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11 Articles in Volume 10, Issue #6
Assessing Pain of the Pediatric Patient in the Emergency Setting
Testosterone Replacement in Chronic Pain Patients
Why Some Patients Require High Dose Opioid Therapy
Raising Pain Tolerance Using Guided Imagery
Long-Standing Groin Pain in a Male Athlete
FDA’s Proposed Risk Evaluation and Mitigation Strategy (REMS) for Opioids
Platelet Rich Plasma Prolotherapy as First-line Treatment for Meniscal Pathology
Cluster Headache
Effectiveness of Laser and Non-Coherent Light Therapies
Opinion on Preliminary Guidelines for the Clinical Diagnostic Criteria for Fibromyalgia
Doctors May Now Electronically Prescribe Schedule II Drugs

Doctors May Now Electronically Prescribe Schedule II Drugs

An in-depth look into the past, present and future of the electronic prescribing of controlled substances.

We have had many inquiries from pain management doctors wanting details of the Drug Enforcement Agency’s (DEA) lift of the ban on ePrescribing Schedule II drugs. The DEA has sent you a letter with the announcement that makes such ePrescribing legal starting June 1, 2010. How did this finally happen and what does it take for you to incorporate ePrescribing into your daily workflow? The following article by Dr. Peter Kaufman, Chief Medical Officer of DrFirst, provides interesting detailed information you will want to know so you can be ready to incorporate this into your daily workflow. ePrescribing is one of the most important pieces of the American Recovery Reinvestment Act (ARRA) that allows doctors to be eligible for federal stimulus dollars towards the purchase an electronic health record (EHR) system. ePrescribing is here to stay and will directly affect your day-to-day operations, so start planning how you can incorporate this into your facility.

In May of this year, physicians across the country received the letter many have been waiting for—a letter from the Drug Enforcement Agency stating that as of June 1, 2010 all Federal restrictions against the use of electronic prescribing for controlled substances (Schedule II – Schedule V) would be lifted. Even though we witnessed a 181% increase in the use of e-prescribing nationwide from 2008 to 2009, the DEA’s outright ban on e-prescribing for controlled substances has been the last great barrier to electronic prescribing adoption over the last 10 years.

Although this notification was received by our country’s doctors with open arms, there were still countless questions left unanswered. What took so long to get this law lifted? Now that this is “legal,” is it “possible?” What do I need to do to ensure that I am ready to e-prescribe controlled substances as soon as possible?

Easing the minds of some skeptical physicians and reinforcing the DEA’s most recent announcement, Thursday, June 3, 2010 marked the beginning of a new era in e-prescribing with a public demonstration of the nation’s first end-to-end electronic controlled substance prescribing system at the 2010 AHRQ Annual Health IT Grantee and Contractor meeting in Washington, DC. This innovative pilot system has been operational in Berkshire County, Massachusetts since September 14, 2009 under the auspices and guidance of the Massachusetts Department of Public Health—the Principal Investigator for this AHRQ grant. Dr. Tom Sullivan, Chief Strategic Officer at DrFirst, conducted the demonstration to show the success of this pilot program and to present the culmination of years of hard work and perseverance from the many organizations involved.

History of Electronic Prescribing

Before diving into detail about this pilot program and the technological innovations that it spawned, it is important to understand the history of electronic prescribing and exactly why this issue was so pressing for so many people.

Over the past several years, doctors, payors, and patients have all begun to realize the patient safety, efficiency and financial benefits of adopting an electronic system for routing prescriptions to the pharmacy and for handling renewal and refill requests as they come in from the pharmacy. Renewals handled through e-prescribing systems drastically reduce phone calls and faxes by transforming this extremely time-consuming process into only a few clicks on their computer thus saving office staff hours every day otherwise spent handling phone calls and faxes from pharmacies. Additionally, modern systems are capable of checking a patient’s insurance information at the point of care to prevent them from paying an unnecessary cost at the pharmacy (and eliminating additional phone calls and faxes) as well as prevent countless adverse drug reactions.

To further catalyze the adoption of e-prescribing, Medicare implemented an incentive program in 2009 to provide financial reimbursements for those physicians that accurately documented their use of an e-prescribing system for their Medicare patients.

