Editor’s note: This is the third installment of a multipart commentary prepared expressly for the May through September 2012 issues of the ACCP Report.

In this continuing series of commentaries exploring whether clinical pharmacy should promote a consistent process of patient care that could apply to any clinical practice setting, we set the stage by providing a background on the issue in part I (see http://www.accp.com/report/index.aspx?iss=0512&art=1) and then provided a summary of five different models of clinical pharmacy practice in part II (see http://www.accp.com/report/index.aspx?iss=0612). In this month’s “part IIIA” (the remainder of this segment will appear next month), we provide a more detailed analysis of each model by detailing its respective strengths, weaknesses, similarities and differences, and applicability to different practice settings.

The availability of many pharmacy practice models provides opportunities to identify a set of requisite clinical practice components. However, it also creates challenges in selecting or creating one “best” patient care process that promotes consistency among clinical pharmacists in all practice settings. We strongly believe that for the profession of pharmacy to advance to the next level of its evolution, and for clinical pharmacists to establish a definitive role within the health care team, a uniform model of clinical pharmacy practice must be implemented. As we note in part I, this model should outline and promote a logical sequence of processes that achieves the objective of improving patient outcomes. The process should include steps—or clearly sequenced activities—that will occur every time a clinical pharmacist sees a patient, no matter the setting, the conditions present, or the medications involved. This practice process should be articulable, measurable, codeable, and researchable. Those outside the pharmacy profession who read a description of the practice should be able to understand it, and clinical pharmacists should be able to implement it routinely. We acknowledge that the impact of such clinical pharmacy practice models on patient outcomes has not yet been convincingly shown, but this is true for the other health professions as well. We believe that additional research to more thoroughly evaluate the benefits of such a practice can only be accomplished once a uniform and consistent process is in place.

As these current models are discussed, ask yourself which model, if any, you think would be best for all clinical pharmacists to adopt. Or, perhaps you believe that a combination of models, or an altogether new model, should be developed. Remember, we know WHO we are. We now need to determine, demonstrate, and communicate specifically WHAT we do, and then do it consistently!

CLINICAL PHARMACY PRACTICE MODELS
Pharmaceutical Care¹
Strengths

The pharmaceutical care model is comprehensive and systematic. This model includes the important components of identification, resolution, and prevention of medication-related problems (MRPs) and a determination of whether patient outcomes have been met, as well as an assessment of the patient’s medication experience. In the pharmaceutical care model, the pharmacist takes responsibility for a patient’s outcomes related to his or her drug-related needs. The model was introduced more than 20 years ago; therefore, it is widely recognized by pharmacists.
Weaknesses

This model (with the terminology used) is probably known mostly to pharmacists and is likely not recognized as readily by other health care professionals or payers. The detailed descriptions of the process are largely available only in texts and have not been published in complete form in the biomedical literature. This restricts the model’s dissemination to those who have access to the texts. Many steps are involved in this process, all outlined in great detail in the textbooks, and an actual patient visit encompassing every component of the model could take a great deal of time and might not be perceived as practical for some busy patient care practices. The general concepts and philosophies of this practice are consistent with what a model of clinical pharmacy practice should be, but it may too prescriptive with respect to its steps.

Medication-related problems exist that may not fit into the available categories. For example, a patient who is unable to use a metered dose inhaler or insulin pen correctly, but who otherwise adheres precisely to his or her medications, would be classified as nonadherent. This problem would be more accurately classified under administration than adherence, but no such category exists.
Applicability to All Clinical Practice Settings

The pharmaceutical care model is largely tailored toward primary care settings; however, it is intended to be applicable to all patient care settings, including hospitals and long-term care facilities. Pharmaceutical care is described as a generalist practice, and its authors maintain that only if pharmaceutical care is practiced widely can specialist practice be developed. From the description, it appears to us that this model focuses more on an “independent” practice model than on models in which the pharmacist works collaboratively with other providers.

