Section I

PHARMACEUTICAL CARE AND THE SCOPE OF PHARMACY PRACTICE

I. INTRODUCTION
1. The Practice of Pharmacy embraces a variety of settings, patient populations, and specialist as well as generalist pharmacists. Central to the practice of pharmacy, however, is the provision of clinical services directly to, and for the benefit of patients. 2. Definition. The term Pharmaceutical care describes specific activities and services through which an individual 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.

II. SCOPE OF PRACTICE WITHIN PHARMACEUTICAL CARE

1. Role. Pharmaceutical care has evolved from an emphasis on prevention of drug- related problems (basically drug management) to extend roles of pharmacists in the Triage of patients, treatment of routine acute illnesses, management of chronic diseases, and primary disease prevention. 2. Function. The provision of pharmaceutical care does not imply that the pharmacist is no longer responsible for dispensing functions. In many instances, however, implementation of pharmaceutical care services necessitates a redesign of the professional work flow, with assignment of technical functions to technical personnel under the direct supervision and responsibility of the pharmacist.

III. UNIQUENESS OF PHARMACEUTICAL CARE

Provision of pharmaceutical care overlaps somewhat with other aspects of pharmacy practice (Table 1). However, pharmaceutical care is not the same as these other areas, which include: 1. Clinical Pharmacy 1. Patient counseling 2. Pharmaceutical services; when the activities of a pharmacy or pharmacy department are performed for faceless patients or charts, the activity is one of pharmacy service, not pharmaceutical care (e.g., chart or drug profile reviews without input from the patient or care giver is not pharmaceutical care).
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Table 1 UNIQUENESS OF PHARMACEUTICAL CARE Traditional Pharmacy Prescription order or OTC request Upon Demand Obey Drug product Clinical Pharmacy Physicians or other health professionals Discontinuous Find fault or prevention Process Pharmaceutical Care Patient Continuous Anticipate or improve Outcomes

Primary Focus Continuity Strategy Orientation

IV. ESSENTIAL COMPONENTS OF PHARMACEUTICAL CARE A. Pharmacist patient relationship

The importance of putting a face and personality with the clinical picture is a key component of pharmaceutical care. A pharmacist can have a caring relationship with a patient but not with a chart or drug profile. A pharmacist cannot have empathy for words on a page or on a computer screen. Pharmaceutical care is based upon a collaborative effort between pharmacist and patient. B. Pharmacists workup of drug therapy (PWDT) The provision of pharmaceutical care is often centered around process described as the PWDT. Although the forms or methods used for this process may vary, the components are essentially the same. 1. Data collection. Collect, synthesize, and interpret relevant information such as: 1. Patient demographic data: age, sex, and race. 2. Pertinent medical information (1) Current and past medical history (2) Family history (3) Social history (4) Dietary history (5) Medication history ( prescription , OTC, social drugs and allergies) (6) Physical findings (e.g., weight, height, blood pressure, edema) (7) Laboratory or other test results (e.g., serum drug levels,potassium level, serum creatinine as relevant to drug therapy) 3. Patient complaints, symptoms, signs.

2. Develop or identify the CORE Pharmacotherapy Plan 1. C Condition or patient need 2. O Outcomes desired for that condition 3. R Regimen selected (prescribed) to achieve that outcome 4. E Evaluation parameters to assess outcome achievement 3. Identify the PRIME pharmacotherapy problems or indications for pharmacist interventions. The goal is to identify actual or potential problems that could compromise the desired patient outcomes (Table 2). 1. P Pharmaceutical based problems 2. R - Risks to patient 3. I Interactions 4. M Mismatch between medication and condition or patient needs. 5. E Efficacy issues 4. Formulate a FARM progress note to describe and document the interventions intended or provided by the pharmacist. 1. F Findings: the patient specific information that gives a basis for, or leads to, the recognition of a pharmacotherapy problem or indication for pharmacist intervention. 2. A Assessment: the pharmacists evaluation of the findings, including a statement of: (1) Any additional information that is needed to best assess the problem in order to make recommendations. (2) The severity, priority, or urgency of the problem. (3) The short-term and long-term goals of the intervention proposed or provided 1. Examples of short-term goals include: eliminate symptoms, lower blood pressure (BP) to 140/90 within 6 weeks, manage acute asthma flare up without requiring hospitalization. b. Examples of long-term goals include: prevent recurrence, maintain BP at less than 135/80, prevent progression of diabetic nerve disease. c. R- Resolution (including prevention): the intervention plan includes actual or proposed actions by pharmacist or recommendation to other health care professionals. The rationale for choosing a specific intervention should be stated. Intervention options may include: (1) Observation, reassessing, or following: no intervention necessary at this time. If no action was taken or recommended, the FARM note serves as a record of the event and should constitute part of the patients pharmacy chart or database.

