Common use of Areas of Responsibility Clause in Contracts

Areas of Responsibility. Consultant To assess the patient and establish the need for sleep onset treatment in neurodevelopmental disabilities. To only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying physical causes are managed where they exist. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire (see Appendix 1) and sleep diary (see Appendix 2) highlighting problems with sleep latency. Consider and discuss treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. Obtain consent for the off label prescribing of melatonin. Perform baseline checks of physical health (including height, weight) Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets Assess and monitor the patient’s response to treatment and make dose adjustments where necessary. If treatment is ineffective and discontinued check for possible complications following discontinuation. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool (see attached) and advise GPs on this. Provide supervision and assessment of the patient during these periods. Ensure the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate clinical information and individual patient information. Communicate treatment changes to the GP promptly within Trust recommended times. Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. GP Monitor the patient’s overall health and well-being. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and accepted. Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristics. Advise patient to attend specialist appointments (at least annually). Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties. To report any adverse drug reactions to the psychiatrist and to the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not under shared care. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. Parent, carer and patient Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. Attend follow up appointments with psychiatrist (at least annually).

Areas of Responsibility. GP responsibilities Consultant To assess the responsibilities  Upon request, share relevant patient information to aid consultant in optimising patient care such as cardiac risk status, psoriasis, list of current medication, ensuring adequate contraceptive precautions in women.  Ensure medical record updated to clearly indicate secondary care co-prescribing whilst consultant stabilises dose.  Respond to shared care request and establish the need for sleep onset treatment in neurodevelopmental disabilitiesif agreed, prescribe lithium by brand name, noting any risk concerns, restrictions to supply quantity and target serum lithium level as advised by consultant. To only prescribe melatonin second-line where non-pharmacological strategies have failed,  Undertake monitoring of serum lithium levels and underlying physical causes are managed where they exist. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire other parameters (see Appendix 14 vi below) such as renal & thyroid function and sleep diary (see Appendix 2) highlighting problems calcium levels.  Monitor for signs/symptoms of change in cardiac function & consult with sleep latencypsychiatrist to arrange ECG & to consider other potential causes if new signs of dysfunction arise. Consider  Copy reports of any monitoring to consultant & discuss how to manage any aberrant results.  Take serum lithium levels 12 to 16 hours after the last dose. Ensure full documentation on the request form of time & date of last dose and discuss blood sampling time to assure validity of results.  Have a system in place to ensure blood test results are reviewed before prescribing and that these and any changes to treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the reasons for treatment, the possible adverse effects and the lack of information are recorded in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. Obtain consent for the off label prescribing of melatonin. Perform baseline checks of physical health (including height, weight) Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets Assess and monitor the patient’s response ‘purple book’ or can be uploaded to treatment the ‘App’ by the patient.  Report unacceptable adverse effects promptlyto consultant.  Be aware of potential for drug interactions and make dose adjustments where necessarymonitor serum levels as appropriate (see 4 vii)  Avoid abrupt discontinuation unless indicated by toxicity or severe side effects. If patient does not attend for routine screening please seek support from neighbourhood team to facilitate.  Provide diagnosis.  Perform baseline tests, copy results to GP. Seek information from GP regarding any cardiac risk, psoriasis and list of current medication.  Discuss treatment is ineffective with patient including benefits, side- effects, blood tests, likely duration, increased relapse risk in bipolar disorder after rapid discontinuation or due to poor adherence.  Provide patient with lithium information, alert card and discontinued check for record book, ensuring details are recorded. Advise on the availability of a smartphone ‘App’ if the patient prefers.  Counsel women on necessary contraceptive precautions; liaise with GP/family planning. Advise women to discuss with consultant as soon as possible complications following discontinuationif becomes pregnant or planning pregnancy. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool  Consider potential drug interactions.  Risk-assess patient, seeking cardiology opinion if ECG abnormal (see attached4 vi below). Risk-assess appropriate supply quantity (see referral criteria).  Start lithium; arrange for serum level and weight monitoring; titrate and stabilise dose. Inform and copy GP test & weight results during dose stabilisation period.  Ask GP if willing to share care. If agreed, transfer prescribing (by brand name) and monitoring of serum levels and other parameters (see 4 vi below) such as renal & thyroid function, calcium levels and new clinical signs/symptoms of cardiac dysfunction.  