ABSTRACT
OBJECTIVES: The objectives of this study were to examine the degree to which long-term care providers are compliant with product labeling regarding administration of alendronate in patients with renal insufficiency and presence of, or predisposition to, upper gastrointestinal disorders; and to observe differences, if any, in prescribing patterns between alendronate and calcitonin-salmon nasal spray in skilled nursing facilities. STUDY DESIGN: We studied retrospectively analyzed patient charts, including medication histories and laboratory data. SETTING: Our study comprised 134 skilled nursing facilities from 21 states. PARTICIPANTS: We studied postmenopausal women, age > or =65 years, receiving either alendronate or calcitonin-salmon nasal spray for a minimum of 2 weeks. MEASUREMENTS: Consultant pharmacists reviewed resident charts submitted the following data for each resident: 2-week history of alendronate or calcitonin use, 2-week history of H2 receptor antagonist or proton pump inhibitor use, most recently documented serum creatinine, actual body weight, and date of birth. RESULTS: Of 905 subjects in the analysis, 38.5% (n = 348) did not have documentation of serum creatinine. Of the 267 alendronate patients for whom creatinine clearance could be calculated, more than half had renal insufficiencies of creatinine clearance <35 mL/min/1.73 m(2) (51.3%, n = 137). In addition, despite widespread information regarding caution in using alendronate in patients with upper gastrointestinal disorders, we found that 33.9% (n = 151) of all alendronate patients were concurrently receiving either H2 receptor antagonists or proton pump inhibitors. Although similar results were observed in the residents taking calcitonin, that agent has no precautions regarding its use in the renally impaired or in patients with gastrointestinal disorders. CONCLUSION: Data from this study indicate that long-term care clinicians might not be adequately differentiating patient profiles and safety criteria when initiating residents on osteoporosis pharmacotherapy, as evidenced by similar prescribing trends in both the alendronate and calcitonin groups. Given its package insert's statements regarding use of alendronate in the renally compromised, results from the alendronate group were particularly problematic as a result of the large number of residents with either insufficient renal function or undocumented serum creatinine. These data demonstrate that osteoporosis could be a disease state that should be more closely analyzed through drug utilization reviews and represent yet another opportunity for improved collaboration between medical directors and consultant pharmacists.
