Drug Topics - December 12, 2008 - (Page 47)

CONTINUING EDUCATION REFERENCES 1. Tremblay v. Kimball, 77 A. 405 at 408 (Me. 1910) 2. Jones v. Walgreen Co., 265 Ill. App. At 320 3. David B. Brushwood. The Pharmacist’s Duty to Warn: Toward a Knowledge-Based Model of Professional Responsibility, 40 DRAKE L. REV. 1, 1-60 (1991) 4. David B. Brushwood. The Pharmacist’s Duty Under OBRA-90 Standards, 18 J. Legal Med. 475,485 (1997) 5. Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003, Pub. L. No. 108-173, 117. 2066 (2003) ALAN SPIES is an assistant professor in pharmacy administration at Southwestern Oklahoma State University. Before coming to Southwestern, he spent ﬁve years as an assistant professor in pharmaceutical, social, and administrative sciences at the McWhorter School of Pharmacy at Samford University. KIMBERLY BURNS is an associate professor at the LECOM School of Pharmacy in Erie, Pa. She received her B.S. in Pharmacy from the University of Pittsburgh School of Pharmacy in 1994 and her Juris Doctor degree from Duquesne University Law School in 2002. She is licensed in Pennsylvania as both a pharmacist and an attorney. Court Holding Learned intermediary doctrine forecloses any duty upon a pharmacist lling a physician’s prescription that is valid and regular on its face, to warn the patient or other ultimate consumer, except insofar as the prescription orders or an applicable statute or regulation expressly requires. Learned intermediary doctrine provides for no general duty to warn under given circumstances; however, exceptions apply when there is speci c knowledge, pharmacy represents that it engages in process of evaluation of medications, or there is something patently and unambiguously wrong with the prescription. In addition, OBRA ’90 did not create private cause of action. State Alabama Case Walls v. Alpharma Pharmacy DTW Duty to warn under speci c circumstances Facts /Duty-to-Warn Allegations Pregnant wife used husband’s Lindane prescription and gave birth to child with medical conditions. Lawsuit alleged that pharmacy failed to provide adequate warning of the risks associated with Lindane. Connecticut Deed v. Walgreens Duty to warn under speci c circumstances Lawsuit alleged that Walgreens violated OBRA ’90 and failed to warn decedent and inform prescribers that the use of the combined medications would cause harm and were unsafe. Georgia K-Mart v. Chamblin No duty to warn Lawsuit alleged that based on OBRA ’90, pharmacy had No general duty to warn based on learned intera duty to warn of any potential side effect, including rare mediary doctrine and interference with physicianStevens Johnson Syndrome. patient relationship. OBRA ’90 does not establish a generalized duty to warn on every possible side effect. OBRA ’90 requires an offer to counsel; patient did not show that pharmacy failed to offer counseling. Patient died after taking generic Cordarone. Lawsuit alleged the pharmacist failed to include the FDA-required Medication Guide and that this was a proximate cause of illness and death. Duty to warn can exist where there are excessive doses or obvious inadequacies on a prescription. Failing to provide a Medication Guide may also constitute a failure to warn by the pharmacist. Louisiana Stanley v. Wyeth Duty to warn under speci c circumstances Massachusetts Brienze v. Casserly Duty to warn under speci c circumstances Lawsuit alleged that the pharmacy had a duty to warn of potential adverse interaction between two drugs taken together that were both dispensed from the same pharmacy. Massachusetts law does impose a duty on pharmacists to warn the customer when lling two prescriptions that adversely interact with one another. Learned intermediary doctrine does not apply to this case. Duty still possible despite the pharmacy lea et provided, which warned of the interaction, and the pharmacy’s offer of counseling. No duty to warn under given circumstances; however, duty may arise under other circumstances. In addition, OBRA ’90 does not alter Michigan common law. Michigan Saukas v. Walker Street Pharmacy Duty to warn under speci c circumstances Lawsuit alleged that under OBRA ’90, pharmacy had duty to warn of drug that interacted with another drug received from pharmacy six months earlier and still taken by patient after re lling through mail-order pharmacy. Mississippi Moore v. Memorial Hospital and Winn-Dixie Duty to warn under speci c circumstances Lawsuit alleged that pharmacy had duty to warn and No duty to warn under learned intermediary docwas negligent in selling a drug that was contraindicated trine. Exceptions to doctrine do apply, but not for for a pregnant woman and that harmed infant. this case. In addition, OBRA ’90 does not give rise to independent cause of action. Texas Morgan v. Wal-Mart Duty to warn Lawsuit alleged that pharmacy had duty to warn of under specific adverse reactions and that OBRA ’90 requires a duty circumstances to counsel. or if reasonable pharmacist would warn Pharmacists do not have general duty to warn patients of potential adverse reactions absent evidence of any special circumstances or neglect in face of which a reasonable pharmacist would have acted. OBRA ’90 also can’t be read as a general duty to warn. Special circumstances could create duty for pharmacists, as their role has changed a lot over the years. DRUG TOPICS W W W.D R U GTO P I C S .C O M D E C . 15, 2008 47 http://WWW.DRUGTOPICS.COM

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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

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