ANTIPSYCHOTICS AND INFORMED CONSENT(KEY ETHICAL ISSUE) - MIND CHARITY EXCELLENT PATIENT GUIDE TO THE RISKS OF USE

http://www.mind.org.uk/help/medical_and_alternative_care/making_sense_of_antipsychotics

 Making sense of antipsychotics
This page is for anyone who wants to know about this type of medication. It explains why these drugs may be prescribed, what their effects are (including side effects), who should avoid them, what happens when people want to withdraw from them and what the alternative treatments might be.

    What should I know before taking these drugs?
    What are antipsychotic drugs?
    How does a doctor decide when to prescribe them?
    How do the drugs work?
    How quickly do they act?
    What dosage should I be on?
    What are the side effects?

FOR FULLARTICLE CLICK ON LINK ABOVE
    
What is neuroleptic malignant syndrome?
    What is tardive dyskinesia (TD)?
    What is tardive psychosis?
    Which type of antipsychotic should I be on?
    When shouldn't people take them?
    Why do people take more than one?
    What happens if I am taking other drugs?
    What is rapid tranquillisation?
    How easy is it to come off these drugs?
    Is there an alternative?
    The different types of antipsychotics
    Older antipsychotics
    Atypical antipsychotics
    Antipsychotics through depot injection
    Anti-Parkinson's drugs
    References
    Useful organisations
    Further reading

What should I know before taking these drugs?
Informed consent

The law says that you have the right to make an informed decision about which treatment to have, and whether or not to accept the treatment a doctor suggests. To consent, properly, you need to have enough information to understand the nature, likely effects and risks of the treatment, including its chance of success, and any alternatives to it. Generally, you can only receive treatment that you have specifically agreed to. Once you have given your consent, it isn't final and you can always change your mind. This consent to treatment is fundamental, and treatment given without it can amount to assault and negligence. To find out more about when treatment can be given without consent, see Mind rights guide 3: consent to medical treatment.
Patient information leaflets

If you are prescribed medication as an outpatient, or from your GP, you should find with it an information sheet called a patient information leaflet (PIL), in accordance with a European Union directive. As an inpatient, you may have to ask for it, specifically. The EU directive sets out what information should be included in the leaflet, and in what order. The order in which the information is given has recently changed, to make it more 'user-friendly'. Many PILs will still follow the old pattern until they are revised, but the information they include should be the same:

    both the trade and general (generic) names
    the strength of the medicine and the form it takes; for example, 'each tablet contains 5mg of drug X'
    who it is intended for; for example, adults, children, babies
    the type of medicine it is; for example, an antipsychotic
    what it is licensed to treat; for example, schizophrenia
    things you need to know before taking it, such as conditions which mean you should either not take it at all, or you should take it with caution
    the instructions for taking it: whether by mouth or other route; at what time of day; when to take it in relation to meals (if necessary)
    a list of possible side effects, with an indication of how likely they are to occur
    the expiry date of the drugs and how to store them
    a full list of all the ingredients, including the extra contents that hold it together as a tablet or capsule, such as maize starch, gelatin, cellulose, and colourings. This information is important because some people may be allergic to one or other of the ingredients, such as lactose or gluten or a colouring. Gelatin is unacceptable to some people because it is an animal product.

The final item on the leaflet tells you that it contains only the most important information you need to know about the medicine, and that if you need to know more, you should ask your doctor or your pharmacist.

There is a lot of information to include in the PIL, so it's often printed in very small type, on a piece of paper that is folded many times, which may get thrown away with the packaging, by mistake. If you do not receive this information with your medicine, you should ask for it from the person who makes up your prescription.

Some of the information is quite hard to understand, and the Commission on Human Medicines (formerly the Committee on Safety of Medicines) has been looking at ways of making it easier. They have produced a leaflet Taking medicines - some questions and answers about side effects which you can find on their website or request by telephone, or may be available in your local pharmacy. There is more information on medicines and their use, in the form of Medicines Guides, available from the Medicines Information Project website. (See Useful organisations.)

You should also consider talking to your pharmacist. Pharmacists are drug specialists, and may be more knowledgeable about your drugs than the doctor who prescribes them. They may be more aware of possible side effects, and also possible interactions with other drugs (this is when a drug changes the effect of other drugs you are taking, makes them less effective, or causes additional side effects). Pharmacists are usually very willing to discuss drugs with patients, and some high-street chemists have space set aside where you can talk privately.

