Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK.

INTRODUCTION: Healthcare professionals (HCPs) and patients have various motives to report adverse drug reactions (ADRs) to their national agency. These motives may differ between countries. OBJECTIVE: The aim of this study was to assess to what extent motives of HCPs and patients to report ADRs differ between countries. METHODS: HCPs and patients from Croatia (HR), The Netherlands (NL), and the UK were asked to complete a web-based survey containing questions regarding demographics and ADR reporting. HCPs and patients could select all motives for reporting that applied to them, with a total of 23 and 24 motives, respectively. Descriptive statistics are presented and Chi-square tests were used to test for differences across the countries, with effect sizes calculated using Cramer's V. RESULTS: In total, 296 HCPs and 423 patients were included (60% and 32% from Croatia, 19% and 44% from NL, and 21% and 24% from the UK, respectively). For most of the motives to report or not to report an ADR, there were no differences between countries. Most HCPs from all countries would be motivated to report an ADR if there was a strong suspicion of causality (89%), if it concerned a severe/serious ADR (86%), and if it concerned an ADR for a new, recently marketed drug (77%). Most patients from all countries agreed that they would report an ADR if it concerned a severe ADR (96%), if the ADR influenced their daily activities (91%), and if they were worried about their own situation (90%). Differences across the countries (p < 0.05 and V ≥ 0.21) were observed for three and four of the HCP and patient motives, respectively. For HCPs, these differences were seen in motives related to legal obligation (65% HR, 24% NL, 38% UK), black triangle medicines (27% HR, 4% NL, 77% UK), and the reporting of well-known ADRs (53% HR, 85% NL, 69% UK). For patients, these differences were seen in motives related to a linkage between the ADR report and the medical notes (59% HR, 60% NL, 30% UK), complexity and time taken to report (25% HR, 13% NL, 40% UK), medicines purchased on the internet (59% HR, 39% NL, 65% UK), and the reporting of embarrassing ADRs (32% HR, 11% NL, 35% UK). CONCLUSIONS: HCPs' and patients' motives to report or not to report ADRs to the national agency were mostly similar across the three countries. Such motives can be used in general strategies to promote and increase ADR reporting. The observed differences provide guidance to further fine-tune ADR reporting at a national level.

Correction to: Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

In the original publication of the article, the headings of columns 3 and 4 in the data table.

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

INTRODUCTION: National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. OBJECTIVE: The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. METHODS: GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ2 test per country and post hoc Pearson χ2 tests in the case of statistically significant differences. RESULTS: Of the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs' awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91% aware of the diclofenac issue to 66% of the ivabradine issue). Cardiologists' awareness ranged from 91% for the ivabradine issue to 34% for the valproate issue. Overall, DHPCs were a common source through which GPs (range: 45% of those aware of the contraceptives issue to 60% of those aware of the valproate issue), cardiologists (range: 33% for the contraceptives issue to 61% for the valproate issue), and pharmacists (range: 41% for the contraceptives issue to 51% for the ivabradine issue) had become aware of the specific safety issues, followed by information on websites or in newsletters. CONCLUSIONS: GPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic area but with risks related to their field of specialisation. DHPCs were an important source for the different professions to become aware of specific safety issues, but other sources were also often used. NCAs should consider the use of a range of sources when communicating important safety issues to HCPs.

Communication on Safety of Medicines in Europe: Current Practices and General Practitioners' Awareness and Preferences.

INTRODUCTION: National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). OBJECTIVE: The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs' awareness of and preferences for safety communications on medicines. METHODS: Web-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, The Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters, and/or in a direct email. From this survey, data from GPs were used and descriptive analyses were conducted. RESULTS: Current NCA practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs, i.e. urgent communication letters for serious safety issues) on their website in addition to distribution to individual HCPs. Educational materials were available on the NCA's website in 10 countries (40%), and 21 NCAs (81%) indicated they had their own bulletin/newsletter, which is often presented on the NCA's website (15 countries; 60%). More than 90% of the 1766 GPs who completed the survey were aware of DHPCs. The most preferred senders of safety information were NCAs and professional bodies, while the preferred channels for keeping up to date with safety information were medicines reference books and clinical guidelines. GPs found the repetition of safety issues useful (range of 80% in the UK to 97% in Italy). Preference for an electronic copy rather than a hardcopy varied per country (36% in Sweden to 72% in Spain). CONCLUSIONS: NCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country.

