The amount of prescription painkillers sold in the U.S. has been skyrocketing since 1999. According to Dr. Tom Frieden, director of the Centers for Disease Control and Prevention (CDC), the number of painkillers prescribed was four times higher in 2010 than in 1999. “In fact, enough prescription painkillers were prescribed in 2010 to medicate every American adult around-the-clock for one month,” he wrote in The Huffington Post. If that’s not startling enough, the CDC reported between 1999 and 2014, more than 165,000 Americans have died from overdoses related to prescription opioids. “Deaths from prescription painkillers are now more than twice as common as those attributed to heroin and cocaine combined,” Dr. Frieden noted.
In response to the high number of overdoses, federal agencies have provided new safety guidelines. The CDC issued new guidelines earlier this month for prescribing opioids for chronic pain. These are geared towards primary care physicians, who prescribe almost half of all opioid medications, according to the agency. The three key recommendations include:
- Choosing non-opioid therapy for chronic pain except in cases of cancer, palliative, and end-of-life-care;
- Prescribing the lowest opioid dose possible; and
- Exercising caution when prescribing opioids and monitoring patients closely.
There is also a decision checklist available for providers to help with implementing the recommendations.
Shortly after the CDC issued their guidelines, FDA announced it would require strong safety label warnings on opioid medications. According to Reuters, short-acting opioids will require labels with the strongest warnings about risks of misuse, addiction, overdose, and death. The agency will also require the warning to note chronic use of these opioids during pregnancy can cause neonatal opioid withdrawal syndrome – a potentially life-threating condition. Additional safety label changes will also be required for all prescription opioid medications to include more risk information.
New York’s Prescription Monitoring Program
New York’s I-STOP, the Internet System for Tracking Over-Prescribing, was passed by the New York legislature in 2012. The law has several mandates, but a key one that went into effect March 27 requires New York providers to submit all prescriptions electronically.
Since 2013, a previous I-STOP mandate required prescribers to consult the state’s prescription monitoring program (PMP) before writing prescriptions for Schedule II, III, and IV controlled substances, such as OxyContin, Vicodin, and Xanax, respectively. So far, the program has been effective in reducing prescribing controlled substances for non-legitimate reasons, according to Forbes.
However, some providers, like Dr. Joanna Starrels, an assistant professor of medicine at Albert Einstein College of Medicine, note the PMP is limited to NY pharmacies’ data and doesn’t provide data about prescriptions filled in neighboring states, where patients often “doctor shop” to obtain multiple controlled substance prescriptions. Although, in Forbes, she praised the system overall stating, “New York’s PMP is a model for other states, in that pharmacies report nearly in real-time and it includes data such as the pharmacy and the method of payment.”
Oklahoma controlling opioid prescriptions with real-time reporting
New York is only the second state to require real-time reporting. Oklahoma has a mandate that was implemented in 2012 that requires real-time reporting; defined as within five minutes of the point-of-sale of a controlled substance prescription at a pharmacy or other dispenser. In addition, Governor Mary Fallin signed H.B. 1948 last April which requires doctors to check Oklahoma’s PMP before prescribing for a patient the first time and to check every six months thereafter for three classes of potentially addicting medications: opiate painkillers, anti-anxiety medications, and the muscle relaxant carisoprodol.
This new law was very much needed. Since 2013, according to an editorial in The Oklahoman, there were 9.6 million prescriptions filled for controlled substances but the PMP was only checked 1.5 million – roughly once for every six prescriptions filled. There were 788 deaths attributed to overdoses the same year with at least 593 involving one prescription drug. Oklahoma has the sixth-highest unintentional drug overdose death rate in the nation.
Don Vogt, the program manager for Oklahoma’s Prescription Monitoring Program, told Healthcare Dive that since HB 1948 was only enacted in November 2015, the data is too preliminary to decipher how it’s affected e-prescribing of controlled substances. Vogt also said Oklahoma was the first state to develop and use a prescription monitoring program – going back to the early 1990’s.
