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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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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What are Empty Calories?

MyPlate.gov., a division of the Dept. of Agriculture offers the following information about foods we eat, and really enjoy, that really don’t give us the nutrients we need but do give us what are referred to as “empty calories.”

caloriesMany of the foods and beverages Americans eat and drink contain empty calories –- calories from solid fats and/or added sugars. Solid fats and added sugars add calories to the food but few or no nutrients. For this reason, the calories from solid fats and added sugars in a food are often called empty calories. Learning more about solid fats and added sugars can help you make better food and drink choices.

Solid fats are fats that are solid at room temperature, like butter, beef fat, and shortening. Some solid fats are found naturally in foods. They can also be added when foods are processed by food companies or when they are prepared. Added sugars are sugars and syrups that are added when foods or beverages are processed or prepared.
Solid fats and added sugars can make a food or beverage more appealing, but they also can add a lot of calories. The foods and beverages that provide the most empty calories for Americans are:

  • Cakes, cookies, pastries, and donuts (contain both solid fat and added sugars)
  • Sodas, energy drinks, sports drinks, and fruit drinks (contain added sugars)
  • Cheese (contains solid fat)
  • Pizza (contains solid fat)
  • Ice cream (contains both solid fat and added sugars)
  • Sausages, hot dogs, bacon, and ribs (contain solid fat)

These foods and beverages are the major sources of empty calories, but many can be found in forms with less or no solid fat or added sugars. For example, low-fat cheese and low-fat hot dogs can be purchased. You can choose water, milk, or sugar-free soda instead of drinks with sugar. Check that the calories in these products are less than in the regular product.

In some foods, like most candies and sodas, all the calories are empty calories. These foods are often called “empty calorie foods.” However, empty calories from solid fats and added sugars can also be found in some other foods that contain important nutrients. Some examples of foods that provide nutrients, shown in forms with and without empty calories are:

 

Food with some empty calories Food with few or no empty calories
Sweetened applesauce (contains added sugars) Unsweetened applesauce
Regular ground beef (75% lean) (contains solid fats) Extra lean ground beef (96% or more lean)
Fried chicken (contains solid fats from frying and skin) Baked chicken breast without skin
Sugar-sweetened cereals (contain added sugars) Unsweetened cereals
Whole milk (contains solid fats) Fat-free milk

Making better choices, like unsweetened applesauce or extra lean ground beef, can help keep your intake of added sugars and solid fats low.

A small amount of empty calories is okay, but most people eat far more than is healthy.

It is important to limit empty calories to the amount that fits your calorie and nutrient needs. You can lower your intake by eating and drinking foods and beverages containing empty calories less often or by decreasing the amount you eat or drink.

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Memorial Day

It isn’t easy to explain Memorial Day to children, but if you are asked, here is a history you might want to share.

Memorial Day is a day of remembrance for those who have died serving our country.

Waterloo N.Y. was officially declared the birthplace of Memorial Day by President Lyndon Johnson in May 1966; however,  it’s difficult to prove the origins of the day. Probably it had many separate beginnings; with towns and gatherings of people honoring their war dead.

Memorial Day was officially proclaimed on 5 May 1868 by General John Logan, national commander of the Grand Army of the Republic, and was first observed on 30 May 1868, when flowers were placed on the graves of Union and Confederate soldiers at Arlington National Cemetery.

The first state to officially recognize the holiday was New York in 1873. By 1890 it was recognized by all of the northern states. The South refused to acknowledge the day, honoring their dead on separate days until after World War I (when the holiday changed from honoring just those who died fighting in the Civil War to honoring Americans who died fighting in any war). It is now celebrated in almost every State on the last Monday in May (passed by Congress with the National Holiday Act of 1971 (P.L. 90 – 363) to ensure a three day weekend for Federal holidays), though several southern states have an additional separate day for honoring the Confederate war dead: January 19 in Texas, April 26 in Alabama, Florida, Georgia, and Mississippi; May 10 in South Carolina; and June 3 (Jefferson Davis’ birthday) in Louisiana and Tennessee.

Traditional observance of Memorial Day has diminished over the years. Many Americans nowadays have forgotten the meaning and traditions of Memorial Day.

What may be needed to return the solemn, and even sacred, spirit back to Memorial Day is for a return to its traditional day of observance. Many feel that when Congress made the day into a three-day weekend in with the National Holiday Act of 1971, it made it all the easier for people to be distracted from the spirit and meaning of the day.

 Memorial Day

Source: usmemorialday.org

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