Prescribing above BNF limits

[yasirkasmi 0]

I've recently started a rehab job and surprise surprise everyone is on 200% - 250% BNF max in terms of antipsychotics. Most have schizophrenia. Most are on two mood stabilisers as well.

Most are still unwell. I'm in the process of trying to reduce people's meds and review them...some are on 50% BNF max depot and 75% max oral...with no clear plan. I want to reduce the meds, but am coming against resistance.

I don't think prescribing above BNF limits is SAFE, EFFECTIVE or DEFENSIBLE.

I would appreciate the views of my most esteemed colleagues...

[Guest Maram]

Maverick,

On paper your assertion of not prescribing above BNF limits is good. In Reality not having the resources to fund Psychological services, Tabloid hysteria about risk to Public from the mentally disordered offenders,lack of in patient beds, Minimal to zilch OT services & Social services streched to breaking point & you are confronted with a patient who is still symptomatic, over a period of time, you start to medicate. it is not uncommon in Rehab & Forensic services may be even LD too to have patients above BNF limits.

The Royal college of psychiatrists consensus statement released in May 2006) states nearly a quarter of all patients are on beyond BNF limits of antipsychotic medication.

http://www.rcpsych.ac.uk/publications/collegereports/cr/cr138.aspx

(the old consensus statement was in 1994)

So it is not an isolated problem.One has to ask why is it that despite the legal issues re:- above BNF limits that a quarter of our patients are on above BNF doses.Not all consultants are daft.so there are some real issues in the real world that guidelines do not address & thats why the above BNF prescriptions goes on..........

[chrispell 22]

The BNF provides a guideline of recommended maximum limits based on manufacturers advice. However if you have a medical degree you can prescribe any dose of any medication. It's just that you then need to justify the decision to do so and be able to show why it was necesary. E.g. a patient with residual symptoms after 900mg/day of clozapine may need augmentation with a second antipsychotic, or someone may partially remit with 20mg Olanzapine and you might want to try an additional 5mg.

I guess the best thing to do is to minimise all unnecessary treatments, and monitor their bloods and ECG for any QT prolongation. At the end of the day there is a huge genetic variation in the way people metabolise drugs, so even at the same dosage, plasma levels will be different in different individuals.

[yasirkasmi 0]

Thanks for the advice. Is there ANY evidence that exceeding BNF limits for antipsychotics actually works?

[Guest Maram]

Yes it exists.

infact the college published 2 books,collection of articles which most of us would have read for PART-2 exams.In that there is an article on high dose antipsychotic medication. There are references too.However it may not be great evidence but evidence does exist.

[sands73 59]

I actually did an audit in a forensic unit on greater than BNF max prescribing.

I would say that the rationale for prescribing high dose should be recorded in the notes and reviewed every 3 months and documented. Also whether the rationale has been discussed with the patient and recorded, whether he has consented or not, and whether it is again discussed with the patient after 3 months.

Also monitoring bloods and ECG at baseline, 3 months and 12 monthly thereafter, and if not done, the reason should be documented- like patient refused or whatever.

There may be some people in whom >BNF max works, especially in heavy smokers, where antipsychotics r rapidly metabolised, but to imagine everybody on the ward on 200-250% is a bit too much, I think!

[yasirkasmi 0]

ROYAL COLLEGE REPORT ON HIGH DOSE ANTIPSYCHOTICS MAY 06

This report replaces Consensus statement on the use of high-dose antipsychotic medication (CR26 from 1993) and The association between antipsychotic drugs and sudden death (CR57 from 1997).

This revised statement reflects the consensus opinion of the members of the Working Group. It addresses the use of high-dose antipsychotic medication only in adult mental health services, and not other psychiatric services such as child and adolescent, elderly, and learning difficulties. Recommendations are made in respect of clinical practice for those involved professionally, as part of a multidisciplinary team or individually, with people receiving antipsychotic medications. Guidance on implementing these recommendations is provided. The issue of compatibility between the proposed recommendations and current relevant treatment guidelines, including the National Institute for Clinical Excellence (NICE) Schizophrenia Guideline (National Institute for Clinical Excellence, 2002) are discussed.

