children

Crushing Circadin® MR tablets

Whether or not it’s OK to crush Circadin® MR tablets is a question that keeps coming up over and over again. This is because it’s the only licensed melatonin tablet in the UK, and it’s probably also the cheapest and easiest to for pharmacies to obtain. This is all good. The problem is that it’s not licensed in kids, and a lot of prescriptions for melatonin are for children. Furthermore, Circadin is a modified release tablet, and as we all know, crushing modified release tablets is a Bad Thing because it’s liable to release all the drug (which someone has taken a great deal of trouble to make release slowly) all at once.

People have died from crushed modified release tablets (though not melatonin).(1-3)

However, in the case of Circadin®, the situation is a little less lethal. Melatonin is often used in immediate-release tablets, and lots of patients don’t need the modified release properties. So it doesn’t matter so much – for those patients – if the modified-release properties are destroyed by crushing.

In fact, the manufacturer – on their Circadin® website, in the Q&A section(4) – states:

Crushing a Circadin® tablet will not damage the active ingredient (melatonin). There are no safety concerns with crushing Circadin®, however it will affect prolonged-release properties of the product. The tablet matrix maintains its prolonged-release properties as long as it is ingested as a whole. The prolonged-release properties will be maintained to some extent also if the tablet is halved or divided into 4 quarters. If it is crushed it will release melatonin similarly to an immediate release formulation. According to the SmPC the tablets should be swallowed whole in order to get the full prolonged-release properties.

The information leaflet on the very nice Medicines for Children website(5) also states:

Modified-release tablets (Circadin) should be swallowed whole unless your doctor or pharmacist has told you otherwise. Your child should not chew the tablet. Sometimes, your doctor or pharmacist may have told you to crush it – this will make it act faster, but the effect will not last as long.

However, anyone advising patients to do this should bear in mind that crushing tablets generally renders them off-licence (although Circadin use is off-licence in children anyway). The GMC has guidance regarding off-licence prescribing here.

So, in short, Circadin® tablets may be crushed if:

  • The patient cannot, or will not, swallow the tablets whole AND
  • The modified release characteristics are not required (e.g. in a patient who would otherwise be prescribed a non-modified release formulation, such as melatonin liquid.

If a patient requires a modified-release formulation, but cannot swallow Circadin® tablets whole, then cutting them in half or into quarters (preferably half rather than quarters if possible) will preserve the matrix formulation which provides the modified-release characteristics to some extent.

Health Warning

If patients (or carers) are advised to crush or divide Circadin® tablets, they should be counselled carefully to ensure that they understand that this recommendation applies only to Circadin® tablets, as it is known that causing the immediate release of all of the drug in the tablet is not harmful in this case.

This advice does not apply to other modified-release products; serious adverse effects have been reported when modified-release formulations have been crushed without first establishing the safety of doing so.

References

  1. ‘I will always blame myself’. BBC [Internet]. 2006 Oct 26 [cited 2015 Aug 5]; Available from: http://news.bbc.co.uk/1/hi/health/6085292.stm
  2. Schier JG, Howland MA, Hoffman RS, Nelson LS. Fatality from administration of labetalol and crushed extended-release nifedipine. Ann Pharmacother. 2003 Oct;37(10):1420–3.
  3. Cornish P. ‘Avoid the crush’: hazards of medication administration in patients with dysphagia or a feeding tube. CMAJ Can Med Assoc J. 2005 Mar 29;172(7):871–2.
  4. Q&A | Circadin® [Internet]. [cited 2015 Nov 13]. Available from: http://www.circadin.com/about-circadin/qa/
  5. Melatonin for sleep disorders | Medicines for Children [Internet]. [cited 2015 Nov 13]. Available from: http://www.medicinesforchildren.org.uk/melatonin-sleep-disorders
Advertisements

Consent – more complicated than it looks

This is another weird experience induced by being a healthcare professional and a law student at the same time (see, I can multitask). You get the same word, but the different professions mean something significantly different by it.

You’d think it would be easy, wouldn’t you? You consent, or you don’t. “Do you want a coffee?” “Yes, of course I want a coffee. What kind of question is that to ask? Give it me now!”

This came up in connection with the Sexual Offences Act 2003 which we’ve been studying in Criminal Law. It also came up on the front page of the Sunday Timeson 17th November, with Professor John Ashton (public health director) stating that the age of consent for sex should be reviewed, with a view to reducing it to 15 instead of 16. In the same article, a barrister specialising in reproductive rights (Barbara Hewson) is quoted as saying that the age of consent should be lowered to 13.

