With a new year right around the corner, pharmacies and pharmacists must prepare for changes at various levels including with their state Boards of Pharmacy. Often times (though not always) new laws are set to take effect at the beginning of the year. It is important to be aware of any new laws coming into effect as they can greatly impact the duties and obligations of pharmacies and pharmacists. One such example is in Ohio, where beginning March 1, 2025, pharmacists will have to comply with an updated “Duty to Report” rule. The new version of this rule, which is codified under Ohio Administrative Code 4729:1-4-02, sets out requirements by pharmacists as it relates to their duties to report certain events to the Board of Pharmacy, in this example the Ohio Board of Pharmacy.
What Licensees Should Know About Duties to Report
Every state Board of Pharmacy has rules surrounding certain reporting requirements. While these rules may vary from state to state, generally, a licensee has a duty to report certain information to the state Board of Pharmacy the pharmacy or pharmacist is licensed in. Sometimes, these obligations extend to require reporting to every state the licensee is licensed in.
A. Reporting of Mental or Physical Impairment
One example of a duty to report by a pharmacist may involve a pharmacist’s observation of a fellow licensee practicing pharmacy while physically or mentally impaired. For example, beginning March 1, 2025, a licensed pharmacist in Ohio must report within 10 days of discovery, any incidents of a licensed individual practicing pharmacy while physically or mentally impaired. In this case, that includes physical or mental impairment that limits the individual’s ability to carry out their professional duties and appears focused on substances including alcohol, drugs, or other chemical substances. However, there are exceptions. For example, under the law, an Ohio pharmacist should not report someone who may have a substance abuse disorder if the pharmacist is aware of the condition as a result of the pharmacist having access to the individual’s protected health information. In addition, a pharmacist should not report someone who voluntarily seeks treatment for a mental health condition or substance use disorder.
B. Reporting Known Violations of Pharmacy Laws, Rules, or Regulations
In some cases, reporting requirements can extend past reporting an impaired licensee. Many states also require a licensee to report known violations of particular laws such as a state’s Practice of Pharmacy Act or any rule and regulation of the Pharmacy Board. Turning again to Ohio as an example, in Ohio, beginning March 1, 2025, a pharmacy must report within 10 days any known violations, attempts to violate, or aiding and abetting the violation of any provisions of Chapter 4729, including the Pharmacy Practice Act, Pure Food and Drug law, and Controlled Substances laws. This also requires reporting a pharmacy technician trainee, registered pharmacy technician, certified pharmacy technician, pharmacy intern, or pharmacist that engages in unprofessional conduct or dishonesty.
C. The Requirement of Self-Reporting
In addition to reporting known violations of other licensees, pharmacists and other pharmacy licensees should keep in mind the ongoing duty to self-report any of their own known violations of applicable pharmacy laws, rules, and regulations to their state Board of Pharmacy. Typically, failing to report under these circumstances can also be a ground for discipline. Again, using Ohio as an example, a pharmacist in Ohio has a duty to disclose any criminal conviction, arrest for a felony, or any disciplinary licensing or registration action taken by another state against the licensee. Reporting must be made within 10 days of the notice of these actions.
D. How to Report
States differ on methods of reporting. Generally, most state Boards of Pharmacy accept notification in writing. It is important to check a state Board of Pharmacy’s website for any relevant forms or specific requirements including procedures. Ohio allows reports to be made by various methods including the Board’s online complaint form available on the board’s website. Reports can also be made by telephone at 614-466-4143. For self-reporting, a licensee of Ohio must submit a Self-Report Form along with supporting documentation. Note, it is important to ensure the confidentiality of any patient information when making a report. This means patient-identifying information should not be disclosed.
How Frier Levitt Can Help
As the end of the year is fast approaching, pharmacists and pharmacies should be cognizant of any changes to their Board of Pharmacy’s rules and regulations. Frier Levitt has represented numerous licensees across the country in the pharmacy industry, including in the State of Ohio. Frier Levitt has worked with pharmacies on notifications as well as other matters involving state licensing boards and has obtained successful results on behalf of pharmacy clients.
Our attorneys take a strategic approach to ensure compliance with state licensing boards. Contact us today to speak with a member of our team.
