Pharmacists’ Duties for Patient Care: A Primer

US Pharm. 2024;49(7):9-12.

Pharmacists’ potential for civil liability to patients is vast under notable theories of jurisprudence. Despite this, courts have varied widely in the scope of obligations a pharmacist could be liable for. The duties owed to patients may be divided into either mechanical or intellectual types of activities necessary to achieve patient safety. Clinical pharmacists have even greater responsibility because the duties undertaken with regard to patient safety are broader, usually under principles of risk management. Irrespective of the liability theory applied in a particular case, the duty is always the same: Protect the patient.

Mechanical Duties

Mechanical obligations include the basic traditional minimal commitments such as filling a prescription correctly with the right medicine. These include filling a prescription with the right dosage form, in the right quantity and strength with the ordered directions, in containers designed to prevent improper deterioration, with child safety caps, in the name of the correct patient, and with the amount of medication required. In one study conducted by Pharmacists Mutual Insurance Company, it was estimated that 83% of all liability claims against pharmacists involved mechanical errors. Although relatively less in terms of sheer number of cases, cognitive errors are trending to impose liability on expanded theories of duty.¹

Traditional Duties

In one of the earliest cases establishing the duties of a pharmacist (Fuhs v. Barber), the court held that a “druggist should exercise highest degree of care in advising purchaser of injurious effect” when preparing a medication.² This court observed that a registered pharmacist “selling drugs, poisons, medicines, and compounds of the same, should always exercise great care, and where a drug, harmless in itself, is to be mixed or used in connection with another, which would then have an injurious effect, and if the purchaser has no knowledge of this effect, he should exercise a high degree of care in advising the purchaser of this injurious effect and of the combination.”

Thus the pharmacist’s duty of “great care” owed to a patient was established. Note that this duty exists whether the medicine is prescription only or OTC or some other class of product prepared or recommended by the pharmacist. Given the date of this decision (1934), liability inures to the licensed pharmacist. Because a professional licensure is involved, the duty is not just ordinary care, but the higher standard of great care.²

In an early case exemplifying traditional limits of liability (Ingram v. Hook’s Drugs, Inc.), a court held that the physician, not the pharmacy, is liable for failing to convey words of caution to the patient.³ That court explained that to do otherwise would unduly inject the pharmacist into the physician-patient relationship. The injection of a third party in the form of a pharmacist into the physician-patient relationship could undercut the effectiveness of the ongoing medical treatment. The court opined: “We perceive the better rule to be one which places the duty to warn of the hazards of the drug on the prescribing physician and requires of the pharmacist only that he include those warnings found in the prescription.”

Intellectual Errors

Intellectual or cognitive duties, a more recent development, include concepts such as the duty to warn the prescriber and/or the patient (caretaker) about avoiding prescription drug misuse, drug-drug interactions, allergic possibilities that are foreseeable considering the patient’s particular circumstances, and taking precautions to prevent others from using the prescribed medications in ways that could be dangerous. These newer cases rely on ideas associated with risk-management theories on duty. The questions here are whether the risks or harms to the patient outweigh the ability to manage those risks and which party is best suited to handle the potential harm.

In the better-reasoned case of Riff v. Morgan Pharmacy, the Pennsylvania Supreme Court applied risk-management principles to hold the pharmacist liable for failure to warn of known risks associated with a prescribed drug.⁴ In this case, the physician prescribed 12 ergotamine (Cafergot; no longer available) suppositories for rectal insertion every 4 hours for migraine headaches. No other warnings were issued on the prescription, and no refills were indicated. The package in which the suppositories were furnished from the manufacturer contained a patient warning not to exceed two suppositories per headache and to take no more than five suppositories in a week’s time. This cautionary statement was not given to the patient. Although disputed at trial, the physician claimed that he did not authorize any refills; the pharmacy claimed that he did permit refills. In any event, over the course of the next few weeks, the patient obtained four additional refills and used 15 to 17 suppositories over this time frame. She suffered toxic effects attributed to this medication and was told that she would likely die or her leg would have to be amputated. The patient survived this incident but suffered severe permanent foot injuries. She then sought damages from both the prescriber and the pharmacy.⁴

