MANILA, Philippines — Medicines should only be purchased from legal and verified sources to avoid substandard drug products that put patients, especially children, at risk, the country’s top health official said this weekend.
“This means you have to make sure you are only buying drug products from drug stores registered with the Food and Drug Administration (FDA),” Department of Health (DOH) officer-in-charge Maria Rosario Vergeire said at Friday’s press conference.
Earlier, the FDA issued a warning against the purchase and use of four contaminated pediatric drug products based on a Medical Product Alert issued by the World Health Organization (WHO).
These were identified by the WHO as Promethazine Oral Solution BP; Pheniramine Maleate, Ammonium Chloride Menthol (Kofexmalin Baby Cough Syrup); Chlorphenamine Maleate, Phenylephrine HBr, Dextromethorphan (MaKOFF Baby Cough Syrup) and Paracetamol Phenylephrine HCl, Chlorphenamine Maleate (MaGrip n Cold Syrup).
All four substandard drug products for children are manufactured by Maiden Pharmaceuticals Ltd. and found to be substandard when distributed in the African region last September, the FDA said.
It added that the substandard drug products contain diethylene glycol and ethylene glycol which are toxic to humans when consumed.
While these products may result in abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury that may lead to death, Vergeire assured the public that none of these drug products are registered with the FDA for distribution in the Philippines.
“When you are buying medicines, make sure it is registered with the FDA. In that way, there is assurance that the drug products are safe and effective for treating the illnesses that you have,” she said.
“What we do is when a company applies for registration, especially a foreign manufacturer, we specifically inspect their good manufacturing practices,” she added.
This verification process, Vergeire said, includes an inspection of the manufacturing site, both local and foreign, “to make sure that the medicines being brought to the country or those being purchased by the public underwent quality control and were not mixed with unwanted chemicals.”