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To better understand barriers associated with the adoption and use of electronic prescribing of controlled substances (EPCS), a practice recently established by US Drug Enforcement Administration regulation.
Prescribers of controlled substances affiliated with a regional health system were surveyed regarding current electronic prescribing (e-prescribing) activities, current prescribing of controlled substances, and expectations and barriers to the adoption of EPCS.
246 prescribers (response rate of 64%) represented a range of medical specialties, with 43.1% of these prescribers current users of e-prescribing for non-controlled substances. Reported issues with controlled substances included errors, pharmacy call-backs, and diversion; most prescribers expected EPCS to address many of these problems, specifically reduce medical errors, improve work flow and efficiency of practice, help identify prescription diversion or misuse, and improve patient treatment management. Prescribers expected, however, that it would be disruptive to practice, and over one-third of respondents reported that carrying a security authentication token at all times would be so burdensome as to discourage adoption.
Although adoption of e-prescribing has been shown to dramatically reduce medication errors, challenges to efficient processes and errors still persist from the perspective of the prescriber, that may interfere with the adoption of EPCS. Most prescribers regarded EPCS security measures as a small or moderate inconvenience (other than carrying a security token), with advantages outweighing the burden.
Prescribers are optimistic about the potential for EPCS to improve practice, but view certain security measures as a burden and potential barrier.
Electronic prescribing (e-prescribing) is an integral component of a health information technology system, and a required component of ‘meaningful use’ of health information technology.1 E-prescribing has the potential to improve the safety, quality, and efficiency of healthcare as well as reduce medication costs.2–4 Until 2010, the US Drug Enforcement Administration (DEA) prohibited the e-prescribing of controlled substances (EPCS) (narcotics, stimulants, and other medications included in Schedules II, III, IV, or V of the Controlled Substances Act), which have the potential for addiction or diversion. While controlled substances only account for 11% of all prescriptions issued, they are prescribed by 90% of prescribers, making it important to incorporate controlled substances into e-prescribing systems.5
In June 2010, the DEA's Interim Final Rule (IFR) on EPCS became effective, allowing for e-prescribing and detailing standards governing its use in the USA.6 The regulations apply to providers, pharmacies, prescribing system application vendors, and pharmacy system vendors. However, many of the security measures for EPCS that meet the DEA regulations have yet to be developed or implemented. These security measures include the following: a process for identity-proofing prescribers; completion of third-party audits of prescribing and pharmacy applications; the format of the networking software necessary to securely transmit a digital signature; and the capability of the pharmacy systems to either digitally sign or receive and archive records. Implementation of the regulation is expected to occur by late 2012 or early 2013, as the operational security issues are resolved and e-prescribing software systems are updated.
To better understand practice changes and barriers associated with the adoption and use of EPCS at the prescriber level, before implementation of EPCS, a survey of prescribers was conducted in a large multispecialty regional healthcare system in Massachusetts. This paper presents the results of this survey, assessing current prescriber practice patterns related to controlled substances, current use of various e-prescribing functionalities, expectations regarding the impact of EPCS on patient safety and quality of care, and perceived barriers to EPCS use. This study is part of a research and demonstration project supported by a grant awarded to the Massachusetts Department of Public Health by the US Agency for Healthcare Research and Quality (grant no. R18 HS17157) to develop and test a secure e-prescribing transmission system for controlled substances in the ambulatory care setting.
E-prescribing has the potential to enhance the safety of pharmacological treatment by reducing medication errors, eliminating illegible hand-written prescriptions, providing warnings and alerts (eg, for drug interactions, allergies, dosage, contraindications) through drug utilization software, and offering access to medication history, including prescriptions issued by other prescribers.7 E-prescribing may reduce the morbidity associated with medication errors, which amounts to more than 2 million adverse drug events annually, of which 130 000 are life-threatening and an estimated 7000 result in death each year.8 9 Studies conducted starting a decade ago evaluating computerized physician order entry systems in hospital settings, indicate they reduce the risks associated with prescribing and dispensing, although other studies found that these systems could increase medication errors, at least initially.10–14 However, e-prescribing systems have evolved considerably in the last decade, and one recent study showed that e-prescribing can decrease medication errors from 42% to 7%.15
E-prescribing also has the potential to improve efficiency by streamlining clinical practice workflow. Up to 30% of the 3 billion prescriptions issued in the USA may result in calls from pharmacies, which takes considerable staff time and interrupts workflow, reducing productivity and increasing cost.16 E-prescribing has been associated with a 53% reduction in calls from, and a 62% reduction in calls to, the pharmacy,17 and savings of 1 h per nurse and 30 min per clerk per day.18 One large practice estimated that e-prescribing saves the practice US$48 000 per year by reducing the time spent handling prescription renewal requests.19 One study indicated that the introduction of streamlined prescribing systems for controlled substances changed patterns of use, increasing opioid use while decreasing that of other controlled substances.20
Finally, e-prescribing has the potential to improve patient satisfaction with care (by reducing waiting time at the pharmacy), improve patient compliance (no lost prescriptions), and reduce the cost of medication to patients (by automatically suggesting less expensive generics and preferred formulations).
