Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance.

Direct oral anticoagulants (DOACs) are increasingly used and are an important cornerstone in antithrombotic therapy. Adverse drug reactions (ADRs) such as bleedings have only partially been investigated during clinical trials. The primary goal was to analyse pharmacovigilance data based on spontaneous reports of gastrointestinal (GI) bleedings with DOACs reported to EudraVigilance. A second goal was to compare GI safety profiles between DOACs based on these signals. All DOAC related GI bleedings mentioned in individual case safety reports (ICSRs) from 2012 till 2017 in the European Economic Area were classified in four GI categories based on the reported site of occurrence of the haemorrhage. Age group and gender of the patient, seriousness and ADR outcome, and the reporter's qualification were assessed per category and per DOAC. Disproportionality analyses were performed to evaluate whether or not the reported ADRs were more prevalent with a given DOAC. ICSRs were bleeding-related in about half of the cases (n = 28,992/53,471). Of these bleedings, >25% was GI-related. Most patients experiencing GI bleedings were between 65 and 85 years old, with no obvious differences between men and women. Stomach, ulcer-related duodenal, and rectal bleedings were the most reported GI bleedings with a fatal outcome in 5.8%, 7.5%, and 9.8% of the cases for rivaroxaban, apixaban, and dabigatran, respectively. The disproportionality data suggest that dabigatran is more frequently involved in GI bleeding events than the other DOACs. DOACs were significantly associated with GI bleedings. Although the data should be interpreted with caution, it seems that dabigatran was associated more often than other DOACs with GI bleedings based on the analysis of spontaneous pharmacovigilance reports.

Pharmacists' involvement in COVID-19 vaccination across Europe: a situational analysis of current practice and policy.

One year since the emergence of the COVID-19 pandemic, rapid response measures have been implemented internationally to mitigate the spread of the virus. Following rapid and successful pre-clinical and human trials, several vaccines have been authorised for use across Europe through the European Medicines Agency and national regulatory authorities. Clinical trials have shown promising results including important reductions in disease severity, hospitalisation and mortality. In order to maximise the public health benefit of available vaccines, there is a pressing need to vaccinate a large proportion of the population. Internationally, this has prompted coordination of existing services at enormous scale, and development and implementation of novel vaccination strategies to ensure maximum inoculation over the shortest possible timeframe. Pharmacists are being promoted as healthcare professionals that enhance roll-out of COVID-19 vaccination programmes. This paper aims to summarise current policy and practice in relation to pharmacists' involvement in COVID-19 vaccination in 13 countries across Europe.

Qualitative study of medication review in Flanders, Belgium among community pharmacists and general practitioners.

Objective Examining the implementation barriers and facilitators of this service as provided by Belgian community pharmacists in collaboration with general practitioners. Setting Community pharmacies in Flanders. Method Qualitative study through interviews of pharmacists and general practitioners. Main outcome measure Opinions and experiences of pharmacists and general practitioners about type 3 medication review. Results Sixteen community pharmacists and thirteen general practitioners were interviewed and generally gave a positive assessment of the project. The general practitioners saw the pharmaceutical and pharmacotherapeutic recommendations of the pharmacists as an added value for the patients. The pharmacists indicated that performing an medication review was time-consuming, but that it improved their professional relationship with general practitioners and patients. They reported obstacles in obtaining information: cumbersome access to individual patient data (laboratory values) and difficulties in finding and choosing adequate medical information sources. Moreover, pharmacists indicated that there is a need for adequate reimbursement and additional training to make the implementation sustainable. Conclusion Both pharmacists and general practitioners were enthusiastic about medication reviews. The implementation improved the interprofessional collaboration. However, important barriers remain, such as the considerable investment of time and the difficulty in gathering all the necessary information. The sustainable implementation of type 3 medication review in Belgium requires adequate reimbursement and additional training.

Association of conflicting information from healthcare providers and poor shared decision making with suboptimal adherence in direct oral anticoagulant treatment: A cross-sectional study in patients with atrial fibrillation.

