Drug Topics - December 12, 2008 - (Page 43)

CONTINUING EDUCATION Medicare Part D In general, Medicare Part D provides prescription drug beneﬁts to everyone enrolled in Medicare, regardless of income or the source of their health care or drug coverage. Medicare Part D substantially affects a great number of Americans, and the federal government chose to use the pharmacist to obtain improved therapeutic outcomes for these individuals. Under Medicare Part D provisions, prescription drug plans are required to provide medication therapy management (MTM) services for “targeted beneﬁciaries” who have multiple chronic diseases or who use multiple medications and are likely to incur costs above a certain level.5 MTM services are to be provided by healthcare professionals, such as pharmacists, and the services are to encompass a broad range of professional activities and responsibilities within the licensed pharmacist’s scope of practice. The services include patient-speciﬁc and individualized services that a pharmacist provides directly to a patient. For providing these services, the pharmacist will receive remuneration based on time, clinical intensity, and resources required to provide them. The pharmacist’s corresponding level of liability for providing these services has yet to be determined, but it can be anticipated that the greater the level of responsibility, the greater the potential for legal liability. Thus, the duty to warn must be taken into consideration. Overall, as a result of several factors, including OBRA ’90 and Medicare Part D, the practice of pharmacy has evolved into much more than mechanical dispensing of medication. FIGURE 2 OBRA ’90 Patient Counseling Requirements* Such discussions must include matters that are significant in the professional judgment of the pharmacist; they include but are not limited to the following: Name and description of the medication Route of administration Dose Dosage form Duration of drug therapy Special directions and precautions for preparation of drugs Administration and use by the patient Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered (including their avoidance and the action required if they occur) Techniques patients can use to monitor their own drug therapy Proper storage Re ll information Appropriate action to take in the event of a missed dose * 42 U.S.C. § 1396r-8(g)(2)(A)(ii) W W W.D R U GTO P I C S .C O M Likewise, as the pharmacists’ role has continued to expand, the potential for imposition of professional and regulatory liability has subsequently increased. One area of malpractice litigation that has continued to evolve as the pharmacists’ role in health care has expanded concerns duty-to-warn cases. Under this theory of liability, patients injured by prescription drugs claim that the pharmacist had a duty to warn about potential adverse effects and other dangers associated with prescription drugs. With these types of cases, courts have been faced with the question of when and to what extent a pharmacist has a duty to warn patients of the dangers involved with a particular drug therapy. Currently, whether a pharmacist has a legal duty to warn patients varies greatly among the state courts that have addressed the issue. The result is a tremendous number of inconsistent legal standards. Of the jurisdictions that have addressed the issue, most have held that there is no general duty for pharmacists to warn patients about their prescribed drugs. These cases reveal three theories relied upon by courts to support the view that pharmacists do not have a general duty to warn: interference with the physician-patient relationship, violation of the learned intermediary doctrine, and/or imposition of liability that would contradict public policy. In determining that pharmacists do not have a general duty to warn, numerous courts have held that to do otherwise would cause interference with the physician-patient relationship. Courts have reasoned that in addition to learning the patient’s medical condition, pharmacists would need access to patient medical records before they could properly warn a patient of the effects of a prescription drug, and this would inappropriately place the pharmacist in the middle of the physician-patient relationship. Other courts have reasoned that to place a duty to warn on pharmacists would cause those attempting to avoid liability to second-guess each physician’s prescription, disrupting the physician-patient relationship. Some courts have based their ﬁnding that pharmacists do not have a duty to warn on the learned intermediary doctrine. This doctrine is derived from the theory that drug manufacturers have a duty to inform physicians of the dangers of prescription drugs and that the physicians are in the best position to choose the appropriate medication and advise patients of the inherent risks of treatment. When courts extend the learned intermediary doctrine to lawsuits against pharmacists, it insulates pharmacists from liability and places upon prescribing physicians the responsibility to warn patients of the possible risks of prescription drugs. Many other courts have determined that pharmacists do not a have a duty to warn because to do so would contradict public policy. Some courts have reasoned that to place a duty to warn on pharmacists would burden the pharmacy profession and expand pharmacists’ liability. Other courts have reasoned that receiving numerous or serious warnings from pharmacists might frighten and confuse patients, causing them to refrain from taking medications D E C . 15, 2008 DRUG TOPICS 43 http://WWW.DRUGTOPICS.COM

Table of Contents Feed for the Digital Edition of Drug Topics - December 12, 2008

Drug Topics - December 12, 2008 Contents Up Front Up Front In Depth Letters Health-System Edition Cover Story: Controlled Substance Disposal a Growing Problem for Hospitals Pharmacists Hope for Speedy Approvals Deaths from C. Difficile Increasing PharmMD Teams with HealthSpring RX Care Commentary Ohio Hospital Automates Pharmacy The Business Outlook for 2009 OTC The Pharmacist's Duty to Warn: Implications for Pharmacy Practice New Products Viewpoint

Drug Topics - December 12, 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.