Signed into law by Gov. Tom Wolf Nov. 27,1 Act 2019-112 (the Act) mandates the common practice among pain specialists of written agreements in connection with the treatment of chronic pain with opioids. Furthermore, the Act for the first time explicitly requires that treatment of chronic pain be “consistent with the Pennsylvania Opioid Prescribing Guidelines” (the Prescribing Guidelines). Notable exceptions include prescriptions for medical emergencies and for cancer, palliative care and hospice patients. Failure to abide by the Act, and its pending regulations, subjects prescribers to sanctions under their professional practice act by their licensing boards. The Act was effective immediately and emergency regulations are due to be promulgated by the Pennsylvania Department of Health by the end of February 2020. Compliance with the Act is required even in the absence of regulations.
The Act mandates not only the existence of the treatment agreement and its contents, but also the steps that must be taken prior to prescribing opioids for chronic pain. Earlier legislation, Act 191 of 2014, required prescribers to query the Prescription Drug Monitoring Database each time an opioid is prescribed to a patient. Now, in addition, the prescriber must determine whether the individual has taken or is taking a prescription drug (e.g., suboxone) for treatment of a substance use disorder (SUD) and, further, personally discuss a range of issues with the patient that basically constitutes the informed consent of the patient: risks of addiction (especially if the patient has an SUD), interactions with alcohol and other central nervous system (CNS) depressants, important information from the drug’s labelling, and nonopioid treatment options available, if applicable, that are consistent with the Prescribing Guidelines. In addition, a baseline urine drug screening must be performed, with quantitative follow-up tests for positive results, before an opioid prescription for chronic pain is issued.
With respect to the treatment agreement, it must include:
- Consent to drug testing when the prescriber deems it necessary
- Policies that the patient must take the medication as prescribed and not share it with others
- Requirement that the patient advise the prescriber of all controlled substances they take
- Describe any reason why opioid therapy may be changed or discontinued by the prescriber
- Written consent to the opioid prescription itself
- The brand or generic name, quantity and initial dose of the opioid being prescribed
- A statement that the medication has been identified by the DEA of having a potential for abuse
- A statement certifying that the prescriber has had the “informed consent” discussion described above
- The signature of the patient, which may be electronic.
- The treatment agreement must be kept in the patient’s medical record.
While the issuance of guidelines by federal and state authorities has already caused some access issues for patients in acute or chronic need of pain relief, it is important to remember that the Act only applies to the treatment of “chronic pain”2 patients with opioids. It does not apply to patients with documented medical emergencies/acute pain, cancer, palliative care and hospice patients or to treatment with other non-opioid controlled substances. The Act is a dense 3.5 pages. It is worthwhile to read through the definitions and determine whether it applies to your practice. If it does, work with a qualified healthcare attorney to create compliant procedures and treatment agreements.
DISCLAIMER: This article is for informational purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.
1. The Act was signed after the publication of my article “Opioid prescription guidelines: Are they mandatory?” in the November 2019 Bulletin.
2. “Chronic pain” is defined as: “Pain that persists or progresses over a period of time that may be related to another medical condition and is resistant to medical treatment. The term does not include acute pain.” Acute pain can become “chronic pain” over a number of visits. Accordingly, prescribers must be diligent in reviewing prior history of the patient’s pain every time it is being treated.