Off-label indications of aspirin in gynaecology and obstetrics outpatients at two Chinese tertiary care hospitals: a retrospective cross-sectional study.

OBJECTIVE: To investigate the prevalence of off-label aspirin indications and the level of scientific support for off-label indications of aspirin in gynaecology and obstetrics outpatients. DESIGN: A retrospective cross-sectional study. SETTING: Two tertiary hospitals (a general hospital and a women and children's specialised hospital) in Xiamen, a city located on the southeastern coast of China. PARTICIPANTS: A total of 4257 prescriptions were included for 2091 female patients aged >18 who visited the gynaecology and obstetrics outpatient clinics and received aspirin treatment. OUTCOME MEASURES: The primary measure of this study was the proportion of off-label indications and of off-label indications supported by strong scientific evidence. Evidence from clinical guidelines and Micromedex is shown using descriptive statements. On-label indications of drugs in the same class as aspirin were also referred to for off-label aspirin use without strong evidence support. RESULTS: All indications of aspirin on outpatient prescriptions were determined as off-label use in this study. The most frequent off-label indication was recurrent miscarriage (2244 prescriptions, 52.71%). Totally, 30.94% of the prescriptions were supported by strong evidence for indications, including recurrent miscarriage with antiphospholipid syndrome and prophylaxis for pre-eclampsia. No drugs in the same class as aspirin had on-label indications for off-label aspirin use without strong evidence support. CONCLUSIONS: This study demonstrated that all indications of aspirin used in gynaecology and obstetrics outpatients at the two tertiary hospitals were off-label and not always supported by strong evidence, implicating that physicians should be cautious when issuing off-label prescriptions. More original clinical research on off-label aspirin use is needed to provide reference for routine clinical practice.

Off-label use of tamoxifen in a Chinese tertiary care hospital.

Background Tamoxifen is an estrogen receptor modulator used for the treatment of breast cancer; however, currently, it is used in many off-label indications. Objective To investigate the prevalence of tamoxifen off-label prescribing and explore available scientific evidence that supports those uses in outpatients. Setting Xiamen maternity and child health care hospital in Xiamen city of China. Method All the prescriptions of outpatients receiving tamoxifen were exported from an electronic prescribing system during a 1-year period. Tamoxifen use was then classified as either on- or off-label according to the criteria we established previously, and the details of the off-label prescriptions were collected. Logistic regression was applied to explore predictive variables. Evidence search was limited to Up-To-Date, the Micromedex database and PubMed. Main outcome measure The rate of off-label use, risk factors identified by logistic regression and evidence exhibition. Results A total of 75% of all the prescriptions available were classified as off-label use. Hyperplasia of the breast was the most frequently prescribed off-label indication. According to the analysis of logistic regression, male patients, patients less than 34 years old, and physicians with a higher professional title were more likely associated with off-label prescribing. After a search in Up-To-Date, the Micromedex database and PubMed, only male infertility, atypical hyperplasia, mastodynia, peripheral precocious puberty and gynecomastia were found to have strong evidence supporting the use of tamoxifen off-label (22.75%). Conclusion Although the off-label use of tamoxifen was common in our hospital, there was a relative shortage of evidence available supporting those uses.

Prescribing errors in electronic prescriptions for outpatients intercepted by pharmacists and the impact of prescribing workload on error rate in a Chinese tertiary-care women and children's hospital.

BACKGROUND: Prescribing errors may, influenced by some risk factors, cause adverse drug events. Most studies in this field focus on errors in prescriptions for hospital inpatients, with only a few on those for outpatients. Our study aimed to explore the incidence of prescribing errors in electronic prescriptions and illustrate the trend of prescribing workload and error rate over time. METHODS: The cross-section study was performed between September, 2015 and November, 2015. Prescribing errors were intercepted by pharmacists using a prescription reviewing system under which prescriptions with errors were transferred to a specific computer and recorded by another pharmacist and the incidence of total prescribing errors and severe errors was then calculated. A subgroup analysis was conducted in accordance to the number of drug orders, the age group of patients, the seniority of physicians, the specialty of physicians, the working day when prescriptions were issued, and the prescribing workload of physicians. A time-series analysis was employed to analyze the trend of prescribing workload and error rate, and the correlation between them. RESULTS: Totally, 65,407 patients were included in this study and 150,611 prescriptions with 294,564 drug orders (including 584 different drugs) were reviewed for identification of errors. A total of 534 prescribing errors (an error rate of 0.34%) were identified. Severe errors accounted for 13.62% of total errors. The subgroup analysis showed prescriptions of multiple drug orders, for pediatric patients aged 29 days to 12 years, from physicians specializing in ophthalmology and otorhinolaryngology, or prescribing on weekdays were more susceptible to errors. A time-series analysis demonstrated no correlation between prescribing workload and error rate which increased at the end of each working shift while prescribing workload decreased. CONCLUSION: Less than 1% of the studied prescriptions came with errors among which one in seven were severe ones. But prescribing errors were in no relation to workloads. What's more, further studies are needed to investigate pharmacist-led intervention to reduce prescribing errors.