Regulation Station

Reporting (Not) Gabapentin

Originally published in January/February 2017 issue of the OVMA Observer.

The Ohio Board of Pharmacy’s recent informational release on prescribers reporting gabapentin they personally furnish/dispense to clients created some confusion with veterinary practices. The rule (OAC 4729-37-12) stipulating gabapentin reporting is associated with dangerous drug monitoring under what is known as OARRS (Ohio Automated Rx Reporting System).

Veterinarians are specifically exempt from the requirements of OARRS, and therefore the rule adding the reporting of gabapentin within the system would not apply to veterinarians, unless they have voluntarily elected to participate in OARRS.


FDA Ban on Powdered Medical Gloves

Citing an “unreasonable and substantial risk of illness or injury,” the U.S. Food and Drug Administration has issued a ban on the use of all powdered surgical and powdered patient examination gloves by medical providers, including veterinary practices. The rule was issued Dec. 19, 2016, with an effective date of Jan. 18, 2017.

The ban extends not just to the future sale of powdered medical gloves, but also to the use of any existing supplies in inventory.


Pick-Up Station Rule Being Simplified

The Ohio Board of Pharmacy has filed a modification to its prescription pick-up station rule (OAC 4729-5-10) that eliminates the need for the pharmacy shipper and receiver to submit documentation to the board. As filed, the rule will not require the completion of a pharmacy board form prior to allowing for a terminal distributor of dangerous drugs (TDDD) licensee to have a prescription shipped directly to them rather than the client. This provision provides that the delivery of the medication directly to the patient (client) would represent a danger to public health or safety, or a danger to the patient without increased involvement by the health care professional.

In other words, if you order a compound medication for which you believe the client will need additional counseling prior to administering it to their animal, or the drug presents a definitive risk to the public if left unattended in the client’s mailbox, then the prescription pick-up station can be utilized.


Pharmacy Board Licensing

The passage of Ohio Senate Bill 319 in December and subsequent signing by the governor will eliminate the single shareholder exemption for prescribers who personally furnish dangerous drugs to their patients from having to obtain a TDDD license. Most veterinary clinics were already required to obtain a TDDD license (the license is for a clinic and not for individual veterinarians), including single shareholder corporations if they possessed compound drugs.

Beginning in spring 2017 (laws take effect 90 days after being signed by the governor), all healthcare prescribers who personally furnish/dispense dangerous drugs must obtain a TDDD license from the Ohio Board of Pharmacy, regardless of their legal corporate structure, if they do not already possess one.

A TDDD license is $40 annually for a veterinary facility. When completing an application, take note of the fee amount, as it is lower than that of other terminal distributor licensees. Please also note that veterinarians are not required to participate in the OARRS reporting system.