ADHD Prescribing Protocol

Introduction

This protocol provides prescribing and monitoring guidance for diagnosis and pharmacological treatemnt of ADHD. For prescribing information refer to Summary of Product Characteristics (SPC) and the BNF. This protocol has been produced following NICE guidance issued in 2018 on the diagnosis and management of ADHD (NG87).

Risk Assessment for Primary Care

NICE guidelines state that the assessment, diagnosis and ongoing management, including shared-care prescribing, for ADHD must be made in secondary care by specialists only. However, over a prolonged period NHS waiting times for assessment, diagnosis and treatment of ADHD has been long (generally about a year) and the situation has been exacerbated by the COVID-19 pandemic so waiting lists are currently up to 4 years. In July 2021, a risk assessment was carried out by BHWC (Brighton Health and Wellbeing Centre) – prior to the merger with Benfield Valley Healthcare Hub into the new organisation as WellBN – clinical members taking into account risks/harm to individual from delays in diagnosis and treatment, use of practice systems and in-house support, and pre-existing guidance. It was concluded that there is a desperate need for initiating ADHD medication in primary care to mitigate the impact of these serious delays leading to associated morbidity and societal impacts such as negative employment/educational effects or relationship problems, for example. However this can only be done if prescribers feel confident and competent to take on the clinical and legal responsibility for the prescribing and the monitoring of these drugs, and in accordance with the protocol set out in this policy. In September 2022, a policy review by the clinical WellBN partners due to safety concerns highlighted the need for additional training to support clinicians making diagnoses and prescribe within the practice. Therefore, only those clinicians who have attended an approved training course (e.g. UKAAN) can diagnose after assessment using a validated interview assessment tool with appropriate documentation and any other necessary medical checks. It is also recommended that anyone prescribing should complete an approved ADHD prescribing course (e.g.UKAAN). 

Prescribing

The prescriber legally assumes clinical responsibility for the drug and the consequences of its use. Any associated monitoring is the responsibility of the prescriber. Note that the pharmacy team will have strict processes in place and ensure reviews and monitoring is met.

Background

ADHD is a common neurodevelopmental disorder characterised by inappropriate levels of activity and impulsivity and an impaired ability to sustain attention. Those affected have difficulty regulating their activities to conform to expected norms, and often fail to achieve their potential. Many have comorbid difficulties such as developmental delays, specific learning problems and other emotional and behavioural disorders. Severe ADHD may be diagnosed as hyperkinetic disorder, which is characterised by a more severe disturbance with significant hyperactivity. Although ADHD begins in childhood, research has shown that it can continue through to adulthood for some. Approximately 15% of children with ADHD retain the diagnosis by age 25. A much larger proportion (65%) are in partial remission, with persistence of some symptoms associated with continued impairment. In adults, social and occupational problems can be caused by difficulties in concentrating, paying attention to detail and completing tasks, together with impulsivity and an inability to plan ahead. Moreover, ADHD is commonly associated with mental health, addiction or behavioural problems.

The NICE ADHD guidelines (NG87) state that a diagnosis of ADHD in children, young people and adults should only be made by a paediatrician, specialist psychiatrist, or other appropriately qualified healthcare professional with training and expertise in the diagnosis of ADHD. For a diagnosis of ADHD, based on a complete history and evaluation of the patient, symptoms of hyperactivity/impulsivity and/or inattention should: meet the diagnostic criteria in DSM-V or ICD-10 (hyperkinetic disorder), AND be associated with at least moderate psychological, social and/or educational OR occupational impairment based on interview and/or direct observation in multiple settings, AND be pervasive, occurring in two or more important settings including social, familial, educational and/or occupational settings.

Drug treatment in ADHD is used for the control of symptoms but is not curative. In the UK, methylphenidate, atomoxetine, lisdexamfetamine and guanfacine (we will not be prescribing guanfacine nor initiating atomoxetine at WellBN) are licensed for the management of ADHD in children and young people from the age of six years. 

Dexamfetamine oral solution is licensed for hyperkinetic states from three years of age, although NICE do not recommend drug treatment in those aged under 5 years of age.

Some modified release methylphenidate products are also licensed for use in adults with persisting symptoms, where they were initiated in childhood and showed clear benefit.

