Publications

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Publications from the UMC

A bibliography listing UMC scientific papers and articles from 2003 to 2009 is available here in Adobe Acrobat format: UMC bibliography 2009 - updated in December 2009.

In addition, we are now able to offer pdfs of some key articles involving UMC authors in Drug Safety (Adis). These may be found in the Practical Pharmacovigilance section of this website.

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Posters presented by the UMC

• Documentation grading of ICSRs and improved data quality management in Vigibase (Lindquist M, Star K, Strandell J)
• Pulmonary fibrosis reported with statins (Kiuru A, Yue Q-Y , Meyboom RH)  
• Hypersensitivity reactions to Umckaloabo (Pelargonium sidoides DC and P reniforme Curtis) (De Boer H, Hagemann U, Bate J, Meyboom RH)
• Concomitant use of glucosamine potentiates the effect of warfarin (Yue Q-Y, Strandell J, Myrberg O)
• Can WHO-database of suspected ADRs be used to support existing information on pharmacokinetic drug interactions? (Strandell J, Bate A, Eiermann B, Lindquist M, Edwards IR) 
• Duplicate detection in the WHO adverse drug reaction database (Norén GN, Bate A, Johansson K, Orre R, Edwards IR)
• Who Where and What in Spontaneous Reports (Star K, Lindquist M)  
• Immune Agranulocytosis and Clarithromycin (Jacobs P, Conforti A, Wood L, Kiuru A, Jones G, Woolf D) 
• Cimicifuga racemosa anaphylax (Frempong W, Kiuru A, Ericsson J, Farah M)
• Linking spontaneous reports with pharmacogenetics (Strandell J, Kiuru A, Lindquist M)
• Bisphosphonates and Ocular side effects (Kiuru A, Fraunfelder F, Edwards IR)
• Selective Serotonin reuptake inhibitors (SSRIs) and blood pressure (Meyboom RHB, Pettersson M, Kiuru A)
• WHO Signals 1998-2001 A follow-up (Star K, Ståhl M, Strandell J, Pettersson M, Lindquist M)
• Impact of signals generated from the WHO database (Ståhl M, Bowring G, Edwards IR, Kiuru A, Lindquist M)
• Pattern recognition using a recurrent neural network and its application to the WHO database (Bate A, Lindquist M, Orre R, Edwards)
• Automated evaluation of signals as group effects or drug specific using the WHO database (Bate A, Lindquist M, Edwards IR, Orre R)
• Pattern detection for celecoxib and rofecoxib in the WHO database (Bate A, Norén N, Orre R, Lindquist M, Edwards IR)
• International availability of translations of WHO and UMC pharmacovigilance texts (Bowring G, Olsson S)
• Vigimed, an international drug safety e-mail discussion group (Johansson K, Meyboom R)

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Viewpoint
Watching for safer medicines

Part 1 - Issues, controversies and science in the search for safer and more rational use of medicines

For the first time in a widely distributed publication, the issues and questions surrounding the safety of drugs are discussed in a simple and accessible way for the general and specialist reader.

Viewpoint Part 1 (2nd edition, June 2010) is written and designed for the widest possible general audience. It centres on the obvious, but publicly little-known truth that no medicine is 100% safe for all people in all circumstances. Viewpoint looks at how hazards can be detected and prevented and the national and international efforts to improve therapy and its safety.

Basic concepts such as benefit and harm, effectiveness and risk are discussed, and explanations of the process of clinical trials and the limitations of information at the point a medicine is first marketed are given. The interpretation of risk statistics is among the topics covered. The importance of ADR reporting is highlighted along with the vital part observant patients play in the drug safety network.

Part 2 - International collaboration, research and resources for the safer and more rational use of medicines

Viewpoint Part 2 is an in-depth account of the WHO Programme and the work of the UMC for a more technical specialist audience. Every aspect of ADR reporting is described and illustrated in detail, from the patient's reporting of symptoms and the doctor's diagnosis of an ADR (or failure to recognise an ADR), through classification of ADRs, methods for assessing cases, to the use of the latest neural network techniques for detecting signals in the WHO international ADR database (Vigibase) and the process for disseminating this information. The intricacies of Vigibase itself are laid out, and the WHO Drug Dictionary (WHO-DD) and the WHO Adverse Reaction Terminology (WHO-ART) - the core tools for coding and analysis of ADR reports ? are explained and illustrated. Viewpoint Part 2 has 68 pages full-colour pages.