The pharmacy sought summary judgment seeking to have the claims against it dismissed and the physician held solely responsible. The court disagreed, first noting: “The maximum dosage for Cafergot suppositories specified in the accepted medical literature is one suppository, with a permissible second suppository in one hour if necessary. The dose is not to exceed two per attack and in no event should the user administer in excess of five in one week.” Most importantly, the court used language that would establish the duty of pharmacists to warn of known dangers of a drug whether or not the warnings may come from a prescriber. In this context, the court stated, in the most telling of its thinking on the subject: “The [pharmacy] would seem to argue that a pharmacy is no more than a warehouse for drugs and that a pharmacist has no more responsibility than a shipping clerk who must dutifully and unquestioningly obey the written orders of omniscient physicians. Such is not the case” [emphasis added].⁴

Reviewing the laws in the state where the case originated, the court observed that in Pennsylvania the practice of pharmacy is regulated. “Pharmacists are required to hold a degree in [pharmacy] from a school accredited by the American Council of Pharmaceutical Education, to complete an internship, and to pass a comprehensive examination administered by the State Board of Pharmacy. Pharmacies are also licensed in Pennsylvania. The purpose of the [Pennsylvania] Pharmacy Act was to ‘regulate the compounding of physician’s prescriptions, preparing drugs, and dispensing them, or other products of an apothocaries calling.’ The Act was remedial in nature and belonged to that class of legislation which had for its objective the protection of the health and safety of the public. The State Board of Pharmacy is empowered and invested with the duty to regulate the practice of pharmacy.”⁴

Significantly, the court continued: “Fallibility is a condition of the human existence. Doctors, like other mortals, will from time to time err through ignorance or inadvertence. An error in the practice of medicine can be fatal; and so it is reasonable that the medical community including physicians, pharmacists, anesthesiologists, nurses and support staff have established professional standards which require vigilance not only with respect to primary functions, but also regarding the acts and omissions of the other professionals and support personnel in the health care team. Each has an affirmative duty to be, to a limited extent, his brother’s keeper.”⁴

Negligence: Statutory and Per Se

In most situations, liability duties involve statutory negligence and/or negligence per se. Statutory negligence arises from duties imposed by a statute, such as the Poison Prevention Packaging Act. A pharmacist who dispenses a medication without child-resistant safety caps to an adult patient without a request for nonsafety caps could be liable if a child accesses the medication and is thereby harmed. Other examples of statutory duties are those imposed by the Omnibus Budget Reconciliation Act of 1990 (or, more colloquially, OBRA ’90), which will be discussed below. Negligence per se occurs when no applicable statutes are available but duties are imposed by common-law notions on the foreseeability of damages.

For example, in the case of Lasley v. Shrake’s Country Club Pharmacy, Inc., the patient’s prescriber ordered glutethimide (Doriden) and codeine simultaneously over a 10-year period.⁵ The patient became dependent on the combination and underwent detoxification and psychiatric care. He sued the pharmacy and the physician for wrongful addiction and sought appropriate damages. The pharmacy claimed that the prescriber was solely responsible and that the pharmacy did not owe the patient any duty of care. The Appellate Court disagreed, finding that the pharmacy owed the patient a common-law duty under prevailing standards of practice. The court stated: “Because this is a negligence action, we first determine whether Shrake’s had a duty to conform to a particular standard of conduct to protect [Lasley] against unreasonable risks of harm. In other words, we must consider, whether the relationship between Shrake’s and Lasley required Shrake’s to use care to avoid or prevent injury to Lasley.”

