David B. Brushwood, BSPharm, JD
The Federal Food Drug & Cosmetic Act determines the classification of pharmaceutical products as being available by prescription only (RxOnly) or OTC. States have the authority to decide who may prescribe and who may dispense RxOnly drugs. Two Texas physicians recently challenged a state law that limits the dispensing of RxOnly medications to licensed pharmacists. The two physicians sued to establish their right to dispense noncontrolled substance medications to their own patients.
Background
Texas law recognizes three exceptions under which physicians are allowed to dispense medications to their own patients: A 3-day supply of medication that is necessary to meet the patient’s immediate needs, medication samples provided to the physician free of charge, and physicians practicing in narrowly defined rural areas.
The physicians sued the board of pharmacy and the board of medicine, contending that their right to “pursue a chosen business” recognized under the state constitution was being violated by the state law. They also contended that their state constitutional right to equal protection under the law was being violated. They argued that there is no rational basis for the exception that applies only to rural physicians.
The defendants moved the court to dismiss the lawsuit, and this motion to dismiss was granted. The physicians appealed.
Rationale
The appellate court first addressed the physicians’ claim that the state law conflicts with their constitutional right to pursue a chosen business. The physicians contended that the law is unconstitutional because it is not rationally related to a legitimate government interest.
The court disagreed, ruling that “having a pharmacist doublecheck medication before dispensing would correct potential errors and improve the health and safety of patients.” The court cited prior case law as well as the 1980 Sesame Street episode “Two Heads Are Better Than One.”
The court referred to a survey that reported “64% of respondents strongly agreed that ‘having a physician/NP and pharmacist both check my medication makes it safer for me to take this medication.’ ”
The court concluded that the Texas law is not “so burdensome as to be oppressive” regarding the physicians’ business interests.
Turning to the physicians’ equal protection argument, the court said, “that a narrow exception exists for a handful of rural doctors does not negate the state’s previously discussed purpose of ensuring the safe dispensing of medication; rather, it merely reflects the state’s attempt to balance that interest with its separate (but related) interest in promoting access to medications for persons who live in rural areas that would otherwise have no or limited access to pharmacies.”
The appellate court affirmed dismissal of the case.
Takeways
This case illustrates the overlap of federal laws that regulate drug products with state laws that regulate professional practice. The goal of both is to promote the health and safety of patients.
The court ruling upholding the challenged Texas law can be justified based on recognition that pharmacists promote patient health and safety in several important ways that may not be applicable to dispensing prescribers. These include:
- Comprehensive review of complete patient medication records, facilitated by computer alerts to identify potential problems with a patient’s entire drug regimen
- Established relationships with suppliers who support pharmacists in assuring authentic product provenance and access to trustworthy alternative products during times of drug shortage
- Experience with insurance claims submission and the resolution of obstacles such as a prior authorization requirement
- A standard of practice that includes a pharmacist’s final check of every prescription prior to its delivery to the patient
The language of the court recognizes two important pharmacist responsibilities. The first of these is the correction of prescribing errors, and the second is the improvement of patient health and safety. It is necessary but not sufficient for a pharmacist to identify errors in a prescription. To justify their exclusive dispensing role, pharmacists must also promote positive therapeutic outcomes for all patients. ■