If you want a thorough and accessible description of the WHO Drug Dictionary or the meaning of neural networks; signal detection or causality assessment; risk management or herbals - or dozens of other topics, Viewpoint Part 2 is for you!
The 2nd edition of Viewpoint Part 1 is available in Adobe Acrobat format and can be downloaded from this site. However, if you would prefer a printed copy, please contact the UMC (see end of this section for contact details).
 French and Spanish translations are also available in print form from the UMC.

• Viewpoint 1 2nd edition (Adobe Acrobat file, 2.1 Mb)
• Summary Viewpoint text only (Adobe Acrobat file, 200 Kb)

A low-resolution pdf of Viewpoint Part 2 (2.1 Mb pdf) is also downloadable.

For more information about Viewpoint, or if you wish to receive a copy of Viewpoint Part 2 or any of the versions of Part 1, please either fax your request to +46 18 65 60 88 or e-mail info@who-umc.org

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Guidelines for setting up and running a Pharmacovigilance Centre

This guide of 25 pages is a good basic text for use in teaching pharmacovigilance. It is available for download here in English, French, Spanish, Portugese and Russian:

English version (Adobe Acrobat, 341 Kb) 
French version (Adobe Acrobat, 110 Kb)
Spanish version (Adobe Acrobat, 115 Kb)
Portugese version (Adobe Acrobat, 575 Kb)
Russian version  (Adobe Acrobat, 473 Kb)

or contact Anette Sahlin at the UMC for a printed copy, or the French or Spanish translations. A limited number of copies are also available in Italian and Korean - please apply for details.

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Uppsala Reports

Uppsala Reports is the UMC's regular news bulletin for everyone concerned with the issues of pharmacovigilance.

To download either left click on the hyperlink or right click and 'Save As'. 

• Uppsala Reports 50 - July 2010 (Adobe Acrobat document, 2 Mb). The 50th edition of Uppsala Reports has lots of pharmacovigilance news from around the world, as well as a look back over the first half-century of issues.
• Uppsala Reports 49 - April 2010 (Adobe Acrobat, 1.3 Mb). The April edition has news on the 5 million reports in the WHO ICSR database as well as graphics showing reporting trends, an introduction to the new UMC Board, a presentation of the Monitoring Medicines project, 'Behind the scenes' in the IT support area of the UMC, reports from Thailand, Costa Rica and Suriname - as well as the Erice Statement, a message from the Director and many more news items and updates.
• Uppsala Reports 48 - January 2010 (Adobe Acrobat, 730 Kb). The January edition includes features on the 32nd meeting of the WHO Programme in Morocco, recent developments in Canada, the Swiss haemovigilance system, surveys to users of the UMC data search facilities and to EU countries about data entry in the WHO global database of ICSRs, and in memoriam Bozidar Vrhovac - as well as reports from a wide range of meetings during the conference season, a message from the Director and many more news items and updates.
• Uppsala Reports 47 - October 2009 (Adobe Acrobat, 1.1 Mb). The October 2009 edition contains a major feature about UMC signal work, news about 'PaniFlow', reporting statistics to the WHO global database of ICSRs, as well as an introduction to the new Director, Marie Lindquist, and reflections on the work of Ralph Edwards; along with many more news features and updates. 
• Uppsala Reports 46 - July 2009 (Adobe Acrobat, 800 Kb). The July 2009 edition contains several introductory articles on new members of the WHO Programme, a report on the UMC pharmacovigilance training course, developments in VigiFlow and the new 'PaniFlow', the new post-marketing surveillance network for vaccines, and a report from the 25th anniversary meeting of the Spanish pharmacovigilance system. There are also reports on UMC collaborations and research, staff news, and a surprise Director's message.
• Uppsala Reports 45 - April 2009 (Adobe Acrobat, 1.3 Mb). The April 2009 edition contains articles on cohort event monitoring and a new tool to manage data collection from such surveillance: CemFlow. There are also reports on pharmacovigilance of antiretroviral medicines, two major projects to boost drug safety in Africa, statistics of the current position with reporting to the WHO ISCR database Vigibase, plus international conference reports and recent publications.
• Uppsala Reports 44 - January 2009 (Adobe Acrobat, 2 Mb). The January 2009 edition concentrates particularly on reports from the anniversary meetings in Uppsala in October 2008, including the WHO Programme meeting. However, there are also features on new member countries (Namibia, Kazakhstan and Andorra), Vigimine, the Drug Dictionary Browser, a report on the WHO ISCR database Vigibase, plus international conference reports and recent publications.

