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　How Safe Are KIDS' Prescription Drugs?

Drugs prescribed to children and adolescents have been much in the news th Canada has issued warnings about some drugs that both patients and physicians trusted,and it has withdrawn others from the 's going on?Parents should understand these complicated and confusing issues.

How Are Prescription Drugs Approved in Canada?

When a pharmaceutical company has a new applies to Health Canada for a licence to sell d oninformation the company provides,including the results of clinical trials,the drug is either approved or the application is rejected.

Is There a Difference in the Way Drugs Are Approved for Children and Adults?

s are tested in adults s Daneman.a clinical investigator at The Hospital for Sick Children in Toronto,says,“we have to be remarkably careful because children are physiologically different than adults and are seen by physicians as a highly vulnerable group.”

What Happens Once a Drug Is Approved?

“Once approved,” explains Daneman.“it's available on the market and doctors can prescribe it for any indication they'd like to.” Even if it has not been tested specifically in says.“physicians may start to use it either in small trials or what we call off-label (use of a prescription drug to treat a condition for which the drug has not been approved) in children.”

How Common Is Off-label Use?

ael Rieder. director of the Adverse Drug Reaction Clinic at the Children's Hospital of Western Ontario,says,“drugs commonly used in children，such as antibiotcs and asthma drugs,are tested in children.” But,he says,“there is a misconception that children take only those did a study looking at a million kids in Canada over a turns out they used l,400 different drugs,of which 60 percent have not been tested,or approved for use in children.”

If a Drug Is Safe in Adults,Why Do You Need to Test It in children?

Health Canada's ika Mithani says.“children are not small adults.”Their physiology is goes for Ottawa-based family physician who writes a column on adverse events for the Canadian Medical Association Journal,says,“Depo Provera is an injectable birth-control product used by women of all one thought to test it in adolescents until agers arelaying down bone density and this drug decreased bone density.”

Are Older Drugs Safer?

“If I were to use a medication off-label that's been around for some time,I'd be less concerned about it.” advises r Nieman.a Calgary pediatrician.“But if you use a medication that's being promoted as che best thing since sliced bread,and you know it's fairly new and are using it off-label,you are a bit nervous.”

How Many Side Effects Are Reported?

In 2004 Health Canada received 10,238 reports of adverse reactions in people of all number of reports has been increasing since 1999,when just under 6,000 were sent e the pharmaceutical outcomes program at the Children's and Women's Health Centre of British Columbia，says,“95 percent of negative reactions are never reported.”Wooltorton explains:“how do you track the more minor,long-term side effects,the ones where kids are a little bit stunted in growth or they are having learning problems in e's no regulation and no financial incentive to report anything at all.”

Should We Be More Careful with Some Drugs?

Uetrecht,a Canada Research Chair in adverse drug reactions,advises extra caution with drugs that affect the central nervous system.“The effects and long-term outcomes of giving these types of drugs aren't totally understood. Make sure the appropriate tests are given to make as clear a diagnosis as that the appropriate treatment is given based on that ing to the patient for a few minutes and prescribing a drug would not be the best there is a severe clinical problem and a clear clinical benefit,then the benefit is worth the risk.”

Can Side Fffects Be Prevented?

If your child has had a reaction to a drug in the past,an allergist can advise if she is still if so,what could be used me Canada is funding an $8.4-million research project that may helpprevent side effects in the by Carleton and geneticist Michael Hayden,director of the Centre for Molecular Medicine and is looking for genetic markers that would signal if a child was at risk for an adverse reaction.“There are genetic differences in the way a lot of physiological processeshappen in the human body,”says Carleton.“It makes sense that those differences would affect the way we process efore,understanding when that situation exists would help us to construct better guidelines.”

What Should You Ask About Your Child's Prescription?

First,be sure it is really necessary,says Wooltorton.“A lot of children don't always need prescriptions for a lot of infections are an example of when antibiotics are sometimes,but not always, there is a tendency in our society to want our kids to be like want to get back to want them to get back to want a quick ‘how wi11 we know the drug is working?'A child with asthma,for example,is usually given a couple of will be to open the should feel better after the First he doesn't,we have a other medication is used to reduce will decrease the number of acute breathless episodes,but it takes time to have an effect.”Find out how long your physician has been using the drug,says Rieder,and what the experience has been doctor may know quite a lot about the drug, even if it is being used off-label.

What Should Parents Watch Out for?

ael Kramcr,of the Canadian Institutes of Health Research,says you should contact your physician“ifyour child is very sleepy or is agitated and unable to should also be concerned about any rashesthat cause blistering or hivcs.”When you pick up a medication at the drugstore,it often comes with a listof potential side a MacPhee,who teaches in the School of Nursing at the University of British Columbia,says,“this is generic re leaving the physician's office,make sure you know what side effects are the ones you need to worry about with your child.”

How Safe Is the System?

In the last 25 to 30 years,we have seen significant advances in the treatment of childhood leukemia.“WhenI was training 30 years ago,”says Daneman,“childhood leukemia had an 80-percent mortality rate;now the survival rate is better than 80 percent.”Another important development:More drugs are being tested now in man says:“if you look at the number of studies that go on,there are many more in the last five to eight years than there were 20 0r 30 years ago.”

h of the following is requested by Health Canada before it permits a drug to be sold?

A) The aize and the weight of the drug.

B) The suggested price of the drug.

C) The results of clinical trials of the drug.

D) The production budget of the drug.

is seen by s Daneman as a highly vulnerable group?

A) Pregnant women.

B) Children.

C) Elderly people over 70.

D) Middle-aged men.

many kinds of drugs are now used by children off-label?

A) 840.

B) 60.

C) 1400.

D) 560.

Provera is a drug that can result in adolescents'_____________.

A) stomach upset

B) low blood pressure

C} high cholesterol

D) decreased bone density

minor and long-term side effects were not reported due to______________.

A) patients' ignorance

B) lack of financial incentive

C) doctor's irresponsibility

D) shortage of health workers

Uetrecht is most concerned about drugs' side effect on________________.

A) the nervous system

B) the digestive system

C) the respiratory system

D) the skeleton system

Uetrecht suggests that an accurate diagnosis is the basis of________________.

A) appropriate treatment

B) prescribing a new drug

C) avoidance of side effects

D) feasible medical tests

project funded by Genome Canada hopes to prevent adverse reactionsafter identifying relevant______________.

a child with asthma suffers acute breathless episodes,he should take medicine to________________.

buying a medicine in a drugstore or getting it from a physician,parents need to watchout for its__________________.