Since January 2006 a new scheme has been in place called the 'Medicines Use Review'. People who regularly take more than one prescription medicine, or take medicines for a long-term illness, are encouraged to go to pharmacists who are operating the scheme, for a full discussion of their medicines and any problems they may have with them. The Medicines and Healthcare products Regulatory Agency (MHRA), who are responsible for overseeing the licensing of medicines, have produced a guide to the scheme (see their website under Useful websites).

Many people would like to have the information about their proposed treatment before they are given the prescription for it, and not after they have got it from the pharmacist and taken it home. The following are issues you might like to discuss with your doctor when she or he gives you a prescription for a drug:

    What is the name of the drug, and what is it for?
    How often do I have to take it?
    How long will I have to take it for?
    If I am taking any other drugs, will it be all right to take them together?
    Will I still be able to drive?
    What are the most likely side effects, and what should I do if I get them?
    Do I have to take it at any particular time of day? For example, if it is likely to make me sleepy, can I take it at night rather than in the morning? If it is likely to make me feel sick, can I take it with or after food?
    When I want to stop taking it, am I likely to have any problems with withdrawal?

You may well think of other questions you wish to ask.

If you have troublesome side effects, or withdrawal symptoms when you stop taking your medication, you can report them yourself to the MHRA on their website or their hotline (see Useful organisations), or on a form which you can get from your pharmacy. You no longer need to go through a health professional to do this, although you can if you wish. You can also see a full list of side effects reported on the same website.
 
What are antipsychotic drugs?

Antipsychotic drugs have been in use since the 1950s. They are sometimes prescribed for anxiety, in very low doses, and occasionally for treating physical problems, such as persistent hiccups, problems with balance, and nausea. Often, they are used for dementia. However, they are generally used to help people who are experiencing psychosis, either as a one-off episode or as part of an ongoing illness. Psychosis is a broad term, which covers schizophrenia and manic behaviour, but people may also experience brief episodes during severe depression or a physical illness, or sometimes because of taking street drugs.
 
Psychosis and antipyschotics

People who are psychotic perceive things and interpret events differently from those around them. This may include hearing things, such as voices, seeing something other people don't see (a hallucination) or thinking things that are not based on reality (a delusion). A person may believe, for example, that he or she is under the control of an outside force. (For more information, see Understanding psychotic experiences, How to recognise the early signs of mental distress, Understanding bipolar disorder [manic depression] and Understanding schizophrenia.)

Antipsychotics are often effective in controlling the symptoms of psychosis, and enable many people to return to normal life. They may lessen delusions, hallucinations, incoherent speech and thinking, and reduce confusion. The drugs can control anxiety and serious agitation, make the person feel less threatened, and also reduce violent, disruptive and manic behaviour. However, not everybody finds antipsychotics helpful, and they can't cure the problem. They can also have very serious side effects, which cause major concern to users.

Antipsychotic drugs are standard, routine treatment for people who are experiencing psychosis, and doctors believe that drug treatment should be started as soon as possible. But recent research has raised important questions about whether people might not do better without using these drugs.

Some research suggests that someone with schizophrenia, who remains on antipsychotics for a number of years, may be less likely to relapse than someone who is not taking them. But a paper published in the Journal of Medical Hypotheses in 2004 suggests that resorting to antipsychotics straight away, as a matter of routine, may worsen long-term outcomes, and that a considerable percentage of those treated would do better if they were not given drugs. This paper suggests that people experiencing their first episode of psychosis should not be treated with drugs, and that every person who is taking antipsychotics should be given the opportunity to withdraw from them, gradually. It suggests that this would dramatically improve recovery rates and reduce the numbers of people who become ill in the long term.
 
Other background information on antipsychotics

There are two main types of antipsychotics: the older antipsychotics and the newer atypical antipsychotics.

The older antipsychotics divide, generally, into two chemical groups:

    Low-potency drugs, such as chlorpromazine (Largactil), which are taken in relatively large doses, tend to be very sedating and cause more antimuscarinic side effects.
    High-potency drugs, such as haloperidol (Dozic, Serenace and Haldol), which require lower doses and tend to cause more neuromuscular side effects.

