Dataset Information

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

ABSTRACT: 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.

SUBMITTER: de Vries ST

PROVIDER: S-EPMC5519651 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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

de Vries Sieta T ST van der Sar Maartje J M MJM Cupelli Amelia A Baldelli Ilaria I Coleman Anna Marie AM Montero Dolores D Šipić Ivana I Andrić Adriana A Wennberg Annika A Ahlqvist-Rastad Jane J Denig Petra P Mol Peter G M PGM

Drug safety 20170801 8

<h4>Introduction</h4>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).<h4>Objective</h4>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.<h4>Metho ...[more]

PMID: 28540672

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Project description: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 ?2 test per country and post hoc Pearson ?2 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.

Project description:ObjectivesTo develop a programme theory for the intervention of patients receiving discharge letters.DesignWe used a realist evaluation approach and captured multiple perspectives of hospital discharge to refine our previously developed programme theory. General practitioner (GP), patient and hospital clinician views of a single discharge event in which they were all involved were collected using semi-structured interviews and surveys. These were then triangulated to match the corresponding discharge letter. Data were qualitatively synthesised and compared in meta-matrices before interrogation with realist logic of analysis to develop the programme theory that maps out how patients receiving discharge letters works in specific contexts.Setting14 GP practices and four hospital trusts in West Midlands, UK.Participants10 complete matched cases (GP, patient and hospital practitioner), and a further 26 cases in which a letter was matched with two out of the three participants.ResultsWe identified seven context mechanism outcome configurations not found through literature searching. These related to the broad concepts of: patient preference for receiving letters, patient comprehension of letters, patient-directed letters, patient harm and clinician views on patients receiving letters. 'Patient choice' was important to the success (or not) of the intervention. Other important contexts for positive effects included: letters written in plain English, lay explanations for jargon, verbal information also provided, no new information in letter and patient choice acknowledged. Three key findings were: patient understanding is perhaps greater than clinicians perceive, clinician attitudes are a barrier to patients receiving letters and that, negative outcomes more commonly manifested when patients had not received letters, rather than when they had.ConclusionsWe suggest how patients receiving discharge letters could be improved to enhance patient outcomes. Our programme theory has potential for use in different healthcare contexts and as a framework for policy development relating to patient discharge.

Project description:Introduction:There are increasing concerns regarding the inappropriate use of medicines with expenditure continuing to grow driven by increasing sales in oncology and orphan diseases, enhanced by their emotive nature. As a result, even high income countries are struggling to fund new premium priced medicines. These concerns have resulted in initiatives to better manage the entry of new medicines and enhance the rational use of medicines (RUM). However, there is a need to ascertain the current situation. We sought to address this by developing the Current Obstacles for Rationalizing Use of Medicines in Europe (CORUM) mapping tool to qualitatively investigate the current situation and provide analysis of current views on RUM and interventions among key European payers and their advisers. The findings will be used to provide future guidance. Methodology:Descriptive study exploring and identifying perceived gaps to achieving optimal RUM. The CORUM tool was based on the WHO 12 key interventions to promote RUM. Results:62 participants took part with most respondents believing their country could improve RUM capacity. This included educational initiatives on the use of clinical guidelines (90%) and the inclusion of problem-based pharmacotherapy in undergraduate curricula and for Continued Professional Development. Key challenges included a lack of regular updates of guidelines, exacerbated by limited funding and a lack of follow-up to monitor adherence to agreed guidelines. RUM could also be enhanced by the development of regional formularies as well as implementing Drug and Therapeutic Committees where these are currently limited. There also needs to be greater co-ordination between RUM and Health Technology Assessment activities, with countries learning from each other. Conclusion:There is an urgent need to improve RUM through improved educational and other activities among European countries, with countries learning from each other. This will involve addressing current challenges and we will be following this up.

Dataset Information

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

Publications

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

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