Now, Ms Hewson has received a lot of adverse publicity (unless one subscribes to the view that all publicity is good publicity, of course). She was the barrister who defended the barrister who stated that the child victim of a paedophile was ‘predatory’, and she has questioned whether the Jimmy Savile case may not have resulted in a moral panic and witch-hunt rather than a sober investigation.

And there was uproar. And outrage.

But let’s just have a look at the facts.

The age of criminal responsibility in this country (the UK) is 10 years. So at the age of 10, you can be convicted of murder. You cannot murder someone by accident: if you kill someone by accident, even by gross negligence, it is manslaughter. To murder someone, you have to form the specific intent either to kill, or to cause grievous bodily harm (and then actually kill them, of course. If you just fantasise about it, it doesn’t count).

And we in the UK believe that a 10 year old can understand concepts of life and death and responsibility enough to form an intent to kill.

Yet we don’t think that that same 10-year-old can consent to sex.

It gets worse. It’s not just actual sexual intercourse; it’s all sexual activity. In the UK, two fifteen-year-olds having a consensual snogging session are both committing a criminal offence under Section 13 of the Sexual Offences Act 2003. (Unless they both think the other is over 16 – and how likely is that?) If it’s two twelve-year-olds kissing, then they’re both committing a Section 13 offence regardless, because liability is strict in the case of children under the age of 13.

And now we get into the medical bit, which muddies the waters even further. Under the Family Law Reform Act 1969 the age of consent to medical treatment was set at 16. However, following the case of Gillick v West Norfolk and Wisbech Area Health Authority the situation got a bit more complicated.

Gillick was about the provision of contraception to girls under the age of 16 without their parents’ knowledge; Mrs Gillick did not want doctors providing contraception to her daughters without her consent. She contended that a) it was a parent’s right to make decisions like that and b) a doctor giving contraception to a girl under the age of 16 would be abetting a criminal offence.

In the event, Mrs Gillick lost. A parent’s right to direct their children’s lives, in the opinion of the court, only went so far as decisions in the child’s best interest. And the prescriber also had the duty to consider the girl’s best interests in the case of contraception. The rules that came from the case regarding the provision of contraception to girls under the age of 16 without parental consent or knowledge were:

  • The patient, although under 16, would understand the advice.
  • The doctor could not persuade the patient to inform her parents or allow the doctor to inform her parents that she was seeking contraception advice.
  • The patient was very likely to begin or to continue having sexual intercourse.
  • The patient’s physical or mental health could suffer unless she received contraceptive advice or treatment.
  • Her best interests required the doctor to give her contraceptive advice, treatment or both without parental consent.
  • These rules have since been extended to cover all medical treatment. So we have the situation where a young person of 15 can be judged competent to form the intent to kill (all children over the age of 10) or to consent to open-heart surgery (if they are judged ‘Gilick Competent’), but not to kiss their boyfriend.

    How’s that for screwed up?

    Back to Barbara Hewson, I think the reason she is vilified is because she is speaking truths that, as a society, we do not wish to acknowledge. Parents don’t like to think that their darling daughter might be doing the horizontal tango. It’s not fashionable to be of the opinion that sexual mores and standards change over time: what was judged permissible (or not) thirty years ago might not be judged the same way today. And can we judge today’s behaviour by yesterday’s standards, or yesterday’s behaviour by today’s standards?

    Barbara Hewson recognises that the ability to make an informed decision does not suddenly land on a person, like bird-droppings, at the age of 16. She also recognises that understanding is global: it’s unlikely that a person can form an intent to kill but not to kiss. So why should we treat killing differently from kissing? The issue is one of understanding and consent.

    The ability to consent develops at different rates in different people; some young people may understand the concepts involved well enough to consent to surgery at 12; others may not. In medicine, we recognise this, and take it into account. Yet the law treats criminal responsibility and sexual behaviour differently – not only as something that gets switched on in everyone on the same date, but the date itself is different depending on what is being consented to.

    In Gillick Lord Bridge (dissenting) was of the opinion that the provision of contraceptives to girls under the age of 16 must be unlawful (regardless of who consents) because sexual intercourse with a girl under the age of of 16 is unlawful. He was of the opinion that girls under the age of 16 should be prevented from having sex – presumably, regardless of what this takes.

