Randomized trial to improve prescribing safety during pregnancy.

OBJECTIVE: This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed U.S. Food and Drug Administration pregnancy risk category D or X medications was effective in decreasing dispensings of these medications. DESIGN: Randomized trial. Pharmacy, diagnostic, and laboratory data were linked to identify pregnant patients prescribed targeted medications. Women (n = 11,100) were randomized to intervention or usual care. Physicians and pharmacists collaborated on the intervention. MEASUREMENTS: The primary outcome was the proportion of pregnant women dispensed a category D or X medication. The secondary outcome was the total number of first dispensings of targeted medications. RESULTS: A total of 2.9% of intervention (n = 177) and 5.5% of usual care (n = 276) patients were dispensed targeted medications (p < 0.001): 1.8% of intervention (n = 108) and 3.9% of usual care (n = 198) patients were dispensed only category D medication(s); 0.9% of intervention (n = 54) and 1.2% of usual care (n = 58) patients were dispensed only category X medication(s); 0.2% of intervention (n = 15) and 0.4% of usual care (n = 20) patients were dispensed both category D and X medications (p = 0.05). This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications (p = 0.03). The study was stopped primarily due to 2 false-positive alert types: Misidentification of medications as contraindicated in pregnancy by the pharmacy information system and misidentification of pregnancy related to delayed transfer of diagnosis information. CONCLUSION: Coupling data from information systems with knowledge and skills of physicians and pharmacists resulted in improved prescribing safety. Systems limitations contributed to project discontinuation. Linking ambulatory clinical, laboratory, and pharmacy information to provide safety alerts is not sufficient to ensure project success and sustainability.

Atenolol-induced breast pain in a woman with hypertension.

OBJECTIVE: To describe a case of atenolol-induced breast pain and swelling in a patient receiving atenolol. CASE SUMMARY: A 54-year-old woman was diagnosed with hypertension with no existing comorbidity. The patient was not taking any prescription medications, but was using an herbal supplement and several other over-the-counter supplements. After diet and exercise failed to control the woman's blood pressure, atenolol 25 mg daily was initiated. She reported symptoms of insomnia 9 days after starting the medication. During a follow-up visit 5 weeks later, the patient reported continued insomnia, as well as a 6 day history of breast pain, swelling, and tenderness. Atenolol was quickly titrated to discontinuation, and a thiazide diuretic was prescribed. Subsequently, the pain and swelling gradually resolved. DISCUSSION: Assessment using the Naranjo probability scale revealed that the adverse reaction was probably associated with atenolol. While rare cases of hyperprolactinemia and galactorrhea have been reported with beta-blocker use, no reports of breast pain caused by this drug class were identified in the literature. CONCLUSIONS: Atenolol has many reported adverse reactions, both common and rare; however, until this report, breast pain and swelling had not been documented adverse reactions. Clinicians should be aware that atenolol may be a cause of nonorganic breast pain and swelling in women.

Randomized trial to improve laboratory safety monitoring of ongoing drug therapy in ambulatory patients.

STUDY OBJECTIVE: To determine whether an electronic tool effectively increases the percentage of patients receiving laboratory monitoring during ongoing drug therapy. DESIGN: Randomized trial. SETTING: Outpatient medical offices of a group model health maintenance organization. PATIENTS: A total of 9,139 patients prescribed ongoing therapy with any of 14 drugs, resulting in 4,871 patient-drug combinations in the intervention group and 4,780 in the usual-care (control) group. INTERVENTION: Physicians and pharmacists jointly developed monitoring guidelines based on published recommendations. Pharmacists were electronically alerted to missing laboratory results and then ordered tests, reminded patients to undergo tests, and reviewed and managed abnormal results. MEASUREMENTS AND MAIN RESULTS: In the intervention group, 64% of patientdrug combinations were monitored, whereas in the usual-care group 58% were monitored (p < 0.001). Differences in monitoring were observed in the intervention versus usual-care groups for amiodarone (71% vs 55%, p<0.01), theophylline (54% vs 28%, p<0.001), carbamazepine (49% vs 32%, p<0.001), lithium (42% vs 28%, p<0.01), phenytoin (44% vs 33%, p<0.001), and metformin (72% vs 67%, p<0.001). Of 1981 laboratory tests ordered, 1,472 (74%) were completed. The tests revealed 181 serum drug concentrations outside the therapeutic range and 126 abnormal serum creatinine, alanine aminotransferase, aspartate aminotransferase, and thyroid-stimulating hormone levels, and complete blood counts. CONCLUSION: A computerized tool plus collaboration of health care professionals effectively increased the number of patients who received laboratory safety monitoring of drug therapy.

Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial.

BACKGROUND: The importance of laboratory monitoring for drugs is reflected in product labeling and published guidelines, but monitoring recommendations are followed inconsistently. Opportunity exists to improve monitoring, with the potential to decrease therapy complications. METHODS: The objective of this randomized trial was to determine whether computerized alerts were effective at increasing the percentage of ambulatory patients with laboratory monitoring at initiation of drug therapy. Physicians and pharmacists teamed up to develop organization-specific guidelines for monitoring selected drugs. In collaboration with physicians, pharmacists were alerted to missing laboratory test results, ordered missing tests, reminded patients to obtain tests, assessed test completion, reviewed test results, and managed abnormal results. Eligible individuals included patients with therapy initiated for any of 15 drugs among 400,000 health plan members. RESULTS: In the intervention group, 79.1% (n = 4076; 95% confidence interval [CI], 78.0%-80.2%) of dispensings were monitored compared with 70.2% (n = 3522; 95% CI, 68.9%-71.5%) in the usual-care group (P < .001). For example, 78.6% of amiodarone (95% CI, 73.1%-83.5%) dispensing was monitored in the intervention group vs 51.4% (95% CI, 44.4%-58.4%) in the group receiving usual care (P < .001). CONCLUSIONS: This study demonstrates the effectiveness of a computerized tool plus collaboration among health care professionals at increasing the percentage of patients receiving laboratory monitoring at initiation of therapy. Coupling data available from information systems with the knowledge and skills of physicians and pharmacists can result in improved patient monitoring.

Meningococcal vaccine use in college students.

OBJECTIVE: To discuss the role of meningococcal vaccine in prevention of meningococcal disease. DATA SOURCES: A MEDLINE search (1966-June 2001) was performed to identify key literature. Search terms included, but were not limited to, meningococcal vaccines, meningococcal meningitis, meningococcal infection, and meningococcus. The search was limited to English-language literature and references dealing with humans. The MEDLINE search was supplemented by a hand search of various bibliographies. DATA SYNTHESIS: The impact of meningococcal disease has caused national and regional organizations to develop recommendations for use of meningococcal vaccine. Even though the meningococcal vaccine can provide benefit, limitations exist. The available vaccine does not cover all meningococcal strains and is not useful in all age groups. The appropriate target groups for prevention of disease through vaccination have been difficult to determine; vaccine use in college students is especially controversial. CONCLUSIONS: Although a meningococcal vaccine is available, meningococcus causes significant morbidity and mortality. Controversy exists over the meningococcal vaccine and its use. Students entering college who will be living in dormitories should be informed of the increased risk of meningococcal disease and be offered vaccination.