Report of the Task Force on Electronic Prescribing Software Standards and Data Storage Members Present: Larry Hadley (KY), chair; Donald Casar (OH); Jeannine Dickerhofe (CO); David Kozera (VA); Lydia Main (WV); Alice Mendoza (TX); Suzanne Neuber (OH); Elvy Paiva (NJ); Joann Predina (OH); Frank Whitchurch (KS). Others Present: Karen M. Ryle, Executive Committee liaison; Carmen A. Catizone, Robert Cowan, Melissa Madigan, Eileen Lewalski, Gertrude Levine, Chris Siwik, NABP staff. Guests: Marcie Bough, American Pharmacists Association; Douglas Hoey, National Community Pharmacists Association; Steven Mullenix, National Council for Prescription Drug Programs; Kevin N. Nicholson, National Association of Chain Drug Stores; Mark H. Siska, American Society of Health-System Pharmacists; Ken Whittemore, Surescripts. Introduction: The Task Force on Electronic Prescribing Software Standards and Data Storage met September 15-16, 2009 at the Hilton Northbrook. This task force was established in response to Resolution 105-1-09, Electronic Prescribing Software Standards and Data Storage, which was approved by the NABP membership at the Association s 105 th Annual Meeting in May 2009. Review of the Task Force Charge: Task force members reviewed their charge and accepted it as follows: 1. evaluate the current regulatory and operational status of the electronic transmission of prescriptions and prescription data; 2. develop standards for software and systems used in the electronic transmission of prescriptions and prescription data; and 3. review the current requirements for the storage of hard copy prescriptions and electronically transmitted prescription data to determine whether alternative storage methods can be utilized.
Recommendation 1: NABP Should Work with Stakeholders and Governmental Agencies to Address Current Problems with e-prescribing Software Systems The task force recommends that NABP collaborate with electronic transmission standard setting groups, such as the National Council for Prescription Drug Programs (NCPDP) and Certification Commission for Health Information Technology (CCHIT), and governmental agencies such as, Centers for Medicare & Medicaid Services (CMS), to address issues identified by the task force such as: standardizing the format of the system screens/interfaces used by prescribing practitioners and pharmacies; mandating that the system produces a final screen review of the prescription drug order by the prescriber before transmission to the pharmacy; standardizing drug nomenclature; standardizing and ensuring safety of sig codes/directions for use; including the patient diagnosis or drug indication on prescription drug orders for high alert and look-alike/sound-alike drugs; encouraging the appropriate use of notes and comments fields found on the prescribers system screen/interface when pertinent to the prescription drug order; the need for pharmacists to be able to electronically request supplemental or clarifying information from practitioners; mandating e-prescribing system training for all users, for example, prescribers and pharmacy personnel; the provision of receipts, instead of prescription drug order reprints, to patients; retransmission of prescriptions; and permitting the transmission of controlled substance prescription drug orders in accordance with federal and state law. Guest participants provided the task force with information pertaining to the various programs and the involvement of their associations and organizations in the electronic transmission of prescription orders. Information brought to the attention of task force members was that existing standards to certify the participation of prescribers and pharmacies only certifies the probable ability to transmit prescription orders in accordance with the NCPDP Script Standard. There is no evaluation of the individual systems for compliance with state and federal laws or patient safety standards. The task force members presented and learned of a number of concerns associated with the present system and certification process that have resulted in serious patient safety issues, the illegal transmission of prescription orders for controlled substances, and unintelligible data transmissions that jeopardize patient safety. Guest participants offered that one of the primary contributing factors could be that some systems were developed by people unfamiliar with the practitioner s workflow and how prescriptions have been traditionally written. Additional explanations rationalized that some systems include a multitude of drop-down boxes (containing, for example, drug names and strengths and sig codes) that do not follow the order of usual prescribing practices. Of major concern to task force members and conveyed to guest participants is that systems often lack a final screen/interface to review the prescription prior to 2
