DEPOT ANTIPSYCHOTIC MEDICATION: GUIDELINES FOR PRESCRIBING AND ADMINISTERING

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1 DEPOT ANTIPSYCHOTIC MEDICATION: GUIDELINES FOR PRESCRIBING AND ADMINISTERING DECEMBER 2016 This policy supersedes all previous policies

2 Policy title Depot Antipsychotic Medication: Guidelines for Prescribing and Administration Policy PHA04 reference Policy category Clinical Relevant to All Clinical staff Date published 2016 Implementation December 2016 date Date last December 2016 reviewed Next review December 2018 date Policy lead Lucy Reeves, Chief Pharmacist Contact details Accountable director Approved by (Group): Approved by (Committee): Document history Membership of the policy development/ review team Consultation Dr Vincent Kirchner, Medical Director Drugs and Therapeutic Committee December 2016 Quality Committee Date Version Summary of amendments March Routine review April Routine review March Routine review Nov Routine review Dec Audrey Coker, Lead Pharmacist for Clinical Services. Drug and Therapeutic Committee members Route of aripiprazole depot updated to include deltoid. Paliperidone three monthly depot is added. Olanzapine depot monitoring advice updated. Administration of depots under restraint added. DO NOT AMEND THIS DOCUMENT Further copies of this document can be found on the Foundation Trust intranet. I DEPOT ANTIPSYCHOTIC MEDICATION GUIDELINES_PRESCRIBING_ADMINSTRATION_PHA04_DEC 2016

3 Contents Page 1 Introduction 1 2 Aims and objectives 1 3 Scope of the policy 1 4 Prior to initiation of depot treatment 1 5 Advice on prescribing depot antipsychotics 2 6 Use of unlicensed doses 17 7 Administration of depot antipsychotic medication 17 8 Use of alternative sites or sites which are off-label 19 9 Depots/LAIs administered under restraint Generic names/brand names Management of patients on long term depot antipsychotics in relapse prevention Intramuscular anticholinergic medication Primary care involvement Zuclopenthixol acetate (Clopixol acuphase) Related policies Dissemination and implementation arrangements Training requirements Monitoring and audit arrangements Review of the policy References 23 Appendix 1: High Dose Antipsychotic Treatment monitoring form 25 Appendix 2: Equivalent doses of antipsychotics 27 Appendix 3: Sites Of Administration 28 Appendix 4: Equality Impact Assessment Form 29 II DEPOT ANTIPSYCHOTIC MEDICATION GUIDELINES_PRESCRIBING_ADMINSTRATION_PHA04_DEC 2016

4 1 Introduction Antipsychotic depot / long acting injections (LAI) preparations are used for maintenance therapy in the treatment of schizophrenia, especially when adherence with oral treatment is unreliable. 2 Aims and objectives To provide guidance on prescribing antipsychotic depot/long-acting injections (LAIs). 3 Scope of the policy This policy is aimed at all clinical staff who are directly involved in the management of patients who are prescribed depot/lai antipsychotic preparations. 4 Prior to initiation of depot treatment Depot preparations should be a treatment option where a service user expresses a preference for such treatment after an acute episode because of its convenience, or as part of a treatment plan in which the avoidance of covert non-adherence (intentional or unintentional) with antipsychotic medication is a clinical priority Following full discussion between the responsible clinician and the service user, the decision to initiate depot antipsychotic injections must take into account the preferences and attitudes of the service user towards the mode of administration and organisational procedures (for example; home visits and location of clinics) related to the delivery of regular intramuscular injections As with oral antipsychotics, service users receiving depots must be maintained under regular clinical review, particularly in relation to the risks and benefits of the medication regimen. 5 Advice on prescribing depot antipsychotics 5.1 Choice of depot antipsychotic The choice of depot medication is determined by the needs of the individual service user. There are few differences between individual older long-acting antipsychotics. Fluphenazine may be associated with relatively more extrapyramidal side effects but perhaps less weight gain. Flupenthixol, halopepridol and fluphenazine are considered equally effective. Zuclopenthixol may be more effective in preventing relapses than others, although this may be at the expense at the increased burden of side effects. Flupenthixol decanoate can be given in very much higher neuroleptic equivalent doses than the other depot antipsychotics and still remain within BNF limits, although it is doubtful that this confers any real therapeutic advantage 2. The typical depot antipsychotics should be considered first-line. 18 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

5 5.1.2 These medicines are long-acting preparations. Therefore service users should be exposed to the oral form of the medicine (or a test dose of the injection) prior to their first full dose of the injection to minimise the possibility of a longlasting idiosyncratic reaction. Patients must be offered a patient information leaflet from the Choice and Medication website located on the intranet. 5.2 Dosages - First generation long-acting antipsychotic injections For first generation long-acting antipsychotics, a test dose must be given. This is a test of the sensitivity or extrapyramidal side effects and any sensitivity of the base oil 2. The allergy status for the medicines and base oil (e.g. sesame oil, vegetable oil derived from coconuts) or excipients e.g. benzyl alcohol must be checked and documented in Electronic patient record (Carenotes) Begin with the lowest therapeutic dose. There is some information that low doses are at least as effective as higher doses. Low doses are likely to be better tolerated See table 1 for when the next dose should be administered Oral antipsychotics may also be prescribed initially. These should be gradually reduced and stopped once therapeutic maintenance dose has been established. If the total dosage exceeds BNF limits, the trust High Dose Antipsychotic Therapy guidelines must be implemented (see appendix 1) The depot should be administered at the longest possible licensed interval, bearing in mind the maximum recommended single dose. There is no evidence to suggest that shortening the dose interval improves efficacy. Injections are painful, so less frequent administration is desirable The observation that some patients deteriorate in the days before the next dose is due is not supported by fact. For some hours to days (with some preparations), plasma levels of antipsychotics continue to fall, albeit slowly after the next injection. Thus patients are most at risk of deterioration immediately after a long-acting injection and not before it. In most trials, relapse occurs only three to six month after withdrawing therapy. This is roughly the time to clear steady state long-acting medicines from the blood Doses should be adjusted after an adequate period of assessment. Attainment of peak plasma levels, therapeutic effect and steady-state plasma levels are delayed with the long-acting injections 1. Attainment of steady state usually takes three months for first-generation antipsychotic depots 3. Doses may be reduced if adverse effects occur, but should only be increased after careful assessment over at least one month, preferably longer When swapping from one first generation antipsychotic depot to another first generation antipsychotic depot, a direct exchange from one depot to another can usually be made 3. If the person has not previously had the new depot, ensure tolerability is checked first with a test dose When swapping from a combination of oral antipsychotics plus depot to a depot alone, relapses are more likely in the first three to four months. If the risk of 19 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

