Update on prescription drug regulations, education initiatives in Ohio
Ohio is currently working to implement a recently-passed law regarding terminal distributor of dangerous drugs (TDDD) licensing. The law requires prescribers that either personally compound drugs or possess compounded drugs to obtain a TDDD license from the Ohio Board of Pharmacy.
This law impacts all prescriber practices that were previously exempted from licensure. Based on the pharmacy board’s recent interpretation of “compounding,” this law even impacts those who are engaged in a form of compounding commonly referred to as “reconstitution” (which can include vaccines).
As of June 2016, the pharmacy board had received a significant amount of feedback regarding this law and is continuing to evaluate how to best implement it. The board is expected to have further guidance following its July meeting, according to an update on its website.
The Ohio Dental Association recently submitted a letter to the pharmacy board expressing concerns with its interpretation of the new law. The letter stated, “While the ODA supports the regulation of compounded drugs, we are concerned that the pharmacy board’s interpretation of what constitutes ‘compounding’ in Ohio is overly broad based on the original intent of the regulation.”
More specifically, guidance recently issued by the pharmacy board indicates that Ohio law does not differentiate between compounding and reconstitution. National compounding rules and guidelines, however, explicitly state that compounding does not include reconstitution or other acts that are performed in accordance with the manufacturer’s instructions. Accordingly, these new rules go beyond national compounding rules and guidelines and are not based on any scientific evidence that the current practice is unsafe or otherwise dangerous for patients.
The letter also acknowledged that dentists already possess a license from the OSDB that allows the rendering of treatment and care within the scope of practice, which includes performing injections. Dentists are also required to routinely utilize the OARRS database and those who prescribe dangerous drugs are required to have a DEA license. The letter concluded, “With these regulations in place, and in light of the fact that there is no evidence to suggest that in-office compounding as practiced today is dangerous, we are confident that a revised, less restrictive, rule will allow dentists in Ohio to continue the safe practice of dentistry, including the administration of diluted or reconstituted drugs, without subjecting them to unnecessary regulatory requirements and expense.”
Pending Legislation
Additionally, pending legislation would expand the TDDD licensure requirement mentioned above to include any health care professional (including dentists, physicians and veterinarians) who possess Schedule I, II, III, IV, or V drugs in their offices. This new initiative is designed to ensure that all locations that have controlled substances are regulated by the pharmacy board. Learn more about Senate Bill 319 on page 1.
Opioid Prescribing Guidelines
Earlier this year, the Governor’s Cabinet Opiate Action Team issued new opioid prescribing guidelines designed to help fight prescription drug abuse. The team recently sent an email to health care providers asking them to complete an online training module regarding the new Acute Pain Opioid Prescribing Guidelines.
The online training module includes a 10-minute training video that summarizes the new guidelines, plus a pre- and post-training quiz to gauge the effectiveness of the training videos.
More information on the new guidelines can be found at opioidprescribing.ohio.gov.