By Peter Pitts
December 9, 2016 at 5:00 am ET
Countries around the world are struggling to adequately monitor the quality of medicines available to their citizenry. From more regular manufacturing inspections, to risk-based investigations into the sourcing of ingredients, to a rethinking of post-marketing surveillance (pharmacovigilance), there isn’t one single solution — and efforts to reach international “harmonization” are part of the problem.
Advising and training countries with severely under-resourced medicines regulatory agencies to adopt the standards and practices of the U.S. Food and Drug Administration or the European Medicines Agency is unrealistic at best and, at worst, dangerous, since it often results in the cutting-and-pasting of western rules and guidances to satisfy international institutions, taking the place of real advances in quality and safety oversight. We must strive to free ourselves from the bonds of “regulatory imperialism.”
What we need are programs for “sanitary democracy” that recognize the situation as it exists and provides both a path for convergence with global best practices and immediate tactical programs that can address the true situation on the ground. Rather than Potemkin pharmacovigilance, sanitary democracy strives to manage what already exists rather than undertaking a full-scale systems redesign. In brief, sanitary democracy is tactical, pragmatic regulation that recognizes the asymmetries inherent in an evolving regulatory ecosystem.
Sanitary democracy is an expedited pathway for pharmacovigilance that embraces a philosophy of multi-variant inputs and the potential leapfrog impact of technologies such as artificial intelligence that result in shortening the reporting-to-action continuum. Artificial intelligence will facilitate what the pharmacovigilance ecosystem lacks today — a coordinated and efficient systems for developing actionable evidence on safety and effectiveness.
Sanitary democracy is based on the concepts of design thinking that require intense cross examination of the filters used in defining a problem and to revise the potential opportunities before developing strategies and tactics. Design thinking requires cross-functional insights into a problem by varied perspectives as well as constant and relentless questioning. Unlike critical thinking, which is a process of analysis, design thinking is a creative process based around the creation of action-oriented ideas.
Today, the absence of these capabilities significantly impacts the public health by creating obstacles for patients and clinicians to receive the meaningful information they need to make informed decisions, perpetuating unnecessarily long delays and gaps in effective and timely safety communications and recall management, hindering the timely development of new and innovative treatment options, and increasing the overall costs and inefficiency of the healthcare system.
Sanitary democracy means collaborative programs to enhance communications between regulatory agencies and physicians, hospitals, pharmacists, and patients to drive more timely post-marketing reports of both adverse events and substandard pharmaceutical outcomes. In an ideal world, this would require national efforts to establish a network of electronic health records, but we do not live in an ideal world. In the real world it must mean using any means available from mobile apps to traditional paper reporting. Leadership + Collaboration = Speed to Action.
Sanitary democracy understands that the perfect mustn’t get in the way of the good. In fact, “good” is a highly worthwhile goal. “Good” recognizes the need for continuous improvement. Data from every source is important — but is not necessarily equal. Which are the “signals” and which the “noise?” Rather than letting this important question stymie progress, Sanitary democracy suggests a more tactical, risk-based decision-making process that ranks information, by source on a reliability scale. Such a strategy recognizes the inherent inconsistency of quality reporting while also understanding the value of quantity as a predictive tool.
Does this mean the death of classic epidemiology? Certainly not. Sanitary democracy recognizes the importance of not only acting faster based on imperfect evidence, but also understanding the real-world impact those actions have on both the lives of patients and (more broadly) the quality of medicines within any nation’s borders. In order to succeed, sanitary democracy must be both pragmatic and evolutionary. That is why, at the very heart of sanitary democracy doctrine, is the belief that the best way to avoid questionable data is to question the data.
Sanitary democracy also believes in the power of predictive evidence, a classic epidemiological strategy, but also in understanding that the lack of post-marketing reports must also be a cause for concern. The lack of signals is an important signal to take into regulatory consideration. This requires regular monitoring of other reporting sources (via bilateral national information sharing) and international repositories such as the World Health Organization’s Uppsala database for global adverse event reporting.
Why sanitary democracy? Because it frees developing nations from the bondage of regulatory systems developed for advanced needs. Lock-step harmonization with western “best practices” are likely pointless considering the profound differences in regulatory staffing levels, overall budgetary limitations, and physician, pharmacist, and patient education. Expecting other nations with less experience and resources to “harmonize” with the FDA or the EMA isn’t the right approach. Just as every nation has it’s own unique culture and cuisine, so too must it design it’s own pharmacovigilance philosophy and structure.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
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