EPCS could provide benefits such as curbing the abuse and diversion of prescription drugs by substantially reducing prescription fraud associated with paper prescriptions (eg, through falsifying prescriptions, prescription pad theft). Prescription fraud and forgery represent between 3% and 9% of medications diverted for abuse by prescription opioid addicts.21 22 Another benefit of EPCS would be to help prescribers identify ‘doctor shoppers’ (individuals who seek prescriptions for controlled substances from different doctors for the purpose of abuse or diversion) by allowing a prescriber to check prescriptions for controlled substances issued by other prescribers for the same patient. These benefits should play an important part in curbing prescription drug abuse, which has become a large and growing crisis.23–26
Adoption of a new technology in medicine is affected by the characteristics of the provider, the features of the technology being implemented, communication channels, and the organizational system's economic constraints within which providers practice.27 Among the features of a technology that facilitate adoption and use are: provider familiarity with the technology; ease of implementation; trialability (ability to test without risk); and the perceived costs and benefits of the technology. Drawing upon this theoretical framework, we surveyed physicians to elicit expectations regarding EPCS in order to understand more clearly the potential path of adoption of EPCS and inform policies aimed at promoting this practice.
Surveys were conducted at ambulatory care test sites based at or affiliated with Berkshire Health System (BHS), the primary provider of healthcare services in Berkshire County, Massachusetts, between January and July, 2009. BHS affiliated practices include nearly 400 physicians, dentists, nurse practitioners, physician assistants, and other clinicians. The survey target population included all prescribers of controlled substances in the BHS network (excluding resident physicians, and physicians in radiology, pathology, and anesthesia, due to limited outpatient prescribing). The survey reported here served as a baseline for assessing experiences with EPCS as part of the research and demonstration project testing this practice.
The survey (available upon request) was developed drawing from the literature, past surveys, and interviews with providers. Questions were developed de novo for this survey to address expectations for EPCS specifically, and to correspond to components related to the Rogers model of technology adoption.27 In addition, questions were adapted from the technology acceptance model used by Tamblyn and associates to assess familiarity with use of health technology.28 The final survey had five domains: (i) current prescribing practice; (ii) current e-prescribing activities; (iii) current prescribing of controlled substances: potential issues with patient safety, convenience, and identifying non-medical use; (iv) expectations for the EPCS system (eg, effect on workflow, patient safety, and potential barriers); and (v) perceptions regarding proposed security measures for use of EPCS. The survey was pilot tested among five providers who were not part of the respondent population, in individual sessions. Providers were asked to indicate which questions were ambiguous or redundant, as well as the time involved in completing the survey. Revisions were made accordingly.
Surveys were then administered in person by the BHS project liaison officer during regular (mandatory) medical departmental meetings, and hand-delivered to additional prescribers not attending the meetings, and all mid-level prescribers and dentists with practices in the immediate geographic area. Respondents received a USB flash drive as an incentive for their participation.
The study protocol was approved by the Institutional Review Boards of Brandeis University, Berkshire Medical Center, and Massachusetts Department of Public Health/Lemuel Shattuck Hospital.
Descriptive statistics were generated on the survey categories of interest. Expectations for the impact of EPCS on prescriber practices were compared between those who were currently using e-prescribing for any medications and those who were not. Exploratory factor analysis was conducted on items related to expectations for EPCS, to identify conceptual themes, using Varimax with Kaiser normalization, using PASW software.29
A total of 246 healthcare practitioners who prescribe controlled substances responded to the survey, yielding a response rate of 64% of BHS affiliated prescribers, and 88% of all physicians attending departmental meetings (table 1). Non-respondent physicians did not differ from respondents regarding age or gender. Most (63.0%) of the surveyed prescribers were male, and a large majority (90.7%) were white and non-Hispanic, consistent with the overall prescriber population, according to BHS officials. The surveyed prescribers represented a wide range of medical specialties, with internal medicine/primary care the largest grouping (20.3%), followed by neurology/psychiatry/substance abuse (12.5%); 10.2% were dentists. In a typical week, prescribers estimated seeing an average of 68 patients, of whom 14.0% had chronic pain, 24.8% were being treated for a mental health disorder, and 17.1% had a recent history of alcohol or substance use disorders. While no information is available from specific practices to confirm these estimates, this is comparable to national estimates of 11%–36% of primary care patients having a psychiatric disorder.30
Regarding prescribing of controlled medications, most (84.5%) prescribers surveyed felt somewhat comfortable (69.7%) or totally comfortable (14.8%) in their ability to identify patients trying to obtain prescription drugs for abuse or diversion (not shown in table 1).
