Tricia Lee Wilkins, PharmD, PhD

: The objective of this study is to present the first information available regarding enablement and use by state and area characteristics of electronic prescriptions of controlled substances (EPCS) by prescribers and pharmacy systems in the United States using 15 months of transactional data, from January 2014 to March 2015, from an e-prescribing network.

: The data used in this study represent electronic transactions of controlled substances from all states and the District of Columbia, from Surescripts. Data in this analysis include prescriber enablement for EPCS, pharmacies with certified and audit-approved software enabled to receive EPCS transactions from prescribers, and number of EPCS transactions. In addition, area characteristics were determined using the Area Health Resource File to define metropolitan and non-metropolitan areas.

: During the study period from January 2014 to March 2015, pharmacies enabled for EPCS grew minimally, from 78% to 79% nationally. National EPCS enablement among prescribers increased 3.7%, from 0.6% to 4.3%. Differences were observed between metropolitan and rural counties. The percent of transactions nationally grew from 0.16% to 1.8% during the study period, more than a 10-fold increase in transactions.

: There has been progress in the adoption and use of EPCS. However, there are marked differences at the state level and between urban and rural areas. EPCS is an important tool to help prescribers provide better care for their patients. Additionally, EPCS provides a complete electronic record of controlled substance prescriptions, critical for public health and law enforcement initiatives that address the misuse and diversion of opioid medications.

The growth of the prescribing of controlled substances over the past decade has paralleled the growth of prescription drug addictions and overdoses in the United States.

There is an increasing association of controlled substances, especially opioid analgesics, with drug overdose deaths, misuse, and drug diversion. The highest rates of death, opioid sales, and nonmedical use are clustered in the Southeast, especially the Appalachian region, and in the Northwest.

 Overdose rates also vary by urban-rural county type, with more rural areas having higher overdose death rates for prescription opioids compared with urban areas.

Until recently, controlled substances were not permitted to be e-prescribed.

 Currently, a prescriber is able to issue electronic prescriptions for controlled substances (EPCS) only when the electronic prescription or electronic health record (EHR) application the practitioner is using complies with the requirements set forth in The Drug Enforcement Administration Interim Final Rule (IFR) passed in 2010.

The rule requires prescribers to apply to certain federally approved credential service prescribers or certification authorities to obtain their 2-factor authentication credential or digital certificate. Additionally, the IFR set out security requirements for providers and pharmacies to lawfully send and receive EPCS.

These security requirements include: (a) an in-person or remote knowledge-based identity proofing process for providers, (b) use of a 2-factor authentication procedure by providers when creating and transmitting an EPCS, (c) use of a digital signature associated with each EPCS transaction, (d) pharmacy capability to digitally sign or receive digitally signed EPCS and store records of such transactions, and (e) the required completion of a third-party audit by both e-prescribing vendors and pharmacy system vendors. If these requirements are met, prescribers are now legally able to electronically send controlled substance prescriptions to pharmacies for dispensing.

Currently, all 50 states and the District of Columbia allow EPCS. Missouri was the most recent state to allow EPCS, with updated controlled substance rules and regulations enacted in July 2015.

 In states where EPCS is legal, all states allow the electronic prescribing of Schedules II-V. New York is the only state that has required mandatory EPCS.

The New York legislature required the date of implementation of this public health law begin March 2016. This will require practitioners to become compliant with the requirements, including the registration of their software applications with the Bureau of Narcotic Enforcement.

 This mandate applies to all New York pharmacies, including rural areas.

Health information technology (health IT), and specifically EPCS, offers the potential to help enhance prescription monitoring and support patient care. EPCS can play an important role in delivery of care by eliminating paper-based fraud and improving work flow to reduce error.

The ability to electronically prescribe controlled substances provides prescribers and their patients the same benefits made possible by e-prescribing, most importantly access to enhanced safety features and clinical decision support. From a public health perspective, the additional security requirements necessary for EPCS are a crucial step towards curbing fraud and diversion that contribute to prescription drug abuse.

 This is because EPCS can support data sharing by prescribers to facilitate appropriate prescribing and improve clinical decision making.

Due to the federal and state-level policy initiatives, it is important to explore the national and state level trends of EPCS. The objective of this study is to present the first information available regarding enablement and use by state and area characteristics of EPCS by prescribers and pharmacy systems in the United States, using 15 months of transactional data from January 2014 to March 2015 from an e-prescribing network.

The data used in this study represent electronic transactions of controlled substances from all states and the District of Columbia from Surescripts, an e-prescription network utilized by a majority of chain, franchise, and independently owned retail pharmacies in the United States. This analysis describes prescriber enablement for EPCS, pharmacies with certified and audit-approved software enabled to receive EPCS transactions from prescribers, and number of EPCS transaction trends from January 2014 to March 2015. We also describe EPCS trends in urban and rural areas.

