The Ministry of Health and Welfare yesterday said that from June next year, pharmaceutical companies will be obliged to package their drugs with easily understandable information.
In a survey conducted this year by the Food and Drug Administration (FDA), 59 percent of respondents said they did not know the name of the drugs they were taking and 50 percent had not read the information provided with their drugs, making them unaware of appropriate doses or possible side effects. In addition, 36 percent of respondents were unaware of the intended purposes of the drugs they were taking.
To make over-the-counter drugs safer to use, the administration is to require the simplification of information required on drug packages and package inserts, administration official Chi Jo-feng (祁若鳳) said.
“The new information format for package inserts obligates companies to list information in order of importance, with the drug name first, followed by its purpose, warning, directions and dosage,” Chi said.
In addition to a consumer service telephone number, six types of information must be printed on the side of packages: The drug’s name, active ingredient, purpose, warnings, directions and dosage, Chi said.
“At present, because complete drug information is only listed on the package insert, if they have not consulted their pharmacist, consumers can only know if the drug is suitable for them after purchasing the drug and reading the package insert,” Division of Medicinal Products section chief Lien Heng-jung (連恆榮) said.
In addition, a QR Code must be applied to new drug packages, so that people with reading disabilities can use their smartphones to scan the code and access voice information on the drug, Chi said.
Companies making products which fail to conform to the new regulations would be subject to fines of between NT$30,000 and NT$2 million (US$910.47 and US$60,698), Chi said.
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