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Chapter 9. Follow-Up EvaluationRobert J. Cipolle, Linda M. Strand, Peter C. MorleySections in this chapter:Key ConceptsPurpose, Activities, and ResponsibilitiesEvaluating Effectiveness of Drug TherapiesEvaluating the Safety of Drug TherapiesDetermining the Clinical Outcome StatusEvaluation for New Drug Therapy ProblemsSchedule for Continuous Follow-Up EvaluationsDocumenting the Follow-Up EvaluationSummaryExercisesReferencesKEY CONCEPTS 1. The purpose of the follow-up evaluation is to determine the patients outcomes in relation to the desired goals of therapy.2. Parameters that reflect both effectiveness and drug safety must be evaluated.3. The evaluation of effectiveness of pharmacotherapy includes measurable improvement in clinical signs and symptoms and/or laboratory values.4. The evaluation of the safety of pharmacotherapy includes evidence of adverse drug reactions and/or toxicity.5. Patient compliance and its influence on outcomes are determined during the follow-up evaluation.6. The outcome status of the patients medical condition being treated or prevented with drug therapy is determined and described.7. The patient is reassessed to determine if any new drug therapy problems have developed.8. The follow-up evaluation is the step in which actual results and outcomes from drug therapies are documented.PURPOSE, ACTIVITIES, AND RESPONSIBILITIES The purpose of the follow-up evaluation is to determine the patients outcomes from drug therapy and to compare these results with the patients goals of therapy. The follow-up evaluation activities and responsibilities are described in Table 9-1.Table 9-1 Follow-Up Evaluation Activities and ResponsibilitiesTable 9-1 Follow-Up Evaluation Activities and ResponsibilitiesActivitiesResponsibilitiesElicit clinical and/or laboratory evidence of actual outcomes and compare them to goals of therapy.Evaluate effectiveness of pharmacotherapy.Elicit clinical and/or laboratory evidence of adverse effects or toxicity to determine safety of drug therapy.Evaluate safety of pharmacotherapy.Document clinical status and any changes in pharmacotherapy that are required.Make a judgment as to the clinical status of the condition being managed with pharmacotherapy.Assess patient for any new problems.Assess patient compliance and identify if any new drug therapy problems have occurred.Schedule next follow-up evaluation.Provide continuous care.Copyright The McGraw-Hill Companies. All rights reserved.Privacy Notice. Any use is subject to the Terms of Use and Notice.Your IP address is 6 Standard of Care 7: Follow-Up EvaluationStandard 7: The Practitioner Evaluates the Patients Outcomes and Determines the Patients Progress Toward the Achievement of the Goals of Therapy, Determines If Any Safety or Compliance Issues Are Present, and Assesses Whether Any New Drug Therapy Problems Have DevelopedMeasurement Criteria1. The patients outcomes from drug therapies and other interventions are documented.2. The effectiveness of drug therapies is evaluated, and the patients status is determined by comparing the outcomes within the expected timeframe to achieve the goals of therapy.3. The safety of the drug therapy is evaluated.4. Patient compliance is evaluated.5. The care plan is revised, as needed.6. Revisions in the care plan are documented.7. Evaluation is systematic and ongoing until all goals of therapy are achieved.8. The patient, family and/or care-givers, and health care providers are involved in the evaluation process, when appropriate.No one cares how much you know, until they know how much you care. Caring is demonstrated through the activities of the follow-up evaluation. This is an essential activity in the provision of pharmaceutical care. It adds new information to the patients medication experience and potentially to the practitioners pharmacotherapeutic knowledge base. The only way to know whether the drug therapy your patient is taking is effective and/or safe is to conduct a follow-up evaluation.Follow-up evaluation activities represent a new step in the health care system that does not routinely occur with drug therapy when pharmaceutical care is not provided.Note You have not provided pharmaceutical care unless and until you have followed-up with your patient to determine what has happened as a result of your clinical decisions, drug therapy advice and care planning.Although all practitioners provide drug therapy advice and instructions with the best of intentions, these well-meaning interventions do not always have positive outcomes.Your clinical decisions, drug therapies, and advice can produce any one of the following three outcomes:The intended positive clinical resultA negative clinical resultNo demonstrable changeIt is difficult to overemphasize the importance of the evaluation step in the patient care process. The follow-up evaluation is where and when practitioners gain clinical experience. Follow-up evaluations provide the evidence of effectiveness and safety.Throughout the assessment and care planning steps of the Pharmacotherapy Workup, you have been assessing your patients drug-related needs. You have been acting on what you think your patients drug therapy problems are, and you have been intervening by doing what you think has the best probability of achieving your patients goals of therapy. All of this rational clinical thinking produces actual (real) results (outcomes). Learning from real results, good or bad (effectiveness or safety), is the working definition of clinical experience. Observing what resulted from your clinical decisions constitutes clinical experience. New knowledge is gained during each follow-up evaluation. The follow-up evaluations are the most productive times for clinicians to learn which medications and which dosage regimens are most