Tuesday, June 14, 2011

Full labeling for drugs in Taiwan required discussion! Who concern about…????

Pharmaceuticals labeling remains clouded in secret 2011/06/15 Of the more than 20,000 pharmaceutical products sold in the country, about 80 have been found to be laced with potentially hazardous diethyl phthalate and di-n-butyl phthalate (DBP) chemicals, a discovery that sheds light on the use of clouding agents not just in food and beverages, but also medicine. Pharmacologists, toxicologists and consumer organizations say the government should make the labeling of all components in drugs transparent so people can have full knowledge of what is contained in the medicine they use. National Taiwan University School of Pharmacy assistant professor Shen Li-jiuan (沈麗娟) said that although the Act Governing Food Sanitation (食品衛生管理法) stipulates that food and food additives should be clearly labeled on the container or the packaging, this rule does not cover pharmaceuticals. The public usually only sees the main components for drugs, while additives such as excipients, or carriers for active agents, are never labeled on the container, packaging or in the instructions because the government does not mandate the practice, Shen said. Even when pharmacists and doctors call the companies, the information may not be available if the firms consider them trade secrets, Shen said, adding this makes it even harder for people to know. Using her clinical experiences as an example, Shen said she once dealt with a patient who was allergic to yeast found in a prescription drug. When she tried to find a substitute drug and asked the Department of Health for information, the department did not have any on hand and she had to contact the drug companies one by one. The ongoing food safety scare also shows that Taiwan's management and control methods are riddled with problems, Shen said.

Pharmaceutical product information disclosure Food and food additives are required to be clearly labeled on the container or the packaging, but not those of pharmaceuticals. When administering drugs for non-emergency situations or extended use, it is the responsibility of the hospital unit in charge to disclose everything patients need to know in a transparent fashion. Even after it was confirmed that more than 80 pharmaceutical products contained plasticizers, the department's Web site still only listed the major components and did not tell the public whether the drugs were laced with diethyl terephthalate. Lin Ja-liang (林杰樑), a specialist on clinical toxicology at the Linkou Chang Gung Memorial Hospital, said the main issue was whether a person is using the medication over the long term. For example, blood-transfusion and intravenous bags — both of which contain phthalate esters (PAE) — are only used in emergencies and for short periods of time, Lin said. In life-and-death situations, this is a necessary evil, Lin said. "Of course it would be better if those products were made -without PAEs," Lin said. However, when administering drugs in a non-emergency situation or when drugs are to be taken over an extended period, it is the responsibility of the unit in charge to tell patients everything they need to know and make the information as transparent as possible. Food and Drug Administration Director-General Kang Jaw-jou (康照洲) said the full labeling of pharmaceutical components was a matter that required further discussion, but as it also involves "trade secrets," talks would have to include the drug producers.

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