Enabling Electronic Prescribing and Enhanced Management of Controlled Medications (Massachusetts)

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Summary:

While the use of electronic prescribing (e-prescribing) has led to significant improvements in medication safety, there remain a number of barriers to its widespread adoption. One significant barrier has been the lack of standards for the electronic prescribing of federally controlled substances (EPCS) (e.g., narcotics, stimulants, and sedatives). This deficit has meant that prescriptions for controlled substances must be manually written or signed, and historically have not been transmitted electronically along with other prescriptions. The security standards needed for EPCS are a unique challenge because they need to allow for the prevention, detection, and elimination of the diversion of these substances from the legitimate medical market to the illicit market. While the Drug Enforcement Agency (DEA) has moved forward with regulations allowing for EPCS, not all States have authorized e-prescribing for controlled substances, particularly those with significant potential for abuse.  

This project was conducted to demonstrate how this particular barrier to e-prescribing can be removed. Specifically, the project team developed the capability to electronically create and securely transmit prescriptions for controlled substances, thus improving medication management at the point of care.  

The main objectives of this project were to:

  • Develop, implement, and verify a system of safe and secure electronic transmission of prescriptions for federally-controlled substances in an ambulatory care setting.
  • Develop and test the interfacing of this e-prescribing system with the Massachusetts Prescriptions Monitoring Program (PMP) to monitor prescription fraud and nonmedical use of controlled medications.
  • Conduct systems process and outcomes evaluations of the improvements to patient care, risk reduction, patient and clinician benefits, patient safety, and information privacy and confidentiality that are expected as a result of this system. 
  • Develop and implement a plan for dissemination of findings.

The study team worked with the Massachusetts PMP to develop a model to reconcile e-prescribed and dispensed controlled substance prescriptions. For the study, providers were given hard tokens, an electronic key to access the system that served as a digital signature of the provider, allowing for two-factor authentication when they created and transmitted EPCS in ambulatory settings. Non-users of the system did not receive tokens until later in the study. Users were surveyed before implementation and again at 6 months. Non-users were surveyed before and after the implementation of the system, and again after they received tokens. 

The surveys indicated that security concerns initially held by the providers were not realized.  Over time the use of EPCS increased dramatically. It was noted that the availability of pharmacies able to dispense EPCS is critical to adoption. The project team concluded that EPCS is a promising tool able to improve public health and public safety by identifying diversion or misuse of controlled substances. It will likely become a major tool to help curb substance abuse and contribute to patient safety, practice efficiency, and positive health outcomes.

Enabling Electronic Prescribing and Enhanced Management of Controlled Medications - 2012

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017157
  • Project Period: 
    September 2007 - May 2012
  • AHRQ Funding Amount: 
    $1,199,794
  • PDF Version: 
    (PDF, 277.73 KB)

Summary: The expansion of electronic prescribing (e-prescribing) to cover federally controlled substances (e.g., narcotics, stimulants, sedatives) was intended to: 1) demonstrate a mechanism for increasing access to these medications, particularly for patients with chronic medical conditions who are frequently prescribed such medications; and 2) reduce the diversion of dangerous pharmaceuticals to non-medical use and abuse. The goal of this project was to foster the safe and productive adoption of e-prescribing of federally controlled substances through the design, implementation, and evaluation of a safe, secure, and efficient system for electronic transmission of controlled substance prescriptions by ambulatory care clinicians at the point-of-care. This work informs the U.S. Drug Enforcement Administration (DEA) as it implements the Interim Final Rule (75 FR 16236) (IFR) governing the e-prescribing of controlled substances (EPCS).

The project team, led by Dr. Grant Carrow and the Massachusetts Department of Public Health (MDPH) Drug Control Program, partnered with health information technology (IT) solution providers DrFirst, Inc. and Emdeon to design, implement, and field-test a system for EPCS in a contained ambulatory care environment within the Berkshire Health System (Berkshire County, MA). Concurrently, the project developed and tested a data interface between the e-prescribing system and the Massachusetts Prescription
Monitoring Program (MA PMP) to monitor nonmedical use and abuse of federally controlled medications while supporting enhanced patient-clinician communication, medication access, and safety of patients with chronic medical conditions.

