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Journal of Psychiatric Intensive Care

Journal of Psychiatric Intensive Care Vol.9 No.2:7784 doi:10.1017/S1742646412000301 c NAPICU 2012 J

Original Research Article

A survey of the use of emergency parenteral medication at a secure psychiatric hospital

Camilla Haw, Jean Stubbs, Simon Gibbon St Andrews Healthcare, Northampton, UK

Background: The use of additional sedative psychotropic medication to calm agitated or aggressive patients is known as rapid tranquillisation (RT). Several studies of RT practice have been conducted in psychiatric intensive care units (PICUs) and acute psychiatric settings. Method: We carried out a cross-sectional survey of the use of parental sedation in an English secure hospital using data from medication charts and case notes. Results: We studied the medication charts of 316 patients and found 203 incidents (all involving intramuscular route) of parenteral sedation involving just 35 patients. The vast majority (30; 85.7%) of those administered parenteral sedation were female and most (23; 65.7%) had emotionally unstable personality disorder. The most common indication was self-harm (44; 21.7%). In 24 (11.8%) instances the patient had requested an injection. A single drug was administered in 159 (78.3%) cases. The most commonly administered drug was lorazepam (152 cases) followed by haloperidol (69) and olanzapine (21). Case note documentation was frequently inadequate and in very few cases was there evidence of physical monitoring. Conclusions: The use of parenteral sedation was rather different from that previously described in PICUs. Hospital policy and NICE guidance were not always being followed. Measures to rectify these decits are being taken.

Rapid tranquillisation; antipsychotic; benzodiazepine; secure unit; survey

INTRODUCTION Aggressive or violent behaviour is one of the commonest reasons patients are admitted to secure care (Dolan, 2001; Davies & Oldeld, 2009). The short-term management of such
Correspondence to: Dr Camilla Haw, Consultant Psychiatrist, St Andrews Healthcare, Billing Road, Northampton, NN1 5DG. E-mail: First published online 22 November 2012

behaviour focuses on non-pharmacological interventions, such as de-escalation, while the use of restraint, seclusion and sedation are considered treatments of last resort. Rapid tranquillisation (RT), or emergency sedation, has been dened as the use of psychotropic medication to control agitated, threatening or destructive psychotic behaviour (Pereira et al. 2005). The National Institute for Clinical Excellence (2005) adopted a somewhat broader

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denition of RT, namely the use of medication to calm/ lightly sedate the patient, reduce the risk to self and/ or others and achieve an optimal reduction in agitation and aggression. The NICE Guideline also states that the use of as required (prn) and one-off (stat) additional doses of oral psychotropic medicines should be considered as part of RT. The two most common classes of drugs used in RT are benzodiazepines and antipsychotics. Although RT can be a reasonably safe procedure, there are concerns about unwanted side effects of medication, principally dystonia with rst generation antipsychotics and respiratory depression with benzodiazepines. Other dangers of RT include neuroleptic malignant syndrome (NMS), needle stick injuries and injuries to patient and staff during restraint. There is also a small but potentially serious risk with antipsychotics of cardiac dysrhythmias leading to sudden death (Ray et al. 2001).

IM over the IV route on the grounds of safety but did not preclude the use of IV sedation. Surveys of the use of psychotropic medication for RT have focused upon general acute psychiatric wards and psychiatric intensive care units (PICUs; see for example Pilowsky et al. 1992; Brown et al. 2010). We could nd only a small literature on emergency parental sedation for patients in low and medium secure care and decided to carry out a cross-sectional audit at our own hospital in order to review local clinical and risk management protocols around RT. A further rationale for the survey was that RT is, at present, a topical issue.

