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Mandatory E-Prescribing for Controlled Substances Has Arrived in Pennsylvania – Health Law Alert

As of October 24, 2019, every licensed health care practitioner (excluding veterinarians) in Pennsylvania is now required to electronically prescribe Schedule II-V controlled substances, regardless of the dosage, by sending prescriptions directly to a pharmacy electronically. 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.

The primary goals of the new e-prescribing law, Act 96 of 2018 (Electronic Prescribing of Controlled Substances) (“Act 96”), are to fight the opioid epidemic by using electronic prescriptions to minimize medication errors, and reduce prescription forgery, diversion and theft. To be clear, this law requires practitioners to issue electronic prescriptions for all controlled substances, not just opioids.

There are a few exceptions to the e-prescription requirement, including, but not limited to:

  • Prescriptions dispensed by a pharmacy outside of Pennsylvania;
  • Prescriptions dispensed by the practitioner in-office;
  • Prescriptions for hospice patients or patients residing in a nursing home or residential care facility;
  • By a practitioner or health care facility that does not have either internet access or an electronic health record system;
  • Where there are temporary technological or electrical failures, provided that the practitioner seeks to correct any issue that is reasonably within his or her control within 72 hours;
  • When a pharmacy that receives the prescription is not set up to process electronic prescriptions;
  • By a practitioner treating a patient in an emergency department or a health care facility when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient’s medical condition; and
  • By a practitioner who has obtained a temporary exemption from the law. A practitioner or health care facility that does not meet an exception to the law and is unable to timely comply with the electronic prescribing requirements may apply for a temporary exemption from the requirements based on economic hardship, technical limitations or exceptional circumstances. The exemption is good for one (1) year.

To comply with Act 96, a practitioner must use an electronic health record (EHR) system or similar software that: (1) provides the capability to create an electronic prescription and send it to a pharmacy; and (2) is certified by the DEA as meeting the federal security requirements for electronic prescribing of controlled substances.

Penalties for violating the Act 96 are $100 per violation for the first 10 violations and $250 per violation thereafter, with a $5,000 per year cap. Finally, practitioners must document in the patient’s medical record when the practitioner is unable to electronically prescribe a controlled substance for the patient (for reasons such as electrical failure, where the patient uses a pharmacy that is not set up to receive prescriptions electronically, etc.).

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Vasilios J. “Bill” Kalogredis is Chairman of Lamb McErlane’s Health Law Department. He was formally shareholder of a law firm in Wayne, PA that he founded in 1981. Bill has been exclusively practicing health law for over 40 years, representing physicians, dentists, group practices, other health care professionals and health care-related entities.

Rachel E. Lusk is an associate in Lamb McErlane’s Health law and Litigation departments.  She represents physicians, dentists, group practices, and other health care professionals and health-related entities in transactional, regulatory, and compliance matters.