Abstract
The aim of this study was to evaluate the clarity and consistency prevalent in dosing directions and measuring devices used for over the counter (OTC) liquid pediatric medications available in United Arab Emirates (UAE). 130 pediatric oral liquid OTC medications with dosing information for children younger than 12 years were studied. The study specifically focused on issues like the inclusion of a measuring device, child resistance packaging, within product inconsistency between dosing directions on the bottle’s label and dose markings on enclosed measuring device, across-product use of non standard units of measurements and abbreviations, use of numeric text according to the Food and Drug Administration recommendations (FDA) and the presence of definitions for abbreviations used. Out of 130 preparations studied, a measuring device was absent only in 16% (21 products, n=130). 31.5% (41 products, n=130) of the preparations studied did not have the child resistant cap. Dosing directions on the label/leaflet and markings on the measuring device were the same in 53.6% (52 products, n=97) and different in 46% (45 products, n=97) of preparations. Superfluous markings (marking in the dosing device that is not referred to in the product labeled dosage instructions) were present in only 21.5% (23 products, n=107) of the cases. Inconsistent text for units (milliliters) was observed in 41.2% (40 products, n=97) products. Inconsistency in expressing teaspoon and tablespoon (inconsistency in expressing teaspoons as tsps or TSP and tablespoons as tbsp. or TBS) was 18.8% (13 products, n=69) and 28.5% (20 products, n=70), respectively. The use of non standard units, tablespoons and teaspoons needs to be quickly reviewed and prevented in the best interest of pediatric population. Key words: Over the counter drugs, United Arab Emirates, pharmaceutical preparations, oral drug administration, self administration.
Highlights
Challenges to pediatric drug therapy include excessive and unnecessary drug use, inappropriate dosage form, inaccurate dosing and improper drug administration (Lawrence, 2009)
The study focused on issues like the inclusion of a measuring device, child resistance packaging, within product inconsistency between dosing directions on the bottle’s label and dose markings on enclosed measuring device, across-product use of non standard units of measurements and abbreviations, use of numeric text according to the Food and Drug Administration recommendations (FDA) and the presence of definitions for abbreviations used
The FDA notes that better measuring devices for over the counter (OTC) liquid drug products will help patients in self administration
Summary
Challenges to pediatric drug therapy include excessive and unnecessary drug use, inappropriate dosage form, inaccurate dosing and improper drug administration (Lawrence, 2009). Drug Administration (FDA) released a new set of voluntary guidelines for the industries responsible for producing, selling and distributing the over-the-counter (OTC) medications (FDA, 2009). Yin et al (2010) in New York, Atlanta and Chicago set out to determine the prevalence of inconsistent dosing directions and measuring devices among popular pediatric OTC’s at the time the United States (US) FDA released new voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing OTC liquid medications, those intended for children. The study concluded that at the time, the FDA released its new guideline, top-selling pediatric OTC liquid medications contained highly variable and inconsistent dosing directions and measuring devices (Yin, 2010)
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