The Pharmacovigilance Branch uses a number of post-marketing risk assessment approaches to ensure 
the continued safe use of drugs. These include mandatory reporting from pharmaceutical manufacturers, spontaneous reporting from health professionals, literature reviews and the exchange of regulatory information with other national drug regulatory bodies.
Among these approaches, the spontaneous adverse drug reaction reporting by the health professionals forms the cornerstone of post-marketing drug safety surveillance. It remains one of the most important ways of monitoring safety of a drug throughout its marketed life. The Adverse Drug Reaction Reporting Form was introduced in 1993. Healthcare professionals can make an adverse drug reaction report through the form.
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Reports can be made by healthcare professionals and pharmaceutical companies via various modes:
- Report online
- Download Form
Print the adverse drug reaction reporting form (pdf file), fill in the information and submit the form by mail or fax to:
Pharmacovigilance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
#11-03 Helios
Singapore 138667
Fax: (65) 6478 9069
- Email the report to HSA_productsafety@hsa.gov.sg
- Phone us at Tel: (65) 6866 3538
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What to Report
Healthcare professionals e.g. doctors, pharmacists and dentists are encouraged to report suspected adverse drug reactions, in particular the serious and fatal reactions to marketed medicinal products.
What is an adverse drug reaction?
An adverse drug reaction is defined as a reaction which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
The Adverse Drug Reaction Reporting Programme relies upon voluntary reporting of suspected adverse drug reactions. Notify the HSA when you suspect there is a causal association between the medicine taken and the adverse drug reaction experienced by the patient. Reporting an adverse drug reaction does not necessarily mean that there is a definite link between the reaction and the product.
In particular, please report:
- All serious and non-serious adverse drug reactions to recently marketed drugs that are on the Singapore market for less than 5 years.
- All serious adverse drug reactions to established drugs, even if the reactions are well known. (This allows us to give advice on how medicines can be used more safely. Additionally drugs in the same therapeutic class can be compared to assess their relative safety.)
- All serious adverse drug reactions to complementary medicines and herbal remedies.
- Unexpected reaction, ie. not consistent with the product package insert or labelling.
- Reactions that are considered as medically significant in the judgement of the healthcare professional, including reactions which:
- Are fatal;
- Are life-threatening;
- Result in or prolong hospitalisation;
- Cause persistent incapacity or disability;
- Cause birth defect.
What information should be included on the reporting form?
An adverse drug reaction report should contain the essential information for assessment. Please fill in as much information as known. Patient's and reporter's identities are kept in strict confidence.
- Patient's details (ie. initials, identity number, gender, age, weight, ethnic group)
- Reporter's details (ie. Name, profession, place of practice, contact number and email address)
- Details of adverse drug reaction (ie. date of onset / first occurrence of reaction, characteristics, location, severity, and timing of reaction)
- Suspected drug(s) (ie. brand name or active ingredient(s), dose, frequency, duration, indication, batch number)
- Concomitant drug(s) (ie. including complementary medicines, consumed at the same time and/or 3 months before)
- Outcome of the patient (Seriousness of reaction; Was the patient hospitalised due to the reaction? Has the patient recovered?)
- Treatment of reaction
- Other relevant information (renal and hepatic functions, known allergies, pregnancy, smoking, alcohol use, rechallenge)
This information is essential for verification and to be used only for further case follow-up if required.
Please do not be deterred from reporting because some details are not known.
Follow-up reports
Any follow-up information for an ADR that has already been reported can be sent to us on another form or can be reported via the other available modes of reporting. Please indicate that it is a follow-up report. It is very important that follow-up reports are identified and linked to the original report.
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What Happens to the Report
- All Adverse Drug Reaction Reporting Forms are reviewed by the Pharmacovigilance Branch.
- These reports are individually reviewed with particular attention to the serious adverse reactions reports.
- The information is then entered into the computer database for use in aggregate analysis.
- This ADR database enables the processing and retrieval of cases according to suspected drugs and adverse drug reactions.
- 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.
The reporting doctor, pharmacist and dentist can request for information associated with a suspected drug by providing us with his contact number and email address.
What regulatory actions can the HSA take?
The Adverse Drug Reaction reports may identity unexpected adverse reaction or indicate that certain adverse drug reaction occur more commonly than previously expected, or that some patients are more susceptible to some problems than others. Such findings can lead to changes in the marketing authorisation, for example restrictions in use, refinement of those instructions or the introduction of specific warnings of adverse reactions in product package insert. Rarely, when a hazard is considered unacceptable, a medicine may have to be withdrawn from the market.
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