A multistate outbreak of nearly 100 human Campylobacter infections linked to puppies sold through pet stores is under investigation by local, state and federal agencies.
As of Dec. 13, a total of 97 people in 17 states have laboratory-confirmed infections or symptoms consistent with a Campylobacter infection and are linked to this outbreak. In Ohio, 32 cases have been linked to the outbreak between June 25 and Oct. 21; six patients have been hospitalized. Nineteen of the cases occurred in females, whereas 13 were male. Individuals range in age from less than a year to 67.
The Ohio Department of Health (ODH), Ohio Department of Agriculture Animal Disease Diagnostic Laboratory (ODA ADDL), various local health departments, Centers for Disease Control and Prevention (CDC), United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA APHIS) and the Food and Drug Administration (FDA) have been involved in the outbreak investigation in Ohio.
The OVMA has been working for several months to share veterinary profession perspectives with the Ohio Board of Pharmacy on a variety of proposed administrative rules. Two of these new rules 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. Both rules become effective on Feb. 22, 2016, and will:
- 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 the last eight months, only Ohio compound pharmacies could provide non-patient -specific medications to Ohio veterinarians. The change re-opens 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”) will allow for a veterinary office to obtain and maintain in stock a “limited quantity” of non-patient specific compound medications which are 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.
To view the complete rules, please click here.
For complete coverage of this and other Board of Pharmacy changes being proposed or finalized, please see the Regulatory Corner column of the next OVMA Observer.
Two key rules that will enhance the ability of veterinary practices to maintain limited supplies of non-patient-specific compound medications on hand, as well as where they can be obtained from, have been filed by the Ohio Board of Pharmacy. OVMA has worked extensively in providing background information and perspectives to the Pharmacy Board on these two as well as other pertinent rules up for review.
Filed on Nov. 30, Rule 4729-16-08 of the Ohio Administrative Code will reverse a prohibition on out-of-state veterinary compound pharmacies providing non-patient-specific medications to a veterinarian. Earlier this year, only Ohio compound pharmacies were permitted to provide non-patient-specific medications. After considerable feedback, the rule is being amended specifically to address those concerns raised by veterinary medicine, to wit:
“A non-resident pharmacy may provide licensed veterinarians non-patient specific compounded drugs for animal use, pursuant to rule 4729-16-12. Such compounding for office use shall comply with applicable federal laws and regulations.”
The net result is a change that will reopen options for Ohio veterinarians to obtain non-patient-specific compound medications for urgent use from either in-state or out-of-state compounders.
Also filed on Nov. 30 was the creation of new Ohio Administrative Code Rule 4729-6-12: Animal Compounded Drugs. This rule will allow a veterinary office to obtain and maintain in stock a “limited quantity” of non-patient-specific compound medications, which are needed for emergency situations, unanticipated procedures, treatments in which a time delay would affect patient outcome, and/or for diagnostic purposes. This new rule expands and replaces a current allowance known as the ”72-hour rule,” which is narrower in focus and was often misunderstood.
Both rules have to undergo an administrative code review process before they go into effect, which should be completed in early February 2016.