6 relapse is high, consider increasing the depot dose and then reduce the oral doses later When swapping from a first generation antipsychotic depot to another antipsychotic, stop the depot and introduce the new antipsychotic when the next depot date is due, remembering that a slow decay of depot plasma levels may occur. So be aware of adding the new medicine too quickly 3. Table : Medicine Test dose Dose range Interval First generation long-acting antipsychotics Fluphenazine in sesame oil Flupenthixol in thin vegetable oil (derived from coconuts) Haloperidol in sesame oil Zuclopenthixol in thin vegetable oil (derived from coconuts) 12.5mg (6.25mg in patients over 60 years) 20mg (consider 5-10mg in elderly patients) 50mg every four weeks ( mg every four weeks in elderly patients) 100mg (consider 25-50mg in elderly patients) Second generation long-acting antipsychotics Aripiprazole (powder None. Response & tolerability and solvent for to oral aripiprazole must be prolonged release checked prior to initiating the suspension) depot. Olanzapine (powder and solvent for prolonged release suspension) Paliperidone LA (prolonged release suspension) Paliperidone three monthly (prolonged release suspension) (Trevicta) Risperidone (powder and solvent for prolonged release suspension) None. Tolerability to oral olanzapine must be checked prior to initiating the depot. None. Response and tolerability to oral risperidone must be checked prior to initiating the depot. None. Stabilisation with paliperidone monthly depot for at least four months must have preceded initiation None. Response and tolerability to oral risperidone must be checked prior to initiating the depot mg every two to five weeks 50 every four weeks - 400mg/week mg every four weeks mg every one to four weeks. Maximum: 600mg every week mg/month 150mg every two weeks to 405mg every month mg/month mg/ three months 25-50mg/2weeks Reasonable steady state is achieved at intervals of two to four weeks Weekly to four weekly Four weekly Weekly to four weekly Four weekly Two to four weekly Four weekly Three monthly Two weekly 20 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

7 5.3 Dosages - second generation long-acting antipsychotic injection Second generation long-acting antipsychotic injections have a relatively lower propensity for extrapyramidal side effects Second-generation long-acting antipsychotic injections do not require test doses 2. Patients to be prescribed risperidone injection or paliperidone monthly depot must be prescribed oral risperidone first to check for tolerability and response to treatment. Patients prescribed paliperidone three monthly depot must be preceded by paliperidone monthly preparation. Patients prescribed aripiprazole or olanzapine depot must be prescribed the respective oral formulation first to check tolerability and response to treatment Risperidone long acting injection A test dose is not required, however response and tolerability to oral risperidone must be confirmed before starting the depot formulation. See table The recommended dose is 25 mg intramuscularly every two weeks. For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered. Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg, while patients treated with higher oral doses should be considered for the higher dose of 37.5 mg. Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first injection. Where patients are not currently taking oral risperidone, the recommended dose is risperidone injection 25mg every two weeks In the elderly, no dose adjustment is required from the recommendation in However there have been anecdotal cases of reduced mobility Deltoid and gluteal intramuscular injections at the same doses are bioequivalent and, therefore, interchangeable After a single intramuscular injection with risperidone injection, the release profile consists of a small initial release of risperidone (<1% of the dose), followed by a lag time of 3 weeks. The main release of risperidone starts from Week 3 onwards, is maintained from 4 to 6 weeks, and subsides by Week 7. Oral antipsychotic coverage should therefore be given during the first 3 weeks of treatment. Oral antipsychotic supplementation on a reducing titration is sometimes required for longer (6-8 weeks) 2, The depot must be administered every two weeks as the pharmacokinetic profile does not allow for longer intervals Opinions on the dose equivalence vary depending on the reference used. Doses of 25-50mg every 2 weeks may equate to oral doses of 1-4mg/day 2, It must be stored in the fridge. 21 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

8 5.4.9 Risperidone injection must be administered every two weeks by deep intramuscular deltoid or gluteal injection. Only needles supplied with the packs should be used. For deltoid administration, use the 1-inch needle alternating injections between the two arms. For gluteal administration, use the 2-inch needle alternating injections between the two buttocks Switching to risperidone long-acting injection 2, 3, 12 Table 2: Switching to or from risperidone long-acting injection Switching from No treatment (new patient or recently nonadherent). Starting risperidone injection Oral risperidone to risperidone injection Oral antipsychotics (not risperidone) to risperidone injection Depot antipsychotic to risperidone injection Recommended method of switching Start risperidone oral at 2mg/day and titrate to effective dose. If tolerated, prescribe equivalent dose of risperidone long-acting injection. Oral risperidone should be continued for at least three weeks, then taper over one to two weeks. Be prepared to continue oral risperidone for longer. For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered. Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg risperidone injection, while patients treated with higher oral doses should be considered for the higher dose of 37.5 mg. Where patients are not currently taking oral risperidone, the oral pretreatment dosage should be considered when choosing the i.m. starting dose. Either:- Switch to oral risperidone and titrate to effective dose. If tolerated, prescribe equivalent dose of risperidone long-acting injection. Oral risperidone should be continued for at least three weeks, then taper over one to two weeks. Be prepared to continue oral risperidone for longer. Or:- Check tolerability and response to oral risperidone if possible. Give risperidone long-acting injection, then the oral antipsychotics should be slowly tapered three to four weeks later. Be prepared to continue oral antipsychotics for longer. Check tolerability to oral risperidone first with one dose if possible. Risperidone long-acting injection should be given one week before the last dose of the previous depot injection 2. Consider Comments Use oral risperidone before giving injection to assure good tolerability. Those stabilised on 2mg/day should be started on 25mg every two weeks. Those on higher doses, start on 37.5mg every 2 weeks. Be prepared to use 50mg every 2 weeks. See above. Broadly speaking for those of low doses, start at 25mg every two weeks, then adjust as necessary. If the patient was previously maintained on doses of middle or upper range of licensed doses, start at 37.5mg or 50mg every two weeks. The continued needs for oral antipsychotics after three to four weeks may indicate higher doses or risperidone longacting injection are required. For those of low doses, start at 25mg every two weeks, then adjust as necessary. If the patient was previously maintained on doses of middle or 22 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

