a simple guide to unlicensed medication

7/29/2019 A Simple Guide to Unlicensed Medication

1/6

A Simple Guide to Unlicensed Medication

For many, the subject of unlicensed medication can be confusing. Questions such as what exactly is

unlicensed medication? Under what circumstances it is prescribed? Is it dangerous and why do

children often get prescribed unlicensed medication? In this guide I hope to shed some light on

commonly asked questions on this subject.

ContentsLicensing a Medication ........................................................................................................................... 2

Under What Circumstances is Unlicensed Medication Prescribed? ....................................................... 3

Why is Unlicensed Medication Used on Children? ................................................................................. 4

Is unlicensed medication dangerous for children? ................................................................................. 5

Is Unlicensed Medication Dangerous for Adults? ................................................................................... 6

Conclusion ............................................................................................................................................... 6
http://www.flickr.com/photos/sparktography/388889060/


2/6

Licensing a Medication

First of all, before we talk about unlicensed medication it is necessary to understand what a licensed

medicine is. Basically in order for a medicine to be sold and marketed in the UK it needs to have a

license. This license must be granted by the MHRA(Medicines and Healthcare products Regulatory

Agency) to make sure that they are beneficial and acceptably safe. This means that the benefits

and the possible side effects of the medicine are weighed up against each other. For example if the

side effects of a medicine are considered high but the benefits are that it can be used to treat a life

threatening illness then this is considered to be acceptable. Of course, on the other hand if medicine

for a minor illness produces a high level of side effects it will be deemed as unacceptable and notgranted a license. The MHRA will also only grant a license if the medicine meets high quality and

safety standards and clinical trials have been done to indicate that the medication is effective in

treating the condition it was developed for.
http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031677&RevisionSelectionMethod=Latesthttp://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031677&RevisionSelectionMethod=Latesthttp://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031677&RevisionSelectionMethod=Latesthttp://www.flickr.com/photos/emagineart/4742089272/http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031677&RevisionSelectionMethod=Latest


3/6

Under What Circumstances is Unlicensed Medication Prescribed?

According toNICEunlicensed medication has a valuable role to play when it comes to caring for

patients , however it is important to note that doctors should always try to prescribe licensed

medication where possible .

So under what circumstances can unlicensed medication actually be prescribed? Well, if a doctor

cannot find a suitable licensed medication to effectively treat a patients symptoms then they may

decide to prescribe medicine to treat the patients condition even though it does not have a

license to treat those symptoms. In these circumstances the medicine is described as off label. For

example certain anti-depressants can in some cases be used to treat pain.

Unlicensed medication can also be medication the doctor prescribes that is waiting to be approved

by the MHRA or is medication not currently licensed that a patient agrees to take as part of a

clinical trial. These days it is common place for unlicensed medication to be prescribed to a patient if

they are unable to take the licensed form of the medication due to special circumstances such as

being allergic to an ingredient or because they suffer from dysphagia and unable to swallow

tablets. In these cases, the unlicensed medication known as a special will be manufactured and

supplied by a manufacturer who holds a specials license issued by the MHRA.

For example, a patient suffering from dysphagia could be prescribed a specialliquid medicine

rather than the solid version of the medication. This avoids complications which can occur if the

patient decides to crush their tablets to avoid the discomfort that would ensue if they tried to

swallow it. Crushing tablets can result in an overdose of medication as this can cause the medication

to be absorbed quicker into the body and also elevate the risk of potential side effects.
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/http://www.rosemontpharma.com/http://www.rosemontpharma.com/http://www.rosemontpharma.com/http://www.flickr.com/photos/andreaskristensson/2500560432/http://www.rosemontpharma.com/http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/


4/6

Why is Unlicensed Medication Used on Children?

Most medicines are only licensed

for use on adults and are clinically

tested on adults. According to

reports30 per cent of drugs

prescribed to under-18s, and up to

95 per cent of drugs given to babies

in intensive care, have never been

tested on children. Therefore these

medicines are indeed unlicensed.

But why is this?