With these benefits driving the adoption of e-prescribing on a national level, the DEA’s ban on using this technology for controlled substances prevented a large segment of the market from being eligible to benefit. To provide a sense of scope to this market, controlled substances make up roughly 11% of all prescriptions written and controlled-substance prescriptions are written by roughly 90% of all providers. To make matters worse, some specialties such as pain management physicians write primarily controlled substance prescriptions. With this said, it is evident that this ban creates a problem for a majority of providers that wished to use an electronic system. The inability to sign and send a controlled drug electronically created the need for a provider to implement two office workflows: one for the controlled substances that must be dealt with by hand and one for all other electronic prescriptions. This inconsistency in workflow ultimately negated the benefits of electronic prescribing as a whole.

Until recently, the Drug Enforcement Agency had placed an outright ban on using this helpful technology for controlled substance prescribing fearing that the systems in place were not secure enough to be trusted with highly abused and addictive medications.

Industry leaders were aware that this absence of approved standards directly contributed to the delay in realizing the potential patient safety, risk reduction and clinical benefits that are made possible through the use of e-prescribing. It was known that in order for e-prescribing and healthcare IT as a whole to become the norm there must be a cooperative agreement between vendors, users, and the DEA to permit the e-prescribing of controlled substances. What everyone needed was a solution to this problem that would enable them to reap the benefits of an electronic system without slowing down their entire office.

The EPCS Project: Birth of ePrescribing

Following talks at a 2006 symposium held by the DEA, the spark was lit when industry leaders, including DrFirst, met with the DEA to discuss a safe and measureable way to enhance the security and accountability of the existing e-prescribing infrastructure to overcome the DEA’s concerns. This critical meeting and several that followed eventually led to a proposal from the Massachusetts Department of Public Health, DrFirst, BrandeisUniversity and Berkshire Health Systems. This Electronic Prescribing of Controlled Substances (EPCS) pilot program was funded by the Agency for Healthcare Research and Quality (AHRQ) and granted a waiver by the DEA to electronically sign and transmit controlled substance prescriptions.

The DEA identified a set of security concerns that had to be addressed by the solution created by the EPCS. The first and most pressing of these issues was authentication. It was imperative to have the ability to positively identify the signer of any prescription and to be able to correctly identify those that either send or receive all controlled substance prescription data. Non-repudiation was another concern as the system would have to ensure that any and all parties involved in a prescribing activity could not reasonably deny their participation. The DEA also stressed the need for a high level of record integrity to ensure that the prescription’s data and signature have not been tampered with or altered after the prescription has been signed. Due to the potential legal ramifications of this pilot program and the DEA’s concern with drug abuse, all systems in place had to have the legal sufficiency for the DEA to successfully prosecute if a misuse occurred—remember that the “E” in DEA stands for “Enforcement.” The DEA’s requirements were designed to prevent diversion to the maximum extent possible and to allow successful criminal investigation and prosecution of any diversion that does occur. The final DEA requirement was for all information to be confidential. Only authorized persons were allowed to have access to any of the data from the EPCS project.

For both the EPCS project waiver and the DEA’s notice of proposed rule making (NPRM), which occurred at approximately the same time, the DEA required 2-factor authentication using a hard token. In the more recent interim final rule, they have relaxed this requirement a bit; more on that later.

The EPCS chose Berkshire County, Massachussets, as the ideal location to host this pilot due to its relative geographic seclusion providing a controlled and extremely measureable environment, as well as its groundbreaking controlled-drug management program. eRx Network provided a safe and secure connection to pharmacies in the county that were willing to step forward and participate in this unprecedented event.

The specific aims of the pilot included developing and verifying a system to allow safe and secure EPCS, linking the system with the existing Massachusetts Prescription Monitoring Program for Schedule II controlled substances, conducting evaluations of process and outcomes (including improvements in patient care, risk reduction, patient and clinician benefits, patient safety and confidentiality), and disseminating the findings accordingly. In addition to these goals, the team focused on keeping the process simple and within the existing practice workflow, maintaining consistency between e-prescribing systems and pharmacies, introducing multiple validation checks, and ensuring there were no changes in responsibility associated with dispensing controlled drugs.

To fulfill these goals, the project team implemented a solution to the new two-factor authentication system needed to allow providers to send controlled substance prescriptions. The EPCS introduced the use of a ‘crypto key’ that, when paired with a unique password, provides the necessary two-factor authentication. A crypto key looks similar to a USB “thumb” drive and is given to each prescriber to be used with the sending of any controlled medication. Using this method, the system bound each physician, PA, or nurse practitioner to his or her unique key, and each individual prescription to its point-of-care vendor. This level of security and transparency helped appease the many security concerns because it enables detailed audits to be generated and made available to the DEA, pharmacy boards, and local and federal law enforcement agencies.