9 Antipsychotic polypharmacy with depot to risperidone injection supplementation with an oral medicine if the risk of relapse is high 3. Or Check tolerability to oral risperidone first with one dose if possible. Switch on the depot due date, supplementing with oral risperidone for three to four weeks 3. Check tolerability to oral risperidone first with one dose if possible. Risperidone long-acting injection should be given one week before the last dose of the previous depot injection. The oral antipsychotics should be slowly tapered three to four weeks later. Be prepared to continue oral antipsychotics for longer. upper range of licensed doses, start at 37.5mg every two weeks. Be prepared to increase to 50mg every two weeks. Aim to treat the patient with risperidone long-acting injection as the sole antipsychotic. The dose should be dictated as far as possible by the total dose or oral and injectable antipsychotic. Risperidone injection to others The last dose of risperidone injection will finally stop releasing risperidone about six weeks later, so wait until then and introduce the new antipsychotic gradually from day Table 3: Approximate dose equivalence of risperidone to paliperidone 2 Risperidone oral (mg/day) Paliperidone oral (mg/day) Risperidone LAI (mg/two weeks) Paliperidone LAI (mg/month) Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

10 5.5 Paliperidone long acting injection Paliperidone LAI is restricted to consultant initiation only within the Trust. A nonformulary form must be completed for the specific patient by the consultant before starting treatment (see the trust formulary). Pharmacy will monitor prescribing to ensure it is appropriate and within the Trust formulary specifications Tolerability and response to risperidone must be established (oral or LAI) before considering prescribing paliperidone LAI There are two methods of initiating paliperidone LAI, depending on if the patient is prescribed risperidone tablets or injection. See Table 4 and 5. It has a nanocrystal technology formulation allowing both an early and sustained release Paliperidone LAI should be administered every calender month. Only needles supplied with the pack should be used. It is stored at room temperature Table 4 11 : Switch from oral risperidone Days Dose Day 1 150mg (deltoid muscle) Day 8 100mg (deltoid muscle) Day 36 75mg which may be adjusted thereafter between mg once every calender month). (deltoid or gluteal muscles). Table 5 11 : Switch from risperidone injection Dose of Risperidone LAI Dose of Paliperidone LAI 25mg every two weeks 50mg every month 37.5mg every two weeks 75mg every month 50mg every two weeks 100mg every month 24 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

11 Table 6: Switching to and from paliperidone palmitate 2 Switching from No treatment, starting paliperidone LAI Paliperidone /Risperidone to paliperidone LAI Oral antipsychotics to paliperidone LAI Depot antipsychotic Antipsychotic polypharmacy with depot Paliperidone LAI to oral antipsychotic Recommended method of switching Check tolerability and response to oral risperidone first. Give the two initiation doses, 150mg IM deltoid on day 1, 100mg IM deltoid on day 8. Maintenance dose starts one month later (Day 36). Give the two initiation doses, followed by the maintenance dose (see table 3 and prescribe equivalent dose). Check tolerability to oral risperidone first with one dose if possible. Reduce the dose of the oral antipsychotic over one to two weeks, following the first injection of paliperidone. Give the two initiation doses followed by the maintenance dose. Check tolerability to oral risperidone first with one dose if possible. Start paliperidone LAI (at the maintenance dose) when the next injection is due. No initiation doses are required 2. Go straight to monthly 3. Check tolerability to oral risperidone first with one dose if possible. Start paliperidone LAI (at the maintenance dose) when the next injection is due. No initation doses are required. Reduce the dose of the oral antipsychotic cover over one to two weeks, following the first injection of paliperidone. Start the oral antipsychotic when the next injection is due, but titrate slowly as paliperidone levels can persist for six months. Comments The lowest most effective maintenance dose should be used. The manufacturer recommends a dose of 75mg monthly for the general adult population. This is approximately equivalent to 3mg/day oral risperidone (see table 5).Maintenance dose adjustments should be made monthly. The full effect of the dose adjustment may not be apparent for several months. Oral paliperidone/risperidone supplementation during initiation is not necessary. The manufacturer recommends a dose of 75mg monthly for the general adult population. If switching from risperidone injection, see table 5 and prescribe the equivalent dose..maintenance dose adjustments should be made monthly. The full effect of the dose adjustment may not be apparent for several months. Aim to treat the patient with paliperidone long-acting injection as the sole antipsychotic. The maintenance dose should be dictated as far as possible by the total dose or oral and injectable antipsychotic 25 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

12 Paliperidone LAI to risperidone LAI Paliperidone LAI to another depot Others to paliperidone LAI Start risperidone injection when the next depot dose is due 3. Start the new depot slowly to avoid additive ADRs and NMS as paliperidone levels can persist for up to six months 3. Oral antipsychotics can be stopped over one week except olanzapine, quetiapine and clozapine which need to be stopped over four weeks to minimise insomnia and cholinergic rebound Elderly population Efficacy and safety in elderly > 65 years have not been established. In general, recommended dosing of paliperidone LAI for elderly patients with normal renal function is the same as for younger adult patients with normal renal function. However, because elderly patients may have diminished renal function, dose adjustment may be necessary Renal impairment Paliperidone LAI has not been systematically studied in patients with renal impairment. For patients with mild renal impairment (creatinine clearance 50 to < 80 ml/min), recommended initiation of paliperidone LAI is with a dose of 100 mg on treatment day 1 and 75 mg one week later, both administered in the deltoid muscle. The recommended monthly maintenance dose is 50 mg with a range of 25 to 100 mg based on patient tolerability and/or efficacy. Paliperidone LAI is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) Avoiding missed doses It is recommended that the second initiation dose of paliperidone LAI be given one week after the first dose. To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week (day 8) time point. Similarly, the third and subsequent injections after the initiation regimen are recommended to be given monthly. To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point. If the target date for the second injection (day 8 ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient's first injection Missed second initiation dose (< 4 weeks from first injection) If less than 4 weeks have elapsed since the first injection, then the patient should be administered the second injection of 100 mg in the deltoid muscle as 26 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

