Working Outside the Dispensing Box: The Roles of the Medical Information Specialist and Medical Science Liaison

As medical information specialists and medical science liaisons, pharmacists use their drug expertise and clinical skills to serve as information providers

Introduction

The pharmaceutical industry offers diverse career opportunities for health care professionals. Although most pharmacists attain positions in community or hospital settings,¹ pharmacists are also uniquely positioned to leverage their knowledge of drug therapy and drug information skills to provide support in industry-based settings. Pharmacists can use their knowledge and skills within various departments of a pharmaceutical company including medical information, medical affairs, clinical development, regulatory affairs, and research and development. As medical information specialists (MISs) and medical science liaisons (MSLs), pharmacists serve as information providers.

The Medical Information Department

Of the various departments mentioned, medical information may be considered an ideal department for pharmacists to leverage their drug information knowledge and skills to provide valued support. Different companies outline varying roles for health care professionals (HCPs) within medical information. These may include roles within publication planning, product dossier development, medical education programs, medical meetings support, and promotional review committees as well as other functions.

The main purpose and the most vital contribution are ensuring that patients and HCPs have the necessary information that is essential for using the company’s products safely and effectively. This function allows pharmacists to utilize their drug information expertise to translate complex scientific information into content that is clearly understood by the information user. Medical information departments within pharmaceutical companies will likely vary in their structures and functions, however, the key functions of the department remain constant for most companies across the pharmaceutical industry.

Medical Information Specialists

MISs within the pharmaceutical industry are primarily responsible for responding to medical information requests from external HCPs and consumers. This process requires a multifaceted approach that entails searching, analyzing, and disseminating evidence-based scientific data related to the company’s products and particular disease states.

The department may be divided into teams that are responsible for single or multiple therapeutic areas. In turn, each team may be accountable for numerous products within a designated therapeutic area.

In order to become an effective medical information specialist, a background in health care and/or drug information is typically required. Postgraduate training programs, including clinical residencies or industrial fellowships with an emphasis on drug information, can further enhance these skills. Information specialists have the added opportunity to enhance their clinical knowledge by attending scientific sessions at national medical meetings. Pertinent scientific data obtained here may be shared with sales representatives or used to update medical information response letters.²

The Drug Information Association (DIA) is a nonprofit organization that advances the discovery, development, and life cycle management of safe and effective medicines.³ In 1995, the DIA developed a core curriculum in medical communications designed to identify and define the key activities of industry-based drug information practice.⁴ This curriculum also distinguishes between industry-based and non-industry-based drug information practice. According to the core curriculum, ⁶ key activities are essential to respond to inquiries from HCPs in an industry setting (Table 1).

Managing Unsolicited Requests

According to the FDA, an unsolicited request is one that is “initiated by persons or entities that are completely independent of the relevant firm.”⁵ When responding to these requests, the information specialist must provide responses that are accurate, fair and balanced, non-misleading, and non-promotional.⁵ The responses may be on-label or off-label. An on-label response essentially means that the information being provided is contained within the product’s prescribing information. An off-label response includes information that is outside the scope of the prescribing information.

There are several methods by which the medical information department receives unsolicited requests for information. Inquiries may be submitted using either the company’s general website or the individual product’s website. Another line of communication is the telephone. For these inquiries, call centers are usually the first line of contact. Specialists within the call center may include physicians, pharmacists, or nurses. Typically, the call center is considered the front line of addressing product questions from requestors. Call center analysts may provide a response as long as the answer is derived from the product label. Examples of requests received by the call center may include questions on dosing, drug interactions, approved indications, and use in specific patient populations.

Complex requests, or those that cannot be answered using the product label, are referred to the medical information department.

