Originally published in July/August 2016 issue of the OVMA Observer.
The Ohio Board of Pharmacy has been busy revisiting and revising a number of administrative rules beyond those on which we have previously reported regarding compounding. As with the compound rules, the OVMA has actively engaged on your behalf in providing perspectives on how the proposed rule drafts would impact the typical veterinary practice.
In a number of instances, modifications were made from the original proposal after OVMA presented information to the Board of Pharmacy. For example, an original draft of the security rule explained below called for all records containing drug information (including patient records) to be secured at the same level and limitation to access as dangerous drugs. The rule now reads that records with drug information must be kept in manner to generally prevent unauthorized access (in other words, not stored in such a way, either in hard copy or electronically, that a member of the public could easily get unsupervised access to records).
Ohio Administrative Code 4729-9-11 Security and Control of Dangerous Drugs
This rule applies to both pharmacies and those with terminal distributor of dangerous drug (TDDD) licenses. Under current rules, almost all veterinary practices should now have a TDDD license with the Ohio Board of Pharmacy. This rule has been in existence for several years, but was substantially rewritten this year to incorporate records containing dangerous drug information (a “dangerous drug,” by definition in statute, includes not just controlled substances but any prescription drug), uncompleted prescription pads and hypodermics.
Under OAC 4729-9-11 Section (B) (1), dangerous drugs, uncompleted prescription blanks, controlled substance order forms, hypodermics and poisons must be in an area secured by locks and/or an electronic barrier to deter and detect unauthorized access. (Such an area may include a “substantially constructed cabinet.”) Importantly, hypodermics at a veterinary facility do not have to be under continual lock and key due to the addition of an exemption in (B) (3) that states hypodermics at a veterinary facility are exempt, providing that during non-business hours the hypodermics are secured, and during business hours they are not stored in areas where members of public would have unsupervised access to hypodermics.
Ohio Administrative Code 4729-5-17 Personally Furnishing Dangerous Drugs
This rule has been substantially rewritten and expanded from requirements on how drugs you personally furnish (i.e., dispense) must be labeled to make clear that a prescriber can designate someone authorized to handle the drug to “prepare and package” the drug to be personally furnished/dispensed. (For controlled substances, only a DVM or RVT; for non-controlled prescription drugs, animal aides are included.) The prescriber must, however, check the drug prior to being dispensed and make a record of the same. While specifying this responsibility is new to the rule, the prescribing veterinarian has always been responsible for ensuring the accuracy of drugs being provided to patients.
The rule also specifies that the prescriber or the prescriber’s designee must offer to provide drug information counseling—to answer questions about the medication, how it is to be given, and so on—prior to it being personally furnished. A prescriber must document refusal in writing, except that prescribers who are veterinarians do not have to document such refusals.
The new rule also addresses a problem unknown but onerous to many, which required the prescriber (i.e., the veterinarian) to be personally present when a dangerous drug was being picked up by a client, in the event the client had any questions. This was of particular concern to solo and mixed animal practitioners, who are more likely to be away from the clinic when a client comes to pick up a drug refill. OVMA worked with the pharmacy board to find a solution to this challenge, and the new rule now allows for the prescriber to be off the premises when non-controlled drugs are being dispensed (federal law requires a veterinarian to provide oversight and security of controlled substances at all times), provided that the prescriber is available by cell phone (electronic communication).