Formulary and Prescribing Guidelines

Transcription

1 Frmulary and Prescribing Guidelines SECTION 1: TREATMENT OF DEPRESSION

2 1.1 Intrductin This guidance shuld be cnsidered as part f a stepped care apprach in the management f depressive disrders. Antidepressants are nt rutinely recmmended fr persistent sub-threshld depressive symptms r mild depressin but can be cnsidered in these categries where there is a past histry f mderate r severe depressin, initial presentatin f sub-threshld depressive symptms fr at least 2 years, and persistence f either mild r sub-threshld depressin after ther interventins 1 have failed. The mst current NICE guidance shuld be cnsulted wherever pssible t btain the mst up t date infrmatin. Fr individuals with mderate r severe depressin, a cmbinatin f antidepressant medicatin and a high intensity psychlgical interventin (CBT r IPT) is recmmended. When depressin is accmpanied by symptms f anxiety, usually treat the depressin first. If the persn has an anxiety disrder and c-mrbid depressin r depressive symptms, cnsider treating the anxiety first. Als cnsider ffering advice n sleep hygiene, by way f establishing regular sleep and wake times; aviding excess eating, aviding smking and drinking alchl befre sleep; and taking regular physical exercise if pssible. Detailed infrmatin n the treatment f depressin in children and adlescents can be fund in sectin 12. Further guidance n prescribing fr lder adults and fr antenatal/pstnatal service users can be fund in sectin 11 and sectin 20, respectively. 1.2 Apprved Drugs fr the treatment f Depressin in Adults Fr licensing indicatins, see Annex 1 Drug 5 Frmulatin 5 Cmments 2,3,4 Fluxetine Amitriptyline Citalpram Caps 20mg, 60mg Liquid 20mg/5ml Tabs 10mg, 25mg, 50mg Liquid 50mg/5ml Tabs 10mg, 20mg, 40mg Drps 40mg/ml (1drp=2mg) 4 drps (8 mg) 10mg tablet Selective sertnin reuptake inhibitr (SSRI) 1st line SSRI (based n acquisitin cst) Tricyclic (TCA). Cnsultant initiatin nly SSRI Biequivalence variatin between frms Clmipramine Caps 10mg, 25mg, 50mg TCA Dsulepin Dulxetine Caps 25mg Tabs 75mg Caps 30mg, 60mg TCA NICE guidelines are categrical when prescribing drugs ther than SSRIs, d nt switch t r dsulepin. Cnsultant initiatin nly Sertnin nrepinephrine reuptake inhibitr (SNRI) Flupentixl Tabs 500mcg, 1mg Other Antidepressant Imipramine Lfepramine Tabs 10mg, 25mg Liquid 25mg/5ml Tabs 70mg Liquid 70mg/5ml TCA TCA 2

3 Drug 5 Frmulatin 5 Cmments 2,3,4 Mirtazapine Mclbemide Parxetine Phenelzine Tabs 15mg, 30mg, 45mg Dispersible Tabs 15mg, 30mg, 45mg Liquid 15mg/ml Tabs 150mg, 300mg Tabs 20mg, 30mg Liquid 10mg/5ml Tabs 15mg Nradrenaline and specific sertnin antidepressant (NaSSa) Reversible MAOI. Cnsultant initiatin nly SSRI Irreversible Mnamine-xidase inhibitr (MAOI). Cnsultant initiatin nly Sertraline Tabs 50mg, 100mg SSRI Trazdne Venlafaxine (300 mg+/day) Caps 50mg, 100mg Tabs 150mg Liquid 50mg/5ml Tabs 37.5mg, 75mg M/R Caps 75mg, 150mg Tricyclic-related Antidepressant SNRI 300mg/day shuld nly be prescribed under the supervisin r advice f a Cnsultant Escitalpram and Rebxetine remain nn-frmulary. Agmelatine is nn frmulary based n the guidance prvided by NICE in relatin t the terminatin f TA 231, July 2011 (due t the lack f evidence t supprt use). 1.2 NICE Clinical Guidelines NICE CG 90 and CG 91, Octber Depressin: Treatment & management f depressin in adults, including adults with a chrnic physical health prblem Chice f antidepressant Cnsider using a baseline assessment fr severity f depressin and regularly review symptms bth clinically and using standard severity rating scales. Initially, nrmally chse a generic SSRI whilst taking the fllwing int accunt: Fluxetine, fluvxamine and parxetine have a higher prpensity fr drug interactins (see current BNF). It may be apprpriate t cnsider sertraline and citalpram in patients wh have chrnic health prblems, as these have a lwer prpensity fr interactins with medicatins fr physical health prblems (see table belw) Parxetine has a higher incidence f discntinuatin symptms (cnsider half lives). See sectin 1.3 SSRIs are assciated with an increased risk f bleeding cnsider prescribing a gastr-prtective drug (e.g. meprazle) in lder adults wh are taking NSAIDs and/r aspirin 3

