Dispensing unlicensed form over licensed.. has it gone too far?!?

[Erystiva]

I completely understand that we need to support the patient, if they cannot swallow tablets then supply a liquid. However when dealing with unlicensed items this can become quite complicated.

Scenario: Patient is prescribed Melatonin, a licensed product is available in tablet form however the patient cannot swallow tablets. Okay, in that circumstance crushing the tablets will make them unlicensed and Circadin is a MR prep so crushing is a no-no anyway. However, until now the patient has been given capsules and the parents have been opening the capsules and pouring contents onto a spoon with a sweet flavoured item (jam, syrup etc.). I have explained to the parents and prescriber that a liquid form is available and that it is favoured over opening capsules and administering them the way that they have been. The question I get this is 'what flavour is the liquid?'.

Now maybe I am being too harsh here, but surely our responsibility is to patient safety and not just to provide the drug that they like the taste of... Im sure the liquid could be mixed in a squash, milky drink or even taken straight and then followed by a sweet flavoured product. The question here is where do we draw the line and put our foot down to both the prescriber and the parents? Prescribing unlicensed/non-formulary items means that the pharmacy has to handle more stock, maintain more accountability logs (for unlicensed items) and source suppliers... I would assume both pharmacy and the prescriber should be promoting licensed alternatives or atleast the best method to administer the medicine.

This probably reads as a heated post, truthfully I am partially venting but would certainly like to hear other professionals experiences in this matter.

[Pharmanaut]

I completely understand that we need to support the patient, if they cannot swallow tablets then supply a liquid. However when dealing with unlicensed items this can become quite complicated.


This probably reads as a heated post, truthfully I am partially venting but would certainly like to hear other professionals experiences in this matter.

If they are happy with taking the granules from the capsule and mixing them with a dollop of whatever they like, I would let them continue doing that.
Far cheaper than unlicensed special, and easier to give continuity of supply.

[Erystiva]

So you would continue with the unlicensed capsules over giving the unlicensed liquid? Cost of either unlicensed prep is not a concern, both forms are cheaper than the European licensed prep which has to be imported at added cost.

[howe928]

if the patient's condition is controlled by the capsules then it might as well stick to it even though a licensed product is available now as changing formulation might affect patient outcome

taste - some people have very well developed taste buds and if they are not going to try the flavoured medicine then for patient's best interest, prescriber would prescribe what the patient would take otherwise it would be a waste

http://www.brightonandhovepct.nhs.uk...policy2006.pdf

Prescribing of Unlicensed Medicines or Offlabel
Use of Licensed Medicines Roles and Responsibilities Of Primary Care Prescribers
22. Responsibility for use of unlicensed medicines or offlabel
use of
licensed medicines rests with the prescriber, who remains
professionally accountable for their judgement and, in so doing, may be
called upon to justify their actions. GPs should, therefore, be particularly
cautious about accepting prescribing responsibility for unlicensed medicines
or offlabel
use initiated in secondary care.

http://www.keele.ac.uk/schools/pharm...e/unlicpsc.htm
Negligence Liability

Doctors have a duty in common law to take reasonable care and to act in a way consistent with the practice of responsible body of their peers of similar professional standing.

Not to meet this standard lays the doctor open to allegations of negligence liability. General practitioners are advised that when using an unlicensed drug the doctor must understand the product and act responsibly with reasonable care and skill. The doctor should recognise the responsibility that such prescribing entails and when obtaining consent to treat should, where possible, tell the patient of the drugs unlicensed status, explaining that the drug has not been fully assessed as standard treatment. A written record should be kept of these discussions so that it can be proved that informed consent was obtained. Provided a doctor acts in this way there is some prospect of successful defence in the event of a claim of negligence.

Considering the prescribing of drugs by general practitioners on the recommendation of hospital consultants, it is believed that a doctor will not be found negligent in a court of law if he can convincingly demonstrate that he acted in accordance with a responsible body of relevant professional opinion.

If a GP has:

taken steps to become familiar with the effects and side-effects of a drug he prescribes, using evidence of a balanced nature,
is able to monitor that drug completely (or satisfies himself that adequate monitoring is taking place),

and has access to effective consultant support if a problem arises,

then it is unlikely that he will be found negligent if a problem subsequently develops.

http://www.nottingham.ac.uk/pharmacy.../PM24and25.pdf
good practice to inform doctor about offlicensed use

http://www.brightonandhovepct.nhs.uk...policy2006.pdf

Supply of Unlicensed Medicines – Roles and Responsibilities of Pharmacists

28. When making a supply of any medicinal product, a pharmacist assumes a
duty of care to the patient. Pharmacists, who supply unlicensed
medicines in response to a prescription, are professionally accountable
for any harm caused by a defect in the medicine that is attributable to
their own actions or omissions. They should take reasonable steps to
satisfy themselves that the prescriber is fully aware of the unlicensed status of
the product and that its unlicensed use is appropriate in the circumstances.

