Enabling Medication Therapy Management

US Pharm. 2008;33(9):Epub.

Medication therapy management (MTM) delivered by pharmacists is an important emerging service in the ambulatory setting.^1-3 Opportunities for community pharmacists to engage in MTM have been created as a result of the Medicare Modernization Act of 2003.⁴ Health information technology (HIT) can play a critical role in enabling pharmacists to engage patients in MTM, resulting in better patient education, improved medication adherence, improved safety, and coordinated care in conjunction with other clinicians.⁵

Interoperable exchange of health information allows the pharmacist to view current medications, laboratory results, diagnoses, and other clinical data that can be incorporated into the MTM session. The term interoperable implies that different computer systems can accurately and securely exchange electronic health data according to standardized protocols and common data sets. In order to maximally benefit from health information exchange to support MTM, pharmacists must be aware of critical needs for data standards, security, and privacy as well as patient consent issues.

The Core Elements of MTM
MTM in the ambulatory setting is typically delivered as a face-to-face interaction between the pharmacist and patient. Five core elements of an MTM service model have been described.⁶ Medication therapy review (MTR) includes a comprehensive review of all current medications including nonprescription and herbal agents, followed by an assessment of medication-related problems by the pharmacist. The personal medication record (PMR) is a comprehensive, reconciled list of all of the patient's medications. The list is provided to the patient and other clinicians for self-management, care coordination, and to facilitate continuity.

The pharmacist also produces a medication-related action plan (MAP). This is a care plan developed collaboratively between the pharmacist and patient and contains a list of action items for the patient to use while tracking progress in self-management. During the encounter, the pharmacist identifies opportunities to intervene on behalf of a patient, including collaborating with physicians or other clinicians. On occasion, the pharmacist may refer a patient to another clinician. Finally, the MTM services are documented in a permanent record.

There are significant opportunities to incorporate HITs into the MTM model. In the MTR phase, the pharmacist can electronically access lists of adjudicated pharmacy claims, typically encompassing the past 90 days. Such lists may be available through the pharmacy's own database, through state-wide resources such as state Medicaid agencies, regional health information organizations (RHIOs), or through national services including RxHub-SureScripts. Information compiled through such lists must be reconciled to remove duplicate entries, etc. In addition, the reconciliation process must include a discussion with the patient to verify which medications are actually being taken and to identify additional nonprescription and herbal agents.

The pharmacist can also employ electronic decision support software to assist in the detection of drug allergies and adverse events, drug–drug interactions, drug–laboratory interactions, drug–disease state interactions, minimum and maximum doses, and age-based, weight-based or body surface area–dependent dosing, etc. Decision support can be made more robust if the pharmacist can electronically access recent laboratory results and lists of diagnoses and clinical problems. Regional or statewide health information networks, often incorporating RHIOs, may be the source of such electronic information. Alternatively, the information may be available directly from a physician's electronic health record or the patient's electronic personal health record (PHR). Interoperable data exchange employing national standards and data formats is critical to facilitate the delivery of important clinical information to the pharmacist to support the MTR phase.

The PMR offers additional opportunities for the pharmacist to employ electronic tools. The PMR represents a fully annotated and reconciled medication list. Ideally, this should be in electronic format so that it can be readily exchanged with other clinicians, hospitals, ERs, and other facilities to enhance the coordination of care. An accurate and comprehensive reconciled medication list is the cornerstone of promoting patient safety and reducing medication errors. Such a list can be directly imported into a physician's electronic health record or the patient's PHR.

The MAP is, likewise, ideally produced in electronic format. This can enhance coordination between clinicians and can facilitate review of the plan by the patient's physicians, other clinicians, case managers, care coordinators, or other health care team members. Similarly, collaborations and referrals between the pharmacist and other clinicians can be enhanced by electronic information exchange in which the PMR and MAP can be instantly forwarded to other health professionals. It is highly desirable to document the MTM session in a permanent electronic record that can be similarly forwarded.

To date, only a few studies have documented the utility of incorporating HIT into MTM. McMahan showed that in the setting of a managed care plan, "the operational components of MTM programs that rely heavily on HIT include patient identification, stratification of care, coordination of care, and safety evaluation. . . HIT is further employed to coordinate the collective efforts of pharmacists and physicians in the administration of care, as well as to monitor medication safety measures."⁷

Data Standards
Since the application of HIT to MTM is relatively new, there are no established national data standards specifically designed for this purpose. However, standards exist for related pharmaceutical applications and can readily be adopted. For example, the Centers for Medicare and Medicaid Services recently published the final rule for electronic prescribing.⁸ The Medicare Part D standard for medication history is the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1 (Version 8.1), October 2005. The medication history standard can be easily adopted to transmit pharmacy history information to the pharmacist engaging in MTM.

