551-10

10.docx

Lesson ten

The role of Pharmacists and their responsibility in filling excessive prescriptions

In May of 2017 the Indianapolis Star reported that opioid overdose visits to Indiana hospitals had increased 60 % in five years.

http://www.indystar.com/story/news/2017/05/16/indiana-ers-see-opioid-overdose-visits-increase-nearly-60-five-year-period/324667001/

Tragically Indiana is not the only state that has suffered this experience. The question has arisen in more than one state of what is the role and responsibility of a pharmacist when the patient appears at the pharmacy with a prescription that the pharmacist knows or should know is excessive. This case from the Indiana Supreme Court precedes the current opioid crisis, but is more relevant than ever.

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HOOKS SUPERX, INC., KATHY O'DELL and CRAIG MERRICK, Defendants-Appellants, v. PATRICK D. MCLAUGHLIN, MICHELLE MCLAUGHLIN, for themselves and as parents, guardians and next friends of Patrick Michael McLaughlin, and Alicia Rose McLaughlin, Minors, Plaintiffs-Appellees.

Supreme Court No. 50S03-9411-CV-1067

SUPREME COURT OF INDIANA

642 N.E.2d 514; 1994 Ind

November 9, 1994, Filed

JUDGES: SULLIVAN, Justice, SHEPARD, C.J. , and DeBRULER, DICKSON, JJ. concur GIVAN, J., dissents without separate opinion. OPINION BY: SULLIVAN OPINION

ON PETITION TO TRANSFER

SULLIVAN, Justice.

Where a pharmacy customer is having a prescription for a dangerous drug refilled at an unreasonably faster rate than the rate prescribed, the pharmacist has a duty to cease refilling the prescription. . . .

. . .

Facts

. . . Patrick McLaughlin injured his back while working as a lumberjack in the state of Washington. In the course of treatment for that injury, he became addicted to propoxyphene, the active chemical in the drugs Darvocet and Darvon. He was treated for the addiction in 1982, 1983, and 1987, but he did not stop using the drug. In 1988, because he was still experiencing pain from the injury, he began treatment with Dr. Bernard Edwards in South Bend, Indiana. Over a period of months in 1988, McLaughlin obtained prescriptions for drugs containing propoxyphene from Dr. Edwards. Most of these prescriptions were filled at a Hook's drugstore in South Bend by pharmacists Kathy O'Dell and Craig Merrick. The prescriptions were dispensed either on the basis of written prescriptions from Dr. Edwards brought to Hook's by McLaughlin, telephone calls to the store from the doctor's office, or as refills.

McLaughlin consumed these drugs at a rate much faster than prescribed. Hooks' records show that dozens of prescriptions for Darvocet or Darvon were filled for McLaughlin between May 1987 and December 1988. For example, [**3] during one sixty-day period in 1988, McLaughlin received twenty-four separate refills of propoxyphene compounds, totaling 1,072 tablets. If consumed according to the prescription, the number of tablets would have lasted a period of 138 days; McLaughlin consumed the tablets in 62 days, almost two and one half times faster than the prescription ordered. In one month alone, propoxyphene prescriptions were filled twelve times, which means that McLaughlin or his wife appeared in the Hook's store once every two or three days.

In late 1988, after Dr. Edwards apparently became aware that McLaughlin was consuming propoxyphene drugs at a rate much faster than prescribed, he refused to furnish any more prescriptions. Shortly thereafter, McLaughlin's wife found her husband holding a shotgun to his head at a time of depression. He did not pull the trigger. Following treatment for drug addition in early 1989, McLaughlin stopped taking all prescription pain medication.

The McLaughlins sought recovery against Hook's on the theory that it breached its duty of care by failing to stop filling the prescriptions because the pharmacists knew or should have known that McLaughlin was consuming the drugs so frequently that it posed a threat to his health. Hook's moved for summary judgment on the grounds that it owed no such duty, or, alternatively, McLaughlin's consumption of the drugs and his suicide attempt constituted an intervening cause of his injuries. The trial court denied the motion . . . A majority of the Court of Appeals concluded that no duty existed and that imposition of a duty would be contrary to public policy because it would undermine the physician-patient relationship. Because of that holding, the Court of Appeals did not reach the issue of causation. The Court of Appeals remanded the case with instructions for the trial court to enter summary judgment in favor of Hook's.