The primary aims of the study were to survey the nature, timing and frequency with which intramuscular (IM) or intra-venous (IV) sedation was given to male and female patients at a large secure (mixture of medium and low secure Relatively little research has been conducted provision) psychiatric hospital. Secondary aims to establish the preferred drugs and doses for use were to establish the main reasons for adminin RT, although there have been four pragmatic istering such sedation, whether or not the local randomised controlled trials (RCTs) of intra- policy was being adhered to and whether or not muscular medication in real-life violent or there was evidence that patients were being agitated patients, known as the TREC studies monitored after being given sedation. (see for example TREC Collaborative Group, 2003; Alexander et al. 2004). A systematic review of guidelines and phase III RCTs of METHOD medication used for rapid tranquillisation, identied only 20 RCTs and concluded there Setting was a lack of high quality clinical trials available and that no particular medication regime for St Andrews Healthcare, Northampton, is a large RT could denitively be recommended over secure psychiatric hospital caring for patients others (Pratt et al. 2008). Similarly, the NICE of a wide variety of ages, many of whom have Guideline (National Institute for Clinical Excel- complex mental health needs and exhibit lence, 2005) states that there are no conclusive challenging behaviour. Although the hospital is benets in terms of effectiveness of one a charity, almost all patients are funded by the antipsychotic over another, of antipsychotics NHS. The study was conducted among the over benzodiazepines or of combination med- male and female forensic and rehabilitation ications over single medication regimes. The services which comprise a total of 414 beds RT policy of our own hospital that was current (275, 66% male; 139, 34% female) in 26 wards at the time of this study recommended the (11 medium secure, 10 low secure, 3 locked and use of lorazepam 2 mg IM and/or haloperidol 2 open units). At the time of conducting this 510 mg IM or alternatively olanzapine IM. survey there was no psychiatric intensive care No mention was made of the use of sedative unit (PICU). The majority of male patients antihistamines. Prescribers were also advised to suffer from schizophrenia and related psychoses refer to the algorithm for RT in the current while the most common diagnoses for female edition of the Maudsley Prescribing Guidelines. patients are emotionally unstable personality The Hospitals RT policy recommended the disorder followed by schizophrenia. Co-morbidity
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A survey of the use of emergency parenteral medication at a secure psychiatric hospital

of psychiatric disorders is common. Four units cater for older adults; the rest are for patients of working age and ve units are for patients with mild learning disabilities and co-morbid mental disorders and/or challenging behaviour. One 23-bed unit is dedicated to the treatment of female patients with emotionally unstable personality disorder using dialectical behaviour therapy. All medium secure units have seclusion rooms, as do four of the low secure units, but none of the locked or open units have them. Hospital RT policy The hospital policy current at the time of the study dened RT as the emergency administration of IM or IV tranquillising/ sedative medication in order to calm a patient and prevent them from being violent towards self, other people or property. Thus, oral medication was not included in the denition (the policy has since been changed and now includes oral drugs). Medication may be as required or written as a one-off (stat) dose and must be prescribed by a doctor. Following the administration of RT the nurse must sign the administration box on the paper medication chart, complete an electronic RT form (this describes the reason for giving the RT, its timing, the drug(s) given and by whom), make an entry in the patients progress notes and carry out monitoring of vital signs and level of consciousness at intervals as agreed with the doctor but usually every 15 minutes following RT. If the patient is uncooperative with monitoring this should be recorded in the patients notes. Data collection Approval for the study was granted by the hospital audit committee. The wards were visited in November and December 2011. All current medication charts (a chart can contain a maximum of three months of prescriptions) were scrutinised and details of any antipsychotic, anxiolytic or other sedative medication such as promethazine and administered IM or IV (excluding depot antipsychotics) were recorded on a paper data entry form (one form was completed for each injection of sedation administered).
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Consent to treatment forms T2, T3 and Section 62 were checked to see that the sedation had been authorised. (Under the Mental Health Act 1983 (amended in 2007) of England and Wales, detained patients beyond the rst three months of treatment have to have their psychotropic medication authorised on a form T2 or T3. If a patient gives informed consent to treatment a form T2 is completed by their responsible clinician. If they either refuse the treatment or are not capable of consenting then a second opinion appointed doctor authorises the treatment on a form T3. Urgent medical treatment can be authorised on a Section 62.) The auditors also checked to see if there were any physical observation charts recording patients pulse, blood pressure, respiratory rate, level of consciousness and blood oxygen saturation on the ward. Patients electronic notes were examined to check that the administration of sedation had been documented as per hospital policy, whether or not the patient was documented as having been restrained or secluded and whether or not there was evidence of physical monitoring of the patient, including level of consciousness or a statement that the patient was refusing physical monitoring. Basic demographic and clinical details were collected from the case notes on all patients who received IM or IV sedation. Anonymised data were entered into SPSS (2009) and subjected to descriptive analyses. RESULTS A total of 316 medication charts were examined belonging to 195 male and 121 female patients. There were 203 IM but no IV sedative injections recorded as being administered to a total of 35 patients. These 35 patients received a median of four injections (range 123). Ten IM injections (IMIs) were given on the four male admission wards and 145 on the three female admission wards. A further 35 IMIs were administered on a low secure ward for older female patients. The remaining 13 IMIs were spread across a number of rehabilitation wards. No IMIs were given on the two wards for older male patients and none on the ward dedicated to the treatment of female patients with emotionally unstable personality disorder.