To determine prescriber enablement for EPCS, we included physicians, nurse practitioners, and physician assistants as prescribers. Using transactional e-prescribing network data as the numerator, we examined trends in the number of pharmacies enabled to accept EPCS, the percent of prescribers enabled to electronically prescribe controlled substances, and the percent of EPCS transactions as measured by dividing the number of total EPCS by the denominator of total controlled substances prescribed.

Counts of total controlled substance prescriptions (electronic and non-electronic) were obtained from the National Association of Chain Drug Stores (NACDS) and used as the denominator to calculate percent EPCS transactions.

 NACDS provides total counts of all electronic and non-electronic controlled substance prescriptions routed through all community pharmacies in the United States.

Area characteristics were determined using the Area Health Resource File to define metropolitan and non-metropolitan areas within each state.

 Metropolitan counties are defined as those that contain a core urban area with a population of at least 50,000, while non-metropolitan counties are defined as those that have a core urban area of less than 50,000, including those counties that are in non—core-based statistical areas.

During the study period from January 2014 to March 2015, pharmacies enabled for EPCS grew minimally, from 78% (46,711 pharmacies) to 79% (47,971 pharmacies) nationally. State enablement varied greatly. For example, pharmacy enablement by state ranged from 30% to 92% in March 2015. Rhode Island had the highest rate of pharmacy enablement for EPCS (96%) and North Dakota had the lowest (30%) (data not shown).

National EPCS enablement among prescribers increased 3.7%, from 0.6% to 4.3% between January 2014 and March 2015. Differences were observed between metropolitan and rural counties. For metropolitan areas, the rise in EPCS enablement mirrored the national trend; however, by the end of the study period, EPCS enablement was slightly higher in metropolitan counties (4.5%) than the national enablement rate (4.3%).

Although the rise in prescriber enablement in rural counties lagged behind national and metropolitan trends, enablement in these counties was 2.6% in March 2015, up from 0.4% in January 2014. Of note, compared with growth observed in the first 3 quarters of 2014 (0.8%), an increase in prescriber enablement was observed in Q4 2014 and Q1 2015 (2.5%) (Figure 1).

As of March 2015, 7 states had an enablement rate above the national average (4.3%), with New York having the highest rate (23.2%) followed by Nebraska (14.3%), Oregon (12.5%), Michigan (11.7%), California (8.0%), Massachusetts (4.8%), and Iowa (4.4%). North Dakota (0.2%), South Carolina (0.3%), Minnesota (0.3%), and Missouri (0.4%) had the lowest enablement rates (Figures 2 and 3).

The percent of transactions nationally grew from 0.16% to 1.8% during the study period, more than a 10-fold increase in transactions. States varied significantly in their use of EPCS. The states with the highest percentages were New York (7.6%), Nebraska (7.5%), California (5.5%), and Michigan (4.7%). The most significant growth occurred in the first quarter of 2015. In January 2014, 16 states had no EPCS transactions. As of March 2015, only 1 state, Missouri, had none (see eAppendix Table, available at www.ajpb.com, for more detailed information).

While the majority (79%) of retail pharmacies and a growing number of prescribers across the United States are enabled for EPCS, challenges remain to the widespread use of EPCS. Until recently, the majority of EHR vendors did not support the security requirements for prescribers to send EPCS; now, nearly 100 vendors do.

 This analysis showed differences in enablement between prescribers in urban and rural counties. Although EPCS was legal in all but 1 US state at the time of this study,

Of the 7 states that have enablement rates above the national average, New York and Nebraska have the highest uptake rates. New York issued a mandate requiring the electronic prescription of all medications as of March 2016.

 This mandate has likely driven the EPCS growth in New York. However, government initiatives are not the only method that have spearheaded the growth of EPCS.

Health systems such as Nebraska Methodist have been at the forefront of EPCS use for the state, thus leading the way for EPCS adoption in Nebraska. This was facilitated, in part, by the Nebraska Information Technology Commission and the fact that the State of Nebraska passed a law allowing for EPCS in 2013, earlier than many states.

An important reason for the promotion of EPCS is its ability to provide key medication information to physicians who may otherwise have little knowledge about a patient’s history with controlled substances. EPCS enables physicians to track and audit controlled-medication usage by their patients.

EHR applications for EPCS make this streamlined and incorporated into the physician workflow. In addition, EPCS serves as an important complement to state-run electronic databases that track the prescribing and dispensing of controlled prescription drugs to patients. These Prescription Drug Monitoring Programs (PDMPs), developed as tools to help curtail the abuse and diversion of prescription drugs, currently 37 states have operational programs and 11 states and territories are developing programs.

