Pharmacovigilance – How To Report An Adverse Drug Event

So many questions comes when trying to ascertain the safety of our drugs in circulation. Such questions includes; are all drugs actually safe? who is to decide drugs that are safe and the ones that are not? If eventually there is any that is not safe, who are we to report to? how can we monitor the safety of drugs? These and so many other questions with regards to drug safety falls under the scope of pharmacovigilance.

The use of drugs has helped to save patients from so may types of diseases, Improve quality of life and decrease the morbidity and mortality rate. However, unexpected negative outcomes can emerge from using a drug which is termed Adverse drug reactions.

Therefore, It is important to look out for, detect, assess, prevent and report any form of this unwanted effects that occurs when drugs are used.

What is pharmacovigilance?

According to the WHO, Pharmacovigilance (PV) is a science or practices that deals with the detection, assessment, understanding, Prevention, documentation and reporting of adverse drug effects or any drug related problems to an appropriate authority.1

The program for International drug monitoring gained worldwide attention following the incidence of thalidomide disaster in 1961 in which thalidomide was given to pregnant women to prevent morning sickness. The babies born to some of these women were badly deformed and it took a while before the link between the deformed babies and the drug was established and the drug was banned.

The regulatory authorities became aware that seemingly safe drug could have potential serious adverse effect. The WHO therefore called for serious closer monitoring of the adverse effects of drug.

The Uppsala Monitoring Center (UMC) became the first collaborating center for pharmacovigilance established by the WHO in 1978 for international drug monitoring. Later, at the end of 2010, about 134 countries became part of the pharmacovilance program including Nigeria and many other countries.

Pharmacovigilance in Nigeria

In Nigeria, the responsibility of Pharmacovigilance in Nigeria solely depends on the National Pharmacovigilance Centre (NPC) NAFDAC. The duties of this body in the regulation and monitoring of the safety of drugs and post market surveillance includes; 2

  • Coordinating of Pharmacovilance activities Nationwide.
  • Promoting safety and rational use of drugs in Nigeria.
  • Coordinating the activities of the National Drug Safety Advisory Committee (NDSAC).
  • Sourcing, collating, preserving, storing, retrieving and dissemination of information on food, drugs, cosmetics, Chemicals, and other NAFDAC regulated products.
  • Building a database that contains the events of Averse drug reactions and other drug related problems.
  • Creation of awareness and training of health professionals, healthcare providers, Marketing Authorization Holders (MAHs) and the general public on the topic of pharmacovigilance.
  • Post Marketing Surveillance of all Regulated Products in collaboration with Marketing Authorization Holders (MAHs).
  • Establishment of Pharmacovigilance centers in Health care facilities and Institutions.
  • Implementation of Risk Management Plans (RMP) in collaboration with the Pharmaceutical Industry and MAHs as appropriate.
  • Implementing National Policy and offering a science based information with regards to drug use safety.

How to report Adverse Drug Reactions in Nigeria

Detection and reporting of adverse drug reactions is not only left for the Pharmacists, Physicians or other health professionals, but also, a duty of the general public. Therefore, NAFDAC tries to train individuals and professionals on how to fill and submit the pharmacovigilance form.

The Pharmacovigilance form is also called the Yellow card or the yellow form. It contains information such as the reporter details, patient details, outcome of the drug and concomitant use of other drugs.

Below is a typical NAFDAC yellow form;

yellow form

Where to get or submit a NAFDAC yellow form

The Nafdac yellow form is available in any of the offices below;

  • Any NAFDAC state office in the 36 states in the country.
  • The National Pharmacovigilance Centre (NPC) NAFDAC Headquarters Wuse Zone 7 Abuja.
  • Any of the Zonal Pharmacovigilance Centres (ABUTH, Shika, FMC, Owerri, LUTH, Lagos, UBTH, Benin, UITH, Ilorin and UMTH, Maiduguri)
  • Also,  there is an online ADR e-Reporting Form.

However, there is also a platform by NAFDAC known as PRASCOR (Pharmacovigilance Rapid Alert System for Consumer Reporting) for alerting the body of any substandard, counterfeit drug or a case of ADR.

Reporting ADRs Via PRASCOR

In any case of suspected Adverse drug reaction E.g. You took Loratidine tablet and can hardly breathe. You will follow the steps below to report the adverse drug reaction to the NAFDAC via an sms.

STEP 1: A consumer sends a text message containing the name of the drug and the suspected adverse drug reaction to the short code 20543. example “I took Loratidine and can hardly breathe”. The sms is free and is available in all Nigerian networks.

STEP 2: An auto response message is sent to the consumer informing him/her that the message have been received and will be contacted back for more details.

STEP 3: Information is sent to the NAFDAC via email and is processed by a NAFDAC staff at the National Pharmacovigilance Centre. The information will help them to get more information from the reporter that will help in filling the ADR form.

When trying to report a product, the NAFDAC advises that you get the following from the product;

  • Product name in English (if in other language, then it has not been registered)
  • Nafdac registered number
  • Date markings (manufacturing date, expiry date and batch number)
  • The manufacturers name and address.

Roles of a Pharmacist in Pharmacovigilance

  1. Pharmacists at all level of practice are to aid in the collection of data that will help in detecting and solving immediate and potential adverse drug effects.
  2. Good Dispensing Practice (GDP) will help a lot to detect and address medication errors that may lead to an ADR.
  3. Through pharmaceutical care,the pharmacists has the responsibility of monitoring and documenting the outcome of a medication.
  4. Health Education is a tool pharmacists can use to create awareness to other health care providers and the general public about drug usage and its safety.
  5. Proper counselling of patients is necessary to avoid the negligence and irrational use of drugs.
  6. The pharmacovigilance form should always be available in pharmacies for easy documentation and report of ADRs.

Summary

Drugs are chemicals or poisons that have the likelihood of reacting or causing an undesired effects to the user. Adverse drug reaction can happen to anyone, therefore, it should be of national if not a global interest to report this events to the appropriate authorities.

In other words, everybody should be trained on post market surveillance and how to report substandard or counterfeit drugs in the market. Most times, when we see culprits of counterfeit drugs or products, we say its not our business whereas we can save a life by doing the needful.

This post will help guide you on how to report any ADR or fake drugs to NAFDAC. You can as well check the body in charge of pharmacovigilance in your country.

It is our duty to save lives, make it count.

Thanks!!!