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Table 1. Characteristics of patients given parenteral sedation (N 5 35) Patient characteristic

Female gender Security level Medium secure Low secure or locked Legal status Section 3 Restricted Other court sections ICD-10 clinical diagnoses* Emotionally unstable personality disorder Schizophrenia and related psychoses Mild learning disabilities Substance misuse Other personality disorders Other diagnoses Age in years Length of stay at St Andrews in years Number of injections of IM medication
*Some patients had more than one diagnosis

30 25 10 20 11 4 23 11 12 5 4 6 Median 32 (range 1852) Median 0.8 (range 0.26.9) Median 3 (range 124)

(85.7) (71.4) (28.6) (57.1) (31.4) (11.4) (65.7) (31.4) (34.3) (14.3) (11.4) (17.1)

Patient characteristics The characteristics of the 35 patients who received IM sedation are presented in Table 1. Patients were predominantly female, had a primary diagnosis of emotionally unstable personality disorder and tended to be given IM sedation relatively early on in their hospital stay (median duration of stay at St Andrews is currently just over two years). Timing of IM sedation Between Monday and Friday the mean daily number of IMIs was 30.8, whereas at the weekend it was lower at 24.5. As would be expected, almost all IMIs were given during the daytime, the peak time being between 12 noon and 8pm. There was no increase at patient meal times or at nursing handover times. For those patients who received a large number of IMIs there appeared to be some clustering of injections over the course of a number of days. Nature and dosages of drugs administered A single drug was administered in 159 (78.3%) cases. In the remaining 44 (21.7%) instances

Table 2. Details of parenteral sedation administered (N 5 203) Drug(s) administered

Lorazepam Lorazepam1Haloperidol Haloperidol Olanzapine Zuclopenthixol acetate Promethazine

Number of doses
108 44 25 21 4 1

(53.2) (21.7) (12.3) (10.3) (2.0) (0.5)

haloperidol and lorazepam had been administered as separate injections at the same point in time. No drug dosages exceeded the British National Formulary (Joint Formulary Committee, 2011) recommended limits but we did not take into account patients usual regular doses of medication. By far the most frequently administered drug was lorazepam (152 cases), followed by haloperidol (69), olanzapine (21), zuclopenthixol acetate (4) and promethazine (1). Details of the drugs administered are given in Table 2. Only 3 (1.5%) patients had a second injection of sedative medication administered within two hours of the rst dose. In 197 (97.0%) of cases the drug(s) administered were already prescribed in the prn section of the medication chart. In ve (2.5%) cases the doctor
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A survey of the use of emergency parenteral medication at a secure psychiatric hospital

Table 3. Documented indications for parenteral sedation (N 5 203) Indication

No reason documented in case notes Self-harm Violence towards persons Generally disturbed behaviour Threats of violence Agitation Threats of self harm Destruction of property In order to take a blood sample

76 44 28 16 12 12 8 6 1

(37.4) (21.7) (13.8) (7.9) (5.9) (5.9) (3.9) (3.0) (0.5)

authorised by a form T2; and 34 (18.2%) doses were not authorised by the current consent to treatment certicate. A total of 23 (11.3%) doses were given under the provision of Section 62. For ten IMIs no consent to treatment forms were found with the medication charts for the two patients concerned. Interestingly, there were 24 (11.8%) instances (all involving detained female patients) where the patient was recorded as requesting IM sedation. Use of other treatments for therapeutic containment In 83 (40.9%) cases it was documented that the patient was restrained and in 20 (9.9%) cases it was documented that the patient was also secluded. Post-RT monitoring In only 5 (2.5%) cases were readings of pulse, blood pressure and respiratory rate recorded. There was only one instance where a pulse oximeter had been used. In only 2 (1.0%) cases was it documented that the patient refused to be monitored. DISCUSSION In this study of male and female patients at a secure hospital, the administration of IM sedation appeared common among female patients with a diagnosis of emotionally unstable personality disorder, especially those on female medium secure admission wards. A small number of patients received a large number of IMIs. The most common indication for IM sedation was self-harm and a minority of patients even requested an injection. In another study of aggressive incidents conducted in a special hospital, a small number of female patients were responsible for the majority of incidents requiring emergency sedation (Tuddenham & Logan, 2005). This is in contrast to emergency prescribing in general psychiatric hospitals and PICUs where the majority of patients receiving IM sedation are male, have psychosis and are aggressive (Pilowsky et al. 1992; Brown et al. 2010).

