American Society of Consultant Pharmacists Issues Public Comment on DEA Rule

WASHINGTON, June 24 -- Arnold E. Clayman, vice president for pharmacy practice and government affairs at the American Society of Consultant Pharmacists, Alexandria, Virginia, has issued a public comment on the Drug Enforcement Administration's rule entitled "Electronic Prescriptions for Controlled Substances". The comment was written on June 22, 2020, and posted on June 23, 2020:

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On behalf of the membership of the American Society of Consultant Pharmacists (ASCP), we are pleased to submit comments regarding RIN 1117-AA61/Docket No. DEA 2181: Electronic Prescriptions for Controlled Substances; Interim Final Rule (IFR).

The American Society of Consultant Pharmacists is the only professional society devoted to optimal medication management and improved health outcomes for all older persons in the United States and abroad. ASCP's senior care pharmacist members manage and improve quality of life for geriatric patients and other individuals residing in a variety of environments including nursing facilities, sub-acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care.

We thank the Drug Enforcement Administration's (DEA) efforts in supporting adoption of electronic technologies and other mediums to securely, safely, and efficiently transmit controlled substance prescriptions. ASCP believes that further enhancements to the electronic transmission process will only enhance patient care and outcomes in older adult populations living in care settings across the nation.

Outstanding Electronic Prescription of Controlled Substances (EPCS) Questions for Additional Comments

1. DEA CURRENTLY REQUIRES THAT THE AUTHENTICATION CREDENTIAL BE TWO-FACTOR TO PROTECT THE PRACTITIONER FROM INTERNAL MISUSE, AS WELL AS EXTERNAL THREATS. IS THERE AN ALTERNATIVE TO TWO-FACTOR AUTHENTICATION THAT WOULD PROVIDE AN EQUALLY SAFE, SECURE, AND CLOSED SYSTEM FOR ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCE WHILE BETTER ENCOURAGING ADOPTION OF EPCS? ARE PRACTITIONERS USING UNIVERSAL SECOND FACTOR AUTHENTICATION (U2F)? ARE PRACTITIONERS USING CELLULAR PHONES AS A HARD TOKEN, OR AS PART OF TWO-FACTOR AUTHENTICATION? IS SHORT MESSAGING SERVICE (SMS) BEING USED AS ONE OF THE AUTHENTICATION FACTORS USED FOR SIGNING CONTROLLED SUBSTANCE PRESCRIPTIONS?

ASCP encourages DEA to employ flexibility in a final rule to be sufficiently flexible so to comport with current standards related to written prescriptions or orders. Although the IFR requires that the actual EPCS be sent by the prescribing practitioner in the prescribing software system; the same does not hold true for written prescriptions or orders in institutional settings. For example, any designated agent of the practitioner in an institutional setting (i.e., hospital) may transmit or otherwise deliver the controlled substance prescription drug order to the pharmacy. Given that long-term care facilities (LTCFs) share the characteristics of this process in other institutional settings, ASCP recommends that DEA allow nurse agents in long-term care facilities to transmit Schedule III-V orders on behalf of the prescribing practitioner. This will help alleviate some of the burden of orders not reaching the pharmacy in a timely manner and will remove a barrier to long-term care facilities adopting EPCS.

ASCP would also ask that DEA review and revise its two factor authentication method to adopt more current technologies which are more flexible and practitioner friendly. ASCP believes this will enhance adoption standards and permit more pracitioners without office settings to prescribe electronically.

Most prescribers are able to send controlled substance orders from their cellphones, and the two-factor authentication is usually a security key. Limitations that LTCFs experience with prescribers who don't use EPCS is their access to a fax machine or having to stop by the LTCF to place the controlled substance order. An alternative to two-factor authentication (2FA) is the universal second factor (U2F) security key. While the 2FA standard is an older technology, the new U2F security standard is interoperable and more secure. ASCP believes that DEA's adoption of the FIDO certified U2F in the final rule would ensure it is employing the most secure and flexible technology.

7. HAVE STAFF WORKFLOWS AT LONG-TERM AND POST-ACUTE CARE FACILITIES FACED BARRIERS DURING THE ADOPTION AND IMPLEMENTATION OF EPCS?

