House Bill 243 Strengthen Opioid Misuse Prevention (STOP) Act
This bill was heard on the House floor on April 10, 2017.
Rep. Greg Murphy (R – Pitt) sent forth an amendment to add the definition of a “targeted controlled substance”. The amendment states that a “targeted controlled substance means any substance included in G.S. 90-90(1) or (2) or G.S. 90-91(d). This amendment passed 111-0.
The amendment states that the pain management agreement between the practitioner and the patient include the following:
- Agreement date
- Patient name and practitioner name
- Relevant diagnosis
- Name of targeted drug, dosage amount, frequency of administration
- Refill policy
- Other pain management therapies used
- Required follow-up with prescribing practitioner
- Random drug testing policy
- Use of Controlled Substances Reporting System by prescribing practitioner
- Acknowledgement by patient that targeted drug(s) can’t be prescribed by other practitioners during this agreement
- Policy for agreement termination
This amendment passed 113-0.
Rep. Gale Adcock (D – Wake) sent forth another amendment to remove the requirements for physician assistants and nurse practitioners to consult with their supervising physician when the use of a controlled substance would exceed a period of 30 days. The amendment would also remove the requirement that physician assistants and nurse practitioners consult with their supervising physician at least once every 90 days to verify the prescription remains medically appropriate for the patient.
This amendment failed 39-74.
The bill passed unanimously with a vote of 144-0. The bill will now move to the Senate. You can read the updated version of the bill here.
Overview (as of March 29, 2017). This bill:
- Seeks to strengthen opioid misuse prevention.
- Requires supervising physicians to personally consult with physician assistants and nurse practitioners who prescribe certain schedule II or III controlled substances for long term use.
- Requires electronic prescribing (e-prescribing) of certain schedule II and III substances.
- Establishes maximum limits for initial prescriptions of certain schedule II and III controlled substances.
- Requires hospice and palliative care providers to provide education requiring proper disposal of unused controlled substances.
- Clarifies allowable funds for syringe exchange programs.
- Requires veterinarian participation in the controlled substance reporting system (CSRS).
- Establishes civil penalties for pharmacies that employ dispensers who improperly report information to the CSRS.
- Expands the role of the NC Department of Health and Human Services (DHHS) in using CSRS to detect and prevent fraud and misuse.
- Mandates dispenser registration for access to CSRS.
- Mandates dispenser and practitioner use of the CSRS.
- Requires DHHS to report practitioners who fail to properly use the CSRS.
- Creates a special revenue fund to support the CSRS.
- Requires an annual report from DHHS on the CSRS.
Part II. Extend Standing Orders for Opioid Antagonist to Community Health Groups
This bill states that a practitioner acting in good faith may prescribe an opioid antagonist to any organization for the purposes of distributing the opioid antagonist to a person at risk of an opioid overdose or a person in a position to assist a person at risk of experiencing an opioid related overdose.
Part III. Improve Opioid Prescribing Practices
Sections 4 & 5:
The bill states that if a prescription for a targeted controlled substance will, or is expected to, exceed a period of 30 days, all physician assistants and nurse practitioners must personally consult with the supervising physician prior to prescribing.
This portion of the bill would require practitioners to electronically prescribe all targeted controlled substances.
This section would not apply to the following:
- Practitioners, other than pharmacists, who dispense directly to a user.
- Practitioners who order a controlled substance to be administered in a hospital, nursing home, hospice facility or residential care facility
- A practitioner who experiences a technological failure.
- A practitioner who writes a prescription to be dispensed at a pharmacy on federal property.
Limits on acute pain:
This portion of the bill would limit practitioners to prescribing no more than a 5-day supply of a targeted controlled substance for acute pain. The bill would exclude prescriptions for post-operative acute pain relief for use immediately after a surgical procedure.
Practitioners also would be limited to prescribing no more than a 7-day supply of any targeted controlled substance upon the initial consultation and treatment of acute pain. Upon another consultation of acute pain, the practitioner may issue a renewal, refill or new prescription.
This part of the bill would make dispensers immune from any civil liability, criminal liability or disciplinary action from the Board of Pharmacy for dispensing a prescription written by a prescriber in violation of the prescribing standards in this bill.
Disposal of Opioids:
This portion of the bill would require prescribers of in-home hospice or palliative care, to provide oral and written information to the patient and the patient’s family regarding the proper disposal of controlled substances.
Part V. Strengthen Controlled Substances Reporting System (CSRS)
This portion of the bill clarifies that all dispensers must report information by the close of the next business day after the prescription is delivered. However, dispensers are encouraged to report the information no later than 24 hours after the prescription is delivered.
All dispensers would be required to report the name of the individual’s supervising physician if the prescriber is a physician assistant or a nurse practitioner.
This portion of the bill also assigns financial penalties for any pharmacy that employs dispensers who have failed to report information after being informed by DHHS that the required information is incomplete.
DHHS is allowed to review prescription information in the CSRS, and may notify practitioners and licensing board of prescribing behavior that:
- Increases risk of diversion of controlled substances;
- Increases risk of harm to the patient;
- Is an outlier among other practitioner behavior.
Practitioner Use of CSRS
Before initially prescribing a targeted controlled substance, a practitioner would be required to review the information in the CSRS pertaining to the patient for the previous year.
For every 3 months that the targeted controlled substance is a part of the patient’s care, the practitioner would be required to review the CSRS. Each review would be documented in the patient’s medical record. Any technological failure hindering access to the CSRS would be documented as well.
The bill states that practitioners are not required to review the CSRS in the following circumstances:
- The controlled substance is administered to a patient in a health care setting, hospital, nursing home or residential care facility;
- It is administered for cancer treatment or another condition associated with cancer;
- The patient is in hospice care or palliative care.
This bill also allows DHHS to conduct periodic audits and report prescribers who are in violation of this section of the bill to the appropriate licensing board.
The CSRS Fund would be created within DHHS as a special revenue fund. The Fund could only be used to operate the CSRS.
General Assembly Report
The Department would be required to report the following information about targeted controlled substances during the preceding calendar year:
- Total number of prescriptions dispensed, broken down by Schedule;
- Demographics of ultimate users to whom prescriptions were dispensed;
- Statistics on the number of pills per prescription;
- Number of ultimate users who were prescribed a controlled substance by two or more practitioners;
- Number of ultimate users with a prescription dispensed in more than one county;
- Number of prescriptions by categories of practitioners.
The bill states that DHHS would continue to work toward establishing interstate connectivity to the CSRS. The bill states that the Department would request $40,035 to establish interstate connectivity for the CSRS and $30,000 for 2 years of ongoing interstate connectivity, service, maintenance and support.
Part VI. Effective Date
Sections 1, 3, 4, 5, 7, 8, 11 and 13 would become effective on July 1, 2017.
The electronic prescribing requirements in this bill would become effective on Jan. 1, 2020.
The day limitations on prescribing would become effective on Jan. 1, 2018.
The creation of the CSRS Fund and the reporting requirements to the General Assembly would become effective on Sept. 1, 2017.
The remainder of this bill would become effective 30 days after the State Chief Information Officer notifies that the CSRS upgrades in the bill have been completed and that the CSRS is fully operational within the Department of Information Technology and connected to the statewide Health Information Exchange.