Guidelines for adverse drug reaction reporting

National Pharmacovigilance Programme

The Medicines Control Council (MCC) has a responsibility to ensure the safety, efficacy and quality of all medicines used by the South African public. The National Pharmacovigilance Programme is coordinated by the MCC and has a dedicated Unit, The National Adverse Drug Event Monitoring Centre (NADEMC), in Cape Town, which monitors the safety of all registered medicines in South Africa.

What is Pharmacovigilance?

Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health.

What is an Adverse Drug Reaction (ADR)?

The Medicines Control Council (MCC) defines an Adverse Drug Reaction (ADR) as a response to a medicine which is noxious and unintended, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse or abuse of a medicine.

Who should report Adverse Drug Reactions?

All health care workers, including doctors, dentists, pharmacists, nurses and other health professionals are encouraged to report all suspected adverse reactions to medicines (including vaccines, X-ray contrast media, traditional and herbal remedies), especially when the reaction is not in the package insert, potentially serious or clinically significant.

What happens to a report?

All ADR reports are entered into a national ADR database. Each report is evaluated to assess the causal relationship between the event and the medicine. A well-completed adverse drug reaction/product quality form submitted could result in any of the following:

  • additional investigations into the use of the medicine in South Africa;
  • educational initiatives to improve the safe use of the medicine;
  • appropriate package insert changes to include the potential for the reaction, and
  • changes in the scheduling or manufacture of the medicine to make it safer.

The purpose of ADR reporting is to reduce the risks associated with the use of medicines and to ultimately improve patient care.

Will reporting have any negative consequences on the health worker or the patient?

An adverse drug reaction report does not constitute an admission of liability or that the health professional contributed to the event in any way. The outcome of a report, together with any important or relevant information relating to the reaction, will be sent back to the reporter as appropriate. The details of a report are stored in a confidential database. The names of the reporter or any other health professionals named on a report and that of the patient will be removed before any details about a specific adverse drug reaction are used or communicated to others. The information is only meant to improve the understanding of the medicines used in the country.

Is the event possibly an ADR?

The following factors should be considered when an adverse drug reaction is suspected:

  1. What exactly is the nature of the reaction? (Describe the reaction as clearly as possible and where possible provide an accurate diagnosis.)
  2. Did the reaction occur within a reasonable time relationship to starting treatment with the suspected medicine? (Some reactions occur immediately after administration of a medicine while others take time to develop.)
  3. Is the reaction known to occur with the particular medicine as stated in the package insert or other reference? (If the reaction is not documented in the package insert, it does not mean that the reaction cannot occur with that particular medicine.)
  4. Did the patient recover when the suspected medicine was stopped? (Some reactions can cause permanent damage, but most reactions are reversible if the medication is stopped.)
  5. Did the patient take the medicine again after the reaction abated (i.e. rechallenge). If so, did the same reaction occur again? (In most situations it is not possible or ethical to rechallenge the patient with the same medicine. If such information is available or if such a rechallenge is necessary, recurrence of the event is a strong indicator that the medicine may be responsible.)
  6. Can this reaction be explained by other causes (e.g. underlying disease/s; other medicine/s; toxins or foods)? (It is essential that the patient is thoroughly investigated to decide what the actual cause of any new medical problem is. A medicine-related cause should be considered, when other causes do not explain the patient’s condition.)

What types of reactions should be reported?

The following adverse drug reactions should be reported:

  • All ADRs to newly marketed drugs or new drugs added to the EDL
  • All serious reactions and interactions
  • ADRs that are not clearly stated in the package insert.
  • All adverse reactions or poisonings to traditional or herbal remedies

Report even if you are not certain that the medicine caused the event.

What Product Quality Problems should be reported?

The following product quality problems should be reported:

  • suspected contamination;
  • questionable stability;
  • defective components;
  • poor packaging or labeling;
  • therapeutic failures.

How can ADRs be prevented from occurring?

Some ADRs are unavoidable and cannot be prevented. However, most ADRs can be prevented by following the basic principles of rational use of medicines.

How are adverse drug reactions reported?

An Adverse Drug Reaction/Product Quality Report Form is enclosed in this book and should be completed in as much detail as possible before returning it by fax or post to any of the addresses provided below.

Report forms may also be accessed through the following URL: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf

Contact details: 012 842 7609/10 (SAHPRA) 021 447 1618 (NADEMC) Fax: 021 448 6181 E-mail: adr@sahpra.org.za

ADVICE ABOUT VOLUNTARY REPORTING

Report adverse experiences with:

  • medications (drugs, vaccines and biologicals)
  • medical devices (including in-vitro diagnostics)
  • complementary/alternative medicines (including traditional, herbal remedies, etc)

Please report especially:

  • adverse drug reactions to newly marketed products
  • serious reactions and interactions with all products
  • adverse drug reactions which are not clearly reflected in the package insert.

Report Product Quality Problems such as:

  • suspected contamination
  • questionable stability
  • defective components
  • poor packaging or labelling
  • therapeutic failures

Report even if:

  • you're not certain the product caused the event
  • you don't have all the details

Important numbers: Investigational Products and Product Quality Problems:

Adverse Events Following Immunisation:

Confidentiality: Identities of the reporter and patient will remain strictly confidential.

Your support of the Medicine Control Council’s adverse drug reaction monitoring programme is much appreciated. Information supplied by you will contribute to the improvement of medicine safety and therapy in South Africa.