GUIDANCE ON THE MONITORING OF PHYSICAL HEALTH PARAMETERS IN PATIENTS WITH SERIOUS MENTAL ILLNESS PRESCRIBED REGULAR ANTIPSYCHOTICS.

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1 GUIDANCE ON THE MONITORING OF PHYSICAL HEALTH PARAMETERS IN PATIENTS WITH SERIOUS MENTAL ILLNESS PRESCRIBED REGULAR ANTIPSYCHOTICS. Apprved by the Leicestershire Partnership Trust Prescribing Grup: August 2009 Reviewed: Review Date: September 2015 Appendix Patients wh find it difficult t cmply with investigatins Dr Mary Barrett 1

2 Guidance n the mnitring f physical health parameters in patients with serius mental illness prescribed regular antipsychtics NICE schizphrenia guidance Befre starting antipsychtic medicatin, ffer the persn with schizphrenia an electrcardigram (ECG) if: specified in the SPC a physical examinatin has identified specific cardivascular risk (such as diagnsis f high bld pressure) there is persnal histry f cardivascular disease, r the service user is being admitted as an inpatient. NICE Biplar Guideline When initiating lng-term treatment f biplar disrder with antipsychtics, weight and height, plasma glucse and lipids shuld be measured in all patients, and an ECG arranged fr patients with cardivascular disease r risk factrs fr it. Prevalence f Diabetes in peple with Serius Mental Illness In peple with schizphrenia, the prevalence f type 2 diabetes may be 2 4 times that f the general ppulatin. In this grup the prevalence f type 2 diabetes has been estimated at 15 18% and the prevalence f impaired glucse tlerance up t 30% (dependent upn age). Multiple risk factrs fr type 2 diabetes such as family histry, higher risk ethnic rigin, besity; sedentary lifestyle and smking may be assciated with peple with schizphrenia. Type 2 diabetes and impaired glucse tlerance may be present in peple with schizphrenia prir t treatment with antipsychtics. 1 The prevalence f type 2 diabetes may be 2 3 times that f the general ppulatin in peple with biplar affective disrder. 1 Effect f antipsychtics n glucse metablism Antipsychtic drugs (typical and atypical) have been assciated with case reprts f ketacidsis. All atypical antipsychtic drugs have been assciated with impaired glucse metablism. The mechanism by which antipsychtics affect glucse metablism is at present unknwn. 1 Effect f antipsychtics n lipids Changes in serum lipids are related t bdy weight change. Antipsychtics may be assciated with weight gain and therefre thse assciated with the greatest weight gain may cause the greatest increase in ttal chlesterl, LDL chlesterl and triglycerides (with a reductin in HDL chlesterl). 2 Current Internatinal Diabetes Federatin Definitin f Metablic Syndrme Central Obesity -Waist circumference 94cm fr Eurpid men, 80cm fr Eurpid wmen - Suth Asian men 90cm, Suth Asian wmen 80cm AND any tw f the fllwing: 2

3 Raised triglycerides - (1.7mml/L) OR specific treatment fr this lipid abnrmality Reduced high-density lipprtein chlesterl (<1.03mml/L in males and <1.29mml/L in females, OR specific treatment fr this lipid abnrmality Raised bld pressure (systlic BP 130mmHg r diastlic85mmhg) OR treatment f previusly diagnsed hypertensin Raised fasting plasma glucse (5.6mml/L) OR previusly diagnsed Type 2 diabetes Further ethnic specificity values available at Atypical Antipsychtics and Metablic Abnrmalities The table belw adapted frm Diabetes Care, 27, 2004, Please nte that typical antipsychtics have als been assciated with weight gain, ketacidsis and present a risk fr diabetes Drug Weight Gain Risk fr Diabetes Wrsened Lipid Prfile Amisulpride + = = Clzapine Olanzapine Risperidne ++ D D Quetiapine/ ++ D D Quetiapine XL Aripiprazle* +/- = = * new drug with limited lng term data ** new drug with limited lng term data, unlicensed in UK + increase effect; = n effect; D discrepant results Mnitring Recmmendatins fr patients with Serius Mental Illness prescribed Regular Antipsychtics Baseline 3 MONTHS after Annually initiating r switching antipsychtics Persnal & Family Histry Waist circumference Weight 3mnthly fr 1 year Bld pressure HBA 1 C plus randm glucse at 3 Fasting lipid prfile 15 Or randm lipid prfile (HDL and triglycerides) mnths U&E FBC LFT 3

