Unnecessary Prescribing of NSAIDs and the Management of NSAID-Related Gastropathy in Medical Practice

Each year, 70 million prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs) are dispensed in the United States [1], 20 million are dispensed in Great Britain [2], and 10 million are dispensed in Canada [3]. The widespread use of NSAIDs has raised concerns because these drugs have substantial gastrointestinal side effects. Studies done in Canada, the United States, Australia, and Great Britain have shown that NSAID use increases the risk for hospitalization and death from gastrointestinal bleeding and perforation [4-16]. Each year, use of NSAIDs accounts for an estimated 7600 deaths and 76 000 hospitalizations in the United States [17] and 365 deaths and 3897 hospitalizations in Canada [12, 18, 19]. One percent to 3% of NSAID users will have gastrointestinal bleeding [20], and 26% will be prescribed antiulcer therapy [11, 21]. Treatment of NSAID-related gastrointestinal side effects accounts for one third of the cost of arthritis therapy [11]. Older age, history of peptic ulcer disease, higher NSAID dose, and concurrent use of corticosteroids and anticoagulants increase the risk for serious gastrointestinal side effects [5]. Almost all deaths from NSAID-related gastrointestinal side effects occur in elderly persons [2]; elderly women seem particularly susceptible [10, 12, 13]. In the mid-1980s, physicians were advised to avoid prescribing NSAIDs to elderly persons and patients with a history of peptic ulcer disease and to use low-dose NSAIDs only when other treatments had failed [2, 6]. In 1990, however, an estimated 58% of women and 53% of men 65 years of age and older in Quebec were prescribed NSAIDs [22]; in Alberta, NSAIDs accounted for 47% of prescriptions for antiulcer therapy in elderly persons [21]. The prevalence of the use of NSAIDs and antiulcer therapy raises questions about whether elderly persons are receiving NSAIDs unnecessarily and whether NSAID-related side effects are recognized and adequately managed. This question is of particular interest in elderly women because they are twice as likely as men to experience adverse NSAID-related gastrointestinal events [12]. In addition, women have been noted to be more likely than men to be prescribed therapy for the same condition [23] and to receive inappropriate therapy [24]. Physician surveys conducted in the United States and Great Britain indicate that 4% to 42% of physicians are unaware of the side effects of these drugs [25], that NSAIDs are frequently chosen as first-line treatment for osteoarthritis [25-27], and that treatment approaches to NSAID gastropathy vary greatly [25, 28]. Less extensive drug knowledge and higher rates of inappropriate prescribing are more common among physicians who have been in practice longer [29, 30] and among general practitioners [30, 31], possibly because of the challenges of keeping up to date on drug therapy [32]. Practice style also seems to influence drug prescribing: Shorter visits are associated with higher prescribing rates [33] and more inappropriate prescribing [34]. Moreover, a controversial Canadian study [35-39] found that general practitioners who saw more patients per day and billed for more services per patient were more likely to prescribe NSAIDs and other drugs [35] and that higher rates of NSAID prescribing were associated with higher rates of hospitalization and death [36]. These researchers speculated that physicians who prescribed more medication spent less time with their patients and delivered worse quality of care; as a result, their patients were sicker. Although the level of NSAID use in the population may be a cause for concern, it is difficult to determine whether elderly patients are actually receiving unnecessary prescriptions or whether NSAID-related problems are being adequately diagnosed. Indications for therapy are rarely documented in sufficient detail to permit retrospective evaluation of the appropriateness of drug treatment decisions [40], and responses to questionnaires that describe cases do not accurately reflect what physicians do in actual practice [41-43]. A physician's ability to diagnose drug-related side effects cannot be ascertained by clinical studies. Only problems that are diagnosed can be assessed; those that go unrecognized or are misdiagnosed cannot [44, 45]. In this study, we attempted to overcome these limitations by using standardized patients [43, 46, 47]. This allowed us to select cases that could be used to evaluate particular aspects of NSAID use and to conduct blinded evaluation of decision making for the same patient in physicians' usual practice environment. Our objectives were to estimate how often NSAIDs were unnecessarily prescribed; whether side effects from NSAID therapy were accurately diagnosed and managed; and whether NSAID treatment decisions were influenced by patient, physician, and visit characteristics. We hypothesized that inadequate recognition and management of NSAID-related