FDA Workshop: Minimizing Medical Product Errors - A Systems Approach

27 Jul 2007

On January 8, 1998, a workshop was held to discuss, in part, medication and prescription errors in the healthcare system of the United States. It was held at Natcher Auditorium, National Institutes of Health, Bethesda, Maryland.

The Workshop was sponsored by: U.S. Food and Drug Administration, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research.

The following are excerpts of the Executive Summary of the Workshop:

Ms. Sharon Smith Holston, who is the Deputy Commissioner for External Affairs, FDA, opened the workshop by saying that some 1.3 million people are accidentally injured by medical therapy in the U.S. and that the misuse of medicines causes thousands of preventable hospitalizations every year and results in estimated costs ranging anywhere from $20 to $75 billion.

But more important than the financial cost associated with errors in medicine, are that the consequences of a medical product mishap can be serious and even life-threatening to the patient.

She said that FDA knows that a problem exists, but that we don't know the true extent of the problem, or whether the problem is getting better or getting worse. FDA does believe, however, that the number of reported incidents is vastly underestimated because most of the reporting is done on a voluntary basis. She said that the goal of the workshop is to consider how FDA should use its' regulatory influence to reduce the risk to all Americans from misused therapeutics.

Dr. Janet Woodcock, who is the Director, Center for Drug Evaluation and Research, FDA, spoke about medication errors from the Center for Drug Evaluation and Research (CDER) perspective. Dr. Woodcock said that errors are not the result of an individual failure, but of a systems failure that results from complex interactions within the health care system and that with proper safety designs of products, we can decrease the potential for injury from the products regulated by FDA.

Medication errors can occur anywhere in the delivery of a drug to the patient, including during the prescribing, repackaging, dispensing, administering of the drug and even while monitoring of the patient. Some causes of medication error are poor communication, ambiguity in the product names, problems with directions for use and problems with abbreviations. Along the continuum, any health professional may contribute to real or potential errors and sometimes, changing the design, the name or packaging of the product can prevent medication errors.

When a medication error occurs, the risk manager of the hospital examines the system within his/her own purview and takes preventive steps. Often, however, discussions of these incidents are not shared with other hospitals, health care professionals, FDA or the drug's manufacturer. She said, that by not sharing these experiences, we are losing an opportunity to prevent similar occurrences.

FDA has received 6000 medication error reports since 1992 and 50 percent are related to confusion in the labeling or packaging of the drug. The total number of serious adverse events that are related to errors number 1,273 with 326 deaths. These numbers only represent a snapshot of what is actually occurring and FDA believes that there are a correspondingly greater number of unreported events.

Currently, FDA has documented that errors can be traced to 441 cases resulting in patient hospitalizations, 235 cases where the patient's life is threatened, 206 cases where patients undergo medical intervention and 65 cases where patients experience permanent disability.

What is CDER doing now to prevent medication errors? First, prior to a drug's approval, CDER's Labeling and Nomenclature Committee reviews the proposed proprietary names to minimize mixups with existing names. In addition, CDER monitors reports of medication errors through the Medication Errors Committee and takes appropriate action.

CDER also provides feedback to health care professionals about medication errors through publications in FDA's Medical Bulletin and the FDA CONSUMER magazine and collaborates with USP and AMA's Institute for Safe Medication Practices.

Dr. Woodcock said that in order to effectively minimize the incidence of medication errors, CDER should focus on preventing the errors relating to product package and labeling prior to approval and correcting the problems that occur after approval. She said the pharmaceutical industry should propose clear and concise labeling and avoid trade names that are misleading or confusing and that the health care team should provide clearly written prescriptions and that practitioners should report the errors so that we can share the knowledge with manufacturers and others.

Diane Cousins, who is the Vice President for the Practitioner Reporting Program at the United States Pharmacopeia (USP) was the next speaker. Ms. Cousins began her talk by discussing USP's experience in practitioner experience reporting and medication errors.

The USP involvement began in 1991, when it became clear that medication error information would be useful in the development and revision of USP-NF standards and USP-DI warnings. The focus of the program is not to identify who made the error, but rather to take a systems based approach by focusing on the causes of errors and analyzing the circumstances surrounding the event.

USP has reported that nearly a third of the reports are cases of potential error, that is, near misses, warnings, or opportunities for error which could, under the right circumstances, lead to inappropriate drug therapy and possible patient harm.

Of the errors actually reaching the patient, approximately one-fourth resulted in temporary patient harm or permanent impairment; 6 percent were fatal. Injectables were reported as the dosage form most often involved in serious and fatal errors.

Over the last year, the most common types of errors reported were medication errors and cases where the wrong drug was prescribed, dispensed or administered.

The top 10 causes of errors include: similar labeling and packaging (1), look alike brand names (2) and sound alike brand names (8). Labeling and packaging problems accounted for 35 percent of reports last year, usually due to confusingly similar trade dress among products or similar packaging of the different strengths of the same product.

Because USP reports show similar labeling as a frequently reported cause of error, error prevention efforts to differentiate product labeling for the most frequently reported drugs causing fatalities should be employed by companies carrying such a product line.

Ms. Cousins closed her remarks by saying that she believed that the time was right to recast product safety evaluation in the pre-approval stages to include a sort of simulation testing for packaging, labeling and nomenclature. Errors should no longer be an excuse to blame, but rather an opportunity to improve medical products and the systems in which they are used.

The next speaker was Dr. Bruce Lambert, who is Assistant Professor, Department of Pharmacy Administration, University of Illinois in Chicago. He said that look-alike and sound-alike errors are name confusion errors that often result in patient injury because of confusion in the process of ordering, dispensing or administering medications.

He said there is not good documentation on how often errors of this type occur, although medication error reporting systems assert that about 20 to 25 percent of reported errors result from look-alike and sound-alike names.

Cognitive, psychological, environmental and workplace factors contribute to these errors and it is the interaction between the cognitive and environmental workplace factors that is the complex cause of these errors. He suggests as a prevention strategy to identify which psychological processes are involved in each type of error.

He said that the most comon kind of medication error occurs because of illegibility of physician handwriting where prescriptions are misunderstood by either pharmacists or nurses. He said that auditory misperception errors occur, as well, when oral orders are given. In addition, there are action errors, such as, when a data processor enters a name incorrectly. The probability of these types of errors increase when drug names look and sound alike.

He recommends that in order to minimize errors due to look and sound-alike names, the following prevention strategies should be considered:

Don't use phonologically similar names,

Use short names instead of long names,

Maintain a quiet environment while dispensing or administering drugs.

Do not store drugs in alphabetical order

Eliminate handwritten and especially handwritten faxed prescriptions

Use barcodes, when necessary including adding the dose and indication on new drugs

Dr. Lambert has developed an automated system to measure phonological and orthographic similarity. By developing automated measures, he said, we may be able to study, in more detail, the relationship between similarity of drug names and the probability of error.

The complete Executive Summary can be found at http://www.fda.gov/oc/workshops/errorsum.htm#public.