The McLaughlins seek transfer. We address the following issues:

1. Whether pharmacists may be legally obligated to refuse to fill validly-issued prescriptions; and

2. Whether, as a matter of law, McLaughlin's suicide attempt and his over-consumption of prescription drugs was an intervening cause of the alleged injuries.

. . .

Duty

HN2 It is axiomatic that without a duty, there can be no recovery in negligence. Whether the law recognizes any obligation on the part of a particular defendant to conform his conduct to a certain standard for the benefit of the plaintiff is a question of law exclusively for the court. . . .

1. Relationship. HN3 It has long been established that the existence of a duty upon one to act with respect to another arises out of the relation between them. That the law recognizes a relationship between pharmacist and customer as one that gives rise to a duty in other circumstances is well-established. . . . Here, we must determine whether the pharmacist has a duty under certain circumstances to refrain from dispensing the prescription as written.

The relationship between pharmacist and customer is a direct one based upon contract and is independent of the relationship between physician and patient. . . . It is a matter of common expectation as well as statute 1 that pharmacists possess expertise regarding the dispensing of prescription drugs. It is a matter of common understanding that customers rely upon pharmacists for that expertise. Upon this basis, HN4 we conclude that the relationship between pharmacist and customer is sufficiently close to justify imposing a duty.

2. Foreseeability. Turning to the next factor to be considered, we note that it is well-established that HN5 a duty is imposed only where a reasonably foreseeable victim is injured by reasonably foreseeable harm. This inquiry into foreseeability involves the same considerations as in the context of proximate cause, except that it is determined by the court as a matter of law, and not, as is usually case with proximate cause, by the trier of fact. Id. It is not disputed here that one who consumes sufficient quantities of addictive substances may become addicted to them, and that such an addiction carries with it certain reasonably foreseeable consequences. . . . Thus, we are satisfied that, for purposes of determining whether a duty exists, the risk of McLaughlin's addiction was foreseeable from the series of events that took place.

3. Public Policy. The third factor to be considered is that of public policy. HN6 "What the public policy of a state is must be determined from a consideration of its Constitution, its statutes, the practice of its officers in the course of administration, and the decisions of its court of last resort." We perceive three policy considerations at stake here: preventing intentional and unintentional drug abuse, not jeopardizing the physician/patient relationship, and avoiding unnecessary health care costs.

There are several explanations for why a pharmacy customer might have a prescription for a dangerous drug refilled at a rate unreasonably faster than that prescribed. Among them are that the customer may have developed an addiction to the drug or that the customer is improperly disposing of the drug. Both of these explanations give rise to the strong public policy interest in preventing intentional and unintentional drug abuse.

Our legislature has expressed this policy interest in many enactments. For example, the Pharmacy Act 2 reflects important public policy concerns about addiction and the health and safety of the customer. In particular, HN7 Indiana Code § 25-26-13-16 (1993) provides:

(a) A pharmacist shall exercise his professional judgment in the best interest of the patient's health when engaging in the practice of pharmacy.

(b) A pharmacist has a duty to honor all prescriptions from a practitioner or from a physician . . . . Before honoring [**11] a prescription, the pharmacist shall take reasonable steps to determine whether the prescription has been issued in compliance with the laws of the state where it originated. The pharmacist is immune from criminal prosecution or civil liability if he, in good faith, refuses to honor a prescription because, in his professional judgment, the honoring of the prescription would:

(1) Be contrary to law;

(2) Be against the best interest of the patient;

(3) Aid or abet an addiction or habit; or

(4) Be contrary to the health and safety of the patient.

(Emphasis added). We reject McLaughlin's argument that the pharmacist's duty arises by virtue of this statute alone because the statute merely permits, but does not require, a pharmacist to decline to fill a valid prescription. Nonetheless, by empowering pharmacists to exercise their professional judgment, the statute does demonstrate that public policy concerns about proper dispensing of prescription drugs and preventing drug addiction might be paramount to policy concerns about interfering with the physician-patient relationship.

