Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment, and prevention of adverse effects or any drug-related problem.
The World Health Organization defines an adverse drug reaction (ADR) as a response to a medicine that is noxious (harmful) and unintended and which occurs at doses normally used in man for the prophylaxis (prevention), diagnosis, or therapy (treatment) of diseases or for the modification of physiological function.
The important point to note is that a patient experiences an unwanted and/or harmful reaction following drug therapy.
A side effect can be defined as an unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug. Such effects are related to the known properties of the drug and can often be predicted.
However, when a side effect occurs above the usual/expected level, it becomes an adverse drug reaction.
In Pharmacovigilance, we are interested in all drug-related reactions. These include side effects and suspected adverse drug reactions. Health professionals and Individuals are therefore requested to report all suspected drug-related problems to the National Pharmacovigilance Centre (NPC) in NAFDAC. Therefore, we expect all reactions to be reported.
All healthcare providers including doctors, dentists, pharmacists, nurses, traditional medicine practitioners, and other healthcare providers are to report all suspected adverse reactions to medicines and related substances including orthodox medicines, vaccines, X-ray contrast media, medical devices, chemicals, cosmetics, traditional and herbal remedies.
All drug-related problems (suspected ADRs and side effects) should be reported using the ADR reporting form, Med Safety App (Mobile E-reporting platform), or through the E-reporting Platform on NAFDAC Website. Reporters must at least provide the following information as requested on the form:
- Name or initials of the patient making sure to include the age and sex
- Description of the adverse reaction making sure to include the date the reaction started.
- Brand or generic name of the suspected medicine including the date the medicine was started and stopped (if applicable)
- Name of the reporter
ADRs should be reported to healthcare providers from where we received the medication or reported to NAFDAC offices in 36 states and FCT.
Reports can be made by:
- Going to the Healthcare Provider (HCP)
- Filling an ADR/Yellow Form. (*forms can be downloaded from the NAFDAC website at nafdac.gov.ng
- E-reporting platform
- Med Safety App
- Green Book App
NCSC is NAFDAC’s public enlightenment and sensitization platform in its campaign to eradicate fake/substandard regulated products and enthrone quality culture amongst secondary school students.
Membership of NCSC is drawn from secondary schools across the 36 states of the Federation and Abuja. Members must therefore be bonafide students of the schools, of good character and high academic standing.
Schools interested in becoming members of the NCSC can apply in writing to the office of the Director-General (NAFDAC). If approved, the schools will then be registered to participate in the club’s activities.
- Circulation of the NAFDAC Consumer Safety Publication (NCSP) to all member schools
- Coordination of club activities at school level
- Workshops on public health issues
- Lectures on NAFDAC regulatory issues
- Members/NAFDAC interaction on a dedicated website – ncsc-nafdac.org
- Annual competitions at state, zonal, and national levels
Award of prizes to students, school coordinators, and member schools at state and national levels
Annual NCSC competitions are organized for member schools at the state, zonal, and national levels in both junior secondary and senior secondary categories, and winners are awarded prizes.
State-level examinations are conducted to identify both state-level and zonal-level winners. First-place winners from the zonal examinations in both categories are invited to the headquarters (Abuja) to participate in a grand finale which is in the form of a quiz competition. The grand winners are recognized and honored at a National Award Ceremony.
