Originally published in the July/August 2017 issue of the OVMA Observer.
Rules and statutory changes in Ohio pharmacy law continue to raise questions among prescribers, and OVMA members are no different. Two of the most common questions are relative to licensing and verification of checking a drug prior to it being dispensed/personally furnished.
First, with respect to licensing, all veterinary locations that receive and keep prescription drugs should have a Terminal Distributor of Dangerous Drugs (TDDD) License from the Ohio Board of Pharmacy. This license is held for the facility/location and not for an individual (unlike a DEA license, which is in the name of the prescriber and is issued by the federal Drug Enforcement Administration). Under current regulations, TDDD licenses should be renewed annually, but the pharmacy board is moving to a two-year licensing system. It requires a prescriber to serve as a “responsible person,” who essentially is the point of contact and authority for oversight of compliance. If that prescriber leaves the practice, a new “responsible person” prescriber needs to be designated and shared with the Board of Pharmacy.
Prior to recent years, there were exceptions to having to obtain a TDDD license—mainly, for single shareholder entities, more commonly referred to as single-doctor practices. This exemption has been chipped away over the last year, first with changes to compound drug rules and then most notably with the passage of Senate Bill 319 last December. Those provisions took effect in early April, but because of an influx of new TDDD licensees entering the system (these changes were for all prescribers, and not just veterinarians), the Board of Pharmacy extended a grace period until June.
Wholesale distributors of prescription drugs are required to verify the existence of a TDDD license prior to selling to you.
Second is the requirement for a prescriber to verify the accuracy of a drug order for a client/patient prior to it being dispensed/personally furnished. This situation sometimes comes to the forefront if a practice undergoes a Board of Pharmacy compliance inspection.
When someone in the practice prepares a new or refill drug order to be sent home with or picked up by a client, a veterinarian must “perform a final check of the dangerous drug prior to it being personally furnished” (Ohio Administrative Code 4729-5-17). Furthermore, “the final check shall be documented using positive identification pursuant to rule 4729-5-01 of the Administrative Code.”
For computer-based record systems, the positive identification methods outlined can present a challenge, as they stipulate that password verification is not sufficient: It must be by manual signature or technology-based identification systems typically only found in human healthcare facilities, due to cost and need.
Acknowledgement that a veterinarian checked the drug being dispensed/personally furnished may be done by written acknowledgement in either the patient record or in a separate drug log. (The rule does not require the original prescribing DVM in the practice to check— only that it be a prescriber.) Both methods meet the requirement; they just need to be readily retrievable if the information is requested by the Board of Pharmacy.
Why the extra step? From a security standpoint, it represents a deterrent to potential internal diversion by non-prescribers. From a veterinary medical perspective, this verification helps ensure the correct medication in the correct dose is provided to the client. If an error were to occur, the prescriber is liable for an adverse outcome, and, of course, if the drug order was not checked prior to being dispensed, this would only magnify the potential liability of the prescriber.
Keep the following in mind during the final check process: First, only a technician or veterinarian can prepare a controlled-substance medication to be sent home with a client, and second, controlled substances need to be secured in a locked area until the client arrives to pick them up. The check rule also only applies to prescription medications. OTC drugs and EPA-regulated products like flea and tick preventatives are not covered by this rule, though the prescriber still has the ultimate responsibility to ensure the correct item was sent home.