4 The risk f suicide attempted suicide r self harm. Mirtazapine, venlafaxine and teazadne have been assciated with the highest abslute risk. Acquisitin cst (Fluxetine is currently lwest) Discuss chice f antidepressant, cvering: Patient chice - the patient s perceptin f the efficacy and tlerability 4 Existing c-mrbid psychiatric disrders such as bsessive cmpulsive disrder, anxiety spectrum disrder etc., thrugh accurate histry taking (Annex 1) Anticipated adverse events fr example, agitatin, nausea and vmiting (with SSRI antidepressants), and discntinuatin symptms (seeannex 2Annex 2) Ptential interactins with cncmitant medicatin r physical illness (there is currently n evidence t supprt using specific antidepressants in particular physical health prblems) Medicatin fr physical health prblem NSAIDs (nn-steridal anti-inflammatry drugs) Warfarin r heparin Thephylline, clzapine, r methadne Triptan drugs fr migraine Aspirin Mnamine xidase B inhibitrs (fr example, selegiline r rasagiline) Recmmended antidepressant(s) 4 D nt nrmally ffer SSRIs but if n suitable alternatives can be identified, ffer gastr-prtective medicines (fr example, prtn pump inhibitrs) tgether with the SSRI. Cnsider mirtazapine, mclbemide r trazdne D nt nrmally ffer SSRIs. Cnsider mirtazapine. D nt nrmally ffer fluvxamine ffer sertraline r citalpram D nt ffer SSRIs ffer mirtazapine r trazdne. Use SSRIs with cautin if n suitable alternatives can be identified, ffer gastr-prtective medicines tgether with the SSRI. Cnsider trazdne when aspirin is used as a single agent. Alternatively, cnsider mirtazapine. D nt nrmally ffer SSRIs ffer mirtazapine r trazdne. Flecainide r prpafenne Offer sertraline as the preferred antidepressant mirtazapine r mclbemide may als be used. When prescribing antidepressants fr lder adults (see sectin 11 fr further infrmatin) Prescribe at an age-apprpriate dse taking int accunt physical health, and existing medicatin (see table abve) 4

5 Mnitr carefully fr side-effects (seeannex 2Annex 2) When prescribing drugs ther than SSRIs, take int accunt: The increased likelihd f the persn stpping treatment because f side effects, and the cnsequent need t increase the dse gradually, as fr example with venlafaxine and tricyclic antidepressants (TCAs) That dsulepin shuld nt be prescribed That irreversible MAOIs (such as phenelzine) shuld nly nrmally be prescribed by a Cnsultant Psychiatrist Take int accunt txicity in verdse fr peple at significant risk f suicide. When initiating antidepressants, especially SSRIs, actively mnitr suicidal ideatins, self-harming thughts and changes in bth. If changes are nticed, increase review frequency. Be aware that: Cmpared with ther equally effective antidepressants recmmended in primary care (such as SSRIs), venlafaxine is assciated with a greater risk f death frm verdse, but the greatest risk in verdse is with TCAs, except fr lfepramine Fr peple wh are nt cnsidered t be at increased risk f suicide, nrmally review after 2 weeks, then regularly every 2 4 weeks in the first 3 mnths fr example, and then at lnger intervals if respnse is gd Fr peple wh are cnsidered t be at increased risk f suicide r are yunger than 30 years, nrmally see them after 1 week and then frequently until the risk is n lnger clinically significant, particularly if they have been cmmenced n a SSRI. Review perids shuld be based n individual assessments D nt prescribe r advise use f St Jhn s Wrt fr depressin Explain the different ptencies f the preparatins available and the ptential serius interactins f St Jhn s Wrt with ther drugs (including ral cntraceptives, anticagulants and anticnvulsants) Explre any cncerns that the persn may have abut taking an antidepressant and prvide infrmatin abut: The gradual develpment f the full antidepressant effect The imprtance f taking the medicatin as prescribed and the need t cntinue beynd remissin Ptential side effects and drug interactins and strategies fr minimisatin The risk and nature f discntinuatin symptms (particularly with drugs with a shrter half-life, such as parxetine and venlafaxine) 5

