Right-to-Try Laws Challenge Pharmacy Code of Ethics

TOP - May 2017, Vol 10, No 2 - HOPA
Chase Doyle

Anaheim, CA—Although beneficence, autonomy, and justice comprise the bulwark of ethical principles in medicine, their prioritization has changed over the course of history. At the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference, Rebecca D. Pentz, PhD, Professor of Research Ethics, Winship Cancer Institute at Emory University, Atlanta, GA, provided a brief overview of these values and described how recent legislation could pose ethical concerns for pharmacists.

“Right-to-try laws, which have been enacted in 33 states, are uncharted territory for providers. These laws state that terminally ill patients have the right to try any investigational agents, even those that have not been approved by the FDA. This is an ethically problematic situation given your code of ethics and what you [as pharmacists] stand for as professionals,” said Dr Pentz.

As Dr Pentz reported, beneficence—taking actions that serve the best interests of patients—has been the overriding principle of medical ethics since the beginning of medicine. Starting in the 1960s, however, the priority of ethical principles changed.

“With new technologies like life support that might be reasonably refused and a greater attention to individual rights throughout society, autonomy became the primary principle. But autonomy has now hit the wall. I don’t think we can put autonomy as the overriding principle anymore,” she said.

According to Dr Pentz, the main reason for this change is medically inappropriate or futile treatment.

“A patient has a right to refuse any treatment, but a patient does not have the right to demand any treatment. As a healthcare professional, you have a duty to offer only beneficial treatments. There is no duty to offer or provide medically inappropriate treatments,” she explained.

In other words, said Dr Pentz, a pharmacist is not a soda machine that exists to dispense the drink—or drug—of a patient’s choosing, even if he or she has a prescription.

However, the way in which right-to-try laws are written, she continued, means there are none of the safeguards that exist with the FDA’s expanded access (eg, compassionate use) program, which enables the use of an investigational new drug outside of a clinical trial by patients with serious or life-threatening conditions.

“With right-to-try laws, there is no agency or board oversight, and there are no limits on duration of therapy. The physician does obtain informed consent, but there is no review by an Independent Review Board,” said Dr Pentz.

According to the American Pharmacists Association Code of Ethics, a pharmacist respects the covenantal relationship between the patient and pharmacist, helping “individuals achieve optimum benefit from their medications” while being “committed to their welfare.” With right-to-try laws, however, a patient may request an investigational agent that is counterindicated for them.

“The physician and patient can dream up any investigational agent, and the right-to-try law says they have the right to try it. Most of the laws indicate that it’s a criminal activity to block access if the physician and patient want it…So, in this situation, you are a [soda] machine,” said Dr Pentz.

Because refusal to provide access is prohibited, a pharmacist’s only options are to nonjudgmentally advise the patient and physician of the dangers or call an ethics consultation.

“This is concerning because the legislatures are not being advised well about these laws. You are professionals and have a duty to help the welfare of the patient, and in some of the cases, I think that may not be served,” Dr Pentz concluded.

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Last modified: April 27, 2020