Understanding the role of the
Medical Information service

What is Medical Information

The Medical Information (MI) service is one of the key pillars of the pharmaceutical industry required by all Marketing Authorisation Holders (MAH) who release a drug on the market, the service acts primarily to answer any questions health care professionals (HCPs) or the general public may have regarding the safe and correct use of medicinal products. Enquiries can range from simple ingredient enquiries which concern the contents of a drug to more complicated clinical enquiries requiring research and collation of scientific material to produce a response. The nature of working in MI therefore entails dealing with a vast variety of different enquiries daily, it is the role of the MI officer to ensure the responses to these enquiries are tailored to the enquirer, answered in full, and align with the guidance set out by the Pharmaceutical Information and Pharmacovigilance Association (PIPA).

The first point of contact

As the Medical Information service deals directly with the public, pharmacists, and other HCPs it can act as the first point of contact for important drug safety information such as adverse drug reactions (ADRs). The MI team must subsequently work cross-functionally with the Pharmacovigilance team to ensure that all spontaneous reports of patients experiencing ADRs received through MI are documented and sent to the relevant regulatory authorities. The reporting of spontaneous ADRs received through MI facilitates the continued evaluation of the risk-benefit ratio of a drug and can even help to identify new side-effects associated with a medicinal product which had not been previously detected.

Not only does the MI service identify and highlight important spontaneous drug safety cases, it can also act as a source for drug quality issues such as damage to a medicinal product, reports of strange taste and smells and in extreme cases instances of falsified medicines and drug tampering. The medical information service must therefore work closely with the quality team to ensure spontaneous reports of drug quality issues are thoroughly investigated in order for the appropriate action to be taken to protect the consumer.

Medical Information service

Dealing with Medical information enquiries

When receiving an enquiry, it is first and foremost most important to understand and clarify what medicinal product the enquirer is seeking information for and the nature of the enquiry. Only once the enquiry is fully understood can the MI officer begin to draft and form an encompassing focussed response. At all times during contact with the enquirer it is important to question whether any information the enquirer is giving constitutes an ADR or a quality issue which requires forwarding on to subsequent team members. Both the query and response to the enquirer are logged in order to keep a record which is provided to the MAH and Qualified Person for Pharmacovigilance (QPPV) during reconciliation for oversight.

References: [1] Article 98 of EC Directive 2001/83

Summary

The MI service requires trained staff members with great customer service and communication skills to understand and answer a large variety of different questions on a daily basis.

Here at JensonR+ we can provide a MI service to all those looking to outsource their MI service requirements, for more information please get in touch at consultancy@jensongroup.com.