Recent prevalence studies reveal that up to a quarter of psychiatric in-patients are prescribed a high dose of antipsychotic medication, with the highest prevalence figures being found in psychiatric intensive care units, rehabilitation wards and forensic units. There are only limited data on the frequency of prescription of high-dose antipsychotics in psychiatric patients receiving care in the community.

The results of the published trials of high-dose antipsychotic medication for treatment-resistant schizophrenia provide no evidence to support such a strategy. On the basis of current evidence, high-dose prescribing, either with a single agent or combined antipsychotics, should rarely be used and then only for a time-limited trial in treatment-resistant schizophrenia after all evidence-based approaches have been shown to be unsuccessful or inappropriate.

Antipsychotic drugs are commonly prescribed in combination for those with a psychotic illness who have shown a lack of a satisfactory response to a single antipsychotic. While the limited research conducted fails to demonstrate convincing benefits for such a strategy, there is evidence that combined antipsychotics are associated with an increased risk of adverse effects and pharmacokinetic interactions. However, there is some support for the addition of a second antipsychotic to clozapine in people with treatmentresistant schizophrenia for whom clozapine alone has proved insufficiently effective.

High-doses of antipsychotic medication are sometimes used for rapid tranquillisation, persistent aggression and to reduce the risk of relapse. However, there is a paucity of research evidence specifically examining the efficacy and safety of high doses for rapid tranquillisation. There is no convincing evidence base for the use of high-dose antipsychotic medication in the management of persistent aggression associated with psychosis, or for relapse prevention in psychosis. Relapse prevention studies have tended not to study high-dosage regimens, but rather have examined standard-dose regimens, and low-dose and intermittent, targeted treatment strategies.

A possible link has been postulated between antipsychotic drugs and ventricular tachycardia and sudden death but no consensus has been achieved on the frequency of these events, the contribution of high dosage, or even whether a true causal association exists. To reduce the risk of arrhythmia, all patients should be assessed (including electrocardiography) for cardiovascular disease prior to the institution of antipsychotic drug therapy. Periodic monitoring of the electrocardiogram (ECG), and electrolytes during therapy is advocated when high-dose antipsychotic drug treatment is used.

The Consensus Working Group makes 22 recommendations, including some under the areas of aggression with psychosis and that of rapid tranquillisation and treatment-resistant psychosis.

I rest my case! Solved! Thanks for all your help. No more high dose antipsychotics for any of my patients!!!

[smithy 0]

DOGMA

[Evan 0]

and a word of caution, reducing a lot of people's meds on one ward at nearly the same time is not safe, not effective and of questionable defensibility

[running 0]

also the problem of withdrawal/rebound symptoms. there is rebound psychosis with antipsychotics which is well documented for complete withdrawal but also should be taken into account if reducing the drugs i would say.

[hectorseyi 1]

Reduction of the neuroleptics that exceed the BNF limit should not be done accross the board. I would advocate that you review each patients history, make it a MDT decision obviously involving patients as well as carers and formulate a care plan on a case by case basis before proceeding.

Also keep in mind what others have said above. From my personal experience while I worked as an SHO in a Forensic and LD unit some reduction after going through the process above yeilded dramatic improvement in the well being and quality of life of some patients, while in some it lead to difficult circumstances.

Overall its a balancing act between risks vs benefits

[yasirkasmi 0]

Thanks for all your suggestions...maybe I didn't explain myself well. Obviously I'm not taking everyone's drug chart and crossing everything off...that certainly is not effective or defensible. It's practically suicide!I'm doing exactly as suggested...MDT plans, discussing it with the patient, reviewing all volumes of notes. Most of my patients are on bucket loads of meds and are still unwell, however one might define unwell as. We have a red sheet for health checks every 3 months for high dose antipsychotic monitoring. T

here don't seem to be any plans for patients, for example being on a bit of depot and a bit of oral of another drug. Two weeks into things, everyone's still alive and more importantly some are a bit better and most are unchanged.