transmission. It is believed that this lack of the ability to take a final look at the prescription drug order has contributed to medication and dosing errors. The task force agreed that standardizing the format of the system screens/interfaces used by both the prescribing practitioner and pharmacy is necessary, as is ensuring that a final screen review of the prescription drug order takes place prior to transmission. Task force members also concurred that it is necessary for the systems to use standardized drug names and standardized and safe sig codes. It was brought to light that many vendors use their own set of sig codes, for example, biw, which could be understood to mean twice weekly or every two weeks. Also noted was that some systems listed drug strengths in a manner that could result in the user choosing the wrong strength, for example, some systems list amitriptyline 100 mg as the first option instead of amitriptyline 10 mg. Members discussed whether the National Drug Code (NDC) should be utilized, and concluded that although the NDC is sufficient for third-party billing, it may not be the best alternative for clinical purposes. It was decided that it might be necessary to develop a completely new drug identification system. It was also determined that medication error reporting data resulting from a computer generated or electronic prescription transmission was imperative for the development of these parameters. Members also discussed whether the patient s medication indication should be included on the prescription drug order. The obvious advantage of mandating such a requirement in the current system and NCPDP Script standards is the ability of a pharmacist to more accurately assess whether the appropriate drug has been prescribed, and not to contravene the prescriber s scope of practice. Such a requirement will also assist with the implementation and provision of medication therapy management services by the pharmacist. Task force members realized that a possible shortcoming of including this information on the prescription is dissemination of patient information to third parties, which could raise confidentiality issues and other concerns outside the scope of this task force. Members agreed, however, that it should be a necessary component in an e-prescribing system for high alert and look-alike/sound-alike drugs. Task force members voiced major concern with notes or comments fields found on system screens/interfaces used by prescribing practitioners. Task force members indicated to the guest participants, based upon their practice experiences and complaints from pharmacists and patients to state boards of pharmacy, that prescribers use these fields as a place to enter additional directions for use or even directions for use that, oftentimes, conflict with the sig code entered by the prescriber. Members stated that this is being done because certain systems sig codes are too difficult to find or not included in the system, or the sig field is too small to handle specialized dosing (for example, dose tapering instructions). Additionally, some pharmacy systems do not allow the pharmacist to view the screens containing such additional information simultaneously with the sig code screen, so the pharmacist may not even know that additional information that has been entered in the notes field has been transmitted. The members conceded that removing the comments or notes fields altogether was not the answer, but agreed that working with the systems developers and standard setting organizations to use only standardized sig codes and implement a red flag or warning screen for both pharmacy and prescriber systems when comments or notes fields are used, along with educating prescribing practitioners on the proper use of these fields, would help eliminate these problems. 3
Along these lines, members also agreed that real-time, two-way electronic communication between pharmacists and prescribing practitioners would assist in resolving issues related to ambiguous or conflicting directions for use and clarifying any information contained in the prescription including patient information, drug name, drug strength, and drug dose. It was determined that interoperability of the systems was paramount for increasing quality and may remedy many of these issues. This type of communication would also allow for the inclusion of supplemental information such as patient weight and laboratory values. The members agreed that appropriate training on the use of e-prescribing systems would be extremely beneficial. Apparently, system training by the vendors is not a usual service and practitioners basically have to learn how to utilize the systems on their own. Untrained ancillary staff utilizing the systems is another issue that appears to be problematic. Members provided anecdotal information indicating that the less a system aligns with a practitioner s normal workflow, the more likely it is that the practitioner will assign a staff member to enter the prescription, leading to increased medication errors. It was agreed that pharmacists should also be educated regarding the most common errors that occur with the systems and situations that should bear caution. The task force stated other concerns about the accountability of e-prescribing systems, including the fact that patients can be provided with receipts or reprints of the original, transmitted prescription and that practitioners and/or office staff also have the ability to retransmit and reprint prescriptions multiple times. It is difficult for pharmacists to ascertain the validity of these reprints and retransmissions and often must take the time to verify them or risk dispensing potentially fraudulent prescriptions. Another issue brought up by the members was that many systems allow the transmission of controlled substance prescriptions, and until new DEA regulations provide for this, policing this issue unfairly falls on the pharmacist. Overall, the task force members concluded that all of these issues should be addressed with major stakeholders, such as NCPDP, CCHIT, and CMS, along with other involved governmental agencies to determine how they should best be remedied. Several approaches, such as revising the systems and standards for interoperability, education and training, and error reporting, should be utilized