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SB 226 - Prescribing and Dispensing of Opioids

The full bill and more information can be found here.

Summary:

Limits the amount of an opioid prescription a prescriber may issue for: (1) an adult who is being prescribed an opioid for the first time; and (2) a child; unless the prescription is for the treatment of specified conditions or circumstances.  Requires documentation in the use of certain exemptions.  Requires a prescriber to issue a prescription for an opioid in a lesser amount if requested by specified individuals and to document the request.  Requires a pharmacist, upon the request of a specified individual, to partially fill the opioid prescription in compliance with federal law.  Requires the pharmacist to document that the opioid prescription was partially filled.  Requires the medical licensing board, in consultation with specified persons, to adopt emergency rules and conditions that will be exempt from the prescription limitations.

Relevance for Pharmacists:

Pharmacists can now partially fill opioid prescriptions when requested by the patient or guardian.  The remaining quantity no longer needs to be filled within 72 hours (a switch from a stricter state law to newer federal law within the Comprehensive Addiction and Recovery Act (CARA)). This bill also limits the day supply of opioid medications to 7 days for patients that have not been previously prescribed opioids by the prescriber and for patients under the age of 18 (exceptions exist such as when treating cancer or substance abuse).  A subsection of this bill allows for a prescriber's professional judgment to trump these restrictions on a case-by-case basis; however, in those cases, prescribers must now document in the patient's medical record that their professional judgment deems a longer day supply necessary.

Exemptions From the 7 Day Limit Rule:
1. If in the physician’s professional judgment, a patient requires more than the seven day supply of opioids. This exception could apply to pain management or any other situation.
2. If a practitioner is treating a patient for cancer.
3. If a practitioner is providing medication assisted treatment for a substance abuse disorder.
4. If a practitioner is providing palliative care. 

Q: Does the pharmacist have to document the exceptions on the prescription?

A: The prescriber must document in the patient’s medical record if they prescribe an opioid under an exemption.  The bill does not address whether the actual prescription requires documentation regarding exemption. 

IC-1-9.7-2
(c) If a prescriber: 
(1) determines that a drug other than an opioid is not appropriate; and 
(2) uses an exemption specified in subsection (b)(1)(B) or 
(b)(2) and issues a prescription for a patient that exceeds the limitations set forth in subsection
(a) the prescriber shall document in the patient's medical record the indication that a drug other than an opiate was not appropriate and that the patient is receiving palliative care or that the prescriber is using the prescriber's professional judgment for the exemption.

Q: If a patient were to fill a partial quantity on one of these prescriptions, would the rest of the prescription be null and void, or would the rest of the quantity be available for the patient to fill? Also, would the partial remaining have a timeframe in which it needs to be completed?

A: The remainder of the prescription may be filled if it is within 30 days of the date of issue of the prescription. For example, if a patient receives a prescription for 30 tablets of an opioid on August 8, 2017 and requests a partial fill of 15 tablets on August 8, 2017, the remaining 15 tablets may be filled up until September 6, 2017 (30 days after the date of issue). However, if the patient brings in that same prescription on September 9, 2017 and requests a partial of 15 tablets, the remaining 15 tablets are automatically null and void.

21 USC 829
(2) Remaining portions

In general
Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II
may be filled; and shall be filled not later than 30 days after the date on which the prescription is written.

Statement from the IN Board of Pharmacy on June 29th, 2017: "Effective July 1, 2017 pursuant to Senate Enrolled Act 226, new laws concerning the prescribing and dispensing of opioids will go into effect.  Please be advised, these changes affect any practitioner who maintains an Indiana controlled substance registration and a federal Drug Enforcement Administration registration as well as any pharmacy or pharmacist dispensing opioid prescriptions. The Indiana Medical Board is currently reviewing the statute should additional considerations for the prescribing of opioids be necessary.
Effective Date: July 1st, 2017

 

Update on Indiana Medical Board Review:

The IN Board of Pharmacy is working with the IN Medical Board and pharmacists to develop bill rules and guidelines regarding various decision areas under this bill.  An initial Medical Board meeting was held in mid July.  The IMB, led by Darren Covington, plans to meet again in August 2017 to discuss bill implementation rules.  Indiana pharmacists find this bill to be vague, and are encouraging the Indiana Board of Pharmacy to: 1) outline the corresponding liability 2) describe the required communication between prescriber and pharmacist, and 3) identify how this will be audited and inspected by Pharmacy Benefit Managers and the Board of Pharmacy.

IPA Position on How Indiana Pharmacists Can Fight the Opioid Crisis (August 24th, 2017):

Pharmacists as a Primary Resource: Pharmacists are medication experts who are adequately trained to counsel patients about their medications, which creates an opportunity for them to take a primary role in reducing opioid misuse.  Pharmacists have this unique opportunity to directly educate the community and patients on the risks associated with taking opioids and how to prevent opioid-related deaths with naloxone.  Not only can pharmacists directly counsel patients when dispensing opioid prescriptions, but they can also lead and/or participate in substance abuse and prevention programs.

Drug Take-Back Program: Although patients pick up their opioid prescriptions from the pharmacy, they are not able to return leftover medication.  This is not only inconvenient, but it may lead to overuse, misuse, or diversion.  If possible, pharmacies should attempt to create a drug take-back program so patients have a known, accepted place where they may return extra opioids without question.  Until then, pharmacists should consistently direct patients to local prescription drug drop boxes for safe disposal of medications.

Monitoring: Pharmacists should be maintaining, and consistently using, their prescription drug monitoring programs and addressing opioid prescribing when appropriate.  Pharmacists should work closely with prescribers to ensure adequate and effective treatment with opioids.