Pharmacist FAQsFrequently Asked Questions for Pharmacists on Electronic Prescriptions MONDAY, AUGUST 30, 2010 CONTINUING UPDATE ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. Board staff continues to receive many inquiries concerning electronic prescriptions for controlled substances (CSERx). By way of recap: The DEA issued a CSERx rule that was “effective” earlier this year. As noted in prior updates, however, the rule is “effective” only in the academic sense. That rule requires any system that either transmits or receives CSERx to be “certified” as meeting DEA’s security and control standards in the CSERx rule. As of today DEA has not certified any transmitting or receiving system as meeting these security standards. Accordingly, CSERx’s still do not meet federal law requirements. Much more information about the rule and its operation may be found here: http://www.ncbop.org/faqs/Pharmacist/ControlledSubstanceE-RXFAQsApr2010.pdf. The DEA has published FAQ guidance on CSERx, which is found here: http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html#faq. So where does that leave everyone? Basically, at the same place we’ve been all along. Any electronically signed prescription for a controlled substance does not satisfy federal law at this time. DEA has also stated clearly (see the DEA FAQ link above) that prescribers may not print out or print out and fax a prescription for a controlled substance that is electronically signed. Rather, the practitioner may print or print/fax a controlled substance prescription that they have actually signed (with the exception of C-II prescriptions, which may be faxed only for residents of long-term care facilities or for terminally ill patients). A pharmacist who receives an electronic prescription for a Schedule III, IV, or V medication may call the prescriber, confirm the prescription, and treat it as a verbal order. Board staff is aware that a number of physicians and physician office managers have insisted – often vehemently – that electronic prescriptions for controlled substances are allowable. This insistence, however well intentioned, is simply not correct. Board staff has asked that the North Carolina Medical Board communicate this information to their licensees to clear up confusion. Unquestionably, the state of being for CSERx is one that is frustrating and confusing. Let’s all hope that the DEA will – and will quickly – certify some CSERx prescribing systems. In the meantime, Board staff encourages pharmacists and prescribers to communicate with their electronic prescribing system vendors about those vendors’ efforts to become certified. Those wishing to register complaints about the implementation – or lack thereof – of the CSERx rule should contact the DEA. Board staff will continue to provide updates on this issue. FRIDAY, JUNE 18, 2010 FURTHER UPDATE ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. In response to the Wednesday, June 16 update on this website concerning implementation of the DEA’s electronic prescribing rule, Board staff has received numerous calls and emails alternatively praising or condemning (mostly the latter) the “Board’s decision to disallow electronic controlled substance prescriptions.” These communications fundamentally misunderstand the update. The Board of Pharmacy has not issued any decision “disallowing” electronic controlled substance prescriptions. Rather, the update alerted pharmacists that the new DEA rule requires software systems for sending and receiving controlled substances to be “certified” by a “third-party auditor” as meeting the DEA rule’s security standards. DEA has not, to date, certified any such systems or identified any auditor that will be allowed to issue the certifications. Therefore, according to the DEA, no electronic prescriptions for controlled substances can be issued at this time. Some correspondents to Board staff have complained about the Board’s failure to certify e-prescribing systems. Please note that the Board has no authority under the DEA’s rule to certify systems. Rather, as discussed the Board’s FAQ on the DEA rule (http://www.ncbop.org/faqs/Pharmacist/ControlledSubstanceE-RXFAQsApr2010.pdf), pharmacists and prescribers should contact their software vendors to inquire about certification status. Pharmacists and others who would like to communicate their feelings on the status of the DEA’s rule may contact the DEA’s Greensboro office at (336) 547-4219. In the meantime, Board staff will continue to communicate updates on the DEA’s rule as often as it receives them. WEDNESDAY, JUNE 16, 2010 UPDATE ON CONTROLLED SUBSTANCE ELECTRONIC PRESCRIPTIONS. Board staff has received many calls and e-mails from pharmacies inquiring whether they may accept electronic prescriptions for controlled substances under the DEA’s new rule on the subject, which was effective June 1. The unfortunate answer at this point is “no.” As noted in the FAQ on this new rule posted by Board