Specific Aims:

  • Develop, implement, and verify a system of safe and secure electronic transmission of prescriptions for federally controlled substances in an ambulatory care setting. (Achieved)
  • Develop and test the interfacing of this e-prescribing system with the Massachusetts PMP to monitor prescription fraud and nonmedical use of controlled medications. (Achieved)
  • Conduct systems process and outcomes evaluations of the improvements to patient care, risk reduction, patient and clinician benefits, patient safety, and information privacy and confidentiality that are expected as a result of this system. (Achieved)
  • Develop and implement a plan for dissemination of findings. (Achieved)

2012 Activities: The focus of activity in 2012 was on identifying and summarizing the findings from implementing and using the EPCS system, as well as developing the final report. Various challenges—including rigorous requirements of the IFR, which was promulgated 2.5 years after the start of this project; the complexity of having to modify the EPCS system well into the project; and interdependency of the various software applications— contributed to achieving full IFR compliance. Due to the additional time allowed by the DEA to meet the IFR mandate, the project team was able to use an 8-month no-cost extension to identify areas in which compliance could be achieved and to complete the project, including preparation of a second published article. The project ended in May 2012.

Impact and Findings: The project recruited, trained, and supported 187 providers, 151 of whom were issued hard tokens over the course of the project. The hard tokens, to be inserted into the computer at the time of EPCS transmission, were part of a two-factor user-authentication process to identify the user and maintain security of the system. Of the 151 providers, 81 (53.6 percent) created and transmitted at least one controlled substance e-prescription. The prescribing providers created and transmitted 9,874 controlled substance e-prescriptions, and those who were active each sent an average of 15.5 such e-prescriptions per day to the participating pharmacies during the last 8 months of the study.

Creating and processing controlled substance e-prescriptions was determined to be more complicated than for e-prescribing of non-controlled drugs due to security requirements associated with the IFR and interdependent IT systems. In particular, there was greater than expected difficulty encountered in deploying the hard token due to compatibility issues with some prescribers’ PC-based operating systems. After an initial transition period, EPCS had a net positive impact on the workflow of the pharmacists.
As with electronic prescriptions for non-controlled drugs, delivery of the EPCS script to the pharmacy improved and in many cases the prescription was ready when the patient arrived at the pharmacy.

In a survey conducted by collaborators at Brandeis University, users of EPCS reported a significant decrease in some of the problems associated with written prescriptions for controlled substances (e.g., incorrect drug or dose was prescribed, prescription altered, or reported lost and required replacing), but not others (counterfeit prescription was discovered). Perceived improvements are consistent with those identified with e-prescribing of non-controlled medications, and with expectations for the potential impact of EPCS. Additionally, although physicians initially expected security measures to be a large burden, especially carrying a security token, these requirements were not a big barrier. These results were published in two papers in the Journal of the American Medical Informatics Association: Early experience with electronic prescribing of controlled substances in a community setting, and Prescribers’ expectations and barriers to electronic prescribing of controlled substances. With the development of new approaches to two-factor authentication such as biometrics and one-time password technology, alternatives to security tokens may be available as EPCS is adopted elsewhere.

Ultimately, the study demonstrated that a safe, secure, and reliable system of EPCS can be adopted with minimal difficulty by a targeted medical community. It was also shown that existing systems can support this process using the recognized standards (NCPDP SCRIPT) with minor modification. There were certain barriers to successful implementation for all prescribers, which serve as lessons as other communities begin to implement EPCS. Most importantly, if a critical number of community pharmacies do not have systems in place to accept EPCS, physicians will not see the value in changing systems and office workflow to accommodate this practice.

Based on a limited sample of controlled substance e-prescriptions and using the NCPDP SCRIPT Transaction Control Reference Number (UIB-030-010), the study showed that it is feasible for a state PMP to reconcile prescriptions transmitted by a prescribing system with prescriptions dispensed by a receiving pharmacy. There are areas that require additional study. With new Federal rules governing EPCS, additional research should build upon the findings of this project to assess workflow and security measures required by the IFR for prescribers and pharmacies. Further refinement and analysis of EPCS data use will also produce assessment models that can be adopted by other PMPs.