(2) (3) (4) (5) (6)

Counseling or educating the patient or care giver Making recommendations to the prescriber Informing the prescriber Making recommendation to the prescriber Withholding medication or advising against use

d. M Monitoring and follow-up: the parameters and timing of follow-up monitoring to assess the efficacy, safety, and outcome of the intervention. This portion of the FARM note should include: (1) The parameter to be followed (e.g., pain, depressed mood, serum potassium level) (2) The intent of the monitoring ?(e.g, efficacy, toxicity, adverse event) (3) How the parameter will be monitored (e.g, interview patient, serum drug level, physical examination) (4) Frequency of monitoring (e.g, weekly, monthly) (5) Duration of monitoring (e.g, until resolved, while on antibiotic, until resolved then monthly for one year) (6) Anticipated or desired finding (e.g, no pain, euglycemia, healing of lesion) (7) Decision point to alter therapy when or if outcome is not achieved (e.g., pain still present after 3 days, mild hypoglycemia more than 2 times a week)

Table 2 PRIME PHARMACOTHERAPY PROBLEM TYPES Pharmaceutical Assess for incorrect Dose Route Duration Form Frequency timing Assess for known contraindication patient medication allergy drug-induced problem improper utilization (i.e., risk is misused) common/serious adverse effects medication error considerations Assess for drug-drug drug-food drug-disease/ condition drug-lab Assess for medication used without indication indication, condition, or complaint untreated Assess for suboptimal selection of pharmacotherapy for indication minimal or no evidence of therapeutic effectiveness suboptimal utilization of pharmacotherapy (taking or receiving medications incorrectly) - patient preference consideration (e.g., undesirable prior experiences with medication , does not believe works) - medication availability considerations - compliance or administration considerations (e.g., inability to pay, unable to administer correctly or at all)

Risks to Patient

Interactions

Mismatch between medication and indications/ conditions/ complaints Efficacy issues

V. CLINICAL SKILLS AND PHARMACISTS ROLES IN PHARMACEUTICAL

CARE

The skills activities and services inherent in the provision of pharmaceutical care include, but are not limited to, the following: 1. Patient assessment 1. Physical assessment 2. Barriers to adherence 3. Psychosocial issues 2. Patient education and counseling 1. interview skills 2. communication skills (e.g., empathy, listening, speaking or writing at the patients level of understanding) 3. ability to motivate, inspire 4. develop and implement patient education plan based on an initial education assessment 5. identification and resolution of compliance barriers 3. Patient- specific pharmacist care plans 1. recognition, prevention, and management of drug interactions 2. pharmacology and therapeutic (innovative and conventional) 3. interpretation of laboratory tests 4. knowledge of community resources, professional referrals 5. communication and rapport with community medical providers 4. Drug Treatment protocols 1. develop and maintain (update) protocols 2. follow protocols as o pharmacist clinician 3. monitor aggregate adherence to treatment protocols (e.g., drug utilization evaluations {DUE} ) especially for managed care or health system facility. 5. Dosage adjustment 1. Identify patients at risk for exaggerated or subtherapeutic response. 2. Apply pharmacokinetic principles to determine patient-specific dosing 3. Order and interpret relevant tests at correct time intervals to assess dosage adjustment (e.g., plasma drug concentrations, blood glucose levels, blood pressure measurements) 6. Selection of therapeutic alternatives 1. use drug information resources effectively 2. review and critique drug literature 3. construct comparative analyses to support therapeutic decisions

7. Prescriptive authority in designated practice sites or positions H. Preventive services 1. Immunizations 2. Screenings 3. Health and wellness education I. Managerial skills 1. plan, direct and implement pharmaceutical care activities within various practice environments, such as community pharmacy, ambulatory care settings, managed or contractual care, home health services, long-term care facilities, inpatient hospital practice, and others. 2. Allocate resources.