Atomoxetine and lisdexamfetamine are both licensed for initiation in adults, where the presence of ADHD symptoms in childhood are confirmed. Guanfacine is licensed for six to 17 year olds for whom stimulants are not suitable. It is not licensed for use in combination with stimulants or for adults with ADHD. It should be noted that Guanfacine is classed as a ‘red’ drug across Brighton and Hove and therefore is not for primary care prescribing.

Prescribing

All Prescribers should have good knowledge of the medicines used for the treatment of ADHD and their different preparations, including their pharmacokinetic profiles, thus allowing treatment to be tailored effectively to an individual (refer to BNF and relevant SPCs). A training session has been arranged for the pharmacy team to ensure monitoring is completed and it is recommended that all prescribers ensure they update their knowledge.

All prescribers:

• Should be aware that effect size, duration of effect and adverse effects vary from person to person.
• Should think about using immediate and modified release (m/r) preparations to optimise effect (e.g. m/r preparation of methylphenidate in the morning and an immediate-release preparation of methylphenidate at another time of the day to extend the duration of effect).
• Must be cautious about prescribing stimulants if there is a risk of diversion, for cognitive enhancement or appetite suppression.
• Must NOT offer immediate-release or m/r stimulants that can be easily injected or insufflated, if there is a risk of stimulant misuse or diversion.
• Should be familiar with the requirements of CD legislation governing the prescription and supply of (prescribing of CDs should not exceed 30 days in duration).

Prescription

First prescription should be on “acute” in order to facilitate a review and avoid unmonitored prescribing

Titrate the dose against symptoms and adverse effects in line with the BNF or BNF for Children until dose optimisation is achieved, that is, reduced symptoms, positive behaviour change, improvements in education, employment and relationships, with tolerable adverse effects. Ensure that dose titration is slower and monitoring more frequent if any of the following are present:

• Neurodevelopmental disorders, e.g. autism spectrum disorder, tic disorders, learning disability (intellectual disability);
• Mental health conditions e.g. anxiety disorders (including obsessive–compulsive disorder), schizophrenia or bipolar disorder, depression, personality disorder, eating disorder, post-traumatic stress disorder, substance misuse;
• Physical health conditions, e.g. cardiac disease, epilepsy or acquired brain injury.

After titration and dose stabilisation, add the medication and dose to the repeat template so the pharmacy team can continue to issue and monitor. Effects and side-effects of drug treatment must be routinely monitored and recorded in the relevant electronic patient record (EPR).

Choice of medication

Young adults (16 & 17 years old)

First-line: Offer methylphenidate (either short or long acting) for ADHD symptoms that are still causing a persistent significant impairment in at least one domain e.g. interpersonal relationships, education and occupational attainment, and risk awareness, after parents have received ADHD-focused information, group-based support has been offered and environmental modifications have been implemented and reviewed.

Second-line: Consider switching to lisdexamfetamine for young adults who have had a 6-week trial of methylphenidate at an adequate dose and not derived enough benefit in terms of reduced ADHD symptoms and associated impairment.

Alternative second-line (reserved for when ADHD symptoms are responding to lisdexamfetamine but cannot tolerate the longer effect profile): Consider dexamfetamine  Third-line: Offer atomoxetine (shared care) OR guanfacine (specialist supply only) if:

• They cannot tolerate methylphenidate or lisdexamfetamine, OR
• Symptoms have not responded to separate 6-week trials of lisdexamfetamine and methylphenidate, having considered alternative preparations and adequate doses.

Adults

First-line: Offer methylphenidate.

Second-line: Consider switching to lisdexamfetamine for adults who have had a 6-week trial of methylphenidate at an adequate dose but have not derived enough benefit in terms of reduced ADHD symptoms and associated impairment.

Alternative second-line (reserved for when ADHD symptoms are responding to lisdexamfetamine but cannot tolerate the longer effect profile): Consider dexamfetamine.

Third-line: Offer atomoxetine to adults if they:

• Cannot tolerate methylphenidate or lisdexamfetamine, OR
• Have symptoms that have not responded to separate 6- week trials of methylphenidate and lisdexamfetamine, having considered alternative preparations and doses.