effective, and which cause harm.The outcomes of drug therapies, drug therapy decisions, drug information, referrals, and other interventions are unknown until the practitioner conducts a follow-up evaluation with the patient. If the result is positive, you have learned that a certain drug regimen was effective in a specific clinical situation, and you will never forget. If the result is negative, you have learned that a certain drug regimen failed to produce the desired results. Either result provides the greatest learning that a student practitioner can experience. The same holds true for learning about adverse effects of drug therapies. If the patient experiences an adverse effect and describes that to you, or if you observe it at the follow-up evaluation, that information is added to your long-term clinical database. Dan Canafax, Pharm.D., a colleague for many years, commonly instructed students and residents on the University of Minnesota renal transplant service If you want to learn about side effects, talk to your patients. They will teach you about side effects.During the follow-up evaluation, the practitioner is looking for evidence of effectiveness, safety, and any new problems that may have occurred since the last visit. At each follow-up, the practitioner is looking for good, bad, and new. In general, the good (effectiveness) comes in the form of the disappearance of the signs and symptoms of the disease or illness. The bad (safety) comes in the form of adverse and harmful effects from drug therapies.EVALUATING EFFECTIVENESS OF DRUG THERAPIES During the follow-up evaluation, the practitioner and the patient compare the goals of therapy with patient outcomes. The most frequent parameters used to evaluate the clinical outcomes that result from a patients drug therapy are clinical and/or laboratory parameters (Fig. 9-1).View LargeFigure 9-1Add to My Saved ImagesPharmacotherapy Workup. See Chapter 6 for details.Figure 9-1Pharmacotherapy Workup. See Chapter 6 for details.Clinical ParametersImprovement in Patient Signs and SymptomsChanges in clinical parameters are frequently used to determine the effectiveness of drug therapy. Positive clinical outcomes are most often associated with the disappearance or diminution of the patients presenting signs and symptoms. Clinical parameters of the disease or illness often include clinical manifestations such as levels of pain, anxiety, mood changes, inflammation, or frequency and severity of cough, seizures, bleeding, sleep disturbances, tremors, and shortness of breath. Changes in these parameters are determined by asking the patient to describe them at the follow-up evaluation and comparing the patients response to what you observed and documented during the assessment interview or the most recent patient encounter.The practitioners observational and clinical inquiry skills are applied during the follow-up evaluation in a similar manner to that of the assessment interview. The practitioner must have the clinical knowledge and ability to gather relevant information from the patient so that an evaluation of the clinical effectiveness of the patients drug therapies can be made. The process of outcomes evaluation is straightforward. What clinical parameters were used to establish the goals of therapy? What is the status of those same parameters today? The practitioner establishes the relationships between (1) the original presenting signs and symptoms of the disease or illness; (2) the clinical parameters used to establish the goals of therapy; and (3) the improvement in those same clinical parameters at the time of follow-up (Fig 9-2).View LargeFigure 9-2Add to My Saved ImagesThe relationships in the patient care process.Figure 9-2The relationships in the patient care process.Copyright The McGraw-Hill Companies. All rights reserved.Table 9-2 presents examples of common disorders in which effectiveness of pharmacotherapy is evaluated based on changes in clinical signs and symptoms.Table 9-2 Clinical Signs and Symptoms Used to Evaluate Effectiveness of PharmacotherapyTable 9-2 Clinical Signs and Symptoms Used to Evaluate Effectiveness of PharmacotherapyTherapeutic indicationClinical parametersBack painSeverity and frequency of pain, range of motion, ability to ambulateMigraineHeadache pain, retro-orbital pain, nausea, vomiting, visual disturbancesMajor depressionMood changes, feelings of sadness, level of energy, interest or enjoyment in usual or favorite activities, insomnia, agitation, fatigue, ability to think or concentrate, thoughts of deathAnxiety disorderLevel of restlessness, concentration, irritability, muscle tension, sleep disturbanceCoughSeverity and frequency of cough, interruption of daily activities or sleepRashChange in color and/or size, associated inflammation, itchingOsteoarthritisUse-related pain in weight-bearing joints including knee, hip, spine, and hands. Stiffness after rest.Copyright The McGraw-Hill Companies. All rights reserved.Laboratory ParametersImprovement in Laboratory Test ResultsOutcome evaluations often rely on changes in laboratory values. In some diseases or conditions, there are few or no clinical manifestations, and outcome judgments are based primarily on improvements in laboratory test results. Hyperlipidemia is a common example in which measurements of the patients serum lipids (cholesterol, low-density lipoproteinsLDL, high-density lipoproteinsHDL, and triglycerides) serve as the parameters to determine the effectiveness of drug therapy. Patients seldom exhibit clinical symptoms associated with hyperlipidemia. Therefore, effectiveness evaluations are often based on laboratory measurements (Table 9-3).Table 9-3 Laboratory Test Results Used to Evaluate Effectiveness of PharmacotherapyTable 9-3 Laboratory Test Results Used to Evaluate Effectiveness of PharmacotherapyTherapeutic