By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
I told you Waterhen was the center of the universe! The breaking edge of medical science is near the Waterhen River, just down from Taylor’s store at the Waterhen Health Unit! In case you missed my last article, let me get you caught up. A few weeks ago, I got to go to Waterhen for the first time. I was invited to speak to an infants, toddlers and parents group about cough and cold medications. The main question was: “Can you give over the counter cough and cold medications to infants and toddlers?” The easy answer is no. I did a little research, gave a presentation to the Waterhen group, then recycled that info for a Shopper’s article. It seems Health Canada is now trying to catch up to Waterhen. They changed the rules on infant and toddler cough and cold medication again.
On Dec 18, 2008 Health Canada said:
Health Canada is advising consumers of the outcome of its review of cough and cold medicines for children under the age of 12.
Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines that have dosing information for children to indicate that these medicines should not be used in children under 6.
The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season. During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under 6, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products. These medicines can still be used in children 6 and older, and adults.
This decision is the result of a Health Canada review of these medicines, including the input of a Scientific Advisory Panel convened in March 2008. Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children. In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel's conclusions and details of the new Health Canada recommendations are posted on the Health Canada Web site.
Health Canada previously issued advice on the use of these medicines in an October 2007 Public Advisory. Based on a preliminary review, Health Canada at that time recommended not using over-the-counter cough and cold medicines in children under 2 years of age, unless instructed to do so by a health care practitioner. The current decision expands on those preliminary recommendations.
Until the relabelling of these products is completed, Health Canada advises parents and caregivers to follow these important guidelines:
□ Do not use these over-the-counter cough and cold medicines in children under 6 years of age.
□ With children older than 6, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included.
□ Do not give children medications labelled only for adults.
□ Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child.
□ Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines.
□ The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity.
□ For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.
□ If you are concerned about the child's health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation.
For more information please visit:
Health Canda at: www.hc-sc.gc.ca/dhp-mps/medeff/res/cough-toux-eng.php
Canadian Pharmacists Association- Common Colds and Influenza – What you need to know at : www.pharmacists.ca/content/hcp/Resource_Centre/Drug_Therapeutic_Info/pdf/CC-Influenza_InfoforPatients-Parents_CPhA.pdf
As always if you have any questions or concerns about these or other products, ask your pharmacist.
Friday, December 26, 2008
Friday, December 19, 2008
Infant Cough and Cold Medications
By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
A few weeks ago, I got to go to Waterhen for the first time. I only got lost a few times between along the way, and it was a really nice drive. I found my way to the Health Unit, which is a very nice building. I was invited to speak to an infants, toddlers and parents group about cough and cold medications. The main question was: “Can you give over the counter cough and cold medications to infants and toddlers?” The easy answer is no. That would have made a rather short presentation, so I went through some of the background information with them. Now I’ll share that information with you.
So back in January 2008 the Food and Drug Administration (FDA) in the US said all cough and cold medications should be avoided in children under the age of two. A little later Health Canada made a similar recommendation. In October 2008 in the US manufacturers warnings said not to give cough and cold products to children under four and to not give any children antihistamines just to make them sleepy. Canadian changes are being considered.
So why all the fuss? Yes, my mom gave me Neo-Citran because it had an antihistamine in it which would make me sleepy. Yes, I gave my own children cough and cold medication before the age of four. But, the fuss boils down to safety and efficacy. For every medication we should ask: Is it Safe? Is it Effective? And What is the Risk versus Benefit of using it? For infant cough and cold medications, let’s start with are they safe?
It is safe to give over the counter cough and cold medication to infants and toddlers MOST of the time. The problem is the dose. Many parents have been giving their children the wrong dose. “No problem,” you say, “I can read. I’ll give my child the right dose!” Well, unfortunately, many parents have already given their children the wrong dose. Between 1969 and 2006 in the US there were 69 deaths in children from antihistamines and 54 deaths in children due to decongestants. Now, eventhough we assume the actual number of deaths are much higher than those reported, and these numbers don’t account for the number of injuries, not deaths that occurred, these are small numbers. When you consider the probable millions of doses of cough and cold medications given to children over the 37 years considered, cough and cold medications didn’t kill many children. But, they did kill and injure some children, so the risk isn’t zero.
