Electronic and Remote Prescribing: Administrative,Regulatory,Technical,and Clinical Standards and Guidelines,April 2013

Abstract

This document recommends standards to be applied in a licensed prescriber's transition to electronic (e-prescribing) and remote prescribing. A perspective inherent in this document is that remote prescribing or telemedical e-prescribing can only be understood within the larger context of e-prescribing, a relatively new tool in the American healthcare toolkit. The purpose of this document is to inform and assist individuals and organizations in providing safe and effective e-prescribing and remote prescribing services on behalf of patients. A list of additional resources and a workflow for e-prescribing are offered as well.

Introduction

“Telemedicine and telehealth both describe the use of medical information exchanged from one site to another via electronic communications to improve patients' health status.”¹ Electronic prescribing (e-prescribing) fits this definition as it is an electronically transmitted designation of a licensed prescriber's intent to treat a patient in collaboration with a registered pharmacist's acceptance of responsibility to fill and dispense the indicated treatment to the patient. This applies whether the e-prescribing is an instance of a licensed prescriber using a computerized physician order entry (CPOE) system of a hospital ward with transmittal to the hospital pharmacy department, an instance in an ambulatory setting where a licensed prescriber transmits an e-prescription from her or his office-based e-prescribing computer application or electronic health record (EHR) to a local pharmacy, or an instance of a telemedical-licensed prescriber generating an e-prescription to a remote pharmacy designated by a patient at a distant site.

Remote prescribing is essentially e-prescribing done at a distance and typically occurs when there is no in-person contact between the provider and patient such as during a telemedicine encounter. Remote prescribing may occur across states or countries, with patient contact being either synchronous or asynchronous.

The licensed prescriber who signs and transmits an e-prescription is responsible, in collaboration with the filling and dispensing licensed pharmacist, for decisions about appropriateness of a specific procedure or course of action, considering all presenting circumstances.

Materials and Methods

The development of this review article entailed the following work plan elements:

• Literature and Web site search for content materials relevant to guidance on e-prescribing and remote prescribing

• Literature gap analysis identifying gaps in documentation of ethical, legal/regulatory (apart from meaningful use relevance), and technical aspects of e-prescribing and remote prescribing

• Write initial draft content of document addressing need for standards and guidelines

• Vet draft document and obtain feedback via the American Telemedicine Association (ATA) Standards and Guidelines Committee

• Engage expert content stakeholders (see Acknowledgments) for input on developing further iterative drafts synchronous with ATA Standards and Guidelines processes and procedures

• Complete the final document as separate publication designed to address gaps in current literature on e-prescribing and remote prescribing

Historical Background

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003² established a national prominence for e-prescribing as a prescribing option in its new Medicare Part D drug benefit program. This Act also established requirements for development of information system standards to facilitate the development and dissemination of e-prescribing technologies. E-prescribing has been defined as follows: “the utilization of electronic systems to facilitate and enhance communication of a prescription or medicine order, aiding the choice, administration and supply of a medicine through knowledge and decision support, and providing a robust audit trail for the entire medicines use process.”³ E-prescribing is a tool. The tool is designed to more efficiently and effectively fulfill the therapeutic intent of the licensed prescriber compared with traditional alternatives. As well, the tool is designed to more efficiently and effectively meet the therapeutic need of the patient compared with traditional alternatives.

From 2003 to 2011, e-prescribing has progressed from a novel application used by a few early adopters to status as a standard tool for medication management used by over 58% of ambulatory licensed prescribers in the United States.⁴ In that the majority of licensed prescribers practicing today were trained in the era prior to the emergence of e-prescribing, it is timely to review key considerations in ethical, legal/regulatory, and technical aspects of e-prescribing. Doing so may serve to position licensed prescribers transitioning to e-prescribing optimally to enhance e-prescribing outcomes on behalf of patients, whether their e-prescribing activities occur in a traditional face-to-face encounter or remotely through a telemedical context. In fact, telemedical e-prescribing has critically important nuances addressed specifically within the legal/regulatory section of the present article. Much of the pertinent information is found in disparate resources in various areas of literature (see Appendix for a list of additional resources and a workflow for e-prescribing). It is the aim of this article to bring that information together in a unified, single source guideline that details applicable standards.

Literature Review

Academic Review

The potential for numerous benefits has been ascribed to e-prescribing, including (a) improved patient safety, (b) improved clinical outcomes, and (c) improved process efficiencies and/or cost reduction. This section reviews a sampling of studies from the academic literature for the purpose of delineating a chronologic roadmap toward progress in our understanding of design and other operant variables impacting attainment of the proposed benefits of e-prescribing. Selected studies reviewed are organized by year published and alphabetically by lead author within each year from 2005 through 2011.

2005

McMullin et al.⁵ published a study on cost savings related to e-prescribing use. The aim of the study was to evaluate sustainability of previously documented e-prescribing cost reductions resulting from use of an e-prescribing system with embedded clinical decision support (CDS). The method was a retrospective review of pharmacy claims data generated by prescribers using an e-prescribing system with embedded CDS compared with prescribers not using the system. Results documented the e-prescribing users' costs to be lower in average cost of new prescriptions, per member per month costs of new prescriptions, and lower expenditures for targeted high-cost category prescriptions. The authors concluded that e-prescribing systems with embedded CDS “shifted prescribing behavior away from high-cost therapies and significantly lowered prescription drug costs.”⁵

2006

Schade et al.⁶ published a study detailing the value of an e-prescribing capability within an EHR system. The aim of the study was to provide “insight into features that might motivate broad adoption in the United States.”⁶ The method was a viewpoint article based on then extant literature review. The results of the literature review noted e-prescribing's ability to improve prescription legibility and thus reduce medical errors. The authors noted in their conclusions that in terms of adopting EHR systems, e-prescribing capability was often the most highly valued component of such systems by adopting clinicians based on published surveys.

