DEA Releases Interim Final Rule on Controlled Substance E-Prescriptions
The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of electronically writing prescriptions for controlled substances (this interim final rule was published in the Federal Register on March 31, 2010). The AGA is pleased that the regulations incorporate a number of physician-friendly suggestions submitted by the AGA.
The regulations will permit pharmacies to receive, dispense and archive e-prescriptions for drugs and other substances that have a potential for abuse and street use, including opioids, stimulants, depressants, hallucinogens and anabolic steroids.
The regulations provide pharmacies, hospitals and practitioners with the ability to use modern technology for controlled substance prescriptions, while maintaining the closed system of controls on controlled substances dispensing. Additionally, the regulations reduce paperwork for DEA registrants who dispense controlled substances, and have the potential to reduce prescription forgery. The regulations may reduce the number of prescription errors by taking advantage of e-prescribing: prescriptions checked for drug-drug and drug-allergy interactions, improper dosing, and limiting transcription errors due to illegible handwriting or misunderstood oral prescriptions. Moreover, they will help pharmacies and hospitals integrate prescription records into other medical records more directly, which may increase efficiency and reduce the amount of time patients spend waiting to have their prescriptions filled. For physicians and their staff, increased use of electronic transmission of prescriptions should reduce the number of phone calls to and from pharmacies.
A major goal of e-prescribing of controlled substances is to prevent illegal drug diversion, protect patient privacy, and provide cost savings and quality improvements to the prescription process. As an example, AGA member Peter Kaufman, MD, is part of an Agency for Healthcare Research and Quality grant/DEA waiver project in Western Massachusetts that is currently studying controlled drug e-prescribing.
Major improvements include:
- Allowing one of the factors in the required two-factor authentication to be a biometric.*
- Identity proofing can be by institution or third-party certification authorities.
- More leeway on how the prescription is written.
- Auditing of vendors has been changed to every two years.
- Record retention was changed to two years, which is parallel to the requirement for paper prescriptions.
- Removal of the requirement for storage of back-up records at another location.
- Monthly logs will still be required, but mandatory review by the practitioner will not be required.
- Vendors do not need to compare users to the DEA list. Rather, prescribers are responsible for knowing if they can legally write controlled drugs; this also applies to paper prescriptions.
*The interim final rule maintains two factors, while adding the possibility of a biometric. In the new regulation, users of e-prescribing systems for controlled substances would have to prove their identities with two of the following three factors: something you know (password), something you have (token) or something you are (biometric).
Biometric identifiers include fingerprints, iris scans, hand prints or face scans to help authenticate the identity of the e-prescribing user. The biometric will be allowed as a substitute for a hard token or a password. If a hard token is used, it must meet specified security standards for cryptographic devices or one-time password devices, and it must be stored on a device that is separate from the computer in use.
The effective date of this regulation is June 1. Comments to the DEA are also due by June 1.