So why do well meaning parents give the wrong dose to their kids? There are four main reasons: multiple ingredients, wrong formulations, kitchen spoons and small margin of error. Multiple ingredients means many cough and cold medications have more than one ingredient. For example if you bought a cough syrup, a anti-sneezing pill and Tylenol cold you could have a decongestant in all three of those products. If you were unaware of this you could give your child 3 times the dose of decongestant that they were supposed to get, and they could get a rapid heart rate or theoretically cause death. Wrong formulation means some products come in different strengths. Acetaminophen (or Tylenol) comes in 80 mg/ml and 160mg/5ml liquid. If a parent uses the 80mg/ml liquid (wrongly) and gives the child 1 tsp (5 mL), the child get 400 mg (not 160 mg) which is 2.5 times too much. Kitchen spoons means don’t use your kitchen spoons to measure your child’s medication. When a pharmacist says 1 teaspoon, we mean 5 mL. A kitchen teaspoon is not calibrated. Kitchen teaspoons vary from 2.5 to 10 mL. So if you use your kitchen teaspoon and I say give the child 1 teaspoon of medication you could be giving them anywhere from ½ the dose to twice the dose you were supposed to. Small margin of error refers to the fact children are small. Since children are small, their medication doses are small. Unfortunately that means even small errors in measuring a child’s medication can be harmful.
So we’ve seen that cough and cold medications have a small but real chance of harming children. We’ve talked about how : multiple ingredients, wrong formulations, kitchen spoons and small margin of error are the main reasons why parents make mistakes. So do cough and cold medications actually work? Are they effective? Probably not. What we need is to run some experiments where we give possibly dangerous chemicals to a bunch of babies….Any volunteers? For good ethical reasons, we don’t test cough/cold meds on babies. Even if we did, it is hard to ask them if they are feeling better or not. Cold medications have been tested on teenagers and adults. There is only a little proof that they improve symptoms like reducing the amount of cough and sneezing in teens and adults. If we assume infants and toddlers are just “little adults”, cold meds should help them a little too, right? The problem is infants and toddlers aren’t just little adults. Their lungs and immune systems are different. So we now think cold meds may not be effective in infants and toddlers at all (remember we can’t actually test meds on them). If cough and cold medications probably don’t help my child’s symptoms, and…If I give them the wrong amount I may harm them…Are Cough and Cold Medications in infants and toddlers worth the Risk? Probably not.
As always if you have any questions or concerns about these or other products, ask your pharmacist.
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
A few weeks ago, I got to go to Waterhen for the first time. I only got lost a few times between along the way, and it was a really nice drive. I found my way to the Health Unit, which is a very nice building. I was invited to speak to an infants, toddlers and parents group about cough and cold medications. The main question was: “Can you give over the counter cough and cold medications to infants and toddlers?” The easy answer is no. That would have made a rather short presentation, so I went through some of the background information with them. Now I’ll share that information with you.
So back in January 2008 the Food and Drug Administration (FDA) in the US said all cough and cold medications should be avoided in children under the age of two. A little later Health Canada made a similar recommendation. In October 2008 in the US manufacturers warnings said not to give cough and cold products to children under four and to not give any children antihistamines just to make them sleepy. Canadian changes are being considered.
So why all the fuss? Yes, my mom gave me Neo-Citran because it had an antihistamine in it which would make me sleepy. Yes, I gave my own children cough and cold medication before the age of four. But, the fuss boils down to safety and efficacy. For every medication we should ask: Is it Safe? Is it Effective? And What is the Risk versus Benefit of using it? For infant cough and cold medications, let’s start with are they safe?
It is safe to give over the counter cough and cold medication to infants and toddlers MOST of the time. The problem is the dose. Many parents have been giving their children the wrong dose. “No problem,” you say, “I can read. I’ll give my child the right dose!” Well, unfortunately, many parents have already given their children the wrong dose. Between 1969 and 2006 in the US there were 69 deaths in children from antihistamines and 54 deaths in children due to decongestants. Now, eventhough we assume the actual number of deaths are much higher than those reported, and these numbers don’t account for the number of injuries, not deaths that occurred, these are small numbers. When you consider the probable millions of doses of cough and cold medications given to children over the 37 years considered, cough and cold medications didn’t kill many children. But, they did kill and injure some children, so the risk isn’t zero.
So why do well meaning parents give the wrong dose to their kids? There are four main reasons: multiple ingredients, wrong formulations, kitchen spoons and small margin of error. Multiple ingredients means many cough and cold medications have more than one ingredient. For example if you bought a cough syrup, a anti-sneezing pill and Tylenol cold you could have a decongestant in all three of those products. If you were unaware of this you could give your child 3 times the dose of decongestant that they were supposed to get, and they could get a rapid heart rate or theoretically cause death. Wrong formulation means some products come in different strengths. Acetaminophen (or Tylenol) comes in 80 mg/ml and 160mg/5ml liquid. If a parent uses the 80mg/ml liquid (wrongly) and gives the child 1 tsp (5 mL), the child get 400 mg (not 160 mg) which is 2.5 times too much. Kitchen spoons means don’t use your kitchen spoons to measure your child’s medication. When a pharmacist says 1 teaspoon, we mean 5 mL. A kitchen teaspoon is not calibrated. Kitchen teaspoons vary from 2.5 to 10 mL. So if you use your kitchen teaspoon and I say give the child 1 teaspoon of medication you could be giving them anywhere from ½ the dose to twice the dose you were supposed to. Small margin of error refers to the fact children are small. Since children are small, their medication doses are small. Unfortunately that means even small errors in measuring a child’s medication can be harmful.
