By Amanda Gardner
Monday, September 10, 2007 12:00 AM
MONDAY, Sept. 10 (HealthDay News) -- The number of serious adverse drug events more than double between 1998 and 2005 in the United States, as did the number of related deaths, a new study found.
"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 study lead author Thomas Moore, of the Institute for Safe Medication Practices, in Huntingdon Valley, Pa.
"This is a subject the public or health professionals just don't like to think about," Moore added. "Doctors don't like to think that what they're doing could be hurting patients. The pharmaceutical industry wants the public focused on benefits, and many people just want to believe this drug is going to help them. We need to focus on this problem. We can manage the risks of prescription drugs if we start to pay attention."
The study results are published in the Sept. 10 issue of theArchives of Internal Medicine.
This is not the first peek into drug-safety issues in the United States. The U.S. Food and Drug Administration recently 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 within and without the agency.
Many of the initiatives are in response to recommendations in an Institute of Medicine report issued in 2006 and prepared at the request of the FDA. Those recommendations included a push for stronger post-marketing surveillance of approved drugs.
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, as defined by the FDA, means an adverse event that results in death, a birth defect, disability, hospitalization or is life-threatening or requires intervention to prevent harm. The events are reported voluntarily to the FDA either directly by or through drug manufacturers, who are required to forward any reports.
From 1998 to 2005, the number of reported serious adverse drug events increased 2.6-fold from 34,966 in 1998 to 89,842 in 2005. The number of fatal adverse drug events increased 2.7-fold during the same time period, from 5,519 in 1998 to 15,107 in 2005.
The number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion to 3.8 billion during that time frame.
Although a total of 1,489 drugs were associated with adverse events, a subset of 51 drugs accounted for a large proportion of the problem: Each had 500 or more reports in any given year. This group of drugs accounted for 43.6 percent of the total adverse event reports.
Drugs related to safety withdrawals were a small part of the picture and, within the subset of 500 drugs, declined from 26 percent of all reported events in 1999 to less than 1 percent in 2005.
Pain medications and drugs that affect the immune system were disproportionately represented among those that caused death.
Moore and his colleagues pointed to three main reasons for the increase.
"First, we do have a more aggressive use of drugs in a growing and older population, but that explains only about one-quarter of the problem," Moore explained. "We've also got a whole group of products that have entered the marketplace since 1998 -- biotech problems. They play a significant role in the toll of adverse events. The third thing we saw, and I think it's the discouraging part, is we saw increases in drugs whose risks we've really known about and should be able to manage. We've had insulin for 50 to 60 years, yet adverse events are increasing rapidly, and I think it's partly linked to the more aggressive treatment of type 2 diabetes."
FDA spokeswoman Sandy Walsh said the reasons for the increase weren't all known. However, she pointed to an increase in public attention to drug safety and use of the Internet to make it easier for consumers to submit adverse-event reports.
The FDA also said it has "undertaken a pilot program to review the safety of new molecular entities about 18 months after approval. We will determine if this formal, systematic review adds value to our current processes. If we were to do this on a full scale, we would need more staff resources."
That still begs the question of what to do about a growing and serious safety problem. According to the study authors, regulatory issues may be at the heart of the problem.
"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.
In a prepared statement, the FDA said the study's findings were in keeping with what the agency had been seeing.
Visit the FDA for more on its drug safety initiative.
SOURCES: Thomas Moore, senior scientist, drug safety and policy, Institute for Safe Medication Practices, Huntingdon Valley, Pa; Sandy Walsh, spokeswoman, U.S. Food and Drug Administration; FDA prepared statement, Sept. 10, 2007; Sept. 10, 2007,Archives of Internal Medicine