Indiana laws/regulations do not refer to collaborative pharmacy practice.

• The statutory definition of the practice of pharmacy references “medication therapy management” (MTM), although Indiana’s definition for MTM does not seem to match up with collaborative pharmacy practice. IND. CODE § 25-26-13-2 (West 2024) (“practice of pharmacy”; “medication therapy management”).

• Another Indiana law provides that a pharmacist has the power to “perform . . . drug regimen review.” IND. CODE § 25-26-13-31(a)(2) (West 2024). Again, the term “drug regimen review” does not seem to match up with collaborative pharmacy practice. IND. CODE § 25-26-13-2 (West 2024 (“drug regimen review”).

• Nevertheless, a separate chapter of Indiana law provides that pharmacists can adjust a patient’s “drug regimen,” under a “protocol.” IND. CODE §§ 25-26-16-1 to 25-26-16-12 (West 2024).

Therefore, Indiana’s term for a CPA is a “protocol” that adjusts a patient’s drug regimen

Short Answer: No, based on the information described below.

• The definition of the “practice of pharmacy” in Indiana does not expressly include prescribing drugs or medications. IND. CODE ANN. § 25-26-13-2 (West 2024).

• Although not contained within the definition of the practice of pharmacy, a pharmacist can prescribe certain specified FDA-approved “devices or supplies.” IND. CODE ANN. § 25-26-13-31(a)(5) (West 2024). This prescribing authorization does not include buprenorphine.

• Also, while a pharmacy is part of the definition of “practitioner,” pharmacists are not one of the types of practitioners eligible for the state’s “practitioner” controlled substance registration that allows the prescribing of controlled substances. IND. CODE ANN. § 35-48-1-24 (West 2024). (Practitioner Controlled Substances Registration Application and Instructions, IND. PROF. LICENSING AUTH. (last accessed Aug., 22, 2024),

• A pharmacy is eligible for a “non-practitioner”controlled substance registration.)

• The above points are consistent with DEA information that registered pharmacists in Indiana cannot obtain the DEA’s mid-level practitioner registration to prescribe controlled substances. (Mid-level Practitioners Authorization by State, DRUG ENFORCEMENT ADMIN. 1 (Nov. 7, 2024))

Short Answer: No, based on the information described below.

• Indiana law provides that pharmacists can “adjust” a patient’s “drug regimen,” under a “protocol.” IND. CODE ANN. §§ 25-26-16-1 to 25-26-16-12 (West 2024).

• There are several ways a pharmacist may adjust a drug regimen including: (1) changing the duration of treatment for a current drug therapy; (2) adjusting the strength, dosage form, route of administration, or strength of a drug; (3) adding a drug; or (4) “issu[ing] a new prescription” for one of the above purposes. IND. CODE ANN. § 25-26-16-2 (West 2024).

• Moreover, “a pharmacist may adjust the drug therapy regimen of the patient or group of patients under the authorization of the physician, including issuing new prescriptions in writing, by electronic transmission, or by other means allowed by law.” IND. CODE ANN. § 25-26-16- 3.5(b)(2) (West 2024).This suggests that, at least in theory, an Indiana pharmacist can prescribe buprenorphine under a drug regimen protocol.

• However, Indiana law governing these protocols does not account for the fact that an Indiana pharmacist cannot obtain a federal DEA mid-level practitioner registration, which precludes the pharmacist from prescribing buprenorphine regardless of what of what the agreement or protocol provides.

• In summary, Indiana law does not expressly prohibit a pharmacist from prescribing buprenorphine under a protocol to adjust a patient’s drug regimen. However, as a practical matter, there is no way to do it because an Indiana pharmacist cannot obtain the state/DEA controlled substance registrations necessary.

Short Answer: Unclear. Based on the information described below Indiana laws and regulations do not clearly answer this question.

• The definition of the “practice of pharmacy” in Indiana law includes “the . . . administering . . . of drugs and devices . . . whether dispensed under a practitioner’s prescription or drug order or sold or given directly to the ultimate consumer.” IND. CODE ANN. § 25-26-13-2 (West 2024) (“practice of pharmacy”). This provision does not limit the drugs for which a pharmacist can administer and therefore could mean that a pharmacist can administer buprenorphine generally.

• However, while there are Indiana laws and regulations expressly covering the administration of immunizations, including training necessary to do it, there are no provisions expressly addressing administration of any other kinds of drugs, including controlled substances.

•  If the general “administering . . . drugs and devices” phrase in the practice of pharmacy definition acts as a broad authorization to administer all drugs and medications, it is unclear why there would be specific more limited provisions in law or regulation. Accordingly, a pharmacist’s ability to administer drugs and medications in Indiana may be limited and not cover buprenorphine.

Short Answer: Unclear. As described in the information below, Indiana laws and regulations do not clearly answer this question.

• Indiana law provides that pharmacists can “adjust” a patient’s “drug regimen,” under a “protocol.” IND. CODE ANN. §§ 25-26-16-1 to 25-26-16-12 (West 2024).

• There are several ways a pharmacist may adjust a drug regimen including: (1) changing the duration of treatment for a current drug therapy; (2) adjusting the strength, dosage form, route of administration, or strength of a drug; or (3) adding a drug; and (4) “issu[ing] a new prescription” for one of the above purposes. IND. CODE ANN. § 25-26-16- 2 (West 2024). This provision may mean that a pharmacist can administer buprenorphine under a protocol. If not, Indiana laws and regulations governing drug regimen protocols do not directly address administering drugs or medications.

