Re: Off-label, unauthorised Rxing in children “widespread” in Europe

[Guest guest]

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500101006

I was looking at the report and noted the way data was collected and

in many countries not collected at all. Interesting, so the numbers

could be much higher since many countries gave no data and the ones

that did had collected data in different ways.

Jim

On 1/27/2011 11:26 AM, jeremy9282 wrote:

Off-label, unauthorised Rxing in

children "widespread" in Europe

 

 

http://www.pharmatimes.com/Article/11-01-27/Off-label_unauthorised_Rxing_in_children_%E2%80%9Cwidespread%E2%80%9D_in_Europe.aspx

The prescribing of off-label

and unauthorised medicines to children is still widespread in

Europe, accounting for 45%-60% of total prescriptions in both

inpatient and outpatient care, says a new report from the

European Medicines Agency (EMA).

The study findings show the

highest rates of use are in very young children and in

children with very severe conditions. It also notes that the

therapeutic classes that are used most frequently off-label or

without a marketing authorisation are: antiarrhythmics,

antihypertensives (renin-angiotensin inhibitors and

beta-blockers) proton pump inhibitors and H2-receptor

antagonists, antiasthmatics, and antidepressants (mainly

selective serotonin reuptake inhibitors,

serotonin-norepinephrine reuptake inhibitors and tricyclic

antidepressants), contraceptives (in adolescents), and

antibiotics (in very young children).

The survey was conducted to

support the development of the EMA's Paediatric Committee

(PDCO)'s inventory of paediatric needs, a list which describes

the different therapeutic areas where research into and

develop of medicnes for children is particularly needed. This

applies to both off-patent medicines and new products,

including authorised drugs and those current under

development.

However, the data made

available to the EMA for the study was `very scarce," with

only 22 - 20 European Union (EU) and two non-EU - countries

out of the 30 invited to participate actually submitting data,

says the Agency. Moreover, a lack of heterogeneity made

inter-company comparisons impossible and there was poor

distinction between different types of drug use in children

(authorised, unauthorised and off-label), which was further

confused by the lack of common terminology in the different EU

countries, it adds.

Data from the UK was obtained

by using the British National Formulary for Children (BNFC).

As expert clinical advisers are used in the UK to advise on

use of unlicensed medicines and off-label uses, there was no

estimation of the nation's existing use (both authorised and

unauthorised/off-label) of paediatric medicines, says the

report.

One important reason for

off-label and unauthorised drug use in children is the current

lack of age-appropriate formulations, including form and

strength, and this produced some surprising results in the study, such as the

high off-label use of many antiasthmatics, despite the high

paediatric incidence of this condition, says the EMA.

Nor was the exercise able to

provide sufficient safety information - only Austria submitted

some safety data - but many publications have established that

adverse effects are more frequent, more serious and more

underreported when medicines are used unauthorised or

off-label, says the report. The Paediatric Regulation is

expected to improve the situation by ensuring that new

products are meeting paediatric needs through the Paediatric

Investigation Plans (PIPs) agreed by the PDCO but, says the

EMA, in the meantime "a number of easy-to-reach solutions

could be proposed at least to make existing medicines

available to all member states and existing information to all

prescribers for the sake of European children."

www.ema.europa.eu

[Guest guest]

Hi Jim

I can only speak for the UK situation. Our health service is "nationalised" all scripts are computer generated & include patients date of birth as well as vaious "security watermarks"

All children scripts are dispensed free of charge.

All scripts have to be handed into pharmacy registered with the Dept Health ....... so one could be fairly certain of data generated here.

Internet purchase of rx drugs is so small here it can be disregarded.

But as for other parts of europe I cannot say & therefore it is possible that the situation, as you say, is worse than EMA suggest.

