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What is Pharmacovigilance
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Relevance of Pharmacovigilance
The conditions under which patients are studied during the pre-marketing phase do not necessarily reflect the way the medicine will be used in the hospital or in general practice once it is marketed. Information about rare but serious adverse drug reactions, chronic toxicity, use in special groups (e.g. pregnant women, children, elderly) and drug interactions is often incomplete or not available. Certain adverse drug reactions may not be detected until a very large number of people have received the medicine.
Other factors which have not been extensively studied but are increasingly being recognised as important contribution to the emergence of unexpected adverse drug reactions are the effects that genetics and environmental influence have on the pharmacokinetic handling of the drugs in the individual patient.
In addition, the increasing popularity of traditional and herbal medicines among consumers poses a different set of challenges for pharmacovigilance. Although these products are believed to be inherently safer than more potent western chemical pharmaceuticals, they present different toxicological problems, e.g. drug-herb interactions, and the potential for adulteration with western medicines for commercial reasons. Consequently, all health products need to be continually assessed for safety within the context of their perceived benefits.
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Current framework for Adverse Drug Reaction (ADR) monitoring in Singapore
The Pharmacovigilance Branch (formerly known as the Adverse Drug Reaction Monitoring Unit, ADRMU) in Singapore was established in 1993. The branch joined the World Health Organisation (WHO) in 1994 as the 40th member of the WHO International Drug Monitoring Programme for international collaboration on drug safety. The branch serves as the national centre for the collation and review of adverse drug reaction reports received from the healthcare professionals, pharmaceutical companies and other regulatory authorities.
The Health Sciences Authority has also appointed a Pharmacovigilance Advisory Committee (PVAC) which comprises experts in the fields of medicine, pharmacy, pharmacology and forensic sciences. One of their main roles is to assess the impact of major drug safety issues and advise HSA on the appropriate regulatory actions to be taken to enhance drug safety.
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Activities of the Pharmacovigilance Branch
The Pharmacovigilance Branch:
- Monitors and reviews local spontaneous Adverse Drug Reactions (ADR) reported by our healthcare professionals to detect signals of potential drug safety problems. These reports are then keyed into the ADR database for use in aggregate analysis. As a member of the WHO International Drug Monitoring Programme, these reports are submitted to the Uppsala Monitoring Centre in Sweden for collation into the world bank of adverse drug reactions.
- Reviews selected Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. PSURs are requested to be submitted every 6 monthly for the first 2 years of marketing in Singapore, annually for the subsequent 3 years and at the first renewal of the product licence. The branch may also extend the period of submission of PSURs if required. In selected cases, the unit may request for the PSURs of specific targeted drugs.
- Maintains contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.
- Assesses the regulatory information relating to safety in order to determine what action, if necessary, to improve safe use. The branch makes recommendations to the licensing unit on product label amendments, product withdrawals and suspension.
- Provides information to end-users through the Adverse Drug Reaction News bulletins, Dear Healthcare Professionals Letters, Drug Alerts and seminars.
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Contact Us
If you need further information, please contact:
Pharmacovigilance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
#11-03 Helios
Singapore 138667
Tel: (65) 6866 3538
Fax: (65) 6478 9069
Email: HSA_drugsafety@hsa.gov.sg
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