Indicate to GP the individual’s target serum lithium level and any restrictions to supply quantity. Advise GP of any risk assessment judgements made e.g. cardiac, overdose or medication interaction risks.  If care is not to be shared, undertake all monitoring and prescribing and copy GP in reports  Assess response in conjunction with adherence.  Evaluate and advise GPs on thisadverse events noted by GP or patient. Provide supervision  Respond to any discontinuation plan advised by consultant.  Discontinue shared care and assessment refer back to Consultant and to Perinatal psychiatrist if informed of pregnancy by patient. Inform midwife and ensure the patient during woman is received in consultant-led maternity care.  Report any adverse effects to the referring specialist and the MHRA yellow card scheme.  Promptly communicate any changes to GP and document these periodsin the patient’s hand held record (purple book)  Advise GP on when and how to discontinue treatment (see 4 iv below). Ensure  Undertake individual review on a case by case basis according to clinical need  Report any adverse effects to the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate clinical information and individual patient information. Communicate treatment changes MHRA yellow card scheme  Patients will only be referred to the GP promptly within Trust recommended timesonce the GP has agreed in each individual case, subject to receiving the relevant clinical information. Unlicensed formulations  The patient will be given a supply of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility Lithium Carbonate or Citrate sufficient for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. GP Monitor 4 weeks maintenance therapy except where the patient’s overall health risk assessment indicates a smaller quantity would be more appropriate. Patient responsibilities  Attend appointments and well-being. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care have recommended tests at recommended intervals  Seek medical attention if they develop diarrhoea or vomiting or become acutely ill for any reason  Be aware of the patient has been transferred and accepted. Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristics. Advise patient to attend specialist appointments (at least annually). Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, possible side-effects effects, especially signs of high lithium level and report promptly to professional involved with their care  Share any other concerns regarding lithium such as an incomplete understanding of their treatment, with professional involved with their care  Maintain their fluid intake, particularly after sweating (e.g. after exercise, in hot climates or swallowing difficultiesif they have a fever), if they are immobile for long periods or if they develop a chest infection or pneumonia. To report any adverse drug reactions  Women should talk to their doctor as soon as possible if they become pregnant or are planning a pregnancy  Seek advice before self-medicating with over the psychiatrist counter preparations.  Carry the lithium alert card. Keep the lithium record book (purple book*) in a safe place and show the alert card to healthcare professionals involved in their care. Take the record book with them to their GP, clinic appointments and to pharmacies when collecting lithium medication (or use the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not under shared care. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. Parent, carer and ‘App’ if patient Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. Attend follow up appointments with psychiatrist (at least annuallyprefers).

Areas of Responsibility. Consultant To assess Pre-treatment checks: • Consider possible drug interactions • Conduct baseline tests (FBC, U&Es, creatinine, LFTs, ESR, CPR, CXR (rheumatology only) Type III collagen propeptide (dermatology only). Patient education: • Discuss benefits vs risks with patient. • Issue / explain “Methotrexate patient held blood monitoring and dosage record booklet” and importance of showing this to all healthcare professionals. • Explain dose (in mgs and no. of 2.5mg tablets) and once weekly administration. • Ask patient to contact GP practice after one week to inform the practice that MTX has been started. • Obtain patient’s consent if MTX is used for an unlicensed indication. Starting of treatment: • Record baseline blood tests in “Methotrexate patient held blood monitoring and establish dosage record booklet” • Issue hospital prescription(s) (minimum 4 weeks). • Ask GP to continue prescribing and monitor blood results, providing details on dose, frequency, dose and timing of any folic acid, baseline test results, frequency of monitoring and next hospital review date OR send fully completed copy of “Initiation / transfer of Methotrexate prescribing” form selecting option A or B to GP. • Monitor efficacy, inform GP of any dose changes and document changes in patient held record book. • Inform GP of any blood test results performed. • Report adverse events to the need for sleep onset treatment CSM and GP. GP • Notify hospital within 14 days if not willing to prescribe MTX under shared care. • Continue to prescribe methotrexate in neurodevelopmental disabilitiesline with hospital recommendation (prescribe 2.5mg tablets only). To only prescribe melatonin second-line where non-pharmacological strategies have failed• Ensure that patient understands weekly dosing interval, and underlying physical causes are managed where they existwhich warning symptoms to report. