Thank you, Dr. Cohn, for the opportunity to testify before the National Committee on Vital and Health Statistics’ Subcommittee on Standards and Security concerning e-prescribing standards. I am here on behalf of the 93,700 members of the American Academy of Family Physicians. The Academy is very interested in issues of health information technology, particularly in seeing software and hardware that is compatible and interoperable across health care settings. While the promise of e-prescribing is important, we are concerned that standards adopted for voluntary e-prescribing as a result of the Medicare Prescription Drug and Modernization Act (MMA) not hamper the larger functions of an electronic health record (EHR).
Clearly, e-prescribing is complicated because of the several parties that can be involved.
- prescribing physician;
- patient’s health plan (files contain data on beneficiary prescription history);
- pharmaceutical reference entities (i.e., First Data) with information on prescribing, dosage, allergic reaction and other drug prescribing information;
- pharmacy benefit managers (PBMs) (retain formulary information and may dispense mail order medications to patients);
- pharmacies (large chains and independents).
In order for all of these parties to communicate, standards will need to allow connectivity between EHRs and a variety of other parties. Family physicians are eager to see a fully functioning EHR that allows communication within the broad community outlined above because there is the great potential for increased safety and productivity from such a system.
Benefits to Family Physicians
E-prescribing can offer significant savings in time, effort, and money for medical practices, physicians and their patients. These savings result from several workflow and information process improvements, such as:
- fewer call backs from the pharmacy or PBM due to improved legibility and completeness of prescribing information;
- decreased telephone time with patients, pharmacies, and health plans regarding prescriptions;
- increased ease of storage and access to patient prescription information within an EHR.
These gains in efficiency, timeliness, and accuracy of prescribing may also significantly enhance, and are related to, patient safety.
Family physicians care about the context in which e-prescribing occurs. The best context for the patient is one in which a comprehensive record of patient health information is available to the prescribing family physician at the time the prescription decision is made. Clearly, refills and renewal are not as complicated, and may not require as much patient information review. However, safety, quality, and cost considerations all favor e-prescribing be done within the comprehensive practice setting, where considerations such as previous drug experience, co-morbidity, drug-drug interactions, and even the patient’s economic situation can be assessed prior to ordering the medication.
Family physicians would prefer that e-prescribing take place within the context of a full-featured EHR, which acts as the central nervous system of a patient’s health care system, and not through a single-purpose application that provides an electronic connection to the pharmacy or PBM, but does not assist the clinician by providing access to other information required for quality clinical decision-making. Small- and medium-sized ambulatory primary care offices, where the majority of health care is delivered in the United States, must also be able to easily implement any e-prescribing standards developed.
Family physicians feel strongly that e-prescribing should be based on choice, not coercion. They do not favor governmental mandates that would force physicians or their practices to engage in e-prescribing, but believe this clinical tool should be voluntary and based on its attractiveness to patients and providers. Doctors should not be forced to adopt technological solutions that are not affordable or which lead to unfair incentives for patients or practices to utilize a particular commercial pathway for medication fulfillment. Such forced adoption, either through governmental or payer mandates, would exacerbate the already precarious financial situation in which many primary care physicians in small and medium-size medical practices find themselves.
Therefore, e-prescribing must be free to physicians and patients. Physicians should not have to pay for e-prescribing through transactions fees or be forced to acquire technologies offered by health plans, pharmacies, PBMs, or their subsidiaries or agents. To allow third parties to determine what technology is acquired in a medical practice would redirect valuable capital that might more appropriately be spent on other technology purchases such as an EHR or other upgrades. Physicians are in the best position to determine their practice management and clinical software needs. Similarly, physicians should not be forced to report practice data to any of these parties, who might later use it for commercial benefit or profit.
In any e-prescribing function, family physicians want to be able to see all of a patient’s prescribing history, from as many sources and databases as possible, in real time and prior to prescribing a new medication. This is an important safety issue particularly for Medicare beneficiaries, two-thirds of whom have multiple chronic conditions. Generic and brand product names are often similar and confusing, especially to the patient on multiple prescriptions. Existing EHRs are not able to exchange drug lists from doctor-to-doctor. Such fragmentation of the health care system often leads to errors of duplication in prescribing of medications. The promise that e-prescribing holds out is that it will correct this problem, but only if physicians have access to the full patient prescribing history.
These opening comments have been general and referred to the overall clinical and practice management environment because family physicians are most concerned about creating an optimal primary care office setting. The following comments will refer to specific aspects of existing standards and pharmaceutical databases.
