Drug Topics - December 12, 2008 - (Page 45)

CONTINUING EDUCATION determined that “pharmacists are held to a high standard of care in correctly ﬁlling prescriptions” but that “they are generally not liable for damages resulting from a properly ﬁlled prescription.” Also, “a pharmacist has no duty to warn the patient of possible side effects of a prescribed medication where the prescription is proper on its face and neither the physician nor the manufacturer has required that any warnings be given to the patient by the pharmacist.” Although the Walker case reiterates that pharmacists do not have a general duty to warn patients about potential side effects, the court appears to leave open the possibility that a pharmacist could have a duty to warn or act on the possibility of harmful interactions between two prescribed medications when the pharmacist has knowledge that the patient is taking the prescriptions together. What was not provided in this case is additional guidance regarding what would constitute “knowledge” on the part of the pharmacist. For example, if in this case the patient’s divalproex prescription was last dispensed by Walker Pharmacy three months instead of six months before the patient received the lamotrigine prescription, would the court have determined that the pharmacist had knowledge about the two medications, thus having a legal duty to warn? Furthermore, the Walker case does not provide information on the type of interaction that may require pharmacist intervention or warning. Would a pharmacist have a legal duty to warn only when there is a potential for a severe or life-threatening interaction, or would moderate or less severe interactions also be included in this duty? Guidance concerning these questions may be found in the opinion of the dissenting judge on the Walker case. The appeals court decision in the Walker case was not unanimously agreed upon by all the judges involved; one judge dissented, taking the position that the pharmacist did have a legal duty to warn or act under the circumstances. In the dissenting opinion, the judge discussed why pharmacists do have a legal duty to act when there is an unacceptable, recognized, and medically signiﬁcant risk of serious harm or death to the patient. Furthermore, the judge stated that this legal duty applies even to separate prescription transactions handled by the same pharmacy, if the transactions were sufﬁciently close in time that it could be reasonably contemplated that the customer might still be taking the earlier prescribed and ﬁlled medication. The dissenting judge discussed how, under the particular circumstances of this case, the prescriptions for divalproex and lamotrigine were ﬁlled within a brief period and that the pharmacy records reﬂected them both being ﬁlled. At a minimum, a simple review of the patient’s pharmacy records, which were under the control of the pharmacy, would have revealed the recent divalproex prescription and allowed the pharmacist to inquire whether the patient was still taking the divalproex. The dissenting judge stated that “pharmacists have the necessary skills and tools to notice W W W.D R U GTO P I C S .C O M errors of drug incompatibility, that pharmacists are in the best position to alert prescribing doctors about possible errors, that by holding pharmacists accountable the quality of healthcare will improve, and that any burden on pharmacists is outweighed by the public beneﬁt.” Instead of dismissing the case as the other judges decided, the dissenting judge would have allowed the case to proceed to a jury trial. Case 2 The Massachusetts case of Brienze v. Casserly involved a patient (Brienze) who had been taking theophylline under the care of his family physician. On a subsequent visit to the same physician, the patient was prescribed ciproﬂoxacin, even though the physician knew the patient was already taking theophylline. The patient took the ciproﬂoxacin prescription to the community pharmacy that had dispensed the theophylline a few days earlier. In addition to the computer system alerting the pharmacist of the drug interaction, the pharmacist also testiﬁed that he was aware of the potential for dangerous drug interaction between theophylline and ciproﬂoxacin. When the patient picked up the ciproﬂoxacin prescription, he declined the offer to speak to the pharmacist and was only provided written patient information that warned in ﬁne print about the potential drug interaction. During the dispensing and distribution of the ciproﬂoxacin, the pharmacist never contacted the physician or warned the patient about the potential drug interaction. In a civil malpractice action against the prescribing physician, community pharmacy, and dispensing pharmacist, the patient alleged that he sustained injuries caused by the adverse interaction between theophylline and ciproﬂoxacin. Speciﬁc to the pharmacy and pharmacist, the patient claimed that they breached their duty to warn him of the potentially adverse interaction. The defense lawyers for the pharmacy and pharmacist requested that the court dismiss the lawsuit, arguing that the pharmacist had no legal duty to warn the patient and that it is the physician who acts as a learned intermediary between the drug manufacturer and the patient, and who has the responsibility either not to prescribe the medications concomitantly or to warn the patient of the potential interaction. The Massachusetts Superior Court disagreed with this argument. Although the court acknowledged a previous Massachusetts Supreme Court duty-to-warn decision holding that pharmacists have no general duty to warn of potential side effects, including when the pharmacist has no speciﬁc knowledge of an increased danger to a particular customer, it also provided that the Supreme Court did not declare pharmacists to have absolutely no duty. Speciﬁc to Brienze, the pharmacist was aware that the patient was already taking theophylline when the ciproﬂoxacin prescription was ﬁlled and that this posed an increased danger to the patient. Therefore, with regard to the pharmacy and pharmacist, the court allowed the civil malpractice action to proceed, holding that “the learned intermediary doctrine, as D E C . 15, 2008 DRUG TOPICS 45 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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