In the continued fight against opioid addiction, Pennsylvania enacted a new law, effective November 27, 2019, that requires prescribers in Pennsylvania to implement additional steps prior to treating a patient’s chronic pain with a controlled substance containing an opioid, including the implementation of an Opioid Treatment Agreement.  The new law can be accessed here: Act 112 of 2019.

In early March, the Pennsylvania Department of Health (DOH) published an Opioid Treatment Agreement Checklist and Frequently Asked Questions, each providing additional clarification on Act 112 and the Opioid Treatment Agreements required thereunder.  At the same time, Temporary Regulations were published in the Pennsylvania Bulletin.

Act 112 mandates that prescribers and patients must review and sign an Opioid Treatment Agreement, if the patient’s existing opioid treatment plan was established on or after November 27, 2019.

The Temporary Regulations specify the numerous items that must be contained in the Opioid Treatment Agreement.  Such items include, but are not limited to, the following:

  • The goals of the treatment;
  • The consent of the patient to a urine test in circumstances where the physician and/or prescriber determines it is medically necessary; and
  • Appropriate disposal methods for opioids that are no longer being used by the patient.

The prescriber must maintain the original signed Opioid Treatment Agreement in the patient’s medical record.

On April 9, 2020, the DOH released further Guidance on Act 112, which summarizes requirements for prescribers, including that they:

  • Establish Opioid Treatment Agreements with patients before issuing the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid.
  • Assess whether the patient has taken or is currently taking a controlled substance prescription drug to treat a substance use disorder.
  • Counsel the patient on treatment goals, expectations, benefits, and risks.
  • Obtain the consent of the patient to a targeted urine test. Note, however, that urine tests are not required for patients experiencing a medical emergency, pain management associated with cancer, or palliative or hospice care.
  • Include the brand name or generic name, quantity and initial dose of the controlled substance containing an opioid being prescribed.
  • Ensure the patient understands the prescriber and the patient treatment responsibilities, and the prescribing policies of the practice.
  • Ensure the patient understands that a controlled substance has potential to be abused, the associated risks of addiction and overdose, increased risk factors of addiction, the dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants, and other information deemed appropriate by the prescriber under 21 C.F.R. 201.57(c)(18).
  • Discuss the efficacy, risks, and benefits of other treatment options, if applicable.

The Guidance also provides important considerations applicable when entering an Opioid Treatment Agreement, including, but not limited to, the following:

  • Ensuring that the patient understands what to do in the event of an overdose (and consideration of a co-prescription of naloxone);
  • Ensuring that the patient understands the dangers and risks of sharing medication, and how to safely store and dispose of medication;
  • Engaging in follow-up discussions with the patient to ensure adherence to the treatment plan; and
  • Actions to take in the event that a patient does not follow the Opioid Treatment Agreement.

If you have any questions regarding implementing Opioid Treatment Agreements in your practice or facility, please do not hesitate to contact us.

Stay tuned to the Health Care Law Matters Blog for more information on Act 112 and the Final Regulations, when issued.