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Off label / off licence prescribing.

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  • 19-02-2018 1:01pm
    #1
    NUTLEY BOY
    Registered Users Posts: 2,344 ✭✭✭


    Many will be aware of the current controversy about reimbursement by the HSE for patients prescribed Versatis. I am not getting in to that specific issue but do have general questions that arise.

    Assume that medicine XYZ is manufactured specifically for conditions A and B.
    Assume that XYZ is licensed / authorised specifically for conditions A and B.

    Q1. Is a medical doctor entitled to prescribe medicine XYZ for conditions other than A or B ?

    Q2. If yes, what is the legal authority to do so ?

    Q3. Is a doctor open to legal comeback for prescribing XYZ for medical conditions outside of the manufacturers specifications and it's authorised applications ?

    This is not a request for medical advice or a real world situation. I just want to understand how off label prescribing works from a medic's perspective.


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    #2
    locum-motion
    Registered Users Posts: 5,143 ✭✭✭locum-motion


    NUTLEY BOY wrote: »
    Many will be aware of the current controversy about reimbursement by the HSE for patients prescribed Versatis. I am not getting in to that specific issue but do have general questions that arise.

    Assume that medicine XYZ is manufactured specifically for conditions A and B.
    Assume that XYZ is licensed / authorised specifically for conditions A and B.

    Q1. Is a medical doctor entitled to prescribe medicine XYZ for conditions other than A or B ?

    Q2. If yes, what is the legal authority to do so ?

    Q3. Is a doctor open to legal comeback for prescribing XYZ for medical conditions outside of the manufacturers specifications and it's authorised applications ?

    This is not a request for medical advice or a real world situation. I just want to understand how off label prescribing works from a medic's perspective.

    A1. Yes.

    A2. They're a doctor. They can prescribe whatever they like.

    However, that does necessarily not mean that:

    i) the pharmacy can get it, or
    ii) the HSE will pay for it.

    Generally, they should only prescribe 'off-license' if there isn't a suitable licensed alternative.

    A3. Possibly. The usual procedure when a pharmacy receives a prescription for an unlicensed medication or a licensed medication that is being used off-license is that the pharmacy gets confirmation from both the prescriber and the patient or their carer that they ARE aware of the unlicensed nature of the prescription and are happy to go ahead regardless. Broadly speaking, this would then imply that if there was some kind of lawsuit afterwards, that the liability lies with the patient themselves and/or the doctor, rather than with the manufacturer of the medicine or the pharmacy. Of course, if the medicine itself is faulty (as in; if it's supposed to have 10mg of active ingredient in it but there was an error in the factory and it actually has 100mg, for example) then that's still the manufacturer's fault.


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    #3
    Dr Brown
    Registered Users Posts: 1,283 ✭✭✭Dr Brown


    locum-motion wrote: »

    A2. They're a doctor. They can prescribe whatever they like.

    GPs can't prescribe "high tech medicines".


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    #4
    locum-motion
    Registered Users Posts: 5,143 ✭✭✭locum-motion


    Dr Brown wrote: »
    GPs can't prescribe "high tech medicines".

    They can, actually. But what I said was...
    locum-motion wrote: »
    ... They're a doctor. They can prescribe whatever they like.

    However, that does necessarily not mean that:

    i) the pharmacy can get it, or
    ii) the HSE will pay for it.


    ...

    To give a more complete answer, though:

    A GP cannot initiate therapy with a High Tech if it's to be paid for by the HSE, but s/he can if it's a private prescription, or they can issue repeat prescriptions for patients who have a 'Lifelong' HT authorisation.


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    #5
    palmcut
    Registered Users Posts: 246 ✭✭palmcut


    Part of the new regulations in relation to the High Tech hub will mean that all High Tech scripts will be consultant only. Currently GPs can prescribe a High Tech medicine that has been consultant initiated.
    The High tech hub is being organised and brought in by the HSE. (think breweries and parties)
    On completion only consultants will be allowed to prescribe and repeat prescriptions for High Tech meds.
    The HSE are very insistent on 6 monthly prescriptions and they say that under no circumstances will a patient receive a High Tech med if their script has expired.
    We will wait and see how organised the HSE is!


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    #6
    echo beach
    Registered Users Posts: 1,252 ✭✭✭echo beach


    The HSE make rules about what they will pay for. A doctor will still be able to prescribe high tech medicines for anyone who has thousands of euro to pay for them out of their own pocket.
    We are all waiting to see how the high tech hub will work but I have a feeling Joe Duffy could be involved again.
    The basic problem is that there isn’t the consultant workforce available to do all the clinical much less the admin work involved. This problem is only getting worse and there doesn’t seem to be a plan to cope with this.