6 The fact that addictin des nt ccur Patients receiving ECT can be prescribed antidepressants simultaneusly and there is evidence that there is a synergistic effect when antidepressants are used. Treatment with antidepressants fr mild depressin is nt rutinely recmmended In every instance, chice f antidepressant shuld be based n the circumstances f the individual being treated and their individual preferences. If after cnsultatin a range f chices are available taking int cnsideratin safety and cncrdance prfiles, the drug f lwest acquisitin cst shuld be selected Early treatment with an antidepressant 4 If increased anxiety r agitatin develps early in treatment with an SSRI, a shrt perid f cncmitant therapy (usually n lnger than 2 weeks) with a benzdiazepine may be cnsidered 4. (This cnsideratin des nt apply t patients with chrnic anxiety and benzdiazepines shuld nly be used with cautin in patients at risk f falls 4.) The patient shuld be infrmed that this is usually a transient effect and shuld last n lnger than a few weeks. If the anxiety r agitatin is unacceptable t the patient, cnsider changing t a different antidepressant (see Annex 3) Lack f respnse t initial antidepressant 4 If imprvement is nt reprted within 2-4 weeks, check that the drug has been taken as prescribed and enquire abut side-effects experienced (see Annex 2 fr side effect prfile). If respnse is absent r minimal after 3 4 weeks f treatment with a therapeutic dse f an antidepressant, increase supprt and cnsider increasing the dse in line with the summary f prduct characteristics (SPC) if there are n significant side effects. If there are side effects r if the patient prefers, cnsider switching t anther antidepressant. (Infrmatin relating t stpping/switching can be fund in Annex 3) If there is sme imprvement by week 4, cntinue treatment fr anther 2-4 weeks at an increased dse. Cnsider switching t anther antidepressant if respnse is still nt adequate; there are side effects; r if the patient prefers t change medicatin If cnsidering switching antidepressant, cnsider a different SSRI Subsequently, if the secnd SSRI is nt effective/well-tlerated, cnsider switching t ne f the better tlerated newer generatin antidepressants such as mirtazapine cnsidering the varius factr mentined abve Subsequently, cnsider substituting with an antidepressant f a different class that may be less well tlerated (such as venlafaxine, r a reversible MAOI, such as mclbemide, r a TCA) Guidance fr Prescribing Venlafaxine: D nt prescribe venlafaxine fr patients with: 6

7 Uncntrlled hypertensin Recent mycardial infarctin High risk f cardiac arrhythmia Mnitr BP at initiatin and regularly during treatment (particularly during dse titratin) Mnitr fr signs and symptms f cardiac dysfunctin Dses f 300 mg daily r mre shuld nly be prescribed under the supervisin r advice f a specialist mental health practitiner Guidance fr prescribing Tricyclic Antidepressants: Tricyclic antidepressants are carditxic (defined as causing a 25% increase in baseline QTc interval) even at therapeutic dses. Therefre, it is advisable t perfrm an ECG and t mnitr BP prir t initiating treatment. NICE des specify that peple wh n lw dse TCAs, and have a clear clinical respnse can be maintained n that dse with careful mnitring. Dsulepin is the mst carditxic, and NICE specifies D nt switch r, dsulepin. D nt rutinely augment an antidepressant with: A benzdiazepine fr mre than 2 weeks Buspirne, carbamazepine, lamtrigine, valprate r thyrid hrmnes. If a persn s depressin has nt respnded t either pharmaclgical r psychlgical interventins, cnsider cmbining antidepressants with CBT Pharmaclgical management f depressin with psychtic symptms 4 Fr individuals with depressin wh have psychtic symptms cnsider augmenting their treatment plan with an antipsychtic medicatin. Shuld augmentatin (with lithium, an antipsychtic such as quetiapine, r anther antidepressant such as mirtazapine) be cnsidered necessary, then advice frm a Cnsultant Psychiatrist shuld be sught; especially if the patient is based in primary care. (see sectins 2 and 3 fr further infrmatin relating t mnitring required fr these drugs) When prescribing Lithium (fr augmentatin f the primary antidepressant) mnitr: Renal and thyrid functin befre treatment and every 6 mnths during treatment (mre ften if there is evidence f renal impairment) Cnsider ECG mnitring in peple at high risk f cardivascular disease 7

