1. WHAT IS PHARMACOVIGILANCE?
Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problem.
2. WHAT IS AN ADVERSE DRUG REACTION (ADR)?
The World Health Organization defines an adverse drug reaction (ADR) as a response to a medicine which 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.
3. WHAT IS THE DIFFERENCE BETWEEN AN ADR AND A SIDE EFFECT?
A side effect can be defined as any 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 may or may not be beneficial. Side 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.
4. SHOULD I REPORT AN ADR AS WELL AS A SIDE EFFECT?
In Pharmacovigilance we are interested in all drug related reactions? These include side effects and suspected adverse drug reactions. Health professionals are therefore requested to report all suspected drug related problems to the National Pharmacovigilance Centre (NPC) in NAFDAC.
5. WHO SHOULD REPORT ADVERSE DRUG REACTIONS?
All health care providers including doctors, dentists, pharmacists, nurses, traditional medicine practitioners and other health care providers are to report all suspected adverse reactions to medicines including orthodox medicines, vaccines, X-ray contrast media, medical devices, chemicals, cosmetics, traditional and herbal remedies.
6. HOW CAN I REPORT AN ADVERSE DRUG REACTION?
All drug related problems (suspected adverse drug reaction and side effect) should be reported using the ADR reporting form also known as the ‘Yellow form’. 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 and address of the reporter including contact details for follow-up if necessary
7. WHERE DO I OBTAIN AN ADR REPORTING FORM AND OR SEND A COMPLETED FORM?
ADR reporting forms can be obtained and or completed ADR forms (individual case safety reports) sent by the following means;
- Any NAFDAC state office in all 36 states of Nigeria and the FCT
- The National Pharmacovigilance Centre (NPC), NAFDAC Headquarters, Wuse, Zone 7, Abuja
- Any of the Zonal Pharmacovigilance Centres (ABUTH, Zaria; FMC, Owerri; LUTH, Lagos; UBTH, Benin; UITH, Ilorin and UMTH, Maiduguri).
- By calling any of these numbers 08086899571, 09 2905110 or 07098211221
- Forms can also be downloaded from the NAFDAC website on www.nafdac.gov.ng
You can also report ADRs through PRASCOR
8. WHAT IS PRASCOR?
PRASCOR – Pharmacovigilance Rapid Alert System for Consumer Reporting is a short code service for consumers to alert NAFDAC of safety and quality issues via SMS.
9. HOW DOES THE SHORTCODE SERVICE (PRASCOR) WORK?
The service works in three simple steps
Step 1:A consumer sends information with the name of the medicine or product and the suspected ADR by SMS to the number (short code) 20543 for free on MTN, Glo and Etisalat. For example: “I took paracetamol and cannot sleep”.
Step 2: An auto response acknowledging receipt of the alert and next steps is sent to the consumer (sender).
Step 3: The information is forwarded to NAFDAC by secure email to be accessed only by NAFDAC staff at the National Pharmacovigilance Centre; the received message will help NAFDAC to contact you for more information that will be used to fill an ADR reporting form if needed or to guide the consumer on what next to do.
10. WHAT IS DONE WITH THE INFORMATION ON THE COMPLETED ADR FORM?
The information obtained from the Individual Case Safety Report (ICSR) is entered into the national adverse drug reaction database and analysed by expert reviewers. A well-completed ICSR submitted to the NPC could result in any of the following:
- Additional investigations into the use of the medication in Nigeria.
- Educational initiatives to improve the safe use of the medicines.
- Institution of appropriate risk minimization measures such as labeling changes to include the potential for the reaction reported by Nigerian health care providers.
- Changes in the scheduling or manufacture of the medicine to make the medicine safer.
- Other regulatory and health promotion interventions as the situation may warrant including change in supply status or withdrawal
11. WHAT ARE THE BENEFITS OF ADR REPORTING TO HEALTHCARE PROVIDERS AND PATIENTS?
Reporting of adverse drug reactions benefits the health care provider and patient in several ways such as
- Making the use of medicines safer
- Improving Quality of patient Care
- Enhancing Patient – healthcare relationship
- Increasing patient’s confidence in healthcare services
- Contributing to Global Knowledge on Drug Safety.
12. ARE THERE ANY NEGATIVE CONSEQUENCES ON THE HEALTHCARE PROVIDER OR THE PATIENT FOR REPORTING AN ADR?
There are no negative consequences for reporting an adverse drug reaction. The adverse drug reaction report does not constitute an admission that a healthcare provider or the drug contributed to or caused the event in any way.
The details of an ADR report are stored in a confidential database in Nigeria and the analyzed report sent to the Uppsala Monitoring Center (UMC). The names of the reporter or any other healthcare provider on a report and the patient are removed before any detail about a specific adverse drug reaction are used or communicated to others.
The information obtained from an ADR report will not be used for commercial or litigation (court case) purposes. The information is only meant to improve understanding and use of the medicines in Nigeria.
ADR reports cannot be used in a court of law under any circumstance.
The National Pharmacovigilance Center NPC, National Agency for Food and Drug Administration and Control (NAFDAC) Plot 2032 Olusegun Obasanjo Way, Wuse Zone 7, Abuja, PMB 5032 Wuse Abuja
NAFDAC offices Nationwide.
NAFDAC Drug Safety Advisory Committee members in the zones.