Prescribers reported having a number of issues regarding prescribing controlled substances prior to e-prescribing (table 2). The most common issues reported to have occurred three or more times in the prior 6 months were prescriptions not covered by insurance (49.1%) and loss of a prescription by the patient requiring issuance of a replacement prescription (26.0%). Over 20% of prescribers reported prescription fraud at least 1–2 times in the prior 6 months, including: prescription altered by patients (18.8%); prescription counterfeited (6.4%); or stolen prescription pads (3.5%). Medication errors were relatively common: 35.1% of prescribers reported having prescribed the wrong medication at least once in the past 6 months (52.0% three or more times) and over 20% reported pharmacy errors (wrong drug, 14.4%, dose or strength dispensed, 22%).
Overall, 106 (43.1%) of the surveyed prescribers were currently using a range of e-prescribing systems for non-controlled substance prescriptions. An average of half (49.9%) of e-prescriptions were input by assistants rather than the prescribers themselves following the encounter with the patient. Prescriptions input by medical assistants are forwarded to the prescriber for signature and sending. Individual prescribers vary widely in the frequency with which they sign and send prescriptions to the pharmacy. Some send prescriptions throughout the day and others send in them blocks at midday and the end of the business day. The e-prescribing system features most frequently used by prescribers were automated renewals (59.8% used it one or more times per day) and viewing their prescribing history for a patient (52.5% used it one or more times per day). Interestingly, many of the system features were rarely used: nearly two-thirds of physicians reported viewing a formulary or responding to drug interaction alerts seldom or never.
In this sample, the majority of systems are not embedded in an electronic health record, and they require separate documentation into a dictated progress note, paper chart, or electronic health record. The majority (76%) of prescribers felt comfortable with their current ambulatory e-prescribing system, but many reported recurrent technical issues with their systems. Prescribers estimated that the following had occurred at least three times in the prior 6 months: system unreliability such as the computer crashing (36.7%); the pharmacy did not receive the prescription in a timely manner (66.9%); and the pharmacy called back to clarify prescription information (58.7%). Other issues (stated in the survey's open-ended comments) pertained to periodic delays in accessing the system once logged on, and specific preferences regarding what information is available on the interface (eg, would prefer a longer prescription history, or lack of availability of prescribing history for physicians not using the system).
Prescribers were asked their expectations (both positive and negative) for EPCS; results are compared between current e-prescribers and non-users of e-prescribing (table 3). A majority of both groups expected EPCS to improve patients' pharmaceutical therapy management within the practice and with other prescribers and pharmacists. Most prescribers (both current e-prescribers and those not e-prescribing) expected EPCS to result in fewer calls from pharmacists to clarify prescriptions, improvement in the accuracy of prescriptions, better identification of misuse and diversion of controlled substances, and improvements in workflow. In both groups, fewer than half felt that the EPCS would lead to financial savings.
As might be expected, current users of e-prescribing were more positive about the potential for EPCS. They were more likely to expect EPCS to: improve work flow and practice efficiency (69.6% vs 58.8%, p<0.10); improve management of pharmaceutical therapy within the practice (74.3% vs 58.1%, p<0.01); and be easy to use (69.6% vs 54.8%, p<0.05); and were less likely to expect EPCS to cause system breaches of patient confidentiality (6.9% vs 14.7%, p<0.05) or involve a learning curve that is disruptive to the practice (14.7% vs 33.4%, p<0.001).
