Network No 22 (April 2008)
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Are you confused about the role of ECGs for patients on high dose methadone? Martin Wilkinson highlights evidence regarding the risk of methadone and sudden cardiac death risk of methadone and sudden cardiac death and gives a practical guide to when an ECG should be considered.
Chris Udenze challenges the idea that being "colour blind" is the most effective way of meeting the needs of Black and Ethnic Minority clients.
Lyn Matthews discusses the links between drugs and street sex work, and the extreme risks and stigma that sex workers face.
Nat Wright gives an overview of the available research and discusses his own experience of prescribing Subuxone, concluding that it is a useful new option for drug treatment.
Daren Garret asks us if there is such a thing as a hard to reach group, or whether it is a term that has been created by services that have made themselves inaccessible and should be doing more to provide treatment for all sections of the community.
Haven't had time to read the new drug strategy? Jim Barnard summarises the main points of the strategy and encourages us to have a closer look.
We asked our members for their views on the 2007 Clinical Guidelines. Hugo Luck, National Treatment Agency Policy Manager, gives answers to our member's concerns.
Are you a GP in Scotland? Get involved in the survey run by The Department of General Practice and Primary Care at the University of Aberdeen.
Nigel Modern, Martin Wilkinson and Judith Yates reply to a GP who is concerned about the role of ECGs with high dose methadone.
Nigel Hewett provides some advice on how to treat a homeless drug user.
See the Bulletin Board for the latest news and events.
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Welcome to this conference edition of Network. We are excited about the conference, from its title "Meeting the needs of diverse populations: hard to reach or easy to Ignore", to the rainbow colours of the programme ...and of course the annual party with this year's theme of "pink and sparkly" - can't imagine why in Brighton! In this edition we have articles which will echo some of the talks that you will hear if you are attending-and give a flavour of the event to those of you who sadly can't make it.
There has been increasing tension in the drugs field over the past year, with two camps apparently having a fundamental disagreement over the role of drug treatment. On one side are the supporters of methadone maintenance, with its core beliefs of harm reduction and the need to support people through their drug taking years with as little damage to the individual as possible whilst encouraging them to make changes to their lives over a period of time, sometimes many years. On the other side are the "new abstentionists" who argue that a reliance on methadone maintenance by drug treatment services is condemning drug users to a future of long term substitute prescribing rather than abstinence, the goal that most drug users aim for. Gordon Morse asks Why Are We Fighting?, and suggests that both these approaches are needed for a successful treatment system. A recent research paper found that in the first two weeks after release from prison, males were 29 times more likely to die than the general population. For females, that figure rose to 69 times (Ref 1)! Overwhelmingly these deaths were drug related, and in particular, overdose due to loss of tolerance. It is clear that achieving and maintaining the abstinence that the majority of drug users say they desire is not always straightforward, and it is important that the debate does not lead to drug users failing to get the support they need, whether it is prescribing support, psychosocial support, peer support or a combination of all of these approaches.
SMMGP are excited to announce our third national primary care development conference entitled "Primary Care Drug Treatment - End of the line, or part of the journey? How to optimise patient choice and opportunity" in Bristol on Friday 26 September 2008. This conference provides practitioners, managers and commissioners with the opportunity to consider how primary care drug treatment services can be developed to deliver the best possible service for patients. For more information see the Courses & Events section of this web site, and contact details are also available on the Bulletin Board.
SMMGP have changed hosts! As of April, we said a fond goodbye to Greater Manchester West Mental Health NHS Foundation Trust (formally Bolton, Salford and Trafford NHS Trust) who have supported us for many years, and say a warm hello to our new hosts the National Treatment Agency who we are looking forward to working with. We will continue to remain an autonomous project with the view of promoting the treatment of drug users in primary care. As we leave the north, we would like to say a special thank you to Kate Hall, our line manager, and Natasha Crabtree our wonderful administrator. We will miss you both.
The new drugs strategy has been launched. Methadone maintenance treatment continues to be endorsed as a central plank of drug treatment. However, the emphasis on reducing crime is even greater, and this, together with the headline grabbing suggestion that benefits for drug users should be dependent on being in treatment, strengthens the coercive tone of this strategy. It is important that the field does not lose the harm reduction message.
1. Michael Farrell and John Marsden: Acute Risk of Drug Related Death Among Newly Released Prisoners in England and Wales. Addiction 103 (2008) pp251-255
"abstinence and harm reduction are not mutually exclusive, they are mutually dependent: for what is abstinence without harm reduction alongside to scoop you up when you fall off the wagon? And what is harm reduction, without the hope that one day you can regain your independence and self-determination?"
Are we fighting? Since Dole and Nyswander published their seminal work on methadone treatment in the Journal of the American Medical Association in 1965 there have been literally scores of published research papers vindicating the harm reduction approach. And the volume of evidence is so great that some researchers argue that there is no point doing any more: the findings in favour of well designed and delivered methadone treatment across all manner of hard, measurable outcomes is incontrovertible. The evidence that these same methadone programmes not only reduce morbidity, mortality and criminality, but also costan unusual benefit for a medical treatment - has led the NHS and other medical systems world wide to push massive amounts of money into funding more methadone treatment provision.
Before methadone, the medical profession had little to offer opiate addiction (I hate the word, but we all know what I mean). The Victorians smoked their opium, or drank laudanum, much as every age of Man has used, and a few abused, every psychoactive chemical that he has stumbled across in nature. Indeed ever since Noah "planted an vineyard and became drunken" after the Great Flood back in chapter 9 of Genesis, perhaps 5000 years ago, Man has had a curiously ambivalent attitude to psychoactive chemical use over the millennia; we have revered it in religious ceremonies (peyote, iboga, etc.), demonised it in prohibitions past and present (alcohol, heroin), profited by it (alcohol, tobacco) and prescribed it to our troops in the present day to make them more effective at killing people (amphetamines).
Indeed before methadone, medicine did a great deal more to create addiction than to "cure" it. Addiction just wasn't something that greatly exercised the medical profession at all. Conventional medicine has always liked to use drugs to treat people, and so when drugs are the problem, we tend to get a bit confused. Before methadone, there was only one "treatment" for excesses: because regaining control that has been lost is so difficult, pragmatically (or perhaps dogmatically as I shall go on to explain), the "treatment" available was to just to permanently abstain.
Abstinence is a concept that has also been with Man over the millennia. Before Noah planted his vines, he was serving his God. Religions of almost every hue have some form of self-denial as part of their practice: from fasting for a few days, to temperance, celibacy and asceticism. So it is easy to see how, when medicine had little to offer, drug addiction became some sort of sin that sought absolution through religious means; Alcoholics Anonymous (AA) was founded within the Oxford Groups, which were a puritanical Christian movement, and the 12 Steps of AA and later Narcotics Anonymous (NA) still use the word "God" no less than five times. In fact AA and NA do not regard themselves as Christian any more and welcome members of any religion, or indeed none at all - but they are still faith based (where the faith is a belief in the process of the Steps themselves) and it is this concept of faith that makes their approach to maintaining abstinence so effective. There are millions of people who would not be alive today if it were not for achieving durable abstinence from some chemical addiction or another, and of course, that doesn't just mean heroin, cocaine and alcohol, but includes the most pervasive and lethal addiction of them all, tobacco.
