The
Drug Enforcement Administration has proposed rules to allow e-prescribing of
controlled substances, such as painkillers and stimulants, and will accept
public comments until Sept. 25.
The proposed rules, as explained in a 62-page Federal Register notice today,
require doctors to use two forms of identification for each transmission of
e-prescriptions for controlled substances in addition to an annual audit of
each system by a certified public accountancy.
Under current rules, doctors may use e-prescribing for most prescriptions but
must sign a written prescription for Schedule II controlled substances, such as
Nembutal, OxyContin and opium. The DEA rule, if it becomes final, would allow
doctors to use the same system for generating and transmitting all
prescriptions.
The rules call for doctors and other prescribers to have their identity
verified in person at a DEA-registered hospital that has granted the doctor
privileges to practice at the hospital, a state professional or licensing
board, or a state or local law enforcement agency.
With their identity verified, doctors could e-prescribe by using two-factor
authentication, which means using a password in addition to a device in the
doctor’s possession that "could be a [personal digital assistant], a cell
phone, a smart card, a thumb drive, or multifactor one-time password token,”
the proposed rules state.
The standard software protocol for transmitting prescriptions to pharmacies,
known as NCPDP SCRIPT, would have to be modified to allow a digital signature
on e-prescriptions, the rules state.
E-prescribing systems in use by doctors, pharmacies and intermediaries would
have to support two-factor authentication and implement strong security so
there would be virtually no possibility that the e-prescription could be
diverted or altered. If a diversion occurred, it would have to be possible to
identify the perpetrator and exonerate the doctor who wrote a legitimate
prescription.
“In the absence of appropriate controls, allowing electronic prescriptions for
controlled substances could exacerbate the already increasing problem
of…controlled substance abuse,” the draft rules state.
“The publication of this proposed rule is an important step toward making
electronic prescribing an option for practitioners who prescribe controlled
substances,” said Joseph Rannazzisi, deputy assistant DEA administrator of the
Office of Diversion Control. “Our goal is to put in place an electronic
prescribing system that is efficient, medically beneficial to patients and
prescribers, and provides security from hackers and others who might seek to
engage in fraudulent prescribing activities.”
E-prescribing advocates had little to say about the rule because they were
analyzing it. "The rule is highly technical, and because the devil is
always in the details, I will review it thoroughly with this in mind: We need
to lift barriers to widespread adoption of e-prescribing, not create new ones,”
said Sen. Sheldon Whitehouse (D-R.I.), who has pushed DEA to issue such a rule.
Doctors at federal health care facilities, such as those run by the Defense and
Veterans Affairs departments, could use their federal identity cards to access
prescribing systems and would not need additional identity proofing, DEA wrote.