Good morning. Thank you for the opportunity to present to this panel the views of the profession of pharmacy and the American Pharmaceutical Association (APhA). I am Ron Jordan, President of HCaliber Consulting Corporation and Immediate Past President of the American Pharmaceutical Association. I am also a Past Chairman of the Standardization Committee of the National Council for Prescription Drug Programs, the ANSI-accredited organization tasked with developing standards for the pharmacy sector.
APhA represents the third largest health profession, composed of more than 210,000 pharmacy practitioners, scientists, and pharmacy students. Since its founding in 1852, APhA has been a leader in the professional and scientific advancement of pharmacy, and in safeguarding the well-being of the individual patient. My testimony focuses on the questions provided by the Subcommittee.
Definitions and requirements for Patient Medical Record Information (PMRI): How would you define or describe PMRI?
Why is comparable PMRI required, what functions does it serve?
How comparable does the PMRI need to be for these purposes, i.e., how precise, how accurate? What are the consequences if the PMRI is not accurate?
How would you define or describe PMRI?
Patient medical record information (PMRI) should describe the past and current experiences, status, and results of an individual patient’s medical therapy encounters. All “relevant” information that can be assembled from the patients numerous medical care providers should be included where “relevance” is determined from the prospective of each individual provider, at the time of an encounter and therefore the collective group of a patient’s medical providers. Much like each provider determines appropriate treatment at any given time, the appropriate level of documentation in the medical record for a given encounter should be weighed individually by a provider considering the current and future consequences of such decisions.
An obvious essential component of patient medical record information is information about medications—both prescription and over-the-counter drugs that are prescribed, dispensed, actually used and otherwise encountered. From the pharmacist’s perspective, which many health providers will also find essential, beyond tracking the medication dispensed, relevant information pharmacists gather about patient progress on certain therapies, potential drug related problems uncovered, and other information used to help patients manage their drug therapy, such as glycosolated hemoglobin levels, lipid profiles, and peak flow volumes are all integral to accurate and complete PMRI.
Let me explain further. Information about medication use is vital to understanding health care. Medications are one of the most common, if not the most common, method of intervention to treat disease or control symptoms. Patient Medical Record Information must include more than just the information from the prescriber about the initiation of therapy--it must also contain information from pharmacists about what medication the patient actually acquired, the interaction of that medication with other therapies that a pharmacist may be aware of, and pharmacist collected assessments of the patients compliance with and achievement of expected outcomes.
For example, a physician may prescribe a medication to manage my hypertension. As the patient, I visit the pharmacy and secure a one-month supply—but due to some side effects of the medication, I do not secure any additional medication after the first month. Not surprisingly, when I next see my doctor, my blood pressure readings have not improved—I didn’t take my medication. I may or may not tell my doctor about my non-compliance with the medication she prescribed—but I am likely to get a new prescription. Whether for another medication or a new prescription for a higher dose of last year’s product, this decision is based on the physician’s assessment that the drug prescribed last year did not work. In reality, my blood pressure readings do not indicate a need for a higher dose or a new medication but rather a need for some medication or other active intervention. Pharmacists can provide information from the about whether medication is actually secured and may also find out from the patient that therapy was discontinued without the physicians knowledge. Pharmacists uncover similar potential drug related problems daily. When they are communicated they help improve the outcomes of therapy.
Today, physicians and pharmacists attempt to share this information through informal mechanisms, including pharmacy-specific information as a component of PMRI would help formalize and support this interchange. Pharmacists have this information in their practice operating systems, documented and compiled according to the electronic standards developed and maintained by the National Council for Prescription Drug Programs (NCPDP) and the pharmacy management computer system vendors.
NCPDP standards provide clinical support tools within the standard, using the Professional Pharmacy Services codes. The codes support the conduct of on-line, real-time drug utilization review (ORDUR), they provide information to the dispensing pharmacist about other medications the patient has secured even from other pharmacies, they identify potential interactions, dosage problems, and permit the pharmacist to assess the relevance of these warnings. These standards support coordination among pharmacists—and could be used similarly with other health care providers’ further enhancing the Patient Medical Record.
Accuracy in confirming the medication provided, the conflicts identified through on-line, real-time drug utilization review, and the pharmacist services provided is extremely important. Information gaps or mis-information about medication therapy can have serious consequences—medications are safe when used appropriately, and any information gaps affect that appropriate use.
Why is comparable PMRI required, what functions does it serve?
PMRI information must be comparable longitudinally within a patient’s record and across multiple patient records. Progression of disease or deterioration of health is tracked through the former, public health research and the latter serves continuous quality improvement systems.