> >> >> > Off-label, unauthorised Rxing in children "widespread" in Europe> >> > http://www.pharmatimes.com/Article/11-01-27/Off-label_unauthorised_Rxing_in_children_%E2%80%9Cwidespread%E2%80%9D_in_Europe.aspx> >> > The prescribing of off-label and unauthorised medicines to children is > > still widespread in Europe, accounting for 45%-60% of total > > prescriptions in both inpatient and outpatient care, says a new report > > from the European Medicines Agency (EMA).> >> > The study findings show the highest rates of use are in very young > > children and in children with very severe conditions. It also notes > > that the therapeutic classes that are used most frequently off-label > > or without a marketing authorisation are: antiarrhythmics, > > antihypertensives (renin-angiotensin inhibitors and beta-blockers) > > proton pump inhibitors and H2-receptor antagonists, antiasthmatics, > > and antidepressants (mainly selective serotonin reuptake inhibitors, > > serotonin-norepinephrine reuptake inhibitors and tricyclic > > antidepressants), contraceptives (in adolescents), and antibiotics (in > > very young children).> >> > The survey was conducted to support the development of the EMA's > > Paediatric Committee (PDCO)'s inventory of paediatric needs, a list > > which describes the different therapeutic areas where research into > > and develop of medicnes for children is particularly needed. This > > applies to both off-patent medicines and new products, including > > authorised drugs and those current under development.> >> > However, the data made available to the EMA for the study was `very > > scarce," with only 22 - 20 European Union (EU) and two non-EU - > > countries out of the 30 invited to participate actually submitting > > data, says the Agency. Moreover, a lack of heterogeneity made > > inter-company comparisons impossible and there was poor distinction > > between different types of drug use in children (authorised, > > unauthorised and off-label), which was further confused by the lack of > > common terminology in the different EU countries, it adds.> >> > Data from the UK was obtained by using the British National Formulary > > for Children (BNFC). As expert clinical advisers are used in the UK to > > advise on use of unlicensed medicines and off-label uses, there was no > > estimation of the nation's existing use (both authorised and > > unauthorised/off-label) of paediatric medicines, says the report.> >> > One important reason for off-label and unauthorised drug use in > > children is the current lack of age-appropriate formulations, > > including form and strength, and this produced some surprising results > > in the study, such as the high off-label use of many antiasthmatics, > > despite the high paediatric incidence of this condition, says the EMA.> >> > Nor was the exercise able to provide sufficient safety information - > > only Austria submitted some safety data - but many publications have > > established that adverse effects are more frequent, more serious and > > more underreported when medicines are used unauthorised or off-label, > > says the report. The Paediatric Regulation is expected to improve the > > situation by ensuring that new products are meeting paediatric needs > > through the Paediatric Investigation Plans (PIPs) agreed by the PDCO > > but, says the EMA, in the meantime "a number of easy-to-reach > > solutions could be proposed at least to make existing medicines > > available to all member states and existing information to all > > prescribers for the sake of European children."> >> >> > www.ema.europa.eu> >> >> >> >>

[Guest guest]

Hi ,

I looked and UK data was supplied but not correct format, not

used.

Several countries are listed near the end that did not include

data, Romania sticks in my mind as lots of drug companies are now

doing research there.

My take on this is it's probably worse than reported. What your

saying about the health system there shocks me that they cannot

produce data that can be used. Hmmm...

Best,

Jim

On 1/27/2011 1:28 PM, jeremy9282 wrote:

Hi Jim

 

I can only speak for the UK situation. Our health service is

"nationalised" all scripts are computer generated & include

patients date of birth as well as vaious "security watermarks"

All children scripts are dispensed free of charge.

All scripts have to be handed into pharmacy registered with the

Dept Health ....... so one could be fairly certain of data

generated here.

Internet purchase of rx drugs is so small here it can be

disregarded.

 

But as for other parts of europe I cannot say & therefore

it is possible that the situation, as you say, is worse than EMA

suggest.

 

 

> >

> >

> > Off-label, unauthorised Rxing in children "widespread"

in Europe

> >

> >

http://www.pharmatimes.com/Article/11-01-27/Off-label_unauthorised_Rxing_in_children_%E2%80%9Cwidespread%E2%80%9D_in_Europe.aspx

> >

> > The prescribing of off-label and unauthorised

medicines to children is

> > still widespread in Europe, accounting for 45%-60% of

total

> > prescriptions in both inpatient and outpatient care,

says a new report

> > from the European Medicines Agency (EMA).

> >

> > The study findings show the highest rates of use are

in very young

> > children and in children with very severe conditions.

It also notes

> > that the therapeutic classes that are used most

frequently off-label

> > or without a marketing authorisation are:

antiarrhythmics,

> > antihypertensives (renin-angiotensin inhibitors and

beta-blockers)

> > proton pump inhibitors and H2-receptor antagonists,

antiasthmatics,

> > and antidepressants (mainly selective serotonin

reuptake inhibitors,

> > serotonin-norepinephrine reuptake inhibitors and

tricyclic

> > antidepressants), contraceptives (in adolescents), and

antibiotics (in

> > very young children).

> >

> > The survey was conducted to support the development of

the EMA's

> > Paediatric Committee (PDC! O)'s inventory of

paediatric needs, a list

> > which describes the different therapeutic areas where

research into

> > and develop of medicnes for children is particularly

needed. This

> > applies to both off-patent medicines and new products,

including

> > authorised drugs and those current under development.

> >

> > However, the data made available to the EMA for the

study was `very

> > scarce," with only 22 - 20 European Union (EU) and two

non-EU -

> > countries out of the 30 invited to participate

actually submitting

> > data, says the Agency. Moreover, a lack of

heterogeneity made

> > inter-company comparisons impossible and there was

poor distinction

> > between different types of drug use in children

(authorised,

> > unauthorised and off-label), which was further

confused by the lack of

> > common terminology in the different EU countries, it

adds.

> >

> > Data from the UK was obtained by using the British

National Formulary

> > for Children (BNFC). As expert clinical advisers are

used in the UK to

> > advise on use of unlicensed medicines and off-label

uses, there was no

> > estimation of the nation's existing use (both

authorised and

> > unauthorised/off-label) of paediatric medicines, says

the report.

