Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study

Duarte, Maria Eduarda; Ferreira, Paula Costa; Soares, Maria Augusta; Cavaco, Afonso; Martins, Ana Paula

doi:10.1007/s40267-015-0227-8

Cited by 21 publications

(51 citation statements)

References 36 publications

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“…In Malaysia, the percentage of reporting was less than those in the UAE and Saudi Arabia, which was 12.9% of the sample . However in Portugal, reporting was better and higher than Malaysia and Saudi Arabia but lower than the UAE, and it reached 38.3% of the surveyed pharmacists . In the UK, the percentage of reporting was better than the UAE, as it was found that 45% of surveyed pharmacists had reported ADEs during the last 3 months of practice …”

Section: Discussionmentioning

confidence: 99%

“…Many international studies were done to identify the barriers towards ADR reporting by healthcare providers and their perspectives in their role of ADR reporting, as well as to highlight its importance in enhancing the safety of medications . In a study conducted in the Eastern region, Saudi Arabia, Khan found that 90% of the pharmacists were not aware of pharmacovigilance and ADR reporting system and 30% were not serious in reporting the events associated with the medications.…”

Section: Introductionmentioning

confidence: 99%

“…The factors shown to hinder ADR reporting to a high extent in Portugal were found to be lack of knowledge about the relationship between ADEs and used drug and inability to detect ADEs in 31.2% of the pharmacists followed by claiming that ADR reporting is time‐consuming in 22.1% of the respondents and then believing that an ADE is expected and known and does not need to be reported in 18.2% of the participants. Other factors that were found to affect ADR reporting insignificantly were complication of the process (12.3%), lack of knowledge of ADR reporting process (9.1%), no response from drug regulatory authorities to which ADR reports were submitted (4.5%) and lack of pharmacotherapeutic knowledge (1.9%) . In the UK, pharmacists believed that lack of time (46.4%) and thinking that ADEs were not serious enough to report (65.2%) were the main barriers towards ADR reporting .…”

Section: Introductionmentioning

confidence: 99%

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Barriers to adverse drug reaction reporting in community practice in the UAE

Alnajjar

Zamzoum

Saeed

2019

J Pharm Health Serv Res

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Objectives This study was aimed at quantification of the pharmacists under-reporting in the UAE community practice, and how do they respond to adverse drug events (ADEs) and the factors behind their acts. Methods A questionnaire-based technique is implemented in this study to quantify the factors contributing to under-reporting of pharmacists in the UAE. The questionnaire is randomly distributed to a sample of 230 pharmacists throughout the UAE. Pharmacists responded either online or manually. Chi-square and logistic regression analysis are used to quantify the collected data. Key findings A statistical analysis of a sample of 230 pharmacists, surveyed randomly, shows that 87.4% of them responded to the questionnaire, 73.6% follows the ADEs seriously, only 48.8% practiced reporting within the last 12 months while the remaining have not responded at all. The complexity of the reporting process, lack of reporting skills and graduation from outside UAE were identified as factors contributing significantly to non-reporting. Conclusions Place of graduation, the complexity of the reporting process and lack of reporting skills were identified as the main barriers hindering ADR reporting. To overcome these difficulties and enhance the reporting level, training programmes on P.V. system, spontaneous reporting and professional guidance of pharmacists should be implemented.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Barriers to adverse drug reaction reporting in community practice in the UAE

Alnajjar

Zamzoum

Saeed

2019

J Pharm Health Serv Res

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“…Issue of under‐reporting of ADRs among healthcare professional was explored by several studies from other nations . In Yemen, to the best of our knowledge, this is the first study conducted among pharmacists practicing in both community and hospital settings from five governorates which aimed at evaluating the knowledge, attitude and practice of both community and hospital pharmacists with regard to pharmacovigilance and ADRs reporting, in addition to determine the barriers towards reporting ARDs.…”

Section: Discussionmentioning

confidence: 99%

“…Issue of under-reporting of ADRs among healthcare professional was explored by several studies from other nations. [21][22][23][24][25][26][27][28][29] In Yemen, to the best of our knowledge, this is the first study conducted among pharmacists practicing in both community and hospital settings from five governorates which aimed at evaluating the knowledge, attitude and practice of both community and hospital pharmacists with regard to pharmacovigilance and ADRs reporting, in addition to determine the barriers towards reporting ARDs. This issue is critical to ensure an effective pharmacovigilance activity because knowledge of pharmacist will reflect the efficiency of ADRs reporting and thus affect the consequences resulted from under-reporting of ADRs.…”

Section: Discussionmentioning

confidence: 99%

Pharmacists' knowledge and perceptions about pharmacovigilance and barriers towards adverse drug reactions reporting in Yemen

Zawiah

Mukred

Al-Jamei

et al. 2018

Journal of Pharmaceutical Health Services Research

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Objective The current study aims to assess Yemeni pharmacists’ knowledge, attitude and practice of adverse drug reactions (ADRs) reporting systems and to determine barriers hindering them from reporting. Methods A cross‐sectional descriptive study was conducted between August and October 2017. One hundred sixty‐two pharmacists practicing in both community and hospital settings were recruited from five governorates using a convenient sampling technique. A validated self‐administered questionnaire was used to collect data and to achieve the study objectives. Descriptive analysis was done using Statistical Package for Social Science version 20. Key findings Out of 260 questionnaires distributed, 162 pharmacists responded (Response rate of 62.3%). In terms of knowledge, 156 (96.3%) were not aware of the existence of ADRs reporting system in Yemen. The overall average knowledge score among pharmacists was 1.2 (SD = 1.2) out of 7. Concerning practice, about (140, 87.0%) of pharmacists disclosed that patients reported at least one ADRs annually. Insufficient clinical knowledge of pharmacist, unavailability of ADRs reporting form and unawareness of existence of the national ADRs reporting system were noticed to be the main barriers towards ADRs reporting. Conclusions Most of pharmacists were unaware of the ADRs reporting system in Yemen. However, advertising, education and intensive training are needed to improve awareness and to ensure an effective ADRs reporting process.

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Pharmacovigilance in the European Union

Kaeding¹,

Schmälter²,

Klika³

2017

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Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study

Cited by 21 publications

References 36 publications

Barriers to adverse drug reaction reporting in community practice in the UAE

Barriers to adverse drug reaction reporting in community practice in the UAE

Pharmacists' knowledge and perceptions about pharmacovigilance and barriers towards adverse drug reactions reporting in Yemen

Pharmacovigilance in the European Union

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