US Pharm. 2008;33(8):60-66.
It has been estimated that fewer than 10%, or only 35,000, U.S. physicians prescribe drugs using electronic methods of communicating with a pharmacy.1 This does not take into consideration the dentists, podiatrists, or other heath care providers who are authorized to prescribe medications. This means that only about 35 million of the 3.5 billion prescriptions annually filled by U.S. pharmacies are electronically prescribed. Couple that with the fact that only about 70% of the nation's pharmacies are capable of receiving electronically prescribed prescriptions.2 Based on available numbers, about 17,000 of the country's 57,000 pharmacies are not taking advantage of this technology.3
Benefits of E-prescribing
The advantages of electronic prescribing (e-prescribing) should be obvious to everyone. E-prescriptions can save time and money for prescribers, pharmacies, and patients. Perhaps that explains why some private health insurers are jumping on the bandwagon and paying prescribers as much as a 6% bonus for e-prescribing.4 Congress has introduced legislation that provides incentives for physicians to adopt technology that permits the use of e-prescribing. Under the bill, known as the Medicare Electronic Medication and Safety Protection Act or, more simply, E-MEDS, Medicare would pay e-prescribers $2,000 in 2009, $1,500 in 2010 or 2011, and $1,000 in subsequent years. Furthermore, the bill would authorize a 1% bonus payment for claims that include an e-prescription. The fee schedule would be reduced by 10% for Medicare claims submitted on or after January 1, 2011, that include a prescription that was not electronically generated.5,6
Digital technology can alert prescribers to potentially harmful drug interactions or allergies. Pharmacists will no longer have to employ the guesswork associated with deciphering nearly illegible handwriting. Computer programs can flag cheaper generic alternatives to brand-name drugs, and with the more sophisticated types of software physicians can prescribe based on the drugs covered under a patient's health plan. Some insurers estimate that e-prescribing can save consumers about $250 annually.7 Many of the 1.5 million medication errors estimated by the Institute of Medicine to occur each year in the U.S. could be curtailed or even eliminated.8 E-prescribing would help control drug interactions by giving prescribers instant access to all prescription medications being used by patients. Arguably, e-prescriptions would reduce diversion of controlled substances if proper security measures were followed.
Things are about to change for a number of reasons. At the moment, there is a coalition of over 26,000 chain and independent pharmacies participating in marketing efforts to raise consumer awareness of this option.9 The coalition has opened www.LearnAboutEprescriptions.com, a Web site that encourages visitors to ask their physicians to transmit prescriptions electronically. A user of the site can plug in a ZIP code and find out which physicians e-prescribe and which pharmacies accept e-prescriptions within a specified geographic area. Add to this a coalition of five physician organizations that have launched their own Web site, www.GetRxConnected.com, designed to encourage all prescribers to adopt this technology. Prescriptions that are electronically prescribed are exempt from the Medicare mandate of using tamper-resistant paper for all prescriptions generated after April 1, 2008. The National ePrescribing Patient Safety Initiative offers free software to physicians who want to e-prescribe.10 The competition may force nonparticipating prescribers and pharmacies to rethink their strategies about the practice.
All this means that community pharmacies should get ready for a big surge in e-prescribing. In addition, Medicare Part D Regulations setting forth e-prescribing standards will take effect in April 2009.11 Perhaps even more of a stimulus to e-prescribing is a major shift in Drug Enforcement Administration (DEA) policy that would allow the practice for controlled substances. The proposed rules were released on June 27, 2008, and the commentary period will remain open until September 25, 2008.12 Look for final regulations soon thereafter. But keep in mind that e-prescribing of controlled substances will not be legal until the regulations are finalized.
E-prescribing will not be required under Medicare, at least for right now. However, under the rules, when a prescriber issues an e-prescription, the format will have to conform to the established requirements. The regulations address four categories: formulary and benefits; medication history; fill status notification; and provider identifiers. Although under consideration, the new guidelines do not address prior authorization, structured and codified patient instructions, and clinical drug terminology. These latter issues are expected to be addressed in future promulgations of the Centers for Medicare and Medicaid Services (CMS). The formulary and benefits section governs how practitioners communicate with plan sponsors about what drugs are covered under their patients' plans and what generic alternatives might be available. The medication history provisions describe how physicians, plans, and pharmacies can share information about what drugs a particular patient is taking or has taken. The fill-status notification standard allows a physician to receive e-mail notices from a pharmacy saying whether a patient has filled a prescription that the prescriber called in. The provider identifier section requires the National Provider Identifier number to track the use of e-prescribed medication.
