The importance of a good medical information partner
By Innomar Strategies
The “dos” and “don’ts” of an MI team
Medical information is the face of the unsolicited enquiry for a company’s products and scientific communications. The close interaction with PV and QA means MI teams are well-versed in PV and quality regulations, such as good pharmacovigilance practices (GVP)2 and good manufacturing practices (GMP)3.
MI team members should be healthcare professionals (HCP) – such as nurse, doctor, or pharmacist – or at least have a science background with relevant training in order to gather, understand, and, where appropriate, provide information in response to requests and to gather relevant information for adverse events (AEs) and product complaints4. However, an MI agent should not provide medical advice, and if asked, should refer the patient to their HCP.
When dealing with more complex products and disease states, it is particularly beneficial to have an agent who is an HCP to manage MI activities so that they can communicate complex responses to the requestor.
In Canada the service must be provided in French or English based on the requestor’s preference.
Soft skills that make a good MI agent
Since MI teams are dealing with patients directly, empathetic communication is an important skill for an agent. Key attributes are an ability to communicate well, to pay attention to detail, to be comfortable speaking with patients on the phone, to be able to provide clear and understandable responses, and to switch tasks as needed, since there are many activities involved when handling an MI call.
For example, when taking a call from a patient who says they are having a problem with a drug, an MI agent needs to be able to probe a bit deeper to better understand the type of problem and whether to follow up with an adverse event report for PV or a complaint report for quality. They need to ask relevant questions to get a clear understanding of the issue reported and record the adverse event in the appropriate form so it can be medically reviewed or investigated5.
Documentation is a key part of MI activities since this is typically the first point of contact for a complainant or reporter of an AE. Medical information agents must ensure they capture the information accurately, fill in the appropriate forms and meet the timelines required. The industry standard is typically one business day to send an AE or complaint report to the PV or QA departments.
Given these time-intensive requirements, a good MI team should have strong standard operating procedures and processes in place. A validated medical information database is key, since MI teams are capturing AEs and complaints. MI teams are routinely brought into PV and QA audits, so good documentation and processes are imperative. Team leaders should also ensure that MI agents are appropriately trained and work is quality checked, to maintain accuracy of information provided and documented.
Most of these activities are trainable, but some of the soft skills that make a good MI agent are more intuitive. In our experience, one important yet often overlooked skill is the ability to get the complete picture or explore the question behind the question being asked. MI agents need to ensure they have the whole story. Why is the patient complaining? What happened to them? What information is missing? Getting those questions answered is vitally important.
Equally, agents need to adapt to the inquirer. If a health professional is calling, the response should be commensurate to that person’s medical expertise. If it is a patient, however, it’s important to keep responses clear and simple. For example, if a patient asks if a product contains gluten, rather than saying the product is safe for celiacs (which may not be a familiar term to all patients) answer in the way the question was asked, such as, “yes, the product is free from gluten.”
Why a good MI partner brings efficiencies
A good MI partner can bring efficiencies for companies. Since MI agents gather information about an AE or complaint, if the initial intake of information is incomplete, multiple follow-ups may be required, which can be a very expensive and time-intensive exercise.
Good information during the initial contact assists pharmacovigilance and quality, which would mean having fewer costly follow-ups that often require back and forth with difficult-to-locate patients or HCPs. Additionally, good intake at the start is key to greater reporting accuracy and completeness.
The MI team also represents the face of a pharmaceutical company, so how an agent interacts with a patient or HCP is likely to impact the overall view that person has of that company. Therefore, MI teams should be careful to represent the company’s values while remaining non-promotional and professional. Whether receiving calls from patients or healthcare professionals, the way the MI responds to queries, concerns, or complaints can leave a lasting impression, which can have a material impact on the pharmaceutical company’s image.
Conclusion: Why a trusted MI team matters
A growing number of companies recognize that the way the MI team engages with and supports patients and HCPs does reflect on the company. Having a team in the same country or region that works closely with PV and QA teams, that is familiar with cultural norms, and that can address questions and concerns about a product while putting patients and HCPs at ease is invaluable.
About the authors
Craig Dsouza
Diana Dobrin
1 Official Languages Act (R.S.C., 1985, c. 31, Government of Canada. https://laws-lois.justice.gc.ca/eng/acts/O-3.01/
2 Good pharmacovigilance practices guidelines (GUI-0102): Overview, Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/pharmacovigilance-guidelines-0102.html
3 Good manufacturing practices, Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices.html
4 Canadian Medical Information Guidelines, The Pharmacovigilance and Medical Information Network, PVN-MI Publications. https://www.pvn-mi.org/bylaws
5 Mandatory Adverse Reaction Reporting Form for Industry, Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-adverse-reaction-reporting-form-industry.html
