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Improving Patient Safety and Product Quality
Michael King, Senior Director, Product & Strategy, IQVIA
Marie Flanagan, Director, Offering Management, Vigilance Detect, IQVIA
Mar 28, 2024

Rapid detection and response to safety signals and product quality trends are critical for protecting public health. Delays in identifying and addressing safety concerns can have significant consequences for patients and erode public and regulator trust in medical products.

Post-market surveillance (PMS) and post-market vigilance (PMV) plays a critical role in ensuring the safety, effectiveness, and quality of medical products, be they pharmaceutical or medical device, throughout their lifecycle, helping to protect patient safety and promote public confidence in the healthcare system.

Regulatory bodies such as the FDA, EMA, MHRA, PMPA, NMPA and other global agencies, regularly issue guidance documents, policy statements, and updates to existing regulations. With a new or changed regulation or reference document being published somewhere in the world every 13 minutes 1, life sciences companies are under huge pressure to keep up with regulatory changes and remain compliant. To maintain global business continuity, organizations need to understand the relevant regulations and processes in different markets, which can be particularly challenging in the Asian and Eurasian economic areas.

Investing in a proactive approach to PMS improves capabilities to identify and address potential safety issues before they become bigger problems, improving patient outcomes, and protecting brand reputation. Siloed information, systems and technology are inefficient and create knowledge bottlenecks, which can lead to weaknesses in a company’s PMS and put patients at risk. For example, consider the PIP scandal when silicone breast implants were filled with industrial-grade silicone instead of medical-grade silicone, severely affecting many women's health.2 Better PMS and earlier detection could have alerted industry and regulators to this issue earlier, with a net effect of reducing the numbers of individuals negatively impacted.

Ensuring the quality and completeness of data is crucial for effective PMS as incomplete or inaccurate data can lead to misinterpretation and delays in recognizing potential risks. The COVID vaccine rollout brought social media into the main equation for life sciences companies as a major source of unstructured data that needs to be monitored and analyzed to ensure any product safety issues are being caught in a timely fashion and remediation provided where required. Identifying signals of potential safety issues among such large volumes of data can be challenging. Recent advancements in technology have seen the development of artificial intelligence (AI) -aided PMS enabling the automation of monitoring of vast amounts of data reducing time, costs, and risk of human error in the vigilance process.

The role of quality, regulatory and safety professionals is to ensure their organization’s compliance with regulations and maintain product safety but there is also a cross-over into the commercial side of business and mindsets are starting to change for the better in realising that safety processes, such as PMS, are not a cost driver but ultimately save costs and support commercial activities. ‘In the past decade, an average of one company per year has seen a 10 percent drop in share price after a single, major quality event (e.g., a major product recall)’3. A proactive PMS can help prioritize areas for improvement and protect and enhance brand equity and reputation, thus increasing revenue. The real winners from medical device and pharmaceutical companies using proactive PMS are the public – voices are heard, safety issues are identified quickly and efficiently and remediated, further harm is prevented, and health outcomes are elevated.

A proactive PMS as part of an end-to-end enterprise quality management system (eQMS) offers the best solution for an organization wanting to ensure product safety, compliance, maintain and enhance brand reputation, and improve healthcare outcomes for patients across the globe.

Find out more about how your organization can transition to a proactive PMS solution by watching this webinar.


References:
1 IQVIA Regulatory Intelligence data — October 2022
2 https://www.nhs.uk/conditions/pip-implants/
3 https://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/public%20sector/regulatory%20excellence/the_business_case_for_medical_device_quality.ashx

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