|NYSVMS provides additional information on BNE daily reporting requirements, effective Aug. 27|
Regulations adopted by the New York State Department of Health on Wednesday, Aug. 21, provide that all dispensing practitioners, including veterinarians, must comply with the "real time” reporting of controlled substance dispensing that was mandated in I-STOP for pharmacies and pharmacists.
As NYSVMS reported to you earlier today, we are pursuing every possible means to have this regulation changed to include the veterinarian’s exemption from these provisions. However, until NYSVMS is successful in having this exemption included in the regulations, veterinarians must comply with this section of the law, which goes into effect on Tuesday, Aug. 27.
Under the "real time” reporting requirement, veterinarians must report any dispensing of a controlled substance to the Bureau of Narcotic Enforcement within 24 hours of the dispensing activity. The reporting is to be done using the Health Commerce System account that veterinarians have already been using to report controlled substance dispensing on a monthly basis.
In addition, the new regulation also requires a veterinarian to submit a "zero report” to the BNE if NO controlled substance has been dispensed. The zero report need not be filed on a daily basis, but must be submitted at least 14 days after the last report of dispensing or the last zero report submitted. If a veterinarian does not dispense any controlled substance for 10 days, but then dispenses a controlled substance on day No. 11, the zero report for days 1-10 and the report of dispensing on day No. 11 can be filed at the same time. BNE will look at the reports to be sure that every day is covered in either a zero report or a report of dispensing.
Because there had been some incorrect reporting of controlled substance dispensing information by pharmacies and veterinarians when the medication was for an animal patient, the new regulations provide a specific format for dispensing animal medications. Controlled substances dispensed for an animal are to be reported under the name and address of the owner, and this information should be reported in the fields for "patient name” and "patient address.” New information fields have been added to the end of the report to allow the veterinarian or the pharmacist to record the species and name of the animal patient.
The regulations provide for a dispensing practitioner to request a waiver from the daily reporting of controlled substance dispensing, and instead to report dispensing activity on a monthly basis, if the practitioner can show economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstances that can be demonstrated in the application for the waiver. The waiver application must be accompanied by a sworn statement of facts detailing the circumstances that support the waiver application. The maximum period of time that can be covered by a waiver is one year, after which another waiver must be obtained by the practitioner.
Remember that it is only dispensing of controlled substances that must be reported to BNE; administration of a controlled substance by a veterinarian or issuing a prescription for a controlled substance are not required to be reported through this system.
If a veterinarian had obtained an HCS account and was reporting controlled substance dispensing prior to the effective date of I-STOP, BNE will look for either a daily report of dispensing or a zero report from that veterinarian after Aug. 27, the effective date of the new provisions. If a veterinarian was not dispensing controlled substances prior to Aug. 27, and consequently had not obtained an HCS account for reporting, the veterinarian does not need to start filing zero reports now.
Further information on the implementation of I-STOP and contact numbers at the Bureau of Narcotic Enforcement can be found in the BNE Spring 2013 newsletter, available online here.
Frequently asked questions about the Prescription Monitoring Program (NYSPMP) and about reporting through the HCS system can be found online here.
Contains Knowledge Center articles related to pharmacy, pet medications, compounding, controlled substances and other topics related to drugs.
Articles related to the business of owning/managing a veterinary hospital/clinic