The Vigilance Branch uses a number of post-marketing risk assessment approaches to ensure the continued safe use of health products. 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 event (AE) reporting by the health professionals forms the cornerstone of post-marketing health product safety surveillance. It remains one of the most important ways of monitoring safety of a health product throughout its marketed life. Healthcare professionals can make an adverse event report through the form.
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How to Report
Reports can be made by healthcare professionals and pharmaceutical companies for the various health products:
- Drugs & Complementary Health Products
- Vaccines
- Forms may be submitted by mail or fax to
Vigilance Branch
Health Products Regulation Group
11 Biopolis Way
#11-03 Helios
Singapore 138667
Fax: (65) 6478 9069
Email the report to HSA_drugsafety@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 events, in particular the serious and fatal reactions to marketed health products.
What is an adverse event?
An adverse event is defined as an event 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 Event Reporting Programme relies upon voluntary reporting of suspected adverse events. Notify the HSA when you suspect there is a causal association between the health product taken and the adverse event experienced by the patient. Reporting an adverse drug reaction does not necessarily mean that there is a definite link between the event and the product.
In particular, please report:
All serious and non-serious adverse events to recently marketed health products that are on the Singapore market for less than 5 years.
All serious adverse events to established drugs, even if the events are well known. (This allows us to give advice on how health products can be used more safely. Additionally drugs in the same therapeutic class can be compared to assess their relative safety.)
All serious adverse events to complementary medicines and herbal remedies.
Unexpected event, ie. not consistent with the product package insert or labelling.
Events that are considered as medically significant in the judgement of the healthcare professional, including events 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 event 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 event (ie. date of onset / first occurrence of event, characteristics, location, severity, and timing of event)
Suspected health product(s) (ie. brand name or active ingredient(s), dose, frequency, duration, indication, batch number)
Concomitant health product(s) (ie. including complementary medicines, consumed at the same time and/or 3 months before)
Outcome of the patient (Seriousness of event; Was the patient hospitalised due to the event? Has the patient recovered?)
Treatment of event
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 AE 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 Event Reporting Forms are reviewed by the Vigilance Branch.
These reports are individually reviewed with particular attention to the serious adverse event reports.
The information is then entered into the computer database for use in aggregate analysis.
This AE database enables the processing and retrieval of cases according to suspected health products and adverse events.
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 events.
The reporting doctor, pharmacist and dentist can request for information associated with a suspected health product by providing us with his contact number and email address.
What regulatory actions can the HSA take?
The Adverse Event reports may identity unexpected adverse event or indicate that certain adverse event 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 events in product package insert. Rarely, when a hazard is considered unacceptable, a registered health product may have to be withdrawn from the market.
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