Target Population: Adults

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

Enabling Electronic Prescribing and Enhanced Management of Controlled Medications - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017157
  • Project Period: 
    September 2007 - May 2012
  • AHRQ Funding Amount: 
    $1,199,794
  • PDF Version: 
    (PDF, 205.74 KB)

Summary: Expansion of electronic prescribing (e-prescribing) to cover federally-controlled substances (e.g., narcotics, stimulants, sedatives) is expected to increase access to needed medications and reduce risks of prescription fraud. The goal of this project is to foster the safe and productive adoption of e-prescribing of federally-controlled substances through the design, implementation, and evaluation of a safe, secure, and efficient system for electronic transmission of controlled substance prescriptions by ambulatory care clinicians at the point-of-care. It will help inform the U.S. Drug Enforcement Administration (DEA) as it implements the recently-promulgated Interim Final Rule (75 FR 16236) governing the electronic prescribing of controlled substances (EPCS).

The project team, led by Dr. Carrow and the Massachusetts Department of Public Health (MDPH) Drug Control Program, is partnering with health information technology solutions providers DrFirst, Inc. and Emdeon to design, implement, and field-test a system for e-prescribing controlled substances in a contained ambulatory care environment. Concurrently, the project is developing and testing a data interface between the e-prescribing system and the Massachusetts Prescription Monitoring Program (MA PMP) to monitor nonmedical use and abuse of federally-controlled medications while supporting enhanced patient-clinician communication, medication access, and safety of patients with chronic medical conditions.

Specific Aims:

  • Develop, implement, and verify a system of safe and secure electronic transmission of prescriptions for federally-controlled substances in an ambulatory care setting. (Achieved)
  • Develop and test the interfacing of this e-prescribing system with the Massachusetts PMP to monitor prescription fraud and nonmedical use of controlled medications. (Achieved)
  • Conduct systems process and outcomes evaluations of the improvements to patient care, risk reduction, patient and clinician benefits, patient safety, and information privacy and confidentiality that are expected as a result of this system. (Ongoing)
  • Develop and implement a plan for dissemination of findings. (Ongoing)

2011 Activities: Activity continued to expand the EPCS system among the study's participating prescribers who had received cryptokeys (hard tokens) and transmitted at least one EPCS. In addition, the project team:

  • Worked with the prescribing and pharmacy application vendors about complying with the DEA's Interim Final Rule (IFR) on EPCS;
  • Addressed operational issues associated with the initial version of EPCS software developed by DrFirst, the prescribing application partner in the project;
  • Facilitated discussions with pharmacy application vendors on securing data for the information technology security expert and the MA PMP;
  • Distributed followup surveys to the second group of providers who received cryptokeys; and
  • Monitored the American Institute of Certified Public Accountants' efforts to develop guidelines for CPA firms that are conducting third party audits of prescribing and pharmacy applications.

The rigorous requirements of the IFR (promulgated 2.5 years after the start of this project), the complexity of the EPCS system, and interdependency of the various software applications contributed to various challenges to achieving compliance with the IFR. The prescribing memorandum of understanding was signed and received by MDPH in April 2011. The DEA required the project team to make a good-faith effort to come into compliance with the IFR and the team worked with the prescribing and pharmacy applications to encourage that outcome. Due to the additional time required to meet the IFR mandate, the project is using an 8-month no-cost extension to complete the project. As last self-reported in the AHRQ Research Reporting System, the project is now completely on track and budget spending is on target.

The project team developed manuscripts, posters, and presentations to disseminate information about the project and broaden the understanding of EPCS and the IFR. These included a poster session titled "Electronic Prescribing of Controlled Medications: Results of a Demonstration Project," presented at AHRQ's 2011 Annual Conference in September, and an article titled "Prescribers' Expectations and Barriers to Electronic Prescribing of Controlled Substances," published in the Journal of the American Medical Informatics Association in September. As the project approaches its conclusion in 2012, the primary focus will be on the development of the final report and on the identification of findings from implementing and using the EPCS system. Providers who do not have the opportunity to extend their use of the current system to electronically prescribe controlled substances will receive communication from the project team congratulating and thanking them for their participation in the study and the contributions that their efforts made to the industry. The communication will advise them of the project's conclusion and share information on lessons learned. The project will continue to monitor developments in other areas of the country as limited rollouts of EPCS emerge and will identify opportunities to gather additional empirical information on the current model.

