Complain about a product or service

FDA Unveils Safe Medication Use Program

Agency also releases drug dosage guidance

By James Limbach
ConsumerAffairs.com

November 5, 2009

Drug Safety • FDA Cracks Down on Web Sites Selling Unapproved Drugs • FDA Unveils Safe Medication Use Program • Bayer Hit With Suit Over Prostate Claims • Feds Seize Alleged Seizure-Inducing Drugs • Matrixx Failed to Give FDA 800 Zicam Complaints • Matrixx Initiatives Pulls Zicam Products • FDA Issues Warning About Zicam Cold Remedy • FDA Issues Warning About Clarcon Skin Products • FDA Requires Additional Warning For OTC Pain Relievers • NY Mandates Multi-Lingual Rx Labels, Counsel • Two Firms Stopped From Making Unapproved Drugs • Supreme Court Upholds Consumers' Right to Sue Drug Companies In State Court • Psoriasis Drug Linked To Three Deaths • Bayer Agrees to Correct Misleading Information about Yaz • FDA Urged to Ditch Darvon • FDA Warns of Skin Numbing Product Dangers • Bayer Pays $97 Million to Settle Kickback Charges • FDA Seizes More Contaminated Heparin • FDA Warns Bayer on "Illegal" Drugs • Feds Seize More Than $24 Million in Unapproved New Drugs • Consumers Increasingly Exposed to Counterfeit Drugs • FDA Wants Black Box Warning on Antibiotics • Public Citizen Sues FDA for Failure to Act on Darvon • FDA Probes Arthritis Drug Link To Cancer • FDA Wants New Labeling Rules To Protect Pregnant, Nursing Women • Anti-Smoking Drug Chantix Linked to Seizures, Heart Problems, Diabetes • Bayer Pulls Trasylol From Market • MIT Researchers Confirm Contamination in Heparin • Be Careful Using Over-the-Counter Creams, Ointments • Another Heparin Producer Announces a Recall • FDA Moves Closer To Setting Up Shop In China • Study Raises Concerns About Anemia Drugs • Congress Hears Warnings about FDA • China Connection in Heparin Problems? • Heparin Linked to Severe Allergic Reactions • Antibiotic Leads to Tendon Ruptures • Second Safety Warning on Fentanyl Skin Patch • Merck Recalls Children's Vaccines • Study: Avandia May Do More Harm than Good • Texas Sues Drug Manufacturer Blamed for West Coast Deaths • Bayer Withdraws Antibleeding Drug Trasylol --- • More drug safety news ...

The Food and Drug Administration (FDA) is promoting a program aimed at reducing the likelihood that you'll be harmed by the medicines you take.

"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 A. Hamburg, M.D.

Millions of people are harmed every year by taking the wrong medicine or too much of the medicine they're supposed to take. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient's condition.

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.

"Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications," said Janet Woodcock, M.D., 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."

As outlined a report, titled, "FDA's Safe Use Initiative -- Collaborating to Reduce Preventable Harm from Medicines," the agency intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.

The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen (Tylenol), implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.

FDA has also made public its new 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.

Accidental overdoses can be caused by devices that are unclear or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use," said Woodcock. "Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications -- the safest and most effective dose -- especially for children."

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.