 PDMP databases can be accessed via an e-prescribing application, or an EHR.

Advances in information systems and health IT have made it possible for states to collect historical data on controlled substances dispensed by pharmacies by establishing PDMPs. This application of technology has shown success in addressing public health concerns of prescription-opioid misuse and abuse.

The US Department of Health and Human Services has made the epidemic of prescription drug abuse, misuse, and diversion a high priority, putting forth an initiative to decrease opioid overdoses, overdose mortality, and the prevalence of opioid use disorder.

 State-led PDMPs are a tool to help curb opioid abuse. PDMPs are often used to help behavioral health prescribers ensure the best care for their patients. In addition, prescribers can use PDMPs to detect patterns of controlled-substance prescribing to support clinical decision making.

For example, 1 year after requiring that prescribers access their state PDMP before prescribing, New York and Tennessee saw decreases in “doctor-shopping” by 75% and 36%, respectively.

 In addition, after implementation of a PDMP program in Florida, oxycodone-caused deaths decreased by 25%.

The ability to maintain an entirely electronic record of controlled substances from EPCS through monitoring will further boost public health efforts to curb misuse and abuse. This is because PDMPs—when universal, real-time, actively managed, and populated by EPCS&mdash;are an effective tool in mitigating this crisis.

In fact, New York State has enacted the Internet System for Tracking Over-Prescribing (I-STOP) through the state’s PDMP to help curb New York’s opioid abuse and diversion. The I-STOP legislation requires prescribers to check the state PDMP prior to prescribing a controlled substance.

This study showed that a majority of pharmacies are enabled for EPCS. However, provider enablement is still low. Educational resources and technical assistance for prescribers may help them adopt EPCS.18 Technical assistance may be especially helpful for prescribers serving rural communities, who face additional difficulties in the task of balancing benefits and risks of controlled substances.

As the adoption and use of EPCS grows, future studies should explore EPCS prescribing patterns by provider type and specialty. In addition, it will be important to explore clinical outcomes associated with increased use of EPCS, specifically opioid-related overdoses and deaths.

The current study has several limitations. First, data used for this analysis were composed of prescribers and pharmacies connected to the Surescripts Network and e-prescribing transactions for controlled substances that flow through the network. Due to the strength of market share, Surescripts can serve as a proxy for national trends analysis.

However, while Surescripts captures the vast majority of outpatient transactions, it does not include transactions from a number of sources, including inpatient e-prescribing in which the prescription goes directly to the hospital pharmacy, e-prescribing that occurs within a closed integrated delivery network (eg, Kaiser Permanente), and transactions that occur solely on competing networks.

From January 2014 to March 2015, there was progress in the adoption and use of EPCS. However, there are marked differences at the state level and between urban and rural areas. State-level regulatory barriers and initiatives have impacted EPCS. EPCS may serve as an important tool to help prescribers provide better care for their patients.

Additionally, EPCS provides a complete electronic record of controlled substances, critical for public health and law enforcement initiatives addressing the misuse and diversion of opioid medications. A multi-stakeholder approach is needed to further the adoption and use of EPCS technology. Policy makers, public health entities, the health IT industry, and providers each have an important role to play.

: Department of Health Management and Informatics, College of Health & Public Affairs, University of Central Florida (MHG), Orlando; Surescripts (JYS, MS, SJ), Arlington, VA; Office of the National Coordinator for Health IT (TLW), Washington, DC.

: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. MHG is an employee of the University of Central Florida. JYS, MS, and SJ are all employees of Surescripts. TLW is an employee of the US Department of Health and Human Services. The views expressed in this publication are solely the opinions of the authors and do not necessarily reflect the official policies of the US Department of Health and Human Services, the University of Central Florida, or Surescripts.

: Concept and design (MHG, JYS, MS, SJ, TLW); acquisition of data (JYS, MS, SJ); analysis and interpretation of data (MHG, JYS, MS, SJ, TLW); drafting of the manuscript (MHG, JYS, MS, SJ, TLW); critical revision of the manuscript for important intellectual content (MHG, JYS, MS, SJ, TLW); statistical analysis (JYS); administrative, technical, or logistic support (MHG, JYS); and supervision (MHG, JYS).

: Meghan Hufstader Gabriel, PhD, Assistant Professor, Department of Health Management and Informatics, College of Health & Public Affairs, University of Central Florida, 4364 Scorpius St, HPAII - Rm 213, Orlando, FL 32816.

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Articles

This study presents the first information available regarding enablement and use by state and area characteristics of electronic prescribing of controlled substances by prescribers and pharmacy systems in from an e-prescribing network.