Head of BPOM Taruna Ikrar said here on Thursday that the theme for the year is 'safe care for every newborn and every child'. Ikrar emphasized the importance of ensuring medicine's safety and efficacy for children, given some 20 percent of Indonesians, or approximately 65 million people, are children.
Moreover, Indonesia's Total Fertility Rate (TFR) is 2.7, meaning that each year, some 4-5 million babies are born.
The children are key to pursuing the golden period of Indonesia, which is in 2045. Hence, it is crucial to ensure that these children grow and develop well by providing them with good education and healthcare, Ikrar stressed.
He reflected upon Indonesia's experience a few years ago, when some children suffered from acute kidney failure caused by ethylene glycol contained in some syrupy medicines.
"We cannot forget that one. That is, in fact, how we need to be careful for the kids and newborns because this is really very sensitive," he said.
He expected that the experience can compel Indonesia to learn to practice pharmacovigilance in ensuring patient safety, as outlined in Law number 17 of 2023 on Health and its implementing regulation, as well as BPOM Regulation number 15 of 2022.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problems.
Taruna stated that BPOM needs public participation to carry out pharmacovigilance, because BPOM's authority lies from pre-market until post-market aspects, whereas pharmacovigilance is part of the post-marketing aspect.
"We need reports from the community. We accept reports from the industry. We accept reports from the hospital. We accept reports even from patients directly. That's why we have the facility like the Halo BPOM," he said.
Reports help BPOM in evaluating products, he said.
He drew attention to a global report about adverse effects and side effects from medicine on kids, which is capped at 7.4 percent. However, in Indonesia, the rate was capped at 11.1 percent.
If there are that many reports, usually it means that there are even more cases that went unreported, he said, calling it an iceberg phenomenon, and it can end up being fatal if it goes unchecked.
Hence, his administration consistently implements policies, and regulations, as well as establishes collaboration with relevant stakeholders like healthcare staff, scholars, businesses, media, and the general public, in a bid to ensure patient safety.
"World Patient Safety Day is a good moment for us, to remind us that patient safety is not a choice. It is mandatory. It is a duty for all of us to do it," he underlined.
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Reporter: Mecca Yumna Ning Prisie
Editor: Azis Kurmala
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