13 soon as possible. A third injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection). The normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy should be followed thereafter Missed second initiation dose (4-7 weeks from first injection) If 4 to 7 weeks have elapsed since the first injection, resume dosing with two injections of 100 mg in the following manner: a deltoid injection as soon as possible, another deltoid injection one week later, resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy Missed second initiation dose (> 7 weeks from first injection) If more than 7 weeks have elapsed since the first injection, initiate dosing as described for the initial recommended initiation of paliperidone LAI above Missed monthly maintenance dose (1 month to 6 weeks) After initiation, the recommended injection cycle of paliperidone depot is monthly. If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals Missed monthly maintenance dose (> 6 weeks to 6 months) If more than 6 weeks have elapsed since the last injection of paliperidone LAI, the recommendation is as follows: For patients stabilised with doses of 25 to 100 mg: a deltoid injection as soon as possible at the same dose the patient was previously stabilised on another deltoid injection (same dose) one week later (day 8) resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy For patients stabilised with 150 mg: a deltoid injection as soon as possible at the 100 mg dose another deltoid injection one week later (day 8) at the 100 mg dose 27 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

14 resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy Missed monthly maintenance dose (> 6 months). If more than 6 months have elapsed since the last injection of paliepridone depot, initiate dosing as described for the initial recommended initiation of paliperidone LAI Sites of administration Deltoid muscle administration The recommended needle size for initial and maintenance administration of the depot into the deltoid muscle is determined by the patient's weight. For those 90 kg, the 1½ inch, 22 gauge needle (38.1 mm x 0.72 mm) is recommended. For those < 90 kg, the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) is recommended. Deltoid injections should be alternated between the two deltoid muscles. Gluteal muscle administration The recommended needle size for maintenance administration of the depot into the gluteal muscle is the 1½-inch, 22 gauge needle (38.1 mm x 0.72 mm). Administration should be made into the upper-outer quadrant of the gluteal area. Gluteal injections should be alternated between the two gluteal muscles. 5.6 Paliperidone three monthly long-acting injection (Trevicta) Paliperidone three monthly depot, is indicated for the maintenance treatment of schizophrenia in adults who are clinically stable on one monthly paliperidone LAI. Patients who are adequately treated for four months or more and do not require dose adjustment may be switched to paliperidone three monthly depot. It is restricted in the formulary, to be requested via the non-formulary route, and should be reserved for service users that are non-compliant with monthly administration and susceptible to relapse Paliperidone three monthly depot must be initiated in place of the next scheduled dose of 1-monthly paliperidone LAI (± 7 days). The dose equivalence is per table 7. Table 7: Paliperidone three monthly depot doses for patients adequately treated with one monthly paliperidone palmitate depot Last dose of one monthly paliperidone palmitate depot 50 mg 175 mg 75 mg 263 mg 100 mg 350 mg Initiate paliperidone three monthly depot at the following dose 150 mg 525 mg There is no equivalent dose for the 25 mg dose of paliperidone montlhy depot Paliperidone three monthly depot must be administered by intramuscular injection once every 3 months (± 2 weeks). If needed, dose adjustment can be made every 3 months in increments within the licensed range, but onset of action may take several months. 28 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

15 5.6.4 If paliperidone three monthly depot is discontinued, its prolonged activity must be considered. Table 8: Doses of one monthly paliperidone palmitate injectable for patients switching from paliperidone three monthly depot If the last dose of paliperidone palmitate is 175 mg 50 mg 263 mg 75 mg 350 mg 100 mg 525 mg 150 mg Initiate 1-monthly paliperidone palmitate injectable 3 months later at the following dose To avoid a missed dose of the depot, patients may be given the injection up to 2 weeks before or after the 3-month time point. Table 9: Missed doses If scheduled dose is missed and the time since last injection is Action > 3½ months up to 4 months The injection should be administered as soon as possible and then resume the 3-monthly injection schedule. 4 months to 9 months See table 10. > 9 months Re-initiate treatment with the monthly paliperidone LAI. The three monthly depot can then be resumed after the patient has been adequately treated with 1-monthly paliperidone palmitate depot for at least four months. Table 10: Recommended re-initiation regimen after missing 4 months to 9 months of paliperidone palmitate three monthly depot If the last dose of paliperidone three monthly depot was Administer 1-monthly paliperidone palmitate injectable, two doses one week apart (into deltoid muscle) Then administer 3- monthly paliperidone LAI Day 1 Day 8 1 month after day mg 50 mg 50 mg 175 mg 263 mg 75 mg 75 mg 263 mg 350 mg 100 mg 100 mg 350 mg 525 mg 100 mg 100 mg 525 mg In general, recommended dosing of paliperidone three monthly depot for elderly patients with normal renal function is the same as for younger adult patients with normal renal function For patients with mild renal impairment (creatinine clearance 50 to < 80 ml/min), dose should be adjusted and the patient stabilised using the monthly paliperidone depot, and then changed to the three monthly depot. It is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min). 29 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

16 5.6.8 No dose adjustment is required in patients with mild or moderate hepatic impairment. Caution is recommended in such patients with severe hepatic impairment Paliperidone three montlhy depot must be administered using only the thin wall needles that are provided in the pack. Needles from the monthly paliperidone LAI pack or other needles must not be used Sites of administration Deltoid muscle administration For those 90 kg, the thin wall 1½ inch, 22 gauge (0.72 mm x 38.1 mm) needle must be used. For those < 90 kg, the thin wall 1 inch, 22 gauge (0.72 mm x 25.4 mm) needle must be used. It should be administered into the centre of the deltoid muscle. Deltoid injections must be alternated between the two deltoid muscles. Gluteal muscle administration The needle to be used for administration into the gluteal muscle is the thin wall 1½ inch, 22 gauge (0.72 mm x 38.1 mm) needle regardless of body weight. It must be administered into the upper-outer quadrant of the gluteal muscle. Gluteal injections must be alternated between the two gluteal muscles. 5.7 Aripiprazole long acting injection For patients who have never taken aripiprazole, tolerability and response with oral aripiprazole must occur prior to initiating treatment with aripiprazole depot. The recommended starting and maintenance dose is 400 mg. Titration is not required. It should be administered once monthly as a single injection (no sooner than twenty-six days after the previous injection). After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for fourteen consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy (after which it should be stopped). If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered Aripiprazole depot is restricted in the formulary and can be requested via the non-formulary route (see the trust formulary) Aripiprazole depot should administered in the gluteal or deltoid muscle The safety and efficacy of aripiprazole depot in the treatment of schizophrenia in patients 65 years of age or older has not been established. 30 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

