New DEA rule means changes to eRx
A restrictive new rule change from the Drug Enforcement Administration, making it more difficult for physicians to prescribe opioids, will necessitate some changes to e-prescribing products and practices.
[See also: DEA: They want a new drug]
Proponents of the DEA's rescheduling of hydrocodone combination products, or HCPs, from schedule III to schedule II contend that the move will help to curtail the epidemic of drug diversion and drug overdose associated with controlled substances.
But detractors assert that the rule change will negatively impact the ability for patients with genuine medical needs to access pain medications.
The DEA implements and enforces titles II and III of the Comprehensive Substance Act. Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, currently accepted medical use in treatment in the U.S., and the degree of dependence the drug or other substance may cause.
The DEA's final rule will move HCPs from schedule III to schedule II, effective Oct. 6, 2014. [PDF]
Sean Kelly, MD, chief medical officer at Lexington, Mass.-based health IT security company Imprivata, says drug diversion is a common problem, and one of the contributors is large numbers of narcotics prescriptions being written.
"In making this change some of the thought is that this should limit the amount of free drug that is out there sitting in people's cabinets that people can take and use and abuse," said Kelly. "It also limits the ability of some providers who are over-prescribing these and putting them out there for consumption on the market."
Kelly, an emergency physician at Beth Israel Deaconess Medical Center in Boston and an assistant professor of medicine at Harvard Medical School, also acknowledges the concerns of people from long term care facilities, palliative care, chronic pain patients and cancer patients who are worried that the this could also limit patients who legitimately need them because they are in chronic pain and need a lot of pain medications.
"My perspective as a practicing physician is that I'm extremely worried about the illegitimate use of these drugs and the numbers of people that come in doctor shopping trying to get medicines. I think it is a good thing to limit the amount of medicines that we can write, which will be one of the benefits of this change."
Kelly says the schedule change will impact the way physicians write prescriptions for Hydrocodone. Doctors will no longer be able to write a prescription for 180 days’ worth of medication; only for 90 days. As a result, more refills will be required.
Some of the concern, said Kelly, is that this will affect people that really need these medications and they will have to see their doctor in 90 days instead of 180, which for some patients will be an inconvenience.
"You could also argue that it's not a bad thing to see your doctor and make sure that you get cared for in a proper way," he said.
But that argument is based on paper-based prescriptions that are handed to patients, Kelly argued. Today, more and more e-prescriptions are being written, and the DEA now allows for the e-prescribing of controlled substances (EPCS), such as hydrocodone and other narcotics.
E-prescribers, EMR vendors, pharmacies prepare for change
David Yakimischak, executive vice president and general manager for medication network services, at Arlington, Va.-based Surescripts, said that the regulations around schedule II are much more restrictive.
"What it means is that to write a prescription for schedule II there are only two ways to do that, one is with wet ink signature (a paper-based prescription handed to the patient) and the other is with e-prescribing, any other means of prescribing such as phone calls, or faxes is not permitted for schedule II," said Yakimischak.
Yakimischak says the e-prescribing component is something Surescripts has been involved with for several years, even before the DEA put out its interim final rule. There are changes needed at the electronic medical record level, at the medical practices, in the Surescripts network and at the pharmacy.
"It's a pretty extensive set of changes that have been put in place and those changes have been implemented over the course of the last three years, but we still have a ways to go," he said. "It's not like the job is finished and everyone is 100 percent ready."
Currently about two-thirds of the pharmacies are fully ready, online receiving electronic prescriptions of controlled substances. Now, with the DEA's new final rule, EMR vendors and medical practices have to step up their games when it comes to the security that's required by DEA , especially with regard to identity management and factor authentication.
Identity management is a very strong ID proofing and issuing of a digital credential that ties that credential to that person.