So it seems blindingly obvious that abstinence is a good thing if you can manage it, and if you can't, then harm reduction strategies are immutably good at, errrr, reducing harm. So why is it that the two philosophies, despite 50 years to work that rather simple concept out, still have exponents of each that seek to discredit or deny the other? Because some of this dogma is profoundly entrenched. We all know of doctors who actively resist their patients wishes for help in achieving abstinence - they use the profoundly patronising excuse that they know best - that the poor patient has no chance of achieving abstinence and will wantonly expose himself to the needless risk of accidental overdose when he relapses due to lost tolerance. And we know of prisons that "re-tox" prisoners prior to release with methadone, after they have achieved abstinence during their sentence, for the same reason. These fears are well founded - but is the person to be denied making an informed choice? And of course we all know others, often those who have found enduring abstinence themselves, and often through faith-based means, who denigrate methadone programmes - who refuse to acknowledge that any good can come from any addictive drug, and espouse abstinence with the same blinkered arguments of the religious zealot.
Perhaps it is because science and spirituality have always been uneasy bed-fellows - maybe it is dogma versus pragma, maybe it is professional vanity, or maybe it is all of the above, but of this I am absolutely certain: Heroin addiction ravages the individual, the family and wider society; it is an epidemic that is escalating despite all of our efforts because neither abstinence nor methadone work for everyone all of the time. The abstinence route demands the agonies of a detox, with all the consequences of facing up to a painful past, a difficult future and a changed identity. And the methadone route demands moving from dependency on one drug, a dealer and a pimp, to dependency on a different drug, a doctor, a pharmacy and a treatment system; neither are very attractive options, but they are all we have and we can not afford the luxury of denying ourselves either of them.
But most important of all, abstinence and harm reduction are not mutually exclusive, they are mutually dependent: for what is abstinence without harm reduction alongside to scoop you up when you fall off the wagon? And what is harm reduction, without the hope that one day you can regain your independence and self-determination?
Are you confused about the role of ECGs for patients on high dose methadone? The issues are far from clear, as highlighted by the 2007 Clinical Guidelines which describe methadone and QT prolongation as "a story still unfolding which, with the passage of time may prove to be a minor or a major issue measured against the many benefits afforded by methadone treatment." However, despite this uncertainty methadone and QT prolongation is raised in the 2007 Clinical Guidelines, so how should clinicians respond? Martin Wilkinson highlights evidence regarding the risk of methadone and sudden cardiac death and gives a practical guide to when an ECG should be considered. For further discussion on this topic see Dr Fixit's Advice - High Dose Methadone & ECGs. Ed.
Take Home Messages
- Methadone (like many other drugs) may increase the QT interval on an ECG.
- QT prolongation is associated with torsades de pointes (a form of ventricular tachycardia).
- Risk of sudden cardiac death due to torsades de pointes is unknown but is likely to be very small.
- Risk of QT prolongation is associated with electrolyte disturbance, CYP 3A4 inhibitors, liver and heart disease, and >100mg methadone daily.
- An ECG should be considered for those at high risk.
- A QT interval of over 0.5s (two and a half large ECG squares) indicates a risk of sudden death.
Remember the risk associated with drugs misuse far outweighs the risk of developing torsades de pointes.
Drug users have an annual mortality rate six times higher than that for a general, age-matched population, with two-thirds of these deaths owing to drug overdoses (Ref 1). It is difficult to be specific about the cause of death, as between 50% and 75% are associated with use of multiple drugs, usually an opiate with benzodiazepines or alcohol (Ref 2). Respiratory depression is the normal mode of death but methadone may also cause an arrhythmia as a result of prolongation of the QT interval (the QT interval is a m easure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle- see table 1). This arrhythmia is known as torsades de pointes (Ref 3), a French term meaning "twisting of the points" and is a potentially lethal ventricular tachycardia that can degenerate into ventricular fibrillation. It probably accounts for about 5% of all sudden cardiac deaths (Ref 4).
Many other drugs used in clinical practice have this side effect (see table 1). Some drugs are no longer used as a result - for example thioridazine and terfenadine. The level of risk varies with the drug and the patient's susceptibility to cardiac problems. A few cases of sudden death on regular therapeutic doses of methadone have made the headlines causing anxiety for prescribers, however there is no evidenced link to torsades de points in these cases.
Table 1: Examples of drugs known to cause QT prolongation
Torsades de pointes associated with very high doses of methadone was first described by Krantz in 2002 (Ref 5), with a retrospective review of 17 patients with arrythmias. The mean daily dose was 397mg (100 to 600mg) a day - very high doses! Fourteen patients were given a pacemaker and all 17 survived. No other patients on high dose methadone were examined so the relative risk was unknown.
In 2003 Kornick (Ref 6) examined the ECG of inpatients who received intravenous methadone. The methadone increased the QT interval by a mean of 41.7ms, p<0.00001, with a significant dose response relationship. However, they concluded that methadone in combination with chlorobutanol additive is particularly associated with a prolonged QTc interval. This additive is not normally used as an additive in the British formulation of methadone. A study in 2005 looked at the ECGs of 83 heroin addicts on methadone doses ranging from 10 to 600mg/daily (mean 87mg). They found 83% with prolongation of the QT interval compared to the reference value for the same age and sex (Ref 7).
In January 2008 a four-year study examined all patients who had sudden cardiac death in Portland and 22 cases were found with therapeutic levels of methadone, and 106 without methadone. The methadone was most often being prescribed for analgesia and not addiction. No prevalence was calculated and hence the excess risk is unknown. This gave methadone the headlines as a "killer drug".
In conclusion it is known that methadone, like many drugs such as erythromycin, may cause a prolongation of the QT interval in some individuals. The risk of sudden cardiac death due to this is unknown but is likely to be very small and the evidence is based on non-randomised, retrospective, non-case controlled studies. The risk associated with drugs misuse probably far outweighs the risk of developing torsades de pointes but we need to make some form of assessment in order to minimise the risk.
For nearly all drugs that cause prolongation of the QT interval the risk is doubled in female patients, and this appears to be dose related so the risk is more likely for those on very high doses of methadone. Pragmatically this means we should consider assessing people's risk if they are on more than 100mg methadone a day and those in the older population who have regular grapefruit juice - not the typical drug addict! A simple check list of factors associated with arrhythmia helps to identify the risk. A previous history of heart disease or unexplained fainting or dizziness may be a pointer. Any condition causing metabolic imbalance including diarrhoea, HIV or hepatitis could also put the patient at risk.
