Identifying and reducing complications of outpatient medications.

In this edition of the Journal, Gandhi et al. report the important and impressive results of their Ambulatory Medicine Quality Improvement Project.1 This study assesses the incidence and significance of drug complications in outpatients. This is a timely article, given the recent report of the Institute of Medicine regarding consequences of medical errors,2 as well as intermittent reports of medical errors in the lay press, which continue to remind us of the hazards posed by our interventions intended to cure and palliate. The paper by Gandhi et al. has several strengths: 1) the authors assessed a large number of outpatients (2248) for adverse drug events; 2) the patients came from a variety of practice settings; 3) the authors compared medical records with patient responses; 4) the severity of adverse events was assessed; and 5) patient characteristics influencing the incidence of drug complications were assessed. The paper also has limitations, many of which are summarized nicely by the authors. I have some additional concerns: 1) a fundamental problem with this paper is the assertion that problems or symptoms which patients attribute to their prescription medications are necessarily the result of those medications. The authors use adverse events listed in the Physicians' Desk Reference (PDR) for a specific drug as a “validity check” for complications. “Verified to be documented” strikes me as too strong an assertion to describe the association of finding the symptom listed in the PDR with the drug's adverse events. The authors concede that they could not assess the resolution of symptoms after drug discontinuation and did not identify rechallenge as an additional method to verify the drug as the culprit for the symptoms; 2) the clinical significance of these “drug-related problems” is uncertain, since over half of these problems did not reach a threshold where the patient experienced worry or discomfort; 3) the derivation of the satisfaction score also is unclear. The authors did not specify how the four questions were used to create the score, whether each question was given equal importance or weighted differently, or how the minimum score could be 50. In addition, there is no evidence that this satisfaction score has been validated. These problems limit the strength of conclusions about the impact of drug complications on patients' satisfaction with care; 4) there was no assessment of problems with over-the-counter drugs, herbal products, vitamins or supplements, and other non-prescription medicinals. Nevertheless, problems with medications certainly can lead outpatients to seek additional medical care. Gandhi et al. reported that 48% of their patients “sought medical attention,” presumably for the drug complications mentioned. A recent prospective, observational study reported that 28% of emergency department visits were due to medication-related problems.3 Of these, 70% were felt to be preventable. As in the Gandhi et al. paper, lack of patient education contributed to the problem. Another prospective study (this one in elderly patients discharged from a hospital to receive home health care) determined that 20% of patients reported adverse drug events during the first month following discharge.4 In that study, female gender, Mini-Mental State Exam score, and the number of new medications at discharge were significantly associated with an increased risk of adverse drug events. Besides minimizing new drugs prescribed for elderly patients at hospital discharge, we can do better at educating these patients about their medications before they leave the hospital.5 Improving patients' knowledge should improve compliance and reduce medication errors and adverse drug events. Evidence suggests that, even in elderly outpatients, appropriate discontinuation of medications after careful review can be accomplished safely in the majority of cases.6 How should we change our practices as a result of the Gandhi et al. article? First and foremost, we should strive for simplicity and patient comprehension as we prescribe. The lowest effective doses of the fewest number of medications is an important perpetual goal. Even the perception of taking too much medication leads to decreased compliance and increased adverse events.7 Physicians should routinely ask patients to bring all their medications with them to clinic visits. This enables more meaningful discussion of frequency of consumption and understanding of indications and potential side effects than simply reviewing the chart for what is listed as the medication profile or relying on a written list provided by the patients or their caregivers. Examining the medication bottles enables physicians to find duplications (e.g., a bottle labeled warfarin and another labeled Coumadin), different pills in one bottle, and ongoing medications that should have been stopped. It is important to include a discussion of over-the-counter drugs and of herbal and other alternative or supplemental compounds because many patients fail to consider these treatments in the same light as prescription drugs even though they are known to cause complications and drug interactions.8–11 Computerized physician order entry can reduce medication errors for hospitalized patients;12 why can't information systems be developed that allow medication profiles, prescription refills, screens for allergies, and point-of-care decision support to be widely available on-line for outpatients? Choosing medications should be a rational process that involves several issues. These issues include a consideration of comorbidities, both as secondary therapeutic targets (e.g., treatment of hypertension with beta blockers in a patient with a history of myocardial infarction) and as risk factors for adverse events (e.g., treatment of angina with beta blockers in a patient with a history of asthma). Direct-to-consumer advertising increases pressure on physicians to prescribe more drugs, drugs that nearly half of patients mistakenly feel are advertised only because they have been found to be completely safe.13 While inquiries by patients spurred by direct-to-consumer advertising may offer opportunities to educate patients about appropriate use of drugs, the process may also lead to frustration with unfulfilled expectations on the patient's part and a consumption of valuable clinic time. Cost is always an important consideration, although it is usually quite complex. The cost of therapy or of an adverse event can vary, depending on the point of view; for example, the cost to the patient versus the health care institution versus the health system versus society as a whole.14 Cost analysis should also consider the potential for future cost avoidance given current resource expenditures. Adverse drug events are not the same as medication errors, and even with a perfect system where no medication errors exist, adverse drug events may occur. Therefore, our job is to maximize the performance of the health care system to minimize medication errors, educate our patients to help identify adverse drug events early, and use therapeutic monitoring properly, all in an effort to drive down the adverse event rate toward the irreducible minimum. Writing unambigous and legible prescriptions will reduce the chance of confusion at the pharmacy. Asking the patient to repeat our instructions about new or especially worrisome medications will help us assure adequate comprehension. Periodic monitoring of laboratory tests (e.g., serum potassium and serum magnesium in patients treated with diuretics, or serum transferases in patients receiving HMG CoA reductase inhibitors) may identify adverse drug events early, before they become manifest by serious morbidity. Ideally, increasing awareness of the importance of adverse drug reactions will help to reduce their occurrence in the future. As pointed out by Gandhi et al., there appeared to be substantial under-documentation of adverse events in the outpatient records of their patients. We can improve recognition and reporting of adverse events by emphasizing their importance in our regular teaching activities with students and house officers, including morning report.15 The problems of inadequate identification and communication of drug complications extends to the external reporting of adverse drug events.16 I hope the paper by Gandhi et al. will encourage additional investigation in the same arena. I applaud the authors for recognizing the importance of this area and contributing to our understanding of problems with medications in outpatients.—Brent G. Petty, MD, Johns Hopkins University School of Medicine, Baltimore, Md.