Labeling for Pediatric Medications

pediatricThe Food and Drug Administration (FDA) has made it easier for parents and health care professionals to find information on pediatric medications. The FDA created a database that covers medical products studied in children under recent pediatric legislation.

The C4 is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

OPT also maintains a Safety Reporting page5 with information on products that have been tied to safety problems that specifically relate to children. This page lists products that have been the subject of an adverse event report presented to FDA’s Pediatric Advisory Committee, a group of outside experts that advises the agency on pediatric treatments, research and labeling. (An adverse event is any undesirable experience associated with a medical product.)  The committee’s recommendation is also given if further actions were necessary to ensure safe use of the product in children.

“We are excited to share this goldmine of information with parents,” says Debbie Avant, R.Ph., the health communications specialist in OPT who helped develop and maintain the database. “We want parents to know they can rely on FDA for accurate, timely information about the medications their children take.”

Pediatric Medication Labels

Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)

Congress’ efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT’s director.

FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:

  • 84 drugs with new or enhanced pediatric safety data that hadn’t been known before;
  • 36 drugs with new dosing or dosing changes;
  • 80 drugs with information stating that they were not found to be effective in children; and
  • 339 drugs for which the approved use has been expanded to cover a new age group based on studies.

The easiest way for parents to use the database is to search by their child’s condition to find all mentions of that condition in all of the labeling information within the database. If you know the name of the drug you want to find, sort the database’s information by trade name.

Avant says parents should note that the database contains the version of the label at the time of the labeling change. It may not be updated with later changes if they don’t affect children.

OPT has also evaluated the amount of progress in the inclusion of pediatric information in drug labeling and has published a research letter in the Journal of the American Medical Association67on May 9, 2012. They found that in 2009, more than 60% percent of the drugs used for both adults and children that were in the Physician’s Desk Reference—a drug information resource for physicians and other health professionals—had specific information on pediatric use, compared to only 22 percent in 1975.

Critical information in the pediatric section of the labeling tells you if the product was studied in children but could not be shown to work. When a product has been studied in adults and cannot be shown to be effective, that information is not put in the label. However, Congress told FDA to put this information in labeling when a product had been studied in children and was not effective.

“There is still much work to be done, as we have only studied two thirds of the products that are already on the market,” says Murphy. “And there is a steady stream of new products approved every year for children and adults.”

Source : FDA Consumer Updates page

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How Clean is your Toothbrush?

Researchers at England’s University of Manchester say your toothbrush can be a breeding place for germs.

They found that one uncovered toothbrush can harbor more than 100 million bacteria, including E. coli bacteria, which can cause diarrhea, and staphylococci (“staph”) bacteria that cause skin infections.

toothbrushSo, how safe is your toothbrush?

Well, according to Gayle McCombs, RDH, MS, associate professor and director of the Dental Hygiene Research Center at Old Dominion University, “There are hundreds of microorganisms in our mouths each and every day. But problems only start when there is an unhealthy balance of bacteria in the mouth.”

Oral hygiene experts agree that no matter how many bacteria live in your mouth, or have gotten in there from your toothbrush, your body’s natural defenses make it most unlikely that you will get sick from brushing your teeth.

Here are some recommended common sense storage toothbrush storage tips from the experts:

  • Don’t Brush Where You Flush – Every toilet flush sends a spray of bacteria into the air. You don’t want the toilet spray anywhere near your open toothbrush. McCombs says. “It’s just common sense to store your toothbrush as far away from the toilet as possible.”
  • Once you’ve moved your toothbrush away from the toilet, here are a few other storage tips to keep your brush as germ-free as possible:
    • Wash off your toothbrush thoroughly with tap water every time you use it.
    • “Bacteria love a moist environment,” Harms says. Make sure your brush has a chance to dry thoroughly before you use it again. Avoid using toothbrush covers, which can create a moist enclosed breeding ground for bacteria.
    • Store your toothbrush upright in a holder, rather than lying it down.
    • No matter how close you are to your sister, brother, spouse, or roommate, don’t ever use their toothbrush. Don’t even store your toothbrush side-by-side in the same cup with other people’s brushes. Whenever toothbrushes touch, they can swap germs.