Exploratory factor analysis was also conducted on the expectations for EPCS (items shown in table 3) to identify concepts related to expectations. This analysis identified three components related to prescribers' expectations for EPCS, conceptualized as: (i) patient management (EPCS will: make it easier to identify diversion or misuse; improve pharmaceutical management; improve management with other prescribers' medications; improve management with pharmacists; and improve communication with patients; Cronbach's α=0.904); (ii) practice efficiency (EPCS will: improve work flow and efficiency; be easy to use; lead to financial savings; and improve patient satisfaction; Cronbach's α=0.774); and (iii) risk aversion to new technologies (EPCS will: cause technical problems with consequences for patient care; cause system breaches of confidentiality; lead to depersonalized patient care; and cause a disruptive learning curve; Cronbach's α=0.725).
Several security measures specific to EPCS were to be required under the demonstration. Prescriber level measures included using a hard token for two-factor authentication of each prescription (see figure 1); keeping the security token with one's self at all times; reporting a lost/stolen token within 12 h; having to re-enter the password after a brief idle; and not being allowed to use a personal electronic device to complete an EPCS prescription. In the demonstration project, the security token is a USB device similar to a thumb drive. For the demonstration, the token will be provided at no charge to participants, is usable in most computer operating systems and could securely be kept on the provider's key ring or in a locked drawer.
Expectations for use of specific security measures were elicited (table 4). Overall, the majority of prescribers (51.9% to 65.4%) considered most to be of little inconvenience. However, keeping the token in one's possession at all times was considered a large inconvenience by 59.2% of prescribers, with 35.3% of all respondents seeing no advantage outweighing the burden. For the other measures, less than one-fourth of the prescribers reported them to be so burdensome as to discourage use of EPCS.
This study was conducted to better understand the expectations and the potential barriers and challenges associated with the adoption and use of EPCS at the prescriber level. Although this survey is limited to one region, BHS represents a broad range of specialties, typical of what a community requires, and a model that commonly exists across the nation. The two hospitals and their medical staff provide coverage for most of the county. The information gleaned from the study and the survey of prescribers will provide insight for those implementing the requirements of the DEA IFR nationally. Provider attitudes toward EPCS were generally consistent with many of the attitudes toward technologies that facilitate adoption: physicians most familiar with e-prescribing had more positive expectations for EPCS and its ease of implementation; and perceived benefits were generally high, but the expected burden was also measurable.
Prescribers seemed comfortable with prescribing controlled substances, with a majority of them feeling comfortable in their ability to identify patients trying to obtain prescription drugs for abuse or diversion. This high comfort level may be due in part to the fact that most of these prescribers attended extensive pain management training sessions conducted at BHS over several years.31
Overall, 43% of the prescribers surveyed in this study had adopted e-prescribing as of 2009, equivalent to Massachusetts overall in 2008 but below the 57% reported in 2009.32 This is higher than the national estimate of 25% for office-based prescribers.33 Although the number of prescribers adopting e-prescribing has doubled each year since 2007, the adoption rate of e-prescribing is still far from universal.34
Consistent with our findings, one study found that while many physicians in office-based ambulatory practices used e-prescribing, only 10% routinely used several key features (ie, to obtain information about potential drug interactions and patient formulary).35 In the current study, the most popular features were those that improved patient management (eg, viewing patient history) or workflow efficiency (eg, automated prescription renewals). Over one-third of prescribers never used system features such as viewing the formulary or other prescribers' prescriptions, which might be related to the limitations of the technology noted earlier. One finding of concern was that 58.8% of prescribers did not or seldom (once or less per week) responded to drug interaction alerts. This corroborates findings showing that prescribers often override medication alerts for drug interactions or allergies generated by e-prescribing systems.36 As these advanced features are critical to the expected benefits of an e-prescribing system, barriers to meaningful use remain a challenge, even when physicians have access to such a system.
While the vast majority (71.8%) of e-prescribers in our study were satisfied with their system overall, several issues emerged, such as occasional unreliability, delays in the completion of a prescription at the pharmacy, and pharmacist calls, even with electronically submitted prescriptions. This highlights the fact that although e-prescribing has been shown to dramatically reduce medication errors, challenges to efficient processes and errors still persist. Errors or ambiguities can be attributed to technology factors (eg, poor user interface design, poor entry form design), end user factors (poor knowledge of the e-prescribing platform or other clinical information, etc), or environmental factors (eg, lack of time, poor location of computer).37 In our survey, 12% of the prescribers admitted that they did not feel comfortable with using the system (eg, the interface, decision support).