In generally, ASCP belives that EPCS adoption by long-term care facilities (LTCFs) has been slower than hospital and outpatient prescribing practices. Barriers and reasons for slow adoption include but are not limited to LTCF's limited resources both in terms of budgeted dollars and personnel, a fragmented electronic health record (EHR) network among hospitals and outpatient practitioner offices which lack interoperability, and typically a network of offsite pracitioners that all use different medical record systems. For example, many LTCFs do not have a dedicated and employed medical director, as such they rely on varying pracitioners in different practices that all use different technology resources making it difficult to consolidate all of the practitioners into a single EPCS software. Also requiring one common EPCS software can lead to practitioner frustration and adoption challenges.

In addition, another common occurrence is that many practitioner's EPCS tranmissions are not integrated with a care facilities EHR or eMAR (electronic medication administration record) resulting in the transmission going directly to the pharmacy and bypassing the LTCF. This places facility personnel temporarily out of the communication loop, which can create confusion and extra phone calls to track down the prescription. This is one reason that many LTCFs still prefer a facsimile method of communication.

ASCP believes the key to encouraging adoption of EPCS is for DEA to ensure that EPCS systems are interoperable with other systems, and particularly if a practitioner is practicing in more than one care setting. It should not matter what system or communication device (e.g., cellphone, laptop, etc.) is being used, as long as all systems recognize the practitioner.

8. WHAT TYPES OF BIOMETRIC AUTHENTICATION CREDENTIALS ARE CURRENTLY BEING UTILIZED (E.G., FINGERPRINT, IRIS SCAN, HANDPRINT)? ARE THERE ALTERNATIVES TO BIOMETRICS THAT COULD RESULT IN A GREATER ADOPTION RATE FOR EPCS WHILE CONTINUING TO MEET THE AUTHENTICATION REQUIREMENTS.

Fingerprint scan appears to be the most common one used. As mentioned previously, an alternative to biometrics that is more secure than 2FA is the U2F security key. 2FA is an older technology. U2F is the new security standard, is interoperable, and is more secure than the current 2FA. FIDO certified U2F should be used. ASCP would encourage DEA to move toward U2F.

9. PREVIOUS COMMENTERS HAVE EXPRESSED CONCERN REGARDING FAILED TRANSMISSIONS OF ELECTRONIC PRESCRIPTIONS. DEA IS SEEKING COMMENT IN RESPONSE TO QUESTIONS: HAVE ANY ENTITIES EXPERIENCED FAILED TRANSMISSIONS (E.G., AN EPCS BEING SENT TO THE WRONG PHARMACY, AN INCORRECTLY FILLED OUT EPCS, AN EPCS FAILS TO SEND, THE PHARMACY DOES NOT HAVE THE PRESCRIBED CONTROLLED SUBSTANCE IN STOCK, OR THE PHARMACY REJECTS THE EPCS)? IF ANY FAILED TRANSMISSIONS HAVE OCCURRED, WHAT ALTERNATIVE MEANS OF SUBMITTING THE PRESCRIPTION TO THE PHARMACY HAVE BEEN USED?

It is our understanding that failed transmissions do occur, but they are seldom. Most EPCS systems appear to have safeguards built in to help prevent these errors. If a failed transmission occurred, a prescriber could revert back to faxing prescriptions or make an emergency telephone call to place the order followed by a written prescription.

Concluding Comments

In addition to the above comments, ASCP supports the comment letter being submitted by the Pharmacy Health Information Technology (PHIT) Collaborative regarding RIN 1117-AA61/Docket No. DEA 2181: Electronic Prescriptions for Controlled Substances; Interim Final Rule (IFR). ASCP is a member of the PHIT Collaborative.

If you have any questions or require additional information, please contact us.

Sincerely,

Arnold E. Clayman, PD, FASCP

Vice President of Pharmacy Practice & Government Affairs

American Society of Consultant Pharmacists

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The rule can be viewed at: https://www.regulations.gov/document?D=DEA-2010-0010-0102

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