Pharmacy Law: Determining the Legitimacy of Opioid Prescriptions

The pharmacists at XYZ Pharmacy are concerned. The pharmacy is in close proximity to a pain management clinic and patients from this clinic regularly present the pharmacists with prescriptions for MS Contin®, oxycodone, methadone, and other opioids in quantities as large as 1,000 tablets for a 1-month supply. Those prescriptions are usually accompanied with prescriptions for fentanyl oral lozenges. A few other physicians in the area also write prescriptions for large quantities of opioids and patients prefer going to XYZ Pharmacy since some of the other pharmacies in town will not fill their prescriptions. The XYZ pharmacists are concerned about the legitimacy of many of these prescriptions, the potential for legal and regulatory scrutiny, and wonder, "What is our responsibility under the law?" The above situation is very general and begs for additional facts with regard to each patient and each physician. Nonetheless, it serves to introduce one of the most perplexing and troublesome issues a pharmacist can face: determining whether an opioid prescription written by a prescriber is legitimately written for the treatment of pain.

Pharmacists’ concerns are exacerbated when several patients present multiple opioid prescriptions for very large quantities and very high dosages from the same prescriber or the same few prescribers. However, large quantities and high dosages are often necessary and legitimate in order to adequately treat severe pain patients. Regulators, law enforcement agencies, and legislatures have clearly articulated that they condone this practice. (See inset, page 2.) Nonetheless, pharmacists may hesitate to dispense these prescriptions fearing the consequences of the legal/regulatory system. In particular, the law imposes a legal duty on pharmacists called the corresponding responsibility doctrine. Simply stated, the corresponding responsibility doctrine places upon the pharmacist an equal legal responsibility with the prescriber to ensure that the prescriptions are written for a legitimate medical purpose.

The treatment of addicts for addiction in the ordinary course of a prescriber’s practice is not a legitimate medical purpose. Except for limited circumstances as described by law, addicts may not be treated for addiction outside of licensed treatment programs. Treating addicts with opioids for pain is a legitimate medical purpose, but sometimes the real purpose of treatment can be hard to determine.

Pharmacists can engage in certain steps and incorporate tools to help them determine if prescriptions are legitimate. They can also help educate pain patients who receive opioids about how to prevent diversion. Diversion and abuse of legitimate prescription drugs, especially among youth, is a significant societal problem.