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A Conceptual Framework For Defining Pharmaceutical Diagnosis Vaughn L. Culbertson, Rodney A. Larson, Paul S. Cady, Milind Kale, and Rex W. Force College of Pharmacy, Idaho State University, Campus Box 8333, Pocatello ID 83204-8333 This paper describes a conceptual framework for identifying, defining, and labeling drug-related problems. This process, which we have termed “pharmaceutical diagnosis,” provides an organizational structure to the delivery of direct patient care responsibilities. The primary educational objectives of pharmaceutical diagnosis are: (i) to characterize the scope of drug-related problems for which pharmacy students and practitioners must assume responsibility; and (ii) to provide students and practitioners with a problem-solving approach to the assessment of clinical problems. Other potential advantages to professional practice include: improved communication of patient-specific information between pharmacists and other health care providers, a standardized format that facilitates aggregation of patient data for similar drug-related diagnoses, and most importantly, a foundation for developing standards of professional practice. Using the principles established within nursing’s diagnostic structure, a preliminary description and taxonomy is presented. The need for a pharmacist-derived diagnostic process is an essential requirement for the effective delivery of pharmaceutical care. The significant implications to pharmaceutical education and professional practice are discussed and, hopefully, will stimulate important debate.

INTRODUCTION

Since its introduction in 1990, pharmaceutical care has gained wide-spread acceptance as the mission of pharmacy. Its enthusiastic endorsement may reflect an intuitive appreciation for the pharmacist’s professional responsibilities even though the abilities and incentives for its application to daily practice are only slowly evolving. Unfortunately, our eagerness to redefine pharmacy practice may have been accomplished without a thorough comprehension of the key elements of pharmaceutical care. As defined by Hepler and Strand(1): Pharmaceutical care involves the process through which a pharmacist cooperates with a patient and other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient. This in turn involves three functions: (1) identifying potential and actual drug-related problems, (2) resolving actual drug-related problems, (3) preventing potential drug-related problems. Although a comprehensive consideration is beyond the scope of this discussion, our objective is to introduce a theoretical problem-solving structure directed at assisting students and practitioners in identifying all drug-related problems (DRPs) and creating a standardized process for their documentation. This critical step in the pharmaceutical care process may ultimately form the foundation for “practice standards” within the profession and has far reaching implications for both pharmaceutical education and practice. Presentation of a preliminary model will hopefully elicit important discussion and stimulate additional refinements and enhancements to the process. DEFINITIONS

Early definitions of pharmacy practice, although serving as the foundation for pharmaceutical care, consistently minimized problem-solving skills. Brodie described pharmacy’s 12

role as “drug use control” which he defined as “a system of knowledge, understanding, judgments, procedures, skills, controls, and ethics that ensures optimal safety in the distribution and use of medication”(2). Similarly, the report of the study commission on pharmacy(3), further defined the profession as a “knowledge system” that provided health services by “concerning itself with knowledge about drugs and their effects upon men and animals.” Both early concepts of professional practice seem to view the patient solely as a recipient of drug knowledge, but not necessarily as a source of clinical information. Presumably, all relevant clinical data was voluntarily presented to the pharmacist for analysis. Under this practice philosophy, drug information centers expanded and the role of pharmacists as purveyors of drug information flourished. Critical thinking abilities, while important, were nonetheless minimized by virtue of the pharmacist’s primary role as an “information manager.” However, the philosophical changes engendered by pharmaceutical care require pharmacists to identify potential DRPs as well as manage ongoing medication problems. Unquestionably, this represents a dramatic paradigm shift from earlier roles. As suggested by Johnson and Bootman, the ability of pharmacists to identify and resolve DRPs before they occur is an especially high priority for the health care system(4). In order to identify all DRPs, especially those representing potential problems, it logically follows that pharmacists must assume greater responsibility for gathering and properly interpreting all pertinent patient information. Thus, pharmacists must possess appropriate data collection skills including effective inquiry strategies, appropriate patient interviewing and communication skills, and efficient problem-solving abilities. Although well accepted as a theoretical concept, pharmaceutical care lacks a universally applicable structural process for identifying DRPs. The Pharmacist’s Work-up of Drug Therapy (PWDT) provides the conceptual framework for a nine step thought process for providing pharmaceutical care(5). The description of PWDT only briefly examines the

