Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment

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1 American Society of Health-System Pharmacists 7272 Wisconsin Avenue Bethesda, Maryland (301) Fax: (301) Drug Enforcement Administration Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA Re: Docket No. DEA-218, Electronic Prescriptions for Controlled Substances, Interim Final Rule with Request for Comment Dear Sir/Madam: The American Society of Health-System Pharmacists (ASHP) is pleased to submit comments pertaining to the Interim Final Rule (IFR) on Electronic Prescriptions for Controlled Substances. For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society's over 35,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. ASHP commends the United States Drug Enforcement Administration (DEA) for publishing this IFR to provide practitioners with the option of writing prescriptions for controlled substances electronically, and allowing pharmacies to receive, dispense, and archive these electronic prescriptions. The Society believes these new regulations will reduce diversion of controlled substances, while enhancing patient safety. ASHP supports the use of computerized entry of medication orders or prescriptions by the prescriber when (1) it is planned, implemented, and managed with pharmacists involvement, (2) such orders are part of a single, shared data-base that is fully integrated with the pharmacy information system and other key information system components, especially the patient s medication administration record, (3) such computerized order entry improves the safety, efficiency, and accuracy of the medication use process, and (4) it includes provisions for the pharmacist to review and verify the order s appropriateness before medication administration, except in those instances when review would cause a medically unacceptable delay.

2 Page 2 Internal Code Number Systems ASHP was also pleased that the DEA requested information on current methods being used to employ internal code number systems, and how best to implement industry standardization in this area. The Society submitted comments to the DEA on this issue on November 9, 2009, and in our comments, we stated that standardizing the format and methods of communicating the assigned extension would help to ensure that every person who prescribes controlled substances in the institution is eligible to do so. ASHP believes that, to accommodate a standardized format for internal code numbers, pharmacy prescription management systems would need to be changed and reformatted to ensure the extension number is properly utilized. Every institution and extension number should be included in a central database, and pharmacy systems should be developed to ensure that, when the institutional DEA number is entered, the extension number would be required before processing could occur. In the IFR, the DEA notes that it should be possible for National Council for Prescription Drug Plan Programs (NCPDP) to add a code for an institution-based DEA number that allows up to 35 characters, with the first nine characters in the standard DEA format, and the remaining characters should be sufficient to accommodate most institutional coding systems until DEA and the industry can standardize the format. ASHP encourages the DEA to work with NCPDP to change its coding structure, to ensure institutional coding systems can be accommodated. ASHP also encourages the DEA to work with Pharmacy Information Systems/Pharmacy Management Systems Vendors to incorporate the expanded standards into their software in an expedient time frame. Long Term and Post Acute Care (LPAC) and Electronic Prescription Application Long Term and Post Acute Care (LTPAC) sites include skilled nursing, nursing and assisted living facilities; home health, independent and adult care environments; rehabilitation facilities; long-term acute care hospitals; and hospice. Prescribing and dispensing in the LTPAC setting involves three-way communications among the prescriber, the pharmacy and the nursing facility or nursing centric entity with the nurse serving as the lynchpin. During prescribing and dispensing in the LTPAC setting, the nurse is responsible for communicating vital information to the prescriber, documenting the prescriber s orders in the patient s chart and then transmitting that prescriber s orders to the pharmacy. In this manner, the nurse serves as the agent of the prescriber, ensuring that the prescriber s orders are documented and followed. In addition, the LTPAC facility maintains a medical record for each resident. The medical record is the central repository of all essential medical, social and legal information about each resident and includes documentation of all care and treatment including all medication orders.