to increase the safety of e-prescribing systems to ensure that the public health is protected. As an element of training, a standardized training manual should be provided by each vendor to each prescribing practitioner and to each pharmacy using the particular e-prescribing system. This would increase the probability of practitioner training and may allow the pharmacy team to troubleshoot system issues as they occur. With a working knowledge of the system, the pharmacy team can perhaps work with the prescriber and vendor to eliminate potential misinterpretations that may be specific to pharmacists but not to prescribers. Recommendation 2: NABP Should Evaluate Response of Standard Setting Groups and if Task Force Concerns Are Unresolved, Develop National Standards The task force recommends NABP evaluate the response from interactions with the standard setting groups, software providers, and governmental agencies, as set forth in Recommendation 4
1. If the concerns identified by the task force are unresolved, then NABP will develop national standards for e-prescribing that focus on those areas. Task force members agreed that although many of the issues fall outside the purview of the boards of pharmacy if they are not addressed by the other parties then, in the interest of public safety, they should be dealt with in an appropriate manner. Boards could revise their rules and regulations to mandate a national standard that would result in revision or termination of a noncompliant e-prescribing system. Recommendation 3: NABP Recommends that an Objective Third-Party Certification Program for e-prescribing Systems be Established The task force recommends that a certification program for e-prescribing systems and intermediaries addressing the accuracy, legality, and quality of electronic transmission be established by an objective third party so that it can effectively address the concerns identified by the state boards of pharmacy and pharmacy providers. The task force determined that it may be necessary to establish an objective third-party certification program for e-prescribing systems when it was realized that the certification currently in place is inadequate for the purpose of protecting the public health. The current certification system offered by Surescripts only provides certification of a technological ability to comply with the NCPDP Script Standards. A new certification program with continuous quality improvement parameters may be an option if the task force s concerns are not addressed. Recommendation 4: Amend Model Act The task force recommends the following changes to the Model Act, including changes to the Model Rules for the Practice of Pharmacy. The revisions recommended by the task force are denoted by underlines and strikethroughs. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy Model Rules for the Practice of Pharmacy --- Section 3. Pharmacy Practice. (a) Prescription Drug Order A Prescription Drug Order shall contain the following information at a minimum: (1) full name, date of birth, and street address of the patient; (2) name, professional title, address, and, if required by law or rules of the Board, DEA registration number of the prescribing Practitioner; (3) date of issuance; 5
(4) name, strength, dosage form, and quantity of Drug prescribed; (5) directions for use; (6) refills authorized, if any; (7) if a written Prescription Drug Order, prescribing Practitioner s signature; (8) if an electronically transmitted Prescription Drug Order, prescribing Practitioner s electronic or digital signature; (9) if a hard copy Prescription Drug Order generated from electronic media, prescribing Practitioner s electronic or manual signature. For those with electronic signatures, such Prescription Drug Orders shall be applied to paper that utilizes security features that will ensure the Prescription Drug Order is not subject to any form of copying and/or alteration. Task force members discussed and debated at great length prior to determining that a revision of the Model Act was necessary to increase public safety. It was decided that the patient s date of birth should be added as a requirement to a valid prescription drug order. Also recommended was the inclusion of the prescribing practitioner s professional title. Members conceded that a written, paper prescription drug order has always provided the title and that including it on an e- prescription drug order would assist the pharmacist in determining the validity of that order and whether it is within the purview of the prescriber s scope of practice. Recommendation 5: NABP Encourage Boards of Pharmacy to Remove Current Requirements for Printing a Hard Copy of Prescriptions Received Via e-prescribing Systems and to Remove Requirements for Hard Copy Prescription Storage The task force recommends NABP encourage the boards of pharmacy to remove any current requirements for printing a hard copy of prescriptions received via e-prescribing systems provided the e-transmitted prescription is readily retrievable and in a readable format that contains all of the information necessary to be considered a valid prescription. The task force also recommends that NABP encourage boards to remove current requirements for hard copy prescription storage provided an imaged format is readily retrievable and readable. Members agreed that the requirement for hard copy prescription storage is antiquated and that the electronic storage is a more practical, efficient, and safe method provided that the information is complete, readily retrievable, provides an audit trail, and is readable. 6