problems and unnecessary NSAID prescriptions in elderly persons would be more likely to occur with shorter visits, female patients, and incomplete assessment of relative contraindications. We also thought that these problems would occur more often with community-based general practitioners than with academically affiliated general practitioners and postgraduate trainees. Methods Design and Population Management decisions for elderly patients with arthritis were assessed in a prospective follow-up study of 112 physicians. Each consenting physician saw two to four standardized elderly patients in his or her practice over a 6- to 8-month period. All physicians were blinded to the identity of the patient, the time of entry, and the nature of the problem being studied. Practices for NSAID prescribing were assessed in four populations of Canadian physicians: academically affiliated general practitioners, residents in family medicine, residents in internal medicine, and community-based general practitioners. To obtain representatives of all four groups, we invited the following to participate in our study: all general practitioners (n = 34) in one hospital-based family medicine residency program, all family medicine residents (n = 32) in a second hospital-based program at McGill University (Montreal, Quebec), all general internal medicine residents in the two hospital-based teaching programs at McGill University (n = 29), and a random sample of Montreal general practitioners listed in the College of Physicians registry (n = 82). Assessment of Medical Management To assess physician management decisions for patients with arthritis, we selected two common clinical problems (Appendix). The first case was used to assess unnecessary NSAID prescribing for a patient with a recent exacerbation of chronic hip pain. In this case, the most likely diagnosis was osteoarthritis (not radiologically confirmed) and the treatment options were lifestyle modification, physiotherapy, and medication. The second case was used to assess the recognition and treatment of NSAID-related side effects in a patient with epigastric pain secondary to NSAID use. In both cases, the patients were 67 years of age, had a history of peptic ulcer disease, and had been prescribed medications for coexistent hypertension and type 2 diabetes mellitus. Standardized patients were recruited from community-based senior citizen groups and screened for suitability by one of the geriatrician investigators. Eight elderly persons were selected, and two men and two women were trained for each case. In 7 to 15 two-hour sessions, standardized patients were trained to present the essential features of the case (history, physical findings, affect) and to record visit time and actions taken by the physician during the visit by using a structured questionnaire for visit documentation [48]. The accuracy of standardized patient presentation and recording was pretested and monitored thereafter by biweekly videotaped investigator-standardized patient visits as quality control assessments. We previously reported that the accuracy of the standardized patients' presentations in double-blinded visit assessments was 96.4% and that the accuracy of visit documentation recording was 77% ( = 0.71 [95% CI, 0.56 to 0.85]) [48]. The provincial health board gave the standardized patients temporary health insurance cards so that they could remain anonymous to participating physicians and so that costs of the study visits could be billed to the research office. Standardized patients arranged visit appointments with the study physicians according to prearranged schedules that allowed approximately one visit per physician per month. After each visit, the standardized patient completed the structured questionnaire to record actions taken by the physician during the visit and returned the completed checklist, prescriptions, referrals, and test requisitions to the research office. To detect unblinding of standardized patients during the study period, we gave participating physicians postcards that were to be returned to the research office if the physicians suspected that a patient was a study patient. At the end of the study period, we retrieved medical charts for all standardized patient visits from physicians' offices. Each physician was scheduled to see one standardized patient for each of the two cases. Academically affiliated and community-based general practitioners saw a male and a female patient for each case (four visits per physician), whereas residents saw one standardized patient per case (two visits per physician). Residents were randomly assigned to a visit from either a male or a female patient for each case. At the time of our study, clinical recommendations for NSAID use had been published [2, 6, 49-52], but no consensus guidelines had been produced. Thus, a consensus panel of eight academically affiliated physicians, representing the fields of rheumatology, geriatrics, clinical pharmacology, internal medicine, and family med