To fight many of the diseases that plague the world’s poorest, we need tools – safe and effective drugs and vaccines that can reduce unnecessary suffering and afford millions the opportunity to lead healthy and productive lives. An essential part of having the right tools, and making sure that the right patients are getting and using them in the right way, is post-market safety surveillance.
Why do we need post-market safety surveillance? New information continues to emerge about the benefits and risks of a drug or vaccine even after a regulator has approved it for use and once patients are taking the medicine under real-world conditions.
Post-market surveillance identifies and collects that data, which has multiple uses:
- Doctors and public health officials can use the information to reduce avoidable patient side effects and better target those who would most benefit from a drug or vaccine;
- The data can help detect substandard and counterfeit medicines, reducing the poor treatment outcomes that can result from those medicines and spur drug resistance; and
- Post-market surveillance generates ongoing safety and effectiveness data that gives patients and governments confidence to participate in immunization and treatment programs.
Historically, developing countries relied upon post-market surveillance in developed countries to identify the risks and benefits of drugs and vaccines. This is understandable because few drugs and vaccines were developed to specifically address the health needs of poor countries. But as access to treatment and immunization has increased in developing countries due to rising incomes and the success of global health initiatives such as the GAVI Alliance, improvements in post-market safety surveillance have not kept pace.
Last year, regulators, pharmaceutical companies, donors, researchers, and public health advocates came together to form the Safety Surveillance Working Group. The Bill & Melinda Gates Foundation sponsored the working group to develop a practical and scalable strategy for improving the monitoring of drug and vaccine safety in developing countries. The product of their efforts is a groundbreaking report, which we are pleased to release today.
The report, entitled Strengthening Post-Market Safety Surveillance in Low- and Middle-income Countries, is based on three common sense principles:
1. Given expanding needs for post-market surveillance but likely limited resources, we must prioritize our capacity building efforts.
2. Progress won’t be made by investing in what effective post-market safety surveillance systems look like in developed countries, rather than what those systems need to do in developing countries.
3. Efforts to improve post-market surveillance should build upon, not duplicate, the good work that the World Health Organization and others are doing in this area.
With those principles in mind, the working group proposed a data-driven and risk-based approach for identifying priority post-market surveillance needs and targeting resources to those strategies most likely to achieve the greatest impact for patients. This report demonstrates that new approach by analyzing the drugs and vaccines that global health programs are projected to introduce in low- and middle-income countries over the next decade.
The results of that analysis are revealing:
- Many of the new drug and vaccine launches will occur in the same countries over a relatively short period of time.
- Many of those countries are clustered together, particularly in East Africa and South Asia.
- Few of these countries have performing post-market surveillance systems, but most have some capacity that may be leveraged.
On the basis of that analysis, the report outlines a plan for strengthening post-market safety surveillance
in developing countries, specifically:
- The surveillance conducted in support of new vaccine and drug introduction should be done in a manner that builds functioning and sustainable post-market safety surveillance systems in priority low- and middle-income countries.
- Promoting regional cooperation and investing in local infrastructure would improve the sustainability of those post-market safety systems and spread their benefits to other countries.
The next 10 years will be vital for improving post-market safety surveillance. Progress can only occur if coordinated international effort by diverse partners, including policymakers, regulators, industry, funders, international technical agencies, and health professionals. A prerequisite for success in post-market surveillance is establishing a baseline of good clinical diagnosis and rigorous causality assessment to ensure that safety data are analyzed and interpreted appropriately.
This report represents innovative thinking in the field and has provided us with a plan for moving forward. Now it is our responsibility to work together on making it a reality.