2007

Fitzhenry et al.⁷ published a study detailing limitations in e-prescribing systems. The aim of the study was to audit for errors in medication ordering and administration within an inpatient CPOE e-prescribing system. The method was a randomized, retrospective comparison of CPOE log files and manual chart audit reviews. The results revealed that errors in dose omissions and dose administration times occurred in the context of a CPOE system, albeit at a very low rate. The authors' conclusions noted the importance of attention to workflow and process synchronicity with e-prescribing capability in optimizing CPOE implementation outcomes.

2008

Ammenwerth et al.⁸ published a systematic review regarding e-prescribing systems' effect on medication errors and adverse drug events (ADE). The aim of the study was to assess relative risk reduction on medication error and ADE by CPOE. The method was a systematic review of the medical literature from 1966 through April 2006. The results revealed that the majority of studies showed a significant relative risk reduction of CPOE systems on medication error rates and ADE. The authors concluded “that electronic prescribing can reduce the risk for medication errors and ADE.”⁸

2009

Reckmann et al.⁹ followed with a more focused systematic review the following year. They narrowed their review to the question of “what evidence exists that CPOE systems reduce prescribing errors among hospital inpatients?”⁹ The systematic review was limited to the time frame from 1998 to 2007. Their findings showed that 75% of studies (9 of 12) demonstrated improvement in prescribing error rates yet noted persistent problems with duplicate orders and drug discontinuances. These persistent problems were thought to possibly be related to CDS design or navigation features of the e-prescribing system. The authors concluded that more research with larger sample sizes and attention to the specific role of CDS in reducing medication error rates should be considered.

Schedlbauer et al.¹⁰ published a systematic review focused on this issue of CDS effect in e-prescribing systems as Reckmann et al.⁹ advised. Their method focused on use of computerized alerts and prompts in reducing prescribing errors. The range of their search extended from 1950 to May 2007. Their findings showed 85% of studies (23 of 27) documented improvement in either reduced medication error rates or ADE avoidance. However, the authors also noted in their conclusions that further work should be directed at the design and display of prompts in assessing their apparent efficacy in decreasing medication error and ADE rates.

Weingart et al.¹¹ published a study of e-prescribing system clinical users' satisfaction with and perception of value of e-prescribing utilization. The method was a random sample survey of licensed prescribers using a commercial, ambulatory e-prescribing system. Results detailed the following responses: (1) 78% of respondents perceived improvement in quality of care as a result of using the e-prescribing system, (2) 83% perceived reduction in medical errors, (3) 71% perceived improved patient satisfaction, and (4) 75% perceived improved clinician efficiency.¹¹ Although a majority of respondents noted persistent problems with alerts triggered by discontinued medications, a minority of respondents noted perception of alert volume as a dissatisfying factor. The authors concluded that CDS-supported e-prescribing system “alerts may lead to clinically significant modifications in patient management.”¹¹

2010

Grossman¹² published findings from a 2008 survey of licensed prescribers using e-prescribing systems undertaken by the Center for Studying Health System Change. The method was an analysis of a subset of data from a survey of e-prescribing usage patterns by over 4,000 ambulatory licensed prescribers. Specifically, the method sought to differentiate between e-prescribing capability (availability of technology) within a practice versus its actual level of use (actual adoption and use of available technology) by prescribers in those practices. Results showed that 41.9% of ambulatory physician respondent practices reported e-prescribing technology available in their practices; however, 23.1% of those reporting availability reported using the technology “only occasionally or not at all.”¹² Furthermore, the analysis found that of those with e-prescribing technology available, only slightly greater than half (59.4%) reported ability to access CDS features, including (a) drug–drug interaction identification, (b) ability to access patient formulary information, and (c) electronic transmission of prescriptions directly to pharmacies. Because of the wording of the survey, estimates may have included practices transmitting prescriptions via computerized fax.¹² The author's analysis concluded that in 2008, prior to the implementation of U.S. programs to support e-prescribing (see Government Accountability Office [GAO] review below), adoption of e-prescribing by ambulatory licensed prescribers remained low with less than half of practices responding and that a significant number of these lacked advanced e-prescribing features.

Moxey et al.¹³ published a study aimed at understanding factors impacting CDS efficacy (acceptance of CDS recommendations by users) in e-prescribing systems. The method was a systematic review of electronic literature for 1990–2007. Results showed factors impacting CDS use within an e-prescribing system were (a) convenient ability to access system, (b) support and training in use of software, (c) workflow integration efficiencies, and (d) perceived appropriateness of alerts and reminders. Results also showed factors facilitating uptake of CDS by users included (a) collegial support, (b) reduced impact on professional autonomy, and (c) reduced interference with patient–physician relationship. The authors concluded that attention to these factors should be addressed when planning and deploying CDS within e-prescribing systems.

