BPOM: e-MESO 2.0 Strengthens Public Role in Reporting Drug Side Effects

Jakarta (ANTARA) - The National Agency of Drug and Food Control (BPOM) has launched an update to the e-MESO application, namely e-MESO 2.0, as an effort to provide a platform for the public to report drug side effects in order to strengthen pharmacovigilance.

BPOM Head Taruna Ikrar in Jakarta on Tuesday said that learning from US data, around 109,000 people die from drugs each year. Additionally, about 2 million US citizens report drug side effects annually.

According to him, these figures are staggering, especially for a country with a population of around 350 million people.

So far, he said, reporting of drug and food side effects has only come from healthcare workers, pharmaceutical services, doctors, or pharmacists. However, there are several challenges, such as the busyness of healthcare personnel who have no time to report, as well as strict bureaucracy.

Therefore, they are expanding reporting to the public because BPOM wants to build not only cooperation with institutions but also with society as a whole. This step, he said, is an effort to give the public the right to speak and the right to protection.

According to him, reports on drug side effects are very important for evaluation, policy-making, and patient safety. For example, by providing information on contraindications or withdrawing a drug from circulation. In addition to protecting the public, public reporting is also important for the pharmaceutical industry, as it can drive product quality improvements.

“In drug testing, there are 4 phases: phase 1 clinical trials, phase 2 clinical trials, and phase 3. Ensuring safety, then ensuring dosage, ensuring efficacy, and so on. But there must also be certainty about the impacts after short-term and long-term use. That is called post-marketing testing,” he said.

Taruna said that so far, post-marketing testing has not been running well in Indonesia. Therefore, citizen reports are expected to help with that aspect.

Through the application, citizens can report various types of medicines and pharmaceutical products, including drugs without distribution permits and illegal drugs. He mentioned that they have also issued a guidebook to help the public access the application.

Taruna assessed that pharmacovigilance or drug monitoring is very important, therefore they issued BPOM Regulation No. 4 of 2026, as a follow-up to Health Law No. 17 of 2023.

He mentioned that pharmacovigilance is one of several criteria assessed by the WHO if one wishes to join as a WHO-listed authority (WHO-Listed Authority).