17 5.7.5 Missed doses Table 11 9 : Missed doses If 2 nd or 3 rd dose is missed and time since last injection is: Action > 4 weeks and < 5 weeks The injection should be administered as soon as possible and then resume monthly injection schedule. > 5 weeks Concomitant oral aripiprazole should be restarted for 14 days with next administered injection and then resume monthly injection schedule. If 4 th or later doses are missed & time since last injection is: Action > 4 weeks and < 6 weeks The injection should be administered as soon as possible and then resume monthly injection schedule. > 6 weeks Concomitant oral aripiprazole should be restarted for 14 days with next administered injection and then resume monthly injection schedule Dose adjustments of aripiprazole depot in patients who are taking concomitant strong CYP2D6 inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than fourteen days. Table 12: Dose adjustments 9 Patients taking 400 mg of aripiprazole depot Strong CYP2D6 or strong CYP3A4 inhibitors Strong CYP2D6 and strong CYP3A4 inhibitors CYP3A4 inducers Patients taking 300 mg of aripiprazole depot Strong CYP2D6 or strong CYP3A4 inhibitors Strong CYP2D6 and strong CYP3A4 inhibitors CYP3A4 inducers Adjusted dose 300 mg 200 mg Avoid use 200 mg 160 mg Avoid use Table 13: Examples of interacting medicines 9 : Strong CYP2D6 Strong CYP3A4 inhibitors Strong CYP3A4 inducers inhibitors Quinidine Ketoconazole Carbamazepine Fluoxetine Itraconazole Rifampicin Paroxetine HIV protease inhibitors Rifabutin Phenytoin Phenobarbital Primidone Efvirenz Nevirapine St John s Wort 31 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

18 5.7.7 Sites of administration Gluteal muscle administration The recommended needle for gluteal administration is a 38 mm (1.5 inch), 22 gauge hypodermic safety needle; for obese patients (Body mass index > 28 kg/m 2 ), a 50 mm (2 inch), 21 gauge hypodermic safety needle must be used. Gluteal injections must be alternated between the two gluteal muscles. Deltoid muscle administration The recommended needle for deltoid administration is a 25 mm (1 inch), 23 gauge hypodermic safety needle; for obese patients, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle must be used. Deltoid injections must be alternated between the two deltoid muscles. 5.8 Olanzapine long acting injection Olanzapine LAI is non-formulary due to its adverse safety profile and subsequent monitoring requirements. Its use in exceptional cases must be approved via the non-formulary process. Appropriate arrangements must be in place for continued administration and monitoring in the community before the non-formulary request will be approved. Where use has been approved, the sections & must be adhered to: Trust staff may also be required to take over prescribing and administration for patients currently established on olanzapine LAI after transfer from another Trust. Likewise a non-formulary form must be completed and arrangements in place for administration and monitoring. Consideration should also be given to switching the patient to an alternative antipsychotic LAI Before prescribing or administering olanzapine LAI, staff must undertake an e- learning package produced by the pharmaceutical company ( Certificates must be retained by ward/team manager After each injection, patients m u s t be observed in a ward or community team base by appropriately qualified staff for at least three hours for signs and symptoms consistent with olanzapine overdose 9. The ward or team base must have resuscitation equipment available. The member of staff undertaking the observation, does not have to be a doctor or nurse, but he/she must report any concerns immediately to a nurse or doctor. At the end of the observation, a nurse must confirm that the patient is alert, oriented, and does not have any signs and symptoms of overdose. For the remainder of the day after the injection, patients should be advised to be vigilant for signs and symptoms of an overdose secondary to post-injection adverse reactions, be able to obtain assistance if needed, and should not drive or operate machinery 10. If during the observation, an overdose is suspected, close medical supervision and monitoring should be initiated and 999 must contacted. 32 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

19 Supervision and monitoring must continue until examination indicates that signs and symptoms have resolved or an ambulance team is present Service users must initially be treated with oral olanzapine before administering the depot to establish tolerability and response. In line with trial studies, the introduction of long-acting IM olanzapine should be made without recourse of cross-tapering of oral medication 5, If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day. See table Olanzapine pamoate releases olanzapine slowly, over six to eight weeks after each injection. The time to steady state is three months Olanzapine pamoate salt provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection. Therefore supervision by a clinician, especially during the first 2 months after discontinuation of olanzapine LAI, is needed when switching to another antipsychotic product Olanzapine LAI must be administered in the gluteal muscle only 10. It is not licensed for administration in the deltoid muscle Olanzapine LAI has not been systematically studied in elderly patients (> 65 years). Olanzapine LAI is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established. A lower starting dose (150 mg/4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant. Olanzapine depot is not recommended to be started in patients >75 years. Table 14: Recommended Dose Regimen Oral Olanzapine Recommended starting dose of Olanzapine Depot Maintenance Dose after 2 months 10mg/day 210mg/2 weeks or 405mg/4 weeks 150mg/2 weeks or 300mg/4 weeks 15mg/day 300mg/2 weeks 210mg/2 weeks or 405mg/4 weeks 20mg/day 300mg/2 weeks 300mg/2 weeks 33 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