• In summary, although Indiana pharmacy law does not expressly prohibit a pharmacist from administering buprenorphine under a protocol it also does not clearly authorize it, and a pharmacist’s general authority to administer buprenorphine outside of a protocol is also unclear.

Short Answer: No, based on the information described below.

• The definition of the “practice of pharmacy” in Indiana law does not expressly include ordering lab tests or evaluating the results. IND. CODE ANN. § 25-26-13-2 (West 2024).

• In addition, ordering lab tests and/or evaluating the results is not in the statutory list of “powers and duties of pharmacists.” IND. CODE ANN. § 25-26-13-31 (West 2024).

Short Answer: No, based on the information described below.

• Indiana law provides that pharmacists can “adjust” a patient’s “drug regimen,” under a “protocol.” IND. CODE ANN. §§ 25-26-16-1 to 25-26-16-12 (West 2024).

• Indiana law identifies six ways in which a pharmacist adjusts a drug regimen. IND. CODE ANN. § 25-26-16-2 (West 2024). None of the six ways reference ordering laboratory tests or evaluating the results.

• Moreover, given the response to question (3A) above, an Indiana pharmacist does not have the authority to order tests or evaluate results as a matter of general practice.

Short Answer: Yes, based on the information described below.

• Indiana’s general telehealth/telemedicine practice law expressly identifies a pharmacist as one of the “practitioners” who can provide “health care services” via telehealth. IND. CODE ANN. § 25-1-9.5-3.5(a)(13) (West 2024).

• “Health care services” include the following concerning a patient to the extent it is part of the practitioner’s underlying scope of practice: (1) assessment; (2) diagnosis; (3) evaluation; (4) consultation; (5) treatment; and (6) monitoring. IND. CODE ANN. § 25-1-9.5-2.5(a)(1) (West 2024).

Short Answer: It depends.

Commercial insurance may cover a limited set of pharmacist services - coverage will vary based on each insurance plan’s policies.

References: 

• Jonathan Hughes, State of the Union: A Review of State-based Laws and Regulations Supporting Pharmacist Payment for Clinical Services, Clinical Pharmacy Forum (July 26, 2024) at https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.2008.

• Pharmacist Authority to Initiate PrEP & PEP and Participate in Collaborative Practice Agreements, Nat’l Alliance of State & Territorial AIDS Directors (Aug. 10, 2023) at https://nastad.org/sites/default/files/2023-08/PDF-Pharmacist-Authority-Initiate-PrEP-PEP.pdf

Short Answer: It depends.

The following pharmacist services are covered under Indiana Medicaid:

• Services and prescriptions provided under IND. CODE ANN. § 25-26-25 (hormonal contraceptives) to an eligible Medicaid recipient. IND. CODE ANN. § 12-15-1.3-6.5 (West 2024).

• Tobacco dependence counseling services. 405 IND. ADMIN. CODE 5-37-3(c)(6) (2024).

• Diabetes self-management training services. (Indiana Health Coverage Programs: Diabetes Self-Management Training Services, Library Ref. No. PROMOD00023, INDIANA 2 (Aug. 8, 2022), https://www.in.gov/medicaid/providers/files/modules/diabetes-selfmanagement-training-services.pdf.
  
  

References: 

• Jonathan Hughes, State of the Union: A Review of State-based Laws and Regulations Supporting Pharmacist Payment for Clinical Services, Clinical Pharmacy Forum (July 26, 2024) at https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.2008.

• Pharmacist Authority to Initiate PrEP & PEP and Participate in Collaborative Practice Agreements, Nat’l Alliance of State & Territorial AIDS Directors (Aug. 10, 2023) at https://nastad.org/sites/default/files/2023-08/PDF-Pharmacist-Authority-Initiate-PrEP-PEP.pdf

Beyond the topics covered above (and excluding methadone) are there any other laws/ regulations governing the way MOUD is provided to patients that currently apply to pharmacists? Such topics might include training/educational requirements for the practitioners providing buprenorphine, information that must be shared to patients, dosage limits, counseling requirements, etc

• Answer: No

Are there any such laws/regulations that currently apply to non-pharmacists?

Indiana law directs the state division of mental health and addiction to “develop a treatment protocol containing best practice guidelines for the treatment of opiate dependent patients” by “an office based opioid treatment provider.” IND. CODE ANN. § 12-23-20-1 (West 2024). The statute expressly includes, among other things, the following requirements for that protocol:

• Regular/random drug testing for certain substances;

• Review of/changes to treatment plan for certain positive drug tests; and

• Clinical standards for medication taper, relapse, and overdose prevention.

In addition, for “office based opioid treatment,” there is a law providing the duties of a supervising physician and prescriber and requirements for the treatment plan, including contents of health care agreements, informed consent, and toxicology screening. IND. CODE ANN. § 12-23-20-2 (West 2024).

A law enacted in 2017 and amended in 2022 provides for a “physician medication assisted treatment training reimbursement program.” IND. CODE ANN. § 12-23-21-1 to 12-23-21-4 (West 2024).