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

Hopes were high because e-prescribing was seen to provide immediate benefits that could greatly improve the delivery of quality health care and speed up the migration to electronic health records.

Although major progress has been made in improving the functionality and interoperability of e-prescribing, recent studies have pointed out that fewer than one in ten doctors have adopted the electronic system.

Several hurdles need to be tore down to make e-prescribing “truly interoperable” and produce the national-scale effects on prescription drug use that were originally envisioned,” health policy analysts reported in the recent issue of Health Affairs journal.

“If current trends continue, e-prescribing still represents a step toward reaping the benefits of IT and automated decision support in health care on a national scale,” they said.

The report was written by Maria Friedman and Anthony Schueth, executives of two separate e-health strategy and management firm in Maryland and Florida, and Douglas Bell, a RAND research scientist and associate professor in the David Geffen School of Medicine at the University of California, Los Angeles.

The trio recommended five policy points that will likely affect increased adoption and interoperability of e-prescribing: moving beyond incentive scheme, making a stronger business case, increasing stakeholders’ involvements, addressing issues of privacy and security, and pilot-testing and industry collaboration.

The current incentive scheme to adopt and use e-prescribing will “help get user adoption beyond its current nascent point,” researchers said, but pointed out that payments alone are not enough.

They cited the Southeastern Michigan e-Prescribing Initiative (SEMI), which suggested that for every $5 spent on incentives, $1 should be invested on user training and education.

Return on investment (ROI) should be clearly quantified for adopters, they said, but added that the value, as distinct from ROI, should also be made at it can be more convincing than ROI numbers alone.

For example, e-prescribing could improve nurses’ work life by eliminating after-hour prescription follow-up, while pharmacists can have more time to deal with patients instead of handling prescription callbacks.

“Value also can be created by adding clinical content or links to e-prescribing for data to improve the quality of patient care, such as laboratory tests or results,” the researchers said.

They also called for the increased involvement of stakeholders. For instance, independent pharmacies in rural areas tend to lack the ability to receive and process e-prescriptions, or if they do, they might not use all features because of concern over transaction fees.

Payers likewise need to make their formularies readily available for use in e-prescribing so doctors can choose less costly alternatives for their patients.

Meanwhile, privacy and security issues have slowed down efforts to expand the use and interoperability of health IT.

Policymakers have been debating whether to expand the 1996 Health Information Portability and Accountability Act to include other entities in the e-prescribing chain beyond prescribers, payers, and pharmacies

“Considerable attention continues to be paid to ensuring the authentication of users, the integrity of prescriptions, and the privacy and security of personal health information that passes through the e-prescribing networks,” the researchers said.

They also said that one of the most valuable lessons learned from HIPAA implementation is the need for pilot-testing before standards are made, saying that even small pilot studies yield valuable results in creating metrics or demonstrating value and ROI.

“The e-prescribing industry has been collaborative in pilot-testing e-prescribing implementations and tweaking standards. The expectation is that this will continue, along with federal funding for larger-scale endeavors,” they said.

For more information:
Friedman MA, Schueth A, Bell DS. Interoperable electronic prescribing in the United States: a progress report. Health Aff (Millwood). 2009 Mar-Apr;28(2):393-403.