pharmacovigilance

 {Photo credit: Jones Dizon/SIAPS.}Training participants try out the Pharmacovigilance Monitoring System (PViMS), a web-based application to help clinicians, regulatory bodies, and implementing partners monitor medicine safety specifically in resource-limited countries.Photo credit: Jones Dizon/SIAPS.

The Philippines has one of the highest TB burdens in the world—and 2.6% of its more than 286,000 new cases in 2015 were of multi-drug-resistant TB (MDR-TB). This threatens the progress the country has made in addressing the deadly disease over the past few decades and its goal to make the country TB-free by 2030. Further, MDR-TB cases will likely rise steadily in the Philippines and the world over the next two decades.

There’s a new medicine that can help. Through a partnership with Janssen Therapeutics of Johnson & Johnson that began in 2015, USAID introduced a program to distribute a new medicine called bedaquiline that helps patients with MDR-TB in low-income countries including the Philippines. The USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, which Management Sciences for Health (MSH) leads, has been helping to roll out bedaquiline in low- and middle-income countries.

But with any new treatment, active pharmacovigilance (PV) is needed to help ensure both patient safety and drug effectiveness. This means being able to monitor patients to identify and evaluate adverse events, such as unexpected or serious side effects, to better understand possible risks and improve treatment protocols.

Saving lives and improving health continues long after diagnosing disease or delivering medicines.

(Watch Faith tell her story)

Faith had been ill for months. She was 31 and had two daughters. She didn’t know what was wrong. A friend urged her to get an HIV test; it came back positive.

Faith started on antiretroviral treatment.

But, in 2013, one of her antiretroviral medicines started to work against her, causing misshapen fat deposits to develop on her body.

When she finally mustered the courage to speak up one year later, her doctor knew just what to do and shifted her to a different medicine.

(Medicine Movers: Kenya from Management Sciences for Health on Vimeo)

Faith didn’t know it, but her report to the doctor became part of a nationwide database that tracks adverse drug reactions, and poor quality or expired medicines.

{Photo credit: Warren Zelman}Photo credit: Warren Zelman

In 2012, the United Nations unanimously passed a resolution endorsing the concept of universal health coverage (UHC), urging governments everywhere to “provide all people with access to affordable, quality health care services”. Management Sciences for Health (MSH) and the US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program are among global champions for UHC and joined global leaders celebrating UHC’s notable inclusion in the Sustainable Development Goals (SDGs) last Fall. Now, we continue to help countries face the obstacles of making UHC a reality.

Access to medicines has not always been at the forefront of the global discourse on UHC, which instead has tended to focus on financing. UHC programs must include adequate health financing and coverage of essential medicines if they are to deliver meaningful health outcomes. Policymakers attempting to establish and maintain UHC programs therefore need to have a sound understanding of the pharmaceutical sector and those pharmaceutical system components that must be considered to ensure ready access to the pharmaceuticals needed to support any UHC program.

{Photo credit: Warren Zelman}Photo credit: Warren Zelman

This week, at the 46th Union World Conference on Lung Health (hashtag ), the US Agency for International Development (USAID)-funded and Management Sciences for Health (MSH)-led, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is launching a new tool to improve how the safety and effectiveness of medicines is monitored in low- and middle-income countries.

All medicines undergo rigorous clinical testing prior to being made publicly available. Continuing to monitor the safety and effectiveness of medicines in real world settings, also referred to as pharmacovigilance, is critically important to ensure that medicines can be used over a prolonged period of time, in conjunction with other medicines, among new patient populations, and in patients with multiple illnesses. 

Low- and middle-income countries, however, often lack the resources, capacity, and systems required to effectively implement pharmacovigilance activities. They often rely heavily on passive reporting methods which can underestimate potential medicines use issues.

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