US FDA unveils safe use initiative that targets preventable harm from use of medicines

The US Food and Drug Administration yesterday announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. 'Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,' said FDA Commissioner Margaret Hamburg.

About 1.5 million preventable 'adverse drug events' occur in the USA every year, according to a 2007 study by the Institute of Medicine, part of the National Academy of Sciences, which also found that the errors cost an estimated $4 billion a year.

Other preventable sources of harm include unintentional misuse of medications, medication abuse and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication, the FDA warned.

'Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,' said Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use,' she added.

"I was frankly stunned at the scope of the problem," the FDA Commissioner said at a news conference Wednesday. The plan, dubbed the Safe Use Initiative, "is something that doesn't require a new scientific discovery or a budget appropriation."

Will scrutinize patient information

The FDA also will scrutinize the information provided to patients, such as package inserts, labels and instructions that pharmacists give when dispensing prescriptions.

Such an examination is long overdue, said Sidney Wolfe, director of Public Citizen's Health Research Group, a non-profit consumer advocacy group, quoted by the Los Angeles Times. 'About 99.5% of pamphlets are completely unregulated. They are missing critical information," Dr Wolfe added.

To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.

Guidance for drugmakers

The agency also made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons. The guidance document, titled 'Dosage Delivery Devices for OTC Liquid Drug Products,' was posted for advanced viewing in the Federal Register on November 4.