David Balderson, Vice President of Global Safety Operations

Challenges in Achieving Excellence in Drug Safety – Part II

David Balderson

[This is the concluding part in our ‘Driving Excellence in Drug Safety’ series. The first post proposed an alternative model that drives excellence in patient safety by successfully incorporating people, quality and compliance excellence; and discussed the importance of People Excellence. This post continues where the first left off and focuses on Quality Excellence and Compliance Excellence.]

Quality Excellence

In the last 5 years the expectation for PV departments to develop a robust QMS has increased dramatically. This has largely been driven by inspections as much as legislation and therefore the focus is often reactive rather than proactive. Many PV professionals are becoming CAPA experts, however CAPAs often patch the problem rather than get to root cause. While understanding the need for a QMS and robust CAPA management system has increased greatly, processes are usually tweaked rather than being truly overhauled. This conservative approach results in over complication and there is a real need for simplification of processes. Organizations can’t build the QMS in isolation from the rest of the corporate QMS structure and safety needs a voice at the corporate level to influence the organization.

While the methodology used to draw conclusions may be questioned, there is a perception that manufacturers continue to submit poor quality reports, as highlighted in a recent ISMP report on “A Critique of a Key Drug Safety Reporting System” which concluded that only 49% of reports submitted by manufacturers to FDA met the ‘basic standard of reasonably complete’ (age, gender and an event date). The report went on to question the value of much of the data being submitted which often reflected the patient population with no attribution to the product. Manufacturers understand the limitations of the data from certain sources and the value it adds in terms of patient safety, but are focused on meeting their regulatory reporting obligations even though more data rarely means better quality data.

Compliance Excellence

ICSR compliance has long been a key driver for any PV department. A benchmark of 98% is widely acknowledged however if you’re hitting that target it doesn’t mean you’re immune from being non-compliant as specific aspects of your PV system may not be under control. From an agency perspective compliance is likely closer to 90%, as demonstrated by a recent Reuters Health report as well as the ISMP report referenced above.

The question therefore arises – Do we focus on ICSR compliance at the expense of what’s of real value from the patient safety perspective? It is important to focus on the quality of sources of the data. Late cases typically come from sources such as market research and patient support programs. Social media may also prove to be a significant source in the future. However, despite the high volumes of case, it’s questionable whether data from these sources have really enhanced our understanding of the safety profiles of products and therefore improved patient safety.

Increased scrutiny and rigor on the overall PV system and the principle behind the QPPV role has been positive but it has created the need for resource intensive monitoring to ensure compliance. So what’s wrong with monitoring? It’s what we are monitoring and where we put resources that are the issue. If we take the reconciliation of Business Partners/distributors, it has become an extremely resource-intensive exercise in order to demonstrate compliance often with little return on the investment. As discussed earlier, the intent is usually to build a PV department with SMEs for RMPs, signal detection etc. but now half the staff is managing contracts and BPs!

As companies expand, they need to ask themselves – whether a one-size-fits-all approach is really appropriate or should they be taking more pragmatic risk-based approaches? While standardization and consistency are key success factors, it would be advisable to take more practical approaches to managing the product portfolio, for example with simpler processes and less resources focused on managing mature products compared with those in the pre-approval period.

The technology to support PV has lagged behind both the evolution in requirements and best practices, as well as external technological and social advances in society as a whole. Safety databases were built as transactional AE repositories and barely keep up with basic AE reporting requirements. Too many patches and extensive customization is needed. Signal detection tools are limited in capability and it’s not easy to integrate or even analyze external data sources. This becomes even more apparent when we think of newer sourced such as social media. Risk and benefit are largely assessed separately by separate resources and cobbled together for a periodic report. There’s been much talk on the use of Real World Data such as EHR, but it really hasn’t come to fruition from an R-B perspective. As an industry we need the technology to improve to make our lives easier and manage resources more effectively.