4 Persnal and Family Histry Thse with a predetermined risk f diabetes include crnary heart disease, wmen with gestatinal diabetes, thse with IGT r IFG. Thse with a high risk fr diabetes include white Eurpean peple aged ver 40 and peple frm Black, Asian and minrity ethnic grups aged ver 25 with a first degree relative with diabetes, and thse with central besity; Wmen with plycystic vary syndrme; Cerebrvascular disease; Peripheral vascular disease; Hypertensin; Patients n prlnged sterid therapy. Any patient with symptms f diabetes shuld be investigated immediately Cmmn symptms f diabetes include plyuria (especially ncturia), plydipsia, urinary incntinence, unexplained weight lss, tiredness, pruritis vulvae / recurrent candidiasis, recurrent infectins / abscesses, balanitis, blurred visin / changes in visual acuity, imptence, pain / numbness / paraethesiae f legs and feet / ft ulcers, nn specific r unexplained symptms Fr patients wh develp symptms f diabetes while taking medicatin: A finger prick capillary bld glucse sample measured n a meter is useful as an initial check, althugh must nt be used fr diagnstic purpses. If any abnrmal r brderline results ccur please refer t GP r Diabetes Specialist fr management Mre frequent testing may be needed dependent n individual status Patients with Serius Mental Illness and Diabetes individual mnitring as required in liaisn with G.P. and Diabetes Specialist. Psychiatrist may liaise re antipsychtic chice Patients with Serius Mental Illness nt prescribed an antipsychtic r taking antipsychtics irregularly (less than 6 weeks regular r prn use) Fllw annual mnitring and take persnal and family histry WHO Diagnstic Criteria fr Diabetes Mellitus 14 In January 2011, the Wrld Health Organizatin (WHO) recmmended that glycated haemglbin (HbA1c) culd be used as an alternative t standard glucse measures t diagnse type 2 diabetes amng nn-pregnant adults. HbA1c levels f 48 mml/ml 6.5%) r abve indicate that smene has type 2 diabetes. Hwever, WHO did nt prvide specific guidance n HbA1c criteria fr peple at increased risk f type 2 diabetes (WHO 2011). A reprt frm a UK expert grup n the implementatin f the WHO guidance recmmends using HbA1c values between 42 and 47 mml/ml ( %) t indicate that a persn is at high risk f type 2 diabetes. The grup als recgnised that there is a cntinuum f risk acrss a range f subdiabetic HbA1c levels and that peple with an HbA1c belw 42mml/ml (6.0%) may als be at risk (Jhn et al. 2012). Psitive Cardimetablic Health Resurce -An interventin framewrk fr patients n antipsychtic medicatin 4

5 References 1. British Jurnal f Psychiatry (2004), 184 (suppl.47), s Schizphrenia and Diabetes 2003 Expert Cnsensus Meeting, Dublin, Diabetes Care (2004), 27, Cnsensus Develpment Cnference n Atypical Drugs and Obesity and Diabetes. American Diabetes Assciatin, American Psychiatric Assciatin, American Assciatin f Clinical Endcrinlgists, Nrth American Assciatin fr the study f Obesity. 3. Ashim S., Warringtn S., Andersn I.M. (2004). Management f diabetes mellitus ccurring during treatment with lanzapine: reprt f six cases and clinical implicatins. J Psychpharmaclgy, 18, Casey D.E., Haipt D.W., Newcmer J.W. et al, (2004). Antipsychtic - induced weight gain and metablic abnrmalities: Implicatins fr increased mrtality in patients with schizphrenia. Jurnal f Clinical Psychiatry, 65, suppl 7, Taylr D, Patn C., Kerwin R (2012). The Suth Lndn and Maudsley NHS Trust 2012 Prescribing Guidelines. Martin Dunitz, Lndn. 6. Summary f Prduct Characteristics fr Aripiprazle (Octber 2011). Bristl- Myers Squibb Pharmaceuticals Ltd and Otsuka Pharmaceuticals (U.K.) Ltd. 7. Summary f Prduct Characteristics fr Amisulpride (August 2012). Sanfi Synthelab 8. Summary f Prduct Characteristics fr Clzapine (August 2012). Nvartis Pharmaceuticals UK Ltd. 9. Summary f Prduct Characteristics fr Quetiapine (August 2012). AstraZeneca UK Ltd. 10. Summary f Prduct Characteristics fr Olanzapine (July 2012). Eli Lilly and Cmpany Ltd. 11. Summary f Prduct Characteristics fr Risperidne (July 2012). Janssen- Cilag Ltd. 12. Summary f Prduct Characteristics fr Paliperidne (August 2012) Janssen- Cilag Ltd. 13. Wrld Health Organisatin (2011). Definitin, Diagnsis and Classificatin f Diabetes Mellitus and its Cmplicatins. Part 1: Diagnsis and Classificatin f Diabetes Mellitus. 14. Internatinal Diabetes Federatin Definitin f Metablic Syndrme NICE Clinical Guideline 38 Biplar Disrder. 16. NICE Clinical Guidelines 82 - Schizphrenia: Cre interventins in the treatment and management f schizphrenia in adults in primary and secndary care 17. NICE Public Health Guidance 38 -Preventing type 2 diabetes: risk identificatin and interventins fr individuals at high risk Updated by Zeibun Patel Lead Pharmacist LPT-Mental Health & Learning Disability Prescribing Grup 5

