Abstract

Pharmacy has historically prided itself on its ability to pioneer innovative patient care as drug development and delivery systems have become more advanced. True advancement in our industry has traditionally been driven by the science behind the drugs. Specialty medications challenge us in providing patient-centric strategies, as specialty pharmaceuticals represent the single most explosive prescription medications market in terms of growth, high cost, and management complexities. Pharmacists must be agile in delivering patient care approaches that meet the needs of patients, prescribers, and payors from a population-based perspective, yet meet and support patients' individual challenges with their disease and medication regimens. The benefits of an agile system, considering the potential of FDA approvals of new drug molecules and the expansion of FDA-approved indications of currently approved medications, are as follows:■As the needs of patients change as new therapies are introduced, pharmacists in agile systems can readily reconfigure or upgrade their services as well as demonstrate adaptability in coping with new and varied situations.■Reprogrammable and reconfigurable service systems, integrated into an information-intensive network, allow an agile pharmacy system to produce patient-specific results.■An agile system allows for a patient-centric system designed to produce specific services for individual patients, not just broad categories of services designed to fit the average person.■An agile system is totally integrated. Ideally, information flows seamlessly from different areas of practice (e.g., community, hospital, specialty pharmacy), from different areas of responsibility (e.g., physician, nurse, pharmacist), and from all of these areas to the manufacturers of the medication to provide seamless pharmaceutical care. This integration ensures that the patient-specific knowledge collected by each health professional is transferred to the others to obtain the optimum patient outcome. The treatment of hepatitis C virus (HCV) infection is an example where specialty pharmacy must be agile in both treatment approach and patient care management as regimens continue to change. Until 2011, the historically accepted standard therapy for chronic genotype 1 HCV infection was dual therapy with a pegylated interferon and ribavirin for 48 weeks. The standard of care for treatment of HCV genotype 1 changed dramatically with the approval of two new direct acting antiviral (DAA) drugs—telaprevir and boceprevir—for use in pegylated interferon-based and ribavirin-based triple therapy. Boceprevir-based and telaprevir-based triple therapy with pe- gylated interferon and ribavirin marked the beginning of a new era in HCV therapy for genotype 1 patients. It began the era of response-guided therapy (RGT), suggesting that a shortened duration of therapy was acceptable for patients meeting certain criteria. Many new drugs are currently under investigation (i.e., next generation protease inhibitors [DDA drugs], polymerase inhibitors, and NS5A inhibitors) that will continue to change current therapy and patient care approaches in addition to interferon-free regimens. The agile approach optimizes patient management as the continuum of care changes and creates continuity to provide a model of seamless pharmaceutical care. The patient-centric approach necessitates that the patient remains a crucial and active link throughout the process. Patients are asked to report to the pharmacist data such as adherence levels, problems with therapy such as adverse effects, and other applicable outcomes. Pharmacists follow up with those patients who may be experiencing adverse effects or failing to respond to treatment. The flow of information and the care of the patient therefore circulate seamlessly among the many players within the agile pharmacy system and provide the decision makers with the proper quality and quantity of pertinent data. The agile approach benefits specialty pharmacy especially as it has grown from a small niche in the marketplace to a significant presence in the practice of pharmacy based on a rich pipeline of complex therapies and regimens. Gary W. Kadlec, BSPharm, MBA, ScD, President, Diplomat Specialty Pharmacy, Flint, MI Gary Rice, BSPharm, MS, MBA, Vice President, Clinical Services, Diplomat Specialty Pharmacy, Flint, MI

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