Dispensing Biotechnology Products: Handling, Professional Education, and Product Information
Preparation, dispensing, and patient education regarding appropriate use of pharmaceuticals are primarily the responsibility of the pharmacist. Traditionally, parenteral products have been available in ready-to-use containers or required dilution with wat
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Dispensing Biotechnology Products: Handling, Professional Education, and Product Information Peggy Piascik and Val Adams
INTRODUCTION Preparation, dispensing, and patient education regarding appropriate use of pharmaceuticals are primarily the responsibility of the pharmacist. Traditionally, parenteral products have been available in ready-to-use containers or required dilution with water or saline prior to use with no other special handling requirements. Hospital pharmacists, in particular, have prepared and dispensed parenteral products for individual patients for many years. While many pharmacists are skilled in handling parenteral products, biotechnology products present additional challenges since they are proteins subject to denaturation and thus require special handling techniques. These challenges will be explained in greater detail in this chapter. Practice issues with biotechnology products may be handled in slightly different ways depending on laws and pharmacy practice standards in each country. This chapter is written primarily from the view of practice in the United States since that is the primary experience of the authors.
PHARMACIST READINESS Pharmacists may be unprepared to provide pharmaceutical care services to patients who require therapy with biotechnology drugs for a variety of reasons including (1) lack of knowledge about the tools of biotechnology; (2) lack of understanding of the therapeutic aspects of recombinant protein products; (3) lack of familiarity with the side effects and patient education considerations; (4) lack of familiarity with the storage, handling, and reconstitution of proteins; and (5) difficulty of handling reimbursement issues. Pharmacists may view biotechnology drugs as quite different from traditional parenteral products and P. Piascik, Ph.D. (*) • V. Adams, PharmD Department of Pharmacy Practice and Science, University of Kentucky, College of Pharmacy, 789 South Limestone Street, Lexington, KY 40536-0596, USA e-mail: [email protected]
familiar oral dosage forms. However, in most respects, the services offered by pharmacists when preparing and dispensing biotechnology products are the same as those provided for traditional tablets or injectable products. To determine the knowledge and skills a pharmacist requires to work with biotechnology drugs, one must first consider who will be storing, preparing, dispensing, and administering the agent. Many agents will be prepared by a pharmacist or other healthcare provider and the drug administered by a nurse, while others will be prepared by the patient and selfadministered. Pharmacists who work in clinics or with home health-care providers need to understand how to store, prepare, and dispense the product to a nurse with instructions to maintain potency and sterility until it is administered to the patient. The knowledge and skill set is similar but has some significant differences from the skills required by a community pharmacist who must be able to teach the patient how to store, reconstitute, and administer the b
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