How comparable does the PMRI need to be for these purposes, i.e., how precise, how accurate? What are the consequences if the PMRI is not accurate?
The PMRI should be as accurate as is technologically and humanly possible. Automated information and electronic evaluation of that information will leave little room to determine the quality or importance of information content. All users of the PMRI must not substitute critical evaluation of information and necessary re-verification of information when making therapeutic decisions based on the PMRI. Content will vary in its precision level and the “perceived accuracy” of content from any users perspective will likely vary with time and circumstances.
The role your medical terminology plays in representing PMRI:
What is the intended purpose of your medical terminology? What is it currently
used for?
What is the clinical domain, scope, or healthcare setting addressed by your
medical terminology?
What evidence do you have of market acceptance of your terminology? {Ask users
what their perceptions of gaps are}
In what areas are you now planning to expand your terminologies?
The medical terminology I will discuss today is a component of the NCPDP telecommunication standard: Professional Pharmacy Services. The purpose of the code set is to facilitate precise and efficient documentation and electronic transmission of information related to professional services performed by pharmacists (PPS), and to support efficient online real time drug utilization review (ORDUR) activities administered by third party claims processors and within a pharmacists own practice management software. As described above, this includes information about pharmacist services related to drug therapy monitoring and management, the detection and management of potential and actual drug related problems such as identifying duplicate therapy or potential interactions among medications obtained at different pharmacies.
The objectives of the code set are:
Improved quality and continuity of care delivered to patients;
Standardization of the electronic documentation and billing infrastructure that supports efficient compensation mechanisms for the delivery of professional services by pharmacists to their patients, and; uniformity across the pharmacy provider industry and the electronic prescription claims processing industry regarding the transmission of drug utilization review conflict messages and responses in an online real time environment. The codes create an environment which aids in the identification and prevention of inappropriate prescription drug therapy with the lowest possible impact on the operational costs and efficiency of pharmacy practice.
The code set classifies medication therapy-related problems that constitute threats to patient health and safety and pharmacist care activities that may be performed to correct or resolve these problems. The three primary clinical topics that are addressed by the code set correspond to the three stages of clinical problem solving: 1) Identification of the drug-therapy problem; 2) selection and implementation of a corrective course of action, and 3) the result or outcome of the intervention activity. These three stages are documented in the following three fields in the PPS coding system:
Reason for Service/Conflict codes describe the medication-related problem or reason that created the need for the pharmacist’s professional service and/or the medication-related conflict identified during ORDUR by a claims processor.
Professional Service/Intervention codes describe the service or intervention performed by the pharmacist in response to the reason or conflict identified.
Result of Service/Outcome describes how the identified problem was resolved, including the final disposition of medication involved, if applicable. Codes in this field allow for the documentation of procedural results and outcomes that can be determined at the time of service.
The domain focus of PPS codes is generalist pharmaceutical care—the drug therapy management services conducted by a pharmacist. As part of NCPDP’s Telecommunication Standard (Version 3 Release 2 and higher), the PPS codes are implemented by virtually every vendor that is currently active in prescription benefit (PBM), electronic prescription claims processing, and pharmacy computer sales. While precise industry values are not available, it is estimated that the vast majority (i.e., over 95%) of the more than 61,000 community pharmacies that are active in the U.S. utilize NCPDP’s telecommunication standard, including PPS codes, in their communications with electronic claims processors. Of the state Medicaid programs, 47 currently use or anticipate using online claims adjudication via NCPDP’s Telecommunication standard.
Additionally, all national professional associations in pharmacy recognize and refer to the PPS codes including, but not limited to: the American Pharmaceutical Association (APhA), the American Society of Health-System Pharmacists (ASHP), the National Association of Chain Drug Stores (NACDS), the Academy of Managed Care Pharmacy (AMCP), and the National Community Pharmacists Association (NCPA).
I must also mention that concerns about the value of the PPS codes have been raised. These codes, particularly their use in conducting on-line, real-time drug utilization review, have been challenged by some users as providing too much information. As the systems which send ORDUR messages are screening systems, some tolerable level of false positives is inevitable. Unfortunately in some user circumstances, the messages are provided so often by the administrators (i.e. the PBM industry) and are commonly identifying problems that a pharmacist has already addressed that the pharmacists frequently override or ignore the messages. The “noise” created by the system may tend to de-sensitize the pharmacist and other practitioners to the truly important messages. To address this problem, APhA is working with the United States Pharmacopeia and other organizations to identify the source of the problem and recommend changes. These solutions, then, will be provided to NCPDP and used to improve the terminology and its use. Such ongoing quality improvement activities—identifying problems at the user level and developing solutions—are important to APhA and to NCPDP, and have supported the broad acceptance of the telecommunication standard and the PPS codes. We are confident that these efforts to identify and resolve the problems will improve this tool—and coordination of the information in the patient medical record will further enhance patient care.
