A consortium of pharmacy groups has sent letters to the Drug Enforcement Agency (DEA) on June 1 requesting clarification on the interim final rule (IFR) on electronic prescriptions for controlled substances.
Posted in the March 31 Federal Register and slated to go into effect June 1, the IFR outlines electronic means to create a system which facilitates the e-prescribing of controlled substances. This for the first time will permit e-prescribing of schedule II, III, IV and V controlled substances.
The National Community Pharmacists Association (NCPA) stated that while it supports the DEA’s efforts to allow e-prescribing of controlled substances, the consortium recommended that DEA recognize the last intermediary, rather than the pharmacy, as the entity that will digitally sign and archive e-prescriptions for controlled substances. “NCPA is concerned that pharmacy applications currently used by its members do not have the capability to digitally sign prescriptions they receive,” the letter stated.
In addition, the NCPA contended that the IFR does not clearly recognize workflow issues related to e-prescribing in long-term care facilities where nursing personnel administer medications and an off-site pharmacy provides medications. NCPA asked the DEA to support the nurse as the agent of the prescriber and for DEA to allow prescribers to transmit prescriptions electronically through computers housed at non-registered long-term care facilities.
The NCPA sent another letter along with the American Society of Consultant Pharmacists, the American Pharmacists Association and the American Society of Health-System Pharmacists, requesting the DEA consider the following recommendations to ensure pharmacists have the needed information to implement and comply with the final regulations:
- Provide additional clarification on changes to e-prescription orders and communications of these changes between a pharmacist and a registrant practitioner;
- Provide additional clarification on the use of digital signatures and the responsibilities associated with verification of a digital signature;
- Provide additional guidance and work in conjunction with the pharmacy industry to standardize internal code number systems added to the standard nine-digit DEA registration format;
- Ensure that an appropriate number of certification or audit entities exist to meet the needs of pharmacy systems in all types of patient care practice setting;
- Provide additional clarification on re-routing/transferring of prescriptions;
- Provide additional clarification on workflow procedures for long-term care settings; and
- Consider additional options for emergency fill procedures.
“We look forward to continuing to work with DEA and other public and private stakeholders to facilitate implementation of the e-prescribing of controlled substances,” the second letter concluded.