Stenner et al.¹⁴ published a study aimed at the effect of CDS on generic prescribing behavior by users of e-prescribing systems. The method was a retrospective review of e-prescribing data before and after implementation of an e-prescribing system embedded with generic substitution CDS and comparison with a control group of prescribers using traditional, handwritten prescriptions. Results showed a near doubling (from 32.1% to 54.2%) of generic substitution among CDS-supported e-prescribers compared with the control group; the effects persisted for 2 years after the intervention. The authors concluded that “implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties.”¹⁴

2011

Cooke et al.¹⁵ published a study aimed at determining first-fill prescription failure rates and factors impacting the same using e-prescribing data. The method was a retrospective study of claims data with a primary outcome measure of failed-to-obtain new antihypertensive medications and a secondary outcome measure of demographic factors related to fill failure. Results showed 24.5% of patients were classified as first-fill failures, accounting for 15.6% of prescriptions. Secondary outcomes analysis showed three factors to be most predictive for first-fill failure: (1) patient newly diagnosed as hypertensive, (2) brand product prescriptions, and (3) managed care insurance. The authors suggested that e-prescribing systems with formulary decision support and fill status messaging support have potential to positively impact patient medication adherence.

Michelis et al.¹⁶ published a study aimed at evaluating e-prescribing impact on attainment of low-density lipoprotein goals among hyperlipidemic patients at an academic medical center. The method was a retrospective cohort study of e-prescribing data within an EHR system. Results showed “patients with an e-prescription were 59% more likely to attain their guideline-based LDL [low-density lipoprotein] goal.”¹⁶ Secondary analysis revealed “for each $10 increase in prescription cost, the likelihood of being at goal decreased by 5%.”¹⁶ The authors concluded that e-prescribing systems with formulary decision support can lead to measurably improved health outcomes.

Lapane et al.¹⁷ published a study aimed at understanding e-prescribing users' perceptions of efficiencies and inefficiencies experienced with e-prescribing system use. The method was a mixed-method study design using qualitative data from 64 focus groups of e-prescribing users using varied e-prescribing systems. The results showed 64% of users ranked the e-prescribing utility as very efficient versus 28% as moderately efficient versus 5% as moderately inefficient versus 3% as very inefficient.¹⁷ Areas in which efficiencies were gained included less time dealing with prescription errors and formulary matching. Areas of inefficiency included inability to electronically prescribe controlled substances and not up-to-date formulary and/or eligibility information in the system. The authors concluded that users of e-prescribing systems perceive workflow efficiency gains but that further gains would be improved by assuring accurate and up-to-date information in the formulary and insurance eligibility support modules.

Yu et al.¹⁸ published a study aimed at evaluating adherence among e-prescribers to CDS black box warnings (Food and Drug Administration–generated warnings regarding medications with serious risks). The method was a pre/post study of 51 ambulatory clinical sites using a single e-prescribing system. The results showed that overall there was a slight increase in nonadherence to black box warnings after the intervention (detrimental effect) except for drug–drug and drug–pregnancy classifications, which showed a slight decrease in nonadherence (beneficial effect). The authors concluded that designers of e-prescribing CDS should not include black box warnings en masse but might wish to consider inclusion of identified subcategories that were deemed clinically relevant by clinical users.

Summary

Several conclusions can be drawn in reviewing this sampling of the e-prescribing academic literature. During the period shortly after passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003,² which gave a national prominence to e-prescribing, evidence began to accumulate in the academic literature of e-prescribing technologies' abilities to positively contribute to improved patient safety outcomes, improved quality of care outcomes, and improved process efficiencies or cost reductions. At the same time, many of the studies noted limitations in the attainment of these goals often related to design and/or contextual operational features. This supports an iterative learning process in implementation of a new technology in which knowledge gained is sequentially built upon. It is notable, however, that the preponderance of evidence is in favor of e-prescribing as an improved technology offering benefits to patients and prescribers when designed and implemented appropriately and carefully.

Governmental Issues Review

To carry forward a review of the e-prescribing value proposition from another perspective, a GAO report addressed “congressional interest in how others have measured and whether or to what extent electronic prescribing improves quality or reduces cost.”¹⁹ However, consideration of the full and exact title of the GAO report sets a framework for understanding the historical U.S. healthcare watershed events of 2008 and 2009. The full and exact title of the GAO report is “Electronic Prescribing: CMS [Centers for Medicare & Medicaid Services] Should Address Inconsistencies in Its Two Incentive Programs That Encourage the Use of Health Information Technology.”¹⁹ In 2008, the U.S. Congress passed the Medicare Improvements for Patients and Providers Act of 2008²⁰ (MIPPA), which provided “incentive payments from 2009 through 2013 to certain Medicare providers—physicians and other healthcare providers, such as physician assistants and nurse practitioners—who have prescribing authority and who adopt and use systems that meet CMS's definition of a qualified electronic prescribing system.”²⁰ In 2009, the U.S. Congress passed the second of the e-prescribing-related financial incentive programs for eligible providers in the Health Information Technology for Economic and Clinical Health (HITECH) Act as part of the American Recovery and Reinvestment Act of 2009 (Recovery Act).²¹ “HITECH established a program, referred to here as the Electronic Health Records (EHR) Program, that provides incentive payments from 2011 through 2016 to Medicare physicians that adopt and ‘meaningfully use’ certified EHR technology, which includes electronic prescribing technological capabilities.”²¹ Thus, the watershed events of 2008 and 2009 were the MIPPA and the HITECH Act, which placed the U.S. government as an instrument of financial incentives to spur the adoption of e-prescribing by licensed prescribers—hundreds of millions of dollars (in aggregate) became available to eligible prescribers—no small incentive.

