A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or harm to a patient according to the FDA. The FDA or the Food and Drug Administration partners with others including U.S. Pharmacopeia and the Institute for Safe Medication Practices to track these errors. The role of the FDA also includes:
- Drug Name Review
- Drug Labels
- Drug Labeling and Packaging
- Bar Code Label Rule
- Error Analysis
- Guidances for Industry
- Public Education
To do all these jobs, the FDA has smaller departments and divisions which focus on certain aspects of medication errors. Two of these include the Center for Drug Evaluation and Research or the CDER and within this, the Division of Medication Error Prevention and Analysis or DMEPA.
The CDER is an organization under the FDA’s control which performs essential public health tasks to ensure that drugs are safe and effective and to improve the health of the people of the United States. The role of the CDER as part of the Food and Drug Administration, is to regulate over-the-counter and prescription drugs. The work by the CDER includes more than just medicines but also items such as fluoride toothpaste, sunscreens and even antiperspirants, all which are considered “drugs”. Five of its strategic management areas include:
- Strong FDA – Staying on the cutting edge of new technology
- Efficient risk management – Removing barriers to innovation in drug development
- Patient and consumer safety – Enhancing drug safety programs and alerting the public to the dangers of importing or buying internet drugs
- Better consumer information – Collaborating with groups to improve information for consumers and offering up-to-date information
- Counterterrorism – Facilitating development of new drugs or new uses for drugs already made to be used as medical countermeasures.
The DMEPA or the Division of Medication Error Prevention and Analysis within the CDER reviews proposed propriety names to reduce the name confusion as well as identifying error prone aspects of labels and packaging of drug products to minimize error. DMEPA also performs post marketing surveillance of medication errors.
As early as 1848 federal regulation of drugs had emerged and by 1905, the AMA or American Medical Association had launched a private and voluntary means of substance control. Since 1906, the FDA has been monitoring and regulating drugs.
To protect consumers, the FDA, the DMEPA and the CDER all have rolls to play in monitoring and regulating drugs in the U.S. Despite these regulations and controls, medication errors still happen every day. Each year, millions are injured and thousands die due to medication errors. If you have been injured due to a medication error, you may be entitled to compensation. To find out if you have a case, contact APKH&C, a medication error attorney. Call us at 877.732.2491 or fill out our free consultation form right away.