Tom Sullivan, M.D.

The Prescriber Role in Controlled Substance Fraud, Abuse and Clinical Workflow Considerations

Much has changed in the prescriber and the clinical IT vendor communities since the DEA issued the Interim Final Rule in early 2010, making electronic prescribing for controlled substances (EPCS) legal at the federal level. For instance, the White House’s decision to highlight the controlled substance drug abuse epidemic and crisis has spurred state legislators and regulators to pass new laws and strengthen existing regulations, such as the regulations that govern the state PDMP registries mentioned in earlier installments of this series. Some of the most far reaching changes have resulted in significant new obligations on physician practices, as well as EHR and EPCS vendors.
Prior to the 2010 IFR, it was generally the responsibility of the dispensing pharmacy to act as the first line of defense in detecting and addressing fraud, abuse, and diversion through strict reporting rules, in addition to its obligation to contact providers or their offices should questions arise over a given prescription. The requirement for detailed, organized audits, paper record keeping, and other protocols had already been in place for some time. The arrival of EPCS has added a series of new responsibilities to physicians and their software vendors. These new responsibilities include: very strict third-party identity proofing, new requirements for 2-factor authentication (often including a “hard token”), certification of the vendor application, and comprehensive electronic audit trails.
In addition to those federal requirements, some states have recently updated their PDMP to near-real-time reporting and secure web availability for all dispensed controlled substance drugs. New York in particular has enacted and recently implemented a mandatory “Duty to Consult” law, though certain waivers are permitted. I expect this will have a significant—and largely beneficial—impact over the next year and beyond, and will do much to help address the controlled substance problems in the state of New York.
Nevertheless, state authorities need to recognize the importance of working with the healthcare IT industry to minimize “the number of clicks” necessary to utilize any given technological solution, while also accomplishing the laudable objective of helping to curb abuse and illegal diversion of controlled drugs. It’s my opinion that these new regulations, along with other trends, have a potential downside in the form of disruptions to physicians’ workflows that could hamper productivity and efficiency across the healthcare industry.
Over the past 20 years, physicians have been paying much greater attention to workflow efficiency. There are so many interruptions and nonclinical obligations in most physicians’ offices today that a large percentage of practicing doctors have become angry and frustrated with a healthcare system that limits the amount of time that they devote to direct patient care. Unfortunately, these frustrations have been exacerbated by recent clinical information technology incentives, penalties, and software requirements that distract these highly-trained individuals from making the best use of their time. The time that physicians spend wrestling with technology is time they cannot spend with their patients. In fact, it is well documented that the burnout rate for physicians is approaching 30-40%, an unacceptable and astonishingly high rate. Clinical IT requirements, healthcare IT usability, and the demands on physicians’ time are all contributing factors to the high burnout rate among doctors, especially among more experienced practitioners, who did not grow up with computers and the Internet.
For these reasons, it’s extremely important that every mandate, incentive, and penalty for clinicians is carefully considered and implemented only after the completion of credible pilot programs. Additionally, there must be a mechanism for constructive feedback, and in some cases delays in deadlines when physicians, their organizations, and the vendor industry have demonstrated the need to make changes to newly instituted statutory programs.
DrFirst has been a proactive leader at both the regional and national levels in designing clinician-oriented, workflow-optimized, and easy-to-use healthcare software designs. We also have a strong history of collaboration with legislators and regulators as they craft new policies and regulations, helping to educate them about the importance of efficient workflow.
In fact, when asked to give a presentation last year to Dr. Farzad Mostashari, former director of the ONC, as well as his sub-committee, I reminded Dr. Mostashari of the wisdom behind what is widely accepted as the first rule of patient care, namely: “Primum Non Nocere” meaning “First of All, Do No Harm.”
Given the observations mentioned above I suggested a contemporary, new rule, namely: “Secundum, Tardus Ne Me,” which, translated from the Latin, means “Second of All, Don’t Slow Me Down.”
I hope that the brief humor generated by that comment, which was instantly Tweeted by Dr. Mostashari, will remind legislators, regulators, software designers, and policy makers that workflow efficiency is a serious industry concern.

1. The Controlled Substance Epidemic and Crisis
2. PDMP – What is it?
3. EPCS – What’s New?
4. Which one is more important…PDMP versus EPCS?
5. The Physician and prescriber role in Controlled Substance Fraud and Abuse