Indications for over-the-counter medications are hard to read due to small letters and difficult terminology

 It was found that consumers had difficulty understanding the indications for over-the-counter medications which can be purchased without a doctor’s prescription. This was due to the packages’ small letters and difficult Chinese glossaries.

 The Korea Consumer Agency (President: Myung-Hee Park, www.kca.go.kr) has investigated 61 over-the-counter-medications which are being sold in the market.  99.2% of them were illegible due to lettering which was smaller than the indication guideline (8pt) for over-the counter-medications.  

 91.8% of the packaging and attached instructions for use were written with difficult Chinese vocabulary and complicated dosages were instructed. (i.e.; 1/5, 2/3 dosage of a powered medication or capsule).   

 Based on the survey, the Korea Consumer Consumer Agency will suggest recommendations to a relevant government agency regarding indications for medications.

※ According to 「the indication guideline for over-the-counter medications」dated on December 18, 2002 by the Korea Food & Drug Administration, it is indicated to use over 8pt sized letters and to change 241 difficult Chinese glossaries to easier words.

■ 99.2% of over-the-counter medications are indicated

in smaller letters than the indication guideline

by the Korea Food & Drug Administration.

 The Korea Consumer Agency has investigated 61 over-the counter- medications which are being sold in the market and analyzed 55 packages, 23 containers, and 46 attached documents.  99.2% (123 items) of them were indicated in smaller lettering than「the indication guideline (8pt) for over-the-counter medication packages and attached documents」. 66.1% (82 items) of them were written in less than 6pt sized letters.

 21 (91.3%) of 23 containers were written in less than 6pt sized letters.  40 (72.7%) of 55 packages and 21(45.6%) of 46 attached documents were indicated in less than 6pt sized letters.  The indications were illegible due to narrow spaced lines and small proportion of length and breadth.

■ Hard to read important information such as expiration date and manufacture’s serial numbers

 Based on the analysis of expiration date and manufacture’s serial numbers of 60 over-the-counter medications, 52(86.7%) products were indicated in less than 8pt sized letters and 18 products (30%) were written in less than 6pt sized letters. 

 The expiration date and serial numbers of 14 products (23.3%) were illegible due to vague shaped embossed letters, small lettering, or light reflection on vinyl coated packages. (Refer to the following samples)

■ 91.8% of products were using difficult Chinese terminology

 56 (91.8%) of 61 surveyed over-the-counter medications were using more than one difficult terminology which were prescribed by「the indication guideline for over-the-counter medication packages and attached documents」.  60 (24.9%) of 241 difficult Chinese terminology were indicated.  Besides, it was hard for consumers to understand the indications because of abstruse Chinese glossaries.       

■ 26.1% of the over-the-counter medications were without

attached document preparation date

 12 (26.1%) of 46 over-the-counter medications including attached documents didn’t indicate the document preparation date.  Even for 12 (35.3%) of 34 products with attached document preparation date, it was indicated that ‘you can refer to the updated information at home page oo or at tel. 000-0000.’  Only 22 (47.8%) of 46 surveyed products contained updated information in the attached documents.

■ 16.4% of the products were unable to be taken according to dosage instructions

 For 10 (16.4%) of the surveyed 61 over-the-counter medications, it was very hard for consumers to take medications according to instructions for a dosage since a dosage was indicated as 1/5, 1/4, 1/3, 1/2 or 2/3 of a powdered medication or capsule.   

 For Normo A (powdered medication), a dosage varied from the age at 1/5 (0.3g) for age of 1~2 years, 1/4(0.4g) for age of 3~4 years, 1/3(0.5g) for age of 5~7 years while the minimum powered package contains 1.5g.   For 200mg of Dapen in a capsule, a dosage was indicated as 100~150mg for age of 3~6 years and 150~200mg for age of 7~10 years.

■ 93.4% of the surveyed over-the-counter medications disregarded Braille indications for the blind

 Only 4 (6.6%) of 61 over-the counter medications were indicated in Braille.  57 (93.4%) of them had little regard for blind people due to lack of indications in Braille.  

※ According to the article 71① of「The pharmaceutical affairs law」and the ordinance 208 of the Ministry for Health, Welfare & Family Affairs law, it is mentioned that ‘The names of product, manufacturer, and importer’s firm shall be indicated in Braille for blind people.’

 Based on the survey results, the Korea Consumer Agency will recommend the following measures to the Korea Food & Drug Administration.  ▲ Specify line spaces in the indications for the over-the counter-medications ▲ Suggest improved indications for expiration date and product serial numbers etc.