Considering these historical events, it is appropriate to return to the focus of the literature review that serves as the basis for understanding the inherent values of e-prescribing for the U.S. healthcare system. As also noted above, MIPPA required the GAO to respond to congressional interest regarding the documented quality and cost potential benefits of e-prescribing. The GAO chose to include this information in its February 2011 report.¹⁹

Specifically, the GAO reviewed and reported on 42 studies regarding either quality and/or cost experiences with e-prescribing. In this case, cost was defined narrowly as any potential cost benefit to an insurer (in that the government is an insurer through its Medicare and Medicaid programs) as opposed to any potential cost benefit to any user of an e-prescribing system (e.g., a licensed e-prescriber or pharmacy system dispensing e-prescriptions). The GAO initial research identified five types of organizations involved in studying and/or publishing their experiences with e-prescribing relative to quality and/or cost effects: “(a) state Medicaid programs, (b) health insurance companies, (c) pharmacy benefit managers, (d) collaborative groups, and (e) state employee benefit plans.”¹⁹ These organizations' materials were augmented by a GAO general literature search dating from January 1, 2005, to May 14, 2010, to compile the total of 42 studies noted.

The GAO report reviewed the 42 studies according to (1) title/authors, (2) individual study methodology, (3) how e-prescribing was determined, (4) outcomes measured, and (5) reported finding. Outcomes measured were noted to include both beneficial changes in medication orders by users of e-prescribing systems as well as patient safety outcomes such as lowered ADE rates. Cost outcome measures included examples of lowered costs due to generic prescribing and/or formulary utilization as well as healthcare cost savings from lowered treatment costs of (avoided) ADEs. The findings did note that e-prescribing systems that use CDS capabilities (e.g., drug–allergy or drug–drug interaction alerts) generally increased the potential “to more safely prescribe medications.”¹⁹ Thus, review of the e-prescribing value proposition from a governmental perspective aligned with the summation found in the prior academic review—the preponderance of the data supported e-prescribing technologies' abilities to improve patient safety, quality outcomes, and process efficiencies or cost factors.

Having reviewed and documented significant support for the value proposition for e-prescribing as a promising technology to improve patient safety, quality outcomes, and process efficiencies or cost reduction, one must then consider and review other key considerations of significance in a transition to e-prescribing capability on the part of licensed prescribers. These other considerations include (a) ethical considerations in e-prescribing as an inherent consequence of the patient–provider relationship in the practice of medicine, (b) legal/regulatory considerations, and (c) technical considerations in order for a licensed prescriber to successfully transition to e-prescribing capability.

Ethical Issues Review

Although it is true that the ethics of e-prescribing do not vary from the ethics of prescribing in general, the advent of technological change heralded by the Internet as a venue for e-prescribing—and the magnitude of financial opportunity therein—makes an initiating section on ethics noteworthy. The anticipated outcomes of ethically based actions are the performance of beneficence and the avoidance of malfeasance (i.e., do good and avoid harm).²² In looking further for more specific ethical guidance, the American Medical Association (AMA) serves as one of the largest advocacy groups composed of and for its physician members, the bulk of licensed prescribers in the United States. Among AMA resources on medical ethics, Opinion 10.015 establishes the patient–physician relationship as the core of the practice of medicine's ethical stance: “The relationship between patient and physician is based upon trust and gives rise to the physicians' ethical obligations to place patients' welfare above their own self-interest and above obligations to any other groups, and to advocate for their patients' welfare. Within the patient–physician relationship, a physician is ethically required to use sound medical judgment, holding the best interests of the patient as paramount.”²³ These key considerations then serve as the basis for a listing of ethical considerations in e-prescribing. Moreover, there is agreement with these considerations at an international level.²⁴

Legal/Regulatory Issues Review

Baszynski²⁵ noted that “in order to effectively discuss prescribing (in the 21^st century), it is important to distinguish between different forms of prescribing physicians engage in while employing telecommunications, and more specifically, the Internet.” Baszynski's contribution to the literature stems from her clarifying related concepts and terms within a legal framework that are often misunderstood by inexperienced licensed prescribers: e-prescribing, remote or telemedical prescribing, and Internet prescribing. E-prescribing is viewed by Baszynski²⁵ as electronic generation and transmission of a prescription as opposed to the previously traditional handwritten mode of prescription generation and transmission (handing it to a patient physically present). Remote or telemedical prescribing is described as usually occurring within the context of an established telemedicine program with a clinician geographically at a distance from the patient; the legal implications of whether this occurs within a state's boundary or across states' boundaries are significant and will be commented on further. Internet prescribing is defined by use of the Internet in the totality of defining the limits of the doctor–patient relationship such that “the most defining characteristic of Internet prescribing is that the entire doctor–patient relationship is rooted in, sustained by, and concludes with Internet communications. The relationship is initiated by a patient through a website. The ‘examination’ is commonly a completed online questionnaire. The prescriptions are issued, authorized, and sent electronically.”²⁵ Another contribution Baszynski²⁵ made was to clarify the preeminent role of state medical boards in determining e-prescribing related legal/regulatory issues such as (a) an acceptable standard of care, (b) bona fide doctor–patient relationship, and (c) risks of prescribing to a patient residing outside the licensed prescriber's state of licensure. Legal case studies where licensed prescribers have experienced financial fines and/or legal sanctions to the point of imprisonment are offered to provide clarity to theoretical considerations.

Medical licensure, or the legal authority to practice medicine within a state's borders, is in most U.S. states conferred by a state medical board delegated the authority to do so by an Act of the state legislature. The state medical board then has the responsibility to interpret and apply medical practice statutes and regulations developed by the legislature or other authorized state regulatory offices (e.g., state boards of pharmacy) to the practice of medicine by licensed practitioners within its borders or the practice of medicine by medical practitioners outside its borders but affecting patients within its borders when a patient has a bona fide patient–physician relationship with an out-of-state medical practitioner. The legal entanglement that may occur in either telemedical (remote) e-prescribing, and certainly Internet prescribing (as defined above by Baszynski²⁵), is that “almost every state medical board has statutes prohibiting the practice of medicine by physicians not licensed by the state's medical board.”²⁵ Moreover, the terms “bona fide patient–physician relationship” and “acceptable standard of care” are often vaguely or not at all defined by many states' legal/regulatory documentation, whereas, in contradistinction, some states explicitly document a requirement for an in-person clinician examination of a patient in order for a legally valid prescription (electronic or otherwise) to result (standard of care issue). Obviously, these documentation constraints impact professional prescribing activities of the telemedical or remote e-prescriber.

