Literature Sources in Pharmacovigilance

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Literature Sources in Pharmacovigilance

• Sten Olsson
• WHO-Uppsala Monitoring Centre Sweden

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Original journals

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

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http//bmj.com/
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Journals of special interest

• Pharmacoepidemiology Drug Safety
• Drug Safety
• Risk Safety in Medicine

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Bibliographic titles review

• Positive
• Fast
• High coverage
• Negative
• Minimal detail
• Current Contents

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Secondary review journals

• Positive
• - Quite fast
• - Some detail
• - High coverage
• Negative
• - Lack of detail
• - Difficult to search systematically -
  (Cost)
• Reactions Weekly

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Expert annotated review

• Meyler's Side Effects of Drugs
• Side Effects of Drugs Annual
• Adverse Drug Reaction Bulletin
• Prescrire
• Expert Opinion on Drug Safety

• Positive
• - Assessment of significance
• - Easy access
• Negative
• - Lack of detail
• - Not completely up-to-date

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Reference books

• Martindale the extra Pharmacopoea
• Meylers Side Effects of Drugs
• Pharmacovigilance from A-Z
• Dictionary of Pharmacovigilance

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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)

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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)

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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)

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References online

• Micromedex
• Includes Martindale, PDR, Alternative Medicines
  and Index Nominum
• Merck Manual
• Includes The Merck Manual of Diagnosis and
  Therapy
• SAMScientific American Medicine

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Computerized literature screening (1/2)

• Positive
• High coverage
• High specificity of search
• Negative
• Requires equipment skill
• Lack of detail

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Computerized literature screening (2/2)

• Medline
• Pubmed is using the MeSH (Medical Subject
  Headings) terminology.
• EMBASE
• Current Contents on CD
• Reactions Weekly on-line

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http//www.ncbi.nlm.nih.gov/entrez/query.fcgi?dbP
ubMed
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WHO Publications

• WHO Pharmaceuticals Newsletter
• WHO Drug Information
• Dialogue in Pharmacovigilance
• Viewpoint 1 2
• Expecting the Worst
• Uppsala Reports

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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

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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