A potentially significant factor that could limit the applicability of this model to all practice settings is the substantial amount of time that pharmaceutical care patient encounters can require, including preparation time reviewing the patient’s chart, actual time involved in the patient encounter, and time required for documentation. It appears that every component of the practice needs to be included, with no allowance for abbreviated applications, should time constraints exist.

Medication Therapy Management (MTM)²
Strengths

This model is a component of Medicare Part D and is therefore well known by pharmacists, other health care professionals, and payers. The model meets the requirement of providing patient-centered health care. The pharmacist, working collaboratively with the patient, is central throughout the five core elements of the MTM process. The pharmacist-patient relationship is kept distinct and separate from the patient’s relationship with the other members of the health care team. Patients are proactively involved not only in the creation and maintenance of their medication therapy plan but also in helping to resolve any MRPs.
Weaknesses

The MTM model does not address in any detail the pharmacist interacting and communicating with the other members of the health care team (e.g., physicians, nurses, and other practitioners who may be caring for the patient) to resolve drug-related problems, which is especially important in many settings. Reference to the MTM model in the institutional setting is limited to transitions of care in and out of the institutional setting. It may be unrealistic for an institutional clinical pharmacist to develop long-term goals and a medication action plan for every one of a patient’s chronic medications, as this occurs more commonly in the ambulatory care setting. The MTM model also emphasizes a considerable amount of paperwork and places a great deal of responsibility on the patient. Patients must keep and maintain their own personal medication record (PMR) and medication-related action plan (MAP). At each visit, changes may be made; hence, the lists and plans must be revised. Because the patient may forget to bring his or her PMR and/or MAP to the appointment, copies must be kept by the clinical pharmacist as well. The paperwork involved requires a great deal of extra work, time, and documentation for the clinical pharmacist.
Application to All Clinical Practice Settings

The MTM model was developed to be applied to all care settings where the patients or their caregivers can be actively involved in managing individual medication therapy. This may occur in the institutional setting during admission or discharge, at the community pharmacy, in the clinic, or within a long-term care facility. Medication therapy management services preferably should occur during face-to-face encounters; however, they can also be performed by telephone.

Although this model was created to be used across all health care settings, two core elements do not translate well to the acute care setting. These two elements are the PMR and the MAP. Patients may be unable to participate actively in their care while in the institutional setting. Although the model references its applicability in all settings, it does not address the pharmacist’s role in providing MTM when the patient cannot participate actively in his or her own care. Therefore, the MTM model is most practically applied in ambulatory care settings.

Medication Management in the Patient-Centered Medical Home (PCMH)³
Strengths

The PCMH comprehensive medication management model embodies important components, including the patient’s medication experience. This comprehensive medication management (CMM) practice is less detailed and prescriptive than some of the other models, with less paperwork and documentation required. More patients can be cared for per unit time because face-to-face contact is not required.
Weaknesses

This model is relatively new and may not be well known to some pharmacists or other health care professionals. However, most payers are quickly gaining familiarity with the PCMH in general, and they will likely be well aware of CMM in the near future. Clinician interventions address MRPs as they are identified, but instituting a monitoring plan (e.g., laboratory monitoring) to assess for adverse effects is not included. In addition, a patient who is unable to use a metered dose inhaler or insulin pen correctly, but who is otherwise adherent to his or her medications, would be in the same MRP category as one who chooses not to take medications. These problems should probably be classified under administration rather than adherence. Furthermore, “incorrect frequency and duration” is not included as an MRP, nor is “medication not covered” or similar issues related to a patient’s ability to afford medications.
Applicability to All Clinical Practice Settings

The PCMH model originates in the primary care setting, usually in a generalist practice. Ideally, CMM resides within the medical home structure. The model incorporates options for the practice to be implemented outside the office or clinic setting, such as in a community pharmacy, within a health plan, or in the institutional environment (although it is unclear whether this is intended to apply to an inpatient setting or an outpatient hospital clinic). In addition, because face-to-face contact is not required in this model, telephonic or “virtual” communications are acceptable. This allows involving clinical pharmacists who may be at a remote location and obviates the requirement that a clinical pharmacist be “embedded” within every practice locale.