Examination and recording of the pulse rate, rhythm and blood pressure of all patients is recommended, and where venous access is possible, check for electrolyte imbalance and liver function. In general it is more likely for an arrhythmia like torsades de pointes to occur if the pulse rate is slow. An ECG prior to commencement of methadone treatment is not advocated. Whether or not to conduct an ECG should be based on a risk-benefit analysis. A baseline ECG may be considered in patients with evidence of one or more of the following risk factors (Ref 8):
- Heart disease
- Liver disease
- Concomitant treatment with CYP 3A4 inhibitors (other QT prolonging drugs)
- Electrolyte abnormalities
- Methadone > 100mg a day
If the ECG is normal with no evidence of QT prolongation, consider repeating it 6-12 monthly if the risk of QT prolongation is high. If the QT is prolonged by more than 470ms (women) or 450ms (men) then the QT risk factors (especially drugs) need to be modified; if over 500ms (two and a half big squares) then the methadone should be reduced or stopped, and a cardiology opinion sought. If the QT is prolonged by more than 550ms, consider stopping and transferring to buprenorphine. For a complete guideline to interpretation of the ECG see the Scottish Government Guidelines (Ref 8). An easy rule of thumb is that if the QT interval is more than two and a half big squares on an ECG (0.5ms) then the patient is at risk of sudden death. Buprenorphine is not associated with this problem. In a head-to-head comparison of buprenorphine and methadone treatments ECGs were taken at baseline and at 17 weeks of treatment. Significant QT prolongation was noted in 23% of those on methadone and 0% of those on buprenorphine (p<0.01) (Ref 9) - more evidence that buprenorphine should be considered as a safer alternative to methadone.
1. Drummer, Syrranen M, Opeskin K, Cordner S. Deaths of heroin addicts starting on methadone maintenance programme. Lancet 1990; 336; 108.
2. Gossop M, Stewart D, Treacy S, Marsden J. A prospective study of mortality among drugs misuser during a 4-year period after seeking treatment. Addiction 2001; 97: 39-47
3. Dessertenne F (1966). "[Ventricular tachycardia with 2 variable opposing foci]" (in French). Archives des maladies du coeur et des vaisseaux 59 (2): 263-72
5. Krantz M et al. Torsades de Pointe associated with very-high-dose methadone. Annals of Internal medicine2002; 136: 501-504.
6. Kornick et al. QTc interval prolongation with intravenous methadone. Pain. 2003: 105; 499-506
7. Maremmani I et al. QTc interval prolongation in patients on long-term methadone maintenance therapy. Europeoan Addiction Research. 2005: 11: 44-49
8. The Scottish Government Consultations. Drug Misuse and Dependence - Clinical Management Update 2007 - 1 Cardiac assessment and monitoring for methadone prescribing.
9. QT-Interval Effects of Methadone, Levomethadyl, and Buprenorphine in a Randomized Trial Erich F Wedam, George E Bigelow, Rolley E Johnson
Chris Udenze challenges the idea that being "colour blind" is the most effective way of meeting the needs of Black and Ethnic Minority clients. He argues that by considering the affects of someone's ethnicity on their lives and their treatment, we are more likely to offer effective interventions than if we ignore this important aspect of people's experience. Ed.
After the first day of last year's RCGP drug misuse conference I felt like I'd had a "snow-ball" but instead of a feeling of elation and excitement, it all turned out to be a bad hit. What was wrong? There were inspirational speakers, hundreds of selfcongratulatory GPs with a special interest in substance misuse with tales of notable successes; our key-note speaker inspired us to tailor our treatment to the individual and rather than consider ourselves as specialists, to learn from our clients. But there was an "elephant" in the room; hardly an acknowledgment of the issue of ethnicity or culture, except for a tokenistic workshop on an Asian project in Luton. When I attended conferences in the 70's and 80's I'd expect to be the only black person there. At the Birmingham conference there were lots of black people ...mostly porters and waitresses!
But what does it matter if our clients are black or white? Aren't we all individuals? Shouldn't we take a "colour blind approach"? Most of the conference attendees were liberal thinkers who would consider themselves anti-racist and accept the need to be culturally sensitive. But what of our more conservative colleagues, the majority, who don't see the point of "all this PC-gone-mad", and who don't understand the need for ethnic monitoring? How can we convince them that race/ethnicity is an issue in the treatment of substance misusers if we ourselves ignore, struggle with and avoid as too contentious the issue of ethnicity? In one of the workshops I attended the speaker talked of the characteristics of prisoners, but overlooked the obvious; when I've been in male prisons I'm struck by how many "brothers" are there- are we becoming like the US where one in ten 25-34 year-old Black men are in prison?
In essence NICE extols us to prescribe "meth" or "subbies" plus lots of harm minimisation, and if the client is reluctant to reduce the dose then to continue on maintenance, thank you, bye, next please. And as much as we can demonstrate some reduction in crime and improvement in social functioning, the reality is that only 3% of clients undergoing substance misuse treatment are likely to become drug-free, and the majority will continue to supplement with their medication with illicit drugs and claim long-term benefits. Instead of addiction to illicit drugs they have iatrogenic dependency - less socially disruptive, but hardly a clinical success story.
If therapy is going to be any more sophisticated than just signing fortnightly scripts then, yes we need to treat each client as an individual, and to recognise that each individual is a product of their gender, sexuality, ethnicity etc. Rather than "treat everyone the same" we should treat "each according to their needs". Wouldn't it be bizarre if we ran drug treatment services that failed to acknowledge that some of our clients are women? That wouldn't be acceptable because we recognise that women have certain needs and experiences that may affect their presentation and treatment- yet it is not considered radical or politically correct to design services to take (some) women's needs into account. Likewise for black people, our life experiences are influenced by a multitude of factors of which our colour is a major factor in terms of education, parenting, values, employment opportunities, experience of the judicial system, and choice of partner/drug/means of sustaining drug habit. We might not understand how growing up in the Gorbals may affect someone's alcohol behaviour or how opium might play a part in the life of an Iranian asylum seeker, so as Phil Barker would say, learn from them.
Five Reasons Why Not to be "Colour Blind"
Ethnic monitoring has been a requirement in the NHS since 1996. Our Trusts will state it is "to ensure equal access to services"- but is it really because we know there is not equal access to services and we need to monitor how those inequalities work and affect access to services?
For Black clients who can feel invisible in society, merely acknowledging their ethnicity is an affirmation of who they are-very powerful for people who are ignored and demonised and have feelings of low self-esteem and powerlessness.
Racism is less blatant now than when I was a child in South London but just as there is a glass ceiling for woman so is there widespread racial prejudice still, whether conscious or sub-conscious - ask Lewis Hamilton or Naomi Campbell. Black people's experiences of public services tend to be negativeis your service so completely different from most other services?
Treatment is clearly more than just about a prescription and the therapist/doctor/drug worker is the most powerful drug of all. We tend to like people like us, and would not be human to have sub-conscious preconceptions about other ethnic groups; being "colour blind" means these prejudices are unchallenged. Considering a clients ethnicity can help address prejudices.
Whilst different ethnic groups are genetically virtually identical, we are increasingly recognising ethnic differences in pharmacodynamics, from betablockers and ACE inhibitors to statins; if we are not looking for ethnic variation in response to substitute prescribing we won't notice it.
Lyn Matthews discusses the links between drugs and street sex work, and the extreme risks and stigma that sex workers face. She argues that proposed changes to the benefits system, and criminalising the act of buying sex could act to further marginalise sex workers. Ed.