Preliminary Impact and Findings: Findings that have been made available throughout the course of the project include: 1) the results of the prescribing provider survey conducted in the first quarter of 2009, which examined provider use of e-prescribing and perceptions of EPCS in their daily practice of medicine; 2) the requirements of the DEA IFR on EPCS; and 3) the challenges, both technical and operational, of introducing EPCS into medical practices and the pharmacy community within the DEA's parameters. Analysis of additional findings is underway and will be available in the final report.

Target Population: Adults

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

Enabling Electronic Prescribing and Enhanced Management of Controlled Medications - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017157
  • Project Period: 
    September 2007 – September 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,199,794
  • PDF Version: 
    (PDF, 354.79 KB)


Target Population: Adults

Summary: Expansion of electronic prescribing (e-prescribing) to cover federally-controlled substances (e.g., narcotics, stimulants, sedatives) is expected to increase access to needed medications and reduce risks of prescription fraud. The goal of this project is to foster the safe and productive adoption of e-prescribing of federally-controlled substances. The project examines the adoption and diffusion of e-prescribing by ambulatory care clinicians at the point-of-care. The aims of the project are being acheived through the design, implementation, and evaluation of a safe, secure, and efficient system for electronic transmission of controlled substance prescriptions. As a result, these efforts are helping to inform the U.S. Drug Enforcement Administration (DEA) as it implements the recently-promulgated Interim Final Rule (75 FR 16236) governing the electronic prescribing of controlled substances (EPCS).

The project team, led by the Massachusetts Department of Public Health (MDPH), Drug Control Program, is partnering with health information technology solutions providers DrFirst, Inc. and Emdeon to design, implement, and field-test a system for e-prescribing controlled substances in a contained ambulatory care environment. Concurrently, the project is developing and testing a data interface between the e-prescribing system and the Massachusetts Prescription Monitoring Program (MA PMP) to monitor nonmedical use and abuse of federally-controlled medications while supporting enhanced patient-clinician communication, medication access, and safety of patients with chronic medical conditions.

Specific Aims:

  • Develop, implement, and verify a system of safe and secure electronic transmission of prescriptions for federally-controlled substances in an ambulatory care setting. (Achieved)
  • Develop and test the interfacing of this e-prescribing system with the Massachusetts PMP to monitor prescription fraud and nonmedical use of controlled medications. (Ongoing)
  • Conduct systems process and outcomes evaluations of the improvements to patient care, risk reduction, patient and clinician benefits, patient safety, and information privacy and confidentiality that are expected as a result of this system. (Ongoing)
  • Develop and implement a plan for dissemination of findings. (Ongoing)

2010 Activities: Throughout the year the project team activated and expanded EPCS access to the initial pilot group of 33 providers, completed the recruitment and activation of the remaining participating providers, and resolved systems errors as they arose. The evaluation team also continued its analysis of baseline provider survey data and conducted a post-implementation survey of the Group I prescribers to assess their perspectives on the EPCS technology after being exposed to it for 6 months. At the end of 2010, there were 157 participating prescribers, of which 142 were in possession of cryptokeys, which are the key pieces of information that control the transmission of EPCSs. In 2010, prescribing providers with cryptokeys created and transmitted 3,246 EPCSs to the nine participating pharmacies.

The project leadership reviewed all implementation issues including one that resulted in a temporary deactivation of the system on July 26, 2010 after it was discovered that, under certain circumstances, an EPCS could be transmitted to a pharmacy without the presence of a cryptokey. After analysis, the cause of the issue was identified and technical modifications were made. The system was reactivated in early October 2010.

