unlicensed medication

[sam_lewis]

what advise would you give to a patient who is prescribed an unlicensed medication. I have always told patients when they are taking an unlicensed medication but a patient asked me what it exactly means. But I wasn't to sure what to tell her, and what the implications are if anything goes wrong, and who would be responsible. Some products from IDIS do not even have a PIL in english??

[Rafael]

Re: unlicensed medication

what advise would you give to a patient who is prescribed an unlicensed medication. I have always told patients when they are taking an unlicensed medication but a patient asked me what it exactly means. But I wasn't to sure what to tell her, and what the implications are if anything goes wrong, and who would be responsible. Some products from IDIS do not even have a PIL in english??

1- not enough tests were done to prove it's effectiveness/safety, and there are no better alternative.
many medicines admin to children are not licensed for use in children
2- GP is responsible for anything and should be able to justify why it has been prescribed.

print any PIL from this site
electronic Medicines Compendium

[SolomonQ]

Re: unlicensed medication

what advise would you give to a patient who is prescribed an unlicensed medication. I have always told patients when they are taking an unlicensed medication but a patient asked me what it exactly means. But I wasn't to sure what to tell her, and what the implications are if anything goes wrong, and who would be responsible. Some products from IDIS do not even have a PIL in english??

why do you need to tell patients if a drug is being used under license or not, by telling patients that the meds they are being told to take are not licensed for that use creates doubts in patients minds and affects the compliance to the therapy, and greatly undermines a doctor in some cases.

This type of information should be only given to patients if asked directly, patients should be told that the medicines has not be tested for its ability to treat this condition, or for it's safety, and normally the drug company would take responsibility if anything went wrong for licensed drug uses, but in this situation the GP or prescriber takes the full responsibility, you can also add from your own experience if the unlicense use is a common one, and your own views on its suitability. Abviously if the pharmacist has any concern for the safety of the patient then the med would not be dispensed anyway, maybe the pharmacist can add this also if s/he feels confident enough.

[Rafael]

Re: unlicensed medication

why do you need to tell patients if a drug is being used under license or not, by telling patients that the meds they are being told to take are not licensed for that use creates doubts in patients minds and affects the compliance to the therapy, and greatly undermines a doctor in some cases.
.

it is an ethical requirement isn't it? they have the right to know that an unlicensed drug has been prescribed for them.

[Rafael]

Re: unlicensed medication

that's a smart way solly, do not mention unless they ask a bit dodgy?

[Fleegle]

Re: unlicensed medication

[quote=Raoul;19266]

1- not enough tests were done to prove it's effectiveness/safety, and there are no better alternative.

Not always the case. The manufacturer often will not apply for a licence at all in countries which it deems unprofitable, usually due to lower population, or lack of perceived profit. (Ireland suffers from this problem) so many drugs which are freely available elsewhere are designated as ULMs in that country.

2- GP is responsible for anything and should be able to justify why it has been prescribed.

Key point..It is always a good idea, prior to dispensing a ULM to obtain a letter of confirmation from the prescriber that he/she will in fact take responsibility for the supply of the medicine. I have had a couple of cases where they refused to do so, and would not give a reason why, therefore I did not supply it.

[Rafael]

Re: unlicensed medication

thanks for correcting me and the advice Fleegle.

[openmind]

Re: unlicensed medication

[QUOTE=Fleegle;19293]

Key point..It is always a good idea, prior to dispensing a ULM to obtain a letter of confirmation from the prescriber that he/she will in fact take responsibility for the supply of the medicine. I have had a couple of cases where they refused to do so, and would not give a reason why, therefore I did not supply it.

The fact that there is a prescription shows that the doctor is taking responsibility. What the percentage of responsibilty is (should the wheels come off) depends on the strength of your Lawyer
A good idea when dispensing a ULM is to ring the doctor and ask if he/she is aware that the med is a ULM, then make a note of this in the PMR/Diary.

[SolomonQ]

Re: unlicensed medication

it is an ethical requirement isn't it? they have the right to know that an unlicensed drug has been prescribed for them

that's a smart way solly, do not mention unless they ask a bit dodgy?

erm that responsibility lies with the prescriber, like I said if you go up to the patient and tell them about the unlicensed bit and safety bit, if is most likely to affect their compliance, patients dont understand this kind of jargon. At the point of dispensing you have to assume the prescriber has done their job in counselling the patient about the nature of their treatment.

Abviously i'm not saying the patient needs to directly ask whether the medicine is licensed etc... alot of vitamin preparations are unlicensed, would you go upto to every patient prescribed such "meds" and tell them it's not licensed??

[Fleegle]

Re: unlicensed medication

[quote=openmind;19321]

The fact that there is a prescription shows that the doctor is taking responsibility. What the percentage of responsibilty is (should the wheels come off) depends on the strength of your Lawyer
A good idea when dispensing a ULM is to ring the doctor and ask if he/she is aware that the med is a ULM, then make a note of this in the PMR/Diary.

I am sorry, but you are wrong.

[jaymags]

Re: unlicensed medication

[QUOTE=openmind;19321]

A good idea when dispensing a ULM is to ring the doctor and ask if he/she is aware that the med is a ULM, then make a note of this in the PMR/Diary.

Depending on where you work some of us would be on the 'phone for every other prescription. Unless a certain drug could potentially cause harm, interactions with other medication, or the dose is potentially harmful, or the patient has a known allergy to medication prescribed why should we contact the doctor for ULM's? Is this not been over cautious? I am just a humble dispenser and fail to see the importance of 'phoning the doctor every time we get a 'script in for ULM's. Please enlighten me.

[Fleegle]

Re: unlicensed medication

Ringing the doc would only apply to POMs, where the responsibility must lie with the prescriber...anything else, no..I wouldn't bother. Apologise for not making myself clear.

Fleeg.

[lamzee]

Re: unlicensed medication

So Fleegle, is this what you do when you get a rx for amitriptyline 10mg, cerazette or potassium citrate mixture, which are all ULM where you live---or do you just do it with the obscure stuff..... :-)

[Fleegle]

Re: unlicensed medication

So Fleegle, is this what you do when you get a rx for amitriptyline 10mg, cerazette or potassium citrate mixture, which are all ULM where you live---or do you just do it with the obscure stuff..... :-)

Amitrip 10mg..yes..often given to kids for bedwetting - possible side effects. Cerazette..yes..don't want to be responsible for possible sudden death. Mist Pot Cit...no.

[lamzee]

Re: unlicensed medication

possible side effects. Cerazette..yes..don't want to be responsible for possible sudden death. .

Hadn't realised that was an issue with cerazette (was hoping to go on it myself...)