When I first entered the HIV prevention field in 1987, the street sex working industry in Liverpool had reached a watershed. Those women who had worked solely to survive or to pay for their alcohol use had started to dwindle. The increased availability of heroin on the streets of Merseyside at the beginning of the 80's had meant many young men and women turned to selling sex as a means of affording their habits. When I initially went out on to the streets of Liverpool's red light district, there were many disgruntled, older women complaining that the younger "smack heads" had taken over and were offering sexual services at much lower rates. The appearance and rapid uptake of crack cocaine towards the latter part of the 80's exacerbated that need, leaving those drug users involved in sex work with few choices and locked in a world with little chance of escape. For many of the young men and women I have worked with over the years, the road to addiction and sex work started early in their childhoods. Disclosures of physical, emotional and sexual abuse have all been sadly too often the norm in my work.
Yet society continues to marginalise, vilify and punish those whose use drugs and sell sex. Few know the reality of the lives of the people they sit in judgment of Liverpool's "red light" district, like so many others around the UK, can be one of extreme violence. The women who work the streets are often subjected to violence and abuse on a daily basis, not only from the customers but also from drug dealers, residents, children and sometimes even the police too. Many women have been raped and beaten up - some even murdered - and it is accepted as a "hazard" of the trade not only by the women themselves but also by those who are meant to protect them. The law has often failed to protect these women. This failure tends to harden sex workers" attitudes, leaving them with little respect for the hypocrisy of a society that covertly uses their services while simultaneously rejecting their need for protection.
"Yet society continues to marginalise, vilify and punish those whose use drugs and sell sex. Few know the reality of the lives of the people they sit in judgment of"
The murder of Lynda Donaldson in 1988 brought home to me how dangerous this work is. The memory of hearing that her badly mutilated body had been discovered dumped in a field, will haunt me forever. Lynda was not just an unknown face staring blankly out from the front page of a newspaper or a TV screen, but someone who had come from my own community, had gone to the same school as me, shared my first name, and knew many of the people I knew. I will also never forget the anguish and suffering of her elderly grandmother who had raised Lynda. The only way she could confirm the lifeless body on the slab was that of her grand daughter, was by a scar on her earlobe. Had Lynda not been using drugs, she would never have turned to sex work. Her grandmother had always felt the drugs would kill her. Instead, it was an unknown assailant who plunged a knife into her back and cruelly took her life.
And Lynda is far from an exceptional case: I was to experience the same sense of despair and loss 17 years later when the body of Anne Marie Foy was found. She had been badly beaten, strangled and her body dumped in bushes - tossed aside like an old tin can or piece of rubbish. Since the 80's, drugs and street sex work have become inextricably linked. While some commentators and politicians have called for even more draconian measures to be taken to solve the problems of drugs and prostitution, such as the Swedish approach of criminalising the act of buying sex, others prefer a more humane and pragmatic approach to this issue. It makes no sense to me to drive the most marginalised and vulnerable people in our societies further underground if we want to maintain contact with a group in such desperate need of help. If we do, we are further endangering their lives and forcing them even further out onto the margins of our society.
And it is not just physical attack that places drug using sex workers at risk. Because of the chaotic nature of their life style, their drug use and poor injecting techniques, conditions such as deep vein thrombosis, abscesses, infected ulcerations and other drug related harm are all too common within this group. It is sad to see that for many of these women, there is still the same unwillingness to come forward for treatment as there was when I first started in the field over 20 years ago. And with the rise of hepatitis B and C and HIV amongst drug injectors, the future looks bleak for many.
Whilst countless people will view prostitution and drugs as a moral issue, I believe that we have to put aside our own moral opinions and prejudices if we are to support those who sell sex to fund their drug dependence to make these critical and difficult changes in their lives. We need to take a holistic approach and to build on the foundations of the harm reduction model. As with most addictions work, there is rarely a quick fix and it can take years for those involved in sex work to move on and rebuild their lives. But with the right kind of help, a willingness to understand their lives, and real and meaningful cooperation between all of the available service providers in an area, genuine change is possible.
The murders of the five women in Ipswich brought home to the people of Britain how vulnerable those are who have to follow the path of sex work to buy drugs, and yet night after night, drug users place their lives at risk by offering sexual services to strangers to buy a bag of heroin or a rock of crack cocaine. If current calls for drug users to lose benefits if refusing treatment go ahead, we will be driving more and more people to the streets and to crime. We cannot change the past, but we can change the future, and we owe it to the memories of all those who have lost their lives to attempt to make a positive difference and protect some of the most vulnerable people in our society.
The 2007 Clinical Guidelines briefly mention Suboxone but conclude that there has not been enough evidence regarding this drug to make any specific recommendations. Nat Wright gives an overview of the available research and discusses his own experience of prescribing Subuxone, concluding that it is a useful new option for drug treatment. Ed.
It is now almost two years since Suboxone became licensed for the treatment of opiate dependence in the UK. The introduction of Suboxone as an additional prescribing medication has sparked passionate debate, not least on the pages of the SMMGP website. This article seeks to give a brief overview of the current issues, present some key findings from existing research, and give some clinical experience to further inform the discussions regarding the place of Suboxone in the current drug treatment system.
Suboxone is a combination preparation of buprenorphine and naloxone. The former is a partial mu receptor agonist and a partial kappa receptor antagonist. Mu and kappa are two of the three opiate receptors, the other one being the delta receptor. Naloxone is a full opiate antagonist. Suboxone is available as sublingual tablets in buprenorphine/naloxone 2mg/500mcg and 8mg/2mg strengths. It is being marketed as having less potential for both abuse and diversion than Subutex (buprenorphine). The pharmacodynamics of Suboxone is that, if it is taken sublingually as licensed, then the absorption of naloxone is negligible and the full opiate effect of buprenorphine is experienced. However if the tablet is injected then there is a risk of the user experiencing the opiate antagonist effect of naloxone, which would precipitate withdrawal from opiates. It is also possible that the opiate antagonist effect would be felt if the user were to snort Suboxone. Therefore it is argued that Suboxone has a place where there is a risk of diversion. Typically this is more of a risk where there is a heightened demand for opiates due to a reduced illicit supply, for example prisons or drug using populations where poverty is a reality, presenting an incentive to sell prescribed drugs to generate income.
Opponents argue that Suboxone is threat to user choice and therefore a potential threat to the therapeutic alliance between clinician and patient. Also, some GPs have been appropriately trained not to prescribe combination tablets if there is no evidence for their effectiveness above single preparation medications and are therefore cautious about prescribing a combination preparation. So is there an evidence base that can help inform the place of Suboxone in the current primary care drug treatment setting? International research has demonstrated the good safety profile of Suboxone when prescribed in community drug treatment settings (Ref 1) and that patients can be easily switched from Subutex to Suboxone without destabilising their treatment (Ref 2). A survey of Finnish drug users who attended a needle exchange program revealed that the street price of Suboxone was less than half that of Subutex (Ref 3). This important piece of work which was funded and conducted independently of pharmaceutical companies would suggest a lower abuse potential of Suboxone relative to Subutex. Whilst it could be argued that this is because, relative to Subutex, Suboxone has a greater side effect profile, this is not borne out by other research.
