LAS VEGAS — Prescription drug overdoses are responsible for more deaths in the United States than gun, knife, and motor vehicle injuries combined, with those involving opioid analgesics increasing 300% since 1999.
Approximately 260 million opioid prescriptions were written in 2012 alone, Surescripts data indicate. “That’s about one bottle of prescription-strength painkilling medication out there for every American, which is a staggering amount when you think about it,” said Sean P. Kelly, MD, an emergency medicine specialist at Beth Israel Deaconess Medical Center and an assistant clinical professor of emergency medicine at Harvard Medical School, both in Boston.
Curbing the ongoing opioid epidemic, which Dr. Kelly called “unprecedented in scope,” will require a multifaceted attack. “One approach is to catch the problem upstream, at the moment of prescribing,” he said.
As the Chief Medical Officer of Imprivata, a software company involved in developing prescriber authentication technology to comply with Drug Enforcement Administration (DEA) standards for electronic prescribing of controlled substances (EPCS), Dr. Kelly works regularly with electronic health record (EHR) vendors to identify workflow solutions to inefficiencies in the prescribing process that make controlled substance misuse and diversion more likely.
“Getting better at understanding who we are prescribing to and how much we are prescribing is part of that,” Dr Kelly said. “We need a more transparent, easier to use, and safer system that leverages good technology.”
Paper-based prescription systems are susceptible to fraud. Approximately one in 10 prescribers will have their DEA number forged and will need to go through the process of getting a new one at some point in their career, according to Dr. Kelly.
In addition to security concerns, paper-based systems pose challenges for gathering metrics for meaningful use e-prescribing requirements. In the current environment, many prescribers of controlled substances are creating dual workflows—one for paper prescriptions and one for electronic—which introduces greater potential for errors, delays, and decreased provider and patient satisfaction.
“As many as 60% of patients being discharged from the hospital or emergency department have at least one prescription for a controlled substance. If a patient leaves with multiple prescriptions, and one is for a controlled substance, many providers will convert the whole batch of prescriptions to the print prescription workflow,” explained Dr. Kelly. “This goes against meaningful use guidelines, and the provider is losing credit for the 4 prescriptions that could have been done electronically.”
In response to the need for more secure and efficient prescribing processes, the DEA first set forth regulations for EPCS in 2010, requiring all EPCS to be approved by the State Board of Pharmacies. The pharmacies used must be certified to accept controlled-substance prescriptions, and the EHR or third-party vendor that handles processing electronic prescriptions must also be certified for controlled substances.
In addition to these regulations, participating subscribers must undergo identity proofing for supervised enrollment in an EPCS program at either an institutional or individual level and must use a system called two-way authentication, which Dr. Kelly has been instrumental in developing, to ensure that the correct provider is authorizing the controlled-substance prescription.
Two-way authentication requires prescribers to meet two of the following requirements at the point of writing the electronic prescription: something you know (ie, a password or token), something you are (Federal Information Processing Standard [FIPS]-compliant fingerprint biometrics), or something you have (FIPS-compliant token or hands-free authentication via a password-protected software application).
“The DEA requires a witness at the hospital level who signs off that the fingerprint is authentic and specific to the prescriber, and one other person in the hospital who has a DEA number who testifies that our process is complete,” explained Dr. Kelly. “Two-signature verification is required for supervised enrollment, which allows the fingerprint to be logged into the software system or a token to be assigned. This confirms, ‘I am who I am, and I’m logged into the system correctly.’”
He said the same procedure can be mimicked in smaller private practices, with a practice manager or lead physician serving as the witness or via a third-party credentialing service provider.
Since the DEA first issued its guidelines, uptake of EPCS has varied by state. In 2015, there were 2.1 million EPCS, with New York accounting for 54%.
As of August 27, 2013, most prescribers in the state of New York are required by law to consult the Internet System for Tracking Overprescribing-Prescription Monitoring Program (I-STOP/PMP) Registry when writing prescriptions for schedule II, III, and IV controlled substances. Legislators there have also made it mandatory to use EPCS by March 27, 2016.
If done correctly, EPCS offers substantial benefit to health systems, physicians, and patients. Health systems have an opportunity to improve patient satisfaction, lower fraud risk, enforce state and federal regulations, and better meet meaningful use e-prescribing requirements.
For physicians, EPCS offers the potential to eliminate dual workflows, reduce errors and fraud, limit exposure of their DEA number, and improve patient satisfaction. For patients, EPCS has the potential to improve overall satisfaction, increase medication adherence, reduce trips to the physician’s office, and reduce wait times at the pharmacy.
“We’ve reach a critical mass. Technology is getting better and we are now getting to the point where there is a strong push toward adopting EPCS,” Dr. Kelly concluded.