Yes. Patients and consumers in South Africa can report suspected medicine side effects directly to the South African Health Products Regulatory Authority (SAHPRA). You do not have to be a doctor, pharmacist or nurse. You can also ask a healthcare professional to report the suspected reaction on your behalf. SAHPRA states that patients, consumers and community workers may report directly to the Authority, and that reporters can come from either the public or private health sector. (Sahpra)
You also do not need to prove that the medicine definitely caused the reaction before reporting it. A side-effect report is a report of a suspected association. SAHPRA specifically advises people to report even when they are not certain that the product caused the event or when some details are missing.
This guide covers who can report medicine side effects, what information to collect, how reporting works in South Africa, which reactions are particularly important to report and what may happen after a report is submitted.
Quick answer: when and how to report a suspected side effect
If you develop a new, unexpected or concerning symptom while using a medicine, you may report it as a suspected side effect. You do not have to decide for yourself whether the medicine was definitely responsible. SAHPRA uses reports from patients, healthcare professionals and other sources as part of its ongoing monitoring of medicine safety. (Sahpra)
Patients currently have several reporting options. SAHPRA provides an electronic reporting portal, a downloadable adverse drug reaction form that can be emailed to [email protected], and the Med Safety App, which is designed for members of the public as well as healthcare professionals. (Sahpra)
Reporting a suspected side effect is separate from getting medical care. If the reaction may be an emergency, get medical help first rather than waiting to submit a report. Sudden swelling of the lips, mouth, tongue or throat and difficulty breathing can be signs of a severe allergic reaction requiring immediate treatment. (nhs.uk)
If you are unsure whether a symptom could be medicine-related, a doctor or pharmacist can help you assess what is happening. You can also read the broader guide to medicine side effects before discussing your symptoms with a healthcare professional.
Who can report a side effect or adverse drug reaction?
SAHPRA says that anyone can report an adverse event. This includes patients and consumers themselves, not only healthcare professionals. Doctors, dentists, pharmacists, nurses, other healthcare workers, community workers, laboratories and people working in either public or private healthcare may also submit reports. (Sahpra)
This means you do not need to return to the person who originally prescribed the medicine before you are allowed to report a suspected reaction. However, speaking to your prescriber, pharmacist, nurse or doctor can still be important because reporting a reaction does not provide diagnosis or treatment.
A healthcare professional may also be able to add useful clinical details, particularly if you were treated for the reaction, had laboratory tests, needed hospital care or are taking several medicines.
Can a family member or caregiver help?
If someone needs help completing a report, a caregiver or healthcare professional can assist with gathering the relevant information. The report should identify the patient appropriately and provide the reporter’s contact details so that SAHPRA can request further information if necessary.
SAHPRA says it does not accept anonymous adverse-event reports. It does, however, state that identifying information about the patient and reporter is kept confidential. (Sahpra)
What information should you collect before reporting?
You do not need every possible detail before making a report. SAHPRA specifically advises people not to delay reporting simply because some information is unavailable. Providing more detail can, however, make the report easier to assess. (Sahpra)
Useful information to have available includes:
- Patient information: initials, age or date of birth rather than a full patient name, plus relevant information such as allergies, pregnancy or other medical conditions where applicable.
- The suspected medicine: trade or brand name if known, generic or active ingredient, dose, how it was taken, how often it was used, why it was being used and when it was started or stopped.
- Other products being used: prescription medicines, over-the-counter medicines, complementary medicines, traditional or herbal products and other treatments taken around the same time.
- The suspected reaction: what happened, when it started, how long it lasted, whether it has resolved and whether it returned.
- What happened afterwards: whether medical treatment was needed, whether the patient was admitted to hospital and the outcome of the reaction.
- Product information where available: batch number and expiry date can be useful, particularly when there may also be a medicine-quality concern.
- Reporter details: the name and contact information of the person submitting the report so that SAHPRA can follow up if more information is required.
Do not abandon a report because you cannot answer every question. SAHPRA’s current adverse drug reaction form explicitly says that suspected reactions can still be reported when the reporter does not have all the details.
How can patients report medicine side effects to SAHPRA?
Patients can report suspected medicine side effects themselves rather than relying exclusively on a healthcare professional.
The electronic reporting portal is available through SAHPRA’s Health Products Vigilance service. SAHPRA specifically provides this as a self-reporting route for consumers. (Sahpra)
The Med Safety App is another patient-facing option. SAHPRA describes it as a mobile application for both members of the public and healthcare professionals to report suspected adverse drug reactions. SAHPRA’s adverse drug reaction form describes the app as its preferred reporting tool for direct electronic submission. (Sahpra)
The adverse drug reaction form can also be completed and emailed to [email protected]. The form covers medicines and biological medicines as well as complementary or alternative medicines, including herbal remedies.
For a broader explanation of the South African reporting process, see the guide on how to report side effects in South Africa.
What counts as a serious or unexpected side effect?
SAHPRA encourages the reporting of suspected reactions generally, but some reports are particularly important for medicine-safety monitoring.