Source: WebMD

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Let’s Keep Kids Safe Around Water!

water safetyKids love the water, whether it is the bathtub, the backyard pool, a river, lake or ocean. But, keeping children safe around water during the summer especially takes all our concentration.

What follows are prevention tips from the Centers for Disease Control.

Learn life-saving skills.  Everyone should know the basics of swimming (floating, moving through the water) and cardiopulmonary resuscitation (CPR).

Fence it off. Install a four–sided isolation fence, with self–closing and self–latching gates, around backyard swimming pools. This can help keep children away from the area when they aren’t supposed to be swimming. Pool fences should completely separate the house and play area from the pool.

Make life jackets a “must.” Make sure kids wear life jackets in and around natural bodies of water, such as lakes or the ocean, even if they know how to swim. Life jackets can be used in and around pools for weaker swimmers too.

Be on the lookout. When kids are in or near water (including bathtubs), closely supervise them at all times. Adults watching kids in or near water should avoid distracting activities like playing cards, reading books, talking on the phone, and using alcohol or drugs.

Here are some other resources on water safety.

The Red Cross offers a Water Safety Quiz http://www.redcross.org/prepare/disaster/water-safety/quiz

waduing Pool Safety for Parents: http://www.health.state.mn.us/divs/eh/pools/wadplsftprnt.html

For more water safety resources and fun activities, visit:

 

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The Online Collection of Personal Information of Kids Under 13

information

OnGuardOnline.gov wants you to know that as a parent, you have control over the personal information companies collect online from your kids under 13.

The Children’s Online Privacy Protection Act gives you tools to do that. The Federal Trade Commission, the nation’s consumer protection agency, enforces the COPPA Rule. If a site or service is covered by COPPA, it has to get your consent before collecting personal information from your child and it has to honor your choices about how that information is used.

What is COPPA?  

The COPPA Rule was put in place to protect kids’ personal information on websites and online services — including apps — that are directed to children under 13. The Rule also applies to a general audience site that knows it’s collecting personal information from kids that age.

COPPA requires those sites and services to notify parents directly and get their approval before they collect, use, or disclose a child’s personal information. Personal information in the world of COPPA includes a kid’s name, address, phone number or email address; their physical whereabouts; photos, videos and audio recordings of the child, and persistent identifiers, like IP addresses, that can be used to track a child’s activities over time and across different websites and online services.

Does COPPA affect the sites and services my kids use?

If the site or service doesn’t collect your child’s personal information, COPPA is not a factor. COPPA kicks in only when sites covered by the Rule collect certain personal information from your kids. Practically speaking, COPPA puts you in charge of your child’s personal information.

How does COPPA work?

COPPA works like this: Let’s say your child wants to use features on a site or download an app that collects their personal information. Before they can, you should get a plain language notice about what information the site will collect, how it will use it, and how you can provide your consent. For example, you may get an email from a company letting you know your child has started the process for signing up for a site or service that requires your child to give personal information. Or you may get that notice on the screen where you can consent to the collection of your child’s personal information.

The notice should link to a privacy policy that’s also plain to read — and in language that’s easy to understand. The privacy policy must give details about the kind of information the site collects, and what it might do with the information — say, if it plans to use the information to target advertising to a child or give or sell the information to other companies. In addition, the policy should state that those other companies have agreed to keep the information safe and confidential, and how to contact someone who can answer your questions.

That notice also should have directions on how to give your consent. Sites and services have some flexibility in how to do that. For example, some may ask you to send back a permission slip. Others may have a toll-free number you can call.

If you agree to let the site or service collect personal information from your child, it has a legal obligation to keep it secure.

What are my choices?

The first choice is whether you’re comfortable with the site’s information practices. Start by reading how the company plans to use your child’s information.

Then, it’s about how much consent you want to give. For example, you might give the company permission to collect your child’s personal information, but not allow it to share that information with others.

