Anticoagulant-associated adverse drug reactions in 2013-15. / Bivirkninger ved bruk av antikoagulasjonsmidler i 2013­15.

BACKGROUND: The aim of this study was to obtain a better insight into the adverse effects profiles of the new direct-acting oral anticoagulants (DOACs). MATERIAL AND METHOD: A review was undertaken of all reports of adverse effects for warfarin, dabigatran, rivaroxaban and apixaban reported to the regional medicines information and pharmacovigilance centres (RELIS) in the period June 2013-May 2015. RESULTS: Approximately 65 000 persons used direct-acting oral anticoagulants and 80 000 used warfarin in the period of the study. A total of 409 reports of adverse effects were included. Altogether 55 % of the reports applied to men. In 76 % of the reports for direct-acting oral anticoagulants and 85 % for warfarin, the patients were more than 70 years of age. The most common adverse effects were haemorrhages (48 % for direct-acting oral anticoagulants and 75 % for warfarin), most of which were cerebral haemorrhages (91 for direct-acting oral anticoagulants and 92 for warfarin). Blood clots (therapeutic failure), cognitive effects, headache and hair loss were some of the other adverse effects. The highest comorbidity was among the patients who died. The number of reported deaths was highest for rivaroxaban (1.1 deaths/1000 users) with a declining incidence for apixaban (0.9 ‰), dabigatran (0.7 ‰) and warfarin (0.6 ‰). There were different degrees of reporting for these medications, and the spontaneous reporting system cannot therefore be used to compare the incidence of adverse effects for the drugs. INTERPRETATION: Adverse effects, including serious effects, may occur when using all anticoagulants. Factors that may increase the risk of adverse effects are advanced age, high comorbidity, reduced renal function, and polypharmacy.

Prescribing of NOACs has outnumbered warfarin: exploring how physicians choose anticoagulant treatments.

PURPOSE: The development of non-vitamin K-dependent oral anticoagulants (NOACs) is a new alternative to treatment with warfarin. The purpose of this study was to explore drug prescription decisions of NOACs or warfarin from hospital physicians in cardiovascular departments. METHODS: A qualitative study with focus group interviews was conducted in three different hospitals. The interview guide explored the background of prescribing anticoagulants (warfarin, dabigatran, rivaroxaban, and apixaban) and experiences with effect and side-effects they had observed in patients. RESULTS: The systematic text condensation eluded four main themes: when to prescribe NOACs, concern about side-effects, pharmaceutical properties and patient adherence, and prescribing policy and intra-professional communication. All available anticoagulants were prescribed. However, no specific NOAC was preferred. Factors perceived as contraindications for NOACs varied among the doctors. Most had observed side-effects of NOACs; however, these rarely influenced prescribing decisions due to small differences in safety profiles. Few drug-drug interactions and fixed daily doses made NOACs easy to prescribe; but some doctors had experienced lack of drug effect for some patients. Non-adherence with NOACs was harder to spot. Some different prescribing cultures had evolved between the different hospitals and between general practitioners. CONCLUSION: The hospital physicians chose anticoagulants based on patient conditions as renal function, bleeding risks, and drug interactions being the most common taken into account. They could not say which NOAC was best, and wish that future studies could compare the different NOACs, and not just compare with warfarin.

How are drug regimen changes during hospitalisation handled after discharge: a cohort study.

OBJECTIVES: To investigate drug regimen changes during hospitalisation and explore how these changes are handled after patients are transferred back into the care of their general practitioners (GPs). DESIGN: Cohort study. SETTING: Patients in this multicentre study had undergone at least one change in their drug regimens at discharge from the general medicine departments at six hospitals in Norway. These changes were altered doses, discontinuation of drugs or start of new drugs. Clinical pharmacists visited the patients' GPs 4-5 months after patient discharge and recorded any additional drug regimen changes. RESULTS: In total, 105 patients (mean age 76.1 years, 54.3% women) completed the study. On average, they used 5.6 drugs at admission (range 0-16) and 7.6 drugs at discharge (range 1-17). On average, 4.4 drug changes per patient (SD 2.7, range 1-16) were made at the hospital, and 3.4 drug changes per patient (SD 2.9, range 0-14) within 4-5 months of discharge. Of the 465 drug changes made in hospital, 153 were changed again after discharge (mean 1.5 per patient, SD 1.8, range 0-13). The drug regimens of 90 of these 105 patients were changed after discharge. The OR for extensive drug changes after discharge (≥ 4 changes) increased significantly with the number of drugs used at discharge from hospital (OR=1.29, 95% CI 1.04 to 1.59). Only 68 of 105 discharge notes contained complete drug lists, and only 24 of the discharge notes were received by the GPs within 7 days. CONCLUSIONS: In addition to the extensive changes in drug regimens during hospitalisation, almost equally extensive changes were made in the initial months after discharge. Surveillance of drug regimens is particularly necessary in the period immediately after hospital discharge.