Healthcare professionals' guide to adverse events reporting

Find out how to report an adverse event to us and learn more about the reporting process for specific adverse events.

What to report

Report any adverse events related to marketed health products, in particular for the following:

  • All adverse events occurring with the use of new health products i.e. those marketed in Singapore for less than 5 years.
  • All serious adverse events, even if the events are well known. This allows us to continuously monitor the incidence of the adverse events locally and assess if there is a safety concern. Additionally, medicines in the same therapeutic class can be compared to assess their relative safety.
  • Unexpected adverse events such as those not consistent with the product package insert or labelling.
Note: Adverse events caused by accidental or deliberate overdoses and medication errors need not be reported.

 

Information required

It is important that your adverse event (AE) reports include at least the following information to facilitate our assessment and necessary follow-ups of the AEs.

For health products other than medical devices

Information required Details

Patient’s details

The following list of patient's details are required to identify duplicate reports:
  • Initials
  • Gender
  • Age
  • Date of birth

Reporter’s details

The following reporter's details are required to request for further information when needed, or for follow-ups on potential safety signals:
  • Name
  • Profession
  • Place of practice
  • Contact number
  • E-mail address

Details of AE

The following details are required for us to assess the causality and seriousness of the AE:
  • Date of onset or latency
  • Concise description of AE (e.g. type of rash)

Suspected health products

The following details are required for suspected health products:

  • Brand name (preferred), to determine brand-specific AE.
  • Therapy dates, to establish temporal association.
  • Batch number, to assess batch-specific quality issues.
  • Dose and indication, to establish the dose-effect association.

Attach photos for Chinese Proprietary Medicines, traditional medicines and health supplements to allow us to ascertain the brand, manufacturer and ingredients of the product.

Concomitant health products To help identify confounders or possible drug interactions, you should include details of health products that were consumed at the same time, or 3 months before the AE.

Other relevant information

The following details are required to help identify confounders:
  • Pre-existing conditions
  • Known allergies
  • Pregnancies
  • Laboratory tests done, and their results
Seriousness of event and outcome
 		The following details are required to help assess causality and seriousness of event:
  • Patient's status due to the AE (e.g. whether the patient was hospitalised due to the AE)
  • Recovery status
  • Sequelae
Treatment of AE
 		Details on whether the patient was treated after the AE, and if yes, to specify the details of the treatment.

 

For medical devices

Information required Details

Medical Device Details

The following are required to identify the affected medical device(s):

  • Brand name
  • Device type (e.g. catheter, stent, etc.)
  • Model or Catalogue No.
  • Serial or Lot or Batch No.

Alternatively, a photo of the device label(s) may be taken to capture the above medical device details.

Event Details

The following details are required for us to assess the causality and seriousness of the AE:

  • Device malfunction observed (e.g. ruptured balloon catheter despite not exceeding the rated burst pressure as per manufacturer’s IFU)
  • Specific patient consequence (e.g. perforation of vessel)
  • Details of follow-up including medical or surgical intervention taken after the event (e.g. cut-down surgery to repair vessel perforation)
  • Patient outcome, if applicable

Reporter’s Details

The following reporter’s details are required to request for further information when needed, or for follow-ups on potential safety signals:

  • Name
  • Email address
  • Contact number

Local Supplier Details (if available)

The information is required for us to contact and follow up on their investigation outcomes:

  • Company name
  • Email address
  • Contact number

 

 

How to report

You are encouraged to report serious adverse events related to the use of health products as soon as you are aware of them, using one of the following methods:

Online submission

 Product type Online reporting
All product types except vaccines and medical devices
Vaccines
Medical Devices

 

Manual submission

Complete the relevant form below and submit to us accordingly.

Product types Reporting forms

Therapeutic products (other than cell, tissue and gene therapy products)
Complementary Health Products such as:
  • Chinese Proprietary Medicines
  • Traditional medicines
  • Health supplements
 Cell, tissue and gene therapy products
Cosmetic products (for company reporting only)

AE reporting guides

Find out more about AE reporting:

 

Reporting guides for specific adverse events