With the new system in place, and physicians and pharmacies on board, the EPCS team was able to finally test their pilot, and after much anticipation, at 12:05 pm EDT on Monday, September 14, 2009, PrakashDarji, MD, of Berkshire Medical Group, sent the nation’s first DEA-approved prescription of a controlled substance electronically, using DrFirst’s Rcopia e-prescribing application. While there have been prior prescriptions sent within closed federal systems, this was the first sent from a physician to a pharmacy using what is most commonly considered the e-prescribing infrastructure.

With the first successful prescription underway, the barrier had been lifted, and the once-blocked trail to the widespread adoption of EPCS had been cleared. The DEA witnessed first-hand how a system, such as DrFirst’s Rcopia, could be enhanced to meet all of their safety and security requirements.

DEA’s Interim Final Rule

On March 24, 2010 the DEA released its Interim Final Rule (IFR) on electronic prescribing for controlled substances, which incorporated the public comments received on the proposed ruling since June of 2008. This rule was written to permit pharmacies to receive, dispense, and archive electronic prescriptions for controlled substances and immediately sparked conversation regarding when it would finally be possible for physicians to freely write controlled drugs using their e-prescribing systems.

The IFR contains a few very significant changes from the NPRM. First of all, it does not require the use of a Crypto key as the sole solution for 2-factor authentication. Also allowed are biometric and one-time password authentications. Other changes are mostly “behind-the-scenes” for users and won’t be discussed here, but will delay the ability of anyone outside the EPCS pilot to actually send controlled-drug prescriptions electronically for a number of months.

Just a few months after the release of the Interim Final Rule the DEA wrote and mailed a letter to every physician with a DEA number stating that EPCS would officially be legal on June 1, 2010. The DEA’s regulation that took effect on June 1st allows prescribers the option to write prescriptions for controlled substances electronically and allows pharmacies to receive, dispense, and archive these electronic prescriptions. The regulation will act to reduce paperwork for pharmacies registered by the DEA and have the potential to reduce prescription forgery. Additionally, the regulations have the potential to reduce the number of prescription errors and will help integrate prescription records into other medical records.

Within weeks of the mailing of the DEA’s letter, Dr. Tom Sullivan had already publically demonstrated this new technology at the 2010 AHRQ Annual Health IT Grantee and Contractor meeting in Washington, DC. With a crowd of a few hundred attendees, Dr. Sullivan was able to put to rest the confusion of the long winded ‘rules’ and letters and was able to finally show people how the pilot system looks, feels and works.

Nationwide System Implementation

Although the system has been proven to be successful in this test environment, there is no industry-wide infrastructure currently available to send the prescriptions through to pharmacies, nor can pharmacies accept them. Although this critical step has already been taken by DrFirst, Inc. and the rest of the EPCS pilot team, collaboration is still needed to transplant this technology from the pilot environment into a nationwide standard.

To be implemented on a national level, it is important to understand the authentication process that doctors will need to perform in order to become eligible. To begin with, the physician’s interaction with the DEA will remain the same—they will only need to obtain a DEA number. As we now know, the sending of controlled substances will require a certified two-factor authentication for each provider. The certification and distribution of the Crypto key, which was done by DrFirst in the pilot, will now be handled by a third-party entity. Additionally, certification can either be done in a face-to-face setting, or remotely by providing some type of specific information (such as financials) or can also be done by a physician’s institution (hospital or health system). Once this has been completed, the doctor will able to satisfy the two-factor requirement. Access control certification is the next step in the process and will tie the third-party authentication to the software vendor, notifying the system that they have obtained the credentials needed to prescribe controlled drugs electronically.

America’s pharmacies also must make upgrades to their systems if this technology is to be used. Vendors, intermediaries —such as Surescripts and eRx Network—and pharmacies are required to add a ‘flag’ into their software’s data structure that will show whether or not a prescription has been 2-factor authenticated. The prescription must be digitally-signed when received, but not necessarily by the dispensing pharmacy. This step will most likely be handled by a number of pharmacy software vendors or pharmacy chain headquarters and will complete the transaction.

Even though there is still work to be done, the most difficult hurdle in the way of prescribing controlled drugs electronically has been passed, and we can all now focus on scaling these solutions for widespread use. We could not be more excited with the recent progress and with the collective efforts of the entire ECPS team. With these advances, we are closer than ever to reaching the full potential of today’s healthcare IT systems.

To view the demonstration at AHRQ online, visit www.youtube.com/drfirst.

Last updated on: January 28, 2012
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