staff (found here: http://www.ncbop.org/faqs/Pharmacist/ControlledSubstanceE-RXFAQsApr2010.pdf), DEA’s rule requires that systems for sending and receiving CSERx must be “certified” by a “third-party auditor” as meeting the security requirements specified in the rule. DEA has stated that no such systems are certified yet; moreover, DEA has not even designated any third-party entities that it will allow to conduct audits and issue certification. Accordingly, it seems unlikely that CSERx can be meaningfully implemented for some time yet. This is, of course, a frustrating state of affairs, particularly given the length of time that the DEA spent in promulgating the rule. Board staff will continue to update North Carolina pharmacists with information on this rule as it becomes available. For further DEA viewpoint on the rule, pharmacists can review a DEA Field Office slide presentation here: http://www.ncbop.org/CSElectronicRxPresentationJune2010.ppt FRIDAY, APRIL 16, 2010 DEA ISSUES “INTERIM FINAL RULE” ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. On Wednesday, March 24, 2010, the DEA issued an “interim final rule” concerning electronic prescriptions for controlled substances. This rule, which will not go into effect until May 24, 2010 at the earliest, is lengthy. Pharmacists should begin reviewing the rule and, particularly, contacting your software and hardware vendors to discuss the security and other requirements that DEA specifies for receipt of electronic controlled substance prescriptions. The text of the interim final rule may be found here. Note that the document is long (334 pages). Most of the document is devoted to responding to comments DEA received on its proposed rule in 2008. CLICK HERE TO READ FAQs ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. -------------------------------------------------------------------------------- Q: May a prescriber electronically transmit a prescription for a controlled substance? A: Electronic prescribing is an increasing fact of life in pharmacy practice today. Many pharmacists are confused, though, about whether or not and under what circumstances e-prescribing is permissible for The Board understands that DEA continues to take the position that e-prescribing for Schedule II substances is never appropriate. 21 C.F.R. 1306.05. Federal law permits faxing of Schedule II prescriptions in limited circumstances (such as for residents of long-term care facilities and hospices). But beyond these narrow cases, e-prescriptions for Schedule II substances are prohibited. These positions may change in the coming months. DEA has for a number of years pledged to take a fresh look at e-prescribing issues, with no visible result. Medicare Part D, however, specifically directs Centers for Medicare and Medicaid Services (CMS) to develop uniform standards for e-prescribing, a practice that the statute encourages as a potential cost-savings and patient safety improvement. CMS and DEA have jointly noticed a conference among their agencies to discuss e-prescribing issues as they relate to CS. It seems almost certain that DEA will be forced to critically reevaluate its position on these issues. -------------------------------------------------------------------------------- Q: Are Internet prescriptions legal? A: The Board of Pharmacy has a Rule, which allows the transmission of prescription orders electronically. It can be found at 21 NCAC 46.1813. It is up to the Pharmacist to determine the legitimacy of each prescription, which arrives in the Pharmacy. One important consideration is the Board’s Rule on prescription orders, 21 NCAC 46.1801(b). Please note that the Rule specifically provides that a Pharmacist shall not fill or refill a prescription if the order was produced from a prescriber without a prior prescriber-patient relationship or without a physical examination. This concept was taken from a policy from the North Carolina Medical Board, which has disciplined physicians for prescribing over the Internet without a prior relationship or physical examination. Both Pharmacists and Physicians have been disciplined for violation of this concept. -------------------------------------------------------------------------------- Q: Can prescriptions be transmitted electronically? A: Board rule at Section .1813 provides that prescriptions may be transmitted electronically. Part of that rule specifies that an electronic signature is acceptable for this kind if transaction. A graphical representation of the prescriber's signature is sufficient to satisfy this rule. But it is not necessary. It is enough that the prescription contains an electronic signature "unique to the practitioner." The Board further notes that e-prescribing standards are in flux, and CMS standards are likely to become the norm in the near future. When in doubt, pharmacists should, of course, call the prescriber to confirm a prescription.
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