Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.
Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.
Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.
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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 />
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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 />
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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 />
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37
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WHO <strong>Pharmaceuticals</strong><br />
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and efficacy of pharmaceutical<br />
products, based <strong>on</strong> informati<strong>on</strong><br />
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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 />
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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 />
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Switzerland<br />
Email: medmail@who.int<br />
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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 />
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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 />
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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