Deepa Arora, Global Head of Drug Safety & Risk Management for Lupin, tells Pharma IQ the good, and the bad that she faced in pharmacovigilance. She also talks about the best way to understand regulatory reporting requirements and tells us what she feels are the biggest challenges in pharmacovigilance today.
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The best way to understand the regulatory reporting requirements is to refer to the country specific regulations and guidelines. It may be useful to directly contact regulatory authorities if there are specific doubts regarding reporting in particular circumstances. Although regulatory authorities are becoming more critical of unnecessary reporting, however, the golden rule of ‘report when in doubt’ still holds true.
But what are some of the biggest challenge in pharmacovigilance today?
Lack of awareness regarding drug safety amongst general consumers as well as healthcare professionals (HCPs) is a major challenge, especially in developing countries explained Deepa Arora, Global Head, Drug Safety & Risk Management, for Lupin.
“Globally, adverse reactions resulting from medication errors cause significant morbidity and mortality. It’s difficult to identify medication errors as there is a general hesitation in sharing the information regarding medication errors. Medication errors that resulted in adverse reactions may not be shared by HCPs due to associated guilt, shame or fear of litigation. On the other hand, HCPs may not feel the requirement to report medication errors that were identified in time and therefore, didn’t result in adverse reactions. As medication errors typically occur in uncontrolled post marketing environment, these can’t be detected by planned studies. Therefore, these need to be addressed on urgent priority as preventing these preventable adverse reactions can significantly reduce the unnecessary suffering of the patients,” she said.
Dr. Arora will be sharing her experience surrounding the best practices in benefit risk analysis to capture and characterise a drug profile at the 3rd Annual Pharmacovigilance Asia 2012 (http://www.pharmacovigilanceasia.com/Event.aspx?id=724574&MAC=PR). Email enquiryiqpc.com.sg to register for the event or for the complete speaker list and topics that will be discussed at the 3rd Annual Pharmacovigilance Asia 2012.