Role of a medical advisor in pharmacovigilance as a business support service.

Sir,

Many clinicians feel that reporting an adverse drug reaction (ADR) will result in questions being raised about their professional competence. Since ADR reporting is not associated with significant immediate return and is time-consuming, many clinicians tend to see it as a burden. Because of the resultant under-reporting, pharmacovigilance (PVig) activities in India are largely below-par, especially when compared with the western world.[1]

A medical advisor (MA) in a pharmaceutical industry is mostly concerned with providing support to the marketed drug, which also involves providing authentic and evidence-based information about their products to the Key Opinion Leaders and consumers and conducting continued medial education programs.[2] MAs often tend to look at PVig as a hurdle for drug promotion and marketing. This is due to the fact that similar to the practicing clinicians, a stigma against PVig has developed in the minds of many MAs.

It has been suggested that regional MAs can be an active part of PVig by providing training to clinicians and medical assessment of the suspected ADRs. They can also support the investigators in clinical trials by reviewing adverse event reports. At the consumer level, MAs can tackle the patient enquiries on drug safety issues. Finally, they can carry out the causality assessment and decision-making about further appropriate actions at the regional level because of their strong clinical background.[3]

In addition to these roles, we propose a system by which MAs can utilize PVig as a means to contribute toward improving the business of the company. MAs form a bridge between the pharmaceutical industry and the practicing clinicians. They provide information pertaining to the drug and to the industry to the clinicians on one hand, and the clinician feedback to the industry on the other. By virtue of this unique position, MAs should utilize PVig as a chance to interact with the investigators (in case of clinical trials) and prescribing clinicians (in post-marketing scenarios).

It is not an uncommon occurrence that when a practicing clinician encounters an ADR during practice, he often switches the brand and/or the drug, instead of exploring the possibility of factors involved in the causation of the ADR, let alone reporting it. MAs should encourage clinicians to report all the ADRs that they come across their practice. In addition, MAs should provide clinicians with authentic and evidence-based information regarding the ADR, its causality, any previous reporting of the ADR in literature, and other related information. MAs should be knowledgeable to clear the doubts of the clinicians regarding ADR reporting, and should allay the anxiety and fears from the minds of the clinicians that act as hindrances in allowing them to tackle with ADRs head-on. Finally, MAs should encourage the clinicians to present and/or publish case reports in conferences and journals.

In this way, MAs would be not only playing a vital role in strengthening the PVig system in India, but also instilling confidence about their product/s in the mind of the clinician, thus improving the business of their brand and of their industry.