Whilst guidance from Royal Colleges and NICE may be dogmatic, they are still guidelines and a frame of reference. Addressing this is beyond the scope of this posted topic. Smithy, whilst not being personal, with PMETB there will be plenty more dogma that you will be subjected to early in your training!

My training has centred around presrcibing within BNF limits and only using 2 antipsychotics when cross tapering, clozapine augmentation with amisulpiride or supplementing a depot with the oral equivalent until established on a depot, apart from consta - which I just don't bother with! This approach has so far not got me or my team into any bother.

I really appreciate the advice.

[Guest j]

what you should do is do saps/sans or some other symptom rating scale and a lunsers on all your above limits patients, then very gradually reduce doses if possible to within limits and on a single drug and either repeat rating scales at intervals or at a specified time period in the future or when under bnf limits. then write up your findings as some kind of case series or something (all with your supervising consultants agreement in advance of course). then you'll be doing what you think is best for your patients, following the guidance and contributing to the knowledge base at the same time.

btw what does the consultant think about your plan to reduce all the doses?

[yasirkasmi 0]

Genius!

Have got the full support of medical staff and other medical colleagues. Obviously I only see these patients every so often, so nursing staff will bear the brunt of any changes...and understandably some are a bit wary.

However it's not just psychotropics that are the problem. Patients are on high dose hypnotics...and they still can't sleep, on bowel care, antacids and supplements that they just don't need...either in the past or in the present. Why is it so much easier to start someone on something than reduce or stop something!?!

Thanks for all the support

[Guest Maram]

I think there are 2 poles in this debate of high dose prescribing,, one pole is no high doses to any patient & the other is why not & ofcourse a huge spectrum in between these 2 poles exist.

how to decide whether high dose psychotropic medication in an individual patient is justified?( so that if there was a legal challenge in the future, the prescriber would'nt have any problem)

The first factor is the setting. Forensic,Rehab,PICU's &Assertive outreach would be the settings where this should be tried in an ideal world. Old age & Child & Adoloscent is a no go( except in the tiny tiny group of patients).General Adult & LD are areas where caution is advised. The recent consensus statement on high dose antipsychotic medication by the college explicitly states its use predominantly forensic & rehab populations.

Second, One must exhaust all conventional guidelines advise like NICE & SIGN Guidance. In our hospital,we present these difficult cases in teaching(weekly) & take the views of all doctors in the hospital & document this in notes & try to follow that advise if possible.this gives some protection & reassurance.Seeking Second Opinion(SOAD) from the MHAC,Nottingham ( for england & wales) is also suggested. This in the court's eyes suggests that due deference to legal processes has been shown & you have also tried to consult a wide body of medical opinion possible.

Third, It is the prescriber's responsibility to monitor for side effects regularly(cardiac,endocrinal,haematological etc....... by doing blood tests,ECG etc......) that is Tolerability & also monitor clinical benefit on a regular basis( either by doing a KGV or by doing regular mental states) & document all the above clearly & legibly.The college consensus statement (again!)recommends 3 monthly reviews and documentation, I think.

Fourth Involve Users & if doubtful capacity, then SOAD.Also involve the carers if patient permits or advocacy etc.... also consider advance directives if possible .

High dose medication is of 2 types :-

1) 1 medication at above BNF doses

2) antipsychotic augmentation.

I would prefer 1 medication at max doses as 1 st choice once guidelines fail to help, then consider augmentation but based on evidence like for example (clozapine with Sulpiride ) & (depakote with lithium) etc..... before going for other eclectic mix and matches.

Use the ones suggested by Maudsley guidelines & psychotropic drug directory etc.......

please dont forget to think of non pharmacological measures like Psychological help,OT etc.... to compliment pharmacotherapy.

my 2 pennies........ as usual.

[yasirkasmi 0]

Thanks for the advice Maram...very systematic. I do think that The College Guidelines, the press release i posted earlier is pretty much against it in any setting, though they acknowledge that a lot of patients in forensic/rehab settings are on high doses.

