An interim rule issued by DEA (Drug Enforcement Administration) would allow E-Prescriptions of controlled substances. The interim rule was published in the March 31 issue of the Federal Register. The final rule will go into effect following a 60-day comment period. The Office of Management and Budget, which has been following the DEA’s rule making, has signed off on the e-prescribing rule. Computer-generated prescriptions from physicians to pharmacies for drugs such as oxycodone (OxyContin, Purdue), methylphenidate (Ritalin, Novartis), diazepam (Valium, Roche), and hydrocodone bitartrate/acetaminophen (e.g., Abbott’s Vicodin or Forest’s Lorcet and Lortab), are illegal until the DEA finalizes this rule.
The highlights of the rule:
- give prescribers the option of e-prescribing controlled substances;
- permit pharmacies to receive, dispense and archive electronic prescriptions;
- reduce paperwork for DEA registrants, such as family physicians;
- help pharmacies and hospitals integrate prescription records into other medical records;
- increase efficiencies and reduce the wait time for patients having prescriptions filled; and
- potentially reduce prescription forgeries.
The rule is available for inspection now and will be officially published as a Notice of Proposed Rule Making (NPRM) on March 31. As with other NPRMs, there will be a 60-day open public comment period before it goes into effect, with potential modification depending on commentary received.
Authentication is a major issue here and only DEA-registered providers can electronically prescribe controlled substances which would require e-prescribing systems to be able to validate the identity of the prescriber and the prescription’s legitimacy. Special watermarked paper (which clinicians needed to purchase from authorized vendors) were used for prescribing such medication before and required a manual signature but now an alternate way of validation must be introduced.
Validation of prescribers should be a two step approach:
1) Someone other than the prescriber must authenticate the prescriber.
2) The other one can be biometric authentication.
The DEA is uncertain about the extent to which existing biometric readers will be used in healthcare settings but believes it is reasonable to allow for such technology because the technology is likely to improve. The rule itself does not require the use of a specific form of biometric technology. However DEA is establishing standards for biometric systems in conjunction with the National Institute of Standards and Technology (NIST) for this purpose.
The change however is pleasant news indeed for the healthcare industry regardless of the final shape of DEA’s rule. The inability to e-prescribe any controlled substance has been a limiting factor for the promotion of the adoption of e-prescribing and of EHR systems. The need of introducing modern technologies in healthcare industry is growing day by day and being able to use modern technologies in this important area of clinical practice is absolutely welcome.
