Medical Product Safety Workgroup

Medicines are generally safe when used as prescribed or as directed on the label, but there are risks associated with taking any medicine. Medical products include drugs, biological products, and medical devices. Incorrect use and inadequate monitoring of many medical products can cause adverse effects. Therefore, a greater focus on the safe use of such products is critical. 

Each year in the United States, adverse drug events (ADEs) — or harm resulting from medication use — cause approximately 1.3 million emergency department visits and 350,000 hospitalizations¹ and result in $3.5 billion in excess medical costs.² ADEs are a serious public health problem, and many of them are preventable. ADEs include allergic reactions, side effects, overmedication, and medication errors. Increasing appropriate use and monitoring adverse effects of medical products will:

• Decrease adverse events and harmful reactions by focusing safety efforts
• Improve the overall effectiveness of treatment by reducing harm from medical products
• Further personalize medical treatment

Ensuring the safe use of medical products aligns with the mission and ongoing initiatives of HHS. These include the National Action Plan for Adverse Drug Event Prevention³ and the 5-point strategy to combat the current opioid overdose crisis.⁴  These efforts will also improve patient safety and health care quality overall.