I work at an institute of pharmaceutical sciences and whenever I teach students how to dispense pharmaceuticals I always remind them not to inject highly lipophilic drugs into intravenous drip bags made of polyvinyl chloride (PVC) plastic in order to avoid di(2-ethylhexyl) phthalate, or DEHP, being released into the bodies of patients, which could potentially harm their health. I never imagined that a supplier of food ingredients would fail to stop DEHP getting into their products, while simultaneously allowing it to get into medicines and food additives. This is a very regrettable situation.
The Food and Drug Administration (FDA) made clear in the Act Governing Food Sanitation (食品衛生管理法) that foods and food additives should be clearly listed on containers and packaging. However, the current plasticizer scare shows that the nation needs to establish a food ingredient tracking system to be able to ascertain product quality. More random inspections need to be performed to stop something similar from happening again.
Even more worrying, though, is the management of drugs. According to the regulations of the Pharmaceutical Affairs Act (藥事法), drug companies only need to list the primary, active ingredients in a medicine, not the additives. This regulation means that medication management is slacker than food standards management. As it is not necessary to list anything other than the main drug ingredients on labels, instruction leaflets, packaging and drug licenses, patients could be harmed because they could be allergic to added ingredients or inactive substances such as coloring agents or solvents.
Take drugs for newborn babies, for example. Certain preservatives can have negative effects on newborn babies, and thus should not be administered. However, because preservatives are not a main ingredient in medicines, they do not have to be listed, meaning that even if drugs do indeed contain such preservatives, there is no way of consumers knowing. In 1937, 105 children died in the US after ingesting a sulfonamide preparation, Elixir Sulfanilamide, mainly because it contained diethylene glycol, something children should not be exposed to.
For example, a tablet of Warfarin, a blood thinner, weighs approximately 0.22g. Of this, only 0.005g are main ingredients, the other 95 percent are additives, commonly known as excipients. Excipients function as dilutants, binders, lubricants, coloring agents and flavor enhancers.
The US Food and Drug Administration’s regulations clearly stipulate that packages of medicines or their instructions must list a product’s main ingredients and all additives. It has also established a database of approved and registered additives that is used both to manage and educate manufacturers.
Before ordering drugs, some large hospitals in Taiwan will closely check the various ingredients, but because there are no mandatory regulations requiring that all ingredients in a drug to be listed, it is difficult for hospitals to request such information from manufacturers. Sometimes manufacturers even claim these are trade secrets and refuse to provide this information.
The management of traditional medicine and health foods is also worth paying attention to. The components of natural medicines and foods differ according to country of origin and season, and they may contain heavy metals, insecticides, herbicides and pollution from poisonous weeds. They are also more prone to being mixed with counterfeit components and artificial dyes. The faith Taiwanese have in traditional herbal medicine is reflected in the way drugs are managed, with Western medicines, health foods and foods managed by the FDA, while traditional herbal medicine is managed by the Committee on Chinese Medicine and Pharmacy. This creates an uncoordinated, non-unified system and the lack of a dedicated authority is a time bomb that could go off at any moment.
Thanks to the Taiwan Healthcare Reform Foundation’s efforts, everyone now pays attention to the labeling on the bags of drugs they receive. However, what is most important is the labeling that drug manufacturers put on containers and packaging because medical staff and patients can all refer to the explanations on these labels. The FDA was officially established last year and I hope the same ideas that are being applied to food safety can be applied to the management of Western drugs, Chinese herbal medicines and health foods.
The nation needs laws that will demand that ingredients are listed on product containers or packaging. In future, demands must be made for drug licenses, instruction leaflets and labels to clearly list all additives or excipients so as to protect the health of the public.
Shen Li-jiuan is an assistant professor at the National Taiwan University College of Medicine’s Graduate Institute of Pharmaceutical Sciences.
TRANSLATED BY DREW CAMERON
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