EPSC: Challenges and Benefits
Today, all 50 states allow e-prescribing for all controlled substances (EPCS). Surescripts, a health information networking company that routes e-prescriptions to pharmacies, reported as of March 1, New York had 47% of total prescribers enabled to electronically prescribe controlled substances and 58% are already electronically prescribing in general. In addition, 95% of New York pharmacies are able to accept prescriptions for controlled substances. This represents a big uptick from a year ago when the state had less than 2% enablement.
Part of the reason New York was able to step up efforts so quickly, according to Surescripts, is because EHR software vendors serving the majority of New York prescribers are already certified to process controlled substance prescriptions electronically. Providers aalso had an extra year to prepare since the law’s implementation date was delayed due to software security issues, according to The New York Times. Yet, although those security issues have been resolved, there are still some large medical centers that have applied for waivers asking for more time past the March 27 deadline, including Montefiore and Mount Sinai Health Systems.
DEA requirements for prescribers
One of the challenges with the new software for EPCS involves DEA security requirements, Dr. Sean Kelly, CMO at Imprivata, told Healthcare Dive, “The DEA has made it pretty hard to be compliant with the e-prescription rules so that’s a big 'if' whether systems can make their technology good enough to be usable for the providers, but still be DEA compliant.” Dr. Kelly explained the agency’s requirements start with a supervised enrollment of prescribers. “You have to make sure it’s really the person being enrolled into the system with fingerprints – and witnessed by someone at the hospital level.”
Lisa Rabideau, RN and Clinical Informatics Manager of the University of Vermont Health Network Champlain Valley Physicians Hospital, a rural, 330-bed hospital, said her hospital was one of the first to go live with Imprivata’s two-factor authentication solution, Confirm ID, which has been integrated into the hospital’s EHR system. She said the hospital limited those who are administrators of the authentication program to three people to ensure everything is done correctly since the “DEA regulations are very strict.”
Rabideau told Healthcare Dive her hospital has been e-prescribing all medications, including controlled substances, since April 2015. Overall, “most patients like it better when their prescription is ready when they get to the pharmacy,” she said. Some have complained they can no longer price shop for their medications although they can still choose any pharmacy that accepts the EPCS.
Every time a controlled substance is prescribed, it has to go through two authentications, explained Dr. Kelly. “One can be a username and password, and the other can be either a fingerprint or a one-time token via an app on a smartphone. That’s a bit of a hassle for physicians compared to just scribbling down a prescription on a piece of paper.” However, he added having the DEA requirements will help with the opioid misuse issue because at least 10% of prescribers have their DEA number stolen...it’s not hard to forge those. Furthermore, “the data is safer is it’s electronic, DEA-compliant and HIPAA-compliant. If there’s an electronic system, it’s all locked-down and easy to see who OK’d which prescription.” Once authentication is completed, the prescription is routed, which also has to be DEA-certified and then on to the pharmacy, which needs to be DEA-certified as well.
Smaller practices may have some challenges with the new requirements, said Dr. Kelly. “There’s a big onus on the smaller practices to try to get the new technology in place." Some providers are frustrated, added Rabideau, because they paid for software that isn’t ready yet to work with the EPCS program.
New York may serve as national role model
Nevertheless, Dr. Kelly said other states are considering similar programs to NY’s I-STOP. “Everyone is watching to see what happens in New York. Almost every state is pushing to do at least the first part of I-STOP, which is to require providers to check the prescription monitoring program as a first step.” He noted the high adoption of e-prescribing of other medications has increased up to 90% in almost every state – establishing the trend of an e-prescribing workflow.
Both Kelly and Rabideau seem optimistic about the I-STOP program. “I think in the long run it’s good. The move to use technology to create a more transparent and accountable prescribing process is a good thing,” Dr. Kelly concluded. Rabideau is hopeful the program will “at least make it more difficult for patients to get controlled substances,” although she acknowledges it’s a challenge for patients with chronic pain. Since many pain medications have been taken off the market because of side effects, she said, “there are fewer options now for patients with pain. It’s either Tylenol, which can kill your liver, Advil that can kill your kidneys, or opioids which can get you addicted. There aren't a whole lot of choices.”