Electronic Prescriptions for Controlled Substances

In 1970, the DEA implemented the Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act (CSA) (21 U.S.C. 801–971). At this time, most transactions, and particularly prescriptions were done on paper.[1]

These regulations ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes. The regulations also deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Part of CSA mandate included that some records must be created and kept on forms that DEA provides and that many controlled substance prescriptions must be manually signed.[1]

In 1999, in response to requests from the regulated community, the Drug Enforcement Administration (DEA) began to examine how to revise its regulations to allow the use of electronic systems within the limits imposed by the existing statutes, while being mindful that the records had to be usable in legal actions. On April 1, 2005, after extensive consultation with the regulated community, DEA published a final rule that allowed the electronic creation, signature, transmission, and retention of records of orders for Schedule I and Schedule II controlled substances, orders that prior to that time had to be created on preprinted forms that DEA issued.[1]

At the same time, DEA began to examine how to revise its rules to allow electronic prescriptions for controlled substances. The DEA had to mindful that regulations on electronic prescriptions must be consistent with other statutory mandates and Federal regulations. Looking back, E-Sign was signed into law on June 30, 2000. It establishes the basic rules for using electronic signatures and records in commerce, and it electronic commerce by giving legal effect to electronic signatures and records and to protect consumers.[1]

In 2003, the Medicare Prescription Drug, Improvement, and Modernization Act was implemented. It contained a requirement pertaining to electronic transmission of prescriptions and prescription-related information for its Medicare program. One of the considerations in support of this move to electronic prescriptions was the view that using electronic prescriptions in lieu of written or oral prescriptions could reduce medical errors that occur because handwriting is illegible or phoned-in prescriptions are misunderstood as a result of similar-sounding medication names. Another consideration is that, if prescription records are linked to other medical records, practitioners can be alerted at the time of prescribing to possible interactions with other drugs the patient is taking or allergies a patient might have. Electronic prescribing systems also can link to insurance formulary lists to inform the practitioner prior to prescribing whether a drug is covered by a patient’s insurance.[1]

The Secretary of the Department of Health and Human Services (HHS) adopted a rule on the transmission standard for electronic prescriptions in November 2005 (revised in June 2006). The standard focuses on the format for the transmitted information, not with the process of creating the prescription or maintaining the record at the pharmacy. The standard specifies fields (name, date, address, etc.) and field lengths for certain transactions including issuing new prescriptions and refills. However, there is no requirement that practitioners or pharmacies use electronic prescriptions. It does require that companies that sponsor Medicare prescription drug coverage establish and maintain an electronic prescription program that meets the standard.[1]

The rule has been written to be consistent with the above delineated HHS standard. However, the context in which the HHS standard was issued was not specific to controlled substances and therefore not designed to provide safeguards against the diversion of controlled substances. The responsibility for establishing regulatory safeguards against diversion of controlled substances falls upon DEA as the agency charged with administering and enforcing the CSA. Accordingly, while the DEA's rule is designed to work in tandem with the HHS standard, its scope is necessarily distinct from the HHS standard.[1]