So we’ve seen that cough and cold medications have a small but real chance of harming children. We’ve talked about how : multiple ingredients, wrong formulations, kitchen spoons and small margin of error are the main reasons why parents make mistakes. So do cough and cold medications actually work? Are they effective? Probably not. What we need is to run some experiments where we give possibly dangerous chemicals to a bunch of babies….Any volunteers? For good ethical reasons, we don’t test cough/cold meds on babies. Even if we did, it is hard to ask them if they are feeling better or not. Cold medications have been tested on teenagers and adults. There is only a little proof that they improve symptoms like reducing the amount of cough and sneezing in teens and adults. If we assume infants and toddlers are just “little adults”, cold meds should help them a little too, right? The problem is infants and toddlers aren’t just little adults. Their lungs and immune systems are different. So we now think cold meds may not be effective in infants and toddlers at all (remember we can’t actually test meds on them). If cough and cold medications probably don’t help my child’s symptoms, and…If I give them the wrong amount I may harm them…Are Cough and Cold Medications in infants and toddlers worth the Risk? Probably not.
As always if you have any questions or concerns about these or other products, ask your pharmacist.
Friday, December 05, 2008
The JUPITER Trial
By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
Back on November 20, 2008 we got to go to a very interesting talk sponsored by the pharmaceutical company AstraZeneca. It was a teleconference going on live across Canada at the same time. There were over 1200 family physicians (and a few pharmacists) listening to some very bright researchers out of Toronto talk about the JUPITER Trial.
The trial talked about a choleterol pill called crestor or rosuvastatin helping people reduce their hsCRP which means there is less inflammation in their blood vessels. None of that made any sense to you? No problem, let’s go through some background information.
Cholesterol medications called statins or HMG-CoA reductase inhibitors are very commonly used. They work very well at reducing cholesterol, especially LDL or bad cholesterol. Researchers have found over time that if we reduce a person’s LDL, they will be less likely to have a heart attack or stroke. So we put people on statins to reduce their chances of heart attacks or stroke.
Not surprisingly, it is not as simple as reduce cholesterol and you reduce the chance of heart attacks and stroke. Nothing with the body is ever that simple. There are people with high cholesterol who don’t have heart attacks and stroke. There are people with low cholesterol who do have heart attacks and stroke. There are even people with actual cholesterol laden partial blockages in their arteries (called plaques) that don’t go on to have a heart attack or stroke. It is only when these plaques become “unstable” that we get problems. The other thing that is going on may be inflammation in the blood vessels and statins might help that too.
We have known for a while that statins do other good things for preventing heart attacks and stroke than just lowering cholesterol. There have been studies that showed with the medication lipitor or atorvastatin there were benefits to reducing heart attack or stroke over and above how much the atorvastatin reduced the cholesterol. So was this because the atorvastatin reduced inflammation in the blood vessels?
This brings us to the JUPITER trial. They used the cholesterol pill rosuvastatin and measured both the LDL and the hsCRP. High sensitivity c-reactive protein (hsCRP) is a measurement of inflammation. One of the ways to look at people in general is to put them in 4 groups
Low LDL, low hsCRP – these people have very few heart problems. They weren’t in the trial.
Low LDL, high hsCRP – this is an interesting group. We wouldn’t normally give these people a statin, because their cholesterol isn’t high. But, this is the group that went into the JUPITER trial. They did give these people rosuvastatin and their hsCRP’s went down.
High LDL, low hsCRP - not in trial. We already know from previous trials that if we give these people a statin they will have less heart problems.
High LDL, high hsCRP - not in trial. We already know from previous trials that if we give these people a statin they will have less heart problems.
So the people in the JUPITER trial with low LDL and high hsCRP had their hsCRP go down with rosuvastatin. This means the inflammation in their blood vessels went down with rosuvastatin. They also had fewer heart problems with rosuvastatin. So reducing hsCRP with statins reduces heart problems, right? Maybe.
Dr. Hrabarchuk gave us a good commentary after the presentation in Dauphin and I have read some other people’s thoughts since about how good the JUPITER trial was. There are some criticisms.