6 RECORD OF PHYSICAL PARAMETER MONITORING FOR PATIENTS ON ANTIPSYCHOTIC THERAPY T be cmpleted fr all patients being treated with antipsychtic(s) (where practical) preferably befre cmmencing treatment. It is recgnised that in sme clinical circumstances it may nt be pssible t mnitr sme r all f these parameters. Reasns t be dcumented in the case ntes. Patient Name: D.O.B: Unit Number: Cnsultant: Ward: Risk Factrs Please circle Cardiac Histry? Y / N Hepatic Impairment? Y / N Obesity? Y/ N Specify Details: Renal Impairment? Y / N Smker? Y / N Date Metablic Parameter Mnitring. Pre-Rx After 3 mnths Annual Checks Persnal and family histry: Cardiac Disease Diabetes Waist Circumference Weight 3 mnthly fr 1 year. ECG Check (QTc interval) (Where apprpriate) Bld Pressure (mm Hg) HBA 1 C (plus randm glucse at 3 mnths) Fasting r randm lipid prfile (HDL and Triglycerides) U&E LFT FBC Signature (please sign AND print name): Designatin: NA NA NA Date Abnrmal Result / Cmments Actin Dctr s Signature ** File in Patients Investigatins sectin in case ntes 6

7 Physical Parameter Mnitring Appendix Patients wh find it difficult t cmply with investigatins The majrity f patients in LPT with serius mental illness wh are taking antipsychtics will be able t enter the Trust s prgramme fr mnitring f metablic parameters withut any prblem. It needs t be acknwledged; hwever, that there are sme individuals fr whm having investigatins is mre difficult, fr example due t their mental state, impaired cgnitive functining r level f engagement with services. This appendix prvides guidance fr clinicians n hw t address this issue It shuld be nted that sme investigatins, particularly thse which are mre invasive, such as bld testing, are mre likely t present difficulties fr patients than ther tests such as waist measurement. It is therefre likely that, fr mst patients, at least sme f the full set f investigatins can be successfully carried ut withut t many difficulties. Specific advice is prvided belw (Strategies sectin) n techniques, which may assist with thse investigatins, which mst cmmnly present difficulties. Fr each case where a patient finds cmplying with investigatins difficult the clinician shuld give cnsideratin t the fllwing principles at each review: 1. Des the patient need t cntinue with the antipsychtic medicatin? If nt then withdrawal f the drug shuld be cnsidered. 2. If the antipsychtic is felt t still be necessary then all reasnable attempts shuld be made t help the patient access all the necessary investigatins see strategies sectin belw. 3. If all reasnable attempts fail then a multidisciplinary meeting shuld be held, including the patient themselves and their relative(s) / carer / advcate as apprpriate, t discuss the fllwing issues: The ratinale fr cntinuing antipsychtic treatment. Reasns fr undertaking metablic mnitring. The risks and benefits f cntinuing antipsychtic treatment withut metablic mnitring being cmpleted. 4. The clinician needs t make an assessment f the patient s capacity t refuse a particular investigatin r investigatins, bearing in mind the principles f the Mental Capacity Act, including the need t ptimise a persn s decisin-making ability and the right t make unwise decisins. 5. Steps 3 and 4 shuld be fully dcumented in the patient s case ntes. 6. If the utcme f this prcess is t cntinue treatment then the clinician shuld ensure that: The results f thse investigatins that have been successfully cmpleted are dcumented. Fr thse investigatins, which have nt been cmpleted, reasns fr nn-cmpletin are dcumented and nging attempts made t help the patient t underg these investigatins (See strategies belw) prir t the next review. The patient shuld be prvided with the necessary infrmatin and supprt t access means t lwer any knwn r suspected risk factrs e.g. Dietary advice, smking cessatin. Strategies, which may assist patients in undertaking investigatins fr metablic parameters mnitring A. Invlve ne r mre individuals wh the patient trusts in bth preparing fr the investigatin and t supprt them in having the test itself. Ensure that these individuals understand the reasns fr having the test, the prcess f the test itself and what their remit will be e.g. sitting next t the persn / prviding reassurance. B. In cnjunctin with number 1, cnsider invlvement f member(s) f the multidisciplinary clinical team in the preparatin prcess and fr prviding supprt in accessing the investigatin. C. Prepare the patient adequately fr the investigatin. This may include: 7

