On Sept. 25, the Medical Licensing Board of Indiana (MLB) adopted the final version of the opioid prescribing rule for chronic pain management, which is expected to become effective approximately Nov. 1, 2014. Here are the changes from the prior emergency rule you will need to know.
|New hydrocodone rule takes effect Oct. 6; get the facts
On Oct. 6, hydrocodone-combination products (HCP) become Schedule II controlled substances in accordance with a new Drug Enforcement Administration (DEA) rule. This places HCPs among the many drugs considered to have a high potential for abuse.
A fact sheet from the AMA can help you understand the DEA’s new prescribing rules on HCPs. Find it on the AMA website.
To eliminate the need for a morphine-equivalent conversion for one particular opiate, the final rule automatically applies to any patient who receives a transdermal opioid patch for more than three consecutive months. Due to safety concerns, it also applies to any patient who is prescribed a hydrocodone-only extended release medication that is not in an abuse deterrent form (first pill).
Additionally, at ISMA’s request pursuant to Resolution 14-45, tramadol is not included in the rule unless the patient receives a high dose - more than 60mg of morphine equivalent dose per day - for more than three consecutive months.
Informed consent has been expanded in three ways:
- Discuss with the patient safe storage practices for prescribed opioids.
- Require the patient to disclose if they are drinking alcohol while taking opioids.
- Provide written warning to patients prescribed hydrocodone-only extended release medication that is not in an abuse deterrent form that discloses the risks associated with taking extended release medications.
“The most significant change to the rule is in drug testing,” explained Julie Reed, ISMA legal counsel. “As expected, the pressure of a federal lawsuit was too much, and the requirement to automatically drug test patients initially and annually was softened. Now, the physician is required to perform or order a drug monitoring test, including a confirmatory test any time the physician determines that it is medically necessary. Unlike before, the frequency is not specified.”
To determine medical necessity, physicians must consider 17 specific factors and an 18th catch-all provision. The MLB clarified that a confirmatory test must use a method selective enough to differentiate individual drugs within a drug class. The drug testing provision continues to be postponed to Jan. 1, 2015.
Important information about tramadol
According to the Office of the Indiana Attorney General, tramadol is not included in the state chronic opioid prescribing rule even though the federal government made it a scheduled controlled substance in August.
“Although doctors always have to comply with both state and federal law, this state rule is one of those rare instances where state and federal laws do not mirror each other,” said Reed. “This rule’s definition of controlled substance is the state definition. And, Indiana has not yet scheduled tramadol as a controlled substance.”
However, state scheduling was attempted last year, and a bill is expected to be introduced in the Indiana General Assembly again this year. If it is successful, tramadol will become a controlled substance under state law, and will then fall under the scope of the chronic opioid prescribing rule. The ISMA successfully advocated for increasing the dose thresholds that must be reached before the rule’s requirements apply to tramadol.
Find the 18 factors that dictate drug testing and other resources on the ISMA website or, contact the ISMA with questions at (317) 261-2060 or (800) 257-4762.
|Current emergency rule
Follow current rule until new rule takes effect
The emergency rule applies if a patient has been prescribed for more than three consecutive months:
- >60 opioid-containing pills per month or
- A morphine equivalent dose >15 mg/day
Once those dose and duration thresholds have been reached, the emergency rule states the physician must take extra steps with that chronic patient to:
- Conduct comprehensive initial assessments
- Develop a treatment plan
- Obtain a specific informed consent
- Schedule regular in-person visits
- Run and review INSPECT reports and drug tests, both initially and annually
- Enter into a pain management contract
- Re-evaluate when high doses are reached