A medication error relates to any event that can cause a patient harm but is considered preventable. These errors can occur throughout the process of medication being used, all the way from prescribing the drug in an online system to the patient taking the medicine. In more severe cases, serious results of a medication error may include hospitalization, disability, birth defects, and even death.
The U.S. Food and Drug Administration (FDA) is the governing body that receives reports of medication errors and has reported an excess of 100,000 cases every year in the U.S. alone. Their system classifies the type of errors that have occurred and the determined cause of each, using data to establish the most common causes of mistakes. The labeling of pharmaceutical products is a significant problem when it comes to medication errors, with incorrect labeling and false information having the potential to cause large-scale problems.
To tackle these labeling issues, the FDA has released a range of standardized guidelines which determine how a provider must label their medicines. By creating consistency among drug packaging and labeling, errors can be minimized as both medical professionals and patients can find the information they need more easily.
This regulation also applies to over-the-counter (OTC) medication, with regulations governing how pharmaceutical products must be labeled. Since OTC products are selected and taken by customers who are often self-medicating, the information and guidance provided on the label are incredibly important and must be 100% accurate. It has been reported that many consumers tend to overlook important label information so a standardized labeling method has been enforced to ensure key warnings and facts are instantly recognizable. With clear instructions being printed on the label of the product as well as warnings, ingredient lists, and dosage guidelines, the safe use of the product can be enforced as much as possible to reduce the likelihood of medication error.
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