People with coexisting conditions

• Offer the same medication choices to people with ADHD and anxiety disorder, tic disorder or autism spectrum disorder as other people with ADHD.
• For young adults (16 & 17 years old) and adults experiencing an acute psychotic or manic episode: stop any medication for ADHD and consider restarting or starting new ADHD medication after the episode has resolved, taking into account the individual circumstances, risks and benefits of the ADHD medication.

Assessment & Diagnosis

1. GP to confirm a diagnosis of ADHD in young adults (aged 16 & 17 years) and adults following an initial discussion about the pathway and expectations with a full baseline assessment in an appointment with sufficient time (total 1 hour): which will be split between a 15-20 minute initial appointment then a 40-45 minute assessment appointment a week or two later.
2. Diagnosis of ADHD is based on an assessment through history and examination using a validated tool – DIVA 2.0 (Diagnostic Interview for ADHD in Adults) – to document evidence against DSM-IV diagnostic criteria from adulthood and childhood across multiple functional domains.
3. Diagnostic screening tools – ADHD Self-Reporting Scale (ASRS) or ADHD Wender-Utah Rating Scale (AWURS) – can be used prior to formal assessment to assist with diagnosis, whilst waiting for an appointment.
4. Use the DIVA 2.0 in-house template on SystmOne to record diagnostic information.
5. Use the Ardens ADHD template on SystmOne in the patient’s electronic medical record for all other parts of the patient’s assessment and reviews.
6. Record the diagnosis Read code on the patient’s medical records as a major problem in the summary – options are listed within the DIVA 2.0 template.
7. Consider other diagnoses which have an association with ADHD – autistic spectrum disorder, hypermobility syndromes, dyslexia, dyscalculia.
8. Consider other diagnoses which may present with similar features to ADHD – bipolar disorder, depression, anxiety, personality disorders.
9. Assessment of mood (depression and anxiety) using the PHQ2, PHQ9 and GAD7 scores is necessary.
10. Record a mental health risk assessment regarding harm to self, including suicide risk, and risk to others using the embedded tool within the Ardens ADHD template.
11. Discuss all therapeutic interventions as outlined in the NICE ADHD Guidelines (NG87) which recommends non-pharmacological therapies principally with support from pharmacological interventions if necessary based on patient preference and severity of symptoms or impact.
12. Signposting to other services to support non-pharmacological therapeutic interventions as outlined in the NICE guidelines, e.g. local social prescribing support, HERA project in-house wellbeing support, newly developed ‘ADHD flower’ of interventions, counselling, support groups (ADHD Aware and The UK ADHD Partnership).
13. Information provided on what to do in a crisis (A&E or MHRSS) or contacting GP/NHS111.
14. If appropriate, decide on the most appropriate drug treatment and discuss benefits and side-effects with the patient and/or parent(s)/carer(s) and provide written information where appropriate. In the case of atomoxetine, this should also include an explanation of the very rare risk of adverse hepatic reactions, what symptoms to look out for and what action to take should they occur.
15. Provide pre-treatment counselling to the patient (and parent(s)/carers). This should include both written and verbal information on the rationale for treatment, benefits, time to response, potential side-effects and precautions, and obtain agreement to initiate treatment.
16. Document all discussions in their electronic patient medical records.
17. Carry out baseline monitoring which must be recorded in their electronic patient medical records on the Ardens ADHD template in SystmOne, and on the relevant section i.e. ADHD formulary sub-template for pulse, rhythm, blood pressure, height and weight and BMI, including ECG if appropriate, use of growth charts in adolescents (see Ongoing Monitoring Schedule below).
18. Refer to neurobehavioural services as usual in order to follow NICE Guideline NG87 outlining the patient’s assessment and management.

Initial prescription appointment

1. Prescribe on “acute” to initiate ADHD medication and inform GP of commencement of treatment.
2. Adhere to the specific regulations for prescribing of methylphenidate, dexamfetamine and lisdexamfetamine which are controlled drugs.
3. Prescriptions for methylphenidate, dexamfetamine and lisdexamfetamine are only valid for dispensing within 28 days from the date of signature and unless there are exceptional circumstances, each prescription should be for no more than 30 days supply.
4. Give consideration to specific school policies on the use of medicines in schools if multiple daily doses in school age children are required.
5. Provide advice on adverse effects.
6. Provide advice on drug interactions with prescription and OTC medication.
7. Book in for review at 4 weeks.