The rules will govern how physicians, pharmacies, and drug plans communicate electronically. In announcing the rules, Department of Health and Human Services (HHS) Secretary Michael Levitt claimed, "More physicians can embrace a technology that can help prevent some of the hundreds of thousands of adverse drug events that occur each year."13 He also noted that e-prescribing would save money for the health care industry.
The hue and cry to get the DEA to permit e-prescribing has been manifested throughout the health care industry. Perhaps the loudest proponent has been the CMS. That agency has taken the position that e-prescribing will play a significant role in efforts to reduce the incidence of drug diversion by alerting providers and pharmacists of duplicative prescriptions for controlled substances.14
Acknowledging that controlled substances are treated differently from noncontrolled substances, the CMS Director of the Office of E-Standards and Services, Troy Trenkle, has stated that the CMS looks forward to working with the DEA in addressing e-prescribing of controlled substances in future pilot programs. He acknowledged that the CMS has been collaborating with the DEA in recent years to identify and adopt commercially acceptable solutions that will allow for the e-prescribing of controlled substances consistent with the e-prescribing of noncontrolled substances. As early as 2005, the National Committee on Vital and Health Statistics recommended that the FDA, CMS, DEA, and state boards of pharmacy recognize current e-prescribing network practices as a basis for securing e-prescriptions.15
In 2006, the CMS and the DEA sponsored a public meeting on e-prescribing controlled substances, seeking comments from everyone potentially affected by the practice. The stated goal was to integrate e-prescribing of controlled substances with mainstream standards. The CMS issued a statement noting that it "looks forward to partnering with DEA on this important step to combat fraud and harmful drug diversion, which also would help advance broader HHS and health care stakeholder goals in the public health arena."16
About 20% of all prescriptions issued in the U.S. are for controlled substances.17 Current rules prohibit e-prescribing of controlled substances. This has been identified as a major barrier to increased use of the practice by physicians.18
The regulations proposed by the DEA would provide physicians and other authorized prescribers with the choice of issuing e-prescriptions for controlled substances. The new rules provide an additional option and do not replace traditional paper methods of communicating prescriptions that may still be used even after the regulations are finalized. In other words, the pharmacy may accept e-prescriptions, but it is not required to do so.
These regulations would also permit pharmacies to receive, dispense, and archive these e-prescriptions. The agency is seeking public comment on the proposed regulations. Any member of the public wishing to submit comments may do so by mail or electronically on or before September 25, 2008.19 Comments sent via regular or express mail should be mailed to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be e-mailed to: firstname.lastname@example.org. Comments may also be sent through www.regulations.govusing the electronic comment form provided on the site.20 The DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel files only and will not accept any other file formats.
The proposed rules provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of restraints on controlled substances dispensing. In addition, the proposed regulations would reduce paperwork for DEA registrants who prescribe or dispense controlled substances and have the potential to reduce prescription forgery. They should also help pharmacies and hospitals in integrating prescription records into other medical records with the benefit of increased efficiency. The rules should help reduce the amount of time patients spend waiting to have their prescriptions filled. Furthermore, with these regulations, the DEA seeks to ensure that patients, prescribers, and pharmacists know that the person who wrote the prescription is who that person claims to be, and that the medication being dispensed by the pharmacist and received by the patient is the medication that was prescribed.
The 62 pages of proposed rules primarily address security issues to ensure that only authorized prescribers issue e-prescriptions and that pharmacies have accessible records so that all practitioners can be held accountable for their actions. Prescribers will have to use two forms of identification to order an e-prescription for controlled substances. The prescriber's identity must be verified in person at a DEA-registered hospital that has granted the physician privileges to practice at the hospital, a state professional or licensing board, or a state or local law enforcement agency. The standard software protocol for transmitting prescriptions to pharmacies, known as NCPDP SCRIPT, would be modified to allow a digital signature on e-prescriptions. The system would have to implement strong security so there would be virtually no possibility that the e-prescription could be diverted or altered. If a diversion occurred, it would have to be possible to identify the perpetrator and exonerate the prescriber who wrote a legitimate prescription.21 In most instances the pharmacy's software vendor for electronic health records will provide the necessary security measures. Even so, the pharmacy will still be held accountable for system failures caused by noncompliance to the standards.