8 Mnitr serum Lithium levels 1 week after treatment s and after every dse change, and then every 3 mnths (see sectin 3 fr full details) When prescribing an antipsychtic, mnitr weight, fasting lipid and glucse levels, and ther relevant side effects (see sectin 2 fr full mnitring requirements f antipsychtics) Maintenance treatment with antidepressents 4 Patients wh have respnded t antidepressants shuld cntinue n said medicatin fr at least 6 mnths after remissin f a single episde. Thereafter, the need t cntinue shuld be discussed with the patient taking int cnsideratin such factrs as residual symptms and cncurrent physical health and psychscial prblems. Patients with 2 prir episdes and functinal impairment shuld be treated fr at least 2 years. Peple wh have had multiple episdes f depressin and wh have a gd respnse t augmentatin shuld remain n this treatment. If ne medicatin is stpped, it shuld be the augmenting agent. 1.3 Tlerance, Craving & Antidepressant Discntinuatin Syndrme 1 Infrm all patients prescribed an antidepressant that these drugs d nt cause tlerance and craving, but they can cause withdrawal symptms n stpping, missing dses r ccasinally n reducing the dse. The symptms are usually mild and self-limiting but ccasinally severe, particularly if the drug is stpped abruptly. This is mre cmmn in drugs with a shrt half-life such as Parxetine and Venlafaxine. Withdrawal symptms usually ccur within 5 days f stpping treatment, r ccasinally during taper r after missed dses (shrt half-life drugs). The perceptin f symptm severity may be wrse if the patient is nt warned f the pssibility in advance. Sme symptms are mre likely with particular drugs Antidepressant Discntinuatin Symptms Patients prescribed shrt half-life drugs (e.g. parxetine); patients wh have taken an antidepressant fr mre than 8 weeks; patients wh develped anxiety at the f antidepressant therapy (particularly SSRI s); patients taking ther centrally acting drugs (e.g. antihypertensives, antihistamines, antipsychtics); children and adlescents; patients wh have experienced discntinuatin symptms befre 1 are mst at risk f develping discntinuatin symptms. Discntinuatin symptms can be avided by reducing lng-term antidepressant dses ver fur weeks (nt necessary with fluxetine). This is mre imprtant with shrt half-life drugs (e.g. parxetine r venlafaxine). MAOI s (especially Tranylcyprmine) may need lnger. 1 (See Annex 3) Hw t treat? Mild symptms reassure patient, and mnitr symptms. Severe symptms reintrduce the riginal drug at the effective dse, r prescribe a drug in the same class with a lnger half-life (e.g. if patient was using parxetine, intrduce fluxetine), withdraw slwly and mnitr. 1 8

9 MAOI s TCA s SSRI s & related Symptms Cmmn: Agitatin, irritability, ataxia, mvement disrders, insmnia, smnlence, vivid dreams, cgnitive impairment, slwed speech, pressured speech. Cmmn: Flu-like symptms (chills, fever, sweating, headache, nausea), insmnia, vivid dreams. Cmmn: Flu-like symptms, shcklike sensatins, dizziness, insmnia, vivid dreams, irritability, crying spells. Occasinally: Hallucinatins, paranid delusins. Occasinally: Mvement disrders, mania, cardiac arrhythmia. Occasinally: Mvement disrders, impaired cncentratin and memry. Drugs mst ften assciated with discntinuatin symptms All (Tranylcyprmine is partly metablised t amphetamine and is assciated with a true withdrawal syndrme ) Amitriptyline Imipramine Parxetine (all SSRIs have the prpensity t cause discntinuatin syndrme) Venlafaxine ( risk f NMS) References 1. Suth Lndn & Maudsley NHS Fundatin Trust Prescribing Guidelines 10 th editin, Infrma Healthcare, Psychtrpic Drug Directry 2010, Bazire S., Fivepin Ltd 3. Summary f Prduct Characteristics fr Individual Drugs [accessed Jan. 2011] 4. NICE CG 90 and 91, Octber Depressin: Treatment and management f depressin in adults, including adults with a chrnic physical health prblem 5. BNF 61 st current editin, March

10 Annex 1 Licensed indicatin(s) fr antidepressants Drug Depressin Anxiety OCD Amitriptyline Panic Disrder Citalpram Clmipramine Dsulepin Scial Anxiety PTSD Dulxetine GAD Bulimia - Nervsa Fluxetine Flupentixl Imipramine Lfepramine MAOI s Mianserin Mirtazapine Mclbemide Parxetine Sertraline Trazdne PMDD Venlafaxine Indicatins crrect as f January 2011 check fr changes in the latest SPC. Abbreviatins OCD = Obsessive Cmpulsive Disrder PTSD = Pst Traumatic Stress Disrder GAD = Generalised Anxiety Disrder PMDD = Pre-Menstrual Dysphric Disrder Only the XL frmulatin f Venlafaxine is licensed fr these indicatins References 1. Summary f Prduct Characteristics fr Individual Drugs [accessed Jan. 2011] 10