Although this model is intended for use in a primary care setting, portions can be applied to other settings. Comprehensive medication management step 2 is a specific process that could be used in inpatient settings (identification and categorization of the patient’s MRPs). The other steps do not apply as much to inpatient settings, as patients are not responsible for taking their own medications, and long-term outcomes are not met during the brief duration associated with a typical hospitalization. Although not described comprehensively, steps 3 and 4 (development of a care plan and follow-up evaluation to determine actual patient outcomes) could be revised to include only the acute problems for which the patient is hospitalized instead of addressing all the patient’s medical conditions. Care plans could then be developed for acute problems, and goals for these acute problems could be established and compared with actual outcomes. However, it is apparent to us that this is not the generally intended application of this practice model.

Society of Hospital Pharmacists of Australia (SHPA) Standards of Practice for Clinical Pharmacy⁴
Strengths

This model (actually, a set of practice standards) is simple, straightforward, flexible, and systematic. The steps associated with the care of patients are familiar to clinical pharmacists. In addition, the SHPA definition of clinical pharmacy practice is closely aligned with the ACCP definition. The model applies to clinical pharmacy practice only.
Weaknesses

The standards are best known by a select group of clinical pharmacists (mainly those who practice clinical pharmacy in Australia) and are probably not widely recognized by other health care professionals or payers. In addition, MRPs, which are the cornerstone of all other models, are not an explicit component discussed in the standards. However, MRPs are incorporated into medication action plan development. Categories of MRPs are not identified.
Applicability to All Clinical Practice Settings

The authors make explicit that the standards were developed for all patient care settings and that they may be adapted for use in a variety of practice settings, aiming to ensure the highest possible quality of patient care. However, the model seems to be predominantly directed toward institutional practice.

Nonetheless, the standards are flexible enough to be adapted to different practice settings. Many processes for delivering clinical pharmacy activities are provided, and those that are appropriate for a particular setting can be selected for use in that practice environment. An example is the medication history; the standards detail procedures for speaking directly with patients, but they also provide guidance in obtaining information when the patient is unable to provide a history (e.g., the intensive care unit patient, or the delirious medical patient). The standards also note that a history may not be obtained for some patients.

Individualized Medication Assessment and Planning (iMAP)^5,6
Strengths

This practice model is simple and not as time-consuming as other models. Therefore, the model could easily be implemented in a busy practice. Two of the key steps are communication of the proposed plan to the primary care provider (which is not always included in the other models reviewed above) and implementation of the plan once consensus is reached. This emphasizes a team care approach. The important components of conducting a comprehensive medication review, identifying and resolving MRPs, and categorizing MRPs and interventions are included.
Weaknesses

Because it is new, this model is probably known only to a limited number of pharmacists and is likely not recognized by other health care professionals or payers at this time. There are lists to select from that document specific MRPs and exactly how they were resolved. These lists would have to be incorporated into an electronic medical record to streamline the process and make it more user-friendly. Moreover, a full description of this model is not yet available (although it is under review and expected to be published in the near future).
Applicability to All Clinical Practice Settings

Although it is now being studied in patients 65 years and older, iMAP is applicable to other age groups as well, especially patients with several comorbidities and those taking many medications. The model could also be easily implemented in all types of clinical practice settings. The only step that might require modification in an acute care setting involves situations in which a discussion with the patient might not be possible (as in step 2, “conduct comprehensive medication review with patient”). However, this review could occur with the patient’s caregiver, whenever possible.