20 6 Use of Unlicensed Doses If for therapeutic reasons clinicians consider a dose of depot medication above the BNF limit is advisable, a full discussion must take place involving the patient, consultant psychiatrist, the prescriber (if the not the consultant) and the nurse who will administer the depot injection. This discussion and its conclusion must be recorded in full in the service user s electronic records For service users detained under the Mental Health Act, and requiring a second opinion, reference must be made on the T2 or T3 forms specifying the dose prescribed and is above maximum licensed dose If the prescribed dose of risperidone injection is above the maximum licensed dose (50mg every two weeks), consideration should be given to prescribing paliperidone LAI as the maximum dose is 150mg every month (see table 3). 7 Administration of depot antipsychotic medication There is a procedure for the s afer use of injectable medicines which is available on the Trust intranet Check the depot is licensed for administration into the preferred muscle site The table below details the sites for administration of depot medication. Appendix 3 contains diagrams of the various injection sites referred to below. Table 15 4 Depot Licensed Site of Injection Practice Points Flupenthixol decanoate Upper outer quadrant (Depixol injection, depixol conc. Injection, depixol low volume) (dorsogluteal region) or lateral thigh (vastus lateralis) Fluphenazine decanoate (Modecate injection, Modecate conc injection) Haloperidol decanoate (Haldol decanoate) Zuclopenthixol decanoate (Clopixol, clopixol conc injection Gluteal region Gluteal region Upper outer quadrant (dorsogluteal region) or lateral thigh (vastus lateralis) Risperidone Gluteal region/deltoid muscle Paliperidone monthly Gluteal region/deltoid depot (restricted in the muscle formulary and obtained via a non-formulary form) Maximum volume into a single site must not exceed 2ml. Maximum volume into a single site is not specified in the SPC. Maximum volume into a single site must not exceed 3ml. Maximum volume into a single site must not exceed 2ml. Fractions of a dose may not be administered. Fractions of a dose must not be administered. 34 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

21 Paliperidone three monthly depot (Trevicta)(restricted in the formulary and obtained via a nonformulary form) Aripiprazole depot (restricted in the formulary and obtained via a non-formulary form) Olanzapine depot (nonformulary) Gluteal muscle region/deltoid Gluteal region/deltoid muscle Gluteal region Fractions of a dose must not be administered. The suspension must be injected slowly as a single injection (doses must not be divided) into the gluteal muscle. Fractions of a dose must not be administered 35 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

22 7.1.4 The gluteal region consists of the dorsogluteal muscle and ventrogluteal muscle. The ventrogluteal muscle has been approved by the Trust to be used as an alternative site to the dorsogluteal, where the BNF states gluteal site. It is acknowledged that this will be administering via an off-label route The dorsogluteal site (upper outer quadrant) is perhaps the most popular site. It is close to the sciatic nerve and gluteal artery and is covered by abundant adipose tissue in most people 13. This may result in the medicine not reaching the target muscle. This may result in reduced medicine uptake and tissue irritation The ventrogluteal site has few major nerves and blood vessels. The muscle is well defined and large. There can be significant differences in fat depth in obese people. Some authors have argued this is the best site because of notably fewer complications, specifically injuries to the sciatic nerve. Additionally, it can be almost guaranteed that a standard 3cm or 4cm needle will penetrate the muscle. In practice mental health nurses are reluctant to use this area because of problems locating the site and a perceived risk of needle stick injury when injection between the V of the index and middle fingers The deltoid muscle is rarely used because of the weak evidence it causes more discomfort. Only small volumes (less than 2ml) are recommended at this site. With the exception of risperidone injection, paliperidone monthly depot, paliperidone three monthly depot and aripiprazole monthly depot which are licensed for administration via this route, the deltoid muscle is not routinely used as a site of administration. There is also a risk of injury to the radial nerve and brachial artery 13. There is no research in regards to other depots The lateral thigh is rarely used. This site is easily accessible, but may result in considerable discomfort 14. However it is licensed for administration of flupenthixol and zuclopenthixol depot 6,8. It could potentially be used for selfadministration under supervision The front of the thigh is not a licensed site of administration. This site may also result in considerable discomfort. 8 Use of alternative sites or sites which are off -label If there is a good clinical reason for using an off-label site e.g. the amount of subcutaneous (fatty tissue) is too great for the needle to deposit the medication into the muscle or the patient chooses not to have the injection in the clinically preferred site, a full discussion including a risk assessment must take place. The discussion should involve the consultant psychiatrist, the prescriber (if not the consultant) and the administering nurse and patient. This discussion and its conclusion must then be fully recorded in the patient s Electronic patient record (Carenotes). The member of staff must have completed the relevant training and supervised practice to equip them to administer in the alternative site safely e.g. the deltoid site. However there is little evidence for other sites in terms of risks and safety. 36 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

23 9 Depots/LAIs administered under restraint Occasionally depot antipsychotic medication may be administered under planned restraint. In keeping with the trust policy, depot antipsychotic medication should be administered with the patient in a prone position When considering which depot antipsychotic medication to use, consideration should be given to the licensed site of injection (see table 15) for example flupenthixol decanote and zuclopenthixol decanoate can be administered in the lateral thigh (a licensed site) in a prone restraint rather than in the gluteal region If an unlicensed site is considered, the advice of pharmacy must be sought. A discussion involving the consultant, prescriber and nurse must be recorded in the patient s electronic patient record (Carenotes) prior to administration. 10 Generic names/brand names Depot / LAI must always be prescribed generically, however paliperidone LAIs must be clearly annotated to distinguish between the different formulations (monthly or three monthly). Table 16 GENERIC NAME Flupenthixol Decanoate Zuclopenthixol Decanoate Fluphenazine decanoate Haloperidol Decanoate Haloperidol injection Aripiprazole long acting injection Risperidone injection Paliperidone monthly depot Paliperidone three monthly depot Olanzapine depot BRAND NAME Depixol Clopixol Modecate Haldol Decanoate Haldol Abilify Maintena Risperdal Consta Xeplion Trevicta Zypadhera 11 Management of patients on long term depot antipsychotics in relapse prevention Patients should be reviewed prior to the next injection including an assessment of the previous injection site checking for signs of swelling, pain, inflammation, infection or tissue damage Clinical reviews should be undertaken every six months and should include a shared understanding of relapse plans and any concerns about treatment If a dose reduction is considered, a risk versus benefit analysis should be done taking in the following point 2 s: o Is the patient symptom free and if so for how long? Longstanding, nondistressing symptoms, which have previously not responded to medication, may be excluded. 37 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