Clinicians reliant purely on their experience are more fallible in their recommendations for clinical practice than evidence derived from rigorous, systematic health care research (Ref 4) and therefore the evidence base is fundamentally important. However, the evidence base for Suboxone is still developing. There are also limitations in evidence based medicine, as it is not possible to provide clinical care to all patients to a "formula" derived from a research study. Therefore it is important that the circumstances of the patient, the preferences of the patient and consensus amongst experts support the current evidence base and contribute to clinical decision making (Ref 5). So is there respected clinical opinion that can further inform the debate? Interestingly, in Australia the National Pharmacotherapy Policy recommends that Subutex be used for those taking daily supervised buprenorphine, whereas Suboxone be used for those taking buprenorphine unsupervised (Ref 6). As for my own clinical experience, over the last 12 months I have overseen the initiation of several hundred users onto Suboxone treatment in HMP Leeds. Currently I feel that the abuse potential of Suboxone is less than Subutex, but greater than methadone mixture. However, the abuse potential of Suboxone relative to methadone would in itself merit evaluation. Anecdotally we have found that as we prescribe higher doses of methadone in prison and at the same time prescribe less Subutex, the number of urine samples positive for methadone increases.
One consistently recurring theme that users report is that compared to Subutex, when taken sublingually, Suboxone dissolves much more quickly. Whilst not dissolving in a matter of seconds, nevertheless this is an important factor in my continued policy of recommending Suboxone above Subutex in the prison treatment setting. It also seems that when snorted, users are more likely to experience headaches with Suboxone than with Subutex. Whether this is because of the increased speed of absorption of the opiate (that has vasodilator properties), or the opiate antagonist effect of naloxone, is neither clear nor important. What is clear is that relative to Subutex, Suboxone appears less amenable to misuse.
Some are of the view that whilst there is a greater need for supervised dispensing in prison settings, this is not necessarily the case for the community setting. It is argued that in the community users should have more choice as to both the medication and the preparation that they take. This is certainly desirable in some cases. However 100% user choice is neither desirable nor achievable. Certainly user choice does not extend to (for example) methadone tablets, methadone ampoules, maintenance benzodiazepines, or maintenance amphetamines, such that these medications are available "on demand". Rather, any treatment decision is a balance between choice, safety and effectiveness (both clinical and cost effectiveness). We know that diversion of buprenorphine occurs in the community. For instance a high percentage of mandatory drug tests in prison settings are positive for buprenorphine, even in prisons where buprenorphine is not prescribed.
In conclusion I would suggest that there is a place for Suboxone amongst other pharmacological interventions for drug users and that in the following situations it would be prudent to consider Suboxone:
- In prisons where methadone is not indicated or tolerated, or prior to release where the user is given a choice between either methadone or buprenorphine therapy.
- In the community where users wish to have take home buprenorphine.
- In the community where treatment is supervised but users have a previous history of imprisonment.
- In the community where treatment is supervised but for economic reasons there is a strong shadow economy for diversion of prescribed drugs.
Clearly there are many drug users who have achieved a significant degree of personal stability through their ability to meet family and employment responsibilities. It is unlikely that for such individuals Suboxone will be the drug of choice. However for others where such stability remains a distant dream and pressure to divert drugs threatens stability, it is likely that Suboxone will have a place.
1. Amass L, Ling W, Freese T, Reiber C, Annon J, Cohen A, McCarty D, Reid M, Brown L, Clark C, Ziedonis D, Krejci J, Stine S, Winhusen T, Brigham G, Babcock D, Muir J, Buchan B, Horton T. Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. American Journal on Addictions. 2004;13 Suppl 1:S42-66
2. Bell J, Byron G, Gibson A, Morris A. A pilot study of buprenorphinenaloxone combination tablet (Suboxone) in treatment of opioid dependence Drug & Alcohol Review. 2004; 23(3): 311-7
3. Alho H, Sinclair D, Vuori E and Holopainen A. Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Drug and Alcohol Dependence 2007; 88: 75-78
4. Haynes R. What kind of evidence is it that Evidence-Based Medicine advocates want health care providers and consumers to pay attention to? BMC Health Services Research. 2002; 2:3, www.biomedcentral.com/1472-6963/2/3
5. Haynes R, Devereaux P and Guyatt G. Clinical expertise in the era of evidence-based medicine and patient choice. ACP Journal Club 2002; 136: 11-14
6. Suboxone: successful switching. Hayllar J. Buprenorphine Awareness Conference. Tele-Conference Proceedings. Manchester 2008
Daren Garret asks us if there is such a thing as a hard to reach group, or whether it is a term that has been created by services that have made themselves inaccessible and should be doing more to provide for all sections of the community. Ed.
What do we mean by "hard to reach"? Is it fair or appropriate that in the first decade of the 21st century we continue to assume that because the majority of our client-base are white, male (presumably heterosexual) opiate users in the 18-35 age range, anyone who falls outside of this profile is somehow difficult? Should people be written off as hard to reach just because their individual needs, politics, gender, culture, age and heritage aren't the default settings in the systems we've inherited, promote and still work within?
Is this not, in essence, just a further extension of the blame culture that still underpins whole swathes of drug treatment provision in the UK, where you'll find the hard to reach group alongside the problematic drug user, the chaotic lifestyle, and the difficult client? Perhaps only when we begin to talk of the problematic treatment regime, the chaotic bureaucracy, the difficult provider and the hard to access service in equal measures will we be at a point where we can work effectively and constructively against a culture of blame and get a clearer understanding of what we mean by hard to reach. Some drug users may be hard to hear, are clearly hard to attract, and are frequently hard to please. But are they really that hard to cater for?
You can almost hear the case for the defence...
"The problem with these people is that we need to show the National Treatment Agency we're supporting these underserved groups, but we just can't get 'em through the doors. No matter what we do, we just can't get them to come to us. We've got booklets in Gujarati and Urdu in the waiting room, we've advertised for Criminal Justice Intervention Team workers in Asian Eye and The Voice, we've got a male ex-user - three years clean, suspected occasional commercial sex worker - that we allow to do volunteer peer-support in our Preparing for Rehab group, and we have women counsellors - so why aren't we attracting a wider range of client?"
Well, maybe we need to reflect on some of the external, additional factors and influences affecting our hard to reach groups before we can get a handle on what else we can do to support them. For instance, the immediate and most common reason you will hear for Black and Minority Ethnic groups not accessing services is "the shame and stigma it will bring on the family". Can I let you into a secret? That's not an exclusively South Asian phenomenon! Admittedly there can be more emphasis placed on the importance of reputation and loyalty to family in some South Asian communities than there is in some white European families, but the notion of shame and stigma remains the same, as you will see should you choose to visit a local parents' support group. So how have we managed to address this issue elsewhere?
Have we managed to address this issue elsewhere? Or does the fact that South Asian users are perceived to have additional needs around families and communities highlight that maybe we don't provide the warm, engaging, anonymised, protective and confidential services we like to think we do? Surely being secretly stabilised on a long-term optimumdose maintenance programme is more likely to protect the family name and bring greater fulfilment and success to any individual than the duality of balancing a street smack habit with the expectations and commitments of home life? But is that simple but very effective message getting out there? Are we educating all our communities enough to get this across? Or are we enabling less effective, knee-jerk treatment options to prosper by not effectively communicating or tailoring them to suit and address the unique needs of unique individuals?
