Consumer FAQsPharmacist FAQs

The Strengthen Opioid Misuse Prevention ("STOP") Act of 2017

FRIDAY, JUNE 30, 2023

SL 2023-65 ENACTS SEVERAL PROVISIONS THAT AFFECT PHARMACY PRACTICE.  On June 29, 2023, the Governor signed into law SL 2023-65, which impacts pharmacy practice in several respects:

  • The law extends State Health Director Betsey Tilson’s authority to issue standing orders on COVID vaccination and treatment through December 31, 2024.  This aligns Dr. Tilson’s authority with the PREP Act declaration extension.  More information about the PREP Act extension is found at the April 14, 2023 website item below and here.
  • The law adds gabapentin to the list of substances whose dispensing must be reported by pharmacists to the North Carolina Controlled Substances Reporting System.  The law exempts reporting of gabapentin that is “a component of a compounded prescription that is dispensed in dosages of 100 milligrams or less.”  This new reporting requirement becomes effective on March 1, 2024. As pharmacists know, the NC CSRS is administered by the Drug Control Unit at the Department of Health and Human Services.  In the coming months, the Drug Control Unit will issue communications concerning implementation of the gabapentin reporting requirements.  Board staff will work closely with Drug Control Unit staff to facilitate those communications.
  • The law adds “controlled substances included in G.S. 90-93(a)(1)a” to the STOP Act’s list of substances that must be prescribed electronically (unless an exception applies).  G.S. 90-93(a)(1)a defines as a Schedule V controlled substance “any compound, mixture or preparation containing an of the following limited quantities of narcotic drugs  or salts thereof, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture or preparation valuable medicinal qualities other than those possessed by the narcotic alone . . . Not more than 200 milligrams of codeine or any of its salts per 100 milliliters or per 100 grams.”  This includes promethazine with codeine Schedule V products.  This new electronic prescribing requirement “does not apply to any product that is sold at retail without a prescription” as allowed by North Carolina law.   The electronic prescribing requirement becomes effective on January 1, 2024. The Board’s STOP Act guidance document has been updated to reflect this change and may be found here.


 

WEDNESDAY, JANUARY 3, 2018

NORTH CAROLINA DIVISION OF MEDICAL ASSISTANCE STATEMENT ON DISPENSING OPIOIDS TO MEDICAID BENEFICIARIES WHEN THE PRESCRIBER HAS NOT OBTAINED A REQUIRED PRIOR AUTHORIZATION.  Due to decades of increased prescribing of opioids, North Carolina is experiencing an opioid epidemic. NC Medicaid worked closely with prescribing physicians and pharmacists to develop the best approach to reduce the oversupply of prescription opioids available for diversion and misuse, promote safe opioid prescribing for patients, and encourage alternative pain management, while minimizing administrative requirements as much as possible. Modifying clinical coverage criteria to promote safe opioid prescribing was identified as an essential and significant step to realize the vision of the North Carolina Opioid Action Plan to reduce opioid deaths by 20 percent by 2021.

On Aug. 27, 2017, NC Medicaid began requiring prior approval (PA) for opioid prescribed analgesic doses that exceed 120 mg of morphine equivalents per day; are greater than a 14-day supply of any opioid; or are non-preferred opioid products on the NC Medicaid Preferred Drug List (PDL). Effective Jan. 2, 2018, the clinical coverage criteria for opioid analgesics was updated to comply with the quantity limits mandated by the Strengthen Opioid Misuse Prevention (STOP) Act, S.L. 2017-74. Prior approval is now required for short-acting opioids for greater than a five-day supply for acute pain and seven-day supply for post-operative acute pain. Prior approval is also required for long-acting opioids for greater than a seven-day supply. Beneficiaries with diagnosis of pain secondary to cancer will continue to be exempt from prior approval requirements.

Soon after implementation of these changes, NC Medicaid began receiving reports from pharmacists that some prescribers were prescribing a 30-day supply of an opioid, but refusing to request prior authorization (PA). This situation has resulted in Medicaid beneficiaries asking the pharmacist to partial fill the opioid prescription with concurrent allowed day supplies or asking to pay cash for the quantity exceeding the quantity paid for by Medicaid.

NC Medicaid is aware that pharmacists may provide a partial fill of a Schedule II controlled substance prescription when the prescription is written and filled in compliance with federal and state law and the partial fill is requested by the patient or the prescriber. However, the intent of our clinical coverage criteria changes were to encourage prescribers to evaluate the medical necessity of an opioid to treat a patient’s chronic pain not related to cancer or end of life care and, when appropriate, request PA for those patients.

NC Medicaid has no authority to prohibit beneficiaries from paying cash for any of their medications and the intent of our clinical coverage criteria changes were not intended to require Medicaid beneficiaries to pay out of pocket for opioids determined to be medically necessary and appropriate to treat their chronic pain. Understanding the intent of our changes to opioid clinical coverage criteria, NC Medicaid encourages pharmacists to use their professional judgement when a Medicaid beneficiary requests to pay cash for their prescribed opioids. Prescribers and pharmacists are also reminded that the Controlled Substance Reporting System (CSRS) collects data on all cash transactions for controlled substances, and this data can be reported to the medical and pharmacy boards for their review and investigation of any suspected inappropriate prescribing or dispensing of controlled substances.

NC Medicaid also encourages pharmacists to contact prescribers who refuse to request PA for an opioid prescription that exceeds criteria to determine the medical necessity for the prescribed opioid and remind the prescriber of the PA requirement. While a pharmacist should not consider failure to follow NC Medicaid PA protocols, by itself, suspicious or inappropriate prescribing, the NC Medical Board continues to encourage pharmacists to report any prescriber they reasonably believe is engaged in suspicious or inappropriate prescribing of any medication.

NC Medicaid appreciates the partnership of all medical and pharmacy providers to combat the opioid crisis in North Carolina and to keep our fellow North Carolinians safe. We realize the impact of these changes to all providers and beneficiaries, but equally realize that these changes were necessary to address this crisis and to promote appropriate opioid prescribing.

Pharmacists with questions about North Carolina Medicaid’s prior authorization program should contact John Stancil at NC DMA:  (919) 855-4305; john.stancil@dhhs.nc.gov.

 


 

TUESDAY, SEPTEMBER 26, 2017

Pharmacists Should Act **NOW** To Register for Access to the North Carolina Controlled Substance Reporting System

The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act.

Among other things, the STOP Act requires all pharmacists to register for access to the North Carolina Controlled Substance Reporting System (“CSRS”), with a narrow exemption.

As a condition of renewing a pharmacist license for 2018, a pharmacist must attest either: (a) he/she has registered, or applied, for CSRS access; or (b) he/she is not employed in a pharmacy practice setting where Schedule II, III, or IV controlled substances are dispensed from a North Carolina-based facility or to North Carolina patients.

Any pharmacist who does not already have a CSRS access registration should immediately apply for one. Pharmacists can access a simple, on-line application here: https://www.ncdhhs.gov/divisions/mhddsas/ncdcu/csrs#csrs4

Note: Pharmacists should register for a “master” account (not a “delegate” account); The STOP Act requires an individual registration – your pharmacy’s registration for purposes of uploading data to CSRS is not sufficient.

 


 

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