Pennsylvania Mandates E-Prescribing for Controlled Substances

Pennsylvania Gov. Tom Wolf on Oct. 24 signed into law House Bill (HB) 353: Electronic Prescribing Requirements for Controlled Substances. Motivated in part by the need to address the diversion of opioids, this new law amends the Pennsylvania Controlled Substance Drug, Device, and Cosmetic Act to require that all prescriptions for Schedule II through V controlled substances must be sent electronically by prescribers, except when dispensed or administered directly to a patient. It is important to note that prescriptions that are generated by an electronic system and subsequently printed or transmitted by fax are not considered electronic prescriptions. Although the law does not go into effect until Oct. 24, 2019, Pennsylvania-based physician practices should begin preparing now to make sure that they can meet its requirements.

Opioid Prescriptions

Prior to the passage of this law, Pennsylvania required all opioid prescriptions to be handwritten, even though all other medicines could be prescribed electronically. In 2016, there were more than 2,200 opioid-related deaths in Pennsylvania, and from June 2017 to June 2018, there were eight drug gang arrests for illegal paper prescriptions, which reportedly accounted for more than 60,000 illegally diverted opioid prescriptions. Given these issues, the bill’s primary sponsor, Rep. Tedd Nesbit (R-Mercer/Butler), described the new law as “a commonsense measure” that will reduce drug diversion resulting from written prescriptions being lost, stolen, or sold, while also maintaining accessibility for patients who require the covered medicines.

The state Department of Health may impose civil monetary penalties for violations of the law, including $100 for each of the first ten violations per calendar year and $250 for each subsequent violation that calendar year up to a total of $5,000. However, prescribers can rest assured that the Department of Health will not report an assessment to the practitioner’s licensing board for violations of the law.

While HB 353 generally covers all prescriptions for Schedule II through V controlled substances, the law also contains a number of exceptions to its requirements, which may make compliance with the law easier for many providers.

Exceptions include:

• Situations identified by the Secretary of Health by regulation.
• Prescriptions issued by a veterinarian.
• When an electronic prescription cannot be issued or received due to a temporary technological or electrical failure.
• Prescriptions issued by a practitioner and dispensed by a pharmacy outside of Pennsylvania.
• Prescriptions issued by a practitioner or health care facility that does not have either internet access or an electronic health record system.
• Prescriptions issued by a practitioner treating a patient in an emergency department or a health care facility when the practitioner determines that using an electronic prescription would make it impractical for the patient to obtain the medicine or would cause an untimely delay resulting in an adverse impact on the patient’s medical condition.
• Prescriptions for hospice patients or patients residing in a nursing home or residential care facility.
• Prescriptions issued for controlled substance compounded prescriptions, and prescriptions containing elements required by the FDA (or other government agency) that cannot be accomplished with electronic prescribing.
• Prescriptions issued pursuant to an established practice agreement between a practitioner and a pharmacist, a standing order, or a drug research protocol.
• Prescriptions issued in an emergency situation pursuant to federal or state law and regulations of the Department of Health.
• When a pharmacy that receives the prescription is not set up to process electronic prescriptions.
• Prescriptions for controlled substances that are not required to be reported to the prescription drug monitoring program system.

If a provider does not meet a listed exception, they may apply to the Department of Health for an exemption from the law’s requirements based upon economic hardship, technical limitations, or exceptional circumstances. The Department of Health also has the discretion to establish additional exemptions by regulation.

The law requires the Department of Health to issue regulations implementing the law within 180 days, and Pennsylvania-based physicians should keep a close eye out for these regulations.