Fri, Sep 25, 2015 - Page 3 News List

OTC drug instructions and packet labeling criticized

TOO CONFUSING:The FDA is being urged to revise its standards for reviewing drug product labeling and usage instructions so consumers do not misuse drugs

By Lee I-chia  /  Staff reporter

The Taiwan Health Reform Foundation yesterday said over-the-counter (OTC) drugs should come with instructions that are easy to understand and drug facts should be printed on the package labeling.

Members of the foundation chanted slogans such as: “We want instructions, not textbooks,” and “Show us the warnings, don’t play hide and seek,” as they urged the Food and Drug Administration (FDA) to demand that drug companies improve their OTC drug labeling and instructions.

Foundation chairperson Joanne Liu (劉淑瓊) said the assembly of the first National Conference on Drug Policies in 2008 passed a resolution that said drug package inserts should be written more explicitly and in a way that makes them easier to understand, but six years later many drugs still come with instructions that are too difficult for most people to understand.

The foundation cited a definition written on the information insert of an OTC drug bought in Taiwan: “This product is a specialized and fast-effective histamine antagonist, which can inhibit the secretion of basal gastric acid and stimulated gastric acid. It can reduce secretion, reduce acidity and the amount of pepsin.”

Foundation chief executive officer Amy Wang (王梅影) said the information insert that came with the same drug bought in the US said the drug “reduces the production of stomach acid and is different from antacids, which neutralize the acid already in your stomach,” which is much easier to understand.

Wang said the drug facts printed on the package labeling of US-bought drugs follow a standard format, including the most important “caution” and a drug use consultation hotline, but the drug facts printed on the package labeling of Taiwan-bought drugs are printed on different sides of the box and are unclear.

Wang said the foundation asked two of its members to buy commonly used drugs — ibuprofen (often used as an anti-inflammatory) and diclofenac (often used in pain relief patches) — for their child and pregnant wife respectively.

They found that the drug labeling of one ibuprofen product said “please read the package insert for details” and did not mention that children under the age of 12 should not use the product, but the drug with the same ingredients from another brand had it clearly printed on the package label.

Liu said if the FDA did not revise its standards for reviewing drug product labeling and usage instructions, consumers might face the negative health risks of drug misuse.

The foundation said the FDA should provide a clear standard format of drug facts and package inserts for drug companies to follow.

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