Should we inform parents if a medication for their child is "off licence"?
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Should we inform parents if a medication for their child is "off licence"?
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As a medical student and then a junior doctor we are warned of the risks of prescribing medications "off licence". For those unfamiliar the term refers to any medicine which has not been fully tested
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Should we inform parents if a medication for their child is "off licence"?
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Should we inform parents if a medication for their child is "off licence"?
posted at 9/9/2012 7:49 PM BST
on bmj.com
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Posts: 1348
First: 25/1/2009 Last: 20/5/2013 |
As a medical student and then a junior doctor we are warned of the risks of prescribing medications "off licence". For those unfamiliar the term refers to any medicine which has not been fully tested in a particular population group or for the indication you intend to use it for. This means that the company who make the medication offer no guarentees of safety and accept no responsibility for side effects or problems which then result. When newly graduated I recall being terrified of such medications and for one drug the nurses were so cautious that they, with the consultants, had written a protocol for the drug which included the doctors drawing up and administering the infusions so that they could not be held at all responsible. It caused me to spend a lot of time learning to work IV pumps and meant I spent more time with my patients while setting up the infusions but no problems came of it as far as I am aware. But now I work in paediatrics I'm aware that many drugs I prescribe are "off licence". I was however suprised to read this news article sent to me by MBillingsley about the degree of the problem for paediatric prescribing. The report quotes figures of 1/3 of drugs used on children and upto 95% of drugs used on neonates being untested in children and suggests that this can inturn contribute to drug errors and unexpected side effects. While the article may have its own political agenda, the figures themselves come from a report from the Children and Young People’s Health Outcomes Forum. The questions raised in the Mail article include asking why research in children's medications is lagging so far behind and should we tell parents that the drug we have prescribed for their child is off licence? Which got me thinking - I dont think I've ever stopped to explain off licence drugs to parents... should we? |
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Re: Should we inform parents if a medication for their child is "off licence"?
posted at 9/9/2012 11:32 PM BST
on bmj.com
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Posts: 578
First: 8/6/2011 Last: 19/5/2013 |
Important notice DrS. Are you refering about medicines that are not included in the national formulary for children ? Some where looking for something else i saw that their is a british national formulary for children . Or am i wrong ? Because if there is , then normaly that contains the lincenced drugs for use on childrens and everything else should not be used . Please illuminate me. |
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Re: Should we inform parents if a medication for their child is "off licence"?
posted at 10/9/2012 6:51 AM BST
on bmj.com
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Posts: 1348
First: 25/1/2009 Last: 20/5/2013 |
In Response to Re: Should we inform parents if a medication for their child is "off licence"?: Important notice DrS. Are you refering about medicines that are not included in the national formulary for children ? Some where looking for something else i saw that their is a british national formulary for children . Or am i wrong ? Because if there is , then normaly that contains the lincenced drugs for use on childrens and everything else should not be used . Please illuminate me. Posted by ikaros Many of the medicines listed in the BNFC are used "off licence", either because they have not been tested on children (doses are usually scaled back from adult dosing) or because they have been tested, but only for limited indications and you are using it for something different! |
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Re: Should we inform parents if a medication for their child is "off licence"?
posted at 10/9/2012 9:14 AM BST
on bmj.com
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Posts: 1264
First: 13/4/2010 Last: 20/5/2013 |
Drug companies only apply for a license where they think there's money to be made. i suspect they see that in most cases doing specific paediatric trials would never give them a return on their money so they just don't bother most of the time. It's important to explain to parents that a drug used "off license" is quite legitimate if it's the right drug to use and you are quite entitled as a medical professional to prescribe off license. Often we do it, even in adults, without knowing we are doing it (e.g. use of beta blockers, tricyclics or anti-convulsants in migraine prophylaxis or the latter two in chronic pain). Off license does not mean contraindicated. It's simply a commercial term - nothing more. Of course we have to take the responsibility for prescribing off license but, in reality, we are responsible for any drug we prescribe whether on or off license. |
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Re: Should we inform parents if a medication for their child is "off licence"?
posted at 5/10/2012 6:21 PM BST
on bmj.com
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Posts: 3
First: 5/10/2012 Last: 9/4/2013 |
In Response to Re: Should we inform parents if a medication for their child is "off licence"?: Drug companies only apply for a license where they think there's money to be made. i suspect they see that in most cases doing specific paediatric trials would never give them a return on their money so they just don't bother most of the time. It's important to explain to parents that a drug used "off license" is quite legitimate if it's the right drug to use and you are quite entitled as a medical professional to prescribe off license. Often we do it, even in adults, without knowing we are doing it (e.g. use of beta blockers, tricyclics or anti-convulsants in migraine prophylaxis or the latter two in chronic pain). Off license does not mean contraindicated. It's simply a commercial term - nothing more. Of course we have to take the responsibility for prescribing off license but, in reality, we are responsible for any drug we prescribe whether on or off license. Posted by skyesteve Of course we do prescribe drugs off license ( this can be for an indication for which the drugs are not licensed, for an age group- children or old age people in whom the drugs were not tested or indeed in pregnancy where no drug is absolutely safe!) and we do take responsibility for them. We should bear in mind that if something goes wrong we alone are held responsible as the drug companies can wash their hands of. In recent years there was a well publicised matter of SSRIs increasing suicide risk in children. Only fluoxetine was studied in children and understandably since then child psychiatrists avoid other SSRIs as a result. Safety/tolerability may significantly differ between age groups and possibly also diagnoses. It is reasonable and I think good practice to discuss with patients/parents the off license prescribing and get their agreement. Spending a few extra minutes on doing this and recording the discussion having taken place, can save one a lot of pain later on if something goes terribly wrong.
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