Adverse Drug Reaction reporting plays a very important role in improving patient safety. Adverse Drug Reaction reporting in clinical settings should become a regular practice, as it would help in identifying any serious or non-serious ADRs that may not have been observed during clinical trials. Proper reporting of ADRs not only helps in identifying new reactions but also assists in evaluating the frequency and severity of known reactions.
WHO CAN REPORT ADR’S :
According to Pharmacovigilance Programme of India (PvPI) eligible reporters include :
Healthcare professionals : Doctors, dentists, pharmacists, nurses.
Non - Healthcare providers : Patients, consumers, caregivers.
Pharmaceutical Industry : Marketing Authorization Holders.
WHAT TO REPORT :
According to PvPI all types of suspected ADR’s can be reported whether they are :
- Known or unknown.
- Serious or non-serious.
- Rare or frequent.
ADRs related to the use of allopathic medicines, vaccines, traditional medicines, medical devices can also be reported.
WHY DOES REPORTING AN ADR MATTERS :
- Helps detects unknown, serious or rare adverse effects of medicines.
- Improves the safe use of medicines in the society.
- Can help in supporting drug safety monitoring after marketing.
- Helps regulatory authorities to issue warnings, update labels or even withdraw unsafe medicines from market if required.
- Encourages safe prescribing practices.
HOW CAN A ADR BE REPORTED :
- Through hospital ADR centers or nearest Adverse Drug Reaction Monitoring Center (AMC).
- Using mobile applications – ADR PvPI or through online portal.
- By direct submission through mail – by filling out ADR reporting form.
IMPORTANT INFO : While reporting an ADR it should contain following four information
- Identifiable patient.
- Identifiable reporter.
- Suspected drug.
- Reaction observed.
NOTE : without these 4 criteria the application cannot be processed.
As healthcare professionals we should encourage patients to report any ADRs that have observed after taking medication – especially in out patient settings .
ADR reporting is not just an responsibility – it is a contribution toward safer healthcare for everyone.
MBH/DB