|General Questions on I-STOP Provisions|
However, most of these issues are not addressed directly by the law or NYSDOH regulations, and we are seeking confirmation from NYSDOH that our interpretations are accurate. The Bureau of Narcotic Enforcement has indicated that they will look for practitioners’ good faith efforts to comply with the new law, and will not penalize them for incorrect reporting as long as they have made that good faith effort to comply.
NYSVMS will advise members if NYSDOH recommends a different course of action in response to any of the questions raised by NYSVMS members. Until that happens, you will show a good faith effort to comply by following these guidelines.
Q: Do veterinarians have to consult the Prescription Monitoring Program (PMP) registry before prescribing or dispensing a controlled substance?
A: Veterinarians are specifically exempted from the requirement that the PMP registry be consulted before prescribing or dispensing a controlled substance for a patient. This requirement applies to most other prescribers and to pharmacies, but not to veterinarians. The NYSVMS worked for this exemption for veterinarians at the time that the I-STOP law was being written.
Q: Are veterinarians now required to prescribe controlled substances electronically or can we still prescribe using a paper prescription form?
A: Veterinarians are specifically exempted from the requirement that controlled substance prescriptions be transmitted electronically to a pharmacy. This requirement applies to most other prescribers, but not to veterinarians. NYSVMS worked for this exemption for veterinarians at the time that the I-STOP law was being written. Veterinarians can still write prescriptions for controlled substances on an official NYS prescription form.
Q: Are veterinarians required to report controlled substance use on a daily basis?
A: Starting with any controlled substances that are dispensed on Aug. 27, veterinarians are required to report that dispensing activity to the NYSDOH, Bureau of Narcotic Enforcement within 24 hours. The reporting is done through the HCS account previously used by the veterinarian to report controlled substance dispensing on a monthly basis.
Any controlled substance administered by the veterinarian and any prescription for a controlled substance written by the veterinarian (and filled at a pharmacy) are not required to be reported by the veterinarian. Controlled substances administered in the hospital must still be recorded on the controlled substance log kept at the hospital as required by DEA.
Q: What about the drugs dispensed from Aug. 1 through Aug. 26, since the last monthly report was submitted?
A: Controlled substances dispensed before Aug. 27 are covered under the prior provisions of law that require dispensing activity to be reported on a monthly basis (by the 15th day of the next month), and your Aug. 1 through Aug. 26 dispensing activities must be reported by this date. However, you may want to submit that report earlier than that date to ensure that all dispensing activities are reported, and there is no confusion within the hospital between the last monthly report and the new daily reports.
Q: If a veterinarian has a DEA registration in order to order controlled substances and administer them to patients in the hospital, but does not dispense them and consequently has never applied for an HCS (or HPN) account, does he/she now have to file zero reports and obtain an HCS account in order to file those reports?
A: Veterinarians who have not dispensed controlled substances since the electronic reporting went into effect in 2006 need not start reporting zero dispensing now.
Q: If a veterinarian has an HCS account and was reporting controlled substance dispensing on a monthly basis, but will no longer dispense controlled substances after Aug. 26, is the veterinarian relieved from the obligation to file any dispensing reports?
A: If BNE has a record of a veterinarian with an HCS account reporting dispensing under that account, they must temporarily keep reporting, even if they are no longer dispensing. If they have truly stopped dispensing, those reports will be zero reports. The regulations address this situation by providing for a practitioner who is filing zero reports to file for a waiver from the requirement that they continue to file zero reports.
"A waiver of the requirement to file a zero report may be issued by the commissioner based upon a showing that a pharmacy or practitioner does not dispense controlled substances within the state of New York.” The veterinarian should continue to file zero reports at least every 14 days until a waiver is received. The maximum period of time for which the waiver will remain in effect is 2 years.
Q: If a veterinarian does not dispense controlled substances, but occasionally takes a euthanasia drug (a controlled substance) on a house call in order to perform a "home euthanasia,” is the veterinarian required to report this activity as dispensing a controlled substance?
A: As long as the controlled substance remains in the possession of the veterinarian and is administered by the veterinarian, it will be considered administration of the controlled substance (not required to be reported) and not dispensing the drug. DEA-registered veterinarians are permitted to transport controlled substances to an unregistered location, such as a client’s home or another location where animals need attention, to dispense controlled substances on an "as-needed and random basis,” provided the veterinarian does not maintain a principal place of professional business at any of these other locations.
Specific Reporting Issues
Q: Does every veterinarian in a veterinary practice have to establish a separate HCS (Health Commerce System) account and separately report their own controlled substance dispensing activities to BNE?
A: No. One veterinarian who holds a DEA license can open a HCS account and report all the dispensing activities in the practice. A recommended practice is for the the HCS account to be opened in the name and DEA registration number of the veterinarian whose DEA registration is used when controlled substances are ordered for the practice. The reports may be filed by a designated staff person who is not a licensed prescriber.
Q: When filing a report of daily dispensing of controlled substances, can the report be filed any time during the next day, or must it be filed within 24 hours from the exact time when the controlled substance was dispensed?
A: The regulations say specifically that the "real time" report of controlled substance dispensing must be filed "not later than 24 hours after the substance was delivered.” A recommended practice is to establish a certain time of day, either the very end of the business day or the beginning of the next day, when reports of dispensing during the previous 24 hours are reported every day. If there was no dispensing during a 24-hour period, a zero report must be filed. A zero report need not be filed every day, but must be filed at least every 14 days. If dispensing occurs after several days of zero dispensing, the zero report must be filed for the time period during which no dispensing occurred, and the dispensing activity must be reported within 24 hours of the dispensing.
Q: Do veterinarians need pharmacy or practitioner DEA numbers?
A: The veterinarian completing the report of controlled substance dispensing must include his or her DEA registration number on the report. Pharmacies are also required to report controlled substance dispensing, and the request for a pharmacy number applies only when the report is being submitted by a pharmacy or pharmacist.
Q: I am a per diem veterinarian, and I work at several different practices. Should my controlled substance dispensing be reported to BNE by the practice, or should I report it?
A: Reporting can be done either way. However, the recommended practice is for the reporting to be done by the person or entity whose DEA registration was used to order the drugs. If you are dispensing controlled substances from the stock at a practice, ordered by the practice under the DEA registration of one of the veterinarian owners of the practice, then the practice should report your dispensing activities along with other dispensing that occurred at the practice. If you order your own controlled substances for your dispensing use while you are at the practice, then you should file the report.
Remember that if you are ordering controlled substances for your use, they must be sent directly to the location where they will be used, and that location must correspond to the address listed on your DEA registration. DEA does not permit any licensed practitioner to transport controlled substances away from the location to which they were delivered, to another location where a different DEA registration is in force. DEA-registered veterinarians are permitted to transport controlled substances to an unregistered location, such as a client’s home or another location where animals need attention, to dispense controlled substances on an "as-needed and random basis,” provided the veterinarian does not maintain a principal place of professional business at any of these other locations.
Q: My practice treats animals that are owned by an animal shelter / humane society / rescue organization. How do we report the owner’s name when reporting that controlled substances are dispensed for use on any of these animals?
A: Controlled substances dispensed to animal patients are to be reported with the owner’s name and address in the "patient name” and "patient address” fields. When there are even slight differences in the way a patient’s name is entered into the system, the registry will treat the records as belonging to different individuals. At this time, the reporting format for an individual’s name requires last name and first name. We have brought to the attention of the Department of Health the issue that you raise about animal ownership, and are waiting for their recommendations. Until they instruct differently, use a consistent reporting format so that all drugs you dispense for animals owned by these organizations will be grouped together under the same owner identification.
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