The Food and Drug Administration today announced the Safe Use Initiative, a 
program aimed at reducing the likelihood of preventable harm from medication use.
Millions of people are harmed every year from inappropriate medication use. 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. 

More detailed information on the new program was contained in a report, 
titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from 
Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s 
annual Science Writers Symposium at the agency’s White Oak Campus in Silver 
Spring, MD.  As outlined in the report, the FDA 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 (CMI),  
communicating about the risk of inadvertent overexposure to acetaminophen, 
implementing safeguards against surgery fires caused by alcohol-based surgical 
preps, and avoiding contamination of multiple use medication vials.

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. 

The term "influenza" refers to illness caused by influenza virus. This is commonly 
also called "flu," but many different illnesses cause "flu-like" systemic and 
respiratory symptoms such as fever, chills, aches and pains, cough, and sore 
throat. In addition, influenza itself can cause many different illness patterns, 
ranging from mild common cold symptoms to typical "flu" to life-threatening 
pneumonia and other complications, including secondary bacterial infections.

The main focus of the following web pages is on the drugs approved by FDA for 
the treatment and prevention of influenza.  Because vaccination is the primary 
means of preventing and controlling influenza, links are also provided to 
information pertaining to vaccines.  For additional updates and comprehensive 
information about flu, please go to http://www.cdc.gov/flu/.  Information provided 
on this web site may change frequently, and should not be used as a substitute 
for individual evaluation by a health care provider, or as the primary means of 
diagnosing influenza or determining treatment.

Read about Tamiflu

Read about Relenza

MEDICINES RECOMMENDED FOR DISPOSAL BY FLUSHING
The following list from FDA tells you what unused or expired medicines you should 
flush down the sink or toilet to help prevent danger to people and pets in the 
home. Flushing these medicines will get rid of them right away and help keep your 
family and pets safe.

FDA continually evaluates medicines for safety risks and will update the list as 
needed.        

Download the medicine list

*These medicines have generic versions available or are only available in generic 
formulations.

Additional Related Resources
New FDA Web Lists Disposal Instructions for Select Medicines
How to Dispose of Unused Medicines
Medication Disposal: Questions and Answers
Federal Guidelines for Proper Disposal of Drugs

How should you dispose of medicines not found on the list?
Do not flush all medicines down the toilet. The FDA recommends that most 
medicines be disposed of in the household trash after mixing them with some 
unpalatable substance (e.g., coffee grounds) and sealing them in a container.  
Unused portions of medicines must be disposed of properly to avoid harm. 
Drug take-back programs for disposal can be another good way to remove 
unwanted or expired medicines from the home and reduce the chance that 
someone may accidentally take the medicine. Contact your city or county 
government's household trash and recycling service to see if there is a take-back 
program in your community and if there are any rules about which medicines can 
be taken back. You can also talk to your pharmacist to see if he or she knows of 
other medicine disposal programs in your area.

More than half a million U.S. children yearly have bad reactions or side effects 
from widely used medicines that require medical treatment and sometimes 
hospitalization, new research shows. Children younger than age 5 are most 
commonly affected. Penicillin and other prescription antibiotics are among drugs 
causing the most problems, including rashes, stomachaches and diarrhea.

Parents should pay close attention when their children are started on medicines 
since "first-time medication exposures may reveal an allergic reaction," said lead 
author Dr. Florence Bourgeois, a pediatrician with Children's Hospital in Boston. 
Doctors also should tell parents about possible symptoms for a new medication, 
she said.

It's based on national statistics on patients' visits to clinics and emergency rooms 
between 1995 and 2005. The number of children treated for bad drug reactions 
each year was mostly stable during that time, averaging 585,922.  No deaths 
resulted from bad reactions to drugs in the data studied, but 5 percent of children 
were sick enough to require hospitalization.

The study involved reactions to prescribed drugs, including accidental overdoses. 
They were used for a range of ailments including ear infections, strep throat, 
depression and cancer. Among teens, commonly used medicines linked with 
troublesome side effects included birth control pills. Bad reactions to these pills 
included menstrual problems, nausea and vomiting. Children younger than 5 
accounted for 43 percent of visits to clinics and emergency rooms; followed by 
teens aged 15 to 18, who made up about 23 percent of the visits.  Similar 
numbers of hospitalized children — about 540,000 yearly — also have bad 
reactions to drugs, including side effects, medicine mix-ups and accidental 
overdoses, recent government research suggests.

Michael Cohen, president of the Institute for Safe Medication Practices, said a 
common problem involves giving young children liquid medicine. Doses can come in 
drops, teaspoons or milliliters, and parents may mistakenly think those amounts 
are interchangeable. Cohen said doctors should be clear about doses and parents 
should be sure before leaving the pharmacy that they understand exactly how to 
give liquid medicine. 

The study was funded by the National Library of Medicine and the National 
Institute of Child Health and Human Development. 

(Source: Lindsey Tanner, AP Medical writer; study appears in October 2009 
Pediatrics).

Written testimony submitted to the House Committee on Veteran’s Affairs - 
Subcommittee on Health

by William Ray Bullman, M.A.M. Executive Vice President, NCPIE