The short answer is, based on the language of Indiana Code § 35-48-7-11.3 and the guidance of the Professional Licensing Agency, it appears that any veterinarian that distributes, dispenses, or prescribes a controlled substance is required to register for INSPECT, and the IPLA requires that each practitioner INSPECT registrant have their own individual DEA License to register. IVMA was recently informed by PLA/INSPECT that if there is more than one licensed veterinarian within a practice, they are all able to dispense medication to patients under the DEA of the practice owner. They will only need to obtain their own individual DEA license if they are prescribing to a patient (providing a written prescription to be dispensed at a pharmacy)

• Prescribing: A registered Physician, Dentist, Veterinarian or any other person licensed by law to prescribe drugs, provides a written order containing instructions for preparation and dispensing to the Pharmacist along with mode of administration for the patient.
• Dispensing: The preparation, packaging, labeling, record keeping, and transfer of a prescription drug to a patient or an intermediary, who is responsible for administration of the drug.

 No, controlled substances that are administered to a patient during the course of surgery or treatment are not reportable to INSPECT.

Every veterinarian (and any other dispensing physician) must report to INSPECT if controlled substances (Schedule II-V) AND GABAPENTIN are dispensed to a patient out of their office. If a veterinarian is providing a written script to a patient that is filled at a pharmacy, the pharmacy is responsible for reporting that prescription data to INSPECT.

The vast majority of veterinary practices do not have, and don’t need, a practice DEA. The owner/veterinarian DEA is used to purchase drugs, etc.

In this case, all dispensations would be reported to INSPECT via the PMP Clearinghouse under the practice owner’s DEA. The practice owner’s DEA would be listed under “Prescriber’s DEA” and “Pharmacy DEA”. The same is true when reporting the name of the prescriber and the name of the “pharmacy”. John Smith, DVM would be listed as the name of the prescriber and the name of the pharmacy/dispenser.

There are two ways to answer this question. If you are a solo practitioner, you will need a DEA in order to purchase the controlled substances and subsequently use them in practice. If a veterinarian is only administering medication or dispensing it out of the office (of a multi-doctor practice, for example), they will need a CSR, but not their own DEA (see Question #1). They will need a CSR and a DEA if they are writing prescriptions to patients that will be filled outside of the facility.

Indiana State law requires an ID to pick up a controlled substance. Pharmacies and other dispensers must collect an ID and record the identification number from anyone picking up a controlled substance. Records pertaining to controlled substances must be kept for 2 years. You can read about this in the federal code (link below). All information about what dispensers need to collect and report to the PDMP can be found in the INSPECT statute: IC 35-48-7

• IC 35-48-7-8.1 Controlled substance prescription monitoring program; information; prescription forms; identification Sec. 8.1. (a)
• IC 35-48-7-5 “Identification number” (this section specifically addresses what to do if the patient is an animal)

Here is the link to the federal code on record keeping and inventory for controlled substances: 21 CFR 1304.04 (a)Maintenance of records and inventories  https://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.html

An INSPECT report summarizes the ephedrine, pseudoephedrine or controlled substances a patient has been prescribed, the practitioner who prescribed them and the dispensing pharmacy where the patient obtained them. Each time ephedrine, pseudoephedrine, Gabapentin or a controlled substance is dispensed, the dispenser is required to submit the following information to INSPECT within 24 hours of dispensation.

1. The patient’s name.
2. The patient’s identification number. If someone other than patient is picking up medication, the patient representative’s identification number.
3. The patient’s date of birth.
4. The national drug code (NDC) number of the controlled substance dispensed.
5. The date the controlled substance is dispensed.
6. The quantity of the controlled substance dispensed.
7. The number of days of supply dispensed.
8. The dispenser’s United States Drug Enforcement Agency (DEA) registration number.
9. The prescriber’s United States Drug Enforcement Agency (DEA) registration number.
10. Patient address information, including city, state and zip code.

Identification for animals should be reported as follows-
Animal’s first name and species, owner’s last name, owner’s DOB. Example: First Name: Maggie Feline, Last Name: Moore, DOB: 04/21/1971

A zero report must be submitted every twenty-four (24) hours for a retail pharmacy and dispensing physician office, or every thirty (30) days for a hospital (Type II) pharmacy. If a controlled substance is dispensed that is equal to or less than a 72-hour supply, that information does NOT have to be reported to INSPECT and the dispenser can continue submitting zero reports. However, if a controlled substance is dispensed that exceeds the 72-hour supply, that prescription must be reported to the INSPECT program within twenty-four (24) business hours.

Indiana requires all pharmacies and dispensers to report controlled substance dispensations to the Indiana PMP via the PMP Clearinghouse. Dispensations must be reported at least within twenty‐four (24) hours (or next business day) from the date on which a drug is dispensed to an Indiana resident.

