General Assembly of 2015/16 Passes Package of Bills Addressing Opioid Epidemic

Education

The General Assembly passed SB 1368, now Act 126 of 2016, which requires all health care licensing boards to develop curriculum related to safe prescriptive practices of controlled substances. The curriculum must include current, age-appropriate information on pain management, alternatives to opioid pain medications, instructions on safe prescribing methods, identification of patients at risk for addiction, and training on managing substance use disorders when treating patients with chronic conditions. Schools will have the option of mandating students complete the course as condition for graduation. Act 126 requires licensing boards to develop the curriculum by August 2017.

Patient Non-opioid Directive Form

Act 126 of 2016 also requires the Secretary of Health to develop and publish a uniform voluntary non-opioid directive that patients may use to deny his or her health care provider from supplying, prescribing or otherwise administering a controlled substance containing an opioid. The Department of Health must post the directive on its website for download. 

Patients will have the right to file a voluntary non-opioid directive form with a provider, and must sign and date the form in front of the provider or his/her designee. The provider must sign the form in the patient’s presence and return a copy of the signed form to the patient. Patients unable to execute the form may designate a guardian or health care proxy to file the form. Patients may revoke the directive form for any reason either verbally or in writing. Providers may also override a previously filed voluntary non-opioid directive form based on documented medical judgment and record this decision in the patient’s chart. 

If a provider assesses a patient’s personal and family history and determines he or she is at risk for a substance use disorder, the provider should query the Prescription Drug Monitoring Program (PDMP) database, sign the directive and note the query and signed form in the patient’s record. 

In cases where patients have signed voluntary non-opioid directive forms, practitioners and their employees acting in good faith will not be subject to criminal or civil liability. Nor will they be considered to have engaged in unprofessional conduct, for failing to offer, prescribe or administer a controlled substance containing an opioid. However, a licensing board may limit or suspend the license, or assess fines, should the provider recklessly or negligently fail to comply with a patient’s form. 

Continuing Education

The General Assembly passed SB 1202, legislation that requires the following of health care providers:
Applicants for an initial license must obtain at least two hours of education in pain management or identification of addiction, and at least two hours of education in the practice of prescribing or dispensing opioids. They may complete this requirement as part of their professional degree educational program or from a continuing education (CE) program taken within 12 months of obtaining an initial license or certificate. 
Dispenses and prescribes applying to renew their licenses or certificates must complete at least two hours of CE in pain management, identification of addition or the practice of prescribing or dispensing of opioids as a portion of the total CE required for biennial renewal. 

Licensing boards are tasked with working with the Department of State to approve courses for pain management, identification of addiction, and the practices of prescribing and dispensing of opioids.
Governor Wolf signed SB 1202, now Act 124, into law on November 2. The law became effective on January 1. PDA will continue to apprise you of developments as the licensing boards begin the process of approving curricula and CE courses.

Prescription Drug Monitoring Program

The legislature used SB 1202 of 2016 to amend the Achieving Better Care by Monitoring All Prescription Drug Program Act to change the way in which dispensers and prescribers query the Prescription Drug Monitoring Program (PDMP) database. 

A dispenser must now query the PDMP system before dispensing an opioid drug product or a benzodiazepine prescribed to a patient if any of the following apply:
The patient is a new patient of the dispenser.
The patient pays cash when they have insurance.
The patient requests a refill early.
The patient is getting opioid drug products or benzodiazepines from more than one prescriber.

The original law required prescribers to query the PDMP system for each patient the first time the patient is prescribes a controlled substance by the prescriber, for purposes of establishing a baseline and thorough medical record. The law also now requires prescribers to query the system if they believe, or have reason to believe using sound clinical judgment, that a patient may be abusing or diverting drugs OR each time a patient is prescribed an opioid drug product or benzodiazepine. This means that prescribers have a choice to either query the system each time they prescribe to a patient OR to query the system if they have reason to believe a patient is abusing or diverting drugs. 

Prescribing Drugs

 In SB 1367, now Act 126 of 2016, prescribers must comply with the following procedure before issuing to a minor the first prescription in a single course of treatment for a controlled substance containing an opioid (regardless of whether the dosage is modified during that course of treatment):
Assess whether the minor has taken or is currently taking prescription drugs for treatment of a substance use disorder.
Discuss with the minor and the minor’s parent, guardian or authorized adult all of the following:
1. The risks of addiction and overdose associated with the controlled substance.
2. The increases risk of addiction to controlled substances for individuals suffering from mental or substance use disorders.
3. The dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants. 
Obtain written consent for the prescription from the minor’s parent, guardian or authorized adult. The prescriber should obtain the consent using forms created by the Bureau of Professional and Occupational Affairs and made available to all prescribers. The form most contain all of the following:
1. The brand name or generic name and quantity of the controlled substance containing an opioid being prescribed and the amount of the initial dose.
2. A statement indicating that a controlled substance is a drug or other substance that the U.S. Drug Enforcement Agency has identified as having a potential for abuse. 
3. A statement certifying that the prescriber engaged discussed risks with the patient. 
4. The number of refills authorized by the prescription.
5. The signature of the minor’s parent, guardian or authorized adult and date of signing.
6. The prescriber must retain the form in the patient’s record. 

Prescribers, with some exceptions, may not prescribe to minors more than a seven-day supply of a controlled substance containing an opioid. If it is an authorized adult (not parent or guardian) signing the consent form, the prescriber may not prescribe more than a 72-hour supply to the minor. 
Prescribers may prescribe to a minor more than a seven-day supply if any of the following apply:
In the prescriber’s professional clinical judgment, more than a seven-day supply of a controlled substance containing an opioid is required to stabilize the minor’s acute medical condition. If this is the case, the prescriber most document the condition and indicate the reason why a non-opioid alternative is not appropriate.
For management of pain associated with cancer, use in palliative or hospice care, or management of chronic pain not associated with cancer. 

On February 4, 2017, the Commissioner of Professional and Occupational Affairs provided notice of the approval of the consent form all prescribers must use when prescribing opioids to patients under the age of 18. The consent form is available on the Bureau's website at www.dos.pa.gov/ProfessionalLicensing.

Emergency Room and Urgent Care Centers

HB 1699, now Act 122 of 2016, impacts health care providers working in hospital emergency rooms and urgent care centers. Providers may not prescribe more than a seven-day supply of an opioid drug product to patients in the emergency room or urgent care center, or to those in observation status. Observation status is defined as patients who receive onsite services from a hospital for more than 23 consecutive hours and who have not been formally admitted as inpatients. 

There is an exemption for providers to issue more than a seven-day supply of an opioid drug product if they believe it is necessary to treat a patient’s acute medical condition or to treat pain associated with cancer or for palliative care. The provider must document in the patient’s record why a non-opioid drug alternative was not appropriate to treat a patient’s medical condition. 

Providers may not write a prescription refill for an opoid drug product and must refer patients for treatment if they suspect the patient is at risk for substance use disorders. 

Drop Off Locations

HB 1737, now Act 123 of 2016, allows the following to serve as drop-off locations for an extra, unwanted or expired prescription drugs or over-the-counter pharmaceutical products, without having to first register with the state:
State and local law enforcement agencies.
Hospitals.
Assisted living facilities.
Home health care agencies.