Quality of care factors associated with unplanned readmissions of older medical patients: a case-control study.

BACKGROUND: Unplanned readmissions befall up to 25% of acutely hospitalised older patients, and many may be potentially preventable. AIM: To assess the type and prevalence of quality of care factors associated with potentially preventable readmissions to a tertiary hospital general medicine service. METHODS: A retrospective case-control study was undertaken of hospital records of patients 65 years or older admitted acutely between 1 January 2005 and 31 December 2010. Readmissions up to 30 days postdischarge (cases) were purposively sampled according to frequencies of primary discharge diagnoses coded during the study period. Non-readmitted patients (controls), matched according to age, sex and primary discharge diagnosis on index admission, were selected in a 1.7:1 ratio. RESULTS: One hundred and thirteen cases and 198 controls were analysed, the former demonstrating a significantly higher comorbidity burden (mean (±standard deviation) comorbidity score 6.6 (±2.2) vs 5.6 (±2.4), P = 0.003) and a higher proportion of individuals with one or more hospitalisations over the preceding 6 months (55.7% vs 8.1%, P < 0.001). Among readmitted patients, 50 (44.3%) were associated with one or more quality factors versus 23 (11.6%) controls (P < 0.001). The most common were: failure to develop/activate an advance care plan (18, 15.9% vs 2, 1.0%; P < 0.001); suboptimal management of presenting illness (13, 11.4% vs 0, 0%; P < 0.001); inadequate assessment of functional limitations (11, 9.7% vs 0, 0%; P < 0.001); and potentially preventable complication of therapy (8, 7.1% vs 1, 0.5%, P = 0.002). CONCLUSIONS: Quality of care factors are more common among readmitted than among non-readmitted older patients suggesting potential for remedial strategies. Such strategies may still have limited effects as older, frail patients with advanced diseases and multimorbidity will likely retain a high propensity for readmission despite optimal care.

Bioavailability of omeprazole 20 mg capsules containing omeprazole 22.5% enteric coated pellets versus a reference product in healthy Bangladeshi male subjects: an open-label, single-dose, randomized-sequence, two-way crossover study.

OBJECTIVE: Omeprazole 20 mg enteric coated capsule formulation is generally prepared either with omeprazole 8.5% or omeprazole 7.5% enteric coated pellets to accommodate in capsule Shell 2, but the use of omeprazole 22.5% enteric coated pellets in capsule Shell 5 for the same amount of omeprazole is a new concept and for the first time in the Bangladesh market. This study was conducted to compare the relative bioavailability and pharmacokinetic properties of two omeprazole 20 mg capsule formulations namely Xeldrin®20 (ACI Ltd., Bangladesh) encapsulated with omeprazole 22.5% enteric coated pellets, as test product and Losec®20 (AstraZeneca, Wilmington, DE, USA) as reference product and to assess whether these formulations meet the FDA requirement for bioequivalence. MATERIALS AND METHODS: 24 non-smoking healthy Bangladeshi male subjects participated in this open-label, randomized-sequence, single- dose, two-way crossover study. Subjects were randomly assigned to receive test formulation, followed by reference formulation or vice versa, as a single dose of 20 mg capsule after 12 h overnight fasting. A washout period of 1 week was maintained between the treatments. Blood samples were collected before study drug administration (baseline) and at 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 9.0, and 12.0 h after study drug administration. Serum omeprazole concentrations were determined using a validated HPLC method with UV detection. The pharmacokinetic parameters were determined by the non-compartmental method. The two formulations were to be considered bioequivalent if the 90% confidence intervals (CI) for the ln-transformed ratios of pharmacokinetic parameters were within the predetermined equivalence range of 80 - 125% according to the guidelines of the US Food and Drug Administration (FDA). Tolerability was assessed on the basis of adverse effects, monitoring vital signs, ECG and laboratory tests at baseline and after completion of the study with the assistance of registered physicians. RESULTS: All 24 subjects completed the study without any adverse effect reported. After administering a single dose of 20 mg of each omeprazole formulation, the obtained mean (SD) values for the test and reference products were 608.40 (116.37) and 588.56 (98.36) ng/ml for Cmax; 1.83 (0.25) and 2.00 (0.30) h for tmax; 1,635.77 (581.25) and 1,639.58 (652.54) h-ng/ml for AUC0-12; and 1,721.12 (572.07) and 1,805.58 (856.39) h-ng/ml for AUC(0-∞) respectively. The mean t(1/2) was 3.33 (1.61) and 3.57 (1.24) h for test and reference product respectively. From paired t-test, no significant differences were observed (p > 0.05) for any pharmacokinetic parameters. The point estimates (90% CI) for the test/reference ratios of the ln-transformed AUC(0-12), AUC(0-∞) and C(max) mean values were 100.73% (91.40 -111.01%), 98.29% (88.45 -109.24%) and 103.06% (99.05 - 07.24%) respectively, which fell within the predetermined FDA bioequivalence range of 80 - 125%. CONCLUSION: This single-dose study found that the test (Xeldrin®20) and reference (Losec®20) 20 mg capsule formulations of omeprazole in these fasting healthy male Bangladeshi subjects met the FDA regulatory criteria for bioequivalence.