Last fall, Pennsylvania Governor Tom Wolf signed into law Act 96 of 2018, which amends the Pennsylvania Controlled Substance, Drug, Device and Cosmetic Act to require practitioners to use electronic prescribing for all Schedule II through V controlled substances, other than controlled substances that are administered or dispensed directly to the patient by the practitioner. The law takes effect on October 24, 2019 and is intended to reduce the diversion of controlled substances by replacing traditional paper prescriptions with e-prescriptions, as written prescriptions are more likely to be lost, stolen, tampered with, or sold through drug diversion.  Practitioners who violate the law are subject to administrative penalties up to a maximum of $5,000 per calendar year.

Act 96 contains quite a few exceptions to the e-prescribing requirement.  For example, the following situations are exempt from the e-prescribing requirements:

  • Prescriptions issued by veterinarians
  • Prescriptions from practitioners that are dispensed by a pharmacy outside of Pennsylvania
  • Prescriptions issued by a practitioner or a health care facility that has no internet access (is there such a practitioner or health care facility in today’s world?) or electronic health records system in place
  • Certain emergency prescribing situations
  • Prescriptions for patients in hospice care or who are residents of nursing homes or other residential health care facilities
  • Prescriptions issued during temporary technological failures (e.g., computer system, application or device failures, loss of electrical power to such system, application or device, or other service interruptions to computer system application or devices that prevent use of e-prescribing technology)
  • Prescriptions issued in connection with an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order, or a drug research protocol
  • Prescriptions issued where the pharmacy that receives the prescription cannot process electronic prescriptions
  • Other situations specified by the Pennsylvania Secretary of Health through regulations

Within six months of the effective date of the new law (or by April 24, 2019), the Pennsylvania Department of Health was to have issued proposed rules describing such “other situations” that qualify for an exemption, as well as regulations setting forth the process for applying for an exemption based on “economic hardship, technical limitations or exceptional circumstances” if an entity or individual subject to the e-prescribing requirements is unable to meet any of the numerous existing exceptions.  However, such proposed regulations have not yet been published.  The Governor’s Regulatory Agenda, published in the Pennsylvania Bulletin at the end of March 2019, indicated the Department of Health is on track to have the regulations in place by the October 24, 2019 effective date of Act 96.

In the meantime, we will continue to monitor the progress of the proposed rules and will provide an update so that practitioners and providers who will be affected by the rules may offer comments on the rules before they become final.