OBJECTIVE: To assess direct oral anticoagulant (DOAC) adherence and to determine possible determinants for suboptimal adherence in Dutch patients with atrial fibrillation (AF). METHODS: Cross-sectional study of DOAC users who completed a self-reported questionnaire. Adherence was measured with Morisky8-item Medication Adherence Scale (MMAS-8). Logistic regression analysis was conducted to investigate determinants affecting adherence. RESULTS: 398 DOAC users completed the questionnaire (mean age 70.6 ± 9.2years). Approximately one in four patients had suboptimal adherence (MMAS-8 < 8). Multivariable analysis showed that patients who felt to have received conflicting information about the treatment, patients with higher educational level and patients who were not sufficiently involved in the treatment choice had a higher odds of suboptimal adherence. CONCLUSION: DOAC adherence was suboptimal. Conflicting information received from different healthcare providers (HCPs), lack of shared decision making and the patients' educational level were determinants negatively affecting DOAC adherence. PRACTICE IMPLICATIONS: Efforts towards identifying suboptimally adherent DOAC patients are needed since they are at higher risk to develop thromboembolic events. Adherence counselling should be systematically and repeatedly encouraged and shared decision making should become more mainstream. Moreover, reinforced education of both patients and HCPs combined with interprofessional collaboration are potential solutions to prevent knowledge gaps and communication of conflicting information.

Community pharmacy-based study of adherence to non-vitamin K antagonist oral anticoagulants.

OBJECTIVE: This study aimed to assess implementation adherence (how well the patient's actual intake matches the prescribed dosing regimen) to non-vitamin K antagonist oral anticoagulants (NOACs) and to explore experiences with and beliefs about NOACs in a real-world sample of long-term NOAC users. METHODS: A cross-sectional observational study was conducted in home-dwelling adults who started taking a NOAC at least 1 year prior to inclusion. Pharmacy dispensing data were used to calculate the Medication Possession Ratio (MPR). Patients were recruited in 158 community pharmacies in Flanders, Belgium. They completed a questionnaire collecting basic characteristics and exploring self-reported adherence to NOACs (using the Medication Adherence Report Scale, MARS) and experiences with and beliefs about NOACs (using the Beliefs about Medicines Questionnaire, BMQ). RESULTS: A total of 766 patients (mean age 76.2±8.8 years, median CHA2DS2-VASc score 4 (IQR=3-4)) were included. The majority (93.5%) used NOAC for stroke prevention in atrial fibrillation. The median MPR was 95.2% (IQR=87.8-99.7) which corresponds with half of the study population not taking their NOAC on at least 17 cumulative days per year. Almost 21% of participants reported non-adherence on the MARS (score <25), with unintentional non-adherence (forgetfulness) most frequently reported (15.4%). Although two-thirds of NOAC users indicated to experience adverse drug reactions, the BMQ demonstrated a positive attitude towards NOAC therapy, where necessity beliefs outweigh the concerns. CONCLUSIONS: Our data indicate that long-term NOAC users have high implementation adherence and a positive attitude towards NOAC therapy. However, taking into account patients' thromboembolic risk and NOACs' short half-lives, further optimisation of NOAC use seems warranted in this population.

The patient pathway in cardiovascular care: A position paper from the International Pharmacists for Anticoagulation Care Taskforce (iPACT).

BACKGROUND: This position paper highlights the opportunistic integral role of the pharmacist across the patient pathway utilizing cardiovascular care as an example. The paper aims to highlight the potential roles that pharmacists worldwide can have (or already have) to provide efficient patient care in the context of interprofessional collaboration. METHODS: It results from a literature review and experts seeking advice to identify existing interventions and potential innovative interventions. We developed a conceptual framework highlighting seven critical phases in the patient pathway and for each of those listed some of the initiatives identified by our experts worldwide. RESULTS: Existing pharmacists' interventions in each of these phases have been identified globally. Various examples in the area of prevention and self-management were found to exist for long; the contribution for early detection and subsequently to timely diagnosis were also quite clear; integration of care was perhaps one of the areas needing greater development, although interventions in secondary care were also quite common. Tertiary care and end of life interventions were found to often be left for other healthcare professionals. CONCLUSION: On the basis of the findings, we can argue that much has been done but globally consider that pharmacists are still an untapped resource potentially useful for improved patient care.

