Pharmacists may be reluctant to provide pharmaceutical care services to patients who require therapy with biotechnology drugs for a variety of reasons including (i) lack of knowledge about the tools of biotechnology; (ii) lack of understanding of the therapeutic aspects of recombinant protein products; (iii) lack of familiarity with the side effects and patient counseling information; (iv) lack of familiarity with the storage, handling and reconstitution of proteins; and (v) difficulty of handling reimbursement issues.
Pharmacists may view biotechnology drugs as quite different from traditional parenteral products like insulin and familiar oral dosage forms. However, in most respects, the services offered by pharmacists when dispensing biotechnology products are the same as those provided for traditional tablets or injectable products. It is important, regardless of the product being dispensed, to ensure that the patient understands the use, dosage regimen, potential adverse effects, proper storage and handling instructions as well as specific training on the administration of the drug and proper disposal of unused medication. When patients do not understand the administration and monitoring requirements of biotechnology products, scheduling training sessions for patients or including a caregiver during the counseling session should be considered to ensure appropriate patient care.
As more novel protein products have come to market and the indications for existing agents have expanded for ambulatory patients, pharmacists are increasingly required to deal with these protein pharma-ceuticals. While the first protein/peptide recombinant products were used primarily in hospital settings, many of these agents are now commonplace in ambulatory settings. The traditional community pharmacy may now dispense products like colony stimulating factors, growth hormone, and interferons to name a few.
Traditional routes of delivery for pharmaceuti-cals have been challenged by the unique characteristics of biotech product delivery. Community pharmacies struggle with maintaining sufficient inventory of high cost products, with in-depth knowledge of the pro-ducts and its characteristics and with product admin-istration. Physicians also have difficulty with inventory and with slow reimbursement. Managed care organizations may have difficulty tracking claims for these products.
As a result, the majority of patients receiving biotech drugs are managed by home health, home infusion or specialty pharmacy services. Specialty pharmacies have evolved to manage out-patient biotechnology therapies for patients. The services offered by these pharmacies go far beyond dispensing biotech products (Suchanek, 2005). These pharmacies have expertise in the following areas:
· Insurance coverage and drug costs
· Pipeline monitoring and management
· Utilization management
· Promoting adherence to drug regimen
· Disease state management
Payers, in particular managed care organiza-tions, now contract with specialty pharmacies to provide biotech and other expensive agents to solve many of the problems these products pose for the payer. The specialty pharmacy market is growing at a rate of 20% per year and is estimated by some experts to reach annual sales of $40 billion in the United States by the end of 2006 (Casemark, 2006).