    His judicial colleague, Lord Templeman (also dissenting) had a different opinion. He stated that a) it was an offence for a man to have sex with a girl under the age of 16; b) that a girl under 16 could not consent to sex; c) that a girl under 16 could not consent to contraception either, but d) if a girl was determined on having sex, then her doctor and parents together could decide that contraception should be provided.

    The judgements in Gillick provide an interesting range of judicial opinion and reasoning. At bottom, the case is about the conflict between law and reality. In law, a girl under 16 cannot consent to sex; a person who has sex with her is committing the offence of rape. Anyone who facilitates the act (other than the girl herself – a girl under 16 cannot be an accomplice to her own rape in the UK) is an accomplice to rape. So how come it’s OK for a doctor to facilitate sex with a girl under 16 years old by providing contraception?

    Much is made (by the judges in the majority) of the ‘well, if she’s going to have sex anyway…’ point, but this is mere damage limitation. It is, if you like, an explanation, or even a defence, but on pure logic, it shouldn’t make the initial act any less illegal.

    Don’t get me wrong; I think that Gillick was correctly decided in practical terms. However, I think the fact that it ever got to court shows the dangerous dichotomy between the law and the reality. Here we have a situation where a professional person is aware – in fact, is certain – that the crime of rape is going to be committed. And what does he (or she) do? Report it? No. They facilitate it.

    There is another point, rarely – if ever – mentioned. What is the position of the young man, or boy, in this situation? He and his 12-year-old girlfriend are going to have sex; she sensibly goes to her GP and gets contraceptives. They have sex. And then he gets arrested for rape.

    In R v G [2008], Baroness Hale states that the reason for the law being written the way it is – particularly that rape of a child under the age of 13 is a strict liability offence, meaning that it is no defence to state that the child consented, or that the accused believed s/he was over 16 – is not only to protect children from paedophiles, but also to protect them from premature sexual intercourse. This is all very logical and morally praiseworthy, of course. However, it does lose its shine when one considers that at the same time the state criminalises a person (even of the same age) who has sex with a girl under 16, the state also allows the girl’s GP to give her contraceptives to enable her to have sex without the risk of pregnancy (OK, technically a very considerably reduced risk).

    The only reason for this situation is that the courts recognised in Gillick that there are some girls under the age of 16 who are capable of consenting to sexual intercourse, and that those girls should have access to contraception. Because, surely, if the prescriber of contraception believed that the girl was being abused, then his/her reaction would be not to simply provide contraception, but to report the suspicion of abuse?

    Yet the law as laid down in statute does not recognise this at all, and criminalises that girl’s sexual partner.

    Isn’t it time, therefore, that we at least acknowledged the inconsistency?

    We have the Mental Capacity Act 2005 which relates to decisionmaking for those without capacity (e.g. by reason of age, or injury) to make their own decisions or consent to medical treatment. It does not set out hard and fast rules for who can consent and who cannot; it defines what incapacity is, and makes it clear that capacity is assumed unless incapacity is demonstrated. A consequence of this is that a person might have capacity to make one decision (e.g. to get married) but not to make another (e.g. to make a will). It would be interesting to see the provisions of the Mental Capacity Act applied to matters of consent in criminal law. Rather than have the illogical and harmful situation where a girl is judged competent to have sex (by her doctor) but anyone who has sex with her is committing an offence because of her incapacity, it might be interesting to have a situation where a girl (or, of course, boy) under 16 is presumed to be nonconsenting unless unless both consent and capacity to consent – judged under the standards of the Mental Capacity Act – were present.

    I doubt, however, that this would ever happen. However logical it might be to judge criminal responsibility, and capacity to consent, on the characteristics of the person involved, I think that to do so would be politically unacceptable. However willing we are to accept that learning disabled people and elderly people are judged by this standard in decisions about their ability to make far-reaching decisions about themselves and others, I think there would be resistance to applying the same standards to children. Not because it is illogical, but simply because society does not wish to acknowledge that a particular fifteen-year-old might be quite capable of consenting to a sexual relationship.

    Society still wishes – in the law – to preserve the fiction of the ‘innocence of childhood’, which is daily assaulted by sexualised images in the media. And, particularly in the case of girls, society is still wedded, I think, to the idea that a ‘good girl’ is a virgin, but that the real villain of the piece is the cad who deflowers her. And so we will remain in the ridiculous situation where young girls are (rightly) given contraceptives – and thus tacit permission – when they wish to embark on a sexual relationship responsibly, but we criminalise their sexual partners.