American Journal of Pharmaceutical Education Vol. 61, Spring 1997

issue of identifying DRPs while providing no clinically useful mechanism. More recently, Canaday and Yarborough addressed the necessity for a systematic process that meets the unique needs of pharmacy. Their innovative process of plan/problem/note extended the DRP problem structure proposed by Strand, et al.(5) and established a documentation system which “distills the concepts of pharmaceutical care into a manageable format”(6). Its primary function was to facilitate practitioners’ efforts in collecting, analyzing, and applying a specific knowledge base in an attempt to understand and resolve clinical problems. Interestingly, this definition closely resembles a well-known and established concept and appears in Webster’s New World Dictionary under the term diagnosis(7). Thus, the term, pharmaceutical diagnosis, has practical application to the delivery of pharmaceutical care and may be defined as a problem-centered, cognitive process used to identify patient-specific, drug-related problems. Essential to this process is the need for comprehensive patient information gleaned from a variety of sources including: (i) patient and/or family interview; (ii) clinical findings observed during physical examination or documented in the medical record; (iii) medical history of the patient or family; and (iv) pertinent laboratory and medical diagnostic information. Appropriate pharmaceutical diagnosis provides the foundation for the rational selection, implementation, and monitoring of pharmaceutical interventions and resulting outcomes for which the pharmacist is accountable. Moreover, it is our assumption that pharmaceutical diagnosis is conceptually identical to medical diagnosis and differs only with respect to application of a specific knowledge domain. This aspect is examined more fully in the succeeding article that details our approach to problembased learning at Idaho State University College of Pharmacy. INSIGHTS FROM NURSING DIAGNOSIS

The term ‘nursing diagnosis’ was introduced in 1953 by Fry(8). However, the first meeting of the National Group for the Classification of Nursing Diagnosis, now known as the North American Nursing Diagnosis Association (NANDA), did not occur until twenty years later, and an official definition was not published until 1990: Nursing diagnosis is a clinical judgment about individual, family, or community responses to actual or potential health problems/life processes. Nursing diagnosis provides the basis for selection of nursing interventions to achieve outcomes for which the nurse is accountable. NANDA’s classification(9) efforts established rules for eligibility and acceptance of ‘nursing diagnosis.’ Initially, the NANDA taxonomic committee established a framework consisting of the following structural components of a nursing diagnosis: a label, that accurately and succinctly describes the diagnosis; a definition, that provides a precise meaning of the diagnosis and helps differentiate it from similar diagnoses; and defining characteristics, that refer to clinical clues, subjective and objective signs or symptoms that, in a cluster, point to a nursing diagnosis. Defining characteristics are further separated into major criteria (i.e., prerequisite for the diagnosis) and minor criteria (i.e., supportive evidence). Related factors pertain to etiologic or contributory factors that influence a change in health status.

Fig. 1. Conceptual relationship of pharmaceutical diagnosis to nursing and medical diagnosis.

Currently, over 130 official nursing diagnoses have been constructed and approved. Additionally, 52 collaborative problems (i.e., those requiring consultation with another health care provider) have been established including adverse drug therapy complications for nine therapeutic categories! A formal classification system of nursing diagnoses was established to allow: (i) retrieval of consistent and accurate information from patient records; (ii) collection, analysis, and synthesis of nursing data for practice and research in a computerized healthcare system; and (iii) reimbursement of nursing activities based on nursing diagnosis rather than a medical diagnosis. DEFINING PHARMACEUTICAL DIAGNOSIS

To extrapolate from Carpenito’s observation in nursing(9), diagnosis is performed by many individuals. The question is not whether pharmacist’s diagnose, but rather what pharmacists can diagnose. Thus, pharmacy, like nursing and other health care disciplines, must establish an explicit taxonomy. Its potential contribution to defining the purpose and function of pharmaceutical care is substantial. It may be useful to begin with a description of what pharmaceutical diagnosis is not. Most importantly, pharmaceutical diagnosis is not an attempt to usurp physician authority, confirm the patient’s medical diagnoses, or identify all of the patient’s health care problems. Interaction with physicians, as well as other qualified non-physician practitioners, is an essential component and ideally leads to a collaborative set of diagnoses that encompass all of the patient’s health care needs (Figure 1). It is not a superficial label given to legitimize pharmaceutical care. Rather, it reflects an explicit, accurate, and clinically useful description of an actual or potential DRP. Finally, pharmaceutical diagnosis is not a perfunctory exercise but establishes a uniform and codifiable system for relating specific patient outcomes to the delivery of pharmaceutical care. A preliminary, but nevertheless useful, pharmaceutical diagnostic structure is presented in Tables I-IV. While it borrows heavily from the constructs established by NANDA, significant differences are necessary to adequately describe


