Stakeholders await final DEA rule to lift E-prescription ban for controlled substances

Posted: July 30th, 2009 | Author: George Getty III | Filed under: Controlled Substances | 3 Comments »

The U.S. Drug Enforcement Agency (DEA) unveiled last year proposed regulations that would provide physicians and authorized prescribers with the option of issuing electronic prescriptions for controlled substances.

The agency had sought public comment on DEA’s draft rule #1117-AA61, titled “Electronic Prescriptions for Controlled Substances.” One year later, stakeholders are still waiting for DEA’s final decision to lift the e-prescribing moratorium on controlled substances.

In one of the recent developments, a bi-partisan group of senators has sent a letter in May to Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius asking for a final resolution on the proposal.

The 11 senators, who signed the letter, said, “E-prescribing is held back by the DEA,” which requires a parallel paper system for scheduled pharmaceuticals. “Obviously, having to run two systems compromises any savings from e-prescribing,” they wrote.

They said e-prescribing of controlled substances, which accounts for 10 percent to 20 percent of all prescriptions, is “an important piece of the puzzle” that could generate $20 billion per year in savings through reduced adverse drug events and patient adherence to prescription regimens.

“Crafting a final rule that advances both health care quality and efficiency, and reduces illegal prescription drug diversion, will require the cooperation, compromise and knowledge of experts at both the Department of Justice and the Department of Health and Human Services,” the senators said.

The DEA has said the proposal, seen by many as an adoption barrier, would equip pharmacies, hospitals, and practitioners with electronic prescribing capabilities while guarding the closed system of controls on controlled substances dispensing.

The American Journal of Health-System Pharmacy published in its July issue the report “Electronic prescribing of controlled substances,” which discussed elements of the proposed e-prescribing rule.

• In-person registration for e-prescribing authority.
  This is intended to ensure that only licensed personnel are registered. The licensee must present evidence from a credentialing authority to be licensed and receive electronic signature authority.
• Level 4 two-factor authentication.
  One factor must be a hardware token; the second may be a memorized pass code or a biometric identifier.
• Authentication at signature.
  This ensures that only the prescriber signs the prescription.
• Strict audit requirements.
  These help identify diversion at the pharmacy to ensure the security of the e-prescribing system.
• Verification of prescriber’s DEA number during prescription filling.
  This ensures that the prescriber is still authorized to issue prescriptions.
• Monthly review and approval of audit logs.
  This allows the prescriber the opportunity to identify problems.
• Archival of digitally signed prescriptions for five years.
  Such archival of records aids in retrospective auditing and investigation.

The Pharmacy Informatics and Technology section of the American Society of Health-System Pharmacists said stakeholders are waiting for a final rule “because it will largely determine whether the burden and costs associated with implementation outweigh the benefits.”

“Should the rule prove to be onerous, providers may opt to continue to prescribe controlled substances using the current paper process. Should the DEA promulgate a rule that is reasonable, many believe that the DEA’s rules will become the de facto requirements for all e-prescribing systems,” it added.

On the other hand, the Pharmaceutical Care Management Association, which represents the pharmacy benefit management firms, believed the proposed rule to permit e-prescribing is flawed.

In a five-page comment letter to DEA, the group said the proposed rule would create unnecessary burdens for doctors and pharmacists. Its president and CEO, Mark Merritt, pointed out the following issues:

• Ensuring generic substitution.
  The proposal is not clear whether changing a prescription to a generic would be allowed under this rule. PCMA recommends that pharmacists be allowed to change prescriptions according to state law and such action should not be considered “altering the prescription during transmission.”
• Verifying DEA registration.
  The proposed rule requires the pharmacy system to verify that the practitioner’s DEA registration is valid through the DEA CSA database. PCMA says such option is very costly, which could drive up costs for the service.
• Prescriber in-person identity proofing.
  The proposed rule requires prescribers to go verify in-person through a DEA registered hospital. PCMA says the process “creates a burden that is onerous and unnecessary and that does not result in the security and assurances that the DEA seeks to achieve.” PCMA recommends service providers be allowed to verify a prescriber’s identification in-person.
• Prescriber work-flow.
  The system requires reauthentication if the practitioner does not use the system for more than 2 minutes. PCMA says this is unreasonable and does not recognize the workflow demands of medical practice. It recommends that the time lapse for reauthentication be revised to 15 minutes.

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