The trial itself was well done, but the improvement is very small. Pharmacist’s letter did the math and to prevent one hard cardiac endpoint (heart attack, stroke or cardiovascular death) you would need to treat 120 people for 1.9 years. That is a lot of people buying and taking a lot of pills to prevent one event.
The hsCRP test is not free. It costs ~$70. Is it worth the money?
Are the good benefits, however small, from lowering LDL or lowering hsCRP or both?
Can we lower hsCRP (and inflammation) by a cheaper method like a low dose ASA?
So should everyone run out and get an hsCRP and then demand their docs lower them with rosuvastatin? Probably not. JUPITER was a very good trial, and had some interesting results, but hsCRP and heart problems needs more study. What is not under debate is that if you have high LDL you should be on a statin. It has been estimated that only about half the people prescribed a statin are still on it six months later. That is definitely bad for their health.
As always if you have any questions or concerns about these products, ask your pharmacist.
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
Back on November 20, 2008 we got to go to a very interesting talk sponsored by the pharmaceutical company AstraZeneca. It was a teleconference going on live across Canada at the same time. There were over 1200 family physicians (and a few pharmacists) listening to some very bright researchers out of Toronto talk about the JUPITER Trial.
The trial talked about a choleterol pill called crestor or rosuvastatin helping people reduce their hsCRP which means there is less inflammation in their blood vessels. None of that made any sense to you? No problem, let’s go through some background information.
Cholesterol medications called statins or HMG-CoA reductase inhibitors are very commonly used. They work very well at reducing cholesterol, especially LDL or bad cholesterol. Researchers have found over time that if we reduce a person’s LDL, they will be less likely to have a heart attack or stroke. So we put people on statins to reduce their chances of heart attacks or stroke.
Not surprisingly, it is not as simple as reduce cholesterol and you reduce the chance of heart attacks and stroke. Nothing with the body is ever that simple. There are people with high cholesterol who don’t have heart attacks and stroke. There are people with low cholesterol who do have heart attacks and stroke. There are even people with actual cholesterol laden partial blockages in their arteries (called plaques) that don’t go on to have a heart attack or stroke. It is only when these plaques become “unstable” that we get problems. The other thing that is going on may be inflammation in the blood vessels and statins might help that too.
We have known for a while that statins do other good things for preventing heart attacks and stroke than just lowering cholesterol. There have been studies that showed with the medication lipitor or atorvastatin there were benefits to reducing heart attack or stroke over and above how much the atorvastatin reduced the cholesterol. So was this because the atorvastatin reduced inflammation in the blood vessels?
This brings us to the JUPITER trial. They used the cholesterol pill rosuvastatin and measured both the LDL and the hsCRP. High sensitivity c-reactive protein (hsCRP) is a measurement of inflammation. One of the ways to look at people in general is to put them in 4 groups
Low LDL, low hsCRP – these people have very few heart problems. They weren’t in the trial.
Low LDL, high hsCRP – this is an interesting group. We wouldn’t normally give these people a statin, because their cholesterol isn’t high. But, this is the group that went into the JUPITER trial. They did give these people rosuvastatin and their hsCRP’s went down.
High LDL, low hsCRP - not in trial. We already know from previous trials that if we give these people a statin they will have less heart problems.
High LDL, high hsCRP - not in trial. We already know from previous trials that if we give these people a statin they will have less heart problems.
So the people in the JUPITER trial with low LDL and high hsCRP had their hsCRP go down with rosuvastatin. This means the inflammation in their blood vessels went down with rosuvastatin. They also had fewer heart problems with rosuvastatin. So reducing hsCRP with statins reduces heart problems, right? Maybe.
Dr. Hrabarchuk gave us a good commentary after the presentation in Dauphin and I have read some other people’s thoughts since about how good the JUPITER trial was. There are some criticisms.
The trial itself was well done, but the improvement is very small. Pharmacist’s letter did the math and to prevent one hard cardiac endpoint (heart attack, stroke or cardiovascular death) you would need to treat 120 people for 1.9 years. That is a lot of people buying and taking a lot of pills to prevent one event.
The hsCRP test is not free. It costs ~$70. Is it worth the money?
Are the good benefits, however small, from lowering LDL or lowering hsCRP or both?
Can we lower hsCRP (and inflammation) by a cheaper method like a low dose ASA?
So should everyone run out and get an hsCRP and then demand their docs lower them with rosuvastatin? Probably not. JUPITER was a very good trial, and had some interesting results, but hsCRP and heart problems needs more study. What is not under debate is that if you have high LDL you should be on a statin. It has been estimated that only about half the people prescribed a statin are still on it six months later. That is definitely bad for their health.
As always if you have any questions or concerns about these products, ask your pharmacist.
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