The newer atypical antipsychotics, such as risperidone, don't produce the most disturbing neuromuscular side effects that characterise the older drugs. However they do cause serious metabolic side effects associated with gross weight gain, for which the term 'metabolic syndrome' is increasingly being used. For a listing of antipsychotics licensed in the UK, see below.

Antipsychotics are also known as major tranquillisers or neuroleptics. Calling them major tranquillisers is misleading, because these drugs don't make people feel tranquil.
Although they can cause drowsiness through their sedative action, they may also cause intense restlessness. Neuroleptic is a better term as it means taking control of the nerves, and refers to the effects these drugs have on thought, behaviour and physical movement.
 
How does a doctor decide when to prescribe them?

Your doctor has to weigh up the advantages and disadvantages of treatment. The benefits to you, your family and friends have to be balanced against the disadvantage of unpleasant side effects. Doctors also have to ask themselves what might happen if the drugs were not prescribed. A person with psychotic symptoms may show dangerous behaviour, or such disturbed ideas, that they put their own or other people's lives in danger. This may also place great strain on carers and the people they live with. Some people who experience psychosis cope better with it than others. If you have had frequent psychotic episodes, you may have developed your own coping strategies, which could mean you need to rely less on medication than other people.

People respond differently to medication, and doctors have to decide on each case, individually. When a drug is prescribed, your doctor should take into account any medical conditions you are suffering from. It may mean that a particular drug is not suitable for you, or only in low
 
How do the drugs work?

No one knows precisely how they work. Most of them have a sedative action, and most of them block the effects of dopamine, a chemical neurotransmitter that carries signals between brain cells. This interrupts the flow of messages, which may be too frequent in psychotic states. One specialist at the University of Newcastle has suggested that they work by causing Parkinsonism i.e. producing the psychological symptoms of this disease such as emotional blunting and demotivation, as well as the physical symptoms, which are already well recognised as side effects.

The new atypical drugs work on other brain chemicals as well as dopamine, and have a rather different range of side effects. Clozapine, in particular, may be successful in suppressing psychosis in some people who have not responded to older drugs
 
How quickly do they work?

This depends partly on how you take them, whether orally or by injection. When they are injected into a muscle, the sedative effect is rapid and reaches a peak within an hour. If you take them by mouth, in tablet or in syrup form, the sedative effect usually takes a few hours longer. However, the psychotic symptoms, such as voices, may take days or weeks to suppress. Nobody knows why.
Depot injections

Some drugs are available in an oil-based, slow-release form given by deep injection, known as a 'depot', into a muscle. Depot injections do not have a fast action, and are given every two to six weeks.
 
What dosage should I be on?

The average dose has tended to rise over the years. This is despite the facts that the most effective dose may be quite low; that increasing the dose will probably not make it more effective; and that it may make the side effects worse. Since the advent of the atypical drugs this trend has reversed, and indeed research has suggested that atypical drugs have no advantages over the older drugs, if the older ones are used at the lowest effective dose.

Doses should be kept as low as possible. High doses can have a zombie-like effect, giving you a mask-like expression and strange movements. It can make it very difficult for you to move normally, to get up and get going in the morning, and to take part in normal activities and social events. Moderate to high doses increase the risk of tardive dyskinesia, which is a serious problem causing involuntary movements. Research suggests that low, maintenance doses are as effective in preventing relapse as higher doses. Older people need smaller doses of drugs, and their health is at risk if they are given too high a dose.

You have a right to know what dosage you have been prescribed, and these vary widely. For example, chlorpromazine (Largactil) can be prescribed in tablet form to physically healthy adults in doses ranging from 75mg up to 1g (1000mg) daily. The aim should be to find the dose that lets you lead as normal a life as possible. If the medication is not working, it's important for doctors to reconsider the treatment rather than automatically putting up the dose.

The National Institute for Clinical Excellence (NICE) current guidelines on the treatment of schizophrenia suggest that doctors prescribe antipsychotics at the lowest effective dose, introducing the drugs gradually. They suggest that people should not be given a high starting dose.
 
Maximum dosage

Among other information, the British National Formulary (BNF) gives maximum doses for some, but not all, of the antipsychotics. A list of drugs appears below, and provides this information, whenever possible. Generally, the drugs aren't licensed for use above these dosages, but hospital doctors do exceed them, at their discretion. They may also prescribe medication to be given 'as necessary' (p.r.n.), which can mean in addition to your regular dose. As a result, your total dose could be above the BNF maximum, although your psychiatrist has a duty to review the total dosage, daily.

