CDC’s opioid prescribing guidelines prompt states to adopt quantity limits
Indiana Governor Eric Holcomb recently signed into law Senate Enrolled Act 226 (SEA 226), which places limits on the opioid quantities that may be prescribed by state-licensed practitioners beginning July 1, 2017.
Prescribing caps on opioids have gained increasing popularity following the March 2016 release of the U.S. Centers for Disease Control and Prevention (“CDC”) Guideline for Prescribing Opioids for Chronic Pain (“Guideline”).1 The CDC Guideline found that opioid therapy for nontraumatic, nonsurgical acute pain is rarely needed for more than seven days—a number that states began adopting into law as a maximum permissible prescribing amount for opioid-containing medications.
Initially, state quantity limits were concentrated in the northeastern United States, but the trend has continued in state legislatures across the nation. At the same time that the Indiana General Assembly moved to adopt SEA 226, neighboring states Ohio and Kentucky also adopted similar measures, which direct their respective professional licensing boards to promulgate rules enforcing acute pain prescribing limits that are consistent with the CDC Guideline.2
Indiana’s New Opioid Prescribing Requirements
Beginning July 1, 2017, Indiana prescribers may not issue an opioid prescription in an amount that exceeds a seven-day supply to patients under the age of 18 or to adult patients receiving a prescribed opioid for the first time from that prescriber. Patients may obtain prescriptions subsequent to the initial seven-day prescription; however, a subsequent prescription may only exceed seven days’ worth of opioids if issued to an adult patient for a legitimate medical purpose.
Prescribers are also permitted to exceed the seven-day prescription limit when providing palliative care to a patient or if, in the professional judgment of a prescriber, the patient’s condition requires opioid therapy for a longer period of time. In both circumstances, the prescriber is required to document in the patient’s medical record that: (1) a non-opiate is not appropriate for the patient’s condition; and (2) the patient is receiving palliative care or the prescriber is exercising his or her professional judgment in prescribing beyond the limitation.
Further, prescriptions that are issued in the treatment of cancer or for the purpose of a patient’s medication-assisted addiction therapy are entirely exempt from the law’s quantity limitation. In the coming months, the Indiana Medical Licensing Board will consider whether additional exemptions to SEA 226 are necessary for adoption through the administrative rule-making process.
The new law will also require Indiana’s prescribers and pharmacists to honor any patient requests to prescribe or dispense a lesser amount of an opioid-containing medication. Upon such request from a patient or a patient’s legal representative or guardian, a prescriber may only prescribe a lesser amount than was initially intended and must document in the patient’s medical record both the request and who made the request. Similarly, if a pharmacist receives a request to partially fill an opioid prescription, the pharmacist must document the request and dispense only the lesser amount. For Schedule II controlled substances, dispensers should also ensure compliance with federal partial fill requirements under 21 U.S.C. § 829.
Practical Takeaways
In advance of the July 1 effective date, Indiana prescribers and pharmacists should review SEA 226 to prepare for compliance with the law’s prescription, dispensing and documentation requirements.
Although SEA 226 does not require prescribers to submit queries to INSPECT, Indiana’s controlled substance prescription monitoring program, prior to issuing prescriptions for controlled substances, prescribers should nevertheless ensure they are registered users and maintain adequate access to INSPECT. Because SEA 226 imposes a seven-day quantity limit for initial opioid prescriptions for adult patients, INSPECT can be a vital tool to assist prescribers in identifying whether an adult patient is receiving an opioid prescription for the first time from that prescriber.
If you have any questions or if you would like additional information on this or related topics, please contact:
- Julie Lappas at 317-977-1490 or jlappas@hallrender.com;
- Hannah Brown at 317-977-1451 or hbrown@hallrender.com; or
- Your regular Hall Render attorney.
1Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49. See recommendation #6 at http://dx.doi.org/10.15585/mmwr.rr6501e1.
2 See Ohio State Board of Pharmacy, “FAQ: New Limits on Prescription Opiates for Acute Pain.” See also Kentucky House Bill 333.