According to theMHRA:

Pharmaceutical companies have

been reluctant to invest in

developing specific treatments or

adapting existing medicines to

meet the needs of the paediatricpopulation, mainly because the

market is small and therefore of

lower commercial interest and the

studies can be difficult, long and

expensive. In addition, developing

a suitable formulation which can

provide an exact dose, for example a syrup, may be technically difficult and expensive on

an industrial scale. This often leaves no alternative to the prescriber than to use 'off-label'

and unauthorised products, without evidence-based information to guide prescribing andgive information about the risk-benefit assessment.
http://www.dailymail.co.uk/news/article-2196906/One-junior-drugs-tested-children-sparking-demand-probe.htmlhttp://www.dailymail.co.uk/news/article-2196906/One-junior-drugs-tested-children-sparking-demand-probe.htmlhttp://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesforchildren/http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesforchildren/http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesforchildren/http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesforchildren/http://www.dailymail.co.uk/news/article-2196906/One-junior-drugs-tested-children-sparking-demand-probe.htmlhttp://www.flickr.com/photos/migrainechick/638193757/


5/6

Is unlicensed medication dangerous for children?

Often, doctors have waited ten years or more after a drug is licensed for use on adults to

use it on children in order make sure that there are no serious side effects.

According to Dr Helen Sammons, vice chair of the medicines committee of the Royal College

of Paediatrics and Child Health- Parents shouldnt be concerned that children are being

treated with unlicensed and off-label medicinesWe know what we should be giving

children and that it works based on our experience and evidence

Also, Professor Ian Lewis, medical director of Alder Hey Childrens NHS Foundation Trust,said: Most of the drugs we use in childrens cancer like leukaemia have not been formally

tested in children but have cured many of them.

However, concerns have still been raised that using unlicensed medication on children

increases side effects and so since thechange in law2007 any new drugs coming to market

must now be tested on children before they can be used on them.
http://ec.europa.eu/health/human-use/paediatric-medicines/http://ec.europa.eu/health/human-use/paediatric-medicines/http://ec.europa.eu/health/human-use/paediatric-medicines/http://www.flickr.com/photos/jbird/72123348/http://ec.europa.eu/health/human-use/paediatric-medicines/


6/6

Is Unlicensed Medication Dangerous for Adults?

There was public outcry a few years ago when the drugAvastin, licensed for use as a cancer

drug, was used to treat wet ADM. The reason for the outcry was not just because of reportsthat many patients developed an inflammatory condition of the eye as a result of the

treatment but that the reason that drug was chosen was because it was cheaper than the

licensed drug-Lucentis.

This, combined with 2011 GMC proposals to alter guidelines allowing doctors to make

decisions on medication based on cost as well as not having to tell patients if they were to

be treated with unlicensed medication, triggered wide spread concern.

However in Feb 2013 theGMC has updated their guidelinesin how unlicensed medicine

should be prescribed. It highlights that patient needs should be the main factor taken into

consideration and not cost and that the patients should be given sufficient information

about any medications proposed to be subscribed in order for them to make an informed

decision.

Conclusion

Unlicensed medication is used for a variety of

different reasons in both children and adults

and can be beneficial when licensed medication

cannot be used- i.e. if the patient suffers from

dysphagia.

Although there is always an associated risk,

doctors will only prescribe an unlicensed

medication if the benefits outweigh the risk. In

the realm of paediatrics, since 2007 any new

drug for use on children will have to be tested

and licensed for children although it is likely

that many older unlicensed drugs will still be

used as many of them have been successful in

curing conditions such as leukaemia. As a

results of the latest GMC guidelines, the choice

of using unlicensed medications will never be

led by cost and all patients will be informed if

their doctor intends to prescribe these to them.
http://c/Users/Tracy/Documents/1.%09http:/www.pharmatimes.com/Article/11-09-01/Off-label_Avastin_use_linked_to_eye_infections.aspxhttp://c/Users/Tracy/Documents/1.%09http:/www.pharmatimes.com/Article/11-09-01/Off-label_Avastin_use_linked_to_eye_infections.aspxhttp://c/Users/Tracy/Documents/1.%09http:/www.pharmatimes.com/Article/11-09-01/Off-label_Avastin_use_linked_to_eye_infections.aspxhttp://www.gmc-uk.org/guidance/ethical_guidance/14316.asphttp://www.gmc-uk.org/guidance/ethical_guidance/14316.asphttp://www.gmc-uk.org/guidance/ethical_guidance/14316.asphttp://www.gmc-uk.org/guidance/ethical_guidance/14316.asphttp://c/Users/Tracy/Documents/1.%09http:/www.pharmatimes.com/Article/11-09-01/Off-label_Avastin_use_linked_to_eye_infections.aspxhttp://www.flickr.com/photos/clintjcl/4001182125/