Once you give a site or service permission to collect personal information from your child, you’re still in control. As the parent, you have the right to review the information collected about your child. If you ask to see the information, keep in mind that website operators need to make sure you are the parent before providing you access. You also have the right to retract your consent any time, and to have any information collected about your child deleted.

What if it looks like a site or service is breaking the rules? 

If you think a site has collected information from your kids or marketed to them in a way that violates the law, report it to the FTC at ftc.gov/complaint.

 

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Hiking with the Kids

School is almost over, summer is fast approaching, and the season of family get togethers, reunions, vacations and barbeques is close at hand. Quite a few of these events may take place in a park, where there will be the chance to take the kids out for a family hike.

Hiking is a great way to spend some quality time together as a family, and is a terrific form of exercise. Getting out in nature, and maybe leaving behind all the instant communication technologies, can be quite liberating too.

hiking

Now, before you get up and hit those trails, there are some simple and important rules you should keep in mind. Remember, you want this to be a fun experience, for both you and your kids.

You can always hike more, but never less.

So, start out with a short hike in mind. If it is going well, you can simply add to it as you go along. Go too far, for too long, and you may be carrying the little ones back to the car.

Safety first.

Bug bites, sunburn and skinned knees are the most common safety issues you want to make sure you can take care of on the trail.

• Sunscreen and bug-spray all exposed skin before setting out on the trail.

• Long pants are better than shorts in protecting the legs from bug bites.

• For the skinned knee, or hand, some anti-biotic cream and band-aids are a good idea to have on hand.

Stay hydrated!

Make sure you bring along plenty of water. There is no such thing as too much water, and the best place to carry your water is inside you. Do not wait until you are thirsty to drink. Stop every 20-30 minutes and take a few swigs of water. Stay away from sugary drinks, straight water is more than good enough.

Keep up your strength.

Have some good energy snacks with you too. Depending on the length of the hike, you may want to stop, perhaps at a scenic viewpoint, and take a little break with something to eat.

Have a plan if…

The last simple rule needs a whistle Make sure each child has a whistle attached to them. I don’t mean in their pocket, I mean around their neck, or looped into their belt, so they cannot lose the whistle. If, they should ever become separated from the group, they can blow the whistle loud and clear, while staying put. Make sure this is explained to them before, and reviewed during, the hike.

Have fun!

These rules, if followed, will go a long way in making that family walk in the woods a good one. Having it be a good time, a good memory, that is the key to getting the kids – and you – to want to do it again. Hiking is a great exercise that can take your kids to great places as part of a life-long activity.

Some helpful websites for making the family hike fun and safe:

Hiking with Kids – American Hiking Society http://www.americanhiking.org/resources/hiking-with-kids/

• A short list of ideas to keep the hike “kid-friendly.”

Helpful Tips on Hiking – American Hiking Society

http://www.americanhiking.org/gear-resources/tips-for-your-next-hike/

• An excellent resource on everything you may need to know about getting started with hiking. From boots to bug-spray, rain gear to snacks, and safety and first-aide on the trail.

hiking

Kids and Hiking – REI

http://www.rei.com/learn/expert-advice/kids-hiking.html

Just Jeff’s Hiking Page

http://www.tothewoods.net/HikingWithKids.html

Tips for Hiking with Kids

http://www.wta.org/hiking-info/children/resources-for-families/how-to/tips-for-hiking-with-kids

 

Article by: Ned M Campbell is the head coach of James Madison High School’s wrestling team in Brooklyn, NY, and is a USA Wrestling nationally certified coach. He is a West Point graduate and former U.S. Army Officer, who also teaches history at James Madison teamHigh School.  Prior to teaching, Ned M Campbell worked with children and adults with disabilities during summer programs with IAHD and Southeast Consortium,  and volunteered time supporting a therapeutic horseback riding program for youth and adults with disabilities.

Campbell is a published writer, and a contributing writer to the “Can Do” Street blog for kids and parents. In addition, he is the voice of Coach Campbell in “Can Do” Street programs.

Editor’s Note: Be sure to check out Coach Campbell’s co-article for kids, on this subject, featured on the “Can Do” Kids blog at http://candostreet.com/blog-kids/

 

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