Originally published in the December 2010 NABP Newsletter
Since new Drug Enforcement Administration (DEA) regulations for controlled substance e-prescribing took effect June 1, 2010, state boards of pharmacy are offering guidance to licensees regarding DEA e-prescribing software requirements and the legality of controlled substance e-prescribing in their respective states. E-prescribing software developers are currently in the process of ensuring that products meet the new DEA requirements and have the required certifications. In addition, some state laws and regulations will require changes before controlled substance e-prescribing will be fully legal.
Rule in Review
DEA’s Interim Final Rule on e-prescribing, formally allows (but does not mandate) electronic prescribing of Schedule II through V controlled substances, and provides the regulations by which this e-prescribing will be governed. According to the new rule, before any given prescriber or pharmacist can prescribe or receive an electronic prescription for a controlled substance, the system (or software) being used must be certified by an approved, outside agency that it meets the new regulations. The new requirements help ensure that controlled substance e-prescribing regulations minimize the potential of controlled substance diversion. And, as DEA notes in its rule, the agency considered the burden on registrants, and allowed enough flexibility to accommodate future advances in technologies and standards.
Boards Offer Guidance
Due to some confusion among prescribers and pharmacists on the front lines, state boards of pharmacy are providing guidance, and stressing to pharmacists that controlled substance e-prescribing shall not be allowed until DEA requirements are met. The North Carolina Board of Pharmacy highlighted the issue for its registrants in an August news post on its Web site, reminding pharmacists that the DEA rule “is ‘effective’ only in the academic sense.” The Board stated that as of the date of posting, “DEA has not certified any transmitting or receiving system as meeting these security standards. Accordingly, [electronic prescriptions for controlled substances] still do not meet federal law requirements.” The North Carolina Board also assured pharmacists that they are correct in not accepting electronic prescriptions for controlled substances at this point. “Board staff is aware,” the post indicates, “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.”
The Nevada State Board of Pharmacy issued a similar caution to pharmacists in its October 2010 Newsletter: “No such systems [meeting the security requirements specified in the rule] are certified to date, nor have any third-party entities been identified to conduct such audits and certification.”
The North Dakota State Board of Pharmacy likewise issued written clarification on its Web site for registrants on electronic prescriptions and what constitutes a legitimate prescription. In its guidance, the Board notes the necessity of e-prescribing software to be certified before it can be used for controlled substance prescribing, and adding,
“[I]t is not anticipated that any software systems will be ready and certified [in the near future].”
Even prior to the new rule, pharmacists navigated the complexities of e-prescribing laws. For example, in its report, the 2009 NABP Task Force on Electronic Prescribing Software Standards and Data Storage noted that many e-prescribing systems allowed the transmission of controlled substance prescriptions despite the legal restriction against doing so, and that “policing this issue unfairly falls on the pharmacist.”
As software systems are updated to meet DEA requirements, laws and regulations in certain states will need changes in order for electronic prescribing of all controlled substances to be legal.
The Wyoming State Board of Pharmacy issued an advisory to this effect in its September 2010 Newsletter to pharmacists. “Under Wyoming state law [electronic] prescribing is still prohibited for scheduled medications,” it states. Other states fall into a similar category, including New York, Indiana, and Delaware.
A number of these states may modify their laws and regulations now that the DEA rule has taken effect. The Wyoming Board, for example, announced in its Newsletter, plans to introduce legislation containing rule changes that would allow for e-prescribing scheduled drugs. The Board, in conjunction with a task force, hoped to have the changes ready to present to the state legislature at its session in February 2011.
Idaho’s current rules and regulations likewise require modification before DEA-compliant e-prescribing systems may be used in that state. “[T]he Idaho State Board of Pharmacy has identified three sections of Idaho code and nine administrative rules that require updating in order for the electronic prescribing of controlled substances to be allowed within Idaho,” the Board told registrants in its September 2010 Newsletter. “This can only be accomplished with the approval of the 2011 Idaho Legislature.”
In certain states, the law does not allow Schedule II e-prescriptions and these laws may remain in place for some time. The Oklahoma State Board of Pharmacy reminded its registrants of this provision in the Board’s July 2010 Newsletter, emphasizing that, even when software has been certified as compliant, “Currently, Oklahoma does not allow e-prescribing for Schedule II substances.” Nevada has taken a similar track. “The Board of Pharmacy has the regulations in place for the e-prescribing of controlled substances, with the exception of Schedule II controlled substances,” the Board advised pharmacists in its October Newsletter. “The Board has elected not to allow Schedule II e-prescriptions at this time, opting to see how things play out with Schedule III through Schedule V e-prescriptions before taking that step.”
Implementation to Impact e-Rx Trends
The new DEA rule removes a barrier to e-prescribing adoption, as prescribers and pharmacists, in theory, would no longer need to maintain a dual workflow to accommodate electronic prescriptions for non-controlled substances and paper prescriptions for listed drugs. Surescripts, which operates an e-prescription network and issues regular reports tracking the status of e-prescribing adoption, in a press release issued March 29, 2010, characterized the “change in the current DEA rules as a top recommendation to support continued growth in e-prescribing.” And continued growth is certainly happening. At the annual Safe-Rx Awards event on Capitol Hill this last September, Surescripts announced that more than 200,000 office-based prescribers were using e-prescribing, up from 156,000 at the end of 2009 (and from 74,000 at the end of 2008).
Further, as implementation efforts continue, various stakeholders may seek further clarification on certain elements of the DEA rule, possibly helping to implement controlled substance e-prescribing across different health care environments. For example, a response sent in by the National Council for Prescription Drug Programs (NCPDP), a non-profit, data standards development organization, drew attention to and requested clarification on issues affecting long-term care and post-acute care settings, and also on such issues as the digital signature option and references to the NCPDP SCRIPT standard.
While the legality of e-prescribing controlled substances will vary from state-to-state for some time to come, e-prescribing as a whole will likely continue to take a firmer hold throughout the country – with the new DEA regulations removing a major barrier to its further adoption. As hurdles are overcome – from logistical challenges at the practitioner level, to the standardization and patient safety deficiencies in software noted by the NABP Task Force on Electronic Prescribing Software Standards and Data Storage, to the updating of state laws – e-prescribing will have a chance to achieve its potential as a universal, efficient, and safer method of helping patients access their medications. NABP will continue to provide updates as the process continues.