For issues of Uppsala Reports before 2009, please visit our Publications Archive, where you may also find Ralph Edwards' commentaries from 2002 to 2009 Reflections on pharmacovigilance.

If you already receive / read Uppsala Reports, do please take a moment to complete a very short questionnaire.

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Writings on Pharmacovigilance

Many of the activities of the WHO Programme for International Drug Monitoring have developed from original ideas and work of Professor David Finney and his contemporaries. The progress in semi-automated signal detection, in recognizing broader patient safety matters, development of terminology and post-marketing surveillance are among many examples.

The UMC has re-published the key ideas and thoughts of David Finney in a volume of 23 papers published over 40 years, tracing Professor Finney's involvement with ADR monitoring and the growth of pharmacovigilance.

Writing on Pharmacovigilance - Selected articles by David J Finney, is available from the UMC.

The charge to cover postage and packing is 250 SEK.

Effective Communications in Pharmacovigilance

The International Conference on Developing Effective Communications in Pharmacovigilance was held in Erice, Sicily, 24-27 September 1997. It was attended by health professionals, researchers, academics, media.

The full report of the conference - The Erice Report - is available from the UMC at a cost of 200 SEK.

The text of "Effective Communications in Pharmacovigilance - The Erice Declaration" is available in Definitions : The Erice Declaration.

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Dialogue in Pharmacovigilance

• Principles in good communications in pharmacovigilance
• Description of players - their activities, interests and needs
• The role of the mass media in public drug education
• Academic journals
• General public drug education, profession education
• Prescribing information
• Pharmacovigilance information for patients
• Communication on ADRs occurring with marketed medicines
• Crisis and recall
• Legal concerns

Dialogue in Pharmacovigilance may be obtained from the UMC for 350 SEK, including postage; see Ordering.

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The UMC's work on herbal synonyms in the form of lists of accepted scientific names and their Latin and vernacular synonyms.

The UMC has constructed a checklist with reference between botanical accepted names, botanical synonyms, and vernacular names. These accepted botanical names have been assigned as such in a collaboration between the WHO Collaborating Centre in Uppsala and the Royal Botanic Gardens, Kew in London.

The botanical synonyms and the vernacular names for the accepted botanical names have been assigned in collaboration with the Department of Systematic Botany at Uppsala University.

Contact details for ordering - see foot of this web page.

Copies are provided to all National Centres in the WHO Programme.

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Expecting the Worst - Crisis Management

The 2nd edition of this UMC publication about anticipating, preventing and managing medicinal product crises came out in August 2010. Completely revised, expanded and with a new chapter on vaccine crises, the 190-page book is aimed not only at member countries of the WHO Programme, but can be highly useful for other organisations in the pharmaceuticals area and beyond.

Theory and good practice guidelines will provide the reader with the resources to be prepared for the worst, and to have the knowledge, plans and skills to anticipate and prevent crises or to manage them capably and professionally.

The chapter titles are as follows:

• Introduction
• Action: the framework for planning - A quick overview
• What is crisis management?
• A general model and rationale for crisis management
• Planning for crisis management
• Risk assessment and risk management
• Crisis communications
• Vaccines and crisis management
• A typical crisis: the first day
• Appendices on case studies, sample guidelines, sources of crisis, stakeholders, media relations, social networking, effective communications and audience psychology; references

Expecting the Worst costs SEK 570, US$75, £50 or ?60.

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Herbal ATC classification

the Uppsala Monitoring Centre has published Guidelines for Herbal ATC Classification and a Herbal ATC Index.

Some herbal remedies have a longstanding use in medicine and their actions are well-defined. For various reasons it has been deemed impractical to incorporate hundreds of herbal remedies in the regular ATC classification. However, experience from the ATC system - particularly in connection with the monitoring of adverse effects of drugs - has shown that such a system would also be suitable for herbal remedies.

In 1998, De Smet proposed a system for ATC classification of herbal remedies which is fully compatible with the regular system. With a few modifications this system has now been adopted and is given in these draft guidelines. The ATC Index lists ATC codes per substance, while this herbals guideline is a help to assign ATC codes to herbal remedies.

In both the ATC and the Herbal ATC systems remedies are divided into groups according to their therapeutic use. Whenever possible the level 1-4 codes in the herbal system are equal to the levels in the regular ATC system.

The Guidelines and Index are available to academic and commercial customers via UMC Products and Services.

