Off-label prescribing - should the patient be informed?

[cardamomginger]

Hi,
Hoping some friendly HCPs out there can give me some information about off-label prescribing. Basically, if a medical device or drug (in my case it was suturing material) is used off-label, i.e. for a purpose other than that intended by the manufacturer, should the patient be informed of this? Should specific consent to such off-label use be obtained from the patient? I've had a scout around on NICE and online and although I've found stuff about how off-label drug use can be a very good thing, I've yet to find anything about the need to inform the patient.
Would be so grateful if anyone has any info on this!
Thank you!!

No, theres no requirement to inform the patient in this country. For a manufacturer to 'label' a device or drug for a specific indication they have to have clinical trial data which is often not economically worthwhile -- but Drs want to use it and do. For instance the vast majority of drugs used for children aren't labelled for use in children

some info here Off label prescribing is very common, so I wouldn't necessarily expect the Dr to discuss it at length with me, but I would expect them to justify the choice they made, if I asked them.

Considering the length of a consultation, IMHO the time is better spent explain the diagnosis and care plan, rather than the minutiae of a licensing issue that would be of little interest to most patients.

I would also bear in mind, for comparison, that they are required to discuss common or risky side effects of procedures/treatments, but not every single possible risk.

I don't know of any rule stating that the Dr must make the patient aware of it, but I do not know for certain. What is your concern?

Damn and blast. Thanks though CMOT! But would it be considered 'good practice' to do so, even if there is no professional requirement? I completely get the point about paediatrics. In palliative care a lot of drug use is off label as well. In both these cases there are often no effective alternatives and off label use is appropriate. In my case they used suture designed for skin and mucosa to stitch muscle layers, even though there is an alternative disolvable suture designed for muscle.

no, most children's medication is off labelling. its not like being given an un-tested trial of something new is it?

NHS advice for doctors in the UK is here www.nelm.nhs.uk/en/NeLM-Area/News/2009---April/02/MHRA-Drug-Safety-Update-Off-label-use-or-unlicensed-medicines---prescribers-responsibilities/

An extract is
"Communicate: best practice is that?

• You give patients, or those authorising treatment on their behalf, sufficient information about the proposed treatment, including known serious or common adverse reactions, to enable them to make an informed decision

- Where current practice supports the use of a medicine outside the terms of its licence, it may not be necessary to draw attention to the licence when seeking consent. However, it is good practice to give as much information as patients or carers require or which they may see as relevant - You explain the reasons for prescribing a medicine off-label or prescribing an unlicensed medicine where there is little evidence to support its use, or where the use of a medicine is innovative"

Sorry all, cross posted by the time I figured out how to do the link!

Thanks Festive. This is a childbirth injury thing. They messed up the stitching on two counts - firstly the inappropriate use of suture and secondly by knowingly leaving deep muscle tears unstitched. They admit to the use of the particular suture and it is clear that it was an off label use (they say it's all fine and dandy, my extremely senior and experienced gynae surgeon who's putting me back together is appalled that they used what they did). And the cheerfully admit to leaving a particular layer of muscle unsutured (they say there was no need to stitch, my gynae is again appalled, and this flies in the face of NICE guidance as well). They have admitted that they should have explained that they were not going to suture this particular layer of muscle, and I was hoping there might be something to say that they should have told me they were using a skin/muscosa suture for muscle.

"its not like being given an un-tested trial of something new is it?"

There will never be tests of a drug on children or pregnant women or breastfeeding mothers because of ethics. However these drugs have been substantially tested on other humans.

The alternative is never to treat children or pregnant/ lacating women. However doctors may feel the level of suffering/ risk from illness is more than the drug risks. This approach has caused disasters like thamidolide babies, however more lives have been saved than lost.

Thanks for the links. I guess the grey area is that I see it as highly relevant that I was sutured with off label suture and they may argue that in my highly traumatised post-birth state they didn't feel it was necessary to tell me....

I understand that really, I am aware that you cannot really do RCTs on kids, I meant to the OP it doesn't mean you're a guinea pig

I don't think its relevant at all, much better to use what communication time you have to explain the problem, the solutions and the risk. If people don't understand that off labelling is common practice then it could well distract from the important points to be covered. I don't think anyone has ever told me that any medication for DS was off label and I don't think they should.

A quick aside about paediatrics, even though my question isn't about that, DD had bad gastric problems due to cows' milk protein intolerance and was prescribed levels of drugs that were in excess of what the manufacturers deemed appropriate. In both cases we were informed that of this and the reasons for prescribing higher doses were explained to us. These weren't rare drugs - ranitidine and lansoprazole - and the doses were pretty bog-standard for gastric paediatrics.

No, is the short word. The doctor, however, takes it upon him or her self the responsibility for the use of the material in a non-licensed way.

here is an example:

Bi-directional barbed sutures, 'licensed' for soft-tissue suturing, used for closing the 'vaginal cuff'.

The study gives a sound rationale for using the suture in this way:

-no need for knots
-better approximation (ie. lining up) of the wound edges
-less time
-less cost

etc.

Whether the suture used was 'inappropriate' is a matter for professional judgement. If the doctor suturing had sound reason for using that particular suture material, the fact that another doctor disagrees is neither here nor there. However, if no reasonable doctor would agree, then it is more concerning.

Also, if there was a case to be pursued, you would have to be able to show that the use of the suture material directly contributed to the complications you experienced, and that those complications don't occur in people who have the other suture material used.

Likewise, the non-sutured muscle. There is sound medical evidence for leaving wounds to heal by 'secondary intention', which is to allow them to mesh themselves using the natural healing process. The very sound alternative is to use 'closed approximation' ie. stitching. But which is most appropriate is a clinical judgement. You would have to show that it was not reasonable to decide to leave this particular wound, not just show that your preferred gynae wouldn't have done. Also, you can't be sure, because your gynae is seeing the end result, not the original wound.

Thanks Lougle. Legally this isn't going to fly (looked into it some months ago), and I wouldn't have the emotional resources and energy to pursue it in any event. So that's not what I'm trying to do. But I do have the energy to write to the hospital and demand a full and thorough explanation of why they did what they did and why they did not inform me of what they were doing and why. They have already admitted that they should have told me that they were not going to suture this particular layer of muscle, which is a start.
I think the point about my current gynae seeing the end results is a good one - this long journey of painful discovery as to what's wrong with me as a result of the birth (have lots of other birth injuries as well that I won't bore you with) has led me to the conclusion that the HCPs who are best placed to comment on the most appropriate management of birth injuries are those who end up having to piece women back together afterwards, not those who are on the labour ward and very often won't be aware when problems occur down the line. But that's another rant for another thread.....

Ah I see. Can be very difficult when some things are a matter of preference/difference of opinion. Those can be difficult to thrash out.

FWIW, it is not usual, AFAIK, to discuss the planned suture material with patients full stop and it very often boils down to surgeon preference.

It amazes me sometimes too - you would think there was an agreed 'best practice' way to do things instead of the old 'MR X likes to use suture Y, but Mr L likes staples' type stuff.

I had 2 x EMCS, one closed with wire and beads, no drain. The other closed with sutures and had a drain in. Totally different. I would have preferred wire and beads both times if given the choice TBH. But I am not a surgeon and they both were adequate.

Sounds like the difference here is that maybe you have had ongoing problems and feel that the suture material made a difference to the outcome? I suspect it would be hard to prove either way.

There is a difference between off label and off license prescribing
It also depends who performed the procedure (nurse/midwife prescribers have a different professional standards and must inform the patient of off label/off license prescribing.
the gmc recommend the patient should be informed if the reason to go off label is not a common one