Executive Summary

On March 10, 2014, the Indiana Board of Pharmacy (“Board”) issued guidance regarding pharmacists’ “corresponding responsibility” in relation to the Medical Licensing Board’s new emergency rule concerning prescribing controlled substances for pain management treatment (“Rule“).1  The Board’s Corresponding Responsibility Guidance (“Guidance“)2 clarifies that the Rule does not place any new requirements on pharmacists to ensure prescriber compliance with the Rule before dispensing. 

Background

The Indiana Medical Licensing Board implemented the Rule, effective December 15, 2013, to establish standards and protocols for physicians in the prescribing of controlled substances for pain management treatment. The Rule applies only if a patient has been prescribed for more than three consecutive months: (1) more than sixty opioid-containing pills a month; or (2) a morphine equivalent dose of more than fifteen milligrams per day. The Rule does not apply to patients who are terminal, residents of a licensed health facility, hospice patients, or patients enrolled in a hospital or hospice inpatient or outpatient palliative care program.

The Rule requires specific prescriptive procedures for physicians, including but not limited to an initial patient assessment, periodic scheduled visits, and a treatment agreement signed by the patient.  The physician is required to annually run a report on the state’s prescription monitoring program, INSPECT, and document in the patient’s chart whether the report is consistent with the physician’s knowledge of the patient’s controlled substance use history. The physician must perform a drug monitoring test annually, and, if the results indicate inconsistent medication use patterns or use of illegal drugs, the physician must review the treatment plan and discuss the revised plan with the patient. The physician is required to discuss with the patient the potential risks and benefits of opioid treatment for chronic pain as well as expectations related to prescription requests and proper medication use.

Pharmacists’ “Corresponding Responsibility”

The Board’s Guidance states that pharmacists do not have any new obligations to ensure that the prescriber is compliant with the Rule before dispensing. There should not be any fear of disciplinary actions from the Board for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice. The Board does not expect pharmacists to practice medicine. 

The Board’s Guidance references the Drug Enforcement Administration’s (“DEA”) Pharmacist Manual, which states that “a pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substances prescription” and that a “pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing prescriber for knowingly and intentionally distributing controlled substances.” 

The Board included a non-exhaustive list of red flags that should alert a pharmacist to critically evaluate whether to dispense the drug such as: (1) prescriptions for combinations of frequently abused controlled substances such as opiates, benzodiazepines, and muscle relaxants; (2) prescriptions written from types of practitioners that normally do not prescribe controlled substances; (3) patients or prescribers from outside of the local geographic region; (4) similar quantities of similar drugs being prescribed by the same practitioner; and (5) patients paying with cash. When a red flag exists, pharmacists should exercise their professional judgment in deciding whether the prescription should be filled. 

Practical Takeaway

The Board has indicated that the Medical Licensing Board’s Rule does not place any requirements on pharmacists to ensure that prescribers are complying with such Rule.  However, to meet expectations of the DEA and the Board, pharmacists should continue to be aware of red flags and exercise sound professional judgment when filling prescriptions.  When red flags are identified, pharmacists should exercise critical thinking skills to determine whether the prescription should be filled.  Pharmacies that do not have policies in place to address this issue may want to consider adopting one.