Literature Sources in Pharmacovigilance

Sten OlssonWHO-Uppsala Monitoring Centre

Sweden

Original journals

• Positive• Fast• Comprehensive information• Negative• Expensive• Low coverage• JAMA• Therapie• New Engl J of Med• Brit Med Journal• The Lancet

http://bmj.com/

Journals of special interest

• Pharmacoepidemiology & Drug Safety

• Drug Safety

• Risk & Safety in Medicine

• Adverse Drug Reactions and Toxicology

Reviews

Journals of special interest

Bibliographic titles review

• PositiveFast High coverage

• NegativeMinimal detail

Current Contents

Secondary review journals

• Positive- Quite fast- Some detail- High coverage

• Negative- Lack of detail- Difficult to search systematically- (Cost)

• Reactions Weekly

Expert annotated review

• Positive- Assessment of significance

- Easy access• Negative

- Lack of detail- Not completely up-to-date

• Meyler's Side Effects of Drugs

• Side Effects of Drugs Annual

• Adverse Drug Reaction Bulletin

• Prescrire

• Expert Opinion on Drug Safety

Reference books

Reference books

• Martindale – the extra Pharmacopoea

• Meyler’s Side Effects of Drugs

• Pharmacovigilance from A-Z

Reference books

Reference books

Textbooks

• Drug induced diseases– Textbook of Adverse Drug Reactions

(Davies, 1998)

– Avery's Drug Treatment (Speight, 1997)

– Drug Benefits and Risks (van Boxtel,

Santoso, Edwards, 2002)

Methodology

– Pharmacovigilance (Mann, Andrews, 2002)– Pharmacoepidemiology (Strom, 2000)– The detection of New Adverse Drug Reactions

(Stephens, 2000)– Methodological Approaches in

Pharmacoepidemiology (ARME-P, 1993)– Guide pratique de pharmacovigilance (Bénichou,

1996)– Principios de epidemiologia del medicamento

(Laporte, Tognoni, 1993)

Textbooks

Textbooks

Textbooks

Textbooks

Reference booksAddressing specific problem areas

• A guide to drug eruptions(Bruinsma)

• Adverse Drug Interactions(Griffin, D'Arcy, 1997)

• Drugs in Pregnancy and Lactation (Briggs, Freeman,Yaffe, 1998)

• Drug-induced Ocular Side Effects (Fraunfelder, 2002)

• Adverse Effects of Herbal Drugs (De Smet et al 1992)

• Adverse Events Associated with childhood vaccines (Instit of Med, 1994)

• Responsibility for Drug-Induced Injury (Dukes,

Mildred, Swartz, 1998)

• Safety of Anaesthetic Drugs(Naguib, 1998)

Reference booksAddressing specific problem areas

Reference booksAddressing specific problem areas

References online

• Micromedex– Includes Martindale, PDR, Alternative Medicines

and Index Nominum

• Merck Manual– Includes: The Merck Manual of Diagnosis and

Therapy

• SAM=Scientific American Medicine

Computerized literature screening (1/2)

• Positive– High coverage– High specificity of search

• Negative– Requires equipment & skill– Lack of detail

Computerized literature screening (2/2)

• Medline– Pubmed is using the MeSH (Medical

Subject Headings) terminology.

• EMBASE

• Current Contents on CD

• Reactions Weekly on-line

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed

WHO Publications• National Pharmacovigilance Systems (Olsson, 1999)

• Pharmacovigilance in Focus (Meyboom, 2001)

• WHO Pharmaceuticals Newsletter

• WHO Drug Information

• Effective Communications in Pharmacovigilance

• Dialogue in Pharmacovigilance

• Viewpoint

NATIONAL ADR BULLETINS• Presciber Update, New Zealand• Australian Adverse Reactions Bulletin• Signals in Adverse Drug Reactions

Monitoring, The Philippines• Butlletí Groc and many other regional

bulletins, Spain• Information från Läkemedelsverket,

Sweden• Drug Information Bulletin, Tanzania

NATIONAL ADR BULLETINS (2)

• Berita Ubat-Ubatan, Malaysia• Folia Pharmacoterapeutica, Belgium• Canadian Adverse Drug Reaction

Newsletter• TABU, Finland• Drug Safety Newsletter, Ireland• Information on Adverse Reactions to

Drugs, Japan• Adverse Drug Reaction News, Singapore