Safety Warning

August 2016
Author: Dr. Mitchell Gandelman, Sciformix Corporation

Pharmacovigilance (PV) has become of paramount importance to everyone in the medical world, including patients, healthcare providers, the pharmaceutical industry, regulators and payers. Failures in PV by any of these stakeholders place a large burden on the healthcare system – especially on patients – but can also lead to poor medical outcomes, increased costs and loss of trust in the healthcare system as a whole. Thus, in order to produce effective drugs, good patient outcomes and deliver healthcare in an efficient manner, all partners must play an active role in PV (1).

For pharma organisations to fulfil their role, they must first understand the effectiveness of their PV system and ensure compliance with regulations where their products are used. Company-initiated audits, both internal and external, can help with this procedure. In a similar manner, regulators carry out inspections – not only in the pharma industry – to ensure compliance with PV regulations. Given the heightened level of scrutiny that the healthcare system is now facing, regulatory assessments are an everyday reality. The findings from these investigations will be provided to the business in an FDA Form 483. Additionally, the FDA can issue warning letters (WLs) to pharma companies for PV problems of regulatory significance. It has been found that most WLs are delivered for violations in PV fundamentals, which can lead to non-compliance in areas such as adverse event reporting, written procedures and periodic adverse drug experience report (PADER) submissions (2,3).

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