Drug Topics- August 11, 2008

16 DRUG TOPICS AUGUST 11, 2008 www.drugtopics.com > > >Latebreakers… In Depth DEA proposes rule to allow electronic prescriptions for controlled substances Ken Krizner P hysicians would have the option of issuing electronic prescriptions for controlled substances under a proposed regulation issued by the Drug Enforcement Administration (DEA). The regulations, which would be voluntary, would also permit pharmacies to receive, dispense, and archive electronic prescriptions. The agency published its proposed regulation in the Federal Register on June 27. The proposed regulations would be an addition to, not a replacement of, the existing rules, according to DEA. The regulations are expected to work in tandem with standards developed by the Department of Health and Human Services on transmitting electronic prescriptions. The regulations would provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled-substance prescriptions while maintaining a closed system of controls on controlled-substances dispensing. In addition, the proposed regulations would reduce paperwork for DEA registrants who prescribe or dispense controlled substances, and they have the potential to reduce prescription forgery. The proposed rules would also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they would help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which would increase efficiency and reduce the amount of time patients spend waiting to have their prescriptions filled, according to DEA. Joseph Rannazzisi, deputy assistant administrator in the Office of Diversion Control for DEA, said, “Our goal is to put in place an electronic prescribing system that is efficient, medically beneficial to patients and prescribers, and provides security from hackers and others who might seek to engage in fraudulent prescribing activities.” DEA is proposing several requirements that registrants must meet: • The electronic prescription service provider must receive a document prepared by an entity permitted to conduct in-person identity proofing of prescribing practitioners regarding the conduct of the in-person identity proofing. • Access to the electronic prescribing system for the purposes of signing prescriptions must meet the standards for Level 4 authentication. • The first recipient of the prescription must digitally sign the prescription and archive the digitally signed version as received. • The first pharmacy system that receives the prescription must digitally sign and archive a copy of the prescription as received. • The pharmacy system must determine whether the DEA registration of the prescribing practitioner is valid. • The pharmacy system must be able to store the complete DEA number, including extensions. • The pharmacy system must have an audit trail that identifies each person who annotates or alters the record. The pharmacy system must conduct daily internal audits to identify any auditable events. • The contents of a controlled-substance prescription must not be altered, other than by reformatting, during transmission. “It is essential that electronic prescribing of controlled substances takes place in a manner that allows for reliable prescribing records so that the prescribing practitioner and the pharmacist who fills the prescription can remain accountable for their actions, as they are when using paper prescriptions,” Rannazzisi said. Pharmacy organizations generally support the concept of e-prescribing. However, two organizations have some reservations about the DEA proposal as it is presently constituted. “There are some aspects of the rule that could present logistical challenges for pharmacies, prescribers, and e-prescribing service providers,” according to a statement by the National Association of Chain Drug Stores (NACDS). Charlie Sewell, vice president of government affairs for the National Community Pharmacists Association (NCPA), said there are many details in the proposal that require careful review. “We want a workable system at the pharmacy level and one that gets physicians to conduct e-prescribing,” he said. “[The proposal] is a step in the right direction, but it was not done as cleanly as it could have been, and it has left a lot of questions unanswered.” Both NACDS and NCPA plan to formally submit comments to the DEA. http://www.drugtopics.com

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Drug Topics- August 11, 2008 Contents Latebreakers Letters DEA Proposes Rule To Allow Electronic Prescriptions for Controlled Substances Merger, Medicare Reform Could Mean Broader E-Prescribing Adoption New Combination Pill Approved for Type 2 Diabetes New Eczema Guildlines Promote Use of Emollients, Then Topical Corticosteroids Agencies Flush Original Strategies in Favor of Promoting Drug Take-Back Programs JP at Large: You Laughing at Me? Pharmacists Find Themselves at Mercy of Prior Authorization State Law Requiring PBM Transparency See Some Gains, Some Losses Global Counterfeiting Still Growing, Says U.S. Commerce Official FDA Saftey Page: Prophylthiouracil Still Confused with Purinethol (mercaptopurine) New Products Bring Lice Treatment to a Head NACDS Marketplace Showcases New Product that Fill Unmet Needs Update on Respiratory Tract Infections Execs Share War Stories About Adopting Technology in their Stores New Products Advertisters Index Classified Viewpoint: Medicare Part D Revisions sorely needed

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