Chee²⁶ looked more narrowly at the practice of telepsychiatry. This author also noted the impact of state-based licensure requirements as a constraint on licensed prescribers who may wish to e-prescribe to a patient residing within a state other than that from which the licensed prescriber holds a license. The basic transaction is viewed as one of “teleporting” the prescriber to the legal jurisdiction of the patient, rather than vice versa. Thus, Chee²⁶ drew a conclusion similar to that of Baszynski²⁵: “telemedical practitioners should consult the rules of the state where their patients reside in addition to the rules of the state where they hold a license.”²⁶

The Center for Telehealth & e-Health Law has published on its Web site a compendium of the legal and regulatory environment of the 50 states, Puerto Rico, and the District of Columbia as it impacts e-prescribing.²⁷ Some specific legal/regulatory provisions that are common among many of the states are detailed by state within a tabular, summary format found at the beginning of the document. Examples of these legal/regulatory provisions are as follows: (1) any requirements for an in-person physical examination or a preexisting patient–physician relationship, (2) any provisions that the physical examination may or may not be facilitated by the use of electronic technology, (3) any requirements regarding the documentation of patient medical history including any provisions specifically prohibiting the use of medical questionnaires or patient-supplied histories as the sole basis of patient historical information for the purpose of prescribing, (4) any requirements for documentation of establishment of appropriate follow-up care, and (5) any provisions for the option of emergency prescribing of controlled substances (found in the summary table on The Center for Telehealth & e-Health Law Web site).²⁷ After presentation of this summary table, the compendium goes on to provide additional state-by-state commentary on these and other individual state issues impacting e-prescribing, either locally or remotely.

What is of interest is the wide variance that is found to exist among the states in their individual approaches to documentation of these select and important factors in effecting legally valid e-prescriptions. For example, in the category of legal/regulatory documentation of specific language addressing provisions for emergency prescribing of controlled substances, at least as of the time of the original The Center for Telehealth & e-Health Law publication (circa May 2011), eight states had language in their legal/regulatory documentation allowing such prescribing, whereas two other states had language expressly disallowing such emergency prescribing of controlled substances. Similar variances can be found in other of the above categories in that four states appear not to have specific documentation addressing the issue of whether a physical examination is required to result in a legally valid e-prescription. However, one must keep in mind that as in all legal/regulatory environments, the states' handling of legal/regulatory provisions impacting e-prescribing is in constant flux and that, in order to be up to date, continuous monitoring of individual states' provisions is required.

An important piece of the legal/regulatory literature impacting e-prescribing, already alluded to by Baszynski²⁵ and Chee,²⁶ is the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Shortly after passage of the Act, the Department of Justice published specific advisement to the pharmaceutical industry and to licensed prescribers in its final rule regarding implementation of the Act.²⁸ Ryan Haight was a college-age student residing in California who was able to obtain a prescription for a controlled substance via an Internet Web site run by a pharmacy dispensing company that in turn employed licensed prescribers for the actual prescribing. Unfortunately, an overdose of the controlled substance medication resulted in the young man's death in 2001. Subsequent investigation led to the uncovering of ethical and legal/regulatory irregularities, some well defined and some not well defined, that ultimately resulted in fines, incarceration, and loss of licensure for the physician involved in the prescribing. Although these penalties were levied under the jurisdiction of the Controlled Substances Act,²⁵ it was clear that arguable loopholes existed as a result of technologic advances represented by Internet e-prescribing capabilities, and it was the aim of the Ryan Haight Act to address these. Among new requirements of the Act were the following: (1) registration and reporting requirements for online pharmacies dispensing over a defined volume of controlled substance prescriptions and that the Web site of the online pharmacy display (2) information relating its compliance with the Act, (3) the names, contact information, and qualifications of the pharmacist-in-charge, and (d) its compliance with the laws and regulations for all states in which it dispenses prescriptions, among others.²⁸ Of course, the Act only impacted pharmacies licensed within the United States; however, other federal requirements make the importation of prescriptions from abroad for the purpose of distribution and sale illegal.

On March 31, 2010, the Drug Enforcement Administration (DEA) published its final rule regarding standards and guidance for the electronic prescription of controlled substances.²⁹ This document provided the DEA's concerns about the potential for diversion of controlled substances via e-prescribing activities. Additionally, it provided guidance for mechanisms to ensure, insofar as reasonably possible, safeguards against diversion efforts when e-prescribing systems are used in the generation, transmission, and dispensing of controlled substance prescriptions. The DEA specifically expressed that “certain requirements must exist for any system to be used for e-prescribing of controlled substances:

• Only DEA registrants may be granted the authority to sign controlled substance electronic prescriptions, schedules I–V;

• The method used to authenticate a practitioner to the electronic prescribing system must ensure to the greatest extent possible that the practitioner cannot repudiate the prescription;

• The prescription records must be reliable enough to be used in legal actions without diminishing the ability to establish the relevant facts and without requiring the calling of excessive numbers of witnesses to verify records; and

• The security systems used by any electronic prescription must, to the greatest extent possible, prevent the possibility of insider creation or alteration of controlled substance prescriptions.”²⁹

Consequently, the DEA put into place standards to be met when using e-prescribing systems that would fulfill the above stated requirements.