"Perhaps only when we begin to talk of the problematic treatment regime, the chaotic bureaucracy, the difficult provider and the hard to access service in equal measures will we be at a point where we can work effectively and constructively against a culture of blame and get a clearer understanding of what we mean by hard to reach"
And what do we do to ensure that, once we've attracted our unique individuals into our services, we have the ability and the wherewithal to retain users in treatment? I remember once talking to a group of Bangladeshi users in Walsall who spoke extensively about the nature of the work ethic in that particular community and the fact that a lot of users work late, long hours as taxi drivers or waiters. How appropriate are early morning appointments going to be for this client group? How inclusive is a supervised consumption scheme if your chemist closes at 12 on a Saturday when you've been working until 6am? Admittedly, these are problems that we encounter on a daily basis with all clients, but we have an additional duty and obligation to ensure culturally sensitive provision under the Race Relations Amendment Act 2000, which places "a duty on specified public authorities to work towards the elimination of unlawful discrimination and promote equality of opportunity and good relations between persons of different racial groups"
One would expect there to be an explicit requirement to address cultural inequalities in DANOS, the Drugs and Alcohol National Occupational Standards which
"specify the standards of performance to which people in the drugs and alcohol field should be working. They also describe the knowledge and skills workers need in order to perform to the required standard."
However, apart from one standard which states workers should "Promote equality and diversity of people" (AA4.2), I couldn't find anything more explicit than that. Perhaps when and if DANOS are reviewed, the whole area of attitudes, motivation and opinions could be included if we are to support our workforces in developing and providing a truly attractive, effective and inclusive service
"Once you've built a trusting, non-judgemental relationship with a client, that's half the battle won"
So what are we going to do to get more underserved groups into our services? Easy - be creative! Take a risk! Be politically brave and prioritise individual outcomes over strategic outputs. Don't just sit in the counselling room or staff room, waiting for users to come to you: get out there, find these groups, identify their needs, build relationships with them and listen. Once you've built a trusting, non-judgemental relationship with a client, that's half the battle won. Let people know you're there for them if they need you, because then, if they really do need you, chances are they won't suddenly be so hard to reach.
Haven't had time to read the new drug strategy? Jim Barnard summarises the main points of the strategy and encourages us to have a closer look. Ed.
Drugs: Protecting families and communities 2008-2018
The new drug strategy was announced on Wednesday 27th Feb 2008. Like the last strategy it is divided into four strands:
- Protecting communities through robust enforcement to tackle drug supply, drug-related crime and anti-social behaviour.
- Preventing harm to children, young people and families affected by drug misuse.
- Delivering new approaches to drug treatment and social reintegration.
- Public information campaigns, communications and community engagement.
In some respects, the strategy is more of the same: continuation of the pooled treatment budget and a continued emphasis on treatment to reduce criminality. However there are specific areas of interest which readers should be aware of (listed below), and we advise readers to read the whole strategy (web link given below).
The strategy re-emphasises the cost benefits of treating drug dependency, this time saying that for every £1.00 spend on treatment £9.50 is saved in health and crime costs. Methadone maintenance is endorsed as effective in reducing harm, mortality and crime. Psychosocial approaches get the thumbs up, specifically: family therapy, mutual aid, community reinforcement and contingency management (when these are paired with pharmacological approaches). Wrap-around services are also endorsed, with the recognition that treatment is most effective when combined with support to tackle any underlying contributory factors such as homelessness.
The strategy recommends the roll out of contingency management, dependant on the findings from the pilots. It does the same thing for injectable heroin and injectable methadone, which again will be rolled out depending on the results from the currently ongoing randomised injectable opioid treatment trial (RIOTT).
There is a major emphasis on the children of drug users and the potential role for primary care in identifying children at risk due to parental drug use. There were specific recommendations encouraging local authorities to make better use of wider kin networks such as grandparents and the need to prevent children falling into caring roles.
There are a number of very significant recommendations for research in the new strategy. Addiction will become one of the four joint priority areas for health research funding, as agreed with the Medical Research Council and the National Institute for Health Research. This will massively increase the potential for research in this field.
Benefit payments and treatment
The headline grabber! It is proposed, albeit vaguely, that drug users will not be able to be signed off from work on the grounds of drug dependency without attending at least an assessment interview with a treatment agency. This could have obvious major implications for GPs. However, it would be interesting to know how many people are signed off sick from work at the moment who are not in treatment.
Major investment is proposed in the Integrated Drug Treatment System, which is to be rolled out across all prisons. Prisoners are to be ensured access to a "minimum standard" of drug treatment. The National Drug Treatment Monitoring System (NDTMS) is to be introduced into prisons via piloting and this could help to ensure better links between prison and community based services (who should be notified when a drug user is released from prison). It is intended that the quality of interventions in the prison estate should be raised across the board and that the skills of the prison and probation workforce should be developed so they can deliver quality drug treatment.
Read the strategy on the Home Office web site
Discuss it on the SMMGP Online Forums
We asked our members for their views on the 2007 Clinical Guidelines. Most felt they will be of benefit for clinicians and for drug treatment, however a number of potential barriers to implementation of the guidelines were identified. Hugo Luck, National Treatment Agency Policy Manager, gives answers to our members' concerns. Ed.
In response to the publication of the 2007 Clinical Guidelines, SMMGP conducted a survey of member opinion. We asked people to give their views on the benefits of the guidelines to the field, and how they thought they would be implemented. The vast majority of members felt they would be of benefit to themselves and the field in general and that it would not be difficult for them to implement the 2007 Clinical Guidelines.
However, when we asked members if they could see any potential barriers to the implementation of the guidelines, over half of our members said yes. We therefore asked Hugo Luck the National Treatment Agency Policy Manager who is overseeing the 2007 Clinical Guidelines implementation process to respond to the potential barriers our members identified.
The new guidelines continue to encourage daily supervised consumption. It is always difficult to persuade clients that supervised consumption is anything other than punitive and they definitely don't seem to see any benefits to it.
It is part of a clinician's responsibility to explain supervised consumption as being necessary for the safety of both the client, and for others. Methadone is a powerful medication, and its effect needs to be carefully monitored in particular in the initial stages of treatment, to ensure that an appropriate dose is reached. The clinician should also explain and encourage the potential benefits to the client of engagement and regular contact with services. Such contact can help to identify and support other problems experienced by the patient.
We won't be doing anything until our local tendering exercise has been completed.
I'm not sure that awaiting the outcome of a tender is the right answer - surely good practice should be adhered to regardless of who holds the contract? A lack of constructive dialogue between commissioners and providers will have an adverse effect upon the services that patients receive. Commissioners should recognise the importance of meaningful needs assessment and commission accordingly. Primary and secondary care providers (management and clinicians) need to take an active part in the commissioning process to ensure that appropriate services are provided which readily adapt to the new guidance and the changing needs of patients.
Barriers include the general lack of specialised training within the pharmacy environment, the stigma surrounding substance misuse and the willingness of pharmacists to involve themselves in supervision of methadone and buprenorphine.
Many undergraduate pharmacy courses now include a substance misuse module, so recently qualified pharmacists will have had some basic substance misuse training which will cover needle exchange, harm minimisation principles and opiate substitution therapy.
For those who qualified before this training was provided, the Centre for Pharmacy Postgraduate Education (CPPE) based at Manchester University (and its counterparts in the other home countries) has produced distance learning programmes for pharmacists and pharmacy technicians which are free for those who are registered.