Overall, the majority of prescribers expected EPCS to improve patient management and efficiency, although one-fourth expected that adopting EPCS would initially disrupt their practice, including the workflow, which historically involved handing the patient the prescription while educating the patient about the medication, its side effects, and its effectiveness. The prescribers surveyed indicated that they expect EPCS to reduce medication errors, improve work flow and efficiency of practice, help identify diversion or misuse of prescriptions, and improve the management of patients' pharmaceutical therapy within their practice. This is consistent with a survey of IT healthcare professionals in which respondents expected EPCS to improve the workflow in the clinical practice (45% of respondents) and improve patient safety (31% of respondents).38
The expectations of prescribers already using e-prescribing were for the most part more positive than those not electronically prescribing, consistent with our conceptual framework that those most familiar with a new technology would be most likely to adopt it. Relatively few prescribers, experienced or not, expected EPCS to bring significant financial savings to the practice, cause depersonalization of the patient's care (by limiting in-person returns for renewals), or breaches of patient confidentiality, although those familiar with e-prescribing were less concerned about breaches of confidentiality.
One main issue that prescribers encountered with paper prescriptions was the high rate of prescription errors. A majority of prescribers expected EPCS to improve the accuracy of prescriptions, reduce medication errors, and result in fewer pharmacy call-backs. Another reported issue with paper prescribing of controlled substances was the high rate of lost prescriptions and prescription fraud or forgery. EPCS should almost completely eliminate the problem of lost prescriptions (by directly transmitting to the pharmacy) and prescription forgery (by eliminating prescription pads). Most prescribers also expected EPCS to help them identify other forms of diversion and misuse of controlled substances such as doctor shopping.
While most of the suggested EPCS security measures were viewed as inconvenient with advantages outweighing the burden, one-third of the prescribers reported that they would use paper prescriptions rather than electronic if required to carry the signature token at all times. It is important to note that in later stages of the project, use of the signature token has not been mentioned as a major barrier to prescribing. This reduced burden may be a result of providers identifying strategies to maintain sole control of the signature token such as keeping it on a key ring or locked in a desk drawer if use is infrequent.
The IFR requires providers to continue many of the tasks required in this research and demonstration project, including identity proofing, using two-factor authentication as part of signing and transmission, using one signature per patient per prescription, and reporting security incidents within a specified time. The basic process for EPCS nationally will be similar to that used in our study, and most security features appeared acceptable to prescribers in this survey. The use of a security token, the most objectionable feature, may be replaced by other two-factor authentication methods. Thus, providers may look forward to the availability of other authentication technologies, including the use of biometrics, which the DEA allowed in the IFR. At the same time, it must be noted that infrastructure costs and technical complexities limit the scalability of such approaches.
New tasks that will be required with EPCS include at least one provider participating in setting access controls at the local level for other prescribers in a practice, and reviewing daily internal reports of auditable events prescribed in the IFR. It remains to be seen what effect these additional tasks will have on the acceptance of EPCS among providers, and whether the additional security measures will inhibit adoption.
Since the DEA promulgated regulations enabling providers to electronically prescribe and transmit federally controlled substance prescriptions in the USA (effective June 2010), the development of security measures specific to EPCS that meet the requirements of the Controlled Substance Act has become more pressing. To facilitate the adoption of EPCS among prescribers, it is crucial to determine expectations and understand the barriers to adoption of EPCS systems, including those stemming from the security measures affecting prescribers. This survey is one of the first to address these issues.
The survey findings have additional policy implications. Since a majority of prescribers have their assistant perform e-prescribing functions for non-controlled substances (and later sign them), it is critical to require that issuing e-prescriptions through secure EPCS systems be only performed by the qualified, DEA registered prescriber, and perhaps entered, but not transmitted, by an assistant. Moreover, developers of EPCS systems, intermediaries, and pharmacy systems should fix frequently reported problems (such as reliability and ease of use) and ensure that prescribers, intermediaries, and pharmacy systems avoid transmission delays. Prescribers should also be required to have enhanced training on how to use the EPCS software and properly create prescriptions for controlled substances before they are authorized to use an EPCS system. Finally, implementing measures aimed at enhancing patient safety should be the principal goal of EPCS systems.
The authors would like to thank DrFirst, Inc., Emdeon, Berkshire Health Systems, and pharmacies within Berkshire County (MA) for their participation in this project. We would also like to thank Florence Paillard and Wendy Colnon for assistance in manuscript preparation.
Funding: This study was funded by the Agency for Healthcare Research and Quality (grant number R18 HS17157).
Competing interests: None.
Ethics approval: This study was approved by the Institutional Review Boards of Brandeis University, Berkshire Medical Center, and Massachusetts Department of Public Health/Lemuel Shattuck Hospital.
Provenance and peer review: Not commissioned; externally peer reviewed.