Pharmaceutical Manufacturer Responses to Health Care Professional and Clinical Pathway Developer Requests for Medical Information

08/16/17
Citation

Journal of Clinical Pathways. 2017;3(6):49-53.

Affiliation

Pfizer US Medical Information, New York, NY; Pfizer Medical, New York, NY; Pfizer Oncology US Field-Based Medical Research, New York, NY.

Correspondence

Dr Teresa McShane

Pfizer, Inc.

235 E. 42nd Street

New York, NY

Phone: (860) 536-4107

Email: teresa.m.mcshane@pfizer.com

Disclosures

Dr D’Ascoli, Mr Meloro, and Dr McShane are employed by and own stock in Pfizer, Inc.

Abstract: Oncology is one of the most complex and rapidly changing fields in medicine. Both practicing health care professionals (HCPs) and developers of clinical pathways require information about the latest developments in product-specific medical information in order to incorporate them into treatment practices and treatment pathways, respectively, to ensure the highest quality of care. Pharmaceutical companies that research, develop, and market new oncology medicines hold the most comprehensive and detailed information about their products. Medical information specialists (MIS) and medical science liaisons (MSLs) therefore play key roles within the pharmaceutical industry in providing HCPs with evidence-based medical information. The purpose of this article is to describe the role of the MIS and MSL in responding to requests from HCPs and clinical pathways developers for up-to-date, evidence-based product information to enable them to make informed decisions about patient care.

Received June 15, 2017; accepted July 13, 2017

Medical oncology is a rapidly changing field. As shown in Figure 1, there has been a significant increase in the number of Food and Drug Administration (FDA) approvals of oncology drugs over the past decade.1 The availability of new oncology medications fosters the continuous development of novel treatment approaches as well as improvements in oncology standards of care.2

At the same time, in the era of precision medicine, there is no such thing as a typical cancer patient or diagnosis. Patient-specific factors can result in inconsistent responses to therapy. To make informed decisions regarding patient care, health care professionals (HCPs) require the most up-to-date medical information on current cancer research and treatments. Incorporating the latest developments in product-specific medical information into treatment practices through clinical guidelines and treatment pathways is essential for improving the quality of care.3

Manufacturers hold the most comprehensive information about their drugs, and it is in their best interest to ensure that the most accurate clinical, scientific, and safety information is disclosed to allow HCPs to make well-informed decisions regarding treatment options for their patients. Pharmaceutical companies are obligated by regulatory agencies, such as the FDA, to provide accurate, balanced, unbiased, and nonmisleading responses to questions and inquiries from HCPs, patients, and other key stakeholders such as clinical pathway developers.4 For pharmaceutical companies, the ultimate goal of providing accurate product-specific and evidence-based medical information to HCPs is to optimize patient safety and treatment efficacy.4

To accomplish this, pharmaceutical companies employ medical professionals with a wide range of backgrounds (eg, medical doctors, pharmacists, nurses, nurse practitioners, and others) as medical information specialists (MIS) and field medical associates. For the latter, different companies use different titles, including medical science liaison (MSL), regional medical director, field medical director, and others. For the purposes of this article, we will use the term MSL to represent this role. These medical professionals are a vital part of Medical Information and Medical Affairs departments for communicating current, clinically relevant, evidence-based, product-specific information as a service in response to specific and unsolicited questions from HCPs.5

For oncology in particular, there has been an increase in the demand for drug-related medical information, as measured by the number of inquiries from HCPs and patients. Pfizer’s United States Medical Information data show that over the last 5 years, corresponding to new oncology drug launches, the number of annual inquiries significantly increased from 1118 in 2011 to 4842 in 2016 (Figure 2). HCPs are asking oncology questions relating to safety, off-label uses, and stability/compatibility, as well as other topics (Figure 3). Given the growth in development and approval of novel oncology treatments, this trend is likely to continue.

In this article, we describe the role of medical information professionals working within pharmaceutical companies in responding to requests for medical information. We also describe the process for providing up-to-date, evidence-based product information to HCPs and clinical pathways developers, enabling them to make informed decisions about patient care.



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