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Table I. Pharmaceutical diagnostic model Definition Diagnostic Label Dosage A dosage regimen outside accepted dosage limits requiring closer drug monitoring, but without High drug dose clinically evident toxicity. Drug overdose Intentional self-administration of a potentially toxic dose. Subtherapeutic dose Dosage regimen below the accepted therapeutic dosage range which does not achieve desired therapeutic outcome. Therapy Sub-optimal therapeutic Drug therapy which does not achieve previously established therapeutic goals or outcomes despite response use of an appropriate therapeutic dosage. Symptoms in which drug-induced causes have been ruled out. Requires medical diagnosis for New therapeutic problem confirmation. Drug use without indication Drug therapy in which there is no identifiable rationale or scientific literature to support use. Duplicative therapy Concurrent drug use with similar pharmacologic actions. Drug use in which alternative therapy is equally effective, more effective, or less toxic and results in Cost-ineffective therapy decreased health care costs. Drug interaction Concomitant drug therapy which is known or suspected to cause altered therapeutic efficacy or Drug-drug interaction increased drug toxicity. Concomitant drug therapy with a food or nutrient source which is known or suspected to cause Drug-dietary interaction altered therapeutic efficacy or increased drug toxicity. Drug-laboratory interaction Altered laboratory measurement or diagnostic test result due to drug use. Drug use which is known or suspected to result in a pharmacodynamic-induced disease Drug-disease interaction exacerbation or adverse drug effect. Pharmacokinetic interaction Identification of physiologic (e.g., age, race, gender) conditions resulting in known or potentially Non-modifiable PK interaction altered pharmacokinetics. Potentially modifiable physiologic conditions or drug use (e.g., smoking, rifampin therapy, etc.) Modifiable PK interaction resulting in known or potentially altered pharmacokinetics. Pathologic conditions (e.g., renal disease, short bowel syndrome) resulting in known or potentially PK-disease interaction altered pharmacokinetics. Iatrogenic disease Drug allergy Unpredictable drug reaction that is immunologically-mediated. Adverse drug reaction An unwanted pharmacologic or idiosyncratic drug response (regardless of drug dose). Drug or substance use leading to physiological or psychological dependence as defined by Drug abuse/misuse DSM-IV criteria. Patient education/counseling Medication education deficit Identification of significant educational deficits resulting in known or potential drug toxicity. Identification of significant educational deficits resulting in failure to comply with the prescribed Medication non-compliance regimen or administration technique. Health Maintenance/Monitoring Assessment of preventive pharmaceutical care needs including vaccinations, prophylactic drug Preventive health maintenance Drug huse in which the risk of ADR is deemed acceptable but requires close monitoring of specific Narrow therapeutic index No DRP detected Drug regimen which achieves desired therapeutic goals. Continued therapeutic monitoring is (stable drug use) indicated.

pharmacy’s unique contributions to patient care. Under this system, 23 pharmaceutical diagnostic categories organized under seven general domains (Table I) are used in conjunction with four levels of diagnostic probability: probable (or actual), at high risk, at risk, and possible (see definitions Table II). In addition to a brief description, each diagnostic label will likely require additional defining criteria to develop a clinically useful hierarchical taxonomy. The primary objectives for such a structure are: (i) to provide a clinically relevant classification scheme which points to a limited number of rational therapeutic interventions; (ii) to establish a systematic and comprehensive diagnostic approach; (iii) to facilitate continuity of care among pharmacists and other health care providers; and (iv) ultimately, to provide support for improved patient outcomes as a result of pharmacist-directed diagnostic strategies. A preliminary taxonomy for a single diagnosis is presented as an example for the drug-drug interaction category 14

(see Table III). The taxonomic structure incorporates six elements consisting of: (i) defining criteria; (ii) pharmaceutical diagnostic label; (iii) mechanism; (iv) primary criteria; (v) pharmacokinetic factors; and (vi) complicating factors. Defining criteria for each diagnostic category contains an explicit set of detailed rules clearly delineating the diagnostic label. Each diagnostic domain would ideally contain a set of “approved diagnoses” that define the explicit drug use circumstances (including subcategories) necessary for each pharmaceutical diagnosis. Mechanism is relatively selfexplanatory and describes the etiology, if known, for the described drug-related problem. This element represents the second part of the diagnostic statement, usually in abbreviated form. Primary criteria constitute the defining clinical presentation including key symptoms (or cluster of symptoms), signs, and laboratory studies which point to a definitive pharmaceutical diagnosis. In circumstances where drug use is considered necessary, this element generates a


Table II. Modifiers for use with diagnostic labels Modifier Description Probable/(Actual) Actual or high probability of a drug-related problem exists.

