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KMID : 1011320100030010036
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 1 p.36 ~ p.45
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A Survey on Introduction of Pharmacovigilance Specialist Certification System
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Kim Hye-Kyung
Kim Young-Sik
Park Young-Kyu
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Abstract
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Objective: This study aims to investigate the awareness and attitudes of healthcare professionals (physicians,
nurses, and pharmacists) toward introduction of pharmaco-vigilance specialist certification system in Korea.
Methods: The questionnaire survey was conducted by healthcare professionals including physicians, nurses and pharmacists for the period of two months. 215 healthcare professionals filled out the prepared survey form and the results were statistically analyzed by using the SPSS program. Pearson’s chi-square test was done.
Results: A total of 49 physicians, 113 nurses, and 53 pharmacists responded. 87.4% of the respondents experienced adverse drug event but almost 33% of the respondents reported that to dispensary, pharmacovigilance department in the hospital, pharmaceutical industry, or Korea Food and Drug Administration. Although 70.7% of the respondents knew ‘spontaneous reporting system’, 52.9% of the respondents knew ‘responsibility to report serious adverse drug event’ and 45.5% of the respondents knew ‘drug safety manager system’. In current system of drug safety manager, candidates are restricted to pharmacist and oriental pharmacist but 59.1% of the respondents thought doctor and nurse could be a candidate for drug safety manager. Just 12.1% agreed current restriction of candidates. Pharmacovigilance specialist certification thought to be necessary in 88.8% of the respondents and 51.6% of respondents thought previous drug safety manager system could complement or develop to pharmacovigilance specialist system.
Conclusion: The great majority of healthcare professionals agreed on the necessity of pharmacovigilance
specialist certification system and previous drug safety manager system could complement or develop to pharmacovigilance specialist system.
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KEYWORD
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Pharmacovigilance specialist, Healthcare professional, Survey
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