Tort Law: Pharmacist Malpractice Liability

Summary

The changing role of the pharmacist is being recognized in law and in practice. A pharmacist is now seen as a professional who can be sued for malpractice in their own right, even when they have correctly filled a prescription.

Background To Pharmacist Malpractice Liability

The modern day role of the pharmacist has changed in many ways. Historically, a pharmacist was required to give the drug ordered in the strength ordered with the appropriate directions. Recent cases have recognized that the pharmacist is a professional who has in certain instances a duty to ensure that medications are prescribed appropriately and that patients understand potential side effects.

Recent studies have shown that pharmaceutical errors are on the increase. Part of the problem according to the pharmacies is that managed care has negotiated price to a point where drugs have to be dispensed at such a rapid rate that it becomes unsafe. Another problem is that some pharmacists are dispensing without thinking first. They accurately dispense the prescription ordered when they should realize that the physician has prescribed an inappropriate drug or an incorrect strength or amount. The General Accounting Office released a report in 1995 which noted that one in four non-institutionalized elderly patients take prescription drugs that are unsuitable for that age group because alternative drugs provide the same therapeutic benefit with fewer side effects. …/…

The hospital-based pharmacist may also be guilty of professional negligence. Two articles published in the July 5, 1995 Journal of the American Medical Association dealt with hospital-based pharmaceutical issues. The first article reported that adverse drug reactions are common in hospitals and are preventable. Errors reported in that study occurred in both the ordering and the administration stage. The second article introduced the idea that underlying system failures are the primary cause of error. The development of appropriate pharmaceutical standards address this problem.

In recent times society has begun to recognize that physicians are not gods and that other health care professionals have responsibilities to patients. The law has recognized that nurses, technicians, and the like, are not physicians’ handmaidens but rather co-professionals with rights and obligations. The same evolutionary process is now occurring for pharmacists. A pharmacist should not be considered merely a robot blindly following the orders of the physician. A pharmacist must have an independent commitment to the patient and must focus on creating a positive outcome from drug therapy. The pharmacist has a responsibility to monitor and evaluate drug therapy with the objective of avoiding bad outcomes and promoting good ones.

Omnibus Budget Reconciliation Act (OBRA ‘90)

In November 1990 Congress enacted legislation as part of the Omnibus Budget Reconciliation Act (OBRA ‘90), which imposed a new condition of participation for a state-administered but federally funded Medicaid program: a state-initiated process designed to detect and rectify problems with drug therapy. The requirement involves a drug usage review both prospectively and retrospectively. Based upon what is learned, pharmacists and physicians are both to be educated.

Under the OBRA ‘90, federal mandate, most states have now adopted rules expanding the obligations of pharmacists by formalizing the requirement of prospective drug utilization review. This, I suggest, creates a standard under which the pharmacist’s actions may be tested in a pharmaceutical malpractice action. …/…

The OBRA ‘90 mandate requires the pharmacist to exercise professional judgment and to offer to discuss with the patient or her care-giver such things as:

“The name and description of the medication, the route, dosage form and duration of therapy, special direction or precautions, harm and severe side or adverse effects, techniques for self-monitoring, proper storage, prescription refill information, action to be taken in the event of a misdose.”

Some pharmacies have read the words “offer to discuss” literally and merely have a clerk ask the patient, “Do you want to talk with the pharmacist?” If the patient refuses, it is noted in a log book. The fact that there is almost unanimous refusal of the offer to talk with a pharmacist gives rise to the argument that the offer is a charade.

State Licensing Boards are obligated to discipline pharmacies and pharmacists who do not adhere to the OBRA ‘90 requirements. …/…

In a recent Colorado Court of Appeals case, it was held that an error by a pharmacist resulting in dispensing the wrong medication was negligence as a matter of law. The Court held that evidence of due care is irrelevant if a mistake in the order processing occurred. The effect of this remarkable holding is that it creates a standard of perfection. It will be interesting to see whether other jurisdictions adopt this standard.

Professional Responsibility Of A Pharmacist

Even without strict liability, it would seem that misfilling a prescription should give rise to pharmacy liability. Often the defense from the pharmacist is that he reasonably misread the prescription. Different courts have held that if there is difficulty reading a physician’s writing a telephone call should be made. Moreover, a pharmacist is held to generally know about a drug and the reason for its prescription. In one case a pharmacist attempted to fill a prescription for Tamoxifen by mistakenly entering the order for Tambocor. The Court reasoned that, even if it was reasonable to read Tambocor instead of Tamoxifen, the pharmacist should have known that the patient’s physician was an oncologist and that the medication she was dispensing was for a heart medication. There was an “obvious conflict” which the pharmacist should have resolved by telephoning the oncologist to confirm the prescription. …/…

In the last ten years the law has begun to recognize that pharmacists’ responsibilities go far beyond merely filling an order. The law has begun to recognize that the pharmacist has a duty to monitor the patient’s use of medication. The Supreme Court of Indiana held in 1994 that a pharmacist has a duty under certain circumstances to refrain from dispensing a prescription as written by a physician. In that case, Hooks Superx, Inc. v. McLaughlin, the Court held that when a patient is having a prescription for a potentially addictive drug refilled at a rate that is unreasonably faster than would be anticipated, the pharmacist has a duty to exercise independent professional judgment and to cease refilling the prescription pending direct and explicit instructions from the prescribing physician.

In that case, the physician had issued a prescription for an addictive pain medication that could be refilled on an as-needed basis. The law suit alleged that the rate of refilling should have alerted the pharmacist who should have known that the plaintiff was consuming drugs so frequently that it posed a threat to his health. The Indiana Court extensively analyzed the relationship of pharmacies to customers. The Court noted that there is a direct relationship between the pharmacist and the patient that is independent of the physician-patient relationship. The Court further recognized that pharmacists have expertise in dispensing drugs and the effect of drugs on people. These factors create a duty for pharmacists to monitor drug use and intervene when a problem becomes evident. …/…

The Hooks holding will have a significant impact on pharmacy law across the country if it is adopted by other jurisdictions. It makes clear that a pharmacist may be liable even when she dispenses a prescription in strict accordance with a physician’s authorization. The opinion also makes clear that the pharmacist’s duty is independent of the physician’s duty.

Conclusion

The standard defense in a pharmacist malpractice case is that it only has an obligation to fill a prescription accurately. This argument flies in the face of current pharmaceutical education and training which stresses that a pharmacist is a professional with professional obligations. There is no question that the pharmacists themselves have recognized that the scope of their responsibilities is expanding.

The courts are beginning to recognize this and to hold that failure to meet this expanding responsibility constitutes pharmaceutical negligence. This is an area not recently visited by the Maine Supreme Judicial Court and one which is ripe for analysis and decision.