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Your comments are needed on controlled substance prescribing rules
e-Reports, Sept. 16, 2013
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As reported in the Aug. 5 issue of ISMA Reports, the Medical Licensing Board of Indiana (MLB) is in the process of adopting emergency rules establishing standards and protocols for the long-term prescribing of controlled substances.

During the 2013 session, the Indiana General Assembly mandated the MLB to adopt the rules, which will likely change again, by Oct. 24 and take effect Dec. 15, 2013.

Want to comment?
Here’s how:
  • Attend the next MLB rule hearing on Wednesday, Sept. 25, 2:30 p.m. in room 130 of the Indiana Statehouse.
  • Submit written comments to the MLB at 402 W. Washington Street, Room W072, Indianapolis, IN 46204.
  • Attend the Thursday, Oct. 24, MLB meeting in Indiana Government Center South, 402 W. Washington Street, Indianapolis, Room W064.
  • Attend ISMA Convention September 20-22 to provide input on Resolution 13-17. Register here.

Or, post comments on the Convention online message board.

As currently drafted, the rules create exemptions for patients who are terminally ill, in palliative or hospice care, or who are residents of long-term care facilities.

For patients who do not fall into an exempt category, the rules apply if a patient has been prescribed more than 60 opioid- containing pills per month or a morphine equivalent dose of more than 15 mg per day for more than three consecutive months.

If a patient is not exempted and meets the dosing threshold, the rules specify steps that both the physician and patient must take if a patient is to receive opioids for chronic pain management. The physician must:

  1. Perform a detailed history and physical exam, and obtain appropriate tests.
  2. Document attempts to obtain and review the patient’s medical records.
  3. Ask the patient to complete a pain assessment tool.
  4. Assess the patient’s mental health status and risk for substance abuse with screening tools.
  5. After an evaluation, establish a working diagnosis and tailor a treatment plan to meaningful and functional goals, which must be reviewed with the patient.
  6. Use non-opioid options when appropriate.
  7. Discuss with the patient risks and benefits of opioids, expectations related to prescription requests, proper medication use, alternatives to opioids, the treatment plan, and counsel women between ages 14 and 55 on fetal opioid dependency and neonatal abstinence syndrome risks.
  8. Enter into a treatment agreement with the patient, which must include goals of treatment, consent to drug screens, your prescribing policies including a rule that patients take the medicines as prescribed with a prohibition on sharing meds. Also, the patient is required to inform the doctor about any other controlled substances they are receiving and give permission for pill counts. Further, the physician must provide reasons the opioid therapy may be changed or discontinued and must retain a copy of the treatment agreement in the patient’s chart.
  9. Conduct periodic face-to-face visits with the patient if medications and the treatment plan are still being stabilized.
  10. Evaluate progress and compliance with the treatment plan and set clear expectations related to therapy, counseling, other treatments, etc.
  11. Run mandatory INSPECT reports at the outset of the treatment plan and at least annually thereafter. Document consistency with physician expectations. (The initial report requirement is waived for patients who meet the rule’s dosing thresholds before Dec. 15, 2013, and the annual report requirement may be postponed to Nov. 1, 2014.)
  12. Conduct mandatory urine or saliva drug monitoring tests, including a confirmatory test, at the outset of the treatment plan and at least annually thereafter. If results indicate noncompliance, physicians must review the treatment plan and document any discussions and changes in the chart. (Same postponement being considered as INSPECT; see item 11.)
  13. Conduct a face-to-face review of the treatment plan and evaluation if the dosage exceeds the 50 mg per day morphine equivalent, and consider specialist referral. If after documented reconsideration and treatment continues, develop and document the revised assessment and plan, including increased risk for adverse outcomes, including death.

The draft rule also reminds physicians that their responsibilities concerning delegation, supervision and collaboration with other staff also apply in the context of prescribing of opioids for chronic pain management.

To view the entire rule, go to in.gov.

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