All dispensers of Schedule II ‐ V controlled substance prescriptions and Gabapentin are required to collect and report their dispensing information

1. To request a data submitter (Pharmacist) account for PMP AWARXE, the user must go to https://pmpclearinghouse.net and click the “Create Account” link in the center of the screen, or go directly to https://pmpclearinghouse.net/registrations/new
   
2. The screen displayed requires the user to enter their current, valid email address, and a password. This email address will act as your user name when logging into the system. The password must contain at least 8 characters, including 1 capital letter, 1 lower case letter, and 1 special character (such as !, @, #, $)

Click here to access the online dispenser guide:
https://www.in.gov/pla/inspect/files/IN%20Data%20Submission%20Dispenser%20Guide.pdf

The veterinary practice will have a PMP Clearinghouse account. All controlled substances and Gabapentin that are dispensed out of a veterinary practice each day must be reported to the State through the Clearinghouse account set up for that practice. The DEA number used to order controlled substances for the practice is the DEA number that needs to be entered into Clearinghouse for dispensations. Each practitioner with a valid, active CSR and DEA needs to be registered for an account in PMP AWARxE to be able to run an INSPECT report on their patients and/or patient owners.

You only need to collect data on the client or person who picks up that prescription if it is a controlled substance or Gabapentin over a 72-hour supply. INSPECT does not collect data on prescriptions that are a 72 hour supply or less.

In this case, you would not need to collect data on the patient or the person picking up the medication because only a 3 day (72 hour) supply is being sent home. No information needs to be collected or reported to INSPECT on controlled substance prescriptions that are a 72 hour supply or less. By 01/01/2021, you will need to run an INSPECT report on the patient before prescribing an opioid or benzodiazepine. The mandatory query law does not apply to all controlled substances, it only requires practitioners to run a search when he or she prescribes opioids and benzodiazepines.

The answer is that it depends… If the relief veterinarian is going to be responsible for reporting his/her own dispensations to the Clearinghouse, then yes, they need to be added as a user. If someone else at the clinic is taking on the responsibility of entering the relief veterinarians dispensations, then there’s no reason to register them. In this case, the person doing the reporting to Clearinghouse for the relief veterinarian’s dispensations would simply enter that veterinarian’s DEA number of the “prescriber” and the dispenser or “pharmacy” DEA would still be the one used to order controlled substances for the practice.

 No – Prescriber delegates (licensed or unlicensed) can be anyone that the veterinarian authorizes to run patient INSPECT reports on their behalf. If that person happens to be a licensed healthcare provider, they should register under the Prescriber Delegate- Licensed role; if they do not have a license, they should register under the Prescriber Delegate- Unlicensed role. Once they complete the registration, an email is sent to their supervisor asking them to approve or deny this person’s registration.

Each Prescriber registered in AWARxE (regardless of their user role) can have up to 10 delegates.

Each location that dispenses controlled substances must report every 24 hours. Both clinic locations can share one Clearinghouse account and have separate logins if they choose. Each location would log into the Clearinghouse and report dispensations under their own DEA numbers.

No, the primary owner does not need to be there in person each time. If someone other than the primary owner comes to the clinic to pick up a prescription, then that person needs to show ID to pick up. The identification number presented to the dispenser should be collected and reported with the dispensation of that medication. State statute requires, “the recipient’s or a recipient representative’s identification card.”

If the primary owner is picking up and the clinic already has their identification on file, then it is not required to collect it each time they are picking up medication. Regarding pick-up ID, the state statute reads, “A pharmacist, pharmacy technician, or person authorized by a pharmacist to dispense a controlled substance may not dispense a controlled substance to a person who is not personally known to the pharmacist, pharmacy technician, or person authorized by a pharmacist to dispense a controlled substance unless the person taking possession of the controlled substance provides documented proof of the person’s identification to the pharmacist, pharmacy technician, or person authorized by a pharmacist to dispense a controlled substance.”

Send a written request to Laura Turner- Pharmacy Board Director: laturner1@pla.in.gov and to Jody Edens- Assistant Pharmacy Board Director: jedens@pla.in.gov 

Yes. In order for practitioners to receive a complete list of all prescriptions dispensed under their personal DEA, they should log into their PMP AWARxE account and navigate to RxSearch > MyRx > MyRx Request (see image below). The practitioner must enter a start and end date for the dispensations they would like to review, then scroll down to the bottom of the page and press search. This information can be printed by either clicking “download PDF” or “download CVS” on the right hand side of the page or by pressing Ctrl and P on the keyboard at the same time. To view dispensations submitted to Clearinghouse, the practitioner should log into their Clearinghouse account and navigate to File Submissions > File Listings. There, they will see a list of dispensations submitted to Clearinghouse by their clinic. To print this list, they can press Ctrl and the letter P on their keyboard at the same time.

 If a practitioner is dispensing a compound drug that contains a controlled substance or gabapentin, click the Compound checkbox in the Drug Information section of the page, complete the required fields for the first drug ingredient, then click Add New to add additional drug ingredients.