The ability to shift demand for medical products may be achieved through a variety of means including the use of product formularies or lists of preferred products, prior authorization requirements, or therapeutic interchange protocols. The process by which long-term care institutions or pharmacies make these decision varies, but typically involves a group of health professionals who are qualified to assess the scientific and clinical literature, consider the effects on quality, and compare relative costs. These decisions affect the use of particular medical products and allow purchasers to gain bargaining power with medical product sponsors. The decisions are made by professionals on behalf of the patients they serve, and the goal is to gain access to the highest quality products at the best negotiated price. For the FDA to assume that incentive-based rebates or discounts are tantamount to medical product sponsor control of the professional decisions of consultant pharmacists, challenges the fundamental independence and basic integrity of the profession.
Most patients served by consultant pharmacists are elderly residents of long-term care facilities.
The elderly have special needs and requirements, particularly with regard to prescription drugs, that are typically not addressed in FDA approved product labeling. Often, medications prescribed for the frail elderly have not been approved for a particular use because the studies required for FDA approval did not include elderly subjects. For this reason, consultant pharmacists need to rely on off-label information to assure appropriate use of many prescription drugs in this population. One example of this practice is the use of anti-seizure medications for psychosis. To limit consultant pharmacists who receive incentive-based rebates, or who work for healthcare organizations that receive such rebates, to FDA approved product labeling in their communications with physicians, nurses, other health professionals or patients would undermine a pharmacist's ability to act in the best interest of patients.