The NTA guidance "Best practice guidance for commissioners and providers of pharmaceutical services for drug users" recommends that pharmacists are provided with support - for example from a dedicated scheme co-ordinator - and there should be pharmaceutical representation on the shared care monitoring group, or its equivalent. Local scheme coordinators should also ensure that they are providing up to date training to community pharmacies and their staff.
The biggest problem with implementing the guidance in primary care is persuading GPs to see drug use as part of their job. Mostly they are resistant in taking on the care of such patients.
It is true that, under the 2004 GP contract, treating drug misuse is not part of core activities, although GPs still have a responsibility to provide general medical services for drug misusing patients. However, we have seen an increase in the numbers of GPs prescribing to drug misusers under enhanced services.
Indeed, given the increased numbers coming into treatment, it is essential that this trend continues in order to ensure secondary care can concentrate on the treatment and stabilisation of more chaotic patients. The NTA - and local commissioners - are supporting GPs, including; the promotion of the RCGP certificate courses; support for SMMGP; the funding of a special edition of the SMMGP newsletter covering recent clinical guidance; and most recently through the publication of a primary care audit tool to inform the annual treatment planning process.
Being a prison we are limited to the prescribing policies we can follow.
Section 7.3 of the 2007 Clinical Guidelines specifically addresses custodial settings. Though the prescribing and other treatment regimes should broadly follow those of community treatment, there are specific factors that need to be taken into account, as follows.
"Although clinicians should regard drug misuse management in prisons as equivalent to any other setting, there are some particular differences they will need to take into account:
- The lower availability of drugs and alcohol in prisons, leading to intermittent intoxication and unanticipated withdrawal episodes.
- Less injecting behaviour but, where it does occur, potentially much higher risk behaviours due to the scarcity of injecting equipment.
- The high volume and frequency of movement of patients.
- The risk of overdose on release due to diminished opioid tolerance (Ref 1).
- A correlation between drug withdrawal and suicide in the first week of prison custody (Ref 2).
- The high value, relative to the patient's limited income, of drugs.
- Limited continuous access for clinicians to prisoners and therefore difficulty monitoring treatment.
- The particular needs of prisoners in custody for very short periods of time.
These factors have been taken into account in the formulation of prison drug treatment policy."
At the implementation events held around the country during the autumn the NTA has made it clear that all areas should review their service provision in the light of the publication of the 2007 Clinical Guidelines (which reflect the relevant NICE guidance) and plan any required changes accordingly. We have made it very clear that this should include local prisons, as PCTs are the responsible commissioners. Therefore prison treatment staff should contact their local DAT and PCT to ensure that they are included in this process.
There is limited availability of funding for buprenorphine locally ...GPs will only offer methadone as it is cheaper than buprenorphine so client choice is irrelevant.
Commissioners should be aware that methadone and buprenorphine were both recommended for the management of opioid dependence by NICE in its 2007 technology appraisal (TA114). NHS organisations are required to fund and resource technology appraisal recommended medicines. This is a core standard for the NHS as set out in Standards for better health (2004), which states the following.
"Patients achieve health care benefits that meet their individual needs through health care decisions and services based on what assessed research evidence has shown provides effective clinical outcomes."
C5 Health care organisations ensure that:
- they conform to NICE technology appraisals and, where it is available, take into account nationally agreed guidance when planning and delivering treatment and care;
- clinical care and treatment are carried out under supervision and leadership;
- clinicians continuously update skills and techniques relevant to their clinical work; and
- clinicians participate in regular clinical audit and reviews of clinical services. (Ref 3)
For clinicians, these are evidence-based interventions recommended by NICE, and as such they have a professional responsibility to implement them. Therefore PCTs and DATs should be reminded of their obligations under Standards for Better Health and work with providers to ensure that both medications are available.
1. Farrell M and Marsden J (2005) Drug-related Mortality Among Newly Released Offenders 1998-2000. London: Home Office, on-line report 40/05.
2. Shaw J, Appleby L and Baker D (2003), Safer Prisons: A National Study of Prison Suicides 1999-2000 by the National Confidential Inquiry into Suicides and Homicides by People with Mental Illness. London: Department of Health.
The Department of General Practice and Primary Care at the University of Aberdeen is to conduct a survey of Scottish GPs to find out about their attitudes to and current management of drug misusers in primary care. This is a repeat of a survey conducted in 2000. Since then a number of changes have occurred, including the new GP contract, a perceived increase in the misuse of psychostimulant drugs, and the use of buprenorphine maintenance treatment for opioid misuse. There have also been some changes in the resources available to GPs to help in the management of drug misusers, including specialist training in substance misuse through the RCGP, and the updated guidelines by the Department of Health and the Scottish Government (The Orange Guide 2007). Our study will compare data at the two time points to assess if and how GPs' management of drug misuse, and their attitudes to treatments and users, have changed since the last survey.
The previous survey in 2000 found a high level of involvement in management of drug misuse amongst Scottish GPs; 61% of responders said that they were treating illicit drug users. Methadone maintenance was the most common treatment option, but more than 40% of GPs offering this treatment appeared to be prescribing outside the recommended dosage range. Specific training in drug dependency treatment was associated with increased confidence in treatment, and GPs' main concerns about managing drug misusers in their practice were about the safety of their staff, other patients and themselves. We hope to repeat the high response rate of the 2000 study to make this comparison as strong as possible.
For further information, please contact Dr Terry Porteous
Tel: 01224 552 700
Nigel Modern, Martin Wilkinson and Judith Yates reply to a GP who is concerned about the role of ECGs with high dose methadone. Ed.
I have a 37-year-old patient who has finally managed to get his life in order on a dose of 160mg methadone daily. He is a leading light in the local service user group, has moved from supported housing into his own flat and is attending a local college for courses in minute taking and agenda setting.
Now the new Orange Book tells me to "monitor" everyone on over 100mg methadone, in case of prolonged QTc interval and risk of sudden death. I suppose I will need to find a way explain this new threat to my patient (in the part of the 10 minute appointment not taken up in signing his scripts, checking his smoking status for QOF, and admiring his college certificates).
So what is the risk to this patient? How often and in what way do I need to monitor? What is a normal QT interval? Do I need to get baseline checks on all patients who come into treatment? Should I change everybody to buprenorphine?
The first thing to highlight here is that we do need to have a sense of perspective and take action proportionate to the level of evidence which has been published on this subject. There is a risk but the exact level of risk is, as yet, unclear. However torsades de pointes arrhythmia during treatment with methadone would correctly be classed as "rare", whilst death from accidental or deliberate overdose with untreated opiate misuse is much more common. We therefore need to be very careful about restricting the appropriate use of methadone for substitute prescribing, including deciding when a particular individual should reduce or stop their methadone, or transfer to an alternative like buprenorphine, which appears to have considerably less effect on the QTc interval than methadone.
The following guidelines should enable you to select those patients who, for instance, require an ECG.
High dose methadone and torsades de pointes
High dose methadone has been reported to induce torsades High dose methadone has been reported to induce torsades de pointes or prolonged QTc interval associated with sudden death.
Those on high doses of over 100mg should be carefully monitored whilst taking methadone.
