Are you at risk for poor therapeutic substitutions?


If therapeutic substitutions are based on cost, rather than efficacy, what's the liability to the pharmacist?


Rx Legal Q&A

Are you at risk for poor therapeutic substitutions?

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Q: I work in a hospital pharmacy where many "therapeutic substitutions" are made. A physician orders Drug A, and we are told to substitute Drug B per our P&T committee therapeutic substitution protocol. We write a chart order stating we are substituting Drug B for Drug A. The drugs we are using are not chosen because of a favorable mechanism of action or reduced side-effect profile. In fact, it seems all of them have a higher incidence of side effects. These drugs are selected based on deals we are receiving from the manufacturers. I am concerned that if I change a drug and the patient experiences an adverse event or a subtherapeutic response, I will incur liability on an individual basis. What are the liabilities of the hospital, physician, and pharmacist if such an event were to occur?

A: All hospitals use some form of inventory and cost control. In almost all hospitals, a part of that control includes use of a medication formulary. The formulary is usually developed by pharmacy personnel at the request, and under the direction, of a P&T committee. Typically, members on the P&T committee include senior physicians and at least one member of the pharmacy staff. One purpose of the committee is to standardize treatment, including medication, protocols.

Since the P&T committee is a part of the hospital's primary medical care function, the hospital is responsible for its actions and is liable for its negligent acts. Individual members of the committee bear some responsibility but have some protection by the concept of team approval. Cost is a legitimate factor that can be taken into business considerations, including the selection of drugs added to the hospital's formulary. Cost cannot, of course, be the only or overriding factor.

As with all negligence cases, the question of legal liability is not whether a mistake was made, but whether the mistake constituted negligence. Noncommittee members of the hospital's professional staff, including pharmacists, are generally not held liable for following the directions of, or for the decisions made by, the P&T committee, unless it could be shown that the pharmacist, or other staff member, knew or should have known that blindly following the protocol in a particular case could result in harm. The pharmacist's duty, in such a case, would be to bring the questions to the attention of the prescribing physician, who may then have to apply for exception to protocol for that patient.

The therapeutic substitution you describe in your question is not unusual and is the norm in most hospitals in the United States. Boards of pharmacy and medical regulations generally accept these procedures. You should, of course, check with the board of pharmacy in your state. In addition, in many cases, when a physician accepts appointment to the hospital's staff, he or she agrees to the formulary procedure and to the process of therapeutic substitution. Therefore, it can be said that the physician who writes a drug order for a nonformulary drug actually means: "Dispense the formulary equivalent for this drug as I agreed when I joined the staff." Physicians often find it difficult to remember which current drug is on the formulary at all given times but understand the procedure and agree to it.

You raise the question of your personal liability for following the formulary. Since the physician has agreed to the formulary and the therapeutic substitution procedure, I have a difficult time seeing any negligence on your part, unless you have special knowledge as to a particular patient or physician. Since everyone in the hospital, including the prescribing physician and the administering nursing staff, has reason to expect the formulary to be followed, you could face liability for failing to dispense according to protocol.

If you believe the P&T committee in your hospital is making medication formulary decisions negligently or recklessly or based upon nonlegitimate criteria, your duty may require you to present your evidence to hospital administration, the P&T committee, or to your state board of pharmacy. If you continue to disagree with the decisions made at your hospital, your professional and ethical beliefs may dictate that you leave employment at that hospital and seek another position.

Ken Baker, R.Ph., J.D.

Ken Baker, R.Ph., J.D., is a VP and general counsel at Pharmacists Mutual Insurance Co.

Disclaimer: This article discusses general principles of law and risk management. It is not intended as legal advice but is designed to promote discussion. Pharmacists should consult their own attorney for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and with the laws in their state and act accordingly.


Ken Baker. Are you at risk for poor therapeutic substitutions? Drug Topics Dec. 8, 2003;147:80.

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