[Guest Maram]

Maverick,

My first post in this thread actually has a link for the stuff you posted on the consensus statement.

I am a member of British association of psychopharmacology & United kingdom psychiatric pharmacy group9UKPPG) & so have a lot of interest in psychopharmacology & so have discussed this on and off with various people interested in thisarea.

They all unequivocally state that high dose psychotropic medication is here to stay, unless we discover some post clozapine options.

Most clinicians want to stay within consensus opinion, but circumstances force them not to.Instead of maligning it as bad practice,lets standardise this practise.

One refrain I heard from a patient who wanted ECT to treat his depression, when i was explaining effects on short term memory etc..... was 'So what doctor, I am never going to be Einstein ! if I have the shock treatment, my life will be bearable, otherwise my memory will be fine, but I will end my life ! '

I am deviating from the topic, but quite often we buy into atypical antipsychotic med rep selling lines' we are efficaceous as haloperidol but have better tolerability'.

The reality many studies of atypicals typically have patients on low dose atypicals, which in real life at those low doses wont work & the haloperidol will be used as comparision or quite often the placebo & it is used at high dose than atypical antipsychotics.

drop out rates of atypicals in many trials is high(compared to other specialities).Infact atypicals dont have EPSE,agreed.But they have other serious problems like sexual dysfunction( notoriously linked to noncompliance) & impaired glucose tolerance etc.....

High dose psychotropic medication is an effective treatment strategy, provided all guidelines measures have been attempted, side effects monitored & a regular review of its benefits if any happens...

Just my personal view.

[Guest j]

evidence based guidelines have flaws. the main one being that there is very little evidence for anything in the treatment of patients who don't respond. the reason for this is pretty simple. it is because drug companies have no interest in funding research in that group.

so for example nice guidance says

atypical (up to max licensed dose)

then atypical (up to max licensed dose)

then clozapine

then who knows. try augmenting.

then it stops.

so, why atypical then atypical?

the answer is because of the service user reps in the group who felt that EPSEs were stigmatising. at the time the metabolic side effects were not recognised. so known side effects were the cause of the guidance not the effects of the drugs. so the guidance recommends drugs that may shorten lives (but are heacvily promoted to psychiatrists and fund are made by companies that fund patient/carer groups)over drugs that stigmatise (but are not promoted and are made by companies that don't fund patient/carer groups).

is that right or wrong? who knows?

when the guidance is reviewed will the guidance stay the same? again, who knows?

for those that don't respond to two different drugs we don't know what works other than clozapine might.

we know that for some patients higher than max bnf doses work when max bnf doses don't, but we don't know which patients will benefit or which drugs will work best. the reason we don't know is that no drug companies will fund the research (because it is not licensed so they can't promote it and because it is for a smaller number of patients and so it is not worth their money) and we know that no-one else will fund it.

so what should we do in this group of resistant patients? i think we should do whatever we can. which means trying higher doses if necessary, but regularly reviewing the effectiveness and doing appropriate physical monitoring and unsurprisingly that is what some of the guidelines suggest.

you could try various other strategies as well like fish oils, cbt, combinations, adding antideps/mood stabilisers or whatever else. they all have limited evidence behind them - either in highly selected groups, or small numbers of patients, or in poorly controlled trials, or whatver.

the simple fact is we don't know what to do, but then again, we don't know what schizophrenia/psychosis is anyway and so the trials are all done on a mixture of patients with similar symptoms that have different causes.

[Guest Maram]

Illuminating post J, although a touch pessimistic.My only addition is we dont anything about anything in a lot of medical & surgical conditions as well. we(psychiatrists) have the humulity to accept our ignorance which the others tend to push it under the carpet.

The recent pressure by Users/Carers groups along with the old age psychiatry faculty,Age concern etc.. when NICE came out saying it is not economically sensible to give acetylcholinestarase inhibitors in mild dementia is also interesting.