Dose stabilisation appointments

1. Monitor effectiveness of medication and adverse effects.
2. Titrate initial dose against symptoms and side-effects over 4 - 6 weeks until dose optimisation has been reached and the patient’s condition is stable.
3. Issue second prescription on acute (if needed).
4. At/after week 12 when patient and if patient stabilised on treatment. i.e., drug tolerated, dose stabilised and blood monitoring parameters are satisfactory, the medication can be added to repeat template and pharmacy team will take over repeat prescribing and monitoring.
5. Record symptoms and side-effects at each dose change.
6. The prescriber may want to continue monitoring the patient’s progress by maintaining close clinical contact by means of a telephone rand this may be beneficial for some patients.
7. Monitor for the development of new seizures or a worsening of existing seizures at every dose adjustment and then at least six-monthly for young adults and review the medication.
8. Monitor behavioural response to treatment and adjust medication as deemed appropriate.
9. Monitor changes in sleep pattern and adjust medication accordingly.
10. Inform patient that if they do not adhere to the follow-up plan at least once every 6 months, (12 months for adults) we will not be able to continue to prescribe medication.

Review

• Patient should be booked in for monitoring of blood pressure, pulse, weight, height (children/adolescents) and BMI prior to GP review.
• Young adults (16 & 17 years old) should be reviewed by a GP at least every 6 months.
• Adults to be reviewed by a GP annually.
• The review should include a comprehensive assessment of clinical need, benefits and side-effects of medication.
• Follow up appointments should be arranged at their review.
• Monitor frequency of prescription requests and contact prescriber if quantities in excess.
• Monitor for changes in the potential for substance misuse and diversion.
• Consider strategies to reduce weight loss if this is a concern.
• If a young adult’s height over time is significantly affected by medication, i.e. they have not met the height expected for their age, consider a planned break in treatment over school holidays to allow 'catch-up' growth.
• For adults, or young people after transition to adult services, adult services healthcare professionals should carry out a comprehensive assessment of the person with ADHD that includes personal, educational, occupational, and social functioning, and assessment of any co-existing conditions, especially drug misuse, personality disorders, emotional problems and learning difficulties.
• Take responsibility for stopping treatment if appropriate, including any treatment breaks. The effect of missed doses, planned dose reductions and brief periods of no treatment should be considered for all treatments.

Common side effects

Methylphenidate:

insomnia, nervousness, headache, decreased appetite, abdominal pain and other gastrointestinal symptoms, and cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure.

Lisdexamphetamine:

insomnia, nervousness, headache, decreased appetite, abdominal pain and other gastrointestinal symptoms, and cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure.

Dexamphetamine

insomnia, nervousness, headache, decreased appetite, abdominal pain and other gastrointestinal symptoms, and cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure.

Dosages

Methylphenidate

Young adults (16&17 years old)

Immediate release (IR) formulations

5mg once or twice daily (breakfast and lunch), increasing daily dose by weekly increments of 5-10mg. Licensed max. dose 60mg daily

Modified release (MR) formulations

Delmosart XL 18mg once daily in the morning, increased in steps of 18mg every 1 week, then adjusted according to response. Licensed max. dose 54mg daily (preferred brand choice)

Concerta XL 18mg once daily in the morning, increased in steps of 18mg every 1 week, then adjusted according to response. Licensed max. dose 54mg daily

Equasym XL 10mg once daily in the morning, before breakfast, increased at weekly intervals if necessary. Licensed max. dose 60mg daily

Medikinet XL 10mg once daily in the morning, with breakfast, adjusted at weekly intervals according to response. Licensed max. dose 60mg daily

IR formulations:

Ritalin® 10mg Medikinet® 5mg, 10mg and 20mg tablets (preferable during initial dose titration, particularly if flexible dose regime required)

MR formulations*:

Delmosart® XL (18mg, 27mg, 36mg and 54mg tablets) (preferred brand choice)

Concerta XL® (18mg, 27mg, 36mg and 54mg tablets) Equasym XL® (10mg, 20mg and 30mg capsules)

Medikinet XL® (10mg, 20mg, 30mg and 40mg capsules)

*MR preparations should be prescribed by BRAND to ensure correct formulation is dispensed.