29. When presented with a prescription for an unlicensed medicine, the
pharmacist should establish that a pharmaceutically equivalent licensed
product is not available. In circumstances where an otherwise suitable
licensed product is not available from normal distribution channels in
reasonable time, it may be necessary for an unlicensed pharmaceutical
equivalent to be supplied. This should be seen as a temporary expedient and
should not be taken as justification for longterm
supply.


PIL avaialble to be printed for patient/carer to read

Use of Unlicensed Medicines and Offlabel
Use of Licensed
Medicines
PATIENT INFORMATION
What is this leaflet about?
Your doctor or pharmacist has given you this leaflet because a medicine that you
have been prescribed is not licensed (unlicensed use) or is being used in a way that
is not covered by the licence (offlabel
use). This leaflet is intended to inform you
that the most appropriate medicine has been chosen to treat your condition and to
help answer any questions that you may have. Please talk to your doctor or
pharmacist if there is anything further that you would like to know.
Why are medicines licensed?
Pharmaceutical companies must hold a licence for each medicine that they sell in
the United Kingdom. The Medicines and Healthcare products Regulatory Agency
(MHRA) issue these licences only after they have assessed information on the
quality, safety and efficacy of the medicine. They have to be sure that the medicine
is made to an acceptable standard of quality and that it works to treat the illness
concerned, the incidence of side effects is understood and any risks can be
managed. Medicines are tested in clinical trials to generate the information that is
necessary for licensing.
Why don’t all medicines have licences?
Medicines are usually only licensed for conditions that have been investigated in
clinical trials. However, many illnesses may not have been studied in this way, but
still need to be treated. In these situations, doctors and pharmacists can use their
medical experience and specialist knowledge to recommend use of unlicensed
medicines or offlabel
use of licensed medicines. They may choose to use:
· A licensed medicine for a purpose that is not covered by the licence (offlabel
use);
· A medicine that is currently undergoing clinical trials, but does not yet have a
licence;
· A medicine that used to be licensed in the UK, but is no longer available;
· A medicine that is only available from abroad and needs to be imported; or
· A medicine that needs to be made specially, because it is not readily available
from a manufacturer.
Why have I been given an unlicensed medicine?
The doctor who is treating you has recommended an unlicensed medicine, because
no suitable licensed alternative is available to treat your condition. For example,
because you are allergic to the normal medicine or because it has never been sold in
the UK or has been withdrawn from the market. Your doctor will have thought very
carefully about prescribing the most appropriate medicine for you.
Should I be worried about taking unlicensed medicines?
Your doctor will have explained to you why they think that this medicine is the right
one for you. If you are worried about taking this medicine, talk to your doctor or
pharmacist about your concerns. They may be able to give you further information
or help to put you in touch with a support group for your illness or condition.
If you experience any unpleasant or unexpected effects whilst taking the medicine,
you should report this to your doctor or pharmacist.
What else do I need to know?
Sometimes, it will take longer for the pharmacist to order in an unlicensed medicine.
In which case, you will need to allow one or two weeks for the pharmacist to obtain
further supplies of your medicine. You should bear this in mind, if you need to get a
repeat prescription from your doctor.

[Erystiva]

Thanks for all of the replies.

Been under some pressure to reduce the number of named patient lines that we buy in, especially lines where we keep several forms and strengths. Your views have certainly been helpful.

[bobbin]

Been under some pressure to reduce the number of named patient lines that we buy in

Who is putting you under pressure?

[Erystiva]

Statement from MHRA - DefaultSP : MHRA

Also the director of pharmacy has requested that we lose as many lines as possible (within reason), so I have been working alongside the pharmacists and prescribers to try and decrease some drug formulations/strengths. Melatonin is just one of many but one that has patients which are more sensitive to a change of formulation.

[hibernia]

Now maybe I am being too harsh here, but surely our responsibility is to patient safety and not just to provide the drug that they like the taste of...

This probably reads as a heated post, truthfully I am partially venting but would certainly like to hear other professionals experiences in this matter.

Perhaps you also need to hear other parents experiences in this matter, especially if their children have special needs that can make giving meds a nightmare. The slighest change in formulation can lead to the child rejecting it completely.

The best way to ensure patient safety is to give medicine the child actually takes.

[Erystiva]

A fair point Hibernia and certainly if the child refuses other formulations then I can understand giving them the formulation that they take.

Thanks all for the feedback!