The medical affairs team of a pharmaceutical organization is tasked with significant responsibilities. It’s the conduit between the company and external stakeholders, physicians and patients. It has to communicate complex information clearly.
Medical information letters are a good example of this challenging role. When a pharma organization receives an unsolicited call for information about an off-label medical product, the medical affairs team has to respond quickly and in accordance with strict regulations.
But just as the role of medical affairs professionals is evolving, so too are the tools and techniques they can use to simplify their tasks. Here we examine some of the requirements of medical information letters and how technology can improve them.
The role of medical affairs professionals is evolving. Their value to the industry has increased and their tasks have become more varied. Historically, the medical affairs team was under the control of another organizational department, according to an article published in the journal Advanced Medical Education Practice.
But nowadays, with the separation of medical affairs and commercial organizational departments being a regulatory requirement, medical affairs professionals have greater autonomy and responsibility to build relationships with healthcare practitioners based on science and driven by medical initiatives.
Despite their growing importance, some medical affairs teams remain slow to adjust to the demands of the patient-centric approach. And they need to be more active in creating and sharing medical knowledge, writes Pierre Jacquet, Christian Seiffert and Sej Brar at L.E.K. Consulting. Being able to educate and inform patients will help to evolve the medical affairs function into a strategic role, they explain.
What is required is a shift in the manner of communication, including medical information letters.
Patients want their communications and information to be delivered in certain ways. Primarily, says Matt Eastwood, global chief creative officer at McCann Health, medical affairs teams need to look to traditional consumer brands for insight on how to make information accessible and easy to understand.
Healthcare practitioners are time-poor. Information overload and time consuming administrative tasks make them unwilling to give time to sales reps, writes Felix Jansson at cloud-based stakeholder platform Monocl. Additionally, most HCPs are familiar with the information from sales reps and prefer dealing with medical science liaisons (MSLs). In fact, Jansson says HCPs tend to spend more than an hour in discussion with MSLs because the quality of data and insight they provide is valuable.
This special relationship should be seized. For Helen Kane, CEO of consultancy Pivot MSL, medical science liaisons are in a unique position to engage HCPs from pre-approval to post-approval of a new product. “MSLs with the right brief, training and direction can be the face of the organisation prior to a drug achieving approval.”
They are closer to HCPs than the commercial teams and MSLs that can weave into their message their organization’s story, vision and values will add more value to the information sharing process.
For medical affairs teams and MSLs in particular, producing medical information letters in response to external requests for information can be challenging. This is especially so when providing information about off-label use of drugs, says Jansson in another Monocl article.
FDA regulations dictate that doctors can prescribe drugs outside their intended use but pharma companies cannot promote their products for off-label use, which refers to unapproved uses. So responses must keep truthful, scientific information separate from promotional content in medical letter responses to unsolicited requests from HCPs.
Jansson differentiates between allowed unsolicited and prohibited solicited requests. The former results from the pharma company prompting requests.
So if an MSL is at an industry event to share data about approved drug use and asks the audience: “Why don’t you ask me about off-label use of the drug?” — that would be considered a prompt. These types of solicited discussions of off-label drug uses – even if kept to science rather than promotion — are not allowed.
There are key considerations for medical affairs teams responding to unsolicited requests for information. Each response needs to include a copy of the FDA-required labeling, for example, which could be the FDA-approved package insert or FDDA-approved patient labeling, writes Thomas Sullivan, founder of medical education company Rockpointe Corporation.
But it also needs to include a clear statement that the FDA has not approved or cleared the product for use, or has approved it for specific indications.
Responses should also include safety information and references for the provided information such as bibliographies of publications in peer-reviewed medical journals or in medical or scientific texts.
Sullivan highlights the challenges medical affairs teams face through social media and other online content. They are allowed to disseminate information on these channels in response to requests for information. But the information needs to be truthful, non-misleading and accurate.
The trouble that arises is the duration that the content is online and the broad audience able to see it. So an organization could be sharing information about off-label uses of their products with people that never requested the information. This could lead to sharing information about the product to someone that did not request it, which could be tantamount to promoting that product for a use the FDA has not approved.
When HCPs require information not found in the product’s package insert, the job falls to the medical affairs team to compile a response from a variety of sources. MSLs will need to scour the medical literature to provide scientific explanations of the product, explains medical science liaison Briana Santaniello.
Collaboration is often required as gathering this data and compiling the report could demand working with the scientific communications department and medical affairs groups, among other teams.
Systems that can collate data into a unified source are essential to manage responses more easily. Likewise, systems that can be integrated across multiple user platforms will enable collaboration.
Stakeholders need educational and high-quality information as medicine becomes more complex. Medical affairs teams need to provide this information while remaining transparent and compliant, according to Mckinsey & Company senior partner Matthias Evers and colleagues. And a lot of this communication is happening digitally.
Yet McKinsey & Company research shows biopharmaceutical companies are not digitally ready. Some 50 percent consider their digital strategy as “conservative” while 40 percent are happy with the current level of digital readiness in which MSLs use basic tablet technology with a gradual shift to virtual formats.
Only 10 percent of biopharmaceutical companies say they invest in digital tools for medical affairs. But by doing so, they’ve managed to support real-time exchanges between HQ and field medical while providing MSLs and opinion leader physicians access to information so they can have virtual relationships.
Adopting digital processes grants pharma companies greater agility in medical affairs, argue the McKinsey & Company team. Organizations should create a digital culture that tries new approaches and adapts systems to needs, knowing that the process is ongoing and fluid.
Medical affairs teams that follow this approach will develop a “test, learn, and can do” attitude, which the researchers say contrasts with traditional processes.
Requests for medical information letters can be plentiful so having a system to capture them, along with record-keeping of adverse events and product complaints can help improve efficiencies for the medical affairs team.
Key to such a system is the ability to funnel all information regardless of its input type into the right software and track to inform future actions and decisions. This is what Anju BUS and AI-based data movement does; it tracks all input as it is collated from a single source.
This technology provides medical affairs teams with “one version of the truth.” We call our technology IRMS, which makes up the core of our medical affairs technology offering. Branching off from that core are the following modules:
The IRMS suite has been engineered in collaboration with more than 150 pharmaceutical, biotech and medical device companies. Of particular importance to the current discussion is IRMS Care. It allows HCPs and consumers to search for published content that has been approved by the client using a secure customized or company-branded website.
Medical affairs teams can use IRMS Care to control the sharing of documents and to grant users the flexibility of self-registration and other customizable features, such as reducing direct contact between medical affairs team and its customers/HCPs through the user portal.
IRMS Care is also responsive and compatible with use on desktops, tablets and mobile devices; it provides insights about product performance and customer needs; it can create separate ‘tenants,’ and fully integrates within the broader organizational IRMS environment.
The medical affairs function is evolving to be of ever-increasing significance. Those working in these roles know that the quantity of information and the variety of sources it comes from can be overwhelming. Choosing a proven technological solution can help with the management and execution of responses to HCPs.
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