indicationLaboratory parametersHyperlipidemiaCholesterol, low-density lipoproteins (LDL), triglycerides, high-density lipoproteins (HDL)AnemiaComplete blood count (CBC), hemoglobin (Hb), hematocrit (Hct), red blood cell count, mean corpuscular volume (MCV), reticulocyte index, serum ferritin, iron-binding capacity, serum iron, serum B12 Cardiac dysrhythmiasElectrocardiogram (ECG, EKG)Diabetes mellitusBlood or plasma glucose, hemoglobin (A1C)Copyright The McGraw-Hill Companies. All rights reserved.Pharmaceutical care practitioners must understand the impact that drug therapies have on specific laboratory tests in order to determine if they are effective. The timing of when to collect the sample for the laboratory test is an important clinical decision. Often the practitioner must decide if the question to be answered at the follow-up evaluation is: Will this drug regimen have any beneficial effect for my patient? In this case, the practitioner would want to know how soon any positive effect can be measured. The more common question is: How much of an impact will this drug regimen have on my patient?Example Most HMG CoA reductase inhibitors (statins) begin to improve serum lipid determinations within a few days (514 days), but generally several weeks (3 to 6) are required to see the full extent of the changes in serum lipids. Waiting only 12 weeks after initiating lipid-lowering pharmacotherapy to measure changes in serum lipids might provide information as to whether the selected therapy is likely to have any effect at all on the patients lipid profile. However, waiting 6 weeks or longer is more likely to provide evidence as to the extent of the benefit the patient is likely to experience from the drug regimen. In the first case, the laboratory test is used to evaluate whether any effectiveness is likely and in the second case, the laboratory test result is used to determine the extent or degree of benefit the patient has received from the drug therapy.Follow-up evaluations of patients with acute disorders can serve to evaluate the final patient outcomes. Follow-up evaluations for patients with chronic conditions serve to establish the present status of the patients condition. Patients with chronic conditions require continuous follow-up which is initially designed to ensure that the drug therapy has in fact produced the desired effects (effectiveness), followed by less frequently scheduled evaluations designed to ensure that the patient remains stable and the drug therapy continues to benefit the patient. Typically, follow-up evaluation schedules are more frequent at first, until the goals of therapy are achieved (desired blood pressure, cholesterol, or level of pain), and then are scheduled less frequently (quarterly or semiannually) in order to determine that the maintenance drug therapy continues to effectively manage the patients condition.EVALUATING THE SAFETY OF DRUG THERAPIES The follow-up evaluation requires proactive practitioner involvement. That is to say, it is here that practitioners assertively assume the responsibility to reach out to patients and demonstrate caring behavior. Experienced pharmaceutical care practitioners understand that it is their responsibility to determine if drug therapies are in fact safe for their patients, and the best way to ensure safety is to determine whether the patient is experiencing any negative effects.It is unacceptable to wait for the patient to contact you if he/she has any side effects from the drug therapies that you provided. This type of passive approach is inconsistent with the value of pharmaceutical care and results in over $175 billion in drug-related morbidity and mortality in the United States each year.13 To conduct a comprehensive, adequate follow-up evaluation requires active communication with each patient and feedback concerning any problems. Such feedback either validates the care plan or questions its appropriateness, thereby leading to improvements in the patients medication experience.Drug products are produced and made available for patient use because they possess a set of pharmacological actions. Most drugs exhibit several related pharmacological activities, some beneficial, some undesirable. Which are considered beneficial and which are considered undesirable depend upon the therapeutic indication (why we are using the drug). However, when you use a drug at doses high enough to exhibit its pharmacological activities, any and all of those pharmacological actions can and will occur. Those actions that are desirable help to achieve the goals of therapy. The undesired actions are most often called adverse effects or side effects.ExampleAspirin is known to have analgesic, antipyretic, and anti-inflammatory properties. It impairs prostaglandin biosynthesis. Aspirin inhibits cyclooxygenase-1 (COX-1) associated with gastrointestinal irritation, renal effects, and irreversible inhibition of platelet aggregation, and also inhibits cyclooxygenase-2 (COX-2) which provides aspirin anti-inflammatory properties. When a patient is treated with aspirin, all of these effects occur to varying degrees. If the intended therapeutic indication was to manage pain (analgesia), then the platelet inhibitory activities, which can aggravate bleeding, are undesirable and would be considered a side effect. On the other hand, if the patient is using aspirin as secondary prevention of a heart attack (MI) or stroke (CVA), then the platelet pharmacology is the desired action and renal and gastrointestinal activities would be considered negative consequences. The aspirin does not know why you are using it. It just exerts all of its pharmacological activities. The practitioner and the patient need to know the intended therapeutic indication and evaluate it for effectiveness. At the same time the practitione