Drug Topics - December 12, 2008 - (Page 44)

Continuing Education IMPLICATIONS FOR PHARMACY PRACTICE as prescribed, which could endanger their health. Although most courts have found, for the reasons just mentioned, that a pharmacist does not have a general duty to warn, a modern litigation trend continues to ﬁnd ways to hold pharmacists liable for their failure to warn patients. A number of states have demonstrated a willingness to recognize that pharmacists do have a duty to warn, while other states have recognized a duty to warn under limited circumstances. Courts in the minority of states that have determined that pharmacists have a duty to warn have relied on the duty-of-reasonable-care standard, the counseling laws under OBRA ’90, or rejection of the doctrine of learned intermediary. Furthermore, a number of jurisdictions that follow the majority view stating pharmacists do not have a general duty to warn have found exceptions to this rule under limited circumstances, including when there are obvious inadequacies or clear errors on the prescription, when the pharmacist voluntarily assumes the duty, or when the pharmacist has special knowledge regarding a patient. Currently, in the assessment of whether and when a pharmacist could be negligent for failing to warn a patient, an essential factor to consider is in which state(s) the pharmacist is licensed to practice. The practice of pharmacy is regulated by each individual state; so is the determination as to whether a pharmacist has a duty to warn and under what circumstances. Unfortunately, what has evolved is a statespeciﬁc duty-to-warn standard for pharmacists that greatly varies among the states that have addressed the issue. In addition to speciﬁc duty-to-warn cases discussed in the next section, the chart on page 47 summarizes recent duty-towarn cases that highlight the legal inconsistencies between the numerous states that have addressed the issue. Duty to warn: Case examples As already discussed, most state courts addressing the legal issue of a pharmacist’s duty to warn have determined that there is no general duty to warn of possible side effects of prescription drugs. However, many state courts have recognized exceptions to this rule, determining that there may be speciﬁc circumstances in which a pharmacist would be required to warn the patient. Although these speciﬁc circumstances continue to evolve through court decisions, one duty-to-warn scenario that has been addressed recently involves whether a pharmacist has a legal duty to warn the patient regarding a potentially adverse interaction between two prescription medications. The following cases help illustrate how two state courts addressed this speciﬁc scenario. Case 1 The Michigan case of Saukas v. Walker Pharmacy involved a patient (Saukas) who experienced a harmful drug interaction after taking the prescription medications divalproex (Depakote) and lamotrigine (Lamictal) together. Initially, the patient was taking divalproex and receiving the prescription from Walker Pharmacy; however, the patient later had the divalproex dispensed by a mail-order pharmacy. While taking the mail-order divalproex, the patient received a new prescription for lamotrigine. The patient submitted the lamotrigine prescription to Walker Pharmacy six months after it last dispensed divalproex for the patient. Owing to time elapsed, the Walker pharmacy computer system failed to alert the dispensing pharmacist to a potential interaction between the divalproex and lamotrigine. The pharmacist accurately dispensed the lamotrigine to the patient as it was prescribed by the physician. After concomitantly taking the prescribed doses of divalproex and lamotrigine, the patient developed Stevens Johnson Syndrome, a life-threatening drug-induced rash. The patient subsequently sued Walker Pharmacy for dispensing a large dose of lamotrigine, alleging that the pharmacy knew or should have known of the potential for a serious interaction with the divalproex. The lamotrigine product information stated, in part: “fatal rashes have occurred while using this medicine … the possibility of a rash may be increased by using too much of this medicine when treatment begins … or taking valproic acid (divalproex) with lamotrigine.” The patient did not dispute that the prescription had been ﬁlled properly, but rather that the pharmacy should have discovered that the patient was still taking divalproex and that the addition of lamotrigine could cause a harmful drug interaction. The legal issue before the court was whether the pharmacist had a legal duty to identify and act on the potential harmful drug interaction. By suggesting that the pharmacist had a legal duty, the patient relied on state pharmacy board regulations that require pharmacists either to refuse to ﬁll prescriptions that the pharmacist has reason to believe could cause harm to the patient or to communicate to the patient information regarding the interaction. However, the trial court disagreed with this argument, noting that the pharmacist had no reason to know the patient was taking both medications and therefore had no reason to decline to ﬁll the prescription or warn the patient or prescriber about the potential harmful interaction. Concluding that Walker Pharmacy did not owe the patient a legal duty under the circumstances, the trial court dismissed the case. The patient appealed the trial court decision to the Michigan Court of Appeals, which afﬁrmed the trial court’s dismissal of the case, agreeing that Walker Pharmacy did not have a legal duty under the circumstances. Speciﬁcally, the appeals court found that the lamotrigine prescription was proper on its face and was not subject to more than one interpretation, and that the pharmacist had no reason to believe the lamotrigine would harm the patient in any way. Therefore, there was no reason to contact the prescriber or to warn the patient about the potentially harmful drug interaction. In support of this decision, the appeals court cited past Michigan cases determining that pharmacists have no general duty to warn or to monitor or intervene in a patient’s drug use. Speciﬁcally, one past Michigan case W W W.D R U GTO P I C S .C O M 44 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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