Personally, I never felt Acetylcholinestarase inhibitors really improve Quality of life of patients significantly(may be a few isolated examples but not significant numbers) although it improves a few points on the Folstein's MMSE.Many in here, might differ; But Old age faculty(already in many parts of the country don't see mental illness graduates from general adult services to old age services, they only see dementia,delirium & late paraphrenia or old age depression,anything that develops after 65 years,if we say please above 65 it is yours they say it is ageist) now under pressure because take dementia away and there would be no justification for existance of huge numbers of old age services(i guess a few will survive) across the length and breath of the country, are joining the user/carer groups to pressurise NICE

Imagine this(I hate to give this example), if your parents were dementing & we did not have NHS, would you pay for cholinestarase inhibitors? some may & some may not.What NICE said is true, they don't represent value for money.

There was recent BMJ which was showing how major pharmaceutical companies were using user/carer groups to pressurise policy makers.Its sinister..... as a wise person once said 'every society needs its sick people to keep a lot of others in jobs'

[yasirkasmi 0]

It'd be great to know how people go about prescribing high dose antipsychotics. Let's say if a patient had been on olanzapine 20 mg for 8 weeks and no improvement had been seen, would people think of another drug or increase it to 25 mg? If no response would you increase it to 30, 35, 40mg...? The thing that baffles me with exceeding BNF limits is that there is technically no limit! If someone is not responding to clozapine do you go up to 1000, 1200?

Despite the extremely informed and creative discussion that we've had, I'm still not convinced that exceeding BNF limits is SAFE, EFFECTIVE or DEFENSIBLE!!!!! It was fun discussing it though. Hope this topic comes up in my spr interview!

Thanks

[Guest j]

the way different people prescribe above limits varies. generally if i was going to go above limits eg of olanzapine it would be because they had showed a good response to it but had some residual symptoms but were tolerating it well, i would then increase to 25 and assess response then possibly up to 30, but i'd go back down to 20 if there was no response. i have seen people on doses of up to 60 a day of olanzapine but personally i would not go that high. i would usually advise a change of drug first rather than going above limits. also, most of the patients i have prescribed above limits for have either had a trial of clozapine and been unable to tolerate it or didn't respond.

the point about bnf limits meets that the drugs are safe, effective and defensible and doses above is clearly not true. there is no bnf max limit for trifluoperazine, so you could prescribe 1000mg a day and it would be within the limit, but it may well not be safe, effective or defensible and i'm obviously not going to advocate that.

also bear in mind that many drugs have safety data that goes much higher than the max bnf dose.

[yasirkasmi 0]

Great advice...thanks...good old stelazine!

[Guest j]

it's a remarkably popular drug actually. i've got a few people who have been taken off atypicals and put on it due to pregnancy and they much prefer it. i don't know why.

[omer 0]

I think BNF limits are only a guide for one's own clinical practise and like J says there is evidence of use of higher than standard doses (though usually for particular prescribed reasons). Even Maudsley guidlances has differing opinions in certain classes (and in our trust it is part of our treatment protocol).

It is defensive in the context of both your own practise and the individual patient ur treating - and if a body of peers would do the same.

Certainly on our PICU - the doses of meds were LEGENDARY - Diaz frequently 120 -160mg/day, olanzapine upto 60mg, etc ...true pioneers of pscyhopharm

somehow those violent/arroused patients always seemed to come back very calm!

[Guest j]

that reminds me. bnf doses change sometimes. eg a few years ago haloperidol max dose was reduced to 30 a day oral and 18 im. prior to that it was much higher (can't remember what, but i've seen lots of patients who were on 100+ about 15 years ago). i think diazepam used to be licensed to much higher doses too - the patient that i saw on the highest dose of diazepam was on 250 a day, prescribed by the gp about 4/5 years ago (at the time the max licensed dose was 30 as it is today).

so anyway, to the point, which was....

for those that think prescribing outside of bnf doses, do you think that everyone who was prescribing eg 50 a day of haloperidol at the time the 30 a day limit came in was immediately practicing in a legally indefensible way?