Jean Stubbs

A survey of the off-label use of mood stabilizers in a large psychiatric hospital

The term ‘off-label’ prescribing refers to the use of a drug outside the terms of its Marketing Authorization, including prescribing for an unlicensed indication. The aims of the study were to determine the frequency of off-label prescriptions for mood stabilizers (lithium and antiepileptics) among inpatients of a large psychiatric hospital, the nature of the off-label clinical indications in use and whether patients had been informed about the off-label usage. A cross-sectional survey of inpatients aged 18-65 years at St Andrew’s Hospital, Northampton, UK and interviews with consultant psychiatrists about off-label usage of mood stabilizers were carried out. Of the 249 patients studied, 75 (30.1%) were receiving one or more mood stabilizers, of which 71 (94.7%) were off-label. The most frequently cited off-label indications for mood stabilizers were: prophylaxis of mood swings (48 cases), treatment of aggression (31), manic symptoms (10), antipsychotic augmentation in treatment-resistant schizophrenia (7) and post-traumatic stress disorder (6). Lithium was prescribed infrequently. The reasons for this are discussed. Although in most instances the psychiatrist was aware the drug was being used off-label, in less than one-third of cases had the patient been informed of this, partly because of anticipated difficulties in their understanding the off-label concept, but also because of concerns that this information could adversely affect compliance. The off-label prescription of mood stabilizers is very common in psychiatry and such usage benefits patients. When prescribing off-label, psychiatrists should consider the evidence that the drug is likely to be effective for the unlicensed indication. Where there is limited evidence of benefit, a trial of the drug, with clinical monitoring, may be indicated. Patients should be fully informed about their medication, and this includes information that the prescription is off-label. Pharmacists can assist this process. The off-label concept may be difficult for some patients to understand.

Prescription errors in psychiatry – a multi-centre study

Medication errors are an important cause of patient morbidity and mortality, of which there have been few reports in psychiatry, especially in the UK. Our aim was to examine the nature, frequency and potential severity of prescribing errors in UK mental health units in a prospective, 1 week survey of errors detected by pharmacy staff in nine NHS trusts. Pharmacists checked 22036 prescription items. In total, 523 errors meeting the study definition were detected (2.4% of prescription items checked). Prescription writing errors (77.4%) were most common, while decision-making errors accounted for 22.6% of errors. In 280 (53.5%) cases the prescribed drug had been administered before the error was detected. Most errors were of doubtful or minor importance but 22 (4.3%) were deemed likely to result in serious adverse effects or death. The error detection rate varied fourfold between trusts. Prescribing errors are fairly common in psychiatry. A small proportion of errors have the potential for serious harm. Pharmacy staff have an important role to play in their management.

Benzodiazepines : a necessary evil? A survey of prescribing at a specialist UK psychiatric hospital

Guidelines on the prescription of benzodiazepines recommend their use be limited to the short-term relief of severe anxiety or insomnia. However, clinical experience suggests that in psychiatry these drugs may be being prescribed more widely. The aim of this survey was to investigate benzodiazepine prescribing in a specialist UK psychiatric hospital using a structured interview with consultant psychiatrists. Prescribers were also asked their views on the UK CSM guidance on benzodiazepines (1988). Of 412 inpatients, 77 (18.7%) were receiving 90 benzodiazepine prescriptions for psychiatric indications. Most prescriptions were for anxiety (45/90; 50.0%), aggression (23/90; 25.6%) and agitation (13/90; 14.4%). Use was commonest for acquired brain injury, schizophrenia and personality disorders. Much usage was chronic (only 4/90 (4.4%) prescriptions had been initiated within the previous 4 weeks) and off-label (85/90; 94.4%). Prescribers were concerned about the addictive nature of benzodiazepines for these patients and to a lesser extent about their abuse potential. Most consultants believed the UK CSM guidance was too restrictive in relation to their clinical practice and needed modification to encompass new indications, for example rapid tranquillization, and specialist prescribing. In psychiatry benzodiazepines are quite frequently used in the management of a number of groups of difficult to treat patients. Although largely not evidence based, some psychiatrists report a favourable risk—benefit ratio for benzodiazepines in the treatment of certain patients.

Augmentation with sulpiride for a schizophrenic patient partially responsive to clozapine

Objective: Schizophrenic patients who are only partially responsive to clozapine pose a therapeutic challenge. In these circumstances some clinicians would consider adding in a second antipsychotic. We present a case report and review evidence for the efficacy of such augmentation strategies.

Off-label use of antipsychotics: are we mad?

The off-label prescribing of antipsychotic drugs to psychiatric patients of all ages is very common. Such off-label use is a necessary part of the art of psychiatry but brings with it increased responsibilities for the prescriber as, if the patient suffered an adverse reaction, liability would rest with the prescriber and/or their employers. This article reviews the frequency and nature of the off-label prescribing of antipsychotic drugs for psychiatric indications to children, adults and the elderly. It also reviews the evidence base for doing so in a variety of common, and also some less common, clinical situations. The review is mainly concerned with off-label indications but a short section on high dose antipsychotics is also included. The review concludes that the off-label prescription of antipsychotics frequently lacks the support of robust clinical trials. When prescribing off-label, the prescriber must carry out a careful risk assessment of the risks and benefits for the individual patient. They should also inform the patient that the prescription is off-label.

