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.
[See also: eRx worthwhile, but still problematic for docs, pharmacies]
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.
"The second part," said Yakimischak, "is a two-factor authentication. It's no longer good enough for EPCS to just be using a password or just be using a biometric or a token or a key, you have to use two out of those three."
Yakimischak explains that there's some cost involved in the issuing of credentials and the software itself. Any time there's an upgrade now that has to happen in the field, that tends to be one of the slowest pieces, he adds, because with these upgrades vendors usually don't just bring out an upgrade for one thing.
"They put in a package of things, twice a year, that has a 100 different new features and the deployment of those," he said. "They have to go through a testing period and then the practice may have to go through some effort to migrate their data, so it's the deployment of this software that is usually the last leg of the puzzle."
As more and more physicians opt for e-prescribing for controlled substances, Kelly is hopeful that this will make it more convenient for chronic pain patients to get the medication they need.
"EPCS makes it easier for physicians to write prescriptions for patients in need while at the same time creating a better security system with an audit trail to prevent over-prescribing of controlled substances for patients who may or may not need them," he said.
The DEA, along with other medical professionals, contends that e-prescribing, including for controlled substances, offers many benefits such as an authentication trail and features that check for drug-drug interactions, allergies and confirmation that the patient is getting the right medicine.
In addition, EPCS can have an impact from a monetary and regulatory standpoint. Kelly points out that there are a number of hospital systems right now that are interested in electronic prescription of controlled substances not just because of this issue around drug diversion and security, but also to help meet meaningful use goals.
"About 13 percent of prescriptions are for controlled substances, so enabling EPCS can help meet meaningful use targets for e-prescribing," he said.
"Stage 2 says that more than 50 percent of prescriptions need to be electronic, so EPCS can help meet these goals," said Kelly. Conversely, not having a system for EPCS in place can make it very hard to meet these numbers.
Physicians, he explains, typically don’t like having to go through two workflows, so they will often default to manually writing prescriptions, even if they have an e-prescribing solution for non-controlled substances. For example, if a patient is discharged with 10 prescriptions and even just one is for a controlled substance, a physician will likely manually prescribe all 10.
While many in the healthcare community applaud the schedule change, others believe that it will ultimately have a negative impact on patients.
John Norton, director of public relations for the National Community Pharmacists Association, said NCPA is not surprised but disappointed with the DEA’s final rule rescheduling hydrocodone combination products.
"While everyone agrees that the level of pain medication abuse is way too high, the challenge is finding remedies that don’t hinder access for patents with legitimate pain needs, especially in long term care settings," said Norton. "For example, a greater effort needs to be undertaken to crack down on the small percentage of prescribers who are driving the problem. We will continue to work constructively with the DEA to find the most effective policies possible."
Thomas E. Menighan, executive vice president and CEO of the American Pharmacists Association added that, while APhA "recognizes the significant public health threat posed by the abuse and misuse of prescription drugs," the group is "concerned that rescheduling hydrocodone-combination products will significantly impact access to pain medication for patients with legitimate medical needs and will ultimately increase health care costs at a time when policymakers are seeking ways to reduce costs."
