The number of serious adverse drug events in the U.S. has more than doubled between 1998 and 2005, says a new study led by Thomas Moore of the Institute for Safe Medication Practices. The study results were published in the September 10 issue of the Archives of Internal Medicine.
"This is the first study to ask the question, 'Are we gaining ground or losing ground in drug safety and improving patient safety in prescription drugs?' And I think, inescapably, the conclusion is that we're losing ground," said Moore.
For the new study, Moore and his colleagues analyzed all serious adverse drug events and medication errors reported to the FDA from 1998 to 2005. A serious adverse drug event is defined by the FDA as one that results in death, birth defect, disability, hospitalization, or is life-threatening or requires intervention to prevent harm. From 1998 to 2005, the number of reported serious adverse drug events increased 2.6-fold from 34,996 in 1998 to 89,842 in 2005. The number of fatal adverse drug events increased 2.7-fold during that same time frame, from 5,519 in 1998 to 15,107 in 2005. Interestingly, the number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion in 1998 to 3.8 billion in 2005. Which drugs caused the most deaths? Pain medications and drugs that affect the immune system were disproportionately represented among those that caused death.
Moore and his colleagues have identified three main reasons for the increase:
1) more aggressive use of drugs in a growing and older population;
2) a new group of products (biotech) have entered the marketplace; and
3) increases in adverse events linked to older drugs (such as insulin) whose risks are well known and should be better managed.
The study authors believe the solution lies with the FDA and its regulation of the drug industry. "I think it's very clear that we need to spend more money, more people, and we need more authority and more independence for the FDA drug safety program," Moore said.
The FDA appears to agree, stating that the study's findings were in keeping with what the agency had been seeing. Recently, the FDA unveiled a set of initiatives intended to counter growing criticism of its operations and to bolster the country's health safety net. The recommendations include a pilot project to assess the safety of drugs after they're on the market, as well as initiatives to improve communication both inside and outside of the agency.
