The Ohio Board of Pharmacy (“Board”) has recently taken informal action to require new retail-based health clinics, primarily staffed by certified nurse practitioners with prescriptive authority, to be licensed as “terminal distributors of dangerous drugs.” This would open these clinics to Board investigation and sanctions (including fines and injunctions) and require compliance with various facility requirements.
Retail-based health clinics have recently popped up across the country in national retail establishments such as Wal-Mart, Target, and CVS stores, as well as regional grocery stores which have in-house pharmacies. These clinics provide entrepreneurs with an entry into the healthcare industry through a delivery system that, depending on state law, does not require physician ownership or control. Such clinics strive to provide consumers with an efficient and convenient alternative to scheduling an appointment with their primary care physician for common illnesses and routine preventative care which would otherwise require time away from work and likely a trip to their local pharmacy. This one-stop-shopping approach combines healthcare and pharmacy services with a primary retail draw under the same roof.
Except for compliance with state medical and nursing board requirements regarding supervision of certified nurse practitioners, and in some cases infectious waste permits issued by the state Environmental Protection Agency, these clinics go largely unregulated in Ohio and are not inspected by state or local health departments. However, recently the Board has taken issue with retail-based clinics that purchase and maintain certain “dangerous drugs,” such as epinephrine or injectible vaccines. Under Ohio law, “dangerous drugs” include, in part, any prescription-only drugs, and any drug intended for administration by injection into the human body other than through a natural orifice. Ohio Rev. Code § 4729.01(F). While certified nurse practitioners may often purchase and maintain these types of dangerous drugs under their prescriptive authority, the Board of Pharmacy claims that an entity that employs these nurses may not do so for a nurse, unless appropriately licensed under Ohio law as a “terminal distributor of dangerous drugs.”
Under Ohio law, a “terminal distributor of dangerous drugs” is defined as a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person’s own use and consumption, and includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist or licensed health professional authorized to prescribe drugs (which includes a certified nurse practitioner with a certificate to prescribe issued under Ohio Rev. Code § 4723.48). Ohio Rev. Code § 4729.01(Q). Licenses must be obtained for each location and a licensed healthcare professional authorized to prescribe drugs must be appointed to maintain supervision and control over the possession and custody of dangerous drugs at each location. Ohio Rev. Code § 4729.55(B).
Interestingly, Ohio law excepts from this licensure requirement persons who possess and administer dangerous drugs in accordance with the professional licensing statutes relating to nurses, physicians and others. Ohio Rev. Code §§ 4729.51(C)(4) and § 4729.01(S) (“Person” includes individuals and entities.) Further, the “practice of nursing” includes administering medications and treatments in the course of the individual’s professional practice. Ohio Rev. Code § 4723.01(B)(5).
Although under Ohio law the professional services of a registered nurse may be rendered through a general corporation or limited liability company, professional association, and certain other types of entities, the Board of Pharmacy appears to have taken the position that these provisions do not provide an exception from the terminal distributor licensing requirements for an entity that employs a licensed prescriber. Ohio Rev. Code § 4723.16(A). Therefore, it appears that a retail-based clinic operating in Ohio that purchases dangerous drugs to be administered by its employed nurse practitioners must either obtain a license as discussed above or change the way it operates.