> >

> > One important reason for off-label and unauthorised

drug use in

> > children is the current lack of age-appropriate

formulations,

> > including form and strength, and this produced some

surprising results

> > in the study, such as the high off-label use of many

antiasthmatics,

> > despite the high paediatric incidence of this

condition, says the EMA.

> >

> > Nor was the exercise able to provide sufficient safety

information -

> > only Austria submitted some safety data - but many

publications have

> > established that ad! verse effects are more frequent,

more serious and

> > more underreported when medicines are used

unauthorised or off-label,

> > says the report. The Paediatric Regulation is expected

to improve the

> > situation by ensuring that new products are meeting

paediatric needs

> > through the Paediatric Investigation Plans (PIPs)

agreed by the PDCO

> > but, says the EMA, in the meantime "a number of

easy-to-reach

> > solutions could be proposed at least to make existing

medicines

> > available to all member states and existing

information to all

> > prescribers for the sake of European children."

> >

> >

> > www.ema.europa.eu

> >

> >

> >

> >

>

[Guest guest]

reports full text ... pdf format

Report on the survey of all paediatric uses of medicinal products in Europe: Executive summary (20/01/2011)

Report on the survey of all paediatric uses of medicinal products in Europe: Questions and answers (20/01/2011)

Report on the survey of all paediatric uses of medicinal products in Europe (20/01/2011)

> > > >> > > >> > > > Off-label, unauthorised Rxing in children "widespread" in Europe> > > >> > > > > > http://www.pharmatimes.com/Article/11-01-27/Off-label_unauthorised_Rxing_in_children_%E2%80%9Cwidespread%E2%80%9D_in_Europe.aspx> > > >> > > > The prescribing of off-label and unauthorised medicines to > > children is> > > > still widespread in Europe, accounting for 45%-60% of total> > > > prescriptions in both inpatient and outpatient care, says a new > > report> > > > from the European Medicines Agency (EMA).> > > >> > > > The study findings show the highest rates of use are in very young> > > > children and in children with very severe conditions. It also notes> > > > that the therapeutic classes that are used most frequently off-label> > > > or without a marketing authorisation are: antiarrhythmics,> > > > antihypertensives (renin-angiotensin inhibitors and beta-blockers)> > > > proton pump inhibitors and H2-receptor antagonists, antiasthmatics,> > > > and antidepressants (mainly selective serotonin reuptake inhibitors,> > > > serotonin-norepinephrine reuptake inhibitors and tricyclic> > > > antidepressants), contraceptives (in adolescents), and antibiotics > > (in> > > > very young children).> > > >> > > > The survey was conducted to support the development of the EMA's> > > > Paediatric Committee (PDC! O)'s inventory of paediatric needs, a list> > > > which describes the different therapeutic areas where research into> > > > and develop of medicnes for children is particularly needed. This> > > > applies to both off-patent medicines and new products, including> > > > authorised drugs and those current under development.> > > >> > > > However, the data made available to the EMA for the study was `very> > > > scarce," with only 22 - 20 European Union (EU) and two non-EU -> > > > countries out of the 30 invited to participate actually submitting> > > > data, says the Agency. Moreover, a lack of heterogeneity made> > > > inter-company comparisons impossible and there was poor distinction> > > > between different types of drug use in children (authorised,> > > > unauthorised and off-label), which was further confused by the > > lack of> > > > common terminology in the different EU countries, it adds.> > > >> > > > Data from the UK was obtained by using the British National Formulary> > > > for Children (BNFC). As expert clinical advisers are used in the > > UK to> > > > advise on use of unlicensed medicines and off-label uses, there > > was no> > > > estimation of the nation's existing use (both authorised and> > > > unauthorised/off-label) of paediatric medicines, says the report.> > > >> > > > One important reason for off-label and unauthorised drug use in> > > > children is the current lack of age-appropriate formulations,> > > > including form and strength, and this produced some surprising > > results> > > > in the study, such as the high off-label use of many antiasthmatics,> > > > despite the high paediatric incidence of this condition, says the EMA.> > > >> > > > Nor was the exercise able to provide sufficient safety information -> > > > only Austria submitted some safety data - but many publications have> > > > established that ad! verse effects are more frequent, more serious > > and> > > > more underreported when medicines are used unauthorised or off-label,> > > > says the report. The Paediatric Regulation is expected to improve the> > > > situation by ensuring that new products are meeting paediatric needs> > > > through the Paediatric Investigation Plans (PIPs) agreed by the PDCO> > > > but, says the EMA, in the meantime "a number of easy-to-reach> > > > solutions could be proposed at least to make existing medicines> > > > available to all member states and existing information to all> > > > prescribers for the sake of European children."> > > >> > > >> > > > www.ema.europa.eu> > > >> > > >> > > >> > > >> > >> >> >> >> >>