The Office of the National Coordinator for Health Information Technology has promulgated the Medication Management Detailed Use case: "intended to facilitate access to necessary medication and allergy information for both providers and consumers when healthcare is sought and delivered, the Medication Management Use Case has the potential to improve medication management through increased information exchange. In specific terms:

• Clinicians will be better supported if more complete information and real-time feedback concerning potential contraindications such as drug–drug and drug–allergy interactions are available;
• Patients will have better access to information about the medications they are taking and will have more involvement in their healthcare; and
• In addition to health benefits, medication management will be better supported when clinicians have more information available about prescription benefits, effective electronic exchange supports the prescribing process, and consumers can request prescription renewals and refills online."⁹

Key features of this use case include defining the need for standardized terminology for medications, standardized terminology for allergies to medications and drug intolerances, and a fully structured and codified SIG. The use case goes on to map out a detailed scenario for both inpatient medication reconciliation and ambulatory medication management. The use case contains a discussion of the need to establish a data set to facilitate the transmission of medication history and allergy information. Possible data standards under discussion include the Continuity of Care Record, datasets related to activities of the Joint Commission, Health Level 7, the Consolidated Health Informatics initiative, the National Council for Prescription Drug Programs, the vocabulary of SNOMED, the National Drug File, Structured Product Labeling, Unique Ingredient Identifier, and RxNorm.

Privacy and Security
The need to maintain privacy and security of protected health information is of paramount importance. Security and privacy must be maintained whenever personal health information is stored or transmitted electronically. A number of issues must be addressed when electronic health information is exchanged:

• Node authentication
• Identity credentials
• Document integrity
• Access controls
• Audit trail
• Nonrepudiation
• Consistent time tracking
• Secure data transfers based on established authentication procedures
• Access logging exchange creating an integrated record of who has accessed specific information across multiple organizations and timeframes.

A number of standards have been developed to address these issues. For example, encryption algorithms and an entire suite of computer security features have been developed by the National Institute of Standards and Technology (NIST).¹⁰ Using these tools, it is possible to electronically authenticate a receiver of data over a network such as the Internet. Strong encryption algorithms and data authentication protocols should be routinely employed whenever personal health information is transmitted over a public network.

In addition, the Certification Commission for Health Information Technology (CCHIT) has developed strict standards to certify electronic health records.¹¹ These standards can be easily adapted to systems that pharmacists employ to administer MTM services. The 2007 CCHIT standards include many security features that control who has access to protected health information. The access control standards impose a requirement that the system must restrict access according to given rules. Access can be controlled based on the identity of a given user, the user's role, and context such as location or time of day.

Following the Audit Trail
An audit trail is critical for maintaining a permanent record of who has accessed a given individual's personal health data. The CCHIT standards require that the system must maintain an audit record of all security-related events that it mediates. Audit records must be time stamped and protected from alteration or deletion. Access to the records is available only to appropriate administrators. The standards require that the system must authenticate all users by password, and strong password rules must be enforced to maximize password complexity. Technical security standards require the use of strong encryption standards from NIST, including the triple-DES or advanced encryption standard. The system must also be able to authenticate the identity of a remote node on the Internet when transmitting personal health information. Authentication is required to be at NIST security level 3, which prevents most types of intrusions.

Written informed affirmative patient consent may be required for the electronic exchange of certain types of sensitive health information. While HIPAA sets federal floor standards for patient privacy and consent, there are other state and federal laws that are more restrictive. Many states have enacted legislation that controls the release of HIV, reproductive, genetic and/or mental health information. In addition, Federal law provides strict control over the release of certain alcohol and substance abuse data.

Since MTM programs will, by necessity, require a complete profile of the patient's medications, it is possible that the existence of a sensitive diagnosis could be revealed by the medication history alone. Thus, the pharmacist engaged in MTM services must become fully educated regarding the specific laws in his or her state. It is therefore recommended that legal advice be obtained regarding the specific requirements of relevant state laws. The most conservative approach to this issue is to ask the patient to sign an affirmative written consent authorizing the release of all medication history, including that which might be related to HIV, mental health, genetic, or alcohol and substance abuse diagnoses. The advantages for the patient can be carefully explained with an emphasis on the ability of the pharmacist to fully evaluate the safety of his or her medication regimen when it is known in its entirety.

Given the potential for pharmacists to engage in a critical role on the health care team, MTM is a major opportunity for expansion of their services in the ambulatory setting. The addition of HIT tools to MTM provides a powerful model for optimizing the clinical value of MTM. However, there are a number of difficult  challenges--including the development of additional national data standards, the maintenance of strict privacy and security, and the development of an informed consent model for patients--that must be addressed. Pharmacists must therefore become educated in the critical aspects of informatics in order to maximize the potential of MTM

REFERENCES

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6. American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model. Version 2.0. 2008. www.pharmacist.com/AM/Template.cfm?Section=Home&
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8. Department of Health and Human Services. Centers for Medicare & Medicaid Services. 42 CFR Part 423. Medicare program; Standards for e-prescribing under medicare part D and identification of backward compatible version of adopted standard for e-prescribing and the Medicare prescription drug program (version 8.1). Final rule. Fed Regist. 2008;73:18917-18942.

9. U.S. Department of Health and Human Services. Office of the National Coordinator for Health Information Technology. Medication Management Detailed Use Case. www.hhs.gov/healthit/documents/UseCaseMM.pdf. Accessed June 23, 2008.

10. National Institute of Standards and Technology. Computer Security Division. Computer Security Resource Center. http://csrc.nist.gov/index.html. Accessed June 23, 2008.

11. Certification Commission for Health Information Technology. www.cchit.org. Accessed June 23, 2008.