VI. PHARMACEUTICAL CARE AS THE MODEL FOR PHARMACY PRACTICE

The concepts, activities,, and services of pharmaceutical care form the basis for provision of clinical services directly to, and for the benefit of patient in all pharmacy practice settings. These settings include home health, hospital, ambulatory care, primary care, consultation, long term care, and community pharmacy practice. Workflow, staffing patterns, processes, and pharmacy programs might differ, but the core approach to patient care remains pharmaceutical care in all settings. Figure 1 & Figure2 illustrate pharmaceutical care models in the institutional and community pharmacy settings.

VII. Documentation of Pharmaceutical Care

Documentation of pharmaceutical care is integral to continuity of care, demonstration of clinician competence, communication among health care providers, evidence of contributions to patient care, and reimbursement of professional services. 1. Pharmaceutical care, including the Pharmaceutical care plan process (CORE, PRIME & FARM), is a systematic method for recording the pharmacists examination of a patient pharmacotherapy and subsequent identification of medication-related problems. 2. In most practice settings, computer software programs maintain patient data and drug profile records. Thus, after documentation of the initial pharmaceutical care plan, patient data or drug regimens are included in subsequent FARM notes only if a change occurs that is relevant to the therapeutic issue being addressed in the note.

3. Forms that summarize pharmacists interventions using a unified coding system are useful for processing reimbursement of billing forms, but these forms are not adequate documentation of pharmaceutical care. These forms do not communicate to other health professionals the depth and quality of pharmacist interventions or the pharmacists plan for ongoing pharmaceutical care.

VIII. Pharmaceutical Care : An ongoing process The patient profile is revised and re-assessed each time a new drug is added to or deleted from the medication regimen, a new disease or condition is diagnosed, or the patient undergoes other clinical intervention, such as surgery. When the patient returns to the pharmacy or is readmitted to the health system facility, the pharmacist uses the patient profile, PWDT, and FRAM notes (maintained in the patient pharmacy chart or in the medical chart) as the basis for ongoing pharmacists-patient interactions. XI. IMPORTANCE OF PHARMACEUTICAL CARE IN TODAYS PHARMACY PRACTICE
1. The potential for medication errors is growing, and one professional group must assume a primary role in addressing this issue rather than fragmented efforts by various groups or individuals. The pharmacist is trained specifically to address these therapeutic issues. 1. The use of prescription and nonprescription medications is growing and now constitutes the primary therapeutic modality available to health care practitioners and patients. 2. The number, complexity, and potency of prescription and non prescription drug products is increasing. 2. The need for pharmaceutical care secures an enduring role for the pharmacist in the American health care system. Every encounter with patients, regardless of practice setting, provider pharmaceutical care. 3. Pharmaceutical care activities integrate pharmacists into the health care system of the future.

Figure 1 - TEMPLATE FOR PHARMACEUTICAL CARE : INSTITUTIONAL

PRACTICE

Data Collection 1. Review patient medical record 2. Review medication profile 3. Interview patient

Develop or identify the CORE Pharmacotherapy Plan Key Points 1. Focus on outcomes, not interventions Identify drug related problems or patient needs (PRIME) 2. Daily pharmacy rounds are important Pharmacists can make rounds without medical team 3. Use this approach with all clinical Formulate a Pharmaceutical Care Plan pharmacokinetic dosing, disease management clinics, Communicate Plan with patient, health care team, etc programs, as 1. 2. 3. 4. 5. 6. 7. 8. 9. Individual dosing Medication without indication Indication without medication Potential or actual allergy or ADR Drug-drug/ lab/ food interaction Optimal drug selection Pharmacokinetics Education Potential cost saving (IV or PO, etc) Plan includes Findings Assessment Resolution/ recommendation Monitoring such

clinical pathways, etc

Document actions taken in patient medical record