The first of the above bulleted requirements is an authority recognition issue, and the second is the related authentication of the appropriate authorized individual to the e-prescribing system. The first issue is addressed in the standards that require licensed, DEA-registered prescribers “to apply to a certified Federally approved credential service provider (CSP) or certification authority (CA) to obtain their authentication credentials or digital certificates.”²⁹ The second issue is addressed in the DEA's setting of the e-prescribing systems' logical access controls that are designed to insure that only appropriately authorized individuals can enter, set up, and/or sign controlled substance e-prescriptions. Furthermore, the actual signing of a controlled substance prescription must involve a “two-factor” authentication method to further insure against internal subversion in that the standard single-factor authentication method (e.g., the knowledge factor such as a password) is easily subverted based on computer systems' experiences. Thus, the DEA's final rule addresses the authority recognition issue and authentication issue requirements.

The third of the above bulleted requirements is an enforcement efficiency issue, and the fourth is an enforcement effectiveness issue. The efficiency issue is addressed in several related mandates by the final rule. The first of these mandates is that application service providers (e-prescribing system vendors) must have their applications certified as meeting DEA technical requirements by certifying authorities identified by category or specifically named by the DEA. Discussed (but not mandated) in the final rule is that application service providers must use the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard of 2011 for ambulatory-based applications or the Health Level 7 standard for hospital-based applications. Another mandate pertains to the required audit trails (monthly logs) of completed controlled substance prescriptions and their archival. Moreover, the e-prescribing system must have an internal auditing ability to identify any instances of “any modifications, annotations, or deletions of an electronic controlled substance prescription or when a functionality required by the rule is interfered with.”²⁹ If the internal audit trail identifies any breach of security events (change of prescription after signature and transmission of e-prescription), then the DEA must be notified within 1 business day of the event being recognized. Thus, the final rule addresses the efficiency and effectiveness requirements noted above.

Although federal law has placed certain restrictions on the medical use of federally controlled substances, the states have regulated the practice of medicine generally.³⁰ As an example of a state's regulation of the practice of medicine, one may consider the California Business and Professions Code, which documents the legal authority for and regulatory mechanisms whereby the State of California licenses medical practitioners within its jurisdiction to practice medicine, including the legal rights of duly licensed practitioners to prescribe medications to residents of the state.³¹ The primary regulatory bodies set forth to provide oversight for these duly authorized legal activities are the California State Board of Medicine and State Board of Pharmacy. Generally, similar duly authorized regulatory bodies exist within each U.S. state and territory and the District of Columbia. As such, it is from these Boards from which the legal authority to prescribe is granted, and it is to these Boards to which authorized prescribers should look for primary legal and regulatory guidance for e-prescribing activities. In fact, the level of regulatory detail of interest to licensed prescribers to which the Boards set forth provisions can be found in the delineation of the exact content elements of a prescription to be legally valid in the State of California.³¹ The DEA's final rule does not preempt any state controlled substance rules. Thus, licensed prescribers need to make sure that they are e-prescribing controlled substances in accordance with both state and federal rules.

Technical Issues Review

There is a significant body of literature regarding technical aspects of e-prescribing. These range from the NCPDP SCRIPT standard, which addresses issues in the transmission of e-prescriptions, to governmental standards and guidelines developed by the Agency for Healthcare Quality and Research and CMS, often offered via publication in the Federal Register. However, in view of the fact that the aim of the guideline product of this effort is to produce for the licensed prescriber transitioning to e-prescribing a concise and pragmatic set of considerations in the context of a busy, day-to-day implementation and use of an e-prescribing system to directly benefit her or his patients, much of the above-noted body of literature is secondary to this defined aim. The following section, and consequent guideline product, will review only materials of a technical nature perceived to be of immediate and necessary import to this more narrowly defined aim. In that nearly all technical considerations flow from established legal/regulatory developments, this section will necessarily reference previously noted information at times.

Once a licensed prescriber has purchased (or her or his organization has purchased) an e-prescribing system or EHR and set up required access and authentication controls according to DEA and state legal/regulatory requirements, the licensed prescriber must know of the differences created by technical aspects of an e-prescribing system compared with the prior practices inherent in generating and conveying a traditional, handwritten prescription. Whittemore³² provided an excellent comparative review of these distinctions, noting the additional content items required for inclusion in the generation of an e-prescription compared with a traditional, handwritten prescription. Although many of the content elements of an e-prescription are similar to the more traditional, hand-written prescription—items such as patient name, address, date of prescription issue, and drug identification (name, strength, dosage form, and quantity)—there are additional requirements created by the e-prescribing environment that go beyond these content elements. These are determined by the NCPDP SCRIPT standard and are embedded in the software of certified e-prescribing systems, for the most part transparent to the licensed prescriber using the e-prescribing system. Examples of these type data elements include (a) identification of the specific pharmacy to which the e-prescription is to be transmitted, (b) prescriber contact information including unique e-prescription network ID, and (c) the National Drug Code number for the prescribed medication where one exists.