Outcome Physician consultation with specific recommendations for resolving the DRPs is indicated.

High risk

Represents use of drug therapy in which risk of adverse drug event is well-documented AND clinically significant, OR relatively common but not always clinically important. Assessment of risk versus benefit is essential, and careful follow-up with frequent monitoring is required if therapy must be used.

Generally, physician consultation is necessary to either initiate a safer therapeutic alternative or develop a coordinated monitoring plan by both the physician and pharmacist.

At risk

Increased risk of adverse drug event is poorly documented OR rare; BUT clinical consequences are potentially serious.

It generally represents circumstances in which the pharmacist assumes responsibility for therapeutic monitoring.

Possible

Represents a problem in which additional information is necessary before a rational pharmaceutical diagnosis can be made.

These are often referred to as rule-out diagnoses (R/O) and frequently require physician collaboration in assessing pathologic etiologies.

Table III. Example taxonomy for a single pharmaceutical diagnosis Pharmacokinetic Drug-drug interactiona Primary criteria Mechanism factors (Diagnostic label) (Manifestations) (Etiology) Inhibition of Presence of any of the Warfarin-Cimetidine: Cytochrome following: P450

Complicating factors May increase severity &/or potential for adverse drug event:

A. cimetidine added to stable warfarin therapy

Pathologic considerations: uncontrolled hypertension

Signs/Symptoms: intracranial, GI, or other internal hemorrhage epistaxis hematoma hematuria bleeding gums purpura black, tarry stools

Onset: usually 3-7 days after starting (C)

peptic ulcer disease renal disease recent surgery or other wounds pericarditis Dose: liver disease or dose-related effect, decreased albumin (altered usually > 400 mg/day warfarin protein binding) Laboratory studies: Pharmacodynamic considerations: INR > 25% over baseline ASA, NSAIDs and other GI or absolute value > 3.5 irritants Duration: indefinite

Other potential subcategories: B. Addition of warfarin to cimetidine C. Discontinuation of cimetidine in warfarin stable patient a

Drug-Drug Interaction—Defining Criteria Concomitant drug therapy (or potential for concurrent use) that is known or suspected to cause: 1. Therapeutic outcome(s) that are outside accepted goals or target ranges (i.e., maybe above or below goals); or 2. Adverse drug effect(s) that is a documented or suspected pharmacological response of the target drug; or 3. Adverse drug effect(s) that is a documented or suspected idiosyncratic response of the target drug.

set of monitoring parameters for use by pharmacists or other health care practitioners. In cases where an actual diagnosis is entertained, this element provides justification and facilitates documentation of specific manifestations (i.e., third part of a diagnostic statement). Complicating factors are usually organized into three subcategories including pathologic, pharmacodynamic, and pharmacokinetic considerations. Presence of any of these factors, which must be assessed by the pharmacist, may alter the incidence or

severity of a particular pharmaceutical diagnosis, and therefore, influence the modifier (i.e., clinical probability) used in the diagnostic statement. The taxonomy outlined in Table III is designed to illustrate the concept of pharmaceutical diagnosis. In this example, a patient presents with gastrointestinal bleeding while receiving warfarin and cimetidine. Several pieces of information are necessary to arrive at a diagnosis of “probable drug-drug interaction.” Characteristics of the drug


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Table IV. Three-part diagnostic statements Modifier Probable At risk (High risk is implied) Possible (or R/O)

(1) Diagnostic label (example) (cimetidine-warfarin), drug-drug interaction (enalapril), medication noncompliance drug use with narrow therapeutic index, (gold)

(2) Due to: (mechanism or etiology) cimetidine inhibition of warfarin metabolism documented refill history

