What is an adverse event?
An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as a “side effect”.
It includes:
- Lack of therapeutic efficacy or reports of worsening of a pre-existing condition
- Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
- Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
- Overdose
- Misuse and Abuse
- Use in pregnancy and breastfeeding
- Product technical complaints e.g. discolored or deteriorated products, improper labeling
Why should I report an adverse event?
We don’t want to miss out on important data which could help us use our medicines more effectively and safely. If you report an adverse event It would also help us to identify rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications
What to report? (Necessary minimum information)
1. Patient particulars
This identifies the person who experienced the Adverse Event.
The particulars include initials, age, gender etc.
2. Event particulars
These describe the symptom/sign. Additional data include: onset, course and outcome of the event.
3. Reporter details
You should provide your name, address and phone number as you may need to be contacted for further information.
If you are not a healthcare professional, provide details of the prescribing doctor too.
4. Drug details
These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event.
Who can I report to?
You can report to:
Any health care professional (Doctors, Dentists, Nurses, Pharmacists,Patients etc)
Non healthcare professional (Patient, relative, friend, etc)
