NABP Legal Briefs: Doody to Warn

December 10, 2010 10:46 am

By Dale J. Atkinson, JD

Originally published in the December 2010 NABP Newsletter

The standards of practice set forth in the practice act and/or regulations (preferably explicitly, but sometimes implicitly) are the barometer or measure expected of a licensed pharmacist when undertaking professional duties and responsibilities. The boards of pharmacy are created and empowered to enforce the relevant laws in the interest of public protection and the failure of a pharmacist to adhere to such standards may threaten the licensure status of the practitioner. In many jurisdictions, the burden of proof necessary to establish wrongdoing in an administrative prosecution is measured by a preponderance of the evidence. Preponderance of the evidence has been described as “more likely than not.” Granted, some jurisdictions adhere to a clear and convincing standard in administrative prosecutions, a somewhat more stringent burden.

Of course, patients or consumers harmed by a pharmacist who fails to adhere to the standards of practice have the right to pursue judicial relief in a civil setting for the remedies and damages caused by such a breach of the standards of practice. Generally, civil remedies for such a breach surface in the form of monetary damages based upon the harm suffered and its relationship to the breach of the duty owed by the pharmacist to the patient. The burden of proof necessary to establish civil wrongdoing is a preponderance of the evidence. The establishment and application of the standards of practice in a civil proceeding will be developed through expert testimony with the findings of a breach of such standards determined by the jury (or judge).

At times, the standards of practice in a civil setting can differ from the applicable standards of practice in an administrative proceeding. This differentiation does not follow common logic, defies statutory or regulatory responsibilities required of a pharmacist operating in a professional setting, and has the potential to result in inconsistent findings of a licensee based upon the same set of facts and under a same (or similar) burden of proof. Further, such determinations undercut the licensure process and threaten the expectations of the consuming patient. After all, pharmacists are the most trusted professionals. Consider the following.

A longtime patient of a physician has been consistently (over a 10-year period) prescribed lithium for her probable manic depressive psychosis. After years of using the lithium, on January 16, 2003, the physician prescribed Tenoretic® to treat the patient’s high blood pressure. When presented at the chain pharmacy, the pharmacist called the physician to verify the Tenoretic prescription. The inquiry was based upon the pharmacist’s knowledge that an interaction between the lithium and Tenoretic could cause lithium toxicity. According to the pharmacist’s notes, the physician told the pharmacist to fill the script and that the physician agreed to monitor the patient. It should be noted that the physician, when deposed in preparation for the civil trial, indicated that he had no recollection of the conversation. The judicial opinion does not address whether there were notes in the physician’s files of this alleged conversation. The prescription was filled on January 20, 2003. Again, the judicial opinion does not address whether the pharmacist undertook counseling of the patient.

On January 27, 2003, the patient appeared at the same pharmacy with a subsequent prescription for lithium, which was filled by a different pharmacist. However, this second pharmacist checked and referred to the notes in the patient’s file with the pharmacy and specifically noted the fact that the physician was to monitor the patient. The second pharmacist did not call the physician. The patient ingested the medications, became ill, and passed away on February 3, 2003, as a result of lithium toxicity.

The estate filed a wrongful death action against the physician and pharmacy. In part, the complaint alleged that the pharmacy failed to warn the decedent of the interaction between lithium and Tenoretic. After some procedural gymnastics, the physician was dismissed from the case based upon a settlement of the allegations related to his involvement. In short, the pharmacy filed a motion for summary judgment whereby the matter can be decided as a matter of law by the judge and without the need for a trial as there are no material issues of fact in dispute. The pharmacy alleged that as a matter of law, the pharmacist was under no duty to warn the physician or the patient of a drug interaction.

The trial court dismissed the pharmacy from the case finding that the “learned intermediary doctrine” precluded an obligation of the pharmacist from a duty to warn. The estate appealed the matter to the appellate court arguing that the lower court erred in finding that the doctrine did not require the pharmacist to warn. In addition, the estate argued that the lower court improperly distinguished a previous Illinois case, Happel v Wal-Mart Stores, Inc.

Addressing the learned intermediary doctrine, the appellate court reiterated such doctrine as providing that manufacturers of prescription drugs have a duty to warn prescribing physicians of a drug or drugs known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to the patient. The court cited several cases recognizing the doctrine as imposing a duty to warn on the physicians, rather than the pharmacists. These previous cases have applied the doctrine and professed a reluctance to require a pharmacist to “interject himself into the doctor-patient relationship and practice medicine without a license.”

Under the facts of the current matter, the court found that the pharmacist (1) properly filled the prescription, (2) took notice of the warning system regarding the potential for interaction, and (3) notified the physician of the potential interaction prior to filling the prescription. Based upon this court’s interpretation of the learned intermediary doctrine, the court found that the pharmacist fulfilled his professional obligations and did not breach any such duty to warn as none existed under the circumstances.

The appellate court next addressed the estate’s argument that the Happel case was dispositive in establishing a duty to warn under the facts of the dispute. In Happel, the Illinois Supreme Court was faced with the issue of whether a pharmacy “has a duty to warn about a known drug contraindication where the pharmacy is aware of a customer’s drug allergies and knows that the medication prescribed by the customer’s physician is contraindicated for a person with those allergies.” In Happel, decided in 2002, the supreme court found a duty to warn based upon the following facts of the case. First, it was undisputed that the pharmacy was aware of the patient’s drug allergies and that the drug combination was contraindicated. Second, the burden on the pharmacist was minimal in that a phone call to the physician could have been made or, alternatively, the contraindication could have been brought to the attention of the patient. Third, there was no real consequence to the pharmacy as it already had a practice of notifying patients of drug allergies. Under the facts, the Happel court found an obligation on the part of the pharmacy to warn the patient and/or physician.

However, the appellate court in the instant case found Happel distinguishable. The court found that the pharmacy did notify the physician by telephone of the interaction between lithium and Tenoretic prior to filling the script. The appellate court in the current matter found that the notification of the physician (whereby the physician was alleged to have agreed to monitor the patient) discharged the pharmacist of any duty that may have existed under a Happel analysis. Accordingly, the appellate court affirmed the dismissal of the pharmacy from the litigation.

Judicial opinions that fail to recognize the education, training, and patient expectations of the pharmacist in the chain of distribution and consumption of dangerous drugs will continue to not only fail to recognize the vital role of pharmacists, but threaten the very public designed to be protected in a state-based licensure system. This opinion whittles away at the duty of a pharmacist to meaningfully participate in the health care of patients. What is equally disturbing is that a judicial opinion of this magnitude is rendered without a citation to the professional responsibilities of pharmacists set forth in the practice acts and regulations, which universally requires counseling of patients. One assumes such counseling would encompass an explanation of potential drug interactions which allow the patient to make an informed medical decision.

Digiovanni v Albertson’s, Inc, No. 1-09-1297 (App. Ct. IL 2010)