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

Abstract

IntroductionNational 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.ObjectiveThe 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.MethodsGPs, 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.ResultsOf 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.ConclusionsGPs, 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 ar...

Implications of Direct Healthcare Professional Communication in Egypt: barriers and preferences of Health Care Professionals

“…Around half of the tested sample (N= 254, 58.7%) declared that they were aware of concerned safety issues, which was a comparable percentage to that found in Netherland study [11], where the awareness of most HCPs with all four safety issues ranged from (56% to 88%), while a higher percentage of (92%) was detected in the European study [14]. Generally in the current study, for the ten tested DHPCs, the sources of such information varied between HCPs where DHPC comprised (N= 149, 36.9%) compared to other sources (conferences, media, journals, colleagues, books and internet) that comprised (N= 149, 61.1%.)…”

“…This study aimed to assess the HCPs' preferences and knowledge of DHPC and to detect barriers hindering the success of DHPC in Egypt. Three other studies were performed for a similar purpose, one in Netherland [11], another in Ghana [4] and a recent one conducted in nine European countries [14]. In the current study, HCPs of different specialties (internists, cardiologists, neurologists, pediatricians, and other specialties), with different experience years (< 20 and ≥ 20 years), several scientific degrees (Bachelor, Masters and Medical Doctorate (MD) degree), worked at different health institutions (university hospitals, educational institutes, and ministry of health) were surveyed through face-to-face interview.…”

“…On the other hand, in the Netherland study (2012) [11], professional journals were the major source of concerned information (59%), followed by DHPC (49%). Later, in 2018, the European study showed that the DHPC was the main source of information followed by messages on websites or in a newsletter or medical journal [14]. This highlights the urgent need for improving the current risk communication method by using additional/complementary sources of information together with DHPC in Egypt.…”

“…Hence, some studies recommended the use of an additional method with DHPC for better risk communication. [4,11,14,15]. To date, the use of DHPC has never been evaluated in Egypt.…”

Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

“…[28] Despite this, it appears that DHPCs represent the most common source of awareness of medicines' safety issues among European GPs, pharmacists and cardiologists. [29] Previous research has indicated that such communications have greater impact on non-specialist drugs and for safety issues with a risk of death and/or disability, [8] however to date, the relationship between characteristics of DHPCs and variation in outcomes has not been evaluated. Further research should also evaluate additional interventions to communicate safety information to healthcare professionals in cluster or stepped wedge randomised controlled trials.…”