In concluding its determinations on the subject of duty and the state of the applicable law, the court noted: “It is better to reserve ‘duty’ for the problem of the relation between individuals which imposes upon one a legal obligation for the benefit of the other, and to deal with particular conduct in terms of a legal standard of what is required to meet the obligation. In other words, ‘duty’ is a question of whether the defendant is under any obligation for the benefit of the particular plaintiff; and in negligence cases, the duty [if it exists] is always the same—to conform to the legal standard of reasonable conduct in the light of the apparent risk. What the defendant must do, or must not do, is a question of the standard of conduct required to satisfy the duty. Thus, the answer to the threshold question in this appeal is that Shrake’s did owe a duty of reasonable care to Lasley.”⁵

The court continued, “In an ordinary negligence action, the standard of care imposed is that of the conduct of a reasonably prudent person under the circumstances. Health care providers and other professionals, however, are held to a higher standard of care than that of the ordinary prudent person when the alleged negligence involves the defendant’s area of expertise. In these cases, the standard is based on ‘the usual conduct of other members of the defendant’s profession in similar circumstances.’” The patient then must show that the pharmacy’s conduct did not adhere to the standard. To establish liability, the court stated, the patient must prove that the “health care provider failed to exercise that degree of care, skill and learning expected of a reasonable, prudent health care provider in the profession or class to which he belongs within the state acting in the same or similar circumstances.” The court imposed this higher standard of care upon pharmacists because they are professionals in the healthcare area.⁵

In its final holding that the pharmacist was liable given the facts of this case, the court stated: “In response to Shrake’s motion to dismiss, [the patient] presented an affidavit from an expert stating that the standard of care applicable to a pharmacist includes a responsibility to advise a customer of the addictive nature of a drug, to warn of the hazards of ingesting two or more drugs that adversely interact with one another, and to discuss with the physician the addictive nature of a prescribed drug and the dangers of long-term prescription of the drug [emphasis added]. Appellants also presented excerpts from the American Pharmaceutical Association Standards of Practice for the Profession of Pharmacy that described similar standards.”⁵

OBRA ’90

Another example of statutory duties is embodied in OBRA ’90. This federal statute and the regulations promulgated thereunder took effect in 1993. OBRA ’90 had several major components: 1) Prospective Drug Use Review, 2) Retrospective Drug Use Review, 3) Assessment of Drug Use Data, and 4) Educational Outreach Programs. The Prospective Drug Use Review component has had the greatest impact on pharmacy practice on a daily basis.⁶ TABLE 1 lists the pharmacy provisions of the Act, and state responses to the Act’s requirements are summarized, in part, in TABLE 2 (both tables available online at www.uspharmacist.com).

As originally passed, the duty to counsel embodied in OBRA ’90 applied only to Medicaid patients.⁶ More importantly, however, the statute required each state and territory to adopt provisions that require counseling, also called warnings or the duty to warn, for all patients (and their caregivers). However, exceptions exist. Patients may opt out of the counseling requirements; further, the laws do not have to apply to hospitalized or other institutionalized patients.

Some jurisdictions limited the directives to new prescriptions only, whereas others made the obligations applicable to both new and refilled prescriptions.⁶ A patchwork quilt of requirements has also unfolded regarding whether the offer to counsel must be made personally by the pharmacist or a technician, orally or in writing. A common practice that has evolved over the years is for a technician or pharmacy clerk to ask patients if they have any questions for the pharmacist and to initial a log if the patient refuses. Whether this practice meets the spirit of the OBRA ’90 mandates is open to question, but it may be valid as a matter of professional judgment.

In a case (Walker v. Jack Eckerd Corp) arising before January 1, 1993 (the effective date of the offer-to-counsel requirement), the Court of Appeals of Georgia ruled that a pharmacist had no duty to warn a patient of, or to refuse to dispense a medication in light of, a potentially severe side effect arising from excessive dosage. Summary judgment entered for the defendant pharmacy was upheld on appeal, but the court noted that this “would not be controlling precedent for cases involving pharmacists’ duties arising after January 1, 1993.”⁷

