Dedicated adverse drug reaction (ADR) monitoring cells across the country are being viewed to give a fillip to widen the job openings for pharmacists. This is because under reporting and poor quality of ADR reports are seen to be the serious challenges in pharmacovigilance, said Dr Pratibha Nadig, Professor and HOD, Pharmacology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru.

With the introduction of many drugs in the market, some with quality concerns and with a changes in environment any drug is prone to cause some reaction that can be life threatening. Therefore monitoring any adverse drug effects and their immediate management is very important for patient care. In addition, there is a need to report and it is also equally critical to disseminate this information to other healthcare professionals for further prevention, she added.

As the clinicians themselves are unable to take up these responsibilities due to patient load at medical centres and various other reasons, the setting up of dedicated ADR monitoring cells manned by pharmacists are seen to be the way forward to offset under reporting and poor quality of data. The monitoring cells complement their effort and then also take up additional work. In fact in hospitals, these cells play a key role in monitoring and reporting of ADRs to the national centre for regulatory actions in the interest of patient safety, said Dr Nadig.

There are several challenges for such analysis such as poor quality drug formulations, vaccines, biologics and biosimilars which need to be reviewed in a more critical manner from the data that is generated. Therefore, the source of data and the details of the information are a key concern. This is where pharmacists are known to chip in their expertise to evaluate the data.

The primary goal of monitoring and reporting is to identify patients that report relief or have an ADR of a particular drug before branding it as a toxic. Hence the assessment plays a crucial role, she said.

The primary responsibility of the ADR monitoring cells is to collect the reports from the hospitals and other medical centres. The pharmacists in change of this will need to intimate on a regular basis to the Pharmacovigilance Programme of India (PvPI) for further analysis. While these tasks appear very simple, but in order to get the right quality and quantity of reports there is a lot more needs to be done, she said.

Quality check and analysis of ADRs are essential. This is to ensure that all drug reaction reports are authenticated. The data should be complete, with no casual assessment along with information on the seriousness, unexpected reactions and medication errors.

The stakeholders in the spectrum of pharmacovigilance view that the AMCs should need to communicate to the healthcare providers on a regular basis and these are seen to strengthen the role of the  pharmacists to ensure better patient care.