Common use of Monitoring Frequency Clause in Contracts

Monitoring Frequency. Blood pressure and heart rate, and assessment for cardiovascular signs or symptoms • Assessment for new or worsening psychiatric and neurological signs or symptoms (e.g. tics, anxiety, symptoms of bipolar disorder) • Explore whether patient is experiencing any difficulties with sleep Every 6 months, and after any change of dose recommended by specialist team. • Weight and appetite • Every 3 months in children 10 years and under • at 3 and 6 months after starting treatment in children over 10 years and young people, and every 6 months thereafter, or more often if concerns arise • every 6 months in adults (Monitor BMI) • Height every 6 months in children and young people plot height and weight of children and young people on a growth chart and ensure review by the healthcare professional responsible for treatment • Assessment of adherence, and for any indication of methylphenidate abuse, misuse, or diversion As required, based on the patient’s needs and individual circumstances • Review to ensure patient has been offered and attended an annual review with a healthcare professional with expertise in ADHD Annually Adverse effects and other management Back to top Any serious adverse reactions should be reported to the MHRA via the Yellow Card scheme. Visit ▇▇▇.▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇▇▇‌ For information on incidence of ADRs see relevant summaries of product characteristics Cardiovascular Resting HR greater than 120bpm, arrhythmia/palpitations, clinically significant increase in systolic BP • In context of recent dose increase, revert to previous dose and discuss with specialist for ongoing management • In absence of recent dose changes, reduce dose by half and discuss with specialist or cardiology for further advice. Weight or BMI outside healthy range, anorexia or weight loss Exclude other reasons for weight loss. Give advice as per NICE NG87: • take medication with or after food, not before • additional meals or snacks early in the morning or late in the evening when stimulant effects have worn off • obtaining dietary advice • consuming high-calorie foods of good nutritional value Discuss with specialist if difficulty persists; dose reduction, treatment break, or change of medication may be required. If a child or young person's height over time is significantly affected by medication (that is, they have not met the height expected for their age), consider a planned break in treatment over school holidays to allow 'catch-up' growth. Haematological disorders Including leukopenia, thrombocytopenia, anaemia or other alterations NB: no haematological monitoring is recommended. Haematological disorders would be a chance finding/due to patient reporting adverse drug reactions. Contact specialist team. Discontinuation should be considered. Referral to haematology may be warranted; use clinical discretion. Psychiatric disorders New or worsening psychiatric symptoms, e.g. psychosis, mania, aggressive or hostile behaviour, suicidal ideation or behaviour, motor or verbal tics (including Tourette’s syndrome), anxiety, agitation or tension, bipolar disorder, depression Discuss with specialist. Stop treatment and consider referral to acute mental health team if suicidal thoughts, mania, or psychosis are present. Methylphenidate should not be continued unless the benefits outweigh the risks. Nervous system disorders Symptoms of cerebral ischaemia, e.g. severe headache, numbness, weakness, paralysis, and Discontinue methylphenidate, refer urgently for neurological assessment New or worsening seizures Discontinue methylphenidate. Discuss with specialist team. Symptoms of serotonin syndrome, e.g. agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, rigidity, nausea, vomiting, diarrhoea Discontinue methylphenidate as soon as possible. Management depends on severity; use clinical judgement and seek advice if necessary. Discuss with specialist team to determine whether methylphenidate can be re-started. Insomnia or other sleep disturbance Review timing of methylphenidate dose and advise as appropriate. Give advice on sleep hygiene. Discuss with specialist if difficulty persists; dose reduction may be required. Suspicion of abuse, misuse, or diversion Discuss with specialist team. Pregnancy, paternal exposure and breast feeding Back to top It is the responsibility of the specialist to provide advice on the need for contraception to male and female patients on initiation and at each review, but the ongoing responsibility for providing this advice rests with both the primary care prescriber and the specialist. Refer to Summary of Product Characteristics (SmPC) [methylphenidate] and BNF/BNFC for comprehensive information. Additional information Back to top Where patient care is transferred from one specialist service or GP practice to another, a new shared care agreement should be completed. Ensure that the specialist is informed in writing of any changes to the patient’s GP or their contact details. References Back to top

