Rx & The Law

The Pharmacist's Duty To The Patient

by Donald McGuire, R.Ph., J.D.
Professional Claims Attorney
Pharmacists Mutual Insurance Company

The practice of pharmacy has undergone tremendous changes in the last few years. The trend has been to move from product dispensers to providers of pharmaceutical care. One of the milestones in this transition was the passage of the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90). Among the requirements of this act are that a prospective drug review be performed and that the patient, or the patient’s caregiver, be counseled on the proper use of the medication, its common side effects, duration of therapy, refill information, etc. Due to time and/or economic restraints, some pharmacists and pharmacies have been slow to embrace OBRA ’90. A recent court decision may give pharmacists more incentive to overcome these obstacles.

Franklin Horner presented two prescriptions to pharmacist Anthony Spalitto in Kansas City, Missouri. The first was for Diazepam 10mg; 1 tablet every 8 hours. The second was for Ethchlorvynol 750mg; 1 capsule every 8 hours. The pharmacist consulted a reference and found that the normal dose for Ethchlorvynol was 500 to 750mg at bedtime. The sedative dose is 100 to 200mg up to three times a day. There is also the possibility of additive CNS depressant effects when the two are used together. Spalitto called the physician’s office and an unidentified person at the office told him that the prescription was correct as written and the physician intended for Horner to be sedated throughout the day. The pharmacist filled both prescriptions. Six days later, Horner was found dead with near toxic levels of Ethchlorvynol in his system.

The patient’s family filed suit against the pharmacist. The pharmacist’s attorney filed a Motion for Summary Judgment based on the undisputed fact that the prescriptions were filled correctly and that was the pharmacist’s only obligation to the patient in Missouri under the ruling in Kampe. The trial court agreed and the case was dismissed. The patient’s family appealed.

The appellate court ruled that the Kampe court confused a pharmacist’s duty to the patient with the specific functions which the pharmacist’s duty requires the pharmacist to perform. The court said that it is wrong to hold that a pharmacist’s duty will never extend beyond filling a prescription correctly. The pharmacist’s duty is to exercise the care and judgment that a reasonably prudent pharmacist would exercise in the same or similar circumstances. While this would certainly include filling a prescription correctly, it could also include many other functions.

The court examined the Pharmacy Practice Act and OBRA ’90 to determine what these other functions could be. The practice of pharmacy as defined in the Pharmacy Practice Act included not only dispensing, but also interpreting and evaluating prescriptions, participation in drug selection as allowed by law, and consultation with patients and other health care professionals about the safe and effective use of drugs. The court also noted the requirements under OBRA ’90 as mentioned in the first paragraph of this article. The court concluded that continuing to follow the Kampe rule would fail to take into account the more expansive role pharmacists play in the provision of health care today. This more expansive role has been recognized by both the legislature and the board of pharmacy.

To hold as Kampe did would denigrate the expertise which a pharmacist’s education provides concerning drugs and their therapeutic use. The Kampe holding also failed to comprehend the role a pharmacist must play in making the valuable, but highly dangerous, service of drug therapy as safe and reliable as it can be.

The court noted that there was not enough evidence in the record to determine whether the pharmacist fulfilled his duty to Horner. Should he have insisted on speaking personally with the physician? Could he have done more to warn both the physician and the patient? Should he have refused to fill the prescription? What would a reasonable and prudent pharmacist do in this situation? These are the questions which will be answered when the trial court continues hearing the case after remand.

The lesson for pharmacists is that the days of "product dispensing" are over. Pharmaceutical care enhances the professionalism of pharmacy practice as well as improving the patients’ overall health care. If you do not keep patient profiles, do not perform a prospective drug review, do not consult with prescribers and patients about the proper use of medications, will you be viewed as a reasonably prudent pharmacist?

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.