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Wednesday, December 1, 2010

Taking Over-the-Counter Medications Safely

You may have heard on the news about a new study that found that most of the popular over-the-counter (OTC) cough and cold, pain-relieving, allergy and stomach drugs just don't explain dosing very well. Nor is there much consistency in product labeling. Parents have been admonished over the years to follow the directions carefully, but as the results of this study found, they still may be giving their children either too much or not enough of a medication simply because inconsistent labeling and inaccurate or unclear measuring devices. Adults may also be taking the wrong dose of medicines.

Here is a summary of the results of the study: Measuring devices were packaged with 148 of 200 products (74.0%). Within this subset of 148 products, inconsistencies between the medication's dosing directions and markings on the device were found in 146 cases (98.6%). These included missing markings (n = 36, 24.3%) and superfluous markings (n = 120, 81.1%). Across all products, 11 (5.5%) used atypical units of measurement (e.g., drams, cc) for doses listed. Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%), 155 (77.5%), and 37 (18.5%) products, respectively. A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbreviation, 163 did not define at least 1 abbreviation.

In November 2009, the US Food and Drug Administration (FDA) released new voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing over-the-counter (OTC) liquid medications, particularly those intended for use by children. Since this recent study found that there are still problems, mandatory guidelines may be necessary.

Here is a summary of the FDA’s recommendations:

Food and Drug Administration Recommendations to Industry for Over-the-Counter Liquid Medications

Presence and Type of Measuring Device

- Measuring devices should be included for all over-the-counter liquid medications.

Within-Product Inconsistency Between Labeled Dosing Directions and Measuring Device

- Devices should be marked with calibrated units of measure that are the same as those specified in the labeled dosage directions.
- Abbreviations used on devices should be the same as those used in directions.
- Devices should not bear extraneous or unnecessary markings.
- Devices should not be significantly larger than the largest dose described.

Across-Product Variability

- Abbreviations should conform to international or national standards.
- Abbreviations should be defined on devices and/or label directions.
- Decimals and fractions should be used with care and conform to recommendations, including use of leading zeros before decimal points to avoid 10-fold errors and use of small font size for numerals in fractions (e.g., rather than 1/2).

Consumer Guidance on Appropriate Use

- Consumers should be encouraged to use measuring devices only with the products with which they are included.
- Consumers should be directed to consult a health care provider when a physician-recommended dose is not marked on the enclosed measuring device.
- Usability studies should be done to confirm understandability and accurate use.

Health literacy is also an issue. 1 in 3 U.S. adults and 1 in 4 U.S. parents have limited health literacy and an even larger number have low numeracy, thus making it difficult to decipher the instructions and markings on many medications. Supporting consumer comprehension by providing clear, consistent, and standardized information increases the likelihood that consumers can safely and effectively use over-the-counter medications.

If you want more information on over-the-counter medications and how to safely use them, check out the following links:

Getting the Most from Your OTC Medicine (American Academy of Family Physicians)

Medicines in My Home: Information for Adults on Using Over-the-Counter Medicines Safely (Food and Drug Administration) – PDF

Over-the-Counter Medicines: What's Right for You? (Food and Drug Administration)

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