Marketing medical information

It is appropriate to recognize that some medications are more susceptible to abuse than others. If two medications are equally effective for a given indication, the one with lower abuse liability would obviously be preferred. Information on abuse liability is necessary for the appropriate regulation of medications and provides a basis for education of physicians, patients, and the public. In this chapter we describe the control of marketed medications, abuse-liability assessment procedures for premarketing testing in laboratory animals and humans, considerations of the formulation properties, and postmarketing surveillance of abuse. Finally, we provide three case studies of marketed medications that have been abused. 

Absent of outside factors, a pharmaceutical company typically addresses diseases affecting large numbers of patients. The size of the market is estimated based on studies of demographic and medical information. Once a disease with a favorable market has been selected, the decision is passed along to the molecular biology team. 

After performing a SWOT analysis and some baseline market research, Carol and the other pharmacists at Care-Rite Pharmacy have decided to develop a Pharmacy Check-up Service (MTM). One of Carol s pharmacists volunteered to put together a prototype patient chart that will be used by the pharmacists to document their activities. The patient chart contains several forms, including a patient history form that requests some basic demographic information (see Fig. 25-2), medical and medication histories forms (see Figs. 25-3 and 25-4), and an authorization to release medical information that is signed and dated by the patient (see Fig. 25-5). Also, a communication form was created to fax clinical information and pharmacists recommendations to the physician (Fig. 25-6). 

Abbreviated new drug applications are submitted to gain approval of generic versions of already approved drug products. Premarket notification [510(k)] applications are the mechanisms for marketing medical devices that are substantially equivalent to already marketed device products. Both of these applications are based on approved similar product information. 

Certification that a reasonable search of all information and other similar legally marketed medical devices has been conducted. 

Marketing applications used within the pharmaceutical and healthcare industry include those computerized systems used to support international artwork and the provision of medical information supporting pharmaceutical and healthcare products released to market. 

Medical Information supporting products released to market can exist in many different formats. The medical information produced for the finished product, whether in label format or as a package insert, should correspond with the actual ingredients that the product is formulated to contain and the method and dosage that corresponds with its license. 

Statements made by, or on behalf of, marketing organizations during promotional audio conferences will also attract regulatory attention if they minimize crucial risk information and promote a drug or device for an unapproved new use. Incorrect, misleading, or incomplete artwork and medical information could lead to the inappropriate use of a drug or medical, device, in which case a recall of that product is usually required. These systems should therefore be validated as they can impact public health. 

Reprints disseminated for medical information or marketing purposes should be those purchased from the publisher. Alternatively, photocopying license fees can be paid, and in the United States a national clearing house exists for this purpose. 

The marketing department works not only on the dollars and cents of selling products, but also on how to best position products in the marketplace. In the development of advertising campaigns and key messages, the medical information department can be very helpful in ensuring... 

A 510(k) is a term commonly used to refer to a pre-market application sent to the FDA. The information in this application documents the safety and efficacy of the finished medical device. If the FDA deems the device to be substantially equivalent to an adequate legally marketed medical device that is currently approved for marketing in the United States, clearance is granted to market the product. Visit www.fda.gov/cdrh/510khome.html for more information. 

Dealing with medical information and complaints of HCP s and patients is another duty that relates to a potential non-compliance with the marketing authorisation off label use, medical related complaints. 

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