Monitoring Frequency. Blood pressure and heart rate, and assessment for cardiovascular signs or symptoms • Assessment for new or worsening psychiatric and neurological signs or symptoms (e.g. tics, anxiety, symptoms of bipolar disorder) • Explore whether patient is experiencing any difficulties with sleep Every 6 months, and after any change of dose recommended by specialist team. • Weight and appetite • Every 3 months in children 10 years and under • at 3 and 6 months after starting treatment in children over 10 years and young people, and every 6 months thereafter, or more often if concerns arise • every 6 months in adults (Monitor BMI) • Height every 6 months in children and young people plot height and weight of children and young people on a growth chart and ensure review by the healthcare professional responsible for treatment • Assessment of adherence, and for any indication of methylphenidate dexamfetamine abuse, misuse, or diversion As required, based on the patient’s needs and individual circumstances • Review to ensure patient has been offered and attended an annual review with a healthcare professional with expertise in ADHD Annually Adverse effects and other management Back to top Any serious adverse reactions should be reported to the MHRA via the Yellow Card scheme. Visit ▇▇▇.▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇▇▇‌ For information on incidence of ADRs see relevant summaries of product characteristics Cardiovascular Resting HR greater than 120bpm, arrhythmia/palpitations, clinically significant increase in systolic BP • In context of recent dose increase, revert to previous dose and discuss with specialist for ongoing management • In absence of recent dose changes, reduce dose by half and discuss with specialist or cardiology for further advice. Weight Anorexia or weight loss, weight or BMI outside healthy range, anorexia or range Exclude other reasons for weight loss loss. Exclude other reasons for weight loss. Give advice as per NICE NG87: • take medication with or after food, not before • additional meals or snacks early in the morning or late in the evening when stimulant effects have worn off • obtaining dietary advice • consuming high-calorie foods of good nutritional value Discuss with specialist if difficulty persists; dose reduction, treatment break, or change of medication may be required. If a child or young person's height over time is significantly affected by medication (that is, they have not met the height expected for their age), consider a planned break in treatment over school holidays to allow 'catch-up' growth. Haematological disorders Including leukopeniaInsomnia, thrombocytopeniasleep disturbance/nightmares, anaemia or other alterations NB: no haematological monitoring is recommendedsedation, sexual dysfunction Review timing of doses and continue treatment unless severe, Give advice on sleep hygiene. Haematological disorders would be a chance finding/due to patient reporting adverse drug reactionsDiscuss with specialist if required Nausea, diarrhoea, abdominal cramps, constipation, dry mouth, headache, dizziness, enuresis, increased daytime urination, tics Continue treatment unless severe. Contact specialist team. Discontinuation should be considered. Referral to haematology Some symptoms may be warranted; use clinical discretionalleviated by concomitant food intake. Psychiatric disorders Discuss with specialist if required New or worsening psychiatric or neuropsychiatric symptoms, e.g. psychosis, mania, aggressive or hostile behaviourdepression, suicidal ideation or behaviourparanoia, motor or verbal tics (including Tourette’s syndrome), anxiety, agitation or tension, bipolar disorder, depression anxiety and agitation. NB: psychosis may occur following consumption of very high doses. Discuss with specialist. Stop treatment and consider referral to acute mental health team if suicidal thoughts, mania, or psychosis are present. Methylphenidate should not be continued unless the benefits outweigh the risks. Nervous system disorders Symptoms of cerebral ischaemia, e.g. severe headache, numbness, weakness, paralysis, and Discontinue methylphenidate, refer urgently for neurological assessment present New or worsening seizures Discontinue methylphenidateStop dexamfetamine and discuss with specialist. Discuss with specialist teamDiscontinuation may be indicated. Symptoms of serotonin syndrome, e.g. agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, rigidity, nausea, vomiting, diarrhoea Discontinue methylphenidate dexamfetamine as soon as possible. Management Man agement depends on severity; use clinical judgement and seek advice if necessary. Discuss with specialist team to determine whether methylphenidate dexamfetamine can be re-started. Insomnia or other sleep disturbance Review timing of methylphenidate dose and advise as appropriate. Give advice on sleep hygiene. Discuss with specialist if difficulty persists; dose reduction may be required. Suspicion of abuse, misuse, or diversion Discuss with specialist team. team Pregnancy, paternal exposure and breast feeding Back to top It is the responsibility of the specialist to provide advice on the need for contraception to male and female patients on initiation and at each review, but the ongoing responsibility for providing this advice rests with both the primary care prescriber and the specialist. Refer to Summary of Product Characteristics (SmPC) [methylphenidatedexamphetamine] and BNF/BNFC for comprehensive information. Additional information Back to top Where patient care is transferred from one specialist service or GP practice to another, a new shared care agreement should be completed. Ensure that the specialist is informed in writing of any changes to the patient’s GP or their contact details. Risk minimisation materials for Amfexa® can be found here. References Back to top