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 |
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Patient’s details
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The following list of patient's details are required to identify duplicate reports:
- Initials
- Gender
- Age
- Date of birth
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Reporter’s details
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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
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Details of AE
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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)
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Suspected health products
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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.
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| 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. |
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Other relevant information
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The following details are required to help identify confounders:
- Pre-existing conditions
- Known allergies
- Pregnancies
- Laboratory tests done, and their results
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Seriousness of event and outcome
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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
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Treatment of AE
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Details on whether the patient was treated after the AE, and if yes, to specify the details of the treatment.
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For medical devices
| Information required |
Details |
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Medical Device Details
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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.
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Event Details
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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
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Reporter’s Details
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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
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Local Supplier Details (if available)
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The information is required for us to contact and follow up on their investigation outcomes:
- Company name
- Email address
- Contact number
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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 |
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| Vaccines |
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| Medical Devices |
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Manual submission
Complete the relevant form below and submit to us accordingly.
| Product types |
Reporting forms |
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Therapeutic products (other than cell, tissue and gene therapy products)
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Complementary Health Products such as:
- Chinese Proprietary Medicines
- Traditional medicines
- Health supplements
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| Cell, tissue and gene therapy products |
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| Cosmetic products (for company reporting only) |
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AE reporting guides
Find out more about AE reporting:
Reporting guides for specific adverse events