Type a Personality, Stress, Anxiety and Health Locus of Control in Patients with Acute Myocardial Infarction.

BACKGROUND: The aim of this study was to define the level of patient exposure to stress in the previous 5 years before acute myocardial infarction (AMI), personality type A assessment, ways of coping with stressful situations, health locus of control and the grade of anxiety (as state and personality trait). SUBJECTS AND METHODS: 118 patients who were consecutively hospitalized during 8 months in our Coronary care unit due to AMI, took part in the study. As controls we examined 103 healthy male volunteers (mean age 60.8±2.93 years). RESULTS: AMI patients presented with higher degree of behavior corresponding to type A personality (F=18.756, p=0.000), and also showed higher degree of anxiety, as state and personality trait (F=23.634, p=0.001; F=19.253, p=0.000), in comparison to healthy controls. Also, AMI patients were significantly more often coping emotionally in stressful situations than control subjects (F=21.354, p=0.000), and they had significantly higher external locus of control compared to healthy subjects (F=13.284, p=0.001). They often considered that they were not able to control their health, namely they evaluated their ability to control their health as weak and were much more often directed to cope with intense emotions (r=0.24, p=0.002). CONCLUSIONS: The study showed that AMI patients psychologically differed from the healthy controls, indicating that they were prone to maladaptive behavioral patterns which could favor development and complicate course of coronary artery disease.

Community nurse assessment of cardiovascular behavioural risk factors--a qualitative analysis within the CroHort study.

The aim of our study was to identify major determinants of cardiovascular behavioural risk factors among subjects at increased risk of cardiovascular disease (CVD). The data for the qualitative analysis were obtained from the Croatian Adult Health Cohort Study (CroHort). The data analysis was based on the principles of Grounded Theory. We have generated the concept of an individual in a vicious circle of risky health behaviour, defined by the low level of motivation and unfavourable personal characteristics which in interaction with unsupportive social environment adversely influence one's health behaviour, leading to negative health outcomes that produce negative effects on one's motivation and social environment. Community nurses assessed that the respondents often weren't adequately recognising their CVD risk and were very reluctant about the change in their risky habits. Our results are supported by the quantitative analysis and are complementing other analyses of the cardiovascular risks within the CroHort study.

Five-year cumulative incidence of physical inactivity in adult Croatian population: the CroHort study.

The aim of this study was to analyze gender and age differences in physical inactivity in Croatia and physical inactivity pattern changes during the five-year period. The study is based on the data obtained from the Croatian Adult Health Cohort Study which was carried out in 2003 and 2008. The prevalence of physical inactivity in 2008 was 37.7%, 36.8% in men and 38.1% in women. In both study waves the prevalence was increasing with age in both men and women. The prevalence is statistically significantly higher in subjects older than 64 years than in younger age groups. The incidence of physical inactivity in the five-year period in total was 29.9%, 27.2% in men and 31.1% in women. The increase in prevalence of physical inactivity despite the number of preventive activities carried out periodically emphasizes the need for systematic and comprehensive approach in increasing the number of regularly physically active individuals.

Cardiovascular diseases, risk factors and barriers in their prevention in Croatia.

Cardiovascular diseases are the leading cause of death in Croatia, with significant regional differences. Despite high mortality rates, high prevalence of various cardiovascular risk factors and well organized public health network, comprehensive system for cardiovascular disease monitoring and interventions does not exist. In this study we analyzed legislation framework and responsibilities of stakeholders relevant for cardiovascular disease surveillance and prevention. According to the international experiences we analyzed characteristics of cardiovascular disease prevention in Croatia and causes of the problems appeared in the preventive programs in Croatia. Analysis showed that primary problem is not inefficiency, but the existence of barriers in preventive activities definition, responsibilities distribution and task implementation. Main cause for such situation is incompatibility of the existing practices in clinical medicine and public health with recommendations from other countries. For the successful prevention of cardiovascular disease in Croatia at least three changes need to be made--define new terms and contents of prevention, define new responsibilities distribution and provide equity in health as basic criterion for successful preventive programs.