Increased risk is associated with:
- Female gender
- Age 35-50
- History of syncope
- Electrolyte imbalance
- Liver abnormalities
- Drugs known to cause QTc prolongation including antihistamines and erythromycin
ECG monitoring is advised for all patients on doses over 150mg. An ECG is probably good practice for those on doses over 100mg with one or more associated risk factors.
The QTc interval is measured from the beginning of the q-wave to the end of the t-wave. A QTc interval of less than 0.42s is normal, and over 0.47s (male) and 0.48s (female) diagnostic of long QTc syndrome.
In practice a QTc interval of over 0.5s (two and a half large ECG squares) is indicative of high risk of sudden death. The QT interval should be corrected for variations in heart rate on ECGs i.e. the QT should be used calculated by the formula "QT interval divided by the square root of the R-R interval in seconds" (Bazett's formula - see Clinical Guidelines 2007, p100). Very fast or very slow rhythms may invalidate this calculation and we suggest if possible you ask for the ECG to be reported on when basing important clinical decisions on the result.
At the time of writing there is systematic coverage of drugs linked to torsades de pointes with grading of likely risk at:
This guideline was produced by Birmingham Drug Misuse GPSIs - updated March 2008 Author: email@example.com. The following were used to inform the guideline:
- Current Problems in Pharmacovigilance 2006;31:1-12.
- Krantz MJ et al. Torsade de pointes associated with very-highdose methadone. Ann Intern Med. 2002 Sep 17;137(6):501-4.
- Department of Health (2007) Drug Misuse and Dependence: UK Guidelines on Clinical Management.
We interpret "careful monitoring" as checking for risk factors in those on greater than 100mg methadone daily and performing an ECG if indicated. Those on more than 150mg methadone daily should, in addition, probably have an ECG done as a matter of course. Nobody so far has suggested pre-assessment of QTc risk on every patient before they commence methadone.
How often their risk needs to be re-assessed is an interesting question; we suggest reassessment during the planning of any subsequent dose increase(s), or if there are any additions to prescribing which might involve QTc prolonging drugs. It would be prudent to follow up in some way people known to have QTc intervals which are borderline, perhaps yearly, but there is no guidance or evidence to aid us in this area.
Perhaps the greatest anxiety in this area is making decisions in individuals for whom bloods for electrolyte and liver tests have been recommended (+/- an ECG) who fail to follow through the plan; this is quite common in the patients we see. A tricky risk analysis then has to be made and sometimes, if someone has repeatedly failed to attend for blood tests and ECG, and if they cannot be done at the surgery the decision may be made that the risks of denying optimal dosing to such a patient, who is likely to be continuing to use street drugs, is likely to be greater than their cardiac risk with the proposed dose increase. These are difficult decisions and they are not taken lightly. An alternative with such individuals might be to use buprenorphine but there are almost certainly going to be practical and patient acceptability issues. We are talking about transfer to buprenorphine from high dose methadone which is difficult and many patients who are liable to continuing illicit use do not want the partial blockade effect of buprenorphine.
The association of methadone with some increased cardiac risk and the probable relative safety of buprenorphine in this respect and in the risk of overdose death may be getting close to tipping the scales in favour of buprenorphine as our first line drug for substitute therapy-but this is a whole separate discussion!
Nigel Hewett provides some advice on how to treat a homeless drug user. Ed.
I have been treating Josh, a 26-year-old man, for a number of years, and I am struggling to keep him in treatment. He has been on methadone, 60mls, for 3 years but I am not sure if his treatment is working for him any longer. Though he has used heroin throughout his time in treatment, his drug use has become more chaotic since his girlfriend asked him to leave five months ago, and tells me he has started to use crack. He has also started to miss appointments, and miss picking up his methadone, and when he does attend he looks dishevelled. At our last appointment he told me he has been sleeping rough for the last two months, and not as I had thought, been staying at a friends. He says the housing department will not offer him accommodation. I am feeling out of my depth, and I am under pressure to take him off our list as he is no longer resident in the practice area. Can you help?
There are a number of ways you can help Josh, not all of which need addressing at his next appointment. The first thing is to reassure him that it is not necessary to have a permanent address in the practice area to remain registered. PCT registration departments cannot usually cope with "No fixed abode" as an address, but they will accept a drop in centre if there is one in the practice area, or "care of" your practice address. You can reassure your partners that this limits your responsibility for providing treatment to within your current practice area, as it is with any other patient.
The next consideration is Josh's safety. If he is not on daily dispensing, then he should go back to it. You can remind him of your practice policy of not replacing lost or stolen prescriptions and explain that daily dispensing will avoid the need to store medication and reduce the risk of him being mugged for his methadone. At the same time you could review his methadone dose. Is his heroin use escalating along with the crack use? He will be even more short of money than previously, so this might be a good time to consider increasing his methadone dose with the aim of reducing his heroin use. Ask about alcohol consumption, for if he is rough sleeping this may be an additional problem. If his alcohol use is problematic consider a period back on supervised consumption - this has the advantage that the pharmacist will review him daily and decline to dispense if he presents intoxicated. Discuss his crack use, is it making him feel better, or is he finding that he doesn't get the same buzz and wonders why he is spending money he doesn't have?
You can help with his homelessness too. You or your drug worker can signpost him to local support agencies, such as homeless drop in centres, the Salvation Army or the YMCA, and they can provide advocacy and advice on local services. Josh needs to try again with the housing department and make a "homeless declaration". At this appointment he needs to convince the housing officer that he is more vulnerable than "an average person" (under the 1996 Housing Act, the local authority is only obliged to provide housing for vulnerable people). A letter from you may help. You should state that you consider him vulnerable because he has a three year history of engaging with a drug treatment programme and now rough sleeping is increasing the risk of additional drug use which will increase health risks including death from overdose.
Finally check again on his vaccination status. If he has previously declined vaccination he may now be at additional risk from hepatitis B due to accidental needle stick injury or sharing kit, and hepatitis A from contaminated food, both of which could be prevented by a rapid course of combined hepatitis A and B vaccine.
Drugs & Alcohol Today
Date: Thursday 1 May 2008
Venue: Business Design Centre, Islington, London
For further information, please contact (0870 890) 1080
10th International Hepatitis C Conference
Date: Tuesday 3 - Wednesday 4 June 2008
For further information, please contact UK Hepatitis C Resource Centre on (0141) 353 6969
Drugs & Alcohol Today
Date: Tuesday 10 June 2008
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SMMGP's 3rd National Primary Care Development Conference
"Primary Care Drug Treatment - End of the line, or part of the journey? How to optimise patient choice and opportunity"
Date: Friday 26 September 2008
Venue: Bristol Mariott Royal Hotel, College Green, Bristol
For further information contact (0207) 604 4826 or e-mail: email@example.com
RCGP Certificate in the Management of Drug Misuse - Part 1
National face-to-face training
Date: 25 September 2008 - Southwark Cathedral, London
Date: 10 November 2008 - RCGP, London
Contact Lorna Boothe at the SMU on (0207) 173 6093 or e-mail firstname.lastname@example.org
Society for the Study of Addiction Annual Symposium 2008
Addiction Across the Life Span, Tracking Processes of Recovery
Date: Thursday 13 and Friday 14 November
Venue: Park Inn, York UK
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