Adverse drug reaction reporting for more than a decade: The need for pharmacovigilance policy implementation in Turkey

Khan, Zakir; Karataş, Yusuf

doi:10.1016/j.jtumed.2021.12.009

Cited by 1 publication

(4 citation statements)

References 11 publications

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“…Various studies have found similar trends, with the majority of HCPs failing to report any ADR despite encountering it during their practice [15,17,37,47]. The rate of ADR reporting by various HCPs is very low in many countries [18,32,48,49] including Tu ¨rkiye [20][21][22]50]. Our finding revealed that a higher proportion of pharmacists (55%) reported ADRs as compared to other HCPs.…”

Section: Plos Onesupporting

confidence: 65%

“…In Türkiye, TÜFAM is primarily responsible for educating and training of HCPs. Additionally, supporting stakeholders including medical schools, pharmacology departments, and hospital PV centers are also accountable for PV-based awareness programs [ 10 , 21 ]. However, TÜFAM and other stakeholders are unsuccessful to arrange training, education sessions, and reviews of HCPs’ actions in a timely and systematic way [ 9 , 20 ].…”

Section: Discussionmentioning

confidence: 99%

“…According to recent data conveyed by Türkiye to the WHO-Upsala Monitoring center (WHO-UMC), the reported ADRs per million population/year for the years 2017, 2018, 2019, 2020, 2021 and 2022 were 84, 94, 99, 89, 91 and 105 respectively [ 21 , 22 ]. However, still, Türkiye ’s reporting rate of ADR is significantly lower than the WHO-UMC’s suggested ideal value (200 ADR reports per million/year) [ 21 , 23 – 25 ]. More proactive initiatives and policy implementations are needed to encourage PV knowledge and ADR reporting behaviors among HCPs to increase the reporting rate of ADRs in Türkiye [ 9 , 10 , 20 ].…”

Section: Introductionmentioning

confidence: 99%

“…The PV program in Tu ¨rkiye is still in its infancy, only a few ADRs have been reported to the centre since the implementation of the PV system. According to recent data conveyed by Tu ¨rkiye to the WHO-Upsala Monitoring center (WHO-UMC), the reported ADRs per million population/year for the years 2017, 2018, 2019, 2020, 2021 and 2022 were 84, 94, 99, 89, 91 and 105 respectively [21,22]. However, still, Tu ¨rkiye 's reporting rate of ADR is significantly lower than the WHO-UMC's suggested ideal value (200 ADR reports per million/year) [21,[23][24][25].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of health care professionals’ knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study

2023

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Background Healthcare professionals’ involvement and reporting of adverse drug reactions are essential for the success of a pharmacovigilance program. The aim of this study was to assess healthcare professionals (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) current knowledge, attitude, practices, and barriers regarding pharmacovigilance and adverse drug reactions reporting in multicentral healthcare settings. Methods A cross-sectional face-to-face survey was conducted among currently working healthcare professionals in various hospitals in ten districts of Adana province, Türkiye from March to October 2022. A self-administered, pretested questionnaire (Cronbach’s alpha = 0.894 for knowledge, attitudes and practices variables) was used for data collection. The questionnaire’s final draft included five sections (sociodemographic/general information, knowledge, attitude, practices, and barriers) with 58 questions. The collected data was analyzed in SPSS (version 25) using descriptive statistics, the chi-square test, and logistic regression. Results Of the total 435 distributed questionnaires, 412 completed the entire questionnaire, yielding a 94% response rate. The majority of healthcare professionals (60.4%; n = 249) had never received pharmacovigilance training. Among healthcare professionals 51.9% (n = 214), 71.1% (n = 293) and 92.5% (n = 381) had poor knowledge, positive attitudes and poor practices, respectively. Only 32.5% of healthcare professionals kept the record of an adverse drug reaction and only 13.1% reported adverse drug reactions. The profession (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) of healthcare professionals and a lack of training were predictors of poor adverse drug reaction reporting (p < 0.05). A statistically significant difference in healthcare professionals and knowledge, attitude and practices scores was also observed (p < 0.05). The main barriers which were supposed to discourage adverse drug reactions reporting by the healthcare professionals were higher workload (63.8%) followed by thinking that a single adverse drug reaction report makes no impact (63.6%) and lack of a professional atmosphere (51.9%). Conclusion In the current study, most healthcare professionals had poor knowledge and practice, but they had a positive attitude toward pharmacovigilance and adverse drug reactions reporting. Barriers to under-reporting of adverse drug reactions were also highlighted. Periodic training programs, educational interventions, systematic follow-up of healthcare professionals by local healthcare authorities, interprofessional links between all healthcare professionals, and the implementation of mandatory reporting policies are critical for improving healthcare professionals knowledge, practices, patient safety and pharmacovigilance activities.

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