Pharmacy & Therapeutics - June 2008 - (Page 356)

Evaluating and Standardizing Medical Devices product, and a relationship with or trust in the manufacturer.4 Furthermore, in 2007, physicians performing hip operations were reimbursed about $2,000 regardless of which device they used, whereas a hospital had to pay device costs between $2,000 and $10,000, depending on the brand of hip implant chosen.5 These factors can create a chasm between a hospital’s cost-containment goals and physician or patient preferences.4 However, a shift may be occurring in this paradigm. Sheri Dodd explained: We can say in general terms that this is changing. The surgeon and department chairs are seeing restrictions and a need for prioritization in terms of which technologies and innovations are brought in unchallenged. Therefore, we are anticipating, at launch of some products, that there will be a review by the hospital’s new technology committee, and I frankly think that we’ll welcome that, assuming a fair and robust review process, because if we are generating evidence to support our product value, providers, purchasers, and patients will receive the benefit.” Potential Conflicts of Interest And the Influence of Manufacturers Potential conflicts of interests have important consequences not only for the individual physicians but also for hospitals, patients, and manufacturers.15 In the device industry, an ongoing dialogue between clinicians and manufacturers is essential to optimize products, instruments, and surgical techniques.2 The early development of a medical device typically requires that a clinician be an important part of the development team.15 Physicians play an influential role in identifying and defining an unmet clinical need, generating early concepts and design solutions, and validating prototypes.15 Such involvement promotes a thorough understanding of a specific device by the clinician.15 Physicians are integral to the entire process that makes the development and introduction of new devices possible.15 A conflict of interest may occur because manufacturers offer consulting fees and honoraria to physicians, which may provide a financial incentive for the physician to select the company’s products.4 Manufacturers also financially sponsor physician programs that suppor t professional skills, medical research, and resident or fellow education.15 Additionally, industry provides grants that support educational, scientific, independent, or policymaking meetings that promote scientific knowledge.15 This activity has received attention by regulators and the media, resulting in regulatory efforts to constrain incentives.4 The trade organization for medical device manufacturers (AdvaMed) has published guidelines for their dealings with health care providers.15 These guidelines address the potential ethical and legal implications of manufacturer–physician relationships and the potential appearance of impropriety with regard to federal law.15 Manufacturers must be sure that they pay only fair market value for new concepts provided by physicians and that consulting fees are clearly related to the value of a physician’s contribution.2 The medical device industry also recognizes that adherence to ethical standards and compliance with applicable conflict-of-interest regulations is critical to ensuring an ongoing mutually productive relationship with health care professionals.15 The close relationship between manufacturers and clinicians has long frustrated hospitals’ efforts to control supply costs.4 Many supporters of standardizing medical devices within hospitals view the physician–vendor relationship as responsible for a “huge breakdown in the system.”4 Manufacturers are viewed as having long influenced physicians’ selection of products as well as product pricing.4 Some hospitals use tactics to gain greater control over manufacturer involvement that preserve the benefits they provide but that curtail vendor influence on decision making.4 Some hospitals control access to their facilities and set boundaries on vendors’ access to physicians; for example, vendors might need hospital certification and a preapproved appointment to enter the facility.4 However, hospitals cannot control clinicians’ relationships with vendors outside their facility.4 Although vendors have been heavily criticized for their perceived attempts to influence clinicians’ choices, their value in the process is nevertheless well recognized.4 Maintaining an appropriate balance between the costs and benefits of the Gaining control of the costs associated with a hospital’s supply chain presents special challenges, because the most expensive supplies … are items for which physicians have strong preferences. Physician preferences may discourage the involvement of doctors in the medical device standardization process.4 Physicians may withhold participation to express resistance to the concept of product standardization, especially when it appears to be imposed and overseen by management.4 Unfortunately, however, without their participation, the process is not valid.4 If standardization does not produce a rigid product formulary imposed and enforced by non-clinicians, physicians may be more willing to be involved in the process.4 Physician cooperation may be facilitated by a clinical resource specialist with clinical experience (often a nurse practitioner) who can rely on practical knowledge and competence.4 Because it is sometimes problematic for hospitals to dictate product choices to physicians, some organizations are instead trying to influence physicians’ decisions by creating incentives.4 These inducements are offered by hospitals to motivate physician involvement and to align them more closely with the financial interests of the hospital with respect to supply-chain decisions. Such creative incentives include improvements in patient care and investments in new technologies and capital equipment.4 Consideration has also been given to “gain-sharing” by physicians, but this approach is often dismissed because of the possibility of a conflict of interest.4 It has also been found that nonfinancial incentives can have as strong or a stronger impact on physician behavior than financial incentives.4 Alignment of physicians with hospitals’ interests in terms of standardizing medical devices and other physician preference items may be a primary factor that distinguishes successful hospitals from those struggling to remain viable.4 356 P&T® • June 2008 • Vol. 33 No. 6

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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