Medication for borderline personality disorder: A survey at a secure hospital

Abstract Objectives. To study the use of medication in the treatment of inpatients with borderline personality disorder (BPD). To survey clinicians’ views on the UK National Institute for Health and Clinical Excellence (NICE) Guideline on BPD. Methods. Cross-sectional survey of the use of psychotropics purely for BPD at a large secure UK psychiatric hospital, together with interviews with the treating psychiatrists. Results. A total of 79 patients had a DSM diagnosis of BPD, of whom 80% were receiving one or more psychotropics and 48% were receiving two or more. Most prescriptions were off-label. Antipsychotics followed by antidepressants were the most frequent class of drug prescribed for BPD. Clozapine was the most commonly prescribed drug and according to the treating psychiatrists the one most likely to lead to a major improvement in target symptoms. Other psychotropics were generally rated as resulting in minor improvement or no change. Clinicians were aware they were prescribing contrary to NICE but justified this on the basis of having to treat severe and complex cases. Conclusions. Use of psychotropics (especially clozapine), off-label prescribing and polypharmacy were very common in these inpatients with BPD. Randomised controlled trials of the use of clozapine in severe BPD are needed.

Administration of medicines in food and drink: a study of older inpatients with severe mental illness.

BACKGROUND Difficulties in administering medicines to older people are common, and medicines are sometimes mixed with food and drink to aid administration. Little is known about this practice or that of covert administration. This study aims to examine the nature, frequency, safety, reasons for and documentation of the administration of medicines in food and drink. METHODS A cross-sectional survey of mainly older adults, who were inpatients at a U.K. tertiary referral centre, was carried out, and nursing staff and consultant psychiatrists were interviewed. RESULTS Of the 110 patients, 34 (30.9%) were receiving medication mixed with food or drink, although for only 52.9% was the procedure documented in the patients care plan and for 64.7% was it documented on the medication chart. No associated safety issues were identified. The main reasons for this practice were swallowing difficulties (61.8%) and refusal to swallow tablets (47.1%). Thirteen out of 110 (11.8%) patients were receiving covert medication, most commonly antipsychotics and anxiolytics or hypnotics. All were detained and lacked capacity to consent. Most had dementia but a few had chronic schizophrenia. For only 46.2% was covert administration documented in the care plan and for 69.2% on the medication chart. CONCLUSIONS Administration of medication in food or drink and covert medication were common in this group of hospitalized patients with severe mental illness. Before administering medication covertly it is important to discuss the matter with the multidisciplinary team and, where appropriate, with the patients relatives. It is also important to ensure that supporting documentation has been completed in order to avoid medico-legal difficulties.

Pseudoakathisia: A Review and Two Case Reports

Pseudoakathisia is a movement disorder associated with the use of neuroleptic medication. There has been disagreement on the precise nature of the condition and its relation to akathisia. The available literature on pseudoakathisia is reviewed. Two cases of pseudoakathisia are reported that demonstrate the reversibility of the diagnosis of pseudoakathisia.

Antipsychotics for BPSD: an audit of prescribing practice in a specialist psychiatric inpatient unit.

BACKGROUND Antipsychotics are widely used for the treatment of behavioral and psychological symptoms of dementia (BPSD). In the light of the increased risk of cerebrovascular events, many countries have issued guidelines concerning their use in treating BPSD. METHODS We carried out an audit of antipsychotic prescribing practice for inpatients with BPSD at a tertiary referral centre using standards derived from two U.K. dementia guidelines. We collated case note and prescription data and interviewed consultant psychiatrists. RESULTS Of the 60 patients with dementia 50 (83%) had BPSD; of these, 28 (56%) were receiving antipsychotics. Those prescribed antipsychotics were more likely to have severe BPSD and to be aggressive and/or agitated. Audit of the 28 patients receiving antipsychotics for BPSD showed generally satisfactory results but there was room for improvement in case note documentation of off-label usage, screening for risk factors of cerebrovascular disease, consultation with relatives and use of an appropriate starting dose and slow titration of the antipsychotic. CONCLUSION Audit of the use of antipsychotics for BPSD is important given the increased mortality associated with their use. Simple audit tools as used in this study can inform clinical practice. Even at a tertiary referral centre prescribing practice could be improved.

Off-label psychotropic prescribing for young persons in medium security

Psychotropic drug prescribing for children and adolescents is frequently off-label and has increased over time and can be controversial. Psychotropic prescribing in two large UK medium secure units for young people has been studied. A total of 89 patients were included, 64% being aged less than 18 years. A total of 137 of 202 (67.8%) of prescriptions were off-label. The most common reasons for a prescription being off-label were the indication (N = 103) and the patient’s age (N = 41). The main classes of drugs involved were antipsychotics (N = 59), antiepileptics as mood stabilisers (N = 22), anticholinergics and hyoscine (N = 15) and antidepressants (N = 11). Aggression (N = 48) and post-traumatic stress disorder (N = 30) were the most common off-label indications. Some antidepressant prescriptions were contrary to advice of the Committee on Safety of Medicines (CSM). Meta-analyses or randomised controlled trials supported 27% of off-label prescriptions, with lesser quality studies supporting a further 29.2% and expert opinion 38.7%, whereas for 5.1% no evidence could be found. Prescribers tended to over-estimate the level of evidence from clinical trials or extrapolated from findings in adults. They often quoted their own experience rather than expert sources to justify their prescribing practice. It is important that prescribers are fully aware of the quality of experimental data and the risk-benefit ratio when prescribing off-label for young persons. If the evidence base is limited, it is particularly important to provide information about the risks and benefits of the treatment to the patient/relatives. A second opinion may be helpful. Both target symptoms and side effects should be monitored and regularly reviewed.