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire • Request and monitor blood tests (see Appendix 1) page 4- monitoring requirements). • Record blood tests in the “Methotrexate patient held blood monitoring and sleep diary dosage record booklet” and practice computer system. • Refer back to hospital if results are not within the normal range, or if there is cause for concern (e.g. toxicity). • Encourage patient to attend reviews and alert secondary care if we know that they are not attending. • Monitor for drug interactions –see Appendix 2) highlighting problems with sleep latency. Consider and discuss treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. Obtain consent for the off label prescribing of melatonin. Perform baseline checks of physical health (including height, weight) Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets Assess and monitor the patient’s response to treatment and make dose adjustments where necessary. If treatment is ineffective and discontinued check for possible complications following discontinuation. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool (see attached) and advise GPs on this. Provide supervision and assessment of the patient during these periods. Ensure the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate under clinical information and individual patient information. Communicate • Adjust dose/ stop treatment changes to the GP promptly within Trust recommended timesas advised by specialist. Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. GP • Monitor the patient’s overall health and well-beingstatus. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and accepted. Refer patients back • Report adverse events to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristicsCSM. Advise patient to attend specialist appointments (at least annually). Re-refer Patient • Read the patient or seek specialist advice from information leaflet included with the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties. To report any adverse drug reactions to the psychiatrist medication and to the Medicines ‘Methotrexate patient held blood monitoring and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not under shared care. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. Parent, carer and patient Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. dosage record booklet’ • Attend relevant follow up appointments with psychiatrist (at least annually)and blood tests • Report any side effects or concerns you have to the Consultant, Nurse Specialist or GP • Show ‘Methotrexate patient held blood monitoring and dosage record booklet’ to any relevant health care professionals.

Areas of Responsibility. Consultant To assess the Provide shared care agreement to GP and retain recordPre-treatment checks: Consider possible drug interactions Conduct baseline tests (FBC, U&Es, creatinine, LFTs, ESR, CPR, CXR (If appropriate), Type III collagen propeptide (dermatology only). Lung function test if concern regarding pulmonary toxicity Patient education: Discuss benefits vs risks with patient. Issue / explain “Methotrexate patient held blood monitoring and establish the need for sleep onset treatment dosage record booklet” and importance of showing this to all healthcare professionals. Explain dose (in neurodevelopmental disabilitiesmgs and no. To only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying physical causes are managed where they exist. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire (see Appendix 1of 2.5mg tablets) and sleep diary once weekly administration. Ask patient to contact GP practice after one week to inform the practice that MTX has been started. Obtain patients consent if MTX is used for an unlicensed indication. Starting of treatment: Record baseline blood tests in “Methotrexate patient held blood monitoring and dosage record booklet” Issue hospital prescription(s) (see Appendix 2) highlighting problems with sleep latencyminimum 4 weeks). Consider Retain prescribing and discuss treatment optionsmonitoring responsibilities until patient is stabilised on treatment. This should include consideration Ask GP to continue prescribing and monitor blood results, providing details on dose, frequency, dose and timing of contra-indicationsany folic acid, interactions baseline test results, frequency of monitoring and cautions, a discussion next hospital review date. (OR send fully completed copy of “Initiation / transfer of Methotrexate prescribing agreement” form located at the reasons for treatment, the possible adverse effects and the lack start of information in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information this document to the parentsGP) Monitor efficacy, carers, inform GP of any dose changes and where appropriate the document changes in patient and answer their questions about melatoninheld record book. Obtain consent for the off label prescribing Inform GP of melatoninany blood test results performed. Perform baseline checks of physical health (including height, weight) Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets Assess and monitor the patient’s response to treatment and make dose adjustments where necessary. If treatment is ineffective and discontinued check for possible complications following discontinuation. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool (see attached) and advise GPs on this. Provide supervision and assessment of the patient during these periods. Ensure the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate clinical information and individual patient information. Communicate treatment changes Report adverse events to the GP. GPReturn completed shared care prescribing agreement to hospital and record on GP promptly clinical system Notify hospital within Trust recommended times. Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility for stopping the melatonin or 14 days if not willing to agree aftercare when the patient reaches 18 years of age. GP Monitor the patient’s overall health and well-being. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and accepted. Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristics. Advise patient to attend specialist appointments (at least annually). Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties. To report any adverse drug reactions to the psychiatrist and to the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not prescribe MTX under shared care. GPs may have other patients that Continue to prescribe methotrexate in line with hospital recommendation (prescribe 2.5mg tablets only). Explain to the patient the weekly dosing interval, and which warning symptoms to report. Request and monitor blood tests (see page 8- monitoring requirements). Record blood tests in the “Methotrexate patient held blood monitoring and dosage record booklet” and practice computer system. Refer back to hospital if results are either not being seen within the normal range, or if there is cause for concern (e.g. toxicity). Ensure patient is scheduled for and attends reviews in secondary care. Monitor for drug interactions –see under clinical information. Adjust dose/ stop treatment as advised by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such Monitor the patients following overall health status. Report adverse events to the advice in appendix 3 or may refer to a specialist for reviewand CSM. Parent, carer PatientRead the patient information leaflet included with the medication and ‘Methotrexate patient Complete a sleep questionnaire held blood monitoring and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. dosage record booklet’ Attend relevant follow up appointments with psychiatrist (at least annually)and blood tests Report any side effects or concerns you have to the Consultant, Nurse Specialist or GP Show ‘Methotrexate patient held blood monitoring and dosage record booklet’ to any relevant health care professionals.

Areas of Responsibility. Consultant To assess the patient and establish the need for sleep onset treatment in neurodevelopmental disabilities. To only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying physical causes are managed where they exist. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire (see Appendix 1) and sleep diary (see Appendix 2) highlighting problems with sleep latency. Consider and discuss treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. Obtain consent for the off label prescribing of melatonin. Perform baseline checks of physical health (including height, weight) ). Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets tablets. Assess and monitor the patient’s response to treatment and make dose adjustments where necessary. If treatment is ineffective and discontinued check for possible complications following discontinuation. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool (see attached) and advise GPs on this. Provide supervision and assessment of the patient during these periods. Ensure the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate clinical information and individual patient information. Communicate treatment changes to the GP promptly within Trust recommended times. Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. GP Monitor the patient’s overall health and well-being. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and accepted. Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristics. Advise patient to attend specialist appointments (at least annually). Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties. To report any adverse drug reactions to the psychiatrist and to the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not under shared care. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. Parent, carer and patient Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. Attend follow up appointments with psychiatrist (at least annually).

Areas of Responsibility. GP responsibilities Consultant To assess the responsibilities • Upon request, share relevant patient information to aid consultant in optimising patient care such as cardiac risk status, psoriasis, list of current medication, ensuring adequate contraceptive precautions in women. • Ensure medical record updated to clearly indicate secondary care co-prescribing whilst consultant stabilises dose. • Respond to shared care request and establish the need for sleep onset treatment in neurodevelopmental disabilitiesif agreed, prescribe lithium by brand name, noting any risk concerns, restrictions to supply quantity and target serum lithium level as advised by consultant. To only prescribe melatonin second-line where non-pharmacological strategies have failed, • Undertake monitoring of serum lithium levels and underlying physical causes are managed where they exist. To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire other parameters (see Appendix 14 vi below) such as renal & thyroid function and sleep diary (see Appendix 2) highlighting problems calcium levels. • Monitor for signs/symptoms of change in cardiac function & consult with sleep latencypsychiatrist to arrange ECG & to consider other potential causes if new signs of dysfunction arise. Consider • Copy reports of any monitoring to consultant & discuss how to manage any aberrant results. • Take serum lithium levels 12 to 16 hours after the last dose. Ensure full documentation on the request form of time & date of last dose and discuss blood sampling time to assure validity of results. • Have a system in place to ensure blood test results are reviewed before prescribing and that these and any changes to treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the reasons for treatment, the possible adverse effects and the lack of information are recorded in relation to longer-term outcomes including effectiveness and adverse effects. