The God Complex…the sequel….
I blogged a few weeks ago about the poor practice – the Medical Paternalism whereby a Doctor – with a deluded sense of importance, intelligence ,authority and infallibility, makes decisions ABOUT you when taking from you the ability to make informed choices about your health.
It received a lot of very interesting attention and so have decided to share with you some more information on the same type of medical judgementalism, and withholding of information which is much too commonplace.Today I want to talk about off-label and off-licences drug use. These may sound very complex but are NOT! So do not avoid asking your doctor – again you are entitled to this information!
What is a licence?
A drug company must have a licence to advertise and sell a medicine. The licence states:
- which illness the medicine can be used for,
- what doses (how much) can be used,
- how the medicine should be given (e.g. by mouth, by injection) and
- which group of patients it can be used for.
All drugs are trialled ..some on a wider scale than others, before a licence is given to the drug company. I am sure you can see the reason that is in our interests to have access to ALL trial information, and equally why the drug companies are NOT making that available. Lets hope that changes soon!
Most drug trials are carried out on healthy adults …neither very young nor very old. And most side-effects suffered and reported, appear on the PIL- the Patient Information Leaflet or the blurb in the box with the medicine. But bear in mind, if a drug trial is relatively small 10 % of 1000 as a sample group as opposed to 10% of 100,000 is a MASSIVELY different implication, when we consider risks and side effects.
What is a Patient Information Leaflet?
This PIL describes:
- what the medicine is used for,
- how to take it,
- and any known side-effects.
This information, however, may have been written about use of the medicine in adults. However, a lot of it will be relevant to children and useful to parents/carers, although the doses recommended in this leaflet may not be right for children/elderly….NOR will the risks and side-effects!
Your chemist will provide a leaflet with each medicine that is dispensed and should you have any queries, you should raise these with your pharmacist. In a hospital situation, you can request these leaflets from the Doctor in charge of your care.
What do we mean by unlicensed use?
When doctors know more about how a medicine works and its possible side-effects they may try using it for:
- other illnesses or conditions, or in
- other groups of patients, such as elderly patients or children.
BUT just because drugs are not given license for use in this group,it is very important that you are clearly informed of any potential adverse reactions which could occur as well as the potential benefits.
What do we mean by off-label use?
If a medicine is used in a way that does not meet the strict rules set out in the licence, this is described as ‘”off-label ” (or confusingly can still be referred to as off-licence use). This includes giving a medicine in a way that is different from that described in the licence.
Off label use would include:
- using the drug for a condition which it is not listed on PIL
- administering or applying the drug in a way NOT described on the PIL
Many of the medicines used in the most vulnerable patients such as children are used in an unlicensed way.
- almost all medicines used in neo-natal care 80%
- a high percentage of in-patient children 50%
- about 11% of children generally.
What information MUST be given by doctors when prescribing? (And on drugs which may have previously been prescribed)
- When doctors prescribe any medicine to a patient, doctors must give patients (or their parents or carers) sufficient information about the medicines they propose to prescribe to allow them to make an informed decision.
- This will include a full and complete explanation of what the purpose of the treatment is, what the expected benefits are and what the risks (or side effects might be). This is important in that treatment options must be considered in an informed way.
- This applies to all medicines but is particularly important when using unlicensed medicines such that patients and carers are fully informed.
- And also extremely important in a population group who may not be able to report side-effects themselves!
- If parents and carers ask questions about the medicines that are prescribed, doctors are required to answer these questions fully and honestly.
so…remember the GMC tells doctors…(Feb2013)
”you MUST give patients (or their parents or carers) sufficient information about the medicines you propose to prescribe to allow them to make an informed decision.”
”you must ALWAYS answer questions from patients (or their parents or carers) about medicines fully and honestly”
- so PLEASE put yourself first…do not be afraid to challenge a practioner refusing
- don’t ever assume you are automatically receiving full information
- ASK before you take any medication…and
- ASK for FULL information from your DOCTOR..
- if in doubt…check the Patient Information Leaflet