For the first time in 25 years, the US Food and Drug Administration has implemented major changes to the way prescription drug leaflets are presented, in a bid to clarify the information they contain to help avoid unnecessary side effects and related patient deaths.
Each year, a staggering 300,000 preventable adverse events are recorded in hospitals in the USA alone, many of which are the result of muddled medical information, according to the agency. As research has shown that giving priority to warnings on the package insert of a drug can help prevent avoidable side effects, the modernised leaflet ensures that crucial information is clearer and more memorable for doctors and patients, says the FDA.
“Americans are overwhelmed with the complexity of health information. We have hit a point of information overload and the public health message is being diluted,” remarked US Surgeon General, Richard H Carmona.
“This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively. This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information.”
Some of the most significant changes to the leaflet include: a new section called Highlights, which gives an accessible summary of benefits and risks associated with taking the drug; a Table of Contents, for easy reference to understandable safety and efficacy data; the product’s first approval date; and a toll-free number and Internet reporting information for suspected side effects.
A new Patient Counselling Information section has also been added to the mix, underscoring the importance of communication between healthcare professionals and patients. Designed to assist doctors in dishing out advice on the uses and limitations of a drug, it is also intended to serve as a guide for risk management.
“Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare,” explained Human Health Services Secretary, Mike Leavitt. “By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients,” he added.
And commenting on the move, Andrew von Eschenbach, MD, FDA Acting Commissioner of Food and Drugs, said: “This redesigned label is a big step in our commitment to giving health professionals the tools and information they need to optimise their clinical practice and choose among a growing number of effective treatments to make more personalised prescribing decisions for their patients.”
