Pharmacovigilance is the practice of using scientific methods to track, record and analyze the effects of pharmaceuticals, with a focus on determining and maintaining the quality and safety of consumer medicines. Every year a record number of people die due to Adverse Drug Reactions (ADR). It becomes increasingly important for all members of clinical trial to be increasingly aware of how to report ADRs so that pharmaceutical companies have a track of the incidents to improve drug safety and efficacy in the future. Sometimes if there are records of multiple ADRs for a particular drug, it has to withdrawn from the market as well. Nurses can play a very important role in Pharmacovigilance as in certain countries like Sweden for instance, they are licensed to prescribe a limited number of drug, and in most other countries, they also form part of the reporting team. This article focuses on the training of nurses in Pharmacovigilance.
Keeping the above in mind, we need to focus on how to train nurses in Pharmacovigilance. The need of the hour is to make them aware of the concept of clinical trials and Pharmacovigilance. Most of the nurses keep tremendously busy with their routine activities of patient care during their work hours and providing them the adequate training can prove to be quite challenging. Pharmaceutical companies can make a conscious effort by organizing various campaigns, targeting nurses, so as to make them aware of various aspects in clinical research and training nurses in Pharmacovigilance. By coordinating with the hospital management, training sessions and workshops can be organized on a regular basis, directing towards the nurses. Many a times we see that workshops and training sessions are organized for members of the ethics committees, principal investigators, study coordinators etc. Maybe it is time wherein the focus needs to be shifted to nurses. Organizations providing training must remember that there is no time limit for an ADR to happen, and during that period, none of the other members involved in the clinical trial for example the principal investigator or the study coordinator may not present at the site to record the event. Regulatory authority, like the DCGI in India has made it mandatory for sites these days to report any SAE occurring within 24 hours of its occurrence. Now for example, an SAE occurs at around 2 am in the morning, in all probability, other members of the study will not be present at the site, exception being of the nurse. In such cases, it is of utmost importance that the nurse is well aware of the process involving in reporting an ADR because if she/he waits for the other study personnel to come in, it might be very late for the site to report the ADR and this can lead to a severe protocol violation and non compliance of the norms established by the DCGI.
Nurses can also opt for various online courses available to educate themselves in Pharmacovigilance. These courses are self paced and can be completed with ease. This may open several doors for them in terms of career changes as well. Many software companies hiring for Pharmacovigilance have made a degree in nursing compulsory for candidates and thus there is tremendous opportunity for nurses who are looking for an alternate career option in this field. For more information on online courses and training in Pharmacovigilance, interested candidates can refer to the website www.jli.edu.in