24 o What is the severity of side effects? (GASS tool) o What is the previous pattern of illness? o Has dosage reduction been attempted before? If so, what was the outcome? o What are the current social circumstances? o What is the potential cost of relapse (e.g. hospital admission, employment)? If after consideration of the points raised, a decision to reduce medication is made: Oral antipsychotics should be discontinued first, if concurrently prescribed The interval between the injections should be increased gradually within licensed limits. If possible, reduce the dose by no more than a third at a time. Reduction in dosage should be made no more frequently than every 3 months if possible, preferably every six months. If the patient becomes symptomatic, this should not be seen as a failure, but as an important step in determining the minimum effective dose that the patient requires. 12 Intramuscular anti-cholinergic medication Some service users may require anti-cholinergic medication to alleviate the side effects of depot medication. Depot preparations do not produce acute extra pyramidal side effects (EPSEs) at the time of administration. If they do occur this may take hours or days. The administration of i.m. procyclidine with each depot is illogical as its anticholinergic effects will have worn off by the time the depot plasma level peaks 2. An anticholinergic is usually prescribed v i a t h e oral or intramuscular routes on an as required basis. 21 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

25 13 Primary Care Involvement Some service users may have depot medication prescribed and administered at their GP practice. This must always be with prior agreement and after clear communication and liaison between the consultant psychiatrist and the GP. Information such as when to review the medication and how to effectively communicate information or any other information between secondary and primary care should be included in the transfer of care. 14 Zuclopenthixol acetate (Clopixol acuphase) There is a separate document for Clopixol Acuphase - Guidance for the use of Clopixol Acuphase (zuclopenthixol acetate) in Adult Mental Health Inpatient Settings. Although an oily based preparation, it is not intended as a long-acting depot. Clopixol acuphase must not be used as a test dose for zuclopenthixol decanoate injection. 15 Related policies Antipsychotic Prescribing Guidelines. Safer Use of Injectable Medicines procedure. Medicines Management Policy. 16 Dissemination and implementation arrangements This document will be circulated to all managers who will be required to cascade the information to members of their teams. It will be available to all staff via the Trust intranet. Managers will ensure that all staff are briefed on its contents and on what it means for them. 17 Training requirements Staff administering depot/lai must be suitably qualified and competent to administer depot injections. Supplementary training for specific LAI preparation must be completed where applicable. For further training requirements please refer to the Trust s Mandatory Training Policy and Learning and Development Guide. 18 Monitoring and audit arrangements 22 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

26 Elements to be monitored Lead How trust will monitor compliance Frequency Reporting arrangemen ts Acting on recommendatio ns and Lead(s) Change in practice and lessons to be shared Process for prescribing medicines Process for medicine administration Chief Clinical ongoing Pharmacist pharmacy review (CP) of medicine charts. Nursing Director ongoing Divisional Leads DTC DTC Required actions will be identified and completed in a specified time frame. Required changes to practice will be identified and actioned within a specific time frame. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be learned with all relevant stakeholders 19 Review of the policy The next review date for this policy is December Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

27 20 References 1 National Institute for Health and Clinical Excellence (2014). Psychosis and schizophrenia in adults. Treatment and management. NICE Clinical Guidance Taylor D. Paton C., Kapur S. The South London and Maudsley NHS Foundation Trust. Oxleas NHS Foundation Trust. Prescribing Guidelines. 12th Edition. London. Informa Healthcare Bazire S. Psychotropic drug directory. The professionals pocket handbook and aide memoire Guidance on the Administration to Adults of Oil-based Depot and Other Long-acting Intramuscular Antipsychotic Injections. Fourth edition. PHGB/NPR/1113/0021 February Sanofi. The specification of product characteristics. Modecate concentrate 100mg per ml (21 February 2014) (online). Available: (accessed October 2016). 6 Lundbeck Ltd. The specification of product characteristics. Depixol injection and conc. Injection (13 May 2014). (online). Available: (accessed October 2016) 7 Janseen Cilag Ltd. The specification of product characteristics. Haldol decanoate. (16/11/2011). (online). Available: (accessed October 2016) 8 Lundbeck Ltd. The specification of product characteristics. Depixol injection and conc. Injection (5 February 2014). (online). Available: October 2016) 9 Otsuka Pharmaceuticals. The specification of product characteristics. Abilify maintena (28/03/2014). (online). Available: (accessed October 2016) 10 Eli Lilly and Company Ltd. The specification of product characteristics. Zypadhera powder and solvent for prolonged release suspension for injection (25/04/2014). (online). Available: (accessed October 2016) 11 Janseen Cilag Ltd. The specification of product characteristics. Xeplion 50 mg, 75 mg, 100 mg and 150 mg prolonged release suspension for injection. (03/12/2013). (online). Available: (accessed October 2016) 12 Janseen Cilag Ltd. The specification of product characteristics. Risperdal Consta 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection. (November 2013). (online). Available: (accessed October 2016) 13 Gray R. et al (2009). Antipsychotic long-acting injections in clinical practice: medication management and patient choice. Br. J. of Psych. 195, s51 s Janseen Cilag Ltd. The specification of product characteristics. Trevicta prolonged-release suspension for intramuscular injection. (September 2016). (online). Availablehttps:// (accessed November 2016) 24 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

28 Appendix 1: High Dose Antipsychotic Monitoring Form HIGH DOSE ANTIPSYCHOTIC MONITORING FORM 24 Name: DOB: Ward: Consultant: Date high dose therapy began: Name of Doctor: Grade: HO SHO SPR Consultant Other Date: Antipsychotic Medication (regular) 2,3 Medicine Dose %BNF Max Please, specify reason(s) for high dose antipsychotic therapy (HDAT) 4,5 Other Medication: CAUTION INCREASED RISK IN FOLLOWING CATEGORIES OF PATIENTS 7 : Old age: Hepatic/renal impairment: Obesity: Weight:.. Heavy user of tobacco or alcohol: History of arrhythmia: ECG 8 QT interval QTc Interval LFTs 9 Alk Phos ALT Total Bilirubin U & Es 9 Na K Urea Creatinine BP, Pulse Temp 10 History of myocardial infarction or IHD: Medicine interactions (inc. medicines with additive ECG effects) Other Baseline Month 1 Month 3 Month 6 Month 9 Month 12 Please, record daily for one week - on initiation of HDAT, and after each increase in dose of antipsychotic. Review Date(s) 11 Has patient/carers been informed of the high dose nature of therapy Yes/No 12 Is high dose therapy covered on the consent form (where applicable) Yes/No 25 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

29 Royal College of Psychiatrists. Consensus statement on high dose antipsychotic medication. Council Report CR138, London. Nov 2014 should be consulted for further advice. The report may be obtained via the Royal College of Psychiatrists website. 26 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