came to the ward to prescribe the medication and in one case a doctor gave a verbal message for a drug to be given. Indications for IM sedation In 37.4% of cases there was no documented reason for the IMI (see Table 3). In some of these cases the patient was described as calm or settled prior to the injection of RT medicine. In other cases there was no description of the patients behaviour. The most common reason given was self-harm, followed by violence towards persons and generally disturbed behaviour. Case note documentation For 53 (26.1%) cases there was no case note documentation that an IM dose of medication had been given. In 139 (68.5%) cases there was documentation in the progress notes giving the timing, name, route and dose of the IMI but in only 58 (28.6%) cases was the required rapid tranquillisation event form completed. Consent to treatment status All 35 patients were detained under the Mental Health Act 1983 (amended in 2007) of England and Wales and all but one were beyond the rst three months of treatment on their section. This one patient had received 16 IMIs, which have been excluded from the following analysis as forms T2 and T3 were not yet applicable. Most (94/187; 50.3%) doses of IM sedation were authorised by a form T3; 26 (13.9%) doses were
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Another nding of our study was that the majority of patients given IM sedation were detained on civil as opposed to court sections. This was also the case in a study conducted in a regional secure unit (McLaren et al. 1990). No doses of sedation were given by the IV route (the hospitals RT policy states the IM route is preferred to IV on safety grounds), again in contrast to an older study of emergency prescribing in a general psychiatric hospital where IV sedation was favoured over the IM route (Pilowsky et al. 1992). In a recent study of RT in seven PICUs no sedation was given by the IV route (Brown et al. 2010). This was also a nding in a study of medication given for aggressive incidents in a special hospital (Tuddenham & Logan, 2005), suggesting that clinicians have now abandoned the IV route. There are a number of possible reasons for the move to IM sedation including ease of administration, that nursing staff can administer the drug and on the grounds of safety. In this study, lorazepam 2 mg was the most common sedative administered, sometimes given concurrently with haloperidol 5 mg. Clinicians are known to favour benzodiazepines over antipsychotics for neuroleptic na ve patients, though preferring the combination of an antipsychotic with a benzodiazepine or just an antipsychotic for non-na ve patients (Pereira et al. 2005). Expert opinion favours benzodiazepines as the mainstay of RT (McAllisterWilliams & Ferrier, 2002). The most commonly used antipsychotic was haloperidol, despite the fact that this drug has been found to be poorly tolerated when used for RT (Huf et al. 2007), the summary of product characteristics (SPC) recommends a pre-treatment ECG and the Maudsley Prescribing Guidelines state that IM haloperidol should be the last drug considered for IM RT (Taylor et al. 2012). The use of IM haloperidol is not favoured by other expert opinion (McAllister-Williams & Ferrier, 2002), though the TREC studies found some positive evidence of efcacy (Alexander et al. 2004). The NICE Clinical Guideline on schizophrenia (National Institute for Health and Clinical Excellence, 2009) states that all psychiatric inpatients should have an ECG prior to any

