Can prescription drugs be taken back from patients?
Rx Legal Q&A
Can prescription drugs be taken back from patients?
If you have a practice-related legal question, please e-mail it to drug.topics@ medec.com.
By Ken Baker, R.Ph., J.D.
Q: As a staff pharmacist at a retail pharmacy chain, from time to time I am asked if prescription medications can be returned to the pharmacy for a refund. My answer has always been, "No, I can't take prescriptions back once they leave the pharmacy." But I cannot find any federal or Pennsylvania state law prohibiting this. Is it up to the best judgment of the pharmacist on duty then, or is there some kind of regulation against this?
A: It seems we all do a lot of things because that's what we were told, without knowing exactly why we were told so. Your question is a good example of one of those thing all pharmacists "know" but are not quite sure why. In this case, there is a good reason, and more than one law prohibiting the redispensing of medication returned to the pharmacy by a patient. You should note, however, that in saying that, I changed your question slightly.
Can you take back medication once the prescription has left the pharmacy? Technically the answer is Yes, you can take it back. But you cannot redispense it; it must be destroyed. What the law prohibits is the dispensing of prescription drugs you have received through other than Food & Drug Administration-approved sources. The answer to your question can be found in the federal Food, Drug & Cosmetic Act and specifically the Prescription Drug Marketing Act of 1987.
The federal law says it is illegal for a pharmacy to dispense any prescription drugs except those received in the normal course of commerce through FDA-approved sources, such as licensed wholesalers or directly from the manufacturers. In addition, several states also forbid the dispensing of prescription drugs returned by a patient. For example, the Iowa Board of Pharmacy has a regulation, stating: For the protection of the public health and safety, prescription drugs shall not be returned, exchanged, or resold... IA BReg 657—6.9(126).
Once a drug leaves your pharmacy, you cannot guarantee "the integrity" of the returned drug. Some exceptions are available, such as drugs delivered by a pharmacy to a controlled environment, such as a nursing home in which the drugs remain under the control of the pharmacy. Even in these cases, the pharmacy must be able to "guarantee" the storage conditions of the drug.
Even if the law did not prohibit the redispensing of prescription drugs, the pharmacist would find the situation ethically challenging. How could a pharmacist know the condition of the drugs once they leave the pharmacy?
Your search was for laws that would prohibit you from taking "prescriptions back once they leave the pharmacy." The problem is not taking them back or refunding money, but what do you do with them? The answer is, you destroy them. You cannot get your money back, since no wholesaler or manufacturer will take returned drugs back from you. As pharmacists, we have always given the shorthand answer: "I can't take a prescription back." The real answer is: "If I take it back, I have to destroy it, so I can't afford to refund your money."
There are times you may want to take back prescription medication for the purpose of destroying it. If a patient dies, the family may not (and should not) want the deceased's prescriptions around the house. The same situation exists if the patient no longer takes a particular prescription medication. Having these drugs around the house may be unwise and even dangerous. While the family can " flush" them, they may ask you to take care of them. This may be a professional service a pharmacist should perform. Also, no pharmacist, and no pharmacy system, is perfect. Even the best pharmacy can make an error and deliver the wrong drug to a patient. In that case, you are not only ethically obligated to take back the prescription—and destroy it—but you would probably decide to refund the money or at least dispense the correct prescription without charge.
If you do ever take prescription items back, you should leave no question in anyone's mind that the drugs will be destroyed. Knowing you took back drugs could raise a question in the public's mind that you "just might sell it." We should do nothing to diminish the trust of our patients.
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. Can prescription drugs be taken back from patients?. Drug Topics 2003;5:60.
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