Prescribers' compliance with summary of product characteristics of dabigatran, rivaroxaban and apixaban-A European comparative drug utilization study.

Despite a tremendous increase of direct oral anticoagulants (DOACs) prescriptions in recent years, only few data is available analysing prescribers' adherence to Summary of Product Characteristics (SmPC). We aimed to assess adherence to registered indications, contraindications, special warnings/precautions, and potential drug-drug interactions for three DOAC compounds (dabigatran, rivaroxaban, and apixaban) in six databases of five European countries (The Netherlands, United Kingdom, Spain, Denmark, and Germany). We included adult patients (≥18 years) initiating DOACs between 2008 and 2015. For several SmPC items, broad definitions were used due to ambiguous SmPC terms or lacking data in some databases. Within the study period, a DOAC was initiated in 407 576 patients (rivaroxaban: 240 985 (59.1%), dabigatran: 95 303 (23.4%), and apixaban: 71 288 (17.5%)). In 2015, non-valvular atrial fibrillation was the most common indication (>60% in most databases). For the whole study period, a substantial variation between the databases was found regarding the proportion of patients with at least one contraindication (inter-database range [IDR]: 8.2%-55.7%), with at least one special warning/precaution (IDR: 35.8%-75.2%) and with at least one potential drug-drug interaction (IDR: 22.4%-54.1%). In 2015, the most frequent contraindication was "malignant neoplasm" (IDR: 0.7%-21.3%) whereas the most frequent special warning/precaution was "prescribing to the elderly" (≥75 years; IDR: 25.0%-66.4%). The most common single compound class interaction was "concomitant use of non-steroidal anti-inflammatory drugs" (IDR: 3.0%-25.3%). Contraindications, special warnings/precautions, and potential drug-drug interactions were present in a relevant number of new DOAC users. Due to broad definitions used for some SmPC terms, overall proportions for contraindications are prone to overestimation. However, for unambiguous SmPC terms documented in the databases sufficiently, the respective estimates can be considered valid. Differences between databases might be related to "true" differences in prescription behaviour, but could also be partially due to differences in database characteristics.

Quality markers of drug information on the Internet: an evaluation of sites about St. John's wort.

PURPOSE: We aimed to evaluate websites about St. John's wort for the quality of their content, including accuracy as reflected by statement of correct indication and mentioning of interacting drugs, the presence of formal criteria as reflected by adherence to published standards for health information on the Internet, and the validity of individual formal criteria as markers of content quality. SUBJECTS AND METHODS: The Internet was searched with the metasearch engine WebFerret for sites about St. John's wort. A cross-sectional survey of a representative sample of randomly selected sites (n = 208) was performed. The main outcomes were the percentage of sites fulfilling the two criteria of content quality, the percentage of sites exhibiting eight formal criteria, and the associations between formal criteria and criteria of content quality, as determined by multivariate logistic regression analysis. RESULTS: Twenty-two percent (n = 45) of the websites correctly listed depression as the only indication for use of St. John's wort, and 22% (n = 46) identified at least one drug interaction with St. John's wort. Citing scientific publications was associated with mentioning the correct indication (odds ratio [OR] = 4.4; 95% confidence interval [CI]: 1.4 to 14) and mentioning of any interacting drug (OR = 6.0; 95% CI: 2.0 to 18). Absence of financial interest was associated with mentioning the correct indication (OR = 5.4; 95% CI: 2.2 to 14) and interacting drugs (OR = 3.1; 95% CI: 1.2 to 7.7). CONCLUSION: The content quality of sites about St. John's wort was generally poor. Our results suggest that Internet users should prefer noncommercial sites that reference the information to scientific publications when searching for drug information.