Additionally, Whittemore³² provided a pragmatically useful section on “prescription data elements requiring extra care and attention when input.” The author noted that drug selection databases within e-prescribing systems should be free of abbreviations for drug names as no time is saved in electronic systems' selections (often from a pull-down menu click) compared with handwritten constraints. Inadequately interpreted abbreviations by the dispensing pharmacist can be a source of medication error. Additionally, the author noted that directions for drug use should not be split between the Sig (instructions to the patient on the appropriate intake of the prescribed medication) field and the notes field, as this may lead to partially missed and therefore incomplete instructions to the patient. Nor should information appropriately entered in the notes field conflict with the Sig field, creating confusion for the pharmacist and serving as another potential source of error in the medication management process. The author noted that knowledge of and attention to appropriate content construction of an e-prescription—both those content elements similar to a traditional, handwritten format and those newly unique to the e-prescribing environment—will serve to enhance the prescription management process to the benefit of the patient, which is the ultimate goal in e-prescribing systems.

Surescripts LLC is a company developed by collaborative elements within the pharmaceutical industry. The most pertinent of its product lines to e-prescribing is the creation and maintenance of a pharmacy health information exchange, providing electronic access to and the transmission of prescription information. Although not the only pharmacy health information exchange operating in the United States, it is seen by many as the largest and most influential. It has strongly contributed to the formation of technical health information exchange standards such as the NCPDP SCRIPT standard in all its versions. Services to licensed prescribers offered via the Surescripts network include the ability to access patient claims-based medication histories and the ability to access patient insurance plan pharmacy benefits' information (e.g., which medications are covered benefits under the patient's insurance plan and at what level of cost to the patient—a proven compliance factor in prescribing). Moreover, Surescripts serves as a certifier under government incentive programs (HITECH and MIPPA) of EHR e-prescribing applications for vendor developers to deliver for use by licensed prescribers.

Surescripts annually compiles and publishes a report on the status of e-prescribing adoption in the United States along with other pertinent information regarding e-prescribing of interest to e-prescribing developers, vendors, and users. In its 2010 annual report on the status of e-prescribing, Surescripts details the adoption of e-prescribing at the national level: “the number of prescribers routing prescriptions electronically grew from 156,000 at the end of 2009 to 234,000 by the end of 2010—representing about 34% of all office-based prescribers.”³³ Information on the Surescripts Web site updates that percentage in 2012 to 58% of all office-based prescribers. Thus, the view is held by many licensed prescribers that e-prescribing has become the new de facto standard for prescription management processes in ambulatory patient care in the United States.

Surescripts also has participated in a consortium of government, business, and clinical stakeholders dedicated to the development and adoption of safe and effective e-prescribing practices: the Center for Improving Medication Management. Participants in this organization include (a) the AMA, (b) the American Academy of Family Physicians, (c) the American College of Physicians, (d) the Medical Group Management Association, (e) e-Health Initiative, and (f ) the BlueCross BlueShield Association, along with other insurers. In 2008, members of this group published the “ Clinician's Guide to Electronic Prescribing.”³⁴ This guide was subsequently updated in 2011.³⁵ Also in 2011, the Agency for Healthcare Research and Quality published implementation toolsets for both physician practices³⁶ and independent pharmacies.³⁷ These guides address pragmatic technical issues in the adoption of e-prescribing by licensed prescribers transitioning to e-prescribing as well as technical and legal/regulatory aspects of e-prescribing adoption. Specifically, the 2011 reports collectively address these topics:

• benefits of e-prescribing

• government incentive programs impacting adoption of e-prescribing

• guidance on e-prescribing adoption decisions including practice readiness assessment and e-prescribing systems' purchase evaluation process

• an overview for recent adopters and those considering e-prescribing adoption of the recently released guidelines for e-prescribing of controlled substances

However, the pertinent baseline document for learning the myriad technical details of the prescribing of controlled substances remains the Department of Justice's Electronic Prescriptions for Controlled Substances; Final Rule.²⁹ This document provides not only the legal/regulatory framework for the DEA's requirements for e-prescribing controlled substances, but also documents important technical provisions noted earlier in the legal/regulatory literature review within the present article. These more technically related provisions pertain to requirements for the appropriate manner of setting up access controls and requirements regarding two-factor authentication and signature of controlled substance e-prescriptions, as well as technical provisions to which e-prescribers must comply in the case of a failed transmission of an e-prescription, among others.

Collaboration Between Healthcare Professionals on Behalf of the Patient

Although this document has been primarily concerned with e-prescribing activities from a licensed prescriber's perspective, the role of the pharmacist is critical to a successful medications management outcome for the patient. Pharmacists are receivers of an electronic prescription. Through their comprehensive knowledge of the safe and effective use of medications, they have the skills to co-manage the clinical aspects of medication therapy. Pharmacists efficiently and effectively translate the language of medication therapy at transitions of care and decipher system requirements into sound medication ordering to ensure accurate electronic exchange of prescriptions and prescription-related information.³⁸

E-prescribing benefits physicians, pharmacists, and patients by reducing the opportunity for medication errors, providing information to prescribers on benefit coverage, and reducing workload for pharmacists so that they can reallocate time to patient care services.³⁹ Physician incentives for adopting e-prescribing promote pushing the electronic prescription from the prescriber to the pharmacy. Promoting the bidirectional exchange of information between the prescriber and the pharmacist will enhance care coordination and improve patient outcomes. As noted, more information on e-prescribing implementation in independent pharmacies has recently been published by the Agency for Healthcare Research and Quality.³⁷

Administrative/Regulatory Standards

In the Introduction e-prescribing is described as a legitimate component of the practice of telemedicine and telehealth. The standards regarding e-prescribing listed below represent a building on the prior work involving Core Standards for Telemedicine Operations.¹

For Organizations and Health Professionals

1. Organizations providing e-prescribing services shall be aware of and shall follow the administrative standards as set forth for organizations and health professionals in the Core Standards for Telemedicine Operations¹ as they pertain to remote prescribing and e-prescribing.

