On June 27, 2008, DEA published a Notice of Proposed Rulemaking (NPRM) to revise the regulation to allow creation, signature, transmission and processing of controlled substances electronically. The DEA gave consideration to over 200 comments while drafting the IFR.

The DEA’s obligation as noted in the rule, is to ensure that the regulations minimize, to the greatest extent possible, the potential for diversion of a controlled substance resulting from non-registrants gaining access to electronic prescribing applications and systems.  The concern of insufficient Security has been the main barrier to allowing the ePrescription of controlled substances.  The authentication methods used in online or desktop applications is generally username and password.  Passwords are easily guessed or broken by using various password guessing programs.

In response to these concerns, the DEA is adopting an approach to identity proofing (verifying that the authenticated user is who he/she claims to be) and logical access control (verifying that the authenticated user has the authority to perform the requested operation).  The DEA will require registrants to apply to certain federally approved credential service providers (CSP) or certification authorities to obtain security certificates.

The strongest requirement of the IFR will be authentication.  The DEA is proposing a two-factor authentication which is defined as two of the following:  something you know, something you have, something you are.  Authentication based only on knowledge factors, such as user names and passwords,  are easily compromised because they can be observed, guessed, or hacked and used without the practitioners knowledge.

The US Government has been using this similar approach for all electronic initiatives.  A draft of the federal electronic authentication guideline can be found here:  http://csrc.nist.gov/publications/drafts/800-63-rev1/SP800-63-Rev1_Dec2008.pdf

The Federal Register is expected to publish the Interim Final rule on March 31, 2010, which will kick off a 60-day comment period.

A draft of the interim final rule (IFR) was posted on March 24, 2010.  The draft can be found here:  http://www.federalregister.gov/OFRUpload/OFRData/2010-06687_PI.pdf

The removal of an impediment to prescription writing was linked to the rise in Schedule II opioids and benzodiazepines prescriptions at the emergency department of the Good Samaritan Hospital Medical Center in New York, researchers claimed.

“Simple regulatory changes and lifting of barriers, such as the utilization of electronic prescriptions, can make significant changes to practice patterns and may change the way patients are treated,” the authors wrote in a study published recently by the Academy Emergency Medicine journal.

The study compared the changes in opioid and benzodiazepine prescriptions before and after the New York State implemented the “Official Prescription Program,” which was designed to reduce the amount of drugs diverted from legitimate medical use by preventing alterations, forgeries and counterfeiting of prescriptions.

The new system, implemented on April 19th, 2006, required all prescriptions to be computer-generated from the doctors’ stations and printed via a dedicated printer onto standardized prescription forms.

Before this, the hospital’s emergency department staff stored a specialized prescription form in a locked cabinet, and physicians had to handwrite and stamp the prescription.

A year before the program was enacted, a little over 2 percent of almost 27,000 charts reviewed in the study were for Schedule II controlled opioids, such as oxycodone. A year after regulatory changes were made, prescription for the same class of drugs increased to 13.6 percent. The same pattern was observed in benzodiazepines, which increased from 1.4 percent to 3.9 percent.

Meanwhile, the corresponding percentages for Schedule III-V opioids, which include hydrocodone and codeine, dropped from 29.9 percent to 18.1 percent during the same period, results showed.

Researchers said the change was attributed from a shift in the prescribing of hydrocodone to oxycodone. Both drugs have similar side effects but oxycodone is associated with less constipation than hydrocodone, giving patients better relief, they added.

“We have demonstrated that clinical practice may be significantly associated with the ease and convenience of prescribing medications,” the authors wrote.

Interestingly, the shift was observed as the result of technological improvements instituted to comply with a state regulation, rather than as a measure to directly address pain management, they said.

“As more EDs shift to electronic medical charting with linked prescription writing, a similar unanticipated change in prescribing patterns could occur,” they concluded.

For more information:

McGerald G, Dvorkin R, Levy D, Lovell-Rose S & Sharma A. (2009). “Prescriptions for schedule II opioids and benzodiazepines increase after the introduction of computer-generated prescriptions.” Acad Emerg Med. Jun;16(6):508-12. Read abstract

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.