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    #7
    palmcut
    Registered Users Posts: 246 ✭✭palmcut


    echo beach wrote: »
    The HSE make rules about what they will pay for. A doctor will still be able to prescribe high tech medicines for anyone who has thousands of euro to pay for them out of their own pocket.
    We are all waiting to see how the high tech hub will work but I have a feeling Joe Duffy could be involved again.
    The basic problem is that there isn’t the consultant workforce available to do all the clinical much less the admin work involved. This problem is only getting worse and there doesn’t seem to be a plan to cope with this.


    Part of the High tech hub system is that pharmacies will only be able to order High tech meds if they have a consultants high tech script on the new high tech form. High tech meds will only be available through this hub.


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    #8
    Dr Brown
    Registered Users Posts: 1,283 ✭✭✭Dr Brown


    Can GP's prescribe an illegal drug ie cannabis if they feel it will benefit their patient ?


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    #9
    RoamingDoc
    Registered Users Posts: 174 ✭✭RoamingDoc


    Dr Brown wrote: »
    Can GP's prescribe an illegal drug ie cannabis if they feel it will benefit their patient ?

    No, a doctor cannot prescribe whatever they want.

    Medications have to be licensed in Ireland by the Irish Medicines Board. Otherwise, there is no legal way for them to be dispensed.


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    #10
    angeldelight
    Registered Users Posts: 5,175 ✭✭✭angeldelight


    RoamingDoc wrote: »
    No, a doctor cannot prescribe whatever they want.

    Medications have to be licensed in Ireland by the Irish Medicines Board. Otherwise, there is no legal way for them to be dispensed.

    That’s not true - unlicensed medicines are prescribed and dispensed every day in Ireland. As long as there is no licensed alternative on the market there’s no issue with procuring and dispensing a medicinal product which is licensed in another country.


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    #11
    locum-motion
    Registered Users Posts: 5,143 ✭✭✭locum-motion


    Dr Brown wrote: »
    Can GP's prescribe an illegal drug ie cannabis if they feel it will benefit their patient ?

    They can prescribe it. As in, they can write it down on a prescription.

    However, the patient will not be able to get it dispensed anywhere!!


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    #12
    locum-motion
    Registered Users Posts: 5,143 ✭✭✭locum-motion


    RoamingDoc wrote: »
    No, a doctor cannot prescribe whatever they want.

    Medications have to be licensed in Ireland by the Irish Medicines Board. Otherwise, there is no legal way for them to be dispensed.

    If you had read the posts above, you'd already KNOW that that isn't true!


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    #13
    palmcut
    Registered Users Posts: 246 ✭✭palmcut


    On a slightly different note; a prescription is not an order. A prescription is a Doctor's recommendation. This recommendation does not have to be followed by a pharmacist if that pharmacist believes that the prescribed item is dangerous or incorrect. The dispensing pharmacist may check the prescription with the prescriber and may still decide not to dispense. The pharmacist is 90% liable for items dispensed on a prescription. In cases where the prescriber has made an error the pharmacist is still liable. It is the pharmacist's job to ensure that the patient is receiving the correct medication.


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    #14
    locum-motion
    Registered Users Posts: 5,143 ✭✭✭locum-motion


    Dr Brown wrote: »
    Can GP's prescribe an illegal drug ie cannabis if they feel it will benefit their patient ?
    locum-motion wrote: »
    They can prescribe it. As in, they can write it down on a prescription.

    However, the patient will not be able to get it dispensed anywhere!!

    My answer to Dr. Brown's question was actually technically incorrect.

    From a document published by the HPRA about cannabis:(My emphasis)
    The Misuse of Drugs (Designation) Order 1988, as amended (‘the Order’), provides for the prohibition of the manufacture, production, preparation, sale, supply, distribution and possession of cannabis, except for limited purposes including research or forensic analysis. Current legislation does not allow for any such use unless a specific licence has been granted by the Minister for Health. The Order also has the effect of prohibiting a doctor or a pharmacist from performing certain activities relating to cannabis. For example, a pharmacist is prohibited from manufacturing, compounding or supplying cannabis. A doctor is prohibited from prescribing and administering cannabis, in addition to the restrictions placed on a pharmacist.


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