br />

Stockholm,Tel: 0046-8-613 61 30,<br />

Fax: 0046-8-24 25 43,<br />

Email: marikka.lindahl@city.akademi-bokhandeln.se;<br />

PRIO Info Center AB,<br />

Prastgardgatan 1-3, 172 29 Sundbyberg,<br />

Tel: (46) 8 441 17 40, Fax: (46) 8 652 81 15,<br />

E.mail: info@prioinfo.se<br />

SWITZERLAND: Huber & Lang, Hans Huber<br />

AG, Länggassstrasse 76, 3000 Bern 9,<br />

Tél: (41 31) 300 45 00, Fax : (41 31) 300 45<br />

90, Email: WHO@HansHuber.com<br />

TRINIDAD & TOBAGO: Systematics Studies<br />

<strong>Ltd</strong>, St Augustine Shopping Centre, Eastern<br />

Main Road, St Augustine, Tel: (1 809) 645<br />

8466, Fax:(1 809) 6458467,<br />

Email:tobe@trinidad.net<br />

UGANDA: Gustro <strong>Ltd</strong>, PO Box 9997,<br />

Kampala , Tel: (256) 41 251 467,<br />

Fax: (256) 41 251 468<br />

Email: Gustro@swiftuganda.com<br />

UNITED KINGDOM: The Stati<strong>on</strong>ery Office<br />

Publicati<strong>on</strong>s Centre, 51 Nine Elms Lane,<br />

L<strong>on</strong>d<strong>on</strong> SW8 5DR, Tel: (44) 0870 660 5522.<br />

Fax: (44) 0870 600 5533.<br />

Email: ipa.enquiries@theso.co.uk<br />

UNITED STATES OF AMERICA: (Books)<br />

WHO Publicati<strong>on</strong>s Center USA, 49 Sheridan<br />

Ave., Albany, NY 12210, Tel: (1-518) 436<br />

9686, Fax: (1-518) 436 74 33,<br />

Email: Qcorp@compuserve.com.<br />

Other countries please c<strong>on</strong>tact:<br />

Autres pays, veuillez prendre c<strong>on</strong>tact avec:<br />

WHO, Marketing & Disseminati<strong>on</strong>,<br />

CH-1211 Geneva 27, Switzerland<br />

Tel: +41 22 791 24 76<br />

Fax: +41 22 791 48 57<br />

Email: bookorders@who.int<br />

45


oms-catalogue 15/07/03 11:36 Page 46<br />

World Health Organizati<strong>on</strong><br />

Marketing and Disseminati<strong>on</strong><br />

Address:<br />

CH-1211 Geneva 27<br />

Switzerland<br />

Teleph<strong>on</strong>e:<br />

+41 22 791 24 76<br />

Fax:<br />

+41 22 791 48 57<br />

Email:<br />

publicati<strong>on</strong>s@who.int<br />

Email for orders:<br />

bookorders@who.int<br />

Order <strong>on</strong>line:<br />

http://bookorders.who.int<br />

World Health Organizati<strong>on</strong><br />

Internet address:<br />

www.who.int<br />

WHO Model Formulary 2002<br />

MDI.PHA.203

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