Pharmaceutical Commerce - November/December 2009 - (Page 7)

oped Specialty Pharmacy Providers deserve Their own Class of Trade The emergence of specialty pharmacies, with fundamental differences from other types of pharmacy providers, warrants the establishment of manufacturer relationships By Robert J. Irene, RPh, Armada Health Care The precedent for any new trade class is evident in the historical evolution of the pharmacy profession into distinct segments that mirror the changing dynamics of healthcare delivery. This transformation has been influenced by pharmacologic and therapeutic advances, prescribing practices and undoubtedly, economics of the target market. Through the relentless efforts of Armada Health Care and its growing constituency of member pharmacies, Specialty Pharmacy is emerging as the newest trade class in the pharmaceutical market. Pharmaceutical manufacturers, government agencies and private payors are beginning to recognize and embrace the advantageous patient-centric services offered by these unique providers. Over the years, the pharmacy profession has undergone constant service improvements due in part to increased clinical expertise and strategic business development surrounding the targeted patient populations and disease states they manage. Healthcare professionals are all familiar with traditional Acute Care, Long Term Care and Home Health/Home Infusion type pharmacies. Each of these segments (and many others) has been afforded the recognition and resultant professional and economic benefits accruing to a unique “class of trade” designation. A brief and cursory review of the genesis of pharmaceutical classes of trade reveals a legal foundation rooted in the RobinsonPatman Act of 1936. A related pharmaceutical case is Abbott vs. Portland Retail Druggist, a Supreme Court case rendered in 1976. Collectively, these legislative or legal actions have created a justification for identifying distinct trade channels as “classes of trade,” as defined by the service requirements and economics of each channel. The establishment of a trade class has historically been instituted to recognize a uniqueness in dispensing venue, specific patient population or more importantly, in professional capabilities. A new relationship with patients Undoubtedly, Specialty Pharmacy providers meet these criteria. Specialty Pharmacies treat a distinct and well-defined patient population in a number of chronic and acute disease states including, HIV, hemophilia, infertility, organ transplant, multiple sclerosis, rheumatoid arthritis and oncology. The nature of the disease state, the drug treatment modalities, administration, side effect management, cost and the ensuing economic burden all serve to create a highly interactive relationship between the patient, physician and clinical or dispensing pharmacist. The requisite capabilities for the practice of Specialty Pharmacy include, but are not limited to: management of prescription persistence and compliance regimens, professional counseling, patient advocacy and outreach, expert reimbursement services, patient training and educational services, 24/7 pharmacist access, sophisticated data management, and proactive patient call-center capabilities. The drugs being handled by Specialty Pharmacy are often quite expensive, and usually require special handling, transport and delivery (i.e. temperature-sensitive storage shipping/handling etc.). In addition, there is an increased reliance on Specialty Pharmacies to manage complicated Risk Evaluation and Mitigation (REMS) programs. The current healthcare market often precludes Specialty Pharmacy compensation for these extra services either on differentiating reimbursement schedules, fee-for-service programs or via access to contractual pricing structures of the medications they dispense. The good news is more and more innovative organizations understand the value of the Specialty Pharmacy channel as it continues to emerge into a distinct class of trade. Pharmaceutical R&D pipelines are robust with the development and launch of new biotech drugs, vaccines and biologics, many of which will call for the aforementioned services provided by Specialty Pharmacies. Furthermore in today’s environment of healthcare reform, appropriate prescription use, patient compliance and detailed informatics are only some of the requisites to the successful management of cost containment initiatives associated with these high-cost specialty pharmaceuticals. In summary, the Specialty Pharmacy channel is clearly defined and well on its way to joining the ranks of other unique pharmacy providers through a universally accepted trade class distinction within the healthcare industry. > Robert J. Irene, RPh, is President of Armada Health Care (Short Hills, NJ, tel: 866 766 4002; Armada is nation’s largest group of specialty pharmacy members and offers a host of Channel Management Solutions to the market. Armada, works closely with manufacturers and other industry partners to craft, monitor and promote custom contracting programs on a host of specialty products to these providers. Armada also organizes the industry’s largest annual specialty pharmacy business summit. Transparency Is the Solution to the medical-Journal ‘Ghostwriting’ Controversy drug companies should keep a goal of effective communications as the priority in medical publications By Don Hannaford, Levick Strategic Communications The media, scholars, researchers and curious individuals are primed to jump to conclusions when they learn that a medical journal article’s contributors include employees of a pharmaceutical company or hired “ghostwriters.” Our society has been conditioned to be skeptical for good reason. The abuse of “words” for profit as opposed to the common good can be unabashed or shadowy, an exposé away from further poisoning the receptiveness of those needing clear information. Four years ago, in the wake of the Vioxx case, media attention swarmed to flush out ghostwriting in medical journal articles. It was a juicy, irresistible story for the media, exposing “secret” deals between pharmaceutical companies and opinion-leading physicians and researchers, who would sign off on an article written by a medical education company that would play up benefits and play down questions about a pharmaceutical product. In reality, most key individuals who agreed to be an author were usually heavily involved in the editing and final product (and usually asked to participate because their known position was in agreement with what the article’s summations would likely conclude). That reality was not as salacious as when the system was abused. Flash forward from 2005 to 2009 to yet another flurry of attention to ghostwritten articles for medical journals. While the impact on specific companies identified with this practice will be for them to look manipulative and anti-consumer, it also throws a harsh light on medical journals themselves— still going on four years after such a public lashing!—and threatens the credibility of any journal article about a product from a pharmaceutical company. Nevertheless, it is folly to abandon the idea of professionally augmented communication (i.e., ghostwriting) because of past misuse. Instead, we must continue to focus on the future of medicine, of pharmaceuticals, and to employ all methods of scholarly communication of crucial medical issues in ways that the credibility and importance are clearly and unequivocally communicated. Someone who knows the subject MUST write about it. Lack of skill in research leads to product failure. Likewise, lack of skill in writing leads to communication failure. Articles based on pharmaceutical company research must be part of the knowledge base. Medical journal articles sponsored by drug companies are a legitimate part of communicating to physicians. Physicians > Don Hannaford is Senior Vice President and Chair of the Public Affairs Practice at Levick Strategic Communications, a Washington, DC, firm specializing in high-profile crisis communications, public affairs, financial and regulatory communications. Previously, Don was Managing Director of the New York office of Zeno Group, and before that, the Washington, DC, office of Manning, Selvage and Lee. He has broad experience in managing communications strategies for national and multinational pharmaceutical manufacturers, healthcare organizations and others. He has a BA dual degree from the University of Pennsylvania. and others must care about the accuracy and relevance of the article, not who assisted in the writing. Drug companies seek ghostwriting services in part because some researchers are not skilled writers. Additionally, when several sources combine to produce an article, an overarching writer is crucial to ensure clarity and flow. To be blunt: there is NOTHING wrong with ghostwriting as long as it is made continued on page 29 > NovemBer/deCemBer 2009 7

Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2009

Pharmaceutical Commerce - November/December 2009
Top News
Business & Finance
Brand Marketing | Communications
SupplyChain | Logistics
Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Editorial Index | Meetings

Pharmaceutical Commerce - November/December 2009