If you are taking more than one antipsychotic drug, you can work out the dose of each (including p.r.n. prescribing) as a percentage of the maximum recommended in the BNF. Add the percentages together to see if you are taking more than 100 per cent in total. You can also ask your doctor or a pharmacist to help you work this out. The Prescribing Observatory for Mental Health (see Useful organisations) has created a ready reckoner chart for wards to help with this calculation. If you think you are taking too much medication, you can ask your doctor to review it.

If you are worried about your diagnosis and treatment, and unsure about the advice you have been given, you could ask either your GP or psychiatrist to refer you for a second opinion.
 
What are the side effects?

People's sensitivity and response to drugs varies enormously. One person may be able to tolerate standard doses with no significant side effects, while someone else may find the same dose has intolerable results.
 
Neuromuscular effects

Antipsychotics, as a group, have a large number of side effects in common. Because they interfere with dopamine, which is important in controlling movement, many of the side effects are to do with the neuromuscular system. These neuromuscular effects include: Parkinsonism, loss of movement, restlessness and muscle spasms.

Parkinsonism
 
Some side effects resemble Parkinson's disease, which is caused by the loss of dopamine:

    Muscles become stiff and weak, so that your face may lose its animation, and you find fine movement difficult.
    You may develop a slow tremor (shaking), especially in your hands.
    Your fingers may move as if you were rolling a pill.
    When walking, you may lean forward, take small steps, and find it difficult to start and stop.
    Your mouth may hang open and produce excessive saliva.

Loss of movement (akinesia)
You may find it difficult to move, and your muscles may feel very weak. This may be mistaken for a symptom of depression.

Restlessness (akathisia)
 
You may feel intensely restless and unable to sit still. This is more than just a physical restlessness and can make you feel emotionally tense and uneasy, as well. The compulsion to move may be overwhelming. You may rock from foot to foot, shuffle your legs, cross or swing your legs repeatedly, or continuously pace up and down. Nursing staff sometimes misread this as a sign of agitation or anxiety, and may wish to treat it by increasing your dose of antipsychotics. If you are very troubled by akathisia, your doctor may be able to prescribe something to reduce it.

Muscle spasms/dystonia (dysphonia and oculogyric crisis)
 
These are acute muscle contractions that are uncontrolled and may be painful. They particularly affect young men. Sometimes the problem affects the muscles of the larynx (voice box), which makes it difficult to speak normally (dysphonia). It can be socially disabling, but is treatable.

Another form of muscle spasm affects the muscles that control eye movements. Called 'oculogyric crisis', it makes the eyes turn suddenly, so that you can't control where you look. This is very unpleasant and can make it dangerous crossing the road, or pouring hot water, for instance. It's also very disconcerting for people around you.

Such neuromuscular symptoms can be reduced with the sorts of drugs that are prescribed to treat Parkinson's disease (see below for more information on these drugs). These symptoms die down while you are asleep, so if you take the antipsychotics as a single daily dose in the evening, you could avoid the worst of them (as well as avoiding daytime sedation). You may want to discuss this with your doctor to find out whether it would be an option for you.
 
Sexual side effects

Many antipsychotic drugs cause levels of the hormone prolactin to rise, which is related to some very common sexual side effects for both women and men, who may feel embarrassed to talk about them:

    Breast development and the production of breast milk can affect men as well as women.
    A drop in sexual desire can make men and women less easily aroused, and cause impotence and sterility in men. Some drugs can interfere with erection and affect ejaculation.
    Priapism, a persistent erection of the penis without sexual arousal, sometimes results. This is rare, but if it occurs you should treat it as an emergency and seek medical advice, because it may cause serious harm to the penis.
    Spontaneous ejaculation is sometimes a problem.
    Loss of periods, vaginal dryness, unwanted hair and acne may occur in women.
    Osteoporosis (loss of bone density) as a consequence of hormone changes is a serious risk for men and women, and increases the risk of fractures.

Some of the atypical antipsychotics have less effect on prolactin and produce fewer of these problems. Note: women who change from an older antipsychotic to an atypical should bear in mind that this may cause prolactin levels to drop back down.  This may cause their periods to return and they may need to think about contraception.
 