(3) Manifested by: (primary criteria: signs/ symptoms/lab data) bleeding gums, black tarry stools. poor blood pressure control

glomerulonephritis

proteinuria

(ASA), drug-disease interaction

bronchospasm in an asthmatic

dyspnea and wheezing

interaction (i.e., time of onset, dose relationship), complicating factors (e.g., preexisting liver disease, past history of peptic ulcer disease, etc.), and other pharmacologic considerations (i.e., concomitant NSAID therapy or alterations in warfarin pharmacokinetics) may increase the probability of the interaction. Although beyond the scope of this paper, the process of arriving at and prioritizing a pharmaceutical diagnosis is a complex iteration of hypotheses testing, integration of basic science knowledge (i.e., pharmacology, pathophysiology), integration of clinical experience, and finally hypotheses re-testing. Since pharmaceutical diagnoses (such as drug-drug interaction) are difficult to prove, it is extremely important for the clinician to have a solid understanding of the factors that influence drug-related problems. Additionally, it is imperative that this process be inculcated throughout pharmacy curricula. While our example may not fulfill all of the desired qualifications of a diagnostic taxonomy, it serves as a useful starting point for categorizing and defining clinically important pharmaceutical diagnoses. Ultimately, the process for reviewing, modifying, and adopting a diagnostic taxonomy may facilitate the development of appropriate pharmaceutical work-ups and establishment of clinically useful diagnostic algorithms. Significance of Diagnostic Statements Table IV presents several examples of pharmaceutical diagnostic statements similar in format to those developed in nursing. Although relatively straightforward, the significance of the three part statement may not be readily apparent. For example, a cursory use of the diagnostic label alone (i.e., without a supporting definition) permits the opportunity for a computer algorithm to automatically screen prescription information upon data entry to generate several “potential diagnoses” (e.g., excessive dose, drug-drug interaction, etc.). Certainly, many pharmacy computer systems are capable of performing these simple screening functions already. However, this circumstance is directly analogous to computer-automated screening of routine laboratory tests performed during hospital admission. Just as a computerderived medical diagnosis, based upon an abnormal laboratory finding, is generally inappropriate, so also is a computer-derived pharmaceutical diagnosis without confirmatory patient assessment and/or corroborating clinical investigation. Thus, use of a three-part diagnostic statement necessitates proficient problem-solving skills and thorough patient assessment for appropriate application of a pharmaceutical diagnosis. To further illustrate, consider the case of a patient receiving a higher than normal dose of albuterol. Under this circumstance, a computer program could easily elicit a “high 16

dose diagnosis” upon prescription data entry. However, depending on the patient’s clinical presentation, several presumptive diagnoses (i.e., differential diagnoses) may be appropriate and a final diagnosis is predicated entirely on the pharmacist’s assessment. If no drug toxicity is discovered, a true diagnosis of “high drug dose,” by definition, is correct and closer clinical monitoring by the pharmacist is warranted. However, if toxicity is discovered during patient evaluation, the correct diagnostic statement is: probable adverse drug effect due to high dose of albuterol manifested by nausea, vomiting, and tremor. Furthermore, other differential diagnoses must be considered and ruled-out. If a suboptimal therapeutic response is detected (despite use of a high dose), a diagnosis of possible drug noncompliance could be considered (e.g., due to inappropriate administration technique). Still other diagnostic considerations are possible depending on specific findings obtained during the “pharmacist-initiated work-up.” It must be emphasized that our suggested diagnostic definitions (Tables I and II) are preliminary, and it is conceivable that different definitions or an entirely new structure may eventually emerge. For our purpose, the intent is to illustrate the essential process of defining each label in specific terms such that all other possible diagnostic labels are excluded (i.e., diagnostic sensitivity and specificity). Several definitions of medication non-compliance can be formulated. However, it must meet specific criteria that differentiate it from sub-therapeutic dose or sub-optimal response. Thus, a group of pharmacists, when presented with the same clinical data, will arrive at the same (or very similar) diagnosis. This creates several advantages, not the least of which, is to ensure that all patients with an appropriate pharmaceutical diagnosis share common elements of specific DRPs. The ability to accurately aggregate clinical data into subcategories for analysis offers important research, economic, and clinical implications. Although pharmaceutical diagnosis may not be the exclusive domain of pharmacists, it cannot be generated by a computer, nor does it fall within the scope of pharmacy technician abilities. In its purest form, accurate pharmaceutical diagnosis must occur prior to implementation of any pharmaceutical intervention (i.e., prevention or resolution of a DRP). Although the importance of patient assessment is easily appreciated, pharmaceutical diagnosis provides the substance and form required of the patient assessment process necessary for pharmaceutical care. IMPLICATIONS