An unexpected reaction is one that is not reflected in the medicine’s Professional Information or Patient Information Leaflet. SAHPRA also particularly wants reports involving new health products and suspected medicine or vaccine interactions. (Sahpra)
For regulatory reporting purposes, serious reactions include suspected events associated with death, a life-threatening situation, admission to hospital or prolonged hospitalisation, a birth defect, significant disability or incapacity, or another medically important condition. (Sahpra)
You do not need to work out the regulatory classification yourself before making a patient report. If you suspect a medicine was connected with an adverse event, you can provide what you know and allow SAHPRA to assess the information.
A report is also not proof that the medicine caused the reaction. SAHPRA’s reporting form explicitly states that submitting an adverse drug reaction report does not confirm that either the reporter or the suspected medicine caused the event.
Do you need proof that the medicine caused the side effect?
No. You may report a suspected side effect.
There are many reasons why it can be difficult to know exactly what caused a symptom. A person may have an underlying illness, be taking several medicines at once, have recently changed treatment or have other factors that could explain the reaction.
That uncertainty is one reason pharmacovigilance reporting exists. SAHPRA advises people to report even when they are not certain that a product caused an event. Individual reports may not establish causation, but reports collectively can help regulators build a clearer picture of a medicine’s safety profile. (Sahpra)
Avoid stopping, reducing or changing a prescription medicine solely because you have submitted a report. Discuss treatment changes with your doctor, pharmacist or other appropriate healthcare professional unless you are dealing with an emergency requiring immediate medical care.
Can your doctor or pharmacist report for you?
Yes. A doctor, pharmacist, nurse or other healthcare professional can report a suspected reaction to SAHPRA on your behalf. SAHPRA specifically advises consumers with possible medicine side effects that a healthcare professional can assess any treatment that may be needed and can also submit the report. (Sahpra)
There can be advantages to involving a healthcare professional, especially when the reaction is complex. They may have access to your medicine history, laboratory results, hospital records and the exact names and doses of your medicines.
However, you do not have to wait for a healthcare professional to report before submitting your own patient report. Direct consumer reporting is an established SAHPRA reporting route. (Sahpra)
What happens after a medicine side-effect report is submitted?
SAHPRA may use the reporter’s contact information to obtain additional details where needed. The Authority states that the identifying information of both patients and reporters is kept confidential. (Sahpra)
A single report does not necessarily prove that a medicine caused a particular problem. Instead, reports contribute to ongoing safety monitoring and can help identify patterns or potential safety concerns that may require further investigation. (Sahpra)
When SAHPRA identifies a genuine safety concern, possible regulatory responses can include changes to medicine warnings or product information, safety communications to healthcare professionals or the public, restrictions on how a product is used, further post-marketing studies, or—in appropriate circumstances—suspension or cancellation of a product’s registration. This does not mean that every individual report will lead to regulatory action. (Sahpra)
Patient reports are therefore useful even when the person reporting cannot prove causation. They become part of the wider body of safety information used to monitor medicines after they are in everyday use.
When should medical care come before reporting?
Reporting to SAHPRA is a medicine-safety process; it is not an emergency medical service.
If you develop difficulty breathing, sudden swelling of the lips, tongue, mouth or throat, collapse or other symptoms that appear immediately dangerous, seek emergency medical care first. Severe allergic reactions can progress quickly and require urgent treatment. (nhs.uk)
You should also seek prompt professional advice when a suspected reaction is serious, worsening, unusual, occurs during pregnancy, affects a child or older adult, involves an overdose or possible medicine interaction, or involves a chronic medicine that should not be changed without clinical guidance.
Once urgent medical needs have been dealt with, the suspected reaction can still be reported to SAHPRA.
Frequently asked questions
Can patients report medicine side effects directly in South Africa?
Yes. SAHPRA states that patients and consumers can report suspected adverse events directly to the Authority. You may also ask a healthcare professional to report on your behalf. (Sahpra)
Do I need proof that my medicine caused the reaction?
No. SAHPRA advises people to report even when they are uncertain that the product caused the event. A report records a suspected reaction; it does not establish that the medicine definitely caused it.
Can my pharmacist help me make a report?
Yes. Pharmacists are among the healthcare professionals who can report adverse events, and they can also help you identify the medicine, dose and other relevant treatment information. (Sahpra)
What if I do not have all the information?
Report what you can. SAHPRA says reporting should not be delayed simply because some information is unavailable. It may contact the reporter later if additional details are needed. (Sahpra)
Is my information kept confidential?
SAHPRA states that the identities of both the patient and reporter are kept confidential. Reporter contact details are nevertheless required because the Authority may need to request additional information about the suspected reaction.
Reporting a suspected side effect is part of medicine safety
Patients have an active role in medicine-safety reporting in South Africa. If you suspect that a medicine has caused an unwanted or unexpected reaction, you do not need to wait until causation has been proven before reporting it.
Collect as much useful information as you reasonably can, get medical advice when symptoms are concerning, and seek emergency care first for urgent reactions. You can then report the suspected side effect directly to SAHPRA or ask a doctor, pharmacist, nurse or other healthcare professional to assist. Every useful report can contribute to the wider monitoring of medicine safety in South Africa. (Sahpra)