Hook's relies on Ingram v. Hook’s Drugs Inc. (1985). . . for the proposition that pharmacists are not responsible for exercising independent judgment about whether to fill a particular prescription because such interference might occur. In Ingram, the plaintiff experienced an adverse reaction to Valium and fell from a ladder. He sued the pharmacy alleging that the pharmacist should have warned him about this and other possible side effects associated with the drug. The Court of Appeals concluded that physicians, not pharmacists, were in the better position to weigh the potential risks and rewards of particular medications for specific patients, and declined to impose a duty upon pharmacists to warn customers about the potential side effects of medication unless such warnings were included in the prescription received from the physician. Although we agree that the responsibility of warning patients about drug side effects lies with physicians, we do not find Ingram controlling because it did not involve the rate at which the customer was consuming drugs. Ingram does not address instances where a pharmacist has personal knowledge that a customer is taking medication more quickly than prescribed.

Despite Hooks' lamentations to the contrary, we do not perceive that physicians and pharmacists will become adversaries if pharmacists are expected to cease refilling prescriptions where the customers are using the drugs much more rapidly than prescribed. . . . (P)hysicians remain ultimately responsible for properly prescribing medication, and recognition of a duty on the part of pharmacists will not replace the physician's obligation to evaluate a patient's needs. We believe recognition of a legal duty will encourage pharmacists and physicians to work together in considering the best interests of their customers and patients.

. . .

. . . Clearly, society has an interest in preventing the overuse and misuse of prescription drugs. Recognizing that pharmacists have a duty in this regard helps further that goal. The duty imposed is simply a practical recognition of the relationship between pharmacist and customer.

. . . Accordingly, we hold HN8 that pharmacists must exercise that degree of care that an ordinarily prudent pharmacist would under the same or similar circumstances. What constitutes due care in a particular case will depend upon the circumstances of that case, and will usually be a question of fact. The determination of whether due care was exercised in a particular case may involve such issues as the frequency with which the pharmacist filled prescriptions for the customer, any representations made by the customer, the pharmacist's access to historical data about the customer, the manner in which the prescription was tendered to the pharmacists, and the like.

In imposing this standard of care, we emphasize that filling prescriptions faster than prescribed is not necessarily a breach of the duty owed. For example, it may be prudent for a pharmacist to refill a prescription at a rate faster than prescribed in the first few days following surgery or in anticipation of travel. Given that cases are usually factually unique, any complete listing here is impossible. We are confident that the skilled pharmacists of our state, particularly when aided with computerized customer information records, will be readily able to determine when a prescription is being refilled at an unreasonably faster rate than the rate prescribed.

Lastly, we emphasize that pharmacists are not insurers against a customer becoming addicted to medication legally prescribed by physicians. Customers are not relieved of responsibility for their own safety. . . . Also relevant may be the customer's own knowledge, . . . and whether the customer acted intentionally, or merely negligently. . . .

Conclusion

Accordingly, we now . . . affirm the trial court in its denial of Hooks' motion for summary judgment. . . .

SHEPARD, C.J., and DeBRULER, DICKSON, JJ. concur

GIVAN, J., dissents without separate opinion.

The majority of courts have not taken the approach that Indiana Supreme Court did in the Hooks case.

The Arkansas Supreme Court in Kowalski v. Rose Drugs of Dardanelle Inc. 378 S.W. 3d 109 (Ark 2011) pointed to decisions from Washington, Massachusetts, Illinois, and Alabama to support its conclusion that pharmacists do not have a duty to warn customers of possible adverse effects of a prescription medications. The Arkansas Court said that to rule otherwise would create a system that requires pharmacists to engage in “second-guessing the physicians or otherwise interfering with the patient-physician relationship”.

The dissent in Kowalski felt that the majority had sold the pharmacy profession short. Query do you agree or disagree with the following statement of the dissent in Kowalski; this decision has “done a disservice to the pharmaceutical profession in general by failing to recognize the high standards observed within the profession itself.” Making the only “duty of pharmacists the duty to act as robots in all situations”.

ASSIGNMENT for lesson ten

As a matter of public policy do you think that Hooks should be responsible in a situation like the one presented or do you believe that the responsibility for the prescription filled lies solely with the physician who wrote the prescription? Explain why your view is the better of the two approaches.