Ken Baker is a pharmacist, lawyer, and former general counsel and senior vice president of Pharmacists Mutual Insurance Company. Ken Baker advises clients in pharmacy law and regulation, risk management, insurance and pharmacy quality programs, and reduction of medical errors. Ken Baker is of counsel and a pharmacist consultant with the Phoenix law firm of Renaud Cook Drury Mesaros, PA. He is licensed to practice law in Indiana.
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Pharmacy Needs a Workable Standard for When to Check the Rx Monitoring Database

Reprinted from the November 30, 2009, "Pharmacy e-Flash" (Food Marketing Institute)

Section 1306.04 of the DEA Code of Federal Regulations states that “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” Pharmacists have often complained that it was difficult for them to comply with this “corresponding responsibility” without knowing what controlled substance prescriptions a patient has filled at other pharmacies. Pharmacists now have such a tool. More than three quarters of states have a prescription controlled substance monitoring program (PMP), either in operation or in the process of being implemented.

The problem with the systems is that a pharmacist in a busy pharmacy can not check the PMP database on every patient who presents a controlled substance prescription. Can a pharmacist and a pharmacy face additional liability when they do not check?

A lawsuit filed in a Clark County, Nevada district court against a number of pharmacies could determine just that. The suit alleges that a pharmacist should have refused to fill a controlled substance prescription for a young lady who was using a considerable amount of controlled substances. She subsequently drove into and killed a delivery truck driver and injured his associate. A year before the accident, fourteen pharmacies had received letters of concern about this patient from the state board of pharmacy. The accident and the lack of action by the pharmacists were the basis of the lawsuit against the pharmacies.

Regardless of the outcome of the Nevada case, the underlying question of the duty of a pharmacist to check and act upon information in the PMP database will remain. Pharmacies need to begin thinking about the question. When and under what circumstances would a reasonable and responsible pharmacist open the PMP database when a patient presents a controlled substance prescription?

These are questions pharmacists should consider now, before something happens to one of their patients. Developing a set of criteria is not a guarantee the pharmacy will not be sued in the future, but a well reasoned plan provides a better defense. A developed standard is also a way to protect the real beneficiaries of the PMP – the patient.


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