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

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

• Martindale – the extra Pharmacopoea

• Meyler’s Side Effects of Drugs

• Pharmacovigilance from A-Z

• Dictionary of Pharmacovigilance

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)

– Adverse Drug Reactions (Lee, 2001)

Methodology

– Pharmacovigilance (Mann, Andrews, 2002)

– Pharmacoepidemiology (Strom, 2000)

– Stephens’ Detection of New Adverse Drug Reactions (Talbot, Waller, 2004)

– Adverse Drug Reactions: A practical guide to Diagnosis and Management (Bénichou, 1996)

Reference booksAddressing specific problem

areas• 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)

• To Heal And Harm: An economic view on drug safety (Silcock and Pritchard, 2003)

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• WHO Pharmaceuticals Newsletter

• WHO Drug Information

• Dialogue in Pharmacovigilance

• Viewpoint 1 & 2

• Expecting the Worst

• Uppsala Reports

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