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Washington News: An Update on Electronic Prescriptions for Controlled Substances
Published in the January 2007 Washington State Board of Pharmacy Newsletter
Drug Enforcement Administration (DEA) is working to permit electronic prescriptions for controlled substances (EPCS). They have identified some performance standards. The standards include: Authentication: The ability to confirm authenticity and positively identify the prescriber/signer. Non-repudiation: The system must be able to assure that the prescriber/signer cannot deny signing the prescription. Record integrity: Assurance that the prescription has not been altered after signature.
DEA believes that electronic prescriptions must be substantially similar to written manually signed paper prescriptions. This is important when establishing evidence in litigation where the burden of proof is beyond a reasonable doubt.
Although DEA had issued a Notice of Proposed Rulemaking to allow the electronic transmission of controlled substances (CS) prescriptions, it was withdrawn in 2004 after the Department of Health and Human Services (HHS) expressed concerns with using public key infrastructure (PKI) technology.
In July 2006, DEA and HHS conducted a two-day public meeting on electronic prescriptions to determine how electronic prescribing systems can meet DEA’s prescription requirements under the Controlled Substances Act. This meeting provided an opportunity for industry – prescribers, pharmacies, software/hardware vendors, and other interested third parties – to give comment. In addition, DEA and HHS wanted to know how this could be accomplished without unduly burdening those involved in the prescribing transaction.
The public meeting included six panel discussions focused on specific areas of expertise: (1) Technical Framework, (2) Practitioner Perspectives, (3) Pharmacy Perspectives, (4) Vendor Perspectives, (5) State Perspectives, and (6) Law Enforcement Perspectives.
You may find additional information about the public meeting at the DEA Diversion Control Program Web site: www.deadiversion.usdoj.gov.
DEA is now meeting regularly with HHS to find solutions to concerns over electronic prescribing. It is working to establish standards that will secure authenticity, non-repudiation, and record integrity. It is looking at other models and conducting the appropriate legal analysis.
The bottom line for Washington State is that Schedule II prescriptions may not be transmitted electronically at this time. A pharmacist must exercise professional judgment when determining the validity of an electronically transmitted Schedule III-V prescription. (See article No. 918 from the October 2006 Newsletter.)
