On the Docket
David B. Brushwood, BSPharm, JD
As the professional responsibilities of pharmacists rapidly expand, and as the standards of practice for pharmacists gradually evolve, it is important to consider whether pharmacy laws create boundaries for pharmacy practice. A recent legal case from Illinois discusses the possible regulatory limits for pharmacist scope of practice.
Background
An inpatient pharmacist at a county health system was assigned to a correctional health unit. One of the services on that unit is an opioid treatment program for detainees, for which pharmacists on the unit administer suboxone and methadone to detainees. The newly assigned pharmacist objected to performing these tasks, contending that a pharmacist’s license allows dispensing of medications but does not permit oral administration of them.
The pharmacist received verbal and written discipline for failing to follow orders instructing her to stop sending emails to management expressing her concerns about the administration of suboxone and methadone by pharmacists. The pharmacist also sent complaints to various government agencies concerning the unit’s requirement for administering medications. The state licensing agency conducted an on-site investigation, during which an investigator observed a pharmacist dispensing and administering suboxone and methadone to five detainees. The agency determined that there had been “no violations under its jurisdiction.”
Several months later, the pharmacist was terminated for an alleged HIPAA violation. The pharmacist contended that this alleged violation was a mere pretext. She argued that she had been fired in retaliation for complaining about unlawful pharmacy practices at the unit, and that making such a complaint is a protected activity under the state Whistleblower Act.
The county health system moved for dismissal of the case. The lower court dismissed the case and the pharmacist appealed.
Rationale
The appellate court said that “Under the plain language of the Pharmacy Practice Act, oral administration of suboxone and methadone does not fall within the practice of pharmacy. However, plaintiff does not cite any section of the Act that states the Act is violated if a pharmacist performs an action outside the scope of the practice of pharmacy. The Act’s purpose is to prevent non-pharmacists from practicing pharmacy, not to define the limits of what actions a pharmacist may take. If plaintiff’s reading of the Act is correct, then it would be unlawful under the Act for a pharmacist to do anything other than the 17 actions described under the practice of pharmacy. Pharmacists would be legally prohibited from performing numerous tasks ancillary to the practice of pharmacy. Such a reading would be absurd.”
The appellate court ruled that “the administration of suboxone and methadone by pharmacists to detainees in the opioid treatment program does not violate the Pharmacy Practice Act,” therefore the state Whistleblower Act does not apply. The court affirmed dismissal of the pharmacist’s lawsuit.
Takeaways
The court’s clear ruling in this case supports the position that the pharmacy profession is not defined by a list of tasks specified in a state licensing law.
The pharmacy profession defines itself through its standards of practice. Government agencies respect the profession’s standards of practice, and government regulatory actions reflect the profession’s standards of practice.
It is important to note that “standards of practice” is a plural phrase. There is no one-size-fits-all correct way to practice pharmacy. There can be several different correct solutions to similar problems that arise in pharmaceutical care. Each of these correct solutions is considered within the standard of care. There are also many incorrect solutions to pharmaceutical care problems. Each of these incorrect solutions is outside the standard of care.
The pharmacy profession faces an opportunity to develop consistency in the recognition of professional standards of care that are flexible enough to incorporate evidence-based clinical judgments and are sufficiently specific to reliably produce optimal drug therapy outcomes.
The days of depending on legal rules to define pharmacy scope of practice are over. It is time for the profession to define itself. ■