Promoting patient safety in the Philippines through improved pharmacovigilance

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects, side effects, or other drug-related issues, and it is essential for patient safety. Health care workers, patients, and consumers must be encouraged to document and report side effects of medicines, as the success of PV depends on collecting vast amounts of quality data to assess whether a particular medicine is safe for public use. It can be challenging to gather this kind of data, and in the Philippines, USAID has successfully initiated advocacy efforts and training programs to encourage health workers and patients to report any untoward side effects and promote patient safety.

Background

Ryann has been working with the Philippines Food and Drug Administration (FDA) for 16 years.

“During that time, I was part of almost all the units of the FDA, but I found my calling in PV,” he explained. “As a pharmacist, I understand the importance of PV for medicines, especially for new medicines that are widely accessible, and I have wanted to build the safety profile of new medicines in the country for a long time.”

However, managing the large quantities of data required for effective PV is not easy—especially given that the FDA’s PV Unit covers the whole of the Philippines. Furthermore, the country’s reporting system should be well suited to the large quantities of data that need to be filed and assessed.

As part of the regulatory requirement for medicines that are in the market, companies and government entities must collate side effect data from their respective information systems, then send these data to the FDA. Originally, this information was sent to the FDA PV unit and they in turn encoded it to the FDA’s Vigiflow system manually. To avoid overloading the system and the PV officers through manual encoding, in 2015, the FDA announced that all future reports must be submitted using an electronic E2B form.

Optimizing systems for greater efficiency

USAID recognized that for effective PV, the FDA needed a more efficient way of capturing and analyzing data, with greater collaboration between the different systems used by the Philippines Department of Health (DOH) and the FDA. While the FDA uses Vigiflow, the DOH implements active tuberculosis (TB) drug monitoring and management using the Pharmacovigilance Monitoring System (PViMS).

To avoid the duplication of entries in these systems, USAID supported the DOH and FDA to establish interoperability between the PViMS and the Vigiflow system. Data encoded in the PViMS can now easily be shared with FDA’s Vigiflow system through the E2B files. Consequently, relevant staff members, such as Ryann and his team, can seamlessly capture more PV data regarding new TB regimens. They also have more time to assess the submitted side effects, as they no longer need to manually encode reports into Vigiflow.

Reaching thousands through virtual and in-person training

With USAID support, Ryann and his colleagues received PV training to build their expertise and optimize their internal PV process and work procedures. USAID and the FDA’s PV Unit collaborated to develop a course on principles of PV and the accurate reporting of side effects to ensure the integrity of their assessment. These learning sessions reached almost 1,000 health workers across virtual and in-person channels, and the free e-Learning course has now been uploaded into the DOH Academy to facilitate continued learning for thousands of people all over the country.

Mentors also visited health facilities to deliver onsite PV training to staff, prioritizing those facilities providing care to people living with HIV. Several new HIV drugs and regimens have entered the market; therefore, greater quantities of information are needed to build up their safety profile.

Spreading awareness for greater public safety

Following these interventions, Ryann has seen a significant increase in the number of quality adverse events reports submitted for TB and HIV medicines that are crucial to enable signal detection, one of the core responsibilities of the PV Unit to actively ensure safety of medicines in the market.

“Thanks to the support from USAID and other development partners, I no longer feel that I am alone in my advocacy,” he said. “I am so happy to hear people talking more widely about PV, and they are aware of its importance.”

Although more work is needed to advance the PV system in the Philippines, Ryann sees that, with support from development partners such as USAID, his dream of having a fully mature PV system to keep the public safe can be realized. This marks the inception of more robust PV, enhancing patient safety across the country.