Drug Topics - December 12, 2008 - (Page 42)

Continuing Education IMPLICATIONS FOR PHARMACY PRACTICE medications. This article will attempt to provide insight into the factors that play a role in determining whether the dutyto-warn standard has been met. The History of the Duty to Warn Pharmacists have always been charged with ﬁlling the correct medication as prescribed by the patient’s physician. There is not a court in the country that would hold otherwise. However, the legal line of how far to expand the duty beyond simply ﬁlling a prescription accurately is difﬁcult to determine. For much of the past century, the “count, pour, lick, and stick” standard of practice was one most courts adopted. However, with advances in pharmacy practice and the adoption of the doctor of pharmacy degree (PharmD) as the entry-level pharmacy degree, courts are beginning to hold pharmacists to a higher standard of practice. One of the ﬁrst cases in the country to expand a pharmacist’s duty beyond solely ﬁlling a prescription correctly occurred in 1910. In that case, the court held that that the law requires a druggist to show “only ‘reasonable and ordinary’ care in compounding prescriptions, in selling medicines, and in performing the other duties of his profession; such care with reference to him means the ‘highest practicable degree of prudence, thoughtfulness, and vigilance,’ and it is ‘proportional to the danger involved.’”1 Furthermore, “a breach of such duty would be negligence rendering him liable for injuries resulting therefrom.” The court concluded that “when the pharmacist applies his knowledge and exercises care and diligence, he is bound to use his best judgment. The pharmacist, however, by using his best judgment does not absolutely guarantee that no mistake will ever be committed in the execution of his duties, and it is plausible that a qualiﬁed pharmacist may make an error that would not be actionable negligence.” Another early case decision that expanded the pharmacist’s duty beyond solely ﬁlling a prescription correctly occurred two decades later in 1932. In that case, the Appellate Court of Illinois stated that “[t]he instant contention is primarily based upon the assumption that a pharmacist is obliged to ﬁll any and all prescriptions. Such is not the law. As a chemist he may know that the physician has erred in his prescription and that to ﬁll it might cause death or serious injury to the patient.”2 It is interesting to note that the court referred to the pharmacist as a chemist, a term that courts have not used in many years. However, this ruling demonstrates that pharmacists are perceived as having special knowledge of prescriptions. Though these early cases demonstrated the judicial system’s reliance upon a pharmacist’s judgment in determining what duty was owed to a patient, the next several decades demonstrated a shift toward cases usually being decided by whether the correct medicine was placed in the bottle. It was not until the early 1980s that the pharmacist’s shield against increased liability began to weaken.3 Even though the cases in the 1980s still held that the pharmacist has no general duty to warn, they began to cite the cases from the early 1900s that discussed how a pharmacist’s legal duty could extend beyond ﬁlling a prescription properly. Since the 21st century opened, courts are beginning to move once again to the standard that it is not enough to dispense the correct medication in the correct amount to the correct patient with the correct directions on the pharmacy label. However, how far a pharmacist must go in fulﬁlling professional and legal responsibilities to advise patients on the proper use and/or potential adverse effects of prescription medications remains undeﬁned. Although this may be troubling to pharmacists, as the standard of care for professionals is usually a combination of tradition, expert opinions, and court rulings, there are federal regulations to help guide pharmacists. Speciﬁcally, regulations under OBRA ‘90 and Medicare Part D provide valuable guidance on the nature of a pharmacist’s duty beyond accurately dispensing prescription medications. Omnibus Budget Reconciliation Act of 1990 The United States Congress expanded, both directly and indirectly, the duty of pharmacists through its enactment of the drug use review provisions in OBRA ‘90. The purpose of OBRA ’90 is, in part, to “enhance the role of pharmacists in providing quality medical care, through a comprehensive drug utilization review program.” Under OBRA ’90, the pharmacist is required to discuss with each person who presents a prescription matters that are deemed signiﬁcant in the pharmacist’s professional judgment, such as special directions and precautions for preparing, administering, and using the drug, common severe or adverse effects or interactions, and contraindications. Pharmacists must also make a reasonable effort to obtain a record and maintain the patient’s history, including known allergies, drug reactions, and medications taken. A more detailed chart highlighting the patient-counseling requirements under OBRA ’90 is provided in Figure 2. Although OBRA ’90 was originally enacted to apply solely to Medicaid patients, most states, through similar legislation, have applied its mandates to all patients.4 Furthermore, many commentators and courts see the federal law as establishing a minimum standard of care for pharmacists. At least one jurisdiction has imposed greater duties on pharmacists, based upon a statute enacted after the passage of OBRA ’90. The Supreme Court of Tennessee held that a pharmacist has a duty to warn patients of the dangers of the prescription drug dispensed by the pharmacist. The court explained that although the standards promulgated by the state board of pharmacy pursuant to OBRA ’90 did not establish the duty owed by a pharmacist, they provided guidance in determining that duty. The court concluded that the pharmacist had a duty to warn the patient of the dangers of the prescription drug at issue, especially when the pharmacist knew that the physician had not warned the patient about the drug. W W W.D R U GTO P I C S .C O M 42 DRUG TOPICS D E C . 15, 2008 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

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