30 1. The consensus working group agreed to take the following as a definition of a high dose: A total daily dose of a single antipsychotic which exceeds the upper limit stated in the summary of product characteristics or BNF and a total daily dose of two or more antipsychotics which exceeds the SPC or BNF maximum using the percentage method. 2. To evaluate if a patient is on high dose antipsychotic therapy: express the dose of each antipsychotic as a percentage of its BNF maximum and add. If the total exceeds 100% - then patient is on high dose antipsychotic therapy (HDAT). For example: a patient on olanzapine 20 mg nocte and clopixol 400 mg i.m each week is on 100% of maximum Olanzapine dose and 66% of maximum clopixol dose: a total of 166% - thus, this Rx does constitute high dose. Such therapy CAN be given but it must be documented as such in the patient s notes. The Royal College of Psychiatric Guidelines (RCPsych) must then be followed. Any further increases in dose/dosages of antipsychotic(s). Should be done slowly waiting at least two weeks, before each subsequent dose increase. (Please note: both Consensus Statement on The use of high dose Antipsychotic Medication and Council Report CR57 The Association between antipsychotic drugs and sudden death do not recommend use of more than one antipsychotic at a time. Additionally, NICE guidance on use of Atypicals does not recommend combining the latter with typical antipsychotics. 3. If the use of prn antipsychotic medication (whether p.o or i.m) pushes patient s therapy into HDAT, please record use of such medication in notes. If this occurs for three or more consecutive days then: review therapy, and if it is decided to continue with the same prescription, please, implement these guidelines. 4. Before high dose therapy is commenced the possibilities of substance misuse, personality disorder, inadequate time to respond, poor adherence, misdiagnosis of psychosis, akathisia and response to Clozapine should be eliminated. 5. Other management techniques should be considered e.g. de-escalation or psychological techniques. 6. Decision to initiate high dose therapy should ONLY be made by a consultant, or registrar with MRCPsych following an individual risk benefit assessment on consultation with the clinical team. Obtaining a second medical opinion should be considered. The decision, risks & benefits, aims and how the outcomes will be assessed must be documented in the case notes/electronic patient record (Carenotes). 7. RCPsych guidelines emphasise the importance of CAUTION to high dose antipsychotic therapy. These include: Old Age History of myocardial infarction Medicine Interactions Hepatic/Renal impairment History of arrhythmia Medicines with additive ECG effects Obesity History of ischaemic heart disease Heavy users of tobacco/alcohol These patients need to be monitored more closely as some patients may be contraindicated to HDAT. Patients should be assessed for cardiovascular disease prior to antipsychotic treatment regardless of dose. Modifiable risk factors for ischaemic heart disease inc. smoking, hypertension, hyperlipidaemia, sedentary lifestyle and obesity) should be identified and managed appropriately. Under the circumstances of rapid tranquillisation where an assessment is difficult and ECGs impossible, it is prudent to avoid high doses. 8. Prior to commencing such therapy a baseline ECG should be obtained. QT and QTc should be noted and the ECG signed. An ECG should be repeated after a few days after initiation and during dose escalation. This is because high dose antipsychotic therapy has been associated with QTc lengthening raising the risk of clinically significant arrhythmias. As long as the dose of antipsychotic remains high an ECG should be carried out every one to three months. In summary ECGs should be obtained at baseline, one, three, six, nine and twelve months later (if patient continues on high dose therapy for this period of time) or more frequently if clinically indicated. Cardiology advice should be sought if any abnormalities manifest. (Please note that if a patient, on antipsychotic therapy (regardless of dose), presents with palpitations, syncope or dizziness an ECG should be performed as soon as possible). 9. RCPsych guidelines also specify that hydration should be regularly checked and that impaired hepatic/renal function be taken into account before initiating therapy (hence, the need for U & Es, and LFTs). These indices should be repeated every three months or more frequently if clinically indicated. That is, please check these indices one-, three, six, nine and twelve months after initiation of high dose therapy or more frequently if clinically indicated. 10. RCPsych guidelines also advise regular checks on pulse, BP and temperature. Please check all three parameters daily for one week upon initiation of high dose antipsychotic therapy and after an increase in antipsychotic dose (once patient is on regular HDAT). 11. A care plan should be specified in the notes re: outcomes and dates of review. If there is no improvement in mental status (on high dose therapy) in three months, then RCPsych guidelines specify that high dose therapy should be abandoned. In summary, review should take place in one, three, six, nine and twelve months later (if patient remains on high dose therapy) or more frequently if clinically indicated. 12. Where possible discuss the decision to commence high dose antipsychotic therapy with the patient and/or patient s carers. 27 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

31 Appendix 2 Table 10: Equivalent doses of antipsychotics 2,3 Antipsychotic Equivalent dose (consensus) Range of values in literature Amisulpride 100mg per day mg per day Benperidol 2mg per day Chlorpromazine 100mg per day - Clozapine 100mg per day mg per day Flupenthixol 2-3mg per day 2-3mg per day Flupenthixol depot 10mg per week 10-20mg per week Fluphenazine 2mg per day 2-5mg per day Fluphenazine depot 5mg per week mg per week Haloperidol 2-3mg per day 1.5-5mg per day Haloperidol depot 15mg per week 5-25mg per week Paliperidone LAI 12.5mg every week or 50mg every month Pericyazine 24mg Perphenazine 10mg per day 10mg per day Pimozide 2mg per day 2mg per day Pipothiazine depot 10mg per week mg per week Promazine 100mg mg per day Risperideone 500micrograms 1mg per day 500micrograms 3mg per day Risperidone longacting injection 12.5mg per week or25mg every two weeks Sulpiride 200mg per day mg per day Trifluoperazine 5mg per day 2.5-5mg per day Zuclopenthixol 25mg per day 25-60mg per day Zuclopenthixol depot 100mg per week mg per week NB: Check the maximum licensed dose for each preparation when using this table. 28 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

32 Appendix 3 Buttock (Gluteus Medius) Site for IM Injection Leg (Vastus Lateralis) Site For IM Injection Hip (Ventrogluteal) Site for IM Injection Arm (Deltoid) Site for IM Injection 29 Depot Antipsychotic Medication Guidelines_Prescribing_Administration_PHA04_DEC 2016

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