Dea

Groups challenge DEA rule on e-prescribing controlled substances

Anne Zieger — Sun, 28 Sep 2008 23:53:27 -0400

A pending rule from the DEA that would impose tight controls on e-prescribing of controlled substances has been slammed by a handful of industry groups as being too restrictive and in some cases too expensive for providers to absorb. To date, many providers have refused to adopt this technology, as they are reluctant to switch back and forth between e-prescribing for some drugs and paper prescribing for controlled substances. The DEA rule, which was long anticipated, was intended to make e-prescribing more practical by making controlled substance e-prescribing legal.

One group criticizing the rule is the American Society of Consultant Pharmacists, which argues that the new rule's requirements don't fit with existing e-prescribing systems, and that they'd be expensive to roll out in rural settings. Meanwhile, it also says that the rules would be incompatible with the needs of long-term-care patients on pain-management therapy, as nurses often make drug recommendations in such settings. (The rules would require the prescriber to be in close physical proximity to the patient.)

The American Hospital Association has also complained about the rule, arguing that it could impose so much legal liability on prescribes that it could prevent them from adopting the new system. One major liability issue, for example, is whether the rules would allow criminal charges to be filed against a prescriber if someone were to steal and misuse an identity-related tool such as a PDA or memory stick.

To learn more about the groups' objections:
- read this Modern Healthcare piece (reg. req.)

Related Articles:
Coalition urges changes in controlled-substance prescribing
Group says controlled-substance rules block e-prescribing
E-prescribing: What's holding it back?

FDA may urge training to dispense narcotics

Anne Zieger — Mon, 18 Aug 2008 09:44:13 -0400

The FDA is considering making a recommendation that doctors get special education to prescribe strong narcotics, despite the fact that it has no power to enforce such a proposal. FDA officials say they're most concerned about high-potency, long-acting narcotics like methadone, fentanyl and some forms of oxycodone. In particular, they've noted that a mix of methadone and fentanyl patches has been associated with patient deaths and injuries from doctor misprescribing or accidental patient misuse.

Under current DEA rules, doctors only need to show that they're licensed to practice medicine to register with the agency, which permits them to prescribe narcotics. There is an exception if doctors want to prescribe buprenorphine as an in-office treatment for narcotics addiction, which requires that they take eight hours of specialized training first. But they can prescribe even buprenorphine without extra training if they're using it to treat pain.

Lately, however, the agency has been under pressure to address issues with these drugs. In addition to recommending training for doctors, and sending out alerts to doctors regarding methadone and fentanyl, the agency is considering new rules requiring drugmakers to monitor how their narcotics are being prescribed.

To learn more about the FDA's plans:
- read this New York Times piece

Related Articles:
Study: Accidental drug overdose rates hit new high
CT Attorney General sues FDA over OxyContin
Off-label use of narcotic raises questions
The FDA approves Cephalon's Fentora for cancer pain

DEA wants tough rules for e-prescribing controlled drugs

Anne Zieger — Mon, 14 Jul 2008 12:09:23 -0400

For a long time, government officials, health plans and IT vendors have been trying to get doctors to write prescriptions electronically. Many doctors have held back, though, because at least 10 percent of their scripts were for controlled substances like OxyContin and Vicodin, which can't legally be e-prescribed--and who wants to switch back and forth from paper to computer? Things may change soon, as the DEA has proposed a rule that would allow physicians to write e-scripts for controlled drugs. That being said, however, it still won't be easy to do. In fact, everyone involved will be required to comply with a boatload of regulations if they want to participate.

The controlled-substances e-prescribing rules impose a range of new regulations on doctors, hospitals and pharmacies that want to participate. Not only would doctors have to register in person with law-enforcement officials, but they'd also have to allow routine audits of their prescription records. Pharmacists, meanwhile, would have to verify weekly that doctors doing the prescribing remain licensed and in good standing, keep digital records of the controlled drug e-prescriptions and notify the DEA within 24 hours in the case of a security violation.

To learn more about the rules:
- read this Modern Healthcare article (reg. req.)

Related Articles:
DEA eases painkiller prescription rules
DEA may allow e-prescribing of controlled substances
DEA allows e-prescriptions for controlled drugs