3 Page 3 ASHP recommends that the DEA clarify the definition of Installed electronic prescription application as defined in Part 1300 of the IFR. The definition states software that is used to create electronic prescriptions and that is installed on a practitioner s computers and servers, where access and records are controlled by the practitioner. The DEA should clarify whether this definition includes software installed at a LTPAC facility that is used by but not owned or managed by the registered practitioner. Further, the IFR assumes that the electronic prescription application and related records can only be housed at a registered location. The IFR uses the term registered location without providing the definition, and it is unclear if the term registered location means the location must be a DEA registrant or the application must be registered with the DEA. Assuming that a DEA registrant (e.g. the facility medical director) takes responsibility for granting system access to a prescriber that is not the owner of the software but has a relationship with the facility, the DEA should clarify whether the LTPAC facility itself must be a registrant if their system is transmitting the prescription. Nurse as Agent Communication of medication orders in the long-term care setting has been supported since version 10.1 of the SCRIPT Standard, and the standard is being used in nursing facilities today. Currently there are prescribers who enter non-controlled substance prescriptions directly into LTPAC prescribing systems. There are also workflows in place where licensed facility nurses enter the electronic prescription on behalf of the prescriber as allowed by state pharmacy regulations (e.g., capturing telephone orders). In either case, it is the responsibility of the nurse to review (but not change) the medication in the context of the patient s other care, to add facility-related administration details such as specific pass times to the order, to consult with the prescriber regarding potential conflicts with other patient care, and to transmit the order to the patient s chosen pharmacy. The prescriber approves the medication order immediately (if entering it directly) or soon thereafter according to applicable regulations. ASHP appreciates the DEA s recognition of the need for a controlled substance electronic prescribing rule to support the facility nurse s review and administration responsibilities, while ensuring that the prescription content required by DEA regulations is not changed once signed by the prescriber. We also agree that it is necessary for controlled substance prescriptions to be signed by the prescriber before transmission to the pharmacy for dispensing. However, clarification is needed to ensure there are no obstacles to implementing the DEA s intent that LTPAC facility staff be able to add information such as pharmacy or other annotations before transmission to the pharmacy.

4 Page 4 Since the DEA s IFR does not account for the LTPAC nurse agent role, and if the DEA does not include the nurse agent role, serious impact will occur to the industry workflow, which may include reconsideration of economic impact. The industry will be forced to build new workflow requirements, perhaps causing federal and state regulatory modifications, as well as force delay in the adoption of electronic prescribing. Or, this could continue the practice of electronic prescribing for non-controlled substance prescriptions and paper for controlled substance prescriptions. Further, the industry would be forced to determine whether the current SCRIPT Standard will suffice or whether data fields will have to be modified or added. If changes or additions are needed it may take time for the Department of Health and Human Services name or mandate a new version of SCRIPT to meet the IFR requirements in the LTPAC setting. Digital Signature ASHP appreciates the ability to transmit controlled substance prescriptions with the data field. Currently, digital signature field(s) do not exist in the SCRIPT Standard as there has not been a business need. The IFR contains two options: Digital signature Field indicating the prescription was signed The digital signature option appears to assume there is a direct connection between the prescriber system and the pharmacy system. In interpreting further, it appears that, if an intermediary is involved, the prescription may not be translated/modified (especially the DEA data ). This translation/modification would render the digital signature invalid. If the transmission is digitially signed (a wrapper), any change to the packet of information - including reformatting - makes the digital signature invalid. If an intermediary performs functions of translation, mapping, etc., it is unclear how the intermediary could perform the same functions in the digital signature scenario. If the DEA is suggesting that individual fields be digitally signed, this would make implementation more complex and would be a significant change to the standard to sign each DEA specified field. ASHP seeks clarification from the DEA on this issue. Third Party Audits Finally, DEA has expanded the kinds of third-party auditors beyond those who perform SysTrust, WebTrust, or SAS 70 audits to include certified information system auditors (CISA) who perform compliance audits as a regular ongoing business activity. The CISA certification is sponsored by the Information Systems Audit and Control Association (ISACA) and is recognized by the American National Standards Institute under ISO/IEC The certification is required by the FBCA for third-party auditors and by the Federal Reserve Bank for its examiners and is approved by the Department of Defense. DEA believes that allowing other certified IT auditors will provide application providers with more options and potentially reduce the cost of the audit.

5 Page 5 ASHP appreciates the DEA expanding auditor choices for the industry. However, ASHP is concerned about whether expertise from certification or audit entities includes healthcare settings. ASHP also has concerns about whether the DEA has reached out to these entities to determine whether they are prepared to begin certifying this industry, since the effective date is June 1, ASHP recommends that the DEA provide information to vendors, pharmacies, and prescribers about these entities. The Society appreciates this opportunity to provide comments. Please feel free to contact me if you have any questions. I can be reached by telephone at , or by e- mail at jcoffey@ashp.org. Sincerely, Justine Coffey, JD, LLM Director, Federal Regulatory Affairs