antipsychotic. Only occasional use was made of the second generation antipsychotic, olanzapine, despite its low rate of extra-pyramidal side effects and lack of signicant QTc prolongation (McAllister-Williams & Ferrier, 2002) and no use was made of IM aripiprazole, the other second generation antipsychotic available as a short-acting IM preparation. The limited use of IM olanzapine may relate to its interaction with parenteral benzodiazepines which may result in excessive sedation, cardiorespiratory depression and death. Only one patient received promethazine even though this drug is considered a useful option in patients who are tolerant of benzodiazepines (Taylor et al. 2012), and the fact that this sedative antihistamine is licensed for sedation (see the SPC) for parenteral promethazine, Very few patients received more than one injection of sedation, unlike in previous studies of RT (Pilowsky et al. 1992; Brown et al. 2010). This may be the result of different patient populations in these studies. In our study many patients were female and had a primary diagnosis of borderline personality disorder, in contrast to other studies where male patients with psychosis predominated. In our study, four patients received zuclopenthixol acetate. This preparation is not suitable for RT because its action is not rapid (sedation usually begins to be seen two hours post injection (Taylor et al. 2012)). Very few patients received a second IMI within two hours of the rst. Clearly, it is necessary to allow sufcient time for medication to take effect. The Maudsley Prescribing Guidelines recommend only repeating the IMI after 3060 minutes have elapsed if there is insufcient effect (Taylor et al. 2012). In the current study, case note documentation was minimal and there was negligible documented physical monitoring of patients postIMI, despite the NICE RT guidance. In only a quarter of cases had hospital policy had been followed and an RT event form been completed. Although we did not systematically study the comments of nursing staff about patients behaviour post-injection, in only a small proportion of cases was the patients level of consciousness described. Previous studies of RT have not examined the associated case note documentation. However, in a survey of
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UK consultant psychiatrists concerning the treatment of acute behavioural disturbance, only 9% said they did not routinely perform routine physical observations post RT (Pereira et al. 2005). There are, of course, difculties in attempting to physically monitor patients with aggressive and challenging behaviour. Where patients have been secluded but are still ambulant, nursing staff are placing themselves at risk of assault by entering the seclusion room in order to perform physical observations. However, the assessment of sedation, respiratory rate and general physical status can be done from a distance and does not require nursing staff to enter the seclusion room. We noted in our survey that consent to treatment forms did not always authorise the IMI and sometimes IM sedation was administered under restraint to patients being treated on a form T2. It would seem unlikely that a patient requiring restraint for an IMI could be giving informed consent for a sedative injection. We searched the case notes, including care plans, of these patients to see if they had made an advance statement that they wished to receive IM sedation should they become acutely unwell. However, no such statements could be found. A further problem was that a copy of the consent to treatment form was not always with the medication chart. The above are signicant shortcomings that need to be rectied and re-audited. We found a minority of patients who requested IM sedation rather than receive an oral dose of sedation. In a previous study, conducted in male and female forensic patients at our hospital, some patients commented that the IM route was preferred because of its more rapid onset and greater efcacy and duration of effect (Haw et al. 2011). But is it ethical to administer IM sedation on request? The oral route is to be preferred on the grounds of safety and when a patient suffering from an emotionally unstable personality disorder requests an IMI, administering one could be viewed as feeding their wish to punish themselves. Our study has a number of limitations including its retrospective and cross-sectional
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design which prevented us from carrying out a detailed study of the timing of IM sedation to individual patients over days and weeks. We did not examine concurrent (regular) medicines and doses and so it was not possible to assess if these IM doses pushed the patients total antipsychotic doses beyond a total percentage dose of 100%. A further limitation is that we did not have psychiatric diagnoses for all the inpatients current at the time of the survey and so were unable to make statistical comparisons between those patients who did and those who did not receive IM sedation. We have used the term sedation rather than RT in describing our study. This is because we cannot be sure that all doses met the denition of RT given in the hospitals policy. Some doses might be better described as the giving of prn sedation. We were unable to discriminate between these two scenarios because of the retrospective nature of the study design. In practice RT is not a clear-cut phenomenon, there are differing opinions as to its denition and there is overlap with prn doses. However, it can be argued that all patients receiving parenteral sedation should be physically monitored post-injection regardless of the circumstances leading to the administration of an IMI. We only studied parenteral medication. RT does, of course, include the administration of oral sedation and hospital policy now reects this fact. In conclusion, emergency parenteral medication was administered to a relatively small number of predominantly female patients many of whom were on medium secure wards. Intramuscular lorazepam was the drug given in the majority of cases and rst generation antipsychotics were favoured over second generation ones. Case note documentation of the rationale for administration of sedation and physical health observations after IMI showed room for signicant improvement and not all medication was authorised by consent to treatment forms. Hospital policy was rarely being followed and a worryingly small percentage of patients underwent any physical monitoring after IM sedation. These results have implications for staff training and policy awareness in order to optimise patient safety and compliance with legal requirements. Our hospital is now running

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Safe Medicines Administration courses for nursing staff, there is a regular audit of compliance with consent to treatment documentation and there are plans for pharmacists to hold training sessions on RT for all clinical staff, particularly on those wards where IM sedation is used frequently. We plan to repeat the audit at a later date to see if documentation has improved. References
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