FDA Strives to Reduce Medication Errors
Over 7,000 deaths occur each year due to medication errors. Since 1992, the FDA has received over 18,000 reports of actual or potential medication errors. To reduce the potential for medication errors, the FDA formed the Office of Postmarketing Drug Risk Assessment (OPDRA) under the FDA’s Center for Drug Evaluation & Research (CDER).
OPDRA, which is comprised of ten clinical pharmacists and one physician, reviews proposed proprietary names for drug products. The objective is to improve consistency and minimize risk with sound-a-like and look-a-like names. OPDRA’s multifactorial review consists of several phases.
The first phase in the review is an expert panel review. An expert panel, consisting of OPDRA members and Division of Drug Marketing & Advertising Communications (DDMAC) representatives, meets weekly to exchange opinions on the safety of new proprietary names.
The second phase in the review is a handwriting and verbal analysis. An analysis of the proprietary name’s visual appearance and pronunciation is performed to determine the degree of confusion the name may have with other drugs currently on the market. FDA health professionals (nurses, pharmacists, and physicians) are utilized to simulate the prescription process. The simulation involves interpreting written prescriptions and verbal orders to identify confusion that may lead to medication errors.
The third phase in the review is computer-assisted analysis. The OPDRA utilizes FDA databases to identify potential sound-a-like and look-a-like proprietary names.
The fourth phase in the review is a labeling and packaging analysis. A safety assessment of the container labels, carton and package insert labeling, and proposed packaging of each product is performed to identify areas of improvement.
The final phase in the review is an overall risk evaluation. The results of each phase are weighed, and other risk factors, such as overlapping strengths, dosage forms, dosing recommendations, indications for use, storage, labeling, and packaging, are considered.
As a consumer, you can help the FDA minimize medication errors by reporting any potential or actual medication errors to MedWatch. MedWatch is the FDA’s medical product reporting and safety information program that was launched in June 1993. All information reported is kept confidential and protected from disclosure by the Freedom of Information Act. The FDA also encourages the public to submit suggestions for preventing errors.
The telephone number to MedWatch is 1-800-FDA-1088.
The first phase in the review is an expert panel review. An expert panel, consisting of OPDRA members and Division of Drug Marketing & Advertising Communications (DDMAC) representatives, meets weekly to exchange opinions on the safety of new proprietary names.
The second phase in the review is a handwriting and verbal analysis. An analysis of the proprietary name’s visual appearance and pronunciation is performed to determine the degree of confusion the name may have with other drugs currently on the market. FDA health professionals (nurses, pharmacists, and physicians) are utilized to simulate the prescription process. The simulation involves interpreting written prescriptions and verbal orders to identify confusion that may lead to medication errors.
The third phase in the review is computer-assisted analysis. The OPDRA utilizes FDA databases to identify potential sound-a-like and look-a-like proprietary names.
The fourth phase in the review is a labeling and packaging analysis. A safety assessment of the container labels, carton and package insert labeling, and proposed packaging of each product is performed to identify areas of improvement.
The final phase in the review is an overall risk evaluation. The results of each phase are weighed, and other risk factors, such as overlapping strengths, dosage forms, dosing recommendations, indications for use, storage, labeling, and packaging, are considered.
As a consumer, you can help the FDA minimize medication errors by reporting any potential or actual medication errors to MedWatch. MedWatch is the FDA’s medical product reporting and safety information program that was launched in June 1993. All information reported is kept confidential and protected from disclosure by the Freedom of Information Act. The FDA also encourages the public to submit suggestions for preventing errors.
The telephone number to MedWatch is 1-800-FDA-1088.
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