Respondeat Superior

Although the pharmacist is responsible for patient safety, the corporate owner (or other form of ownership, such as a partnership) of the pharmacy where the practice of pharmacy occurs can also be held liable under the theory of respondeat superior, a Latin term meaning “let the master answer.” This doctrine means that the operator of the pharmacy is responsible for (and has vicarious liability for) acts of its agents (pharmacist and other employees).⁸

Civil Liability

Civil liability is designed to make the patient “whole” after suffering actual damages (compensatory) and pain or suffering damages incurred as a result of a pharmacist’s negligence. Criminal laws, on the other hand, are used to punish a pharmacist (or technician or clerk) for intentional harms caused to a patient when the pharmacist has been found guilty beyond a reasonable doubt. This is most often the case when the employee is said to have been acting outside the scope of his or her employment. Note also that malpractice insurance will not cover the costs of litigation or fines levied on the employee. An insurance company could elect to cover the litigation costs of criminal accusations by declining to pay any criminal verdicts.⁹

Clinical Practice

Clinical pharmacists—irrespective of the place of pharmacy practice, whether hospital, institution, clinic, or even community settings—usually assume broader duties than would be necessary in a typical local pharmacy. Such additional undertakings could involve reviewing patient charts, evaluating the appropriateness of prescribed medications, selecting the best drug based on the patient’s particular situation, determining generic bioequivalence, actual prescribing, consulting directly with prescribers or nurses, reviewing medication fills (cart examinations and evaluations), and determining the duration of therapy. There are, of course, numerous other practices that involve clinical pharmacists. Each of these activities could lead to additional responsibilities and judgments against the pharmacist or institution where clinical pharmacy is practiced. As might be imagined, several economic considerations exist in favor of expanding clinical practices to all pharmacists.¹⁰

Conclusion

Liability is a term that encompasses a vast field of professional practice settings. The concepts also involve a variety of theories that could be used to impose liability or damages that could occur in certain situations. Regardless of practice setting, pharmacists must be vigilant to avoid errors, whether mechanical or judgmental. Civil liabilities are designed to compensate patients who have suffered as a result of wrongful acts by the pharmacist or the technicians under his or her supervision. Criminal penalties may be imposed for the most egregious errors. These could include fines or incarcerations of individuals. As stated at the outset of this discussion, the duty is the same in all cases: Protect the patient.

REFERENCES

1. CNA and Healthcare Providers Service Organization. Pharmacist professional liability exposure claim report: 3rd edition. June 2023. www.hpso.com/getmedia/261a3590-6368-41e6-857c-f2bf9dbdf6ea/CNA_CLS_PHARM_072823_CF_PROD_SEC-(1).pdf. Accessed June 13, 2024.
2. 140 Kan. 373,36 P.2d 962 (Kan. Sup. Ct., No. 31722, 1934).
3. 476 N.E.2d 881 (Ind. App. 1985).
4. 508 A.2d 1247 (1986).
5. 880 P.2d 1120 (Az. App. 1994).
6. See Vivian JC, Fink JL III. OBRA ’90 at sweet sixteen: a retrospective review. US Pharm. 2008;33(3):59-65. (Adapted from a poster presented at the American Society for Pharmacy Law 32nd Annual Meeting/American Pharmacists Association 154th Annual Meeting, Atlanta, Georgia, March 16-19, 2007, and winner of the Research Award from the American Society for Pharmacy Law, 2007.)
7. 434 S.E.2d 63 (Ga. App. 1993).
8. 800 F. Supp. 173 (M.D. Pa. 1992).
9. See, e.g., Labatt CB. Commentaries on the Law of Master and Servant: Including the Modern Laws on Workmen’s Compensation, Arbitration, Employers’ Liability, Etc., Etc. Rochester, NY: The Lawyers Co-operative Publishing Co; 1913. Consider also Engelhardt J, Engelhardt C. Establishing corporate and institutional liability with agency principles and equitable doctrines. MI Bar J. 2024;103(5):14.
10. Fein AJ. The 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. Drug Channels Institute; March 2024. Also see Terrie YC. Supporting provider status for pharmacists. US Pharm. 2023;48(10):39-42.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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