Medical Information in Pharmaceuticals
Medical Information (MI) is the collection, handling and dissemination of information on medications, and their safe and correct use. The MI department or function is the primary interface between the Marketing Authorisation Holder and the patient/consumer or healthcare professional. Their work involves taking medical enquiries, which are usually received via dedicated MI hotlines, to call centres or MI functions, and ensuring the consistent and controlled response to these enquiries. MI functions are also required to gather information relevant to patient safety or product quality and report this information to relevant internal functions or vendors responsible to safety or quality activities.
MI activities can be performed in-house by the pharmaceutical manufacturer or outsourced to a specialist medical information service provider. Regardless of where and by whom the activities are performed, a compliant MI system needs to be in place with capabilities and documented procedures to undertake the following:
- Record the nature of the information requested as well as the contact details of the enquirer (subject to compliance with applicable local and regional data protection requirements)
- Be able to solve verbal and written enquires using the appropriate communication channels
- Have in place a Frequently Asked Question (FAQ) repository to speed-up the reviewing process in case of recurrent enquires
- Respond to unique enquires with accurate non-standard answers after having conducted appropriate investigation and analysis
- Identify and report to the responsible Pharmacovigilance (PV) function relevant safety information including (but not limited to) adverse events, off label use, medication errors misuse, abuse, pregnancies, etc.
- Identify and report product quality complaints on pharmaceutical products to the relevant quality function
- Stay to date with latest scientific publications and company guidance
Additionally, the MI function may be engaged with or support the following activities:
- HCP/patient engagement activities such as patient support programmes, market research, patient registries, investigator initiated studies, ensuring quality and safety information is captured and communicated as previously detailed
- Participation in scientific conferences and publication of scientific literature
- Review the accuracy of MI used on marketing and promotional materials
- Provide training to company sales representatives and the medical science liaisons (MSLs)
- Inform and promote the best practice in the use of medicines
ESMS Global Partnership
QVigilance work with and recommend ESMS Global as a preferred and trusted partner for provision of MI services to our clients. The two companies have already worked collaboratively and effectively in the provision of PV and MI services and have developed a standard template safety data exchange agreement to ensure efficient communication and exchange of information of shared clients.
An example of our successful partnership and seamless collaboration with ESMS Global is presented in the following case study: