Originally published in the March/April 2016 issue of the OVMA Observer.
Following several months of work, member input and dialogue with the Board of Pharmacy, new veterinary compounding rules took effect Feb. 22. While a variety of compounding rules were followed and commented on, the two of principle interest to most OVMA members provide greater latitude to exercise your medical judgment and serve clients as they pertain to the access and use of non-patient-specific compound drugs.
Ohio Administrative Code 4729-16-08 reverses a prohibition on out-of-state veterinary compound pharmacies providing non-patient-specific medications to a veterinarian. For approximately 10 months, only Ohio compound pharmacies could provide non-patient-specific medications to Ohio veterinarians. The change in rule 4729-16-08 reopens options for Ohio veterinarians to obtain these compound medications from either in-state or out-of-state compounders.
Ohio Administrative Code 4729-16-12: “Animal Compounded Drugs” provides greater latitude and flexibility to meet urgent and emergent patient medical needs by allowing for a veterinary office to obtain and maintain in stock a “limited quantity” of non-patient-specific compound medications needed to treat urgent situations, unanticipated procedures or treatments, or for diagnostic purposes. The veterinarian can administer the medication and/or dispense no more than a seven-day supply. For circumstances needing more than seven days, you would submit a patient-specific prescription to the compound pharmacy to complete treatment.
The Board of Pharmacy is still reviewing changes to OAC 4729-9-11, which covers security. As originally proposed by the Board of Pharmacy, the security rule would have been modified to restrict access to not only dangerous drugs, but also any record containing drug information, including patient records, and all hypodermics. These provisions would have required any prescriber, including veterinarians, to create security parameters to secure all patient records and hypodermics, similar to measures used in pharmacies. OVMA objected on the grounds that such a requirement would result in significant costs and reconfiguration within clinics, with no real discernable benefit in terms of limiting drugs to non-authorized persons.
Filing comments under what is known as the “Common-Sense Initiative,” OVMA was able to petition for the removal of the language. An alternate section that records are to be maintained under appropriate supervision and control emerged, so as to prevent the public from easily accessing them. In other words, behind a receptionist desk or stored electronically on a computer would provide some barrier to anyone in the public going through records that are not their own.
For hypodermics, we again sought removal from the proposed rule, citing that they are commonly available to the public in retail pharmacies, Tractor Supply Company stores and online; however, a long-standing but rarely enforced section of Ohio Revised Code (3719.172 stipulates that at least some access restrictions exist for terminal distributors of dangerous drugs. Specifically, the law says than anyone who is authorized to possess a hypodermic shall not “fail to take reasonable precautions to prevent any hypodermic in the person’s possession from theft or acquisition by any unauthorized person.”
As a result, the Board of Pharmacy submitted alternative language that exempts hypodermics at veterinary facilities from the more stringent portions of the rule, instead requiring that hypodermics be reasonably secured during non-business hours, and during hours of operation they not be stored in areas that aren’t normally supervised, such that anyone from the public would have unauthorized access to hypodermics.
The Board of Pharmacy is still reviewing proposed changes to OAC 4729-5-17, which covers personally furnishing by prescribers, and is considering a new policy affecting renewals and new applications for terminal distributors of dangerous drug (TDDD) licenses. OVMA is making efforts to persuade the Board to revisit its new policy on TDDD license application and a renewal of requiring knowledge of any employee in violation of the law; this includes some traffic offenses, tax assessments, etc. We will share more details in the next Observer on these rules and any progress we have made.