2. Organizations and health professionals providing e-prescribing services shall be aware of and should adhere to the following ethical considerations:

a. The patient–prescriber relationship is the core of the practice of medicine's ethical stance.

b. The patient's well-being is of utmost importance in guiding all e-prescribing activities.

c. The licensed prescriber's sound medical judgment is to be applied to all e-prescribing activities.

3. Organizations and health professionals providing e-prescribing services shall be aware of the following legal/regulatory considerations specifically pertinent to e-prescribing:

a. State medical boards and state boards of pharmacy are the primary regulatory authorities within each state related to issues governing e-prescribing.

b. If a licensed prescriber e-prescribes for a patient who resides in a state other than that for which the prescriber holds a license, the legal/regulatory constraints of the patient's state of residence must also be considered.

c. Specifically, any legal/regulatory requirements constraining the following:

1. performance of an in-person examination of the patient, whether face-to-face or via a legitimately established telemedicine program;

2. circumstances in which documentation of a prior patient–physician relationship is required; and

3. documentation that a patient–physician encounter that results in an e-prescription has met the prevailing standard of care in regard to history taking, physical examination, diagnostic assessment, and therapeutic plan including provisions for follow-up care to monitor therapeutic efficacy.

d. For an e-prescription to be valid, it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

e. When there is a discrepancy among federal, state, and local regulations governing e-prescribing, generally the more restrictive provisions prevail.

4. Organizations and health professionals providing e-prescribing services shall be aware of the following legal/regulatory considerations specifically pertinent to the e-prescribing of controlled substances:

a. For an e-prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

b. E-prescribing controlled substances is an option as long as all DEA requirements are met.

c. The individual practitioner affixing her or his digital/electronic signature to an e-prescription for a controlled substance is responsible for ensuring that the e-prescription conforms to all legal requirements: federal, state, and local.

d. When there is a discrepancy among federal, state, and local regulations governing e-prescribing, generally the more restrictive provisions prevail.

e. Whether or not provisions exist modifying or waiving standard legal/regulatory constraints in emergency controlled substance e-prescribing.

f. When an e-prescription for a controlled substance results in an electronic transmission failure, then a replacement prescription must note that it is to replace a failed transmission e-prescription and as well indicate the original date and pharmacy destination for that original e-prescription.

For Clinical/Technical Standards

1. Organizations providing e-prescribing services shall be aware of and shall adhere to the clinical and technical standards as set forth for organizations and health professionals in the Core Standards for Telemedicine Operations¹ as they pertain to remote and e-prescribing.

2. Organizations and health professionals providing e-prescribing services shall be aware of and shall adhere to the following clinical/technical considerations specifically pertinent to e-prescribing:

a. The required content elements of a valid e-prescription.

b. That an e-prescribing application must be certified as meeting DEA requirements for the option of electronically prescribing controlled substance prescriptions.

c. That licensed prescribers must participate in and complete an identity proofing process for the option of electronically prescribing controlled substance prescriptions.

d. That two individuals will be required to enter and approve logical access controls to the e-prescribing system and that one of these must be a registrant.

e. That a two-factor authentication is required to electronically/digitally sign a controlled substance e-prescription.

f. That any breach of security of the two-factor authentication devices (either PIN/password, hard token, and/or biometric) must be reported to the DEA within 1 business day; and that failure to do so may result in loss of DEA registration and the licensed prescriber being held accountable for any controlled substance prescriptions generated as a result of the use of breached authentication devices.

g. That documentation of patient consent is required prior to electronically accessing third-party (insurer, pharmacy, pharmacy benefit manager) databases.

3. Organizations and healthcare professionals providing e-prescribing shall know how to access third-party databases for the purpose of optimizing the electronic medication management process: validating medication histories where available and/or viewing lower-cost options when desired/appropriate.

4. A prescriber providing e-prescriptions shall, at a minimum, disclose his or her name, business location, and license number for all states in which he or she is licensed.

5. For the purpose of knowledge maintenance, it is recommended that an individual and/or team within the practice should be designated responsibility for keeping all practice associates up-to-date with the evolving legal/regulatory requirements impacting the practice's e-prescribing activities. Ideally, a licensed prescriber within the practice should be a participant in this process.

Footnotes

Acknowledgments

The authors acknowledge the following individuals and all members of the ATA Standards and Guidelines Committee and ATA support staff: Nina Antoniotti, PhD, MBA, RN, Program Manager, Marshfield Clinic Telehealth Network, Marshfield, WI; Libby Baney, JD, Vice President, FaegreBD Consulting, and Attorney with Faegre Baker Daniels LLP, Washington, DC; Jordana Bernard, MBA, Senior Director, Program Services, ATA, Washington; Virginia Herold, Executive Director, California Board of Pharmacy, Sacramento, CA; Elizabeth A. Krupinski, PhD, Professor and Vice Chair of Research, Department of Medical Imaging, University of Arizona, Tucson, AZ; Tim Lim, PharmD, Pharmacy Informatics Specialist, Dignity Health, Sacramento; Jonathan Linkous, MPA, Chief Executive Officer, ATA; Shelley Shapiro, RPh, FASCP, Executive Director, Pharmacy eHealth Information Technology Collaborative, Alexandria, VA; Betsy L. Thompson, MD, DrPH, Chief Medical Officer, San Francisco Regional Office, CDR, U.S. Public Health Service, Centers for Medicare & Medicaid Services, San Francisco, CA; and Ken Whittemore, Jr., RPh, MBA, Senior Vice President, Professional and Regulatory Affairs, Surescripts LLC, Arlington, VA.

Disclosure Statement

No competing financial interests exist.

Appendix

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