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Pharmacovigilance in Focus

The collaboration between the UMC and Adis International has resulted in an updated version (2006) of the reprint collection entitled Pharmacovigilance in Focus - the Theory and Practice of Pharmacovigilance. This book now contains a selection of 20 articles, previously published by Adis mainly in the journal Drug Safety. The articles, by Ralph Edwards, Marie Lindquist, Ronald Meyboom, Sten Olsson and others, cover the following topic areas:

• General Issues
• Practical Issues - National Centre Context
• Practical Issues - International Pharmacovigilance
• From Data to Rational Drug Use
• Perspective

Ronald Meyboom from the UMC and Rosie Stather from Adis have put this 180-page reprint collection together.  Through a generous arrangement with Adis, many of the articles in Pharmacovigilance in Focus are available as pdfs in the Practical Pharmacovigilance section of this website.

Please contact info@who-umc.org for details about obtaining a copy.

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Publications from WHO related to pharmacovigilance

WHO Technical Reports

WHO Technical Report No 425: International Drug Monitoring, The Role of the Hospital (Geneva 1969). Please contact the UMC if you would like the pdf in English, French or Spanish.

WHO Technical Report No 498: International Drug Monitoring, The Role of National Centres (Geneva 1972). The English version of this key formative text is downloadable in pdf format here (2.0 Mb). Please contact the UMC if you would like the pdf of the French, Spanish or Russian versions.

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The Importance of Pharmacovigilance

A critical examination of the strengths and weaknesses of present systems of safety monitoring, in order to increase their impact, and an overview of the challenges facing pharmacovigilance in the future.

Involvement in Drug Safety Monitoring by WHO
Partners in Pharmacovigilance
Pharmacovigilance in Drug Regulation
Pharmacovigilance in Clinical Practice
Pharmacovigilance in International Health
Considerations for the Future
This publication is downloadable here from the WHO website.

A limited number of copies are also available in Korean - please apply for details.

This 48-page book is free; ISBN 92-4-159015-7, published 2002.

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The Safety of Medicines in Public Health Programmes

The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool. A 60-page document from the Quality Assurance and Safety of Medicines team of the World Health Organization. Print orders via e-mail: bookorders@who.int

A pdf version is downloadable here (560 Kb)

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WHO Pharmaceuticals Newsletter

From the year 2000, drug safety information provided by the National Centres was incorporated in the WHO Pharmaceuticals Newsletter.  More info on :
http://www.who.int/medicines/publications/newsletter/en/

(From 2000, the ADR Newsletter was incorporated in the WHO Pharmaceuticals Newsletter, and no further issues were distributed from the UMC.) For old editions of the ADR Newsletters issued by the UMC, please visit our Publications Archive.

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Pharmacovigilance: ensuring the safe use of medicines

An excellent 6-page overview of pharmacovigilance and its importance in the WHO Policy Perspectives on Medicines series is downloadable here (Adobe Acrobat, 120Kb).

 Pharmacovigilance: ensuring the safe use of medicines WHO Policy Perspectives 9

 La farmacovigilancia: garantía de seguridad en el uso de los medicamentos Perspectivas politicas de la OMS 9

 Pharmacovigilance : assurer la sécurité d'emploi des médicaments Perspectives Politiques 9

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The WHO practical handbook on the pharmacovigilance of antimalarial medicines

This Practical Handbook on the Pharmacovigilance of Anti-Malarials is a detailed manual giving a step-by-step approach to the pharmacovigilance of anti-malarials. It is intended as a source of practical advice for pharmacovigilance centres. In addition, it provides details on how to conduct cohort event monitoring, the method of active safety surveillance for collecting information on all adverse events occurring after treatment. The manual also details how to perform causality assessment and signal identification.

The WHO practical handbook on the pharmacovigilance of antimalarial medicines (Adobe Acrobat 1.5Mb)
ISBN 978 92 4 154749 9 © WHO 2008

WHO guidelines on safety monitoring of herbal medicines

The WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems (ISBN: 92 4 159221 4), is available from:
Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland
E-mail bookorders@who.int  

The 32-page main contents are:
Introduction, Background; Objectives, Glossary
Pharmacovigilance and the WHO International Drug Monitoring Programme
Challenges in monitoring the safety of herbal medicines
Safety monitoring of herbal medicines
Communication
References, bibliography

There are also five useful annexes and the complete text of 'Guidelines for setting up and running a Pharmacovigilance Centre' (see above for full details).

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Ordering

To order UMC publications, please contact the UMC Sales & Marketing Department. 

Publications Archive

In our publications archive you can find old editions of Uppsala Reports and the now discontinued Adverse Reaction Newsletter.

Publications page last updated 19 August 2010