8 A descriptin f the investigatin prcess in the frmat mst accessible t the patient, fr example phtgraphs, pictures r diagrams. The preparatin prcess may need t be carried ut ver a perid f time and the infrmatin presented repeatedly in rder fr the patient t becme familiar and cmfrtable with it. Fr sme patients it may be apprpriate t simulate the investigatin using the apprpriate equipment e.g. practicing putting n the sticky pads acrss the chest fr an ECG. Cnsider a visit t the department cncerned prir t attending fr the investigatin, t allw the patient t becme familiar with the envirnment and staff and t give chance fr any questins/ cncerns t be addressed. Liaisn with the department invlved is ften useful in this prcess, and they are usually very helpful in prviding the necessary materials / arranging visits. D. Chse the mst cmfrtable setting fr the patient t undertake the investigatin, as far as is practicable. Many investigatins can be carried ut in the patient s wn hme r day-care setting (If these felt mst apprpriate), r the patient may be mre cmfrtable attending the GP Surgery r a General Hspital setting. E. Fr investigatins which usually require the patient t attend a particular department r clinic e.g. ECG testing, it is useful t liase with the setting in questin t ensure access is made as easy and quick as pssible and t alert them f any pssible difficulties that may ccur. The mst apprpriate individual in each particular case may undertake the liaisn prcess, fr example the patient s CPN/CLDN r carer, with invlvement and supprt frm the clinician as needed. The clinics invlved are usually very helpful in advising quiet times t attend, alltting first appintment slts t avid waiting etc. F. Fr patients wh experience difficulties with bld testing, a desensitisatin package shuld be tried as a first step. This can be accessed thrugh the cmmunity psychiatric nurses. If this prves insufficient then cnsideratin may be given t the fllwing: Is the patient ging t be accessing any ther medical / dental / surgical investigatin r treatment prcess in the near future that will require them t be sedated? If s, then it may be pssible t arrange fr the metablic parameters bld testing t be carried ut at this time, in liaisn with the clinician / team invlved. The patient shuld be made aware, as far as is pssible; that bld testing fr the purpses f metablic mnitring is t be carried ut whilst they are under sedatin. The use f adjuncts e.g. Lw-dse ral lrazepam t reduce anxiety and / r Emla cream t minimise discmfrt t assist the prcess. The use f any adjuncts shuld be discussed and agreed with the patient and carer(s) and the utcme f this discussin dcumented in the medical ntes and a prtcl drawn up fr their use. If the abve strategies are unsuccessful, and the clinician feels there are sufficient medical grunds fr pursuing bld testing, then cnsideratin may be given t using buccal / nasal midazlam as an alternative t ral lrazepam. The fllwing pints shuld be cnsidered: The decisin t use this strategy shuld weigh up the balance f ptential risks, such as respiratry depressin, against the benefits f successful testing. The decisin shuld be made in the setting f a multidisciplinary meeting, invlving the patient and their carer / family / advcate, and be dcumented in the medical ntes. A prtcl shuld be drawn up fr administratin f the midazlam and shuld include what t d shuld there be any cncern abut the patient s cnditin during / fllwing the administratin prcess. Cnsideratin shuld be given t the mst apprpriate setting fr the administratin f midazlam / carrying ut f bld testing / mnitring f the patient until fully recvered, including access t emergency medical equipment and t emergency medical help if needed. The patient shuld be as fully infrmed as pssible prir t the prcedure taking place. 8

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