As the need for drug therapy management services expands, so will the need for the PPS codes. Adverse drug reactions and the problems resulting from medication use are extensive—estimated at yielding $76 billion in health care costs annually. The need for drug therapy management services is high, and the role of ORDUR and PPS in supporting the identification and resolution of such problems is essential.
How does your medical terminology relate to other medical terminologies?
Currently, the use of PPS is limited to the documentation and provision of medications and accompanying drug therapy management services. As noted previously, however, integration of information about medication and its use is vital to an effective patient medical record, and an important component of Patient Medical Record Information.
How does your medical terminology relate to healthcare message
format standards?
Which message format standards reference or include your medical
terminology?
Is the use of your medical terminology within these message format
standards required, preferred, or optional?
As part of NCPDP’s Telecommunication Standard (Version 3 Release 2 and
higher), the PPS codes are implemented by virtually every vendor that is
currently active in prescription benefit (PBM), electronic prescription claims
processing, and pharmacy computer vendor. The use of the PPS codes is mandatory
for the transmission of on-line, real-time drug utilization review messaging
and professional pharmacy services although the implementation of code
generation systems is left to the user agency.
Are there issues related to medical terminologies that deserve
government attention or action?
What are they?
What can be done to address these issues in a one- to four-year time frame? A
five- to ten-year time frame?
Addressed in Item #6.
Are there issues related to the comparability of PMRI?
If so, what should be the role of the government?
Is there a need for increased coordination among terminology
developers? If so what type.
Is there a need to coordination between terminology developers and
message standard developers? What type or form should it take?
In the short run (1-4 years)/long run (5-10 years)?
Pharmacists have a unique perspective on how electronic standards can facilitate and sometimes hinder progress down a path toward improved patient care and a truly integrated health system. Pharmacists are the most frequently encountered health care professional, and they also rely more consistently on their computers in providing care than other medical professionals. In the United States, pharmacists in inpatient and outpatient practice settings use computers to perform their job. The profession’s reliance on automation and external electronic communication extends beyond simple administrative and practice financing functions such as those seen in dentistry and medicine. This communication has been facilitated through the standards setting activities of the National Council for Prescription Drug Programs (NCPDP).
The majority of standards and terminology used by pharmacists are used only by pharmacists. Documenting and tracking information about medication dispensing and use is unique to the profession, with the exception of some limited dispensing by physicians. As mentioned previously, a patient medical record is incomplete without information about medication use. Integration of the information from pharmacy systems with other health care providers is a goal—and required to facilitate interdisciplinary, provider-to-provider electronic health care knowledge exchange.
Multiple syntax’s and standards can inter operate in the health care system if appropriate business models, transaction data element compatibility and clearing requirements are specified. Volatile market structures in the rapidly integrating health care environment will ultimately determine the best standards, standard setting organizations and business models.
It is clear, however, that some areas of health care information exchange standardization will never be solved without stronger, higher power intervention. Coordination of standards development organizations' data dictionaries with assigned secretariats for various health sector domains should go a long way to ensuring the success of coordinated and useful patient medical record information.
The NCVHS subcommittee on PMRI is clearly reaching out for input from appropriate organizations and many qualified individuals. The ANSI accredited standards development organizations, ANSI-HISB, WEDI, and national claims and billing committees hold great resources that can be leveraged to your advantage in this difficult task. While most of these groups have regular input from members of the various health professional associations, we note the legislated formal inclusion of the national associations representing dentistry, without similar commitment to official medicine, nursing or pharmacy consultation. Your recommendations must insure pharmacy’s compatibility with clinical information systems of other health care disciplines and organizations.
Administrative simplification will best be accomplished by working to identify the real problems that need to be addressed in a broad-based, open and participatory process. Further, taking full advantage of the standards which are widely accepted and currently functioning in a specific health sector so as not to impose undue administrative difficulties or wasteful expenses should be an important consideration.
Patient Medical Record Information requires coordination of information from many sectors. Information about medication use and drug therapy management is an important component, and the Professional Pharmacy Services Codes vital to communicating such information. Ultimately better coordination and exchange of information between health care professionals will lead to the systems we all desire for patient care and optimal health outcomes for the citizenry.