Pharmacovigilance
This page contains answers to common questions handled by our support staff, along with some other questions, tips and tricks that we have found useful and presented here as questions.
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Please follow this link to Download the ADR forms
1. QUESTION: WHAT IS PHARMACOVIGILANCE? 2. QUESTION: WHAT IS AN ADVERSE DRUG REACTION (ADR)? 3. QUESTION: WHAT IS THE DIFFERENCE BETWEEN AN ADR and A SIDE EFFECT?4. QUESTION: WHO SHOULD REPORT ADVERSE DRUG REACTIONS? 5. QUESTION: WHERE DO I SEND COMPLETED ADR CASE REPORT FORM? 6. QUESTION: WHAT IS DONE WITH THE INFORMATION ON THE COMPLETED ADR FORM? 7. QUESTION: WHAT ARE THE BENEFITS OF ADR REPORTING TO HEALTH PROFESSIONAL? 8. QUESTION: ARE THERE ANY NEGATIVE CONSEQUENCES ON THE HEALTH WORKER OR THE PATIENT FOR REPORTING AN ADR?9. QUESTION: HOW CAN I GET AN ADR REPORTING FORM?1. QUESTION: WHAT IS PHARMACOVIGILANCE? ANSWER: Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problem. 2. QUESTION: WHAT IS AN ADVERSE DRUG REACTION (ADR)? ANSWER: The World Health Organization defines an adverse drug reaction as a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases, or for the modification of physiological function. The important point to note is that patient experiences an unwanted and/or harmful reaction following drug therapy.
3. QUESTION: WHAT IS THE DIFFERENCE BETWEEN AN ADR and A SIDE EFFECT?ANSWER: 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. It must be stressed that in Pharmacovigilance we are interested in all drug related reactions ? this includes side effects and suspected adverse drug reactions. Health professionals are therefore requested to report all drug related problems to the National Pharmacovigilance Centre.
4. QUESTION: WHO SHOULD REPORT ADVERSE DRUG REACTIONS? ANSWER: All health care professionals/workers, including doctors, dentists, pharmacists, nurses, traditional medicine practitioners and other health professionals are to report all suspected adverse reactions to drugs including Western medicines, vaccines, X-ray contrast media, medical devices, cosmetics, traditional and herbal remedies.
5. QUESTION: WHERE DO I SEND COMPLETED ADR CASE REPORT FORM? ANSWER: The completed ADR form is to be sent to the National Pharmacovigilance Centre, personally, by post or by fax. It can also be sent to the nearest NAFDAC state office or to any of the National Advisory Committee member. A copy should be kept by the health professional for documentation and reference, but the original is to be sent to the NPC.
6. QUESTION: WHAT IS DONE WITH THE INFORMATION ON THE COMPLETED ADR FORM? ANSWER: The information obtained from the completed ADR report is entered into National/international adverse drug reaction database and analysed by expert reviewers. A well-completed adverse drug reaction reporting form submitted to the NPC and subsequently to the WHO monitoring Centre in Uppsala, Sweden 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 medication. ? Appropriate package insert changes to include the potential for the reaction reported by Nigerian health professionals and workers. ? 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.
7. QUESTION: WHAT ARE THE BENEFITS OF ADR REPORTING TO HEALTH PROFESSIONAL? ANSWER: Reporting of adverse drug reactions benefits the health professional in several ways such as ? Guaranteeing Patient Safety ? Improving Quality of Care Offered to Patients ? Enhancing Patient Confidence in Practitioners ? Contributing to Global Knowledge on Drug Safety issues 8. QUESTION: ARE THERE ANY NEGATIVE CONSEQUENCES ON THE HEALTH WORKER OR THE PATIENT FOR REPORTING AN ADR?ANSWER: There are no negative consequences for reporting an adverse drug reaction. The adverse drug reaction report does not constitute an admission that a health professional 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 health professionals named 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 is not to be used for commercial purposes. The information is only meant to improve our understanding and use of the medicines in Nigeria. ADR reports cannot be used in a court of law under any circumstances.9. QUESTION: HOW CAN I GET AN ADR REPORTING FORM?ANSWER: Prepaid ADR forms can be obtained from and submitted / mailed to 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. |