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Opioid Education in Indiana

WHAT YOU NEED TO KNOW

In January of 2018, the IVMA Board of Directors approved assembling the Veterinary Opioid Education Task Force. This task force is charged with assessing the laws that pertain to the legal prescribing and dispensing of opioid drugs by veterinarians in Indiana. The task force has been working to assimilate the best and most accurate information for IVMA members. This work illustrates one more important value of your IVMA membership. (This information is provided to assist you in navigating INSPECT and its reporting requirements. For specific questions, contact INSPECT directly for clarification.)
INSPECT Guidelines for Veterinarians – click here
Indiana Data Submission Dispenser Guide – click here

WHAT YOU NEED TO DO

1. Register for the INSPECT database.  Beginning January 1, 2019, a practitioner who is permitted to distribute, dispense, prescribe, conduct research with respect to, or administer ephedrine, Pseudoephedrine, or a controlled substance in the course of the practitioner’s professional practice or research in the United States must be certified under section 11.1(d)(4) of this chapter to receive information from the INSPECT program. (This applies to Veterinarians who hold an Indiana CSR.) INSPECT (Indiana Scheduled Prescription Electronic Collection and Tracking Program) is Indiana’s own prescription drug monitoring program (PDMP) that serves as a tool to reduce the abuse, acquisition and diversion of prescription drugs in Indiana.

Essentially, INSPECT is an on-line controlled substance database that attempts to:
·         Maintain an available warehouse of patient information for health care professionals
·         Provide an important investigative tool for law enforcement

INSPECT is designed to help identify patients (or in the case of veterinarians, the owners of veterinary patients), who are addicted to opioids and engage in something called “doctor shopping” in which they go from doctor to doctor, or pharmacy to pharmacy to obtain as many prescriptions of opioids as possible.
Veterinarians using this tool can contribute to reducing the impact of the opioid abuse crisis in their communities.

ACTION: Become familiar with, and sign up for, participation in the INSPECT program:  https://www.in.gov/pla/inspect/ This should have been completed by January 1, 2019. Register today if you have not yet done so.  

2. Once registered for INSPECT, REGISTER TO REPORT WHAT YOU DISPENSE FROM YOUR PRACTICE TO THE APPRISS PMP CLEARINGHOUSE. Reporting to the Clearinghouse is required.  Prescription data submissions are now being submitted through the Appriss PMP Clearinghouse. Please use the following link: https://pmpclearinghouse.net.

All controlled substances (72-hour supply or more) dispensed from a pharmacy, physician’s office, clinic or hospital must be reported to INSPECT within 24 hours of the dispensation. This does not include any medication administered directly to a patient within a facility. These prescriptions can be reported to INSPECT through the PMP Clearinghouse. Each facility that dispenses controlled substances can register for a PMP Clearinghouse account using the link listed above.

3. Continuing education on opioid prescribing and potential abuse will be required to renew your Controlled Substances Registration (CSR) by October 15, 2019. According to Indiana law, all practitioners who renew their CSR must complete two (2) hours of continuing education during the previous two years addressing the topic of opioid prescribing and opioid abuse.

Click here to learn more about CE opportunities offered by IVMA.

4. Veterinarians will be required to query the INSPECT database before prescribing controlled substances beginning January 1, 2021.  More information from IVMA will be forthcoming to assist you with how to comply with this new change in Indiana law.

This information is provided to you as a service from the Indiana Veterinary Medical Association.

FREQUENTLY ASKED QUESTIONS…………………

  1. Do I need my own DEA to participate in INSPECT? 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).
  2. Clarify the definition of dispensing and prescribing.
    1. 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.
    2. 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.
  3. Do I report controlled substances that I administer during the course of my daily practice? No, controlled substances that are administered to a patient during the course of surgery or treatment are not reportable to INSPECT.
  4. Do I report to INSPECT if I prescribe a controlled substance prescription? Every veterinarian (and any other dispensing physician) must report to INSPECT if controlled substances (Schedule II-V) 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.
  5. Does a veterinary practice also need its own DEA number or can the practice use the DEA license of the practice owner to purchase drugs and dispense controlled substances during the course of their veterinary practice? 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.
  6. If you have multiple veterinarians practicing under said DEA for the clinic/practice owner, how do those dispensed controlled substances get reported to INSPECT? Is the reporting done under the DEA of the practice and/or practice owner? 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.
  7. Do I actually need an individual DEA if only administering a controlled substance, but never dispensing or prescribing? 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.
  8. What is the law regarding the documentation needed when dispensing a controlled substance to a client or person bringing in the animal for treatment? They must capture the owner’s and/or the person who brought in the animal DOB? How is verification of ID (i.e. driver’s license, etc.) supposed to be captured by the veterinarian when dispensing? 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

  1. If I registered for INSPECT after the January 1, 2019, deadline, do I need to go back and report to the Clearinghouse? The INSPECT team is working with their compliance staff to determine whether or not dispensing physicians (including veterinarians) need to retroactively report all 2019 dispensations to INSPECT.
  2. What sort of information is collected by INSPECT? 
    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, or a controlled substance is dispensed, the dispenser is required to submit the following information to INSPECT within 24 hours of dispensation.
    The patient’s name.
    B. The patient’s identification number. If someone other than patient is picking up medication, the patient representative’s identification number.
    C. The patient’s date of birth.
    D. The national drug code (NDC) number of the controlled substance dispensed.
    E. The date the controlled substance is dispensed.
    F. The quantity of the controlled substance dispensed.
    G. The number of days of supply dispensed.
    H. The dispenser’s United States Drug Enforcement Agency (DEA) registration number.
    I. The prescriber’s United States Drug Enforcement Agency (DEA) registration number.
    J. 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

  1. How often do I have to zero report to INSPECT? 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.
  2. Once I am registered for INSPECT, how do I register to report to the Clearinghouse? 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 are required to collect and report their dispensing information. We do not collect information on gabapentin at this point.

Perform the following steps to create an account:  

  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

  1. Where can I obtain the continuing education needed to renew my Controlled Substances Registration later this fall? Any veterinarian that possesses a Controlled Substances Registration (CSR) must renew the CSR by October 15, 2019. This will occur when you renew your veterinary license. In order to renew the CSR, you must have two hours of continuing education addressing the topic of opioid prescribing and opioid abuse. The IVMA is offering a 2-hour continuing education offering on May 15, 2019. Further, the IVMA is offering two self-study CE options on the IVMA website. Learn more at invma.org

To register for the PDMP and to perform patient look-up requests please use the following link: https://indiana.pmpaware.net/login/

Prescription data submissions now being submitted through the Appriss Clearinghouse. Please use the following link: https://pmpclearinghouse.net

If you had an account on the original Indiana Prescription Monitoring Program system, please check your email for information regarding access to the new website.

If you are unable to locate the email or if you require technical assistance please contact support at 844-446-4767 or submit your request to inspect@pla.in.gov and someone will assist with account updates and password resets within 24 hours.