In 2014, the Indiana Medical Licensing Board passed regulations establishing standards and protocols for physicians to follow when prescribing opioids to treat their patients participating in chronic pain management programs. The regulations are intended to curb the potential for opioid abuse in chronic pain management programs and hopefully, provide the intended pain relief while at the same time protecting against addiction and diversion.
Opioids are defined a controlled substance containing opium or one or more of its natural and synthetic derivatives, in chronic pain management programs, as opposed to pain management for those with terminal conditions, patients residing in nursing facilities, hospice programs, and patients in palliative care programs.
The regulations encourage but do not mandate the use of an abuse deterrent formulation of opioid medication, which has an opioid formulation with properties that deter the intentional, non-therapeutic use, even once, to achieve a desirable psychological or physiological effect, in other words to discourage the patient from abusing the opioid to get high.
Chronic pain is pain persisting beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathological process that causes continuous or intermittent pain over months or years. The prescribing and monitoring requirements apply to Indiana physicians when a patient has been prescribed more than 60 opioids pills in a month for more than three consecutive months; when a patient has been prescribed a morphine equivalent dose of more than 15 milligrams per day for more than three consecutive months; when a patient has been prescribed a transdermal opioid patch for more than three consecutive months; when a patient has been prescribed a certain type of tramadol for more than three consecutive months; or when a patient has been prescribed an extended release opioid medication that is not in an abuse deterrent form for which FDA-approved abuse deterrent is available.
In an initial evaluation of a chronic pain patient, the physician must obtain a focused history; conduct a physical examination, and order appropriate tests; obtain and review records from prior health care providers to supplement the physician’s understating of the patient’s chronic pain problem; ask the patient to complete an objective pain assessment tool to better understand the patient’s specific pain concerns; and assess both the patient’s mental health status and substance abuse risk using validated screening tools. Once the initial evaluation is completed, the physician must establish a working diagnosis and tailor a treatment plan to meet meaningful and functional goals. The physician and patient must review the chronic pain management goals periodically.
The regulations require the physician to, where medically appropriate, utilize non-opioid options in addition to or rather than prescribing opioids.
Once the chronic pain treatment program is established, the physician must discuss the plan with the patient, including the potential risks and benefits of opioid treatment for chronic pain. The physician and patient must also discuss (and manage) the patient’s prescriptions requests and proper medication use.
The physician is obligated to explain to the patient alternatives to opioids and describe in plain language the treatment plan’s key elements. The physician must counsel women between 14 and 55 who are capable of child bearing on the risks to a fetus if the mother takes opioids while pregnant. The physician must discuss the risk of dependency and addiction, and safe storage practices. The physician must provide the patient with a written warning disclosing the risks of taking certain extended relief medications if these medications are not in the regulation-mandated abuse deterrent formulation.
Finally, the physician and patient must discuss the risks and benefits of using an abuse deterrent formulation rather than a non-abuse deterrent formulation.
The physician and patient must sign a Treatment Agreement outlining the treatment goals, the patient’s consent to drug monitoring testing, the requirement the patient take the medication as prescribed, and the patient must not share his or her medications with others. Additionally, the patient must promise to tell the physician of any other controlled substances he or she is taking and whether he or she drinks alcohol. The patient must allow the physician to conduct random pill counts. And, the opioid treatment may be changed or stopped at the physician’s discretion.
The patient must visit the physician at least every four months, or more often if needed. During these periodic visits, the physician shall determine if the chronic pain management program is achieving the desired pain relief without the patient abusing the prescribed opioid medication.
Once a year, the physician shall obtain a report of the controlled substances prescribed for the patient so that the physician can be assured he or she knows of the controlled substances the patient may be taking in addition to the treatment program’s prescribed medications.
The physician may require the patient to undergo drug monitoring testing to determine the presence of medications if the physician suspects the patient is not taking the prescribed opioid, diverting the opioid, using illicit street drugs in addition to the prescribed opioid, among other suspicions.
These regulations are intended to address the potential for opioid abuse and misuse in chronic pain management programs, including the patient’s diversion or over-use of opioids; and, they recognize the great potential for opioid abuse in chronic pain management programs. The regulations set specific parameters for opioid use in chronic pain management and monitoring and testing to prevent opioid abuse and diversion. In short, the regulations provide valuable tools to safeguard both the patient and the public from opioid abuse.
Any physician with patients in a chronic pain management program must be familiar with and adhere strictly to these requirements. Failure to do so may result in claims against the physician for improperly prescribing addictive opioids and thus creating a danger to the patient and pubic.