Similarities and Differences Among Practice Models

A common emphasis in almost all of the models reviewed above is the identification and resolution of MRPs. The pharmaceutical care and CMM models have identical categories of MRPs, and both have some gaps in documenting potential MRPs and determining potential interventions. The SHPA standards do not explicitly discuss MRPs, but clinical problem identification (based on clinical pharmacist expertise) is one of its components. The iMAP model includes several more categories for MRPs that appear to encompass more of what a clinical pharmacist may do, such as identifying needed laboratory monitoring for efficacy or toxicity, recognizing incorrect duration or frequency of a medication, or identifying suboptimal medication administration (as a separate category from nonadherence). These are not always included as separate MRPs in other models. The pharmaceutical care model employs its own terminology for MRPs, calling them DTPs (drug therapy problems). The MTM model is unique in requiring a patient to maintain a PMR and a MAP, which puts more responsibility on the patient but also potentially provides more documentation. The pharmaceutical care model involves many steps and the use of required categorizations.

The SHPA standards are more than just a practice model. The standards document provides a comprehensive discussion of everything involved in clinical pharmacy practice, including the extent and operation of clinical pharmacy services, procedures for caring for individual patients, training and education of pharmacists, research, required resources, staffing structure and levels, quality assurance, and documentation. The format of the model differs from that of other models. Medication-related problems are not explicitly categorized but, instead, are incorporated into the medication history, assessment of current medication management, clinical review, and decision to prescribe a medication.

Conclusion

Each of the above clinical pharmacy practice models appears to have advantages and disadvantages when considered as a general model for clinical pharmacists. In addition, we were unable to identify evidence that any of these practice models leads to improvement in individual patient or health system outcomes, reduced health care costs, or other benefits. Of course, one must recognize that none of these models have been studied sufficiently to yield that level of evidence. With clinical pharmacists using several different practice models, confusion exists both within and outside the profession regarding the practical aspects of “clinical pharmacy practice” and what exactly the clinical pharmacist does.

In our opinion, every model shares the same weakness: the profession has failed to adopt any clinical pharmacy practice process as its sole model. Therefore, the precise patient care roles, responsibilities, and capabilities of the clinical pharmacist are not widely appreciated by other health care professionals or the public.

Can this weakness be addressed successfully? We believe so. First, we suggest that a consistent model for clinical pharmacy practice needs to be determined, adopted, and implemented by clinical pharmacy organizations and clinical pharmacists. Next, this practice needs to be communicated and demonstrated to those outside the pharmacy profession, and in so doing, the practice needs to be implemented consistently. Such an approach can then serve as a foundation for future pharmacy education, training, research, credentialing, and reimbursement. Only once a uniform clinical pharmacy practice model is in place can we show the rest of the health care world WHAT it is we do. In next month’s installment (“part IIIB”), we will demonstrate the application of the models discussed above to both an ambulatory care and acute care “case.” In part IV, the concluding segment of this commentary (which will appear in September), we will present a model for discussion and seek member input on this issue. Be sure to watch for these articles in the forthcoming issues of the ACCP Report.

^aCommittee members: Ila Harris (Chair), Beth Phillips (Vice Chair), Eric Boyce, Sara Griesbach, Charlene Hope, Denise Sokos, and Kurt Wargo.

References

1. Cipolle R, Strand L, Morley P. Pharmaceutical Care Practice: The Patient-Centered Approach to Medication Management Services, 3rd ed. New York: McGraw-Hill, 2012.
2. American Pharmacists Association and National Association of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model. Version 2.0. March 2008. Available at http://www.pharmacist.com/mtm/CoreElements2. Accessed January 2, 2012.
3. Patient-Centered Primary Care Collaborative Resource Guide: The Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes. Available at http://www.pcpcc.net/files/medmanagement.pdf. Accessed January 2, 2012.
4. The Society of Hospital Pharmacists of Australia (SHPA). SHPA standards of practice for clinical pharmacy. J Pharm Pract Res 2005;35:122-46.
5. Roth MT, Burkhart JI, Esserman DA, Crisp G, Kurz J, Weinberger M. Individualized medication assessment and planning (iMAP): optimizing medication use in the primary care setting. Under review, July 2012.
6. Crisp GD, Burkhart JI, Esserman DA, Weinberger M, Roth MT. Development and testing of a tool for assessing and resolving medication-related problems in older adults in an ambulatory care setting: the individualized medication assessment and planning (iMAP) tool. Am J Geriatr Pharmacother 2011;9:451-60.