An Assessment of Preparation Methods and Personnel Requirements in a Medical Information Department during Product Launc
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An Assessment of Preparation Methods and Personnel Requirements in a Medical Information Department During Product Launch Tiffany Donald, PharmD Medical Information Specialist, GlaxoSmithKline Christi Marsh, PharmD Medical Information Manager Solvay Pharmaceuticals, Inc. Laurel Ashworth, PharmD Professor of Clinical and Administrative Sciences, Director, Drug Information Center, Mercer University College of Pharmacy and Health Sciences
Key Words Product launch; Personnel requirements; Industry; Workload; Medical information; Training Correspondence Address Laurel Ashworth, PharmD, Mercer University College of Pharmacy and Health Sciences, 3001 Mercer University Drive, Atlanta, GA 30341-4155 (e-mail: [email protected]).
A survey of medical information (MI) departments was conducted to gain an industrywide perspective of the launch process. In addition, a second survey was conducted that quantified activities during product launches at Solvay Pharmaceuticals, Inc. (Marietta, GA). Of the 52 initial companies invited to participate in the study, 26% (N = 14) provided responses. The majority of the surveyed teams consisted of two to three personnel from the MI department, and preparation activities began less than 3
INTRODUCTION Within the past 14 years, more than 1,200 new drug applications (NDA) were approved by the US Food and Drug Administration (FDA) (1). Representing the efforts of over 90 pharmaceutical companies, the FDA approved a total of 113 new drug applications in 2004. While product approval represents the result of years of hard work, the success of the new product relies heavily on the efforts that take place both prior to and following FDA approval (2). A successful product launch requires coordination and communication between many departments within a pharmaceutical company. By providing a wide range of services to both internal and external customers, a medical information (MI) department is able to showcase its value as an information resource for the company. During the prelaunch period, defined as the time prior to introduction of a new product to the market, MI personnel are often expected to maintain current workload activities while simultaneously carrying out additional responsibilities associated with the new product launch. These responsibilities may include the following: development of a comprehensive product bibliography and index to facilitate access to the
months prior to launch. Overall, product launches at Solvay Pharmaceuticals required an average of 1.62 MI personnel and 52.6 hours of self-training. Activities began an average of 6 months prior to the expected launch date. While working on the launch team, MI personnel were responsible for an average of 2.25 additional products. Based on product launch experience at Solvay Pharmaceuticals, a formula was developed to estimate workload during future product launches at Solvay Pharmaceuticals.
product’s published medical literature, preparation of standard written medical response letters for anticipated inquiries, formul
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