By Dr Rosie Harding & Dr Elizabeth Peel
According to official statistics, a significant minority of people living with dementia are prescribed antipsychotic drugs. These are used to treat behavioural and psychological symptoms. The 2012 National Dementia and Antipsychotic Prescribing Audit suggests that there has been a fall in the prescription of these medications. However, less than half of GP practices in England participated and thousands of people with dementia are still prescribed antipsychotic drugs each year. What many perhaps don’t know is that only one antipsychotic (Risperidone) has actually been licensed for use in elderly people with dementia. The rest of these drugs are prescribed “off-label”.
Before any drug is prescribed to a patient, unless it’s being used in a clinical trial, it needs to have a marketing authorisation (commonly called a license) from either the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). Before a manufacturer can get a license for a medication, the drug must be extensively tested for both safety and efficacy. But once a license has been granted, prescribers can use the drug to treat any condition, not just those that they have been tested for. This practice is called “off-label” prescribing. So, currently, thousands of people living with dementia are prescribed medication by their doctors that has not been tested for the purpose it is being prescribed. There is no reliable data about its effectiveness, and even more importantly, its safety in this group of vulnerable older people. In our research with 185 family carers of people living with dementia “off-label” prescription of antipsychotics was reported in the majority of instances where their loved ones had been given these drugs. Carers reported that the licensed drug was only given in 21% of cases.
Antipsychotics have a range of side effects, but perhaps most well-known is the risk of over-sedation, which is why they are often described as “zombie drugs” or a “chemical cosh”. Many carers in our research talked about the harmful impact their loved ones had experienced because of these drugs. “It left my dad in a zombie state,” said one daughter. Another woman’s husband was “very much like a zombie because of the antipsychotic drugs”, and a daughter described her mother being left “catatonic”. Carers were very clear about the damage these drugs can do: “I was appalled at the use of anti-psychotic drugs … They are EVIL! … They make people worse not better”.
Clinical trials have shown that these drugs have high rates of ‘placebo effects’, raising serious questions about their effectiveness. Shockingly, it has been known for several years that antipsychotic drugs can be harmful to elderly people with dementia, because they increase the risk of stroke and death. Yet because of the lack of regulation of this form of prescribing, there are essentially no options for legal redress for anyone harmed by off-label prescription. Because antipsychotics are prescription-only drugs, there would be no claim against the seller or the manufacturer. The commonplace nature of these types of prescriptions also rules out a claim of clinical negligence through the operation of the Bolam test, which looks to a ‘respectable body of medical opinion’ to determine the appropriate standard of care.
It is essential to be clear that off-label prescription is an important tool for medical professionals, and can often be very helpful in taking forward new, effective and safe uses of licensed drugs. Prescribing off-label is also important in both paediatric and geriatric medicine, because clinical trials aren’t usually carried out on children or older people. We are not arguing that off-label prescription should be made illegal. Instead, we think that the best way to tackle the use of ineffective and potentially harmful antipsychotics to chemically control people with dementia would be to introduce some regulatory controls on the off-label prescription of pharmaceutical products. This would emphasise the need to warn patients of the risks, including the fact that a prescription is off-label, and provide a framework for documenting both adverse effects and effectiveness. It would help protect vulnerable people, especially those who lack the capacity to consent to treatment. Greater regulation would also provide a route to redress for people harmed by off-label prescriptions, through the duty that healthcare professionals have to warn of the risks of treatment, and could also protect healthcare professionals from liability by providing a record of consent to treatment.
If controls on the off-label prescription of antipsychotics were introduced, then there would be no impact on their prescription for licensed uses, such as schizophrenia and bipolar disorder. There would also be no effect on the use of the one antipsychotic that does have a license that covers behavioural and psychological symptoms of dementia. Controls on off-label prescriptions would also prevent prescribers from simply switching from using antipsychotics to using off-label prescriptions of other mind-altering drugs that are of similarly unproven effectiveness, or have different side effects. There are other benefits from introducing this kind of regulatory process. Other vulnerable patient groups could be protected from potential harms associated with off-label prescription. Medical professionals would still have the flexibility to prescribe off-label where they think this is the best treatment for their patients. Introducing tighter legal controls on off-label prescribing practices could also encourage pharmaceutical companies to carry out the clinical tests necessary to determine the safety of alternate uses of their medications and so increase the licensed treatments available. Finally, it could encourage the development of more effective medications, and save the costs of ineffective and unnecessary off-label prescription.
Dr Elizabeth Peel is a Senior Lecturer in Psychology at Aston University, Birmingham UK, and Ageing Lives lead for the Aston Research Centre for Healthy Ageing (ARCHA). She was awarded a British Academy Mid-Career Fellowship for the ‘Dementia Talking’ project. Dr Rosie Harding is a Senior Lecturer in Law at the University of Birmingham, UK. Her research focuses on how law works in everyday life, from a socio-legal perspective. She is currently developing an interdisciplinary research network of scholars interested in ‘Re-Valuing Care’. Together, they are the authors of “‘He was like a zombie’: Off-label prescription of antipsychotic drugs in dementia” in the The Medical Law Review, which is available to read for free for a limited time.
The Medical Law Review is established as an authoritative source of reference for academics, lawyers, legal and medical practitioners, law students, and anyone interested in healthcare and the law.
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Image credit: Photograph of nurse giving patient medication by kali9 via iStockphoto.
I’m all for clinical trials but at this point, off label prescriptions are the least of our problems when it comes to dementia. Risperidone has a lot of harmful side effects even if it is approved for the condition. Antipsychotics are not that different from each other so this is a non problem. Dementia, by the way, does not affect only older people. And a zombie state is unfortunately sometimes the only option when it comes to violent and compulsive behaviour. Only when you have seen a loved one shivering with fear and in a constant state of terror do you understand that until somebody finds the cure for this horrible condition, all palliative care, zombifying or not, is more than welcome.