Reporting Serious Adverse Events Karasha Moodley,

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Reporting Serious Adverse Events Karasha Moodley, Zanele Munyai, Yerma van Wyngaardt Introduction: NDOH mission: improve health status by prevention of ill health. Health Charter: right to complain, complaints investigated, response to the

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Reporting Serious Adverse Events Karasha Moodley, Zanele Munyai, Yerma van Wyngaardt<br>
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Introduction: NDOH mission: improve health status by prevention of ill health.








Health Charter: right to complain, complaints investigated, response to the complaint.<br>
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Definitions Adverse event: “any untoward medical occurrence that may present during treatment with a medicine/intervention but which does not necessarily have a causal relationship with this treatment.”
Adverse reaction: “ a response to a medicine/intervention which is noxious and unintended.”
Unexpected adverse reaction: “one in which the nature, specificity, severity and outcome is not consistent with the applicable product information.”<br>