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This application is a service of the Singapore Government.

Health Sciences Authority

Report Adverse Events related to Health Products

AE3

Reporting Guidelines

The Vigilance and Compliance Branch uses a number of post-marketing risk assessment approaches to ensure the continued safe use of health products in Singapore. These include mandatory reporting from pharmaceutical manufacturers, spontaneous reporting from healthcare 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 healthcare professionals forms the cornerstone of post-marketing health product safety surveillance. It remains one of the most important ways of monitoring the safety of a health product throughout its marketed life.

 

What to report

What is an adverse event?

An adverse event (AE) is defined as any untoward medical occurrence that may present during treatment with a health product (e.g. western drug, vaccine, biologics, medical device, complementary medicine or cosmetics) but which does not necessarily have a causal relationship with this treatment. It excludes AE caused by accidental or deliberate overdoses and medication errors.

The AE Reporting Programme relies upon voluntary reporting of suspected AEs. Notify the HSA when you suspect there is a causal association between the health product taken and the AE experienced by the patient. Reporting an AE does not necessarily mean that there is a definite link between the event and the product.

Report any AE related to marketed health products, in particular:

  • All AEs related to newly marketed health products (i.e. marketed for less than 5 years)
  • All serious* AEs related to established therapeutic products, even if the events are well known. (This allows us to give advice on how these products can be used more safely. Additionally drugs in the same therapeutic class can be compared to assess their relative safety.)
  • Serious* AEs related to medical devices, complementary medicines and cosmetics
  • Unexpected event, ie. not consistent with the product package insert or labelling.

*A serious AE is one which leads to the following outcomes:

  • Death or life-threatening event;
  • In-patient hospitalisation or prolonged existing hospitalisation;
  • Persistent or significant disability or incapacity;
  • Congenital anomaly;
  • Medically significant event

Further information on AE reporting for selected health products can be found at the hyperlinks below

 

What information should be included on the reporting form?

INFORMATION REQUIRED RATIONALE

Patient’s details

Initials, gender, age/date of birth

To identify duplicate reports

Reporter’s details

Name, profession, place of practice, contact no., email address

To request for further information when needed or follow-ups on potential safety signals

Details of AE*

Date of onset/latency, concise description of AE (e.g. type of rash), severity

To assess causality and seriousness of AE

Suspected health products

Brand name or active ingredient(s), dose, indication, therapy dates, batch number

For suspected complementary health products, please attach a photo if available

Brand name (preferred): To determine brand-specific AEs

Therapy dates: To establish temporal association

Batch number: To assess batch-specific quality issues

Photo of the suspected complementary health product: To ascertain the brand, manufacturer and ingredient(s) of the product

Concomitant health product(s) including vaccines, complementary medicines consumed at the same time and/or 3 months before the AE To identify confounders or possible drug interactions

Other relevant information

Pre-existing conditions, known allergies, pregnancies, laboratory tests done and results

To identify confounders

Seriousness of event and outcome

Was the patient hospitalised due to the event? Recovery status, sequelae

To assess causality and seriousness of event.

Treatment of AE

Yes/No. If Yes, specify the treatment

*To facilitate the reporting of AEs, HSA has developed a few educational documents:

For selected AEs:

For various product types:

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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How to report

Reports can be made by healthcare professionals and pharmaceutical companies for the various health products:

(Estimated time to complete form: 10-20 mins)

Vigilance and Compliance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
#11-03 Helios
Singapore 138667
Fax: (65) 6478 9069


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How would your report contribute to the safety surveillance of health products?

Local context

Your report, once submitted, is captured in our national database for aggregate analysis. The AE reports may identify unexpected AEs or indicate that certain AEs occur more commonly than previously expected, or that certain patients are more susceptible to some problems than others. Such findings can lead to regulatory actions such as updating the package inserts with relevant warnings, restricting the use of the affected health products and alerting healthcare professionals with advisories. 

HSA communicates safety information regularly using various channels such as Press Releases, Dear Healthcare Professional Letters posted on Ministry of Health-Health Professional Portal website and the Adverse Drug Reaction (ADR) News Bulletin.

Global contributions

HSA also contributes to the World Health Organisation (WHO) International Drug Monitoring Programme by submitting anonymised local AE reports to the WHO-Uppsala Monitoring Centre in Sweden for international surveillance of adverse drug reactions.


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How to access HSA Adverse Event Online Database 

HSA AE Online Enquiry contains information about suspected local AEs to health products, captured from AE reports and submitted to HSA by healthcare professionals as well as product registrants. 

 

To access HSA AE Online Database:

Table 1: List of suggested reportable Adverse Events Following Immunisation (AEFIs*)

Reportable AEFI* Onset time interval^
  • Anaphylactoid reaction (acute hypersensitivity reaction)
  • Anaphylaxis
  • Persistent (more than three hours) inconsolable screaming
  • Hyptonic-hyporesponsive episode
  • Toxic shock syndrome
Within 24 hours to 48 hours of immunisation
  • Severe local reaction
  • Sepsis
  • Injection site abscess (bacterial/sterile)
Within 7 days of immunisation
  • Seizures, including febrile seizures
  • Encephalopathy
Within 14 days of immunisation
  • Acute flaccid paralysis
  • Branchial neuritis
  • Intussusception
  • Thrombocytopenia
Within 3 months of immunisation
  • Lymphadenitis
  • Disseminated BCG infection
  • Osteitis/osteomyelitis
Between 1 and 12 months after BCG immunisation
  • Death
  • Hospitalisation
  • Disability
  • Any other severe and unusual events suspected to be associated to the vaccine

No time limit

*An AEFI is defined as any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.1

**The list of reportable AEFIs is meant as a guide and by no means exhaustive. In general, healthcare professionals are advised to report all events following immunisation as long as no other clear cause has been identified. This would include events whereby a causal link to a vaccine has not been established.

^Onset interval is meant as general guiding principle and will depend on the antigen and adverse reaction, as well as patient factors.

 

References

  1. Definition and application of terms for vaccine pharmacovigilance: Report CIOMS/WHO Working Group on Vaccine Pharmacovigilance 2012.
  2. World Health Organisation Western Pacific Region Immunization Safety Surveillance. Guidelines for immunization programme managers on surveillance of adverse events following immunization. Second edition.

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