Although contemporary practice espouses the role of pharmacists in “identifying drug-related problems,” no useful process currently exists to guide practitioners. Historically,


the pharmacist’s role in any diagnostic process has generally been criticized, often vehemently, within the pharmacy community. Acceptance of the philosophical constructs of pharmaceutical diagnosis is long overdue. Moreover, its implications to pharmaceutical education and practice are significant. Of foremost importance, pharmaceutical diagnosis establishes an operational definition and provides a framework for delineating pharmacist responsibilities. As previously described, the nursing profession has undergone a similar evolution and now has a sophisticated and welldescribed process in place. While much can be learned from our nursing colleagues, significant differences are inherent. Nevertheless, development and implementation of a standardized pharmaceutical diagnostic procedure affords a mechanism by which the profession can initiate a painstaking but essential self-evaluation. It represents the next step in defining a standard of practice for which pharmacists should be held accountable. Unquestionably, it is a formidable and enormous undertaking. Acceptance of pharmaceutical diagnosis within academia will foster profound and exciting changes in pharmacy education. Its potential for defining pharmacist responsibilities similarly affords academicians with a framework for educating and assimilating students into their future role. Re-orientation and development of didactic coursework to teach the basic concepts of pharmaceutical differential diagnosis are potential outcomes. Additionally, rather than case-based exercises, sequential courses in problem-based learning will be required to teach and refine the problem-solving and diagnostic skills required of pharmacy students. The distinctive similarities between the medical and pharmaceutical diagnostic process allow direct application of educational strategies developed in medicine. A supplemental manuscript describing our adaptation of these methods to pharmaceutical diagnosis follows this discussion. Re-training programs to refine the diagnostic approach of current practitioners will be necessary, and may facilitate a more rational transition to pharmaceutical care. Since many clinical faculty may not approach patient care in this manner, the process must occur within academia as well. Nevertheless, the appreciation and intuitive understanding of the process will likely facilitate easy adaptation and is essential for development of “real world” application of pharmaceutical diagnostic concepts. The resources for developing practitioner-based training programs are probably substantial but have the advantage of direct application to daily practice. Application of scientific methods to the evolution of pharmaceutical diagnosis is an essential component. Pharmaceutical diagnosis engenders an entire new field of study in which current knowledge is applied and new knowledge is generated towards the foundation and validation of diagnostic strategies, much the same as occurs within medicine and nursing. It affords substantial scholarly opportunities for clinical faculty and practitioners to develop and test new practice standards. The significance of pharmaceutical diagnosis may have far reaching implications related to documentation and reimbursement of pharmaceutical care outcomes. The abil1

Critical challenges: Revitalizing the Health Professions for the Twentyfirst Century, The Third Report of the Pew Health Professions Commission, San Francisco CA (November 1995).

ity to relate outcomes to specific pharmaceutical diagnoses (just as in the case of medical diagnoses) is a potentially useful procedure for demonstrating the economic and clinical benefits accruing from pharmaceutical care. Similarly, the ability to define the pharmaceutical work-up necessary for specific diagnoses is intriguing and may facilitate efforts to establish reimbursement (or economic justification) for several diagnostic categories. As alluded to earlier, documentation using a clinically useful and reproducible format is a critical professional need. Pharmaceutical diagnosis affords a mechanism for efficiently organizing and communicating patient data. A well defined diagnostic statement succinctly and accurately conveys to colleagues and other health care providers the pharmacist’s rationale for all therapeutic and monitoring recommendations. In simple terms, pharmacist communication, both within the profession and externally, is enhanced and continuity of care is facilitated. Appropriate documentation of pharmaceutical diagnoses, recommendations, and outcomes permits a more effective assessment mechanism for administrators, and constitutes a fundamental cornerstone for clinical performance evaluations. Thus, careful documentation of pharmaceutical care activities, including pharmaceutical diagnosis, allows for more accurate assessment of an individual pharmacist’s contributions to patient care. The recent Pew Commission report suggests that a significant surplus of pharmacists will occur in the near future1. However, this prediction is likely based upon pharmacy’s distributive functions and may not accurately reflect the manpower needs required under a pharmaceutical care model. Although confirmation of societal benefits directly relating to pharmaceutical diagnosis (and pharmaceutical care) is essential, the potential for improved outcomes is plausible and worthy of active investigation. Undoubtedly, the manpower needs necessary to perform at this higher cognitive level is much greater than that required for distribution. Ultimately, the ability to efficiently perform pharmaceutical diagnosis will face several legal challenges, similar to those already confronting pharmaceutical care. Pharmacists, regardless of setting, will require the legal authority to collect or efficiently access medical record information, perform physical assessments, and order appropriate clinical laboratory tests. Establishment of a sound theoretical model demonstrating the rationale and benefits of this information will likely assist these legislative efforts. SUMMARY

