FDA Receives Over 100,000 Suspected Medication Error Reports Each Year

The FDA reports that it receives over 100,000 reports of suspected medication errors in the United States every year. A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.

Medication errors can occur throughout the medication-use system, such as when prescribing a drug, upon entering information into a computer system, when the drug is being prepared or dispensed, or when the drug is given to or taken by a patient. Serious harmful results of a medication error may include death, life threatening situation, hospitalization, disability, and birth defect.

The FDA reviews the drug name, labeling, packaging, and product design to identify and revise information that may contribute to medication errors. The FDA reviews:

– Proposed proprietary (brand) names to minimize confusion among drug names. With the help of simulated prescriptions and computerized models, FDA determines the acceptability of proposed proprietary names to minimize medication errors associated with product name confusion.

– Container labels to help healthcare providers and consumers select the right drug product. If a drug is made in multiple strengths – e.g., 5 mg, 10 mg, and 25 mg, – the labels of those three containers should be easy to differentiate. The label design may use different colors or identify the strength in large bold numbers and letters.

– Prescribing and patient information to ensure the directions for prescribing, preparing, and use are clear and easy to read.

After drugs are approved for marketing in the United States, the FDA monitors and evaluates medication error reports. FDA may require a manufacturer to revise the labels, labeling, packaging, product design or proprietary name to prevent medication errors. The FDA may also issue communications alerting the public about a medication error safety issue, by way of Drug Safety Communications, Drug Safety Alerts, Medication Guides and Drug Safety Podcasts.

To avoid errors and encourage safe use of drugs, the FDA recommends:

– Tablets and other oral dosage forms should have distinct and legible imprint codes so healthcare providers and consumers can verify the drug product and strength.

– Oral syringes and other dosing devices co-packaged with a liquid oral dosage form should be appropriate for the doses to be measured. Dosing errors have been reported when an oral syringe is labeled in milligrams but the dose is prescribed in milliliters.

– The package design should protect the consumer against incorrect use. Medications applied to the skin (topical) should not be packaged in containers that look like the containers usually associated with eye, ear, nasal, or oral products. Similar looking containers have resulted in people putting a topical product in the eye, ear, nose, and mouth.


If you or a loved one suffered injuries (or worse) as a result of a bad drug/defective drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find drug claim lawyers in your state who may assist you.

Turn to us when you don’t know where to turn.

This entry was posted on Monday, January 14th, 2019 at 5:30 am. Both comments and pings are currently closed.

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