I just finished writing an article on over-the-counter (OTC) drugs and how their safety and market approvals are managed (look for it in the May issue of PharmTech). As a consumer, something stood out in my research. No matter how many times a drug product’s label is revised and reviewed by companies and regulatory authorities, and no matter the extent of the safety and effectiveness studies completed and approved, the safety of a drug ultimately rests in the hands of the consumer. As patients or caregivers, it is our responsibility to read a drug label or information packet thoroughly, to measure a dose appropriately, and to monitor when and how often a drug should be taken.
Standard-setting bodies, regulatory authorities, and industry have been battling this challenge for years. Because they can’t come into our homes to help us take medication properly, they have gone over in painstaking detail the way a label should read so that it can be easily understood by the average consumer. They are constantly revising the way labels and information packages should be written, designed, and distributed.
Most recently, FDA is considering the use of one-page information sheets for prescription products (say goodbye to those multiple page inserts found in pharmacy prescription bags) and USP is looking toward a national standard for prescription labels. FDA also recently released a guidance for industry to help improve label comprehension studies (drug manufacturers perform these studies to test consumer understanding of product labels). Across the Atlantic, EMA is considering better harmonizing drug labels and package leaflets across the European Union.
These efforts are important and may help consumers in self-selecting OTC as well as self-administering OTC and prescription products, but consumers also need to be more vigilant. How many times, for example, have you thrown away a medication’s packaging or prescription leaflet simply because you’ve taken it before and know exactly how much to take, and how often? I certainly have. What if the drug’s dosage or strength changed since the last time you took it, however? You would never know and could end up taking too much, or too little of the product. What if you are taking a new drug, and there are drug interactions that you need to be aware of, but don’t because you didn’t read the fine print on the label?
A pharmacist can help answer questions and a doctor can prescribe the right dosage, but once we as consumers bring home a medication, there’s no one there to help make sure we administer the drug properly. This is our responsibility.