The pharmacist’s role in diagnosis is not a new concept but was recognized over twenty years ago. Mikeal and colleagues modified the American Public Health Association’s definition of medical care and applied the term pharmaceutical care to describe(10): “The provision of any personal health service involving the decision whether to use drugs...including the range of services from prevention, diagnosis, and treatment...” Thus, analogous to nursing’s early recognition and slow evolution, pharmacy has not readily embraced its diagnostic role in the delivery of health care. Just as pharmaceutical care introduces fundamental philosophical and behavioral changes, acknowledgment of pharmaceutical diagnosis as


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an essential pharmaceutical care responsibility may necessitate an even greater philosophical re-orientation. A second major paradigm shift in professional practice and education may be necessary for recognition and acceptance of these responsibilities. Since it likely represents development of new skills and a fundamentally different approach to patient care, greater obstacles to its acceptance may exist. Formal establishment of a well-defined and universally accepted taxonomy is exciting, however. Most importantly, it is a conceptual framework established by pharmacists to consistently and accurately identify DRPs necessary for the efficient and effective delivery of pharmaceutical care. The recent public embarrassment surrounding the inability of pharmacists to detect important drug interactions(11), may partially reflect, an inability to accurately perform these “diagnostic work-ups” and assess the clinical significance of patient-specific complicating factors. While not a panacea for the profession, pharmaceutical diagnosis is a potential stepping stone towards acceptance of the appropriate skills, responsibilities, and standards of practice necessary for delivery of high quality pharmaceutical care. We sincerely hope this discussion elicits considerable thought and creates an open forum for debate and discussion. It is our strong conviction that a well-constructed and accepted pharmaceutical diagnostic framework is needed to

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facilitate the diagnosis, prevention and resolution of drugrelated problems. Am. J. Pharm. Educ., 61,12-18(1997);received 10/15/96,accepted 1/10/97. References (1) Hepler, C.D. Strand, L.M., “Opportunities and responsibilities in pharmaceutical care,” Am. J. Hosp. Pharm., 47, 533-543(1990). (2) Brodie, D.C., “Drug-use control: Keystone to pharmaceutical service,” Drug Intell. Clin. Pharm., 1, 63-63(1967). (3) The Report of Study Commission on Pharmacy, Pharmacists for the Future, Health Administration Press, Ann Arbor MI (1975). (4) Johnson, J.A. and Bootman, J.L., “Drug-related morbidity and mortality: A cost-of-illness model,” Arch. Intern. Med., 155, 19491956(1995). (5) Strand L.M., Morley, P.C., Cipolle, R.J., Ramsey, R. and Lamsam, G.D., “Drug-related problems: their structure and function,” DICP Ann. Pharmacother., 24, 1093-1097(1990). (6) Canaday, B.R. and Yarborough, P.C., “Documenting pharmaceutical care: creating a standard,” Ann. Pharmacother., 28, 292-296(1994). (7) Guralnik D.B., Webster’s New World Dictionary, 2nd ed., Simon and Schuster, Inc. New York NY (1986) p. 388. (8)Fry, V., “The creative approach to nursing,” Am J Nursing, 53, 301302(1953). (9)Carpenito, L.J., Nursing Diagnosis—Application to Clinical Practice, 6th ed., J.B., Lippincott, Philadelphia PA (1995) p. 4. (10) Mikeal, R.L., Brown, T.P., Lazarus, H.L., and Vinson, M.C., “Quality of pharmceutical care in hospitals,” Am. J. Hosp. Pharm., 32, 567574(1975). (11) Anon, “Danger at the drugstore,” U.S. News and World Report, (Aug., 26, 1996) pp. 46-53.