On March 31, 2010, the DEA published its Interim Final Rule (IFR) on Electronic Prescribing of Controlled Substances in the Federal Register. The Final Rule went into effect on June 1, 2010, resulting in the allocation of significant project resources to analyze the changes and assess its impact on the project. As the project team gained a better understanding of the IFR and the requirements of each section, efforts to come into compliance were initiated on several fronts. The team has been in discussions with the DEA on compliance with the IFR for prescribing and pharmacy applications and the framework for revisions to the memorandum of agreement with the MDPH Drug Control Program. Since the promulgation of the IFR, the project partners, in conjunction with the DEA, conducted a gap analysis of the DEA requirements to determine the extent of the prescribing and pharmacy application compliance. This analysis provided the foundation for waivers to be included in new memoranda of agreement between the DEA and MDPH for prescribing and pharmacy applications. Project leadership and DrFirst explored the options for securing an identity-proofing process and establishing a relationship with certification authorities for the participating providers. The project team also reached out to the American Institute of Certified Public Accountants (AICPA) and the Information Systems Audit and Control Association, referenced in the IFR, to determine the readiness of their membership to conduct third-party audits for prescribing and pharmacy applications, as required in the IFR. As a result of these discussions, the Trust Services Task Force of the AICPA has begun developing audit guidelines for the accounting industry, which will initially be conducting the required third party audits.

To help inform the industry about EPCS and the DEA’s IFR, the project team collaborated with Emdeon on the development and airing of a town hall Webinar in September 2010. The Webinar was aired twice and was attended by more than 300 providers, pharmacists, vendor representatives, and State regulators. Because of the successful attendance, planning has begun for several additional Webinars focusing on industry segment-specific issues. The project team also conducted an orientation on the requirements of the IFR for the Berkshire County pharmacy managers who are participating in the project.

During 2010, the project also collaborated with DrFirst to create an interface file of Schedules II through V prescriptions to be securely accessed by the MA PMP on a periodic basis. The availability of this data, along with dispensed prescription information currently received by MA PMP from the pharmacies, will allow the reconciliation of prescribed to dispensed federally controlled medications. In order for this to occur, however, the MA PMP recognized there needed to be a key field, preferably a sequencing number, in each database. To achieve this, the MA PMP staff worked closely with the American Society for Automation in Pharmacy in the development of its PMP Standard version 4.1 to ensure a specific field for this purpose was included when the Standard was released at the beginning of January 2011. As a result of these efforts, the MA PMP will be using a new field to validate the process of reconciling prescribed and dispensed controlled substances prescriptions created within the scope of the project.

Additional presentations included the project team’s first public demonstration of EPCS at the Agency for Healthcare Research and Quality Grantee and Contractor Health IT Conference in June. The evaluation team also presented project-related posters at the Academy Health Annual Research Meeting in June and the American Public Health Association Annual Meeting in November.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): The project team is mostly on track for meeting all its aims and milestones and the project budget is moderately underspent. Throughout the project year, the activities remained slightly behind schedule due to circumstances beyond the control of the project team, such as the significant delay in receiving a waiver from the DEA at the beginning of the project, followed by a 6-month period during which the project could not proceed with plans to activate EPCS until certain issues were resolved between the DEA and the Department of Health and Human Services. The project did not fully regain lost time and requested a no-cost extension, which was approved through September 29, 2011.

Preliminary Impact and Findings: In terms of system participation among the active providers, operational satisfaction appears to be high. However, anecdotal reports suggest that some providers may not be using the EPCS system for several reasons, including the lack of a participating pharmacy in the immediate service area, patients’ pharmacy preferences, low controlled-substances prescribing patterns in some participating specialties, and slow provider adoption of EPCS technology. A followup provider survey is planned for 2011 to evaluate these issues.

Based on the project team’s gap analysis of the IFR, consensus among the participants is that compliance with the IFR requirements will be achieved gradually by the end of the project. Compliance with certain IFR sections may be achieved sooner if pharmacies can operationalize polices and procedures. The DEA and MDPH acknowledged, however, that because of technological and industry standard processing limitations, it may not be possible to come into compliance with all sections of the IFR before the conclusion of the project in September 2011. More specifically, completion of third party certification audits of prescribing and pharmacy applications, the revisions of the National Council for Prescription Drug Programs transmission standards, and the ability of pharmacy applications to use, read, and store digital signatures may not be finalized until the last quarter of 2011.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

Enabling E-Prescribing and Enhanced Management of Controlled Medications - Final Report

Citation:
Carrow, G. Enabling Electronic Prescribing and Enhanced Management of Controlled Medications - Final Report. (Prepared by Massachusetts Department of Public Health under Grant No. R18 HS017157). Rockville, MD: Agency for Healthcare Research and Quality, 2012 (PDF, 333.59 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
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