A chart review was conducted for pediatric patients with cystic fibrosis who were admitted to the Children’s and Women’s Health Centre of British Columbia between June 1, 2001, and October 1, 2005. This study period was selected to capture data before and after the previously described case that had precipitated routine monitoring of prolactin in patients with cystic fibrosis who were receiving domperidone. Patients who were receiving domperidone and for whom prolactin level had been measured at least once were included in the chart review. Patients who did not have cystic fibrosis were excluded because only patients who had this disease and were receiving domperidone therapy routinely underwent prolactin monitoring at this institution. A list of all inpatients for whom domperidone therapy had been prescribed during the study period was obtained from records in the Pharmacy Department, and a list of all patients who had had samples drawn for determination of prolactin level was obtained from the Department of Pathology and Laboratory Medicine. Only inpatients were included, as laboratory records from outside the institution (especially for patients referred from outside the hospital’s immediate geographic location) were not readily available for review. The 2 lists were cross-referenced to generate a final list of patients whose charts were retrieved for review.Data collected in the chart review included demographic characteristics, medication history, domperidone doses, frequency of administration, duration of therapy, serum prolactin values, and the times at which the samples were drawn for serum prolactin determination. Data reflecting the efficacy of domperidone therapy (e.g., gastric emptying scans, reflux studies, severity of symptoms), any reported toxic effects of domperidone (e.g., signs or symptoms associated with abnormal serum prolactin levels), and patients’ compliance with the regimen were also captured. official canadian pharmacy
All measurements of serum prolactin were obtained using the Beckman Access Immunoassay System (Beckman Instruments, Inc, Fullerton, California), a paramagnetic- particle chemiluminescent immunoassay system that quantifies serum prolactin levels within the range of 0.25 to 200 Hg/L. All prolactin values were compared with the laboratory’s normal reference ranges as follows: 2.6—13.1 Hg/L for males and 3.3—26.7 Hg/L for premenopausal females.
The way in which prolactin values were used for monitoring was characterized by calculating the percentage of patients with elevated prolactin levels and the percentage of elevated values that resulted in dosage adjustment, and by evaluating the results for dual samples drawn from patients for whom within- range prolactin levels had raised questions about patient compliance. Appropriateness of therapy was evaluated by considering how the prolactin values had been interpreted.
Medians and ranges were calculated for nonparametric data.