The wider worldview of drug safety monitors and reporters promises great progress–contingent on cooperation.
The National Center for Biotechnical Information published an intriguing and important article in 2010 titled “Pharmacovigilence: A Worldwide Master Key for Drug Safety Monitoring.” Pharmacovigilance is an umbrella term used to describe the processes for monitoring and evaluating adverse drug reactions (ADRs) around the globe.
“The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries,” the NCBI reported. In the United States, we are accustomed–some might say programmed–to think of the FDA as the first and last words on drug safety. This particular report clearly and concisely explains why and how the bigger picture is helpful.
However, the NCBI recommendations do not take the FDA and national programs abroad off the hook, pointing out that “A regular flow and exchange of information in this way means that national pharmacovigilance programs are ideally placed to identify gaps in our understanding of medicine-induced diseases.”
The NCBI describes a complex and vital relationship between various categories of partners in the practice of drug safety monitoring. These partners, it says, “must jointly anticipate, understand and respond to the continually increasing demands and expectations of the public, health administrators, policy officials, politicians and health professionals.”
The report goes as far as listing the key “Worldwide Soldiers of Pharmacovilgilance,” whose free-flowing communication and cooperation would potentially power great improvements in drug safety:
- The Quality Assurance and Safety Team in the World Health Organization’s Department of Essential Drugs and Medicines Policy
- The Uppsala Monitoring Centre, which manages the international database of ADR reports received from National Centers
- The National Pharmacovigilance Centers, active surveillance programs of major drug regulatory authorities.
- Hospitals and academia
- Health professionals
The NCBI definition of “health professionals” is broad enough to include those working in the pharmaceutical industry, but even then these make up only a portion of one category, leaving over five full categories to help counteract the powerful marketing and profit motives.
Also, it’s important to note that just because a group’s name issues an international timbre doesn’t mean it should be trusted blindly. The World Drug Safety Congress 2016 in Chicago, for example, has scheduled three keynote speakers (out of four total) who are high-level pharmaceutical company executives.
Regarding clinical trial regulation specifically, the NCBI says that in recent years there has been a substantial increase in the number of clinical trials in developed and developing countries. “Safety monitoring of medicines in common use should be an integral part of clinical practice. Education and training of health professionals in medicine safety, exchange of information between national pharmacovigilance centers, the coordination of such exchange, and the linking of clinical experience of medicine safety with research and health policy, all serve to enhance effective patient care,” says the report.
Though it’s a mouthful, we Americans would do well to expand our drug safety expectations beyond “the FDA” and begin including the broader term “international pharmacovigilance organizations” in the conversation.