Quality Indicators for Appropriate Medication Use in Vulnerable Elders

Medications are a centrally important aspect of the care of elderly patients, especially vulnerable elders, and are the final common pathway for most therapeutic decisions. While they make up only 14% of the U.S. population, persons 65 years of age and older consume more than 30% of all prescription drugs (1). Because they more often experience acute and chronic illnesses, elders are particularly likely to benefit from the therapeutic and preventive effects of pharmaceutical therapy. However, aspects of the aging process that occur in healthy elders and that are considerably magnified in vulnerable elderly patients increase their risk for drug side effects (2). These include impaired renal function in clearing drugs that are primarily excreted by the kidney; reduction in hepatic blood flow, liver size, and phase I degradative metabolic processes; increased body fat at the expense of lean body mass, which increases the volume of distribution for lipid-soluble drugs and extends their half-life; and aging-induced changes in receptor sensitivity, which can further complicate the prediction and assessment of drug effects. Another important aspect of medication use in vulnerable elders is that the patient, caregivers, or even physician often mistake side effects for the onset of new illness, or worse, for aging itself. Such side effects include confusion, forgetfulness, gait instability, parkinsonian signs, incontinence, and fatigue. Because complex, frail elderly patients with multiple comorbid conditions are generally underrepresented in clinical trials of drugs, the effect of particular doses on such patients is more difficult to predict from the available clinical literature. This factor, in turn, contributes to therapeutic nihilism: Potentially life-saving medications, such as those that reduce serum cholesterol levels, may be underused because too few older adults were enrolled in key efficacy studies to allow conclusions on their use in this populationa kind of pharmacologic paradox. However, with few exceptions, as more studies begin to enroll adequate numbers of older patients, the benefits seen in younger patients are found to occur in this age group as well. As a result, the central issue in considering drug misuse in the elderly is no longer just concern about drug-induced side effects. An additional area must now be assessed as well: underutilization of necessary medications to treat conditions such as depression, isolated systolic hypertension, or hyperlipidemia. Such underuse has joined overuse and misuse as indicators for assessing the prescribing of medications to older patients. Comprehensive programs to measure the quality of medication use in vulnerable elders should evaluate each of these domains to provide the most thorough measure of the appropriateness of drug use in such patients. Methods The methods for developing these quality indicators, including literature review and expert panel consideration, are detailed in a preceding paper (3). For medication use, the structured literature review identified 5171 titles, from which abstracts and articles relevant to this report were identified. On the basis of the literature and the authors' expertise, 16 potential quality indicators were proposed. Results Of the 16 potential quality indicators, 12 were judged to be valid by the expert panel process (see the quality indicators), 1 was merged with an accepted indicator, and 3 were not accepted. We summarize the literature reviews that support each indicator judged to be valid by the expert panel process. Quality Indicator 1 Drug Indication IF a vulnerable elder is prescribed a new drug, THEN the prescribed drug should have a clearly defined indication documented in the record BECAUSE the medication may have been prescribed for an indication that was unclear or transient. Supporting Evidence. Documenting the indication for a new prescription is such a basic axiom of good medical practice that no clinical trials have assessed it. Over time, older patients are particularly vulnerable to the addition of multiple medications to their regimen at a rate that is generally greater than the rate of medication reassessment and withdrawal. Through a lapse in communication or absence of reevaluation, medications begun for a transient problem may be inadvertently continued indefinitely. In the case of medications prescribed to treat behavioral symptoms, the absence of a specified, clear indication for the drug makes it difficult to assess whether the medication is indeed meeting the need for which it was prescribed (as described in indicator 4). Clear specification of an indication for each drug can facilitate evaluation of the effectiveness of the regimen, help the patient to better understand the regimen (as described in indicator 2), and assist in the continuity of care when physicians other than the patient's usual caregiver are responsible for care (for example, during an acute hospitalization). For each medication in the active regimen, it is important to ascertain that its indication is still present; if the original indication is no longer present or if none can be found, a cautious trial of tapering may be appropriate. Quality Indicator 2 Patient Education IF a vulnerable elder is prescribed a new drug, THEN the patient (or, if incapable, a caregiver) should receive education about the purpose of the drug, how to take it, and the expected side effects or important adverse reactions BECAUSE such education may improve adherence and clinical outcomes and may alert patients or caregivers to potential adverse effects. Supporting Evidence. The medication regimens of vulnerable elderly patients are generally more complex than those of healthier elderly or younger patients. Nevertheless, in routine practice clinicians rarely have additional time to explain the regimen to the patient or caregiver. This is particularly significant if the patient has cognitive impairment. Because the side effects of a drug may have no obvious connection to the indication for which it is being prescribed (for example, anorexia or nausea from digoxin or parkinsonian symptoms from haloperidol), such education may be the only way that a patient or caregiver can identify the origins of an adverse drug effect in its early stages. For preventive therapies that provide no symptomatic benefit, adequate explanation of the need for the therapy is often necessary to persuade the patient to continue taking the regimen as directed. All patients who receive medication therapy should be educated about the purpose of any new medication, how to take the medication, and any expected side effects and possible important adverse effects. One of the goals of patient education is to improve adherence to therapy and, ultimately, improve clinical outcomes. A 1998 meta-analysis reviewed 153 studies published between 1994 and 1997 that evaluated methods to improve adherence (4). The authors found that one-on-one educational interventions significantly improved adherence measures and clinical outcomes. A randomized, controlled trial involving patients with hypertension showed that an educational intervention improved adherence to therapy and blood pressure control (5). A hospital-based educational intervention in older patients increased medication knowledge and improved adherence (6), and a multidisciplinary inpatient educational program for patients with congestive heart failure improved adherence to therapy after 30 days (7) as well as clinical outcomes. In a study of patients with chronic heart failure (8), an educational intervention improved adherence as well as clinical and functional outcomes. Quality Indicator 3 Medication List For ALL vulnerable elders, the outpatient medical record of every physician and the hospital medical record should contain an up-to-date medication list BECAUSE such a list can make it possible to identify and eliminate inappropriate duplication of therapies, correct potentially dangerous drugdrug or drugdisease interactions, and streamline the drug regimen to improve adherence. Supporting Evidence. A significant portion of physician visits for older patients taking multiple medications consists of reviewing current medications. An up-to-date medication list that is readily available enables a physician to review the necessity of ongoing drug therapy and to evaluate any potential drug interactions. This medication list should also include over-the-counter medications because these medications can have significant interactions with prescription drugs. In addition, an allergy list also helps prevent prescribing errors that can cause allergic reaction. Computerization of medication lists can make feasible and efficient screening for inappropriate drug use, allergies, and interactions. A recent cohort study (9) implemented a computer-based evaluation of prescription data to target drugage interactions, excessive maximal daily dosages, and drugdisease interactions. Inappropriate prescribing triggered telephone calls to physicians by pharmacists with specific geriatric training. This intervention demonstrated a reduction in inappropriate drug use, inappropriate dosing, and potential drugdisease interactions. Although this study was not a randomized, controlled trial, it illustrates the potential for automated screening of medication lists to improve prescribing and supports the recommendation for comprehensive medication lists. Quality Indicator 4 Response to Therapy EVERY new drug that is prescribed to a vulnerable elder on an ongoing basis for a chronic medical condition should have a documentation of the response to therapy within 6 months BECAUSE such an approach can help to clarify whether a drug is meeting the therapeutic goal for which it was prescribed. This documentation can provide a rational basis for continuation of the regimen if it is effective, modification if it is ineffective, or discontinuation if the underlying ind