MR formulations may be preferred over IR formulations due to convenience, improving adherence, reducing stigma (no need to take medication at school or in the workplace), reducing problems of storing and administering CDs at school, the risk of stimulant misuse and diversion with immediate release preparations, pharmacokinetic profiles.

The different types of products are not interchangeable and the BNF recommends prescribing by brand name to avoid the risk of de-stabilisation from different release characteristics of the XL products dispensed generically.

Adults:

(unlicensed for initiation in adults)

Begin with low doses (5 mg three times daily for IR formulations or the equivalent MR dose) Increase dose according to response up to a maximum of 100 mg/day. (Higher doses by specialist only )

Lisdexamphetamine

Young adults (16 & 17 years old)

Initially 30mg once daily in the morning, increased in steps of 20mg every 1 week if required. Maximum dose 70mg/day

Adults: (licensed in adults)

Initially 30mg once daily in the morning, increased in steps of 20mg every 1 week if required. Maximum dose 70mg/day

Formulations available:

Elvanse® 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules

Elvanse Adult® 30mg, 50mg and 70mg capsules

Elvanse is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate

Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults

Monitoring

Baseline

Document all ADHD reviews on the patient’s electronic medical record using the Ardens ADHD template and other relevant templates.

A review of mental health and social circumstances, including:

• presence of co-existing mental health and neurodevelopmental conditions
• current educational or employment circumstances
• risk assessment for substance misuse and drug diversion
• care needs

A review of physical health, including:

• a medical history, considering conditions that may be contraindications for specific medicines
• current medication
• height, weight and BMI (measured and recorded against the normal range for age and gender)
• baseline pulse and blood pressure (BP)
• a cardiac examination (including checking for murmurs)
• an ECG (some treatments may affect the QT interval but we keep a low threshold and monitor all patients) 

Ongoing Monitoring

Ongoing monitoring by the GP and pharmacist must be through the Ardens ADHD template and ADHD formulary sub-template.

Height (under 18s only) – 6 monthly – If growth is affected significantly, consider a break in drug treatment over the school holidays to allow “catch-up” growth.

Weight, BMI and appetite – 6 monthly – Monitor weight more frequently than 6 monthly if concerns arise. Discuss strategies to reduce weight loss or manage decreased weight gain.

Heart rate – 6 monthly and before and after each dose change – If there is sustained resting tachycardia (more than 120 beats per minute) or arrhythmia measured on 2 occasions, reduce the dose of medication and refer to a paediatric cardiology specialist.

Blood pressure – 6 monthly and before and after each dose change – If systolic blood pressure >95^th percentile (or a clinically significant increase) measured on two occasions, reduce the dose of medication and refer to a hypertension/cardiology specialist.

Patients should be monitored for the risk of diversion, misuse and abuse of CNS stimulants.

Monitor for changes in the potential for drug misuse and diversion, which may come with changes in circumstances and age.

Clinical system searches within SystmOne will be used to assist the monitoring and reviews and will be overseen by the Lead Pharmacist and IT Lead.

Seeking Support or Specialist Guidance/Referral

Certain situations will require further advice from secondary care specialists as outlined above, or for significant adverse drug reactions, or if there is doubt about the diagnosis.

If in doubt or there is lack of confidence in managing ADHD or individual patient, do not initiate treatment but discuss in-house with colleagues at the weekly practice clinical meeting.

Patients who do not attend regular planned reviews may have their prescribing suspended or stopped which will need to be communicated to the patient outlining the risks of not monitoring and documenting within their electronic patient records. Additionally cases should be discussed within the weekly practice clinical meeting to facilitate consistency in care and managing risk.

The WellBN ADHD Protocol was written by Lead Pharmacist Shilpa Patel & Dr Francis Richards 18th July 2021. Reviewed by Shilpa Patel & Dr Sam Hall & Dr Francis Richards 13th April 2022 Reviewed by Dr Peter Devlin September 2022 Reviewed and updated 30th January 2023 by Dr Francis Richards