In a move that will only encourage more e-prescribing, on July 1, 2008, RxHub, a joint venture of pharmacy-benefit managers CVS Caremark, Express Scripts, and Medco Health Solutions, will combine its operations with SureScripts, a private company founded by the National Community Pharmacists Association and the National Association of Chain Drug Stores.22 The merger of the country's two largest e-prescription networks will create a single, secure network for the exchange of digital health information. The owners of RxHub and SureScripts will each retain a 50% stake in the new venture, which will initially go by the name SureScripts-RxHub. Both parties stand to gain financially.
Enabling physicians to prescribe based on the drugs covered under a patient's health plan will help to drive formulary compliance, important to pharmacy benefit managers and insurers, while pharmacies can save time and money through fewer calls to physicians' offices.
1. Fields G, Mathews AW. Digital prescriptions gain favor. Wall Street Journal. June 20, 2008. http://online.wsj.com/article/SB121366320111679275.html. Accessed June 26, 2008.
2. Pharmacies to push e-prescribing. Health Data Management. April 29, 2008. www.healthdatamanagement.com/news/electronic_prescriptions26165-1.html. Accessed June 27, 2008.
3. Pharmacy: looking ahead. US Pharm. 2004;8(29):72. ww.uspharmacist.com/index.asp?show=article&page=8_1322.htm. Accessed June 28, 2008.
4. Knight VE. Digital prescriptions gain favor. Wall Street Journal. June 17, 2008. http://online.wsj.com/article/SB121366320111679275.html. Accessed June 28, 2008.
5. Why should I e-prescribe with my local pharmacies? GetRxConnected. www.getrxconnected.com/AAFP/content/2/No-Technology.aspx. Accessed June 28, 2008.
6. Mathews AW, Radnofsky L. E-prescribing gets support in Congress. Wall Street Journal. June 5, 2008. http://online.wsj.com/article/SB121261854593146619.html. Accessed June 27, 2008.
8. Trenkle T. Director, Office of E-Standards and Services, CMS. The benefits of electronic prescribing. Testimony before the Senate Judiciary Committee on Electronic-Prescribing, U.S. Senate. December 4, 2007. http://www.hhs.gov/asl/testify/2007/12/t20071204c.html. Accessed June 23, 2008.
9. See note 6, supra.
10. Free electronic prescribing for every physician in America. National ePrescribing Patient Safety Initiative. www.nationalerx.com/?gclid=COHNvpHlkpQCFQUHQQodmBXCtQ. Accessed June 28, 2008.
11. Glendinning D. Part D standards aim to encourage e-prescribing. AMNews. April 28, 2008. www.ama-assn.org/amednews/2008/04/28/gvl10428.htm. Accessed June 18, 2008.
12. Electronic prescriptions for controlled substances; proposed rule. Department of Justice, Drug Enforcement Administration. Docket No. DEA-219P. 73 FR No. 125; 36722. June 27, 2008. www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064806431fd&disposition=attachment&contentType=html. Accessed June 27, 2008.
13. See note 11, supra.
14. See note 8, supra.
15. NCVHS Letter. March 4, 2005. Recommended Action 1.1. "Interagency cooperation, working closely together with all interested stakeholders, utilizing current platforms as much as possible, is vital to further growth in e-prescribing. Toward this end, the Administration supports pilot programs that could identify gaps in current e-prescribing security measures as a useful starting point. Pilots should be coordinated with other key health care stakeholders to ensure that mainstream solutions are developed." www.hhs.gov/asl/testify/2007/12/t20071204c.html. Accessed June 23, 2008.
16. See notes 8 and 12, supra.
17. Ferris N. E-prescribing of controlled drugs could be allowed soon. Government Health IT. June 20, 2008. www.govhealthit.com/online/news/350439-1.html. Accessed June 26, 2008.
18. Goldstein J. Why e-prescribing hasn't caught on. Wall Street Journal. June 16, 2008. http://blogs.wsj.com/health/2008/06/16/why-e-prescribing-hasnt-caught-on/. Accessed June 27, 2008.
19. DEA statement for the international day against drug abuse and illicit trafficking. Drug Enforcement Administration. June 27, 2008. www.usdoj.gov/dea/pubs/pressrel/pr062708p.html. Accessed June 27, 2008.
20. See note 12, supra.
21. Ferris N. DEA proposes rules to allow e-prescribing of controlled substances. Government Health IT. June 27, 2008. www.govhealthit.com/online/news/350451-1.html. Accessed June 30, 2008.
22. Knight VE. Electronic-prescription plan is set. Wall Street Journal. July 1, 2008. http://online.wsj.com/article/SB121487827346718397.html?mod=djemHL&apl=y&r=646426. Accessed July 1, 2008.
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