11 Annex 2 Summary f Drug Particulars (relative side effect prfile) Drug 1 Max Daily Dse (mg) Adult (Licensed) Max Daily Dse (mg) Elderly (Licensed) Relative Side Effects at Average Dses (mstly dse-related) Cardiac Nausea Sedatin Antichlinergic Overdse Txicity Prcnvul sant Sexual Dysfunct in Tricyclics (TCAs) Amitriptyline Clmipramine Dsulepin Imipramine 300 (Hsp) 200 (Outpt) Lfepramine 210 <Ad SSRIs Citalpram Fluxetine Parxetine 50(depressi n) 60 (thers) Sertraline Tricyclic-Related Mianserin Trazdne Iscarbxazid 200 (usually30-90) 600 (Hsp) 300 (Outpt) 60 (4-6weeks) then 40 <Ad MAOIs Phenelzine 90 (90) Tranylcyprmine 30 (30) SNRIs Dulxetine 120 Cautin ?? ++ Venlafaxine 375 (tabs) 225 (SR caps) 375 (tabs) 225 (SR caps) Others Flupentixl ? + Mirtazapine Mclbemide ? + Key +++ = Marked effect ++ = Mderate effect + = Mild effect 0 = Little effect? = Unknwn <Ad = Less than Adult dse NR = Nt Recmmended References 1. Psychtrpic Drug Directry 2010, Bazire S., Fivepin Ltd 2. MHRA Drug Safety Update, Vlume 5, N 5, December

12 Switching Antidepressants Annex 3 TO: Citalpram/ Escitalpram Dulxetine Fluxetine MAOI - Phenelzine Mirtazapine Mclbemide Parxetine Rebxetine Sertraline Tricyclics Trazdne Venlafaxine FROM: Citalpram/ Escitalpram Withdraw - at 60mg Withdraw - Start fluxetine at 10mg 1 week Crss-taper 2 weeks parxetine at 10mg Crss-taper sertraline at 25 mg Crss-taper Withdraw befre ing titratin at 37.5mg/day. Increase slwly Dulxetine 1 week 1 week Crss-taper Crss-taper Withdraw ing titratin Withdraw then venlafaxine Fluxetine fr 4 7 days. Start citalpram Stp. Wait fr 4 7 days. Start dulxetine 5-6 weeks fr 4 7 days. Start mirtazapine 5 weeks fr 7 days. Start parxetine rebxetine 2mg b.d. fr 4 7 days. Start sertraline 25mg fr 4 7 days. Start fr 4 7 days. Start lw dse 4-7 days then at 37.5mg/ day. Increase. slwly MAOI - Phenelzine fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks fr 2 weeks Mirtazapine at 60 mg 1 week 1 week fr 24 hurs Withdraw then venlafaxine Mclbemide fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs fr 24 hurs Parxetine at 60mg fr 2 weeks Crss-taper fr 2 weeks Crss-taper Crss-taper Withdraw ing titratin at 37.5mg/day. Increase slwly Rebxetine Crss-taper Crss-taper fr 1 week fr 1 week Crss-taper fr 1 week fr 1 week Crss-taper Crss-taper Crss-taper Crss-taper cautiusly Sertraline at 60mg fr 2 weeks Crss-taper fr 2 weeks Crss-taper Crss-taper Withdraw ing titratin venlafaxine at 37.5mg/day. Tricyclics halve dse and citalpram then slw withdrawal Crss-taper halve dse and fluxetine then slw withdrawal fr 1 week Crss-taper fr 1 week halve dse and parxetine then slw withdrawal Crss-taper halve dse and sertraline then slw withdrawal halve dse and trazadne then slw withdrawal Crss-taper cautiusly. Start venlafaxine at 37.5mg/day Trazdne at 60mg fr 1 week Crss-taper fr 1 week Rebxetine 2mg b.d. Crss-taper venlafaxine at 37.5mg/day. Venlafaxine Crss-taper cautiusly. Start at 10mg/day at 60mg n alternate days. Increase slwly Crss-taper cautiusly. Start at 20mg n alternate days at least 1 week Crss-taper cautiusly at least 1 week Crss-taper cautiusly. Start at 10mg/day Crss-taper cautiusly Crss-taper cautiusly. Start at 25mg/day Crss-taper cautiusly. Start at very lw dse Crss-taper cautiusly References 1. Suth Lndn & Maudsley NHS Fundatin Trust Prescribing Guidelines 10 th editin, Infrma Healthcare, 2010