Medication Risk Management

Historically, the FDA has interpreted the requirement that a drug must be “safe” to mean that the benefits of a drug outweigh its risks. The determination was made on a “categorical” basis, where the totality of risks was weighted against the totality of benefits when considered for the purposes outlined in the drug product's labeling. If a drug did not meet this criterion, it was not approved or its label was rewritten to narrow the conditions for use. This logic was endemic in the FDA for most of the 20th century. On average, two to four drugs over each 5-year period were withdrawn from the marketplace after post-marketing surveillance data uncovered new risks. Similarly, on occasion, the FDA would require some special “tool” or intervention to improve a product's safety profile. Harm associated with medication remains the second most common type of incident in hospitals, as reported by the Clinical Excellence Commission. Health services actively review medication safety. The vast majority of medication errors result in no injury. A minor injury may result, for example, in a patient needing an increased level of monitoring. Even if incidents result in minor injury, managers and staff still take any errors very seriously, reviewing the actions around the incident and making improvements as a result. FDA's new concepts for risk management amount to a “cultural shift” in the logic of drug approval and the FDA's role. The key events that led to this change can be traced to a series of reports that highlighted the need for improved medical safety. In 1999, the IOM released a report entitled, “To Err is Human.” This report reviewed the nature and cause of medication errors, estimating that up to 98,000 people died each year due to these errors. In their assessment, the IOM included both adverse drug reactions and human errors in drug administration. The report captured the attention of news reporters and the government. Headlines proclaimed alarm at the larger number of fatalities caused by medical errors. Consequently, there was a government-wide initiative started to develop methods and institute procedures to reduce medical errors. Statements made by FDA officials regarding some of these withdrawals suggested that the FDA no longer believed that passive oversight and re-labeling drugs with new warnings was sufficient. Furthermore, the FDA no longer believed that it was sufficient to identify safe conditions of use in the label and that healthcare professionals and patients had to comply with advocated directions of use for the drug to remain on the market.