Medical information requests are documented using an electronic data management system. These systems assist the medical information department in tracking metrics relevant to the type of request, requestor, and region from which the request is received. These data are then used to assess for any new or emerging signals. For example, review of the systems report during a given month may identify that the majority of requests received pertain to a product’s use for an off-label indication. The medical information department will then use this signal to draft a standard response letter that would include information from the public literature and save it for dissemination for similar requests received in the future.

For requests that are received from an HCP, information specialists will conduct a comprehensive literature search to appropriately provide the HCP with information that will assist him or her in making the best clinical decision for his or her patient.

In order to be effective in providing these responses, an established and developed expertise in clinical medicine and drug information is essential. For all responses, reliance on evidence-based medicine is critical in order to effectively manage requests.⁶ This process requires a thorough understanding of the medication and disease state relevant to the request.

For requests that are received from a consumer, medical information specialists may choose to provide data that are available within the product’s prescribing information and if necessary, refer the consumer to their HCP for further information.

When a question is received, the specialist will initially determine whether there are scientific data readily available for dissemination through standard response letters that have been previously prepared and approved.

An appropriate search strategy with the use of proper search terms and limits is essential for obtaining relevant search results. Once the search is completed, a thorough analysis of the literature for quality and relevance is conducted. Items that are assessed include key issues related to internal and external validity, such as the trial design, safety and efficacy results, and the size of the study population. A more critical evaluation will also include an assessment of the dosing regimen, inclusion and exclusion criteria, how objectives were measured, and whether the results of the study support the authors’ conclusions.⁷ It is important to note that the items mentioned here are not all-inclusive and additional components and areas may be analyzed when assessing the significance of a study.⁶

Following a critical evaluation of the literature, the relevant scientific data and overall conclusion are then either compiled into a written response or provided verbally. These interactions do not include recommendations regarding management of the patient and are not promotional in nature.²

Peer Review Process

Medical information response letters that are newly created or updated undergo a peer review process. While the process may differ from one department to another, in most instances, at least one additional colleague within the team will review the response letter. A strong foundation and knowledge base within the field of drug information is vital in ensuring that the content of the letter is accurate, relevant, and scientifically sound.⁴ In addition, proficiency in medical writing is necessary for the letter to be effective in communicating the response to the requester in a concise yet informative manner.

Medical Information Support at Medical Meetings

Medical meetings may serve as arenas for medical information specialists to make a valuable impact. Critical functions served by information specialists at these events may include booth preparation, documenting incoming requests, providing support at the medical information booth, and managing any unsolicited requests from HCPs that require follow-up. These meetings provide the company with a better understanding of the latest topics being discussed amongst the scientific community and offer an opportunity to address questions about supported products.

During these meetings, information specialists primarily provide support at the medical information booth during the scheduled exhibit hours.² HCPs have the opportunity for a face-to-face scientific exchange of medical information pertaining to the company’s products or therapeutic areas. Similar to the way unsolicited requests received via website or phone are handled, information is presented in a confidential, non-promotional, evidence-based manner. Some unsolicited requests may require follow-up after the event. If this is the case, the specialist will document and manage these requests in a manner similar to requests received at headquarters.

Role as Educators

MISs also serve as a fundamental resource for providing critical product and therapeutic area training to internal business partners. Moreover, MISs are able to deliver various types of training sessions.² The internal business partners for these sessions may include sales representatives, MSLs, or call center associates.

Educating the sales force is vital in ensuring that the sales representatives’ interactions with HCPs are informative, insightful, and handled with confidence. The on-label scientific data may be presented during the training in various formats, including a didactic setting where MISs share the data and respond to any questions that may arise, or an interactive role-playing workshop where different scenarios are simulated.² This type of training may also be used with associates at call centers. It is important to note that sales representatives cannot provide information that is off-label, and may only speak from the data that are contained within the scope of the product’s prescribing information.

Promotional Review

A promotional review committee is comprised of internal representatives fromdepartments that may include legal, marketing, regulatory, medical information, and editorial. This committee reviews on-label, promotional, and educational materials related to products and disease states that are created for external customers including physicians and other HCPs.² Promotional material can be presented in a journal or website, or broadcast on national television.