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. Obtain consent for the off label prescribing of melatonin. Perform baseline checks of physical health (including height, weight) Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets Assess and monitor the patient’s response ‘purple book’ or can be uploaded to treatment the ‘App’ by the patient. • Report unacceptable adverse effects promptlyto consultant. • Be aware of potential for drug interactions and make dose adjustments where necessarymonitor serum levels as appropriate (see 4 vii) • Avoid abrupt discontinuation unless indicated by toxicity or severe side effects. If patient does not attend for routine screening please seek support from neighbourhood team to facilitate. • Provide diagnosis. • Perform baseline tests, copy results to GP. Seek information from GP regarding any cardiac risk, psoriasis and list of current medication. • Discuss treatment is ineffective with patient including benefits, side- effects, blood tests, likely duration, increased relapse risk in bipolar disorder after rapid discontinuation or due to poor adherence. • Provide patient with lithium information, alert card and discontinued check for record book, ensuring details are recorded. Advise on the availability of a smartphone ‘App’ if the patient prefers. • Counsel women on necessary contraceptive precautions; liaise with GP/family planning. Advise women to discuss with consultant as soon as possible complications following discontinuationif becomes pregnant or planning pregnancy. Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep monitoring tool • Consider potential drug interactions. • Risk-assess patient, seeking cardiology opinion if ECG abnormal (see attached4 vi below). Risk-assess appropriate supply quantity (see referral criteria). • Start lithium; arrange for serum level and weight monitoring; titrate and stabilise dose. Inform and copy GP test & weight results during dose stabilisation period. • Ask GP if willing to share care. If agreed, transfer prescribing (by brand name) and monitoring of serum levels and other parameters (see 4 vi below) such as renal & thyroid function, calcium levels and new clinical signs/symptoms of cardiac dysfunction. • Indicate to GP the individual’s target serum lithium level and any restrictions to supply quantity. Advise GP of any risk assessment judgements made e.g. cardiac, overdose or medication interaction risks. • If care is not to be shared, undertake all monitoring and prescribing and copy GP in reports • Assess response in conjunction with adherence. • Evaluate and advise GPs on thisadverse events noted by GP or patient. Provide supervision • Respond to any discontinuation plan advised by consultant. • Discontinue shared care and assessment refer back to Consultant and to Perinatal psychiatrist if informed of pregnancy by patient. Inform midwife and ensure the patient during woman is received in consultant-led maternity care. • Report any adverse effects to the referring specialist and the MHRA yellow card scheme. • Promptly communicate any changes to GP and document these periodsin the patient’s hand held record (purple book) • Advise GP on when and how to discontinue treatment (see 4 iv below). Ensure • Undertake individual review on a case by case basis according to clinical need • Report any adverse effects to the patient is aware of the need to review the melatonin every 6 months. Provide the GP with appropriate clinical information and individual patient information. Communicate treatment changes MHRA yellow card scheme • Patients will only be referred to the GP promptly within Trust recommended timesonce the GP has agreed in each individual case, subject to receiving the relevant clinical information. Unlicensed formulations • The patient will be given a supply of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. To take responsibility Lithium Carbonate or Citrate sufficient for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. GP Monitor 4 weeks maintenance therapy except where the patient’s overall health risk assessment indicates a smaller quantity would be more appropriate. Patient responsibilities • Attend appointments and well-being. Review the patient in accordance with specialist advice every 6 months. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care have recommended tests at recommended intervals • Seek medical attention if they develop diarrhoea or vomiting or become acutely ill for any reason • Be aware of the patient has been transferred and accepted. Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial characteristics. Advise patient to attend specialist appointments (at least annually). Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, possible side-effects effects, especially signs of high lithium level and report promptly to professional involved with their care • Share any other concerns regarding lithium such as an incomplete understanding of their treatment, with professional involved with their care • Maintain their fluid intake, particularly after sweating (e.g. after exercise, in hot climates or swallowing difficultiesif they have a fever), if they are immobile for long periods or if they develop a chest infection or pneumonia. To report any adverse drug reactions • Women should talk to their doctor as soon as possible if they become pregnant or are planning a pregnancy • Seek advice before self-medicating with over the psychiatrist counter preparations. • Carry the lithium alert card. Keep the lithium record book (purple book*) in a safe place and show the alert card to healthcare professionals involved in their care. Take the record book with them to their GP, clinic appointments and to pharmacies when collecting lithium medication (or use the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the Yellow Card Scheme. xxxxx://xxxxxxxxxx.xxxx.xxx.xx/ Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital Pharmacy. Melatonin not under shared care. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. Parent, carer and ‘App’ if patient Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of treatment. Attend follow up appointments with psychiatrist (at least annuallyprefers).