Antimuscarinic or anticholinergic effects

The drugs affect acetylcholine (another chemical messenger) and this may cause drowsiness, dry mouth, blurred vision, dizziness, constipation, feeling sick, difficulty passing water and rapid heartbeat. Constipation may be severe, and should be taken seriously. Low blood pressure can be a problem, especially in older and frail people, and it may contribute to falls; hot baths increase the risk.

Heart rhythm
 
Several antipsychotics have been implicated in sudden deaths. Although these have been investigated, with no clear conclusion, sudden deaths have been linked to high doses of antipsychotics (above the BNF maximum) and to polypharmacy, when people are on several different antipsychotics at the same time. Many of these drugs affect the heart rhythm. The Royal College of Psychiatrists' guidelines suggest that people on high doses of antipsychotics should be given an ECG before treatment starts and every one to three months, while the dose remains high. Whatever your dose, if you have unexplained blackouts, you should have your heart rhythm monitored. Be cautious with grapefruit and grapefruit juice, because it's thought this might increase the impact on heart rhythm.

Sedation
 
Sleepiness is a common side effect with antipsychotics, but some, such as chlorpromazine, are more sedating than others.

Eye problems
 
Various antipsychotics may be responsible for different eye disorders. These include blurred vision and difficulty reading, a build up of granular deposits in the cornea and lens (which doesn't usually affect sight), degeneration of the retina (the light-sensitive part of the eye) that restricts vision and may be serious, an oculogyric crisis (see above), and glaucoma (increased pressure inside the eye). Any antipsychotic can cause narrow-angle glaucoma, which is a medical emergency. You should not take the low-potency antipsychotics if you have had glaucoma.

Weight gain
 
Weight gain is a very common side effect with a number of antipsychotics, including some of the atypical drugs, and causes a lot of distress. It is linked to increased appetite and decreased activity, but is mainly caused by changes in metabolism - the way your body uses food and converts it to energy or stores it as fat. This means that dieting may be of limited use. You may put on a lot of weight, and this may increase your risk of developing diabetes, and other physical health problems.

Metabolic syndrome, including diabetes
Some side effects, associated especially, but not exclusively, with atypical antipsychotics, are linked, and have begun to be referred to as 'metabolic syndrome'. This group of symptoms: weight gain and obesity; high blood sugar; high blood pressure, and high cholesterol, puts people at risk of heart disease, stroke and diabetes. The risk is increased by dietary factors, such as drinking sugary carbonated drinks and eating a lot of fatty, sugary foods. Everyone, especially those with a family history of diabetes, should have their blood glucose monitored while they are taking these drugs. You should also tell your doctor if you have a family history of cardiovascular disease such as high blood pressure or heart attack. Metabolic syndrome is thought to cause a two- to three-fold increase in the risk of death from cardiovascular disease.

Agranulocytosis
 
A number of blood disorders are linked to antipsychotics. The most serious is agranulocytosis, a serious blood disorder, which involves the loss of one type of white blood cell. It reduces resistance to infection and has led to deaths in the past. It's very rare with the older antipsychotics, and is a particular risk of clozapine.

Other physical effects
 
Some people develop blood clots in the veins (thromboembolism), linked to low-potency drugs as well as clozapine.

Liver disorders and jaundice are sometimes linked to using these drugs.

There are various skin problems that may occur. If you get a rash, you should go to the doctor straight away. Any allergic rashes usually occur within the first two months of starting treatment and disappear when the drug is stopped. Some types of skin may develop a blue-grey discoloration. Your skin may become more sensitive to sunlight, especially at high doses, so you should protect your skin from the sun.

You may have problems with regulating body temperature. It may be too high or too low, both of which may make you feel a little unwell.

Another problem that might occur is difficulty urinating.
 
Emotional effects

Antipsychotics can sometimes make people more excited, agitated and aggressive. They can also cause emotional changes, such as depression. Others may have an antidepressant effect, although the available information about this is contradictory. Some drugs cause an emotional unease, making people restless, giving them bizarre dreams and disturbing their sleep. They can make people feel out of touch with reality or strange in familiar surroundings (depersonalised and derealised). It may also cause them to become more withdrawn, socially.