Information specialists are an integral part of this process, from initial review to final approval. Before a committee meeting, specialists review promotional material to ensure that it is accurate, scientifically sound, and relevant. During the meeting, specialists have the opportunity to share their scientific insights with the committee, enabling the specialist to verify that the medical integrity of the promotional material is maintained.²

Medical Science Liaisons

Similar to information specialists, MSLs provide valuable medical support by liaising with HCPs to identify unmet medical needs relevant to a specific therapeutic area and to communicate pivotal clinical trial data for the medicines they are supporting.

In an attempt to foster scientific peer-to-peer dialogue, pharmaceutical companies hire individuals with scientific degrees (most commonly PharmDs, but also PhDs and MDs) and postgraduate training and/or clinical experience for these roles. Consequently, science liaisons are often perceived as more credible and knowledgeable than their sales colleagues.⁸ Maintaining scientific credibility by providing medical information in a scientifically accurate, fair, and balanced approach and achieving expert understanding of the product and therapeutic area are vital elements of the role.

The primary objective of science liaisons is to serve as the regional scientific resource and therapeutic area expert to their customers. These customers may include physicians, pharmacists, and other decision makers who can impact patient care.

The role of medical science liaisons can best be described in contrast to the more commonly recognized role of the pharmaceutical sales representative. Within any given pharmaceutical company, both sales representatives and MSLs serve as local ambassadors of their firm and function as field-based extensions to their respective departments. While the function and objective of sales representatives are to increase the prescribing of their assigned medicines to appropriate patients, the goals of MSLs are aligned with the HCPs that they interact with—advancing standards of care and optimizing patient outcomes.⁸ The similarities and differences between information specialists, science liaisons, and sales representatives are described in online Table 2.

It should also be noted that liaisons serve as field agents for a company’s research and development division, specifically medical affairs. Medical affairs can be best characterized as the “development” within research and development; it oversees all medical aspects of a drug’s development after it has been approved. Medical affairs is responsible for developing and communicating a product’s scientific value through activities such as determining which scientific publications should be developed based on the available clinical trial data, developing thought leaders and advocates for a given product, formulating a health outcomes model to evaluate the cost-effectiveness of a new therapy, and supporting medical education and research within a therapeutic area. Medical affairs is primarily comprised of physicians who are considered therapeutic area experts within their particular field. However, pharmacists are also well positioned to make significant contributions within medical affairs as they have broad scientific knowledge across most therapeutic areas.

Pharmacists in medical affairs may provide support by offering drug information services to internal and external stakeholders, furthering the scientific body of knowledge of key products by implementing publication plans, supporting business development proposals by investigating new routes of administration or dosing schedules, and managing medical conference objectives, which may include the dissemination of the latest product data to the scientific community.⁹ The responsibilities of medical affairs professionals must be independent of commercial interests and all medical guidance must be evidence-based, utilizing professional clinical practice experience, published literature, or in-house databases that may include clinical trial study reports. In comparison with medical information professionals who primarily manage medical information requests, the overall scope for medical affairs professionals is more attuned to the continuous development of the medical strategy plan for key targeted products.

As field-based extensions to their headquarters-based counterparts in medical information, science liaisons have access to many of the same resources, including external literature databases, internal databases, and the information provided within standard response letters developed in response to frequently asked questions regarding a specific product. The ability of science liaisons to access and critically evaluate the content provided by these resources is vital to their clients. Furthermore, liaisons regularly discuss the information contained within the product’s prescribing information. However, the prescribing information does not and is not meant to reflect all known information about a product.⁴ While the prescribing information serves as the basis for promotional activities of sales representatives, the services that liaisons provide become invaluable when an HCP is seeking, or seeking to understand, medical information beyond what is included on the label.

