We’re losing ground on drug safety. This is sobering news, according to the Institute for Safe Medication Practices, based on a study published this week in the Archives of Internal Medicine. The number of serious adverse drug events more than doubled between 1998 and 2005 in the United States, as did the number of related deaths. The FDA says that an adverse drug event is, “an injury resulting from the use of a drug….” including:
• Harm caused by the drug (adverse drug reactions and overdoses)
• Harm from the use of the drug (including dose reductions and discontinuations of drug therapy).
This topic doesn’t get nearly enough attention. The Institute of Medicine’s (IOM’s) report, Preventing Medication Errors, denounced drug safety in 2006. Since then, the FDA’s post-marketing surveillance strategies have been shallow and slowly implemented.
• Harm caused by the drug (adverse drug reactions and overdoses)
• Harm from the use of the drug (including dose reductions and discontinuations of drug therapy).
This topic doesn’t get nearly enough attention. The Institute of Medicine’s (IOM’s) report, Preventing Medication Errors, denounced drug safety in 2006. Since then, the FDA’s post-marketing surveillance strategies have been shallow and slowly implemented.
The total number of drugs associated with adverse events was 1,489. But a small group of 51 drugs accounted for nearly half of the adverse events reported. Note that drugs related to safety withdrawals – such as Vioxx — were a small part of the problem. In fact drugs related to safety withdrawals declined from 26% of all reported events in 1999 to under 1% in 2005. The drugs with the most adverse effects tend to be pain medications and drugs that affect the immune system. But there have also been increases in drugs whose risks we’ve known about for a long time – such as insulin, that’s been around for over 50 years. The researchers attribute adverse events due to insulin to more aggressive treatment of type 2 diabetes. As the public’s lack of trust in the pharmaceutical industry continues to wane, this news can’t help but move the lack-of-trust-o-meter further south.
Health Populi’s Hot Points:
• Know your drug risks, and how to correctly take prescribed medications.
• If you don’t understand your drug risks, ask your doctor or your pharmacist for more information until you do.
• Stay abreast of drug recalls at http://www.recalls.gov/medicine.html.
• Contact your legislator about prescription drug safety.
Health Populi’s Hot Points:
• Know your drug risks, and how to correctly take prescribed medications.
• If you don’t understand your drug risks, ask your doctor or your pharmacist for more information until you do.
• Stay abreast of drug recalls at http://www.recalls.gov/medicine.html.
• Contact your legislator about prescription drug safety.
Sources: FDA (fda.gov), Institute for Safe Medication Practices (www.ismp.org/), Archives of Internal Medicine (archinte.ama-assn.org/, Drug recalls (www.recalls.gov/medicine.html)
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Jane was named as a member of the AHIP 2024 Advisory Board, joining some valued colleagues to prepare for the challenges and opportunities facing health plans, systems, and other industry stakeholders. 
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