Creating an Interprofessional guideline to support patients receiving oral anticoagulation therapy: a Delphi exercise.

Background Oral anticoagulation therapy has proven beneficial impact on the prevention of thromboembolic events. However, the use of antocoagulatns also increases the risk of bleeds. To maximize the benefits and minimize the risks of the treatment, guidance on appropriate use of oral anticoagulants is essential. An international guideline describing relevant components and requirements for pharmaceutical care for patients receiving a therapy woth oral antocoagulants would increase the quality of care. However, recommendations on pharmaceutical care for patients on anticoagulation is lacking. Objective This study aims to develop an interprofessional guideline to support patients in their use of oral anticoagulation therapy. Method Two systematic literature searches were performed on existing guidelines on the management and interventions to improve-oral anticoagulant use, to generate possible recommendations. Subsequently, an international expert panel with 26 pharmacists with extensive experience in clinical and/or scientific work on anticoagulation from a total of 22 European and 4 non-European countries was constituted. With this (geographically well distributed) expert panel, a four-round internet-based Delphi technique was conducted to reach consensus on their relevance. Items were ranked on a 1-10 scale of agreement. A median agreement score of ≥ 7.5 was considered the threshold for consensus. Levels of importance were rated on a 1-3 scale. Setting A global network of 26 pharmacists specialized in oral antocoagulation therapy. Main outcome measure Development of inter-professional guideline. Results After the four Delphi rounds 18 guideline recommendations were formulated. Consensus of opinion was achieved for all recommendations (median agreement: 8.5-10.0), whereas mean levels of importance were between 1.1 and 2.0 (SD: 0.2-0.7). The following domains were rated as most important targets for improving the care around oral anticoagulation: 'INR-monitoring', 'Transfer of care between health care settings', 'Adherence to medication', 'Patient communication and engagement', and 'Medication reconciliation and medication review'. Conclusion The 18 recommendations included in this guideline provide the base for optimization of anticoagulation care across different countries/healthcare systems. Future work involves translating the guideline recommendations into clinical practice. Once implemented, the recommendations of the guideline will support health care providers with the pharmaceutical care for patients on, oral anticoagulation which will improve the effective and safe use of these medicines.

Correction to: Pharmacists' confidence when providing pharmaceutical care on anticoagulants, a multinational survey.

In the original publication of this article, the article note has been missed and published online.

Pharmacists' confidence when providing pharmaceutical care on anticoagulants, a multinational survey.

Background Guidelines on the management of orally anticoagulated patients are continuously evolving, leading to an increased need for pharmacists to be fully integrated in care provision. Objective To identify self-reported gaps in confidence among practicing pharmacists in the area of anticoagulation. Setting Pharmacists in different work settings in different countries. Method Cross-sectional international survey from October 2015 till November 2016 among pharmacists working in different settings to assess their level of confidence when delivering anticoagulants as well as to identify possible educational needs regarding this medication class. Validation of the survey was ensured. Results Responses from 4212 pharmacists originating from 18 countries were obtained. Pharmacists' level of confidence was significantly higher (p < 0.001) when advising patients on vitamin K antagonists (VKAs) versus non-vitamin K antagonists (NOACs). In general, hospital pharmacists displayed higher confidence levels compared to community pharmacists when advising patients on anticoagulation (p < 0.001). Two distinct patterns of confidence levels emerged relating to basic and advanced pharmaceutical care. Confidence levels when providing advanced pharmaceutical care were significantly higher for Oceania and lower for South America (p < 0.005). Conclusions Pharmacists felt more confident in supporting patients receiving VKAs compared to the more recently introduced NOACs. With the increasing use of NOACs and the risks pertaining to anticoagulation therapy, it is essential to invest in education for pharmacists to address their knowledge gaps enabling them to confidently support patients receiving oral anticoagulants.