The day-to-day medical information activities that science liaisons are involved with include providing responses to unsolicited requests for off-label information, disseminating and discussing the latest clinical data presented at national medical congresses or published in a recent medical journal, or providing an in-service on a therapeutic area to medical fellows at a teaching institution. All of these activities are done in a non-promotional, objective manner.

Requests for medical information often supplement these in-person meetings and help to close the “medical inquiry loop.”

Conclusion

Clinical drug knowledge expertise and the ability to effectively communicate complex data to requestors are essential skills for MISs and MSLs. The support they provide ultimately leads to better clinical decision making and improvement of patient lives.

Additionally, a developed skill set in researching and critically evaluating published literature is a defining criterion for both roles. This critical foundation is the basis for all interactions that occur between the information specialist, science liaison, and HCPs. Reliance on evidence-based medicine is essential, and the scientific aptitude demonstrated by these professionals ensures that the data provided are applicable, comprehensive, and significant to the medical community. Although the impact of direct patient care may not be clearly evident in these roles, the patient-focused perspective of pharmacists who serve as information specialists or science liaisons can truly make a difference.

Dr. Bhambri currently serves as the US medical director at Pfizer Inc and is part of the North America Medical Affairs Team. He is also a practicing pharmacist in a community setting.Dr. Khan serves as senior manager on the global medical information team at Alexion Pharmaceuticals, Inc.Dr. Lam is currently associate director, medical affairs training at Celgene Corp, where he drives the planning, development, and execution of global medical and scientific training. He is also the founder of Aeterna Laurus, Inc, an education management and consulting company that partners with nonprofit colleges and universities to develop and deploy best-in-class, health care—focused, vocational training programs across institutions.Dr. Abdulsattar is currently recognized as a board certified pharmacotherapy specialist. In his current role, he serves as the global medical lead for the primary indication of Eliquis (apixaban) and partners with internal and external stakeholders to drive Eliquis’ global strategy.Audrey Schnell is a fourth-year PharmD candidate at the University of North Carolina Eshelman School of Pharmacy. She received her Bachelor of Science in Biology with a minor in leadership studies from the University of Florida. She has served as a medical affairs summer associate on Pfizer’s North American Medical Team for the past 2 summers.

References

• Doucette WR, Gaither CA, Kreling DH, Mott DA, Schommer JC. “National Pharmacist Workforce Survey: 2009,” Presented to Pharmacy Manpower Project, Inc., March 1, 2010, Accessible at http://www.aacp.org/resources/research/pharmacymanpower/
• Cadogan AA, Fung SM. The changing roles of medical communications professionals: evolution of the core curriculum. Drug Inf J. 2009; 43: 673-684.
• About DIA. Drug Information Association Web site. http://www.diahome.org/sitecore/content/Home/About-DIA. Accessed July 3, 2012.
• Graves DA, Baker RP. The core curriculum for medical communications professionals practicing in the pharmaceutical industry. Drug Inf J. 2000; 34: 995-1008.
• Guidance for industry: responding to unsolicited requests for off-label information about prescription drugs and medical devices. Food & Drug Administration Web site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf. Accessed May 30, 2012.
• Bryant PJ, Pace HA, eds. The pharmacist’s guide to evidence-based medicine for clinical decision making. Bethesda, MD: American Society of Health-System Pharmacists, Inc.; 2009.
• Sperry M, Bryant PJ. perform the critical evaluation. In: Bryant PJ, Pace HA, eds. The pharmacist’s guide to evidence-based medicine for clinical decision making. Bethesda, MD: American Society of Health-System Pharmacists, Inc.; 2009.
• Morgan DK, Domann DE, Collins GE et al. History and evolution of field-based medical programs.Drug Inf J. 2000; 34: 1049-1052.
• Wolin MJ, Ayers PM, Chan EK. The emerging role of medical affairs within the modern pharmaceutical company. Drug Inf J. 2001; 35: 547-555.