National Council for Prescription Drug Programs (NCPDP)
NCPDP represents the retail pharmacies and is the standard for pharmacy claims to go to PBMs and payers, also known as the NCPDP Standard. This has been widely adopted and is used by the pharmacies to send eligibility inquires and pharmacy claims to payers and PBMs. It is a proprietary standard (e.g., similar to X12 and HL-7) that is so widely used that it was adopted under HIPAA. In short, it is the one clear area where the vendors, not a standards body, established the standard, not a standards body.
When Palm Pilot e-prescribing began started around 1998, several PDA prescribing functions were developed (ePhysician, iScribe, ePocrates, Allscripts, and several others). At the same time, NCPDP, as the predominant standards body for pharmacies, started work on NCPDPScript – a standard for e-prescribing. It is a message standard for:
- formatting prescriptions;
- sending them to the pharmacy;
- sending refill requests to the practice;
- sending proprietary message exchanges.
Unfortunatley, NCPDP lumps too many things together and does not support the specificity most practicing physicians need to define prescribing. It was built from the pharmacy perspective to replicate paper prescriptions, but does not provide all the functions necessary for a physician to prescribe in a variety of settings. For example, it does not deal with ordering home care IVs, or ordering drugs to be administered in the practice setting. The standard does not address the complexity of dosing. Instead, the standard combines all dosing information essentially under ‘sig’ portion of the message. While this allows physicians the flexibility to write free-text, it is not detailed enough for the clinical encounter. Instead, physicians will require:
- real-time automated checks on dosing;
- drug-drug interactions;
- other high-priority safety checks;
- definitions of dose and units;
- standardized enumeration (for example, bid versus 2x/d, twice a day, or qAM and qPM);
- standardized descriptions for delivery (for example, po is clear, versus by mouth, orally).
Instead, we need to create a standard that will allow the transmission of different categories of data that are rolled together currently, at the risk of being lost, or not recorded at all. We need more categories of data where data can be communicated and we need a controlled vocabulary set to define exact meaning script-to-script and system-to-system. Physicians also need to be able to pull information from a variety of sources to make the most informed clinical decision.
Sources and Databases for Drug Information
Some examples of pharmaceutical databases are FirstDataBank, Multum, Medispan, MicroMedex. None is complete, however, some are better in some areas than others, and all are proprietary. The best sources are actually the Poison Control Centers, who have all of these systems as well as the text references. In addition, they also have overdose data that no database currently collects. There are also useful consumer sites, such as www.storknet.com for important information about the interactions of pharmaceuticals during in pregnancy and lactation.
The problem for any of the databases is drug naming. The drug names in these databases, even for generics, are dissimilar. If a physician were to search a prescription written using one name with a drug-drug interaction program utilizing another name, he/she has a danger of misinterpretation or inexactitude with potentially patient harming consequences.
The federal government’s RxNorm project to normalize drug names does not solve this problem since it lumps data. The National Drug Code Directory (NDC) codes down to the level of dosage forms, taking physicians to the other extreme. For example, there is a unique NDC code for every single preparation of amoxicillin from every single manufacturer, including all the generics. Also, these systems are all quite expensive, and their use by vendors means the cost is passed on to the customers, i.e., the doctors. While the cost of these databases or e-prescribing functions might easily be supported within an institutional setting, it would quickly become prohibitive in the small physician office. Yet the advantages of e-prescribing are quickly eroded if all physicians in all settings are not given an equal chance to participate. Physicians will also need to be able to search for formulary data to see what is covered under their patients’ benefits.
Sources of Formulary Information
Currently, formulary information is not presented in any standardized fashion and can be held by the employer, health plan or PBM. Physicians need a clear and quick way to check formulary data during the clinical encounter. Often, it is difficult to determine whether there is a formulary or what entity has developed. Patients seldom know that they have a PBM, or have any contact information concerning their PBM.
The development of standards for e-prescribing is an important step forward for a health system based on interoperable electronic health information technology. Family physicians are working to see the development of compatible interoffice technology as well as interoperable across care and payer settings. The Academy wishes to stress the importance of appropriate message texts, access to clinical databases, and allowing e-prescribing to take place within an EHR. Likewise, family physicians believe that third parties should not collect information about their prescribing patterns for any purpose. Thank you for the opportunity to appear before the NCVHS Subcommittee on Security and Standards regarding this topic.