lNATIONAL FUNDING/ACCESS DECISIONS
EPISTATUS OROMUCOSAL SOLUTION
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (November
2017 ) that midazolam oromucosal solution (Epistatus®)is
accepted for use within NHS Scotland for the treatment of
prolonged, acute, convulsive seizures in patients aged
10 years to less than 18 years.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution,
oromucosal solution, solution for injection, infusion, solution
for infusion
Solution for injection
▶Midazolam (Non-proprietary)
Midazolam (as Midazolam hydrochloride) 1 mg per
1mlMidazolam 5 mg/ 5 ml solution for injection ampoules|
10 ampouleP£ 16. 89 DT = £ 8. 18 c
Midazolam 2 mg/ 2 ml solution for injection ampoules|
10 ampouleP£ 5. 00 DT = £ 5. 00 c
Midazolam (as Midazolam hydrochloride) 2 mg per
1mlMidazolam 10 mg/ 5 ml solution for injection ampoules|
10 ampouleP£ 6. 75 DT = £ 6. 89 (Hospital only)c|
10 ampouleP£ 6. 94 DT = £ 6. 89 c
Midazolam (as Midazolam hydrochloride) 5 mg per
1mlMidazolam 50 mg/ 10 ml solution for injection ampoules|
10 ampouleP£ 33. 77 DT = £ 29. 41 c
Midazolam 10 mg/ 2 ml solution for injection ampoules|
10 ampouleP£ 7. 65 DT = £ 6. 02 c
▶Hypnovel(Roche Products Ltd)
Midazolam (as Midazolam hydrochloride) 5 mg per 1 mlHypnovel
10 mg/ 2 ml solution for injection ampoules| 10 ampouleP£ 7. 11
DT = £ 6. 02 c
Solution for infusion
▶Midazolam (Non-proprietary)
Midazolam (as Midazolam hydrochloride) 1 mg per
1mlMidazolam 50 mg/ 50 ml solution for infusion vials| 1 vialP
£ 9. 56 – £ 11. 00 c
Midazolam (as Midazolam hydrochloride) 2 mg per
1mlMidazolam 100 mg/ 50 ml solution for infusion vials| 1 vialP
£ 9. 05 – £ 12. 50 c
Oral solution
▶Midazolam (Non-proprietary)
Midazolam (as Midazolam hydrochloride) 2 mg per
1mlMidazolam 2 mg/ml oral solution sugar free sugar-free|
118 mlPsc
Oromucosal solution
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS:May contain Ethanol
▶Buccolam(Shire Pharmaceuticals Ltd)
Midazolam (as Midazolam hydrochloride) 5 mg per
1mlBuccolam 7. 5 mg/ 1. 5 ml oromucosal solution pre-filled oral
syringes sugar-free| 4 unit doseP£ 89. 00 DT = £ 89. 00 c
Buccolam 10 mg/ 2 ml oromucosal solution pre-filled oral syringes
sugar-free| 4 unit doseP£ 91. 50 DT = £ 91. 50 c
Buccolam 5 mg/ 1 ml oromucosal solution pre-filled oral syringes sugar-
free| 4 unit doseP£ 85. 50 DT = £ 85. 50 c
Buccolam 2. 5 mg/ 0. 5 ml oromucosal solution pre-filled oral syringes
sugar-free| 4 unit doseP£ 82. 00 DT = £ 82. 00 c
▶Epistatus(Special Products Ltd)
Midazolam (as Midazolam maleate) 10 mg per 1 mlEpistatus
10 mg/ 1 ml oromucosal solution pre-filled oral syringes sugar-free|
1 unit doseP£ 45. 76 DT = £ 45. 76 c
2 Mental health disorders
2.1 Attention deficit
hyperactivity disorder
Attention deficit hyperactivity
disorder 01-Sep-2017
Description of condition
Attention deficit hyperactivity disorder (ADHD) is a
behavioural syndrome characterised by hyperactivity,
impulsivity and inattention, which can lead to psychological,
social, educational or occupational impairment. While these
symptoms tend to co-exist, some people are predominantly
hyperactive and impulsive, while others are principally
inattentive. Symptoms typically appear in children 3 – 7 years
of age, but may not be recognised until after 7 years of age,
especially if the predominant trait is inattention.
ADHD is usually a persisting disorder. Most older children
with a sustained diagnosis will go on to have difficulties in
adulthood, which may include continuing ADHD, personality
disorders, emotional and social difficulties, and substance
misuse.Aims of treatment
The aims of treatment are to reduce functional impairment
and the severity of symptoms, and to improve quality of life.Non-drug treatment
gChildren and their carers should be advised about the
value of a balanced diet, good nutrition and regular exercise.
h
Parent-training is an intervention that teaches parents
and carers to use behaviour therapy techniques with their
child.gInpre-schoolchildren, parent-training/education
programmes for the child’s carers is thefirst-line
recommendation for management. Group-based
training/education programmes are recommended for carers
ofschool-agedchildren with moderate or severe impairment.
Drug treatment should be reserved for school-aged
children with severe symptoms and impairment or for those
with moderate levels of impairment who have refused or not
responded sufficiently to non-drug interventions.hDrug treatment
gIn school-age children presenting with severe
impairment, drug treatment should be initiated by a
specialist. Continued prescribing and monitoring of drug
treatment can be performed by general practitioners, under
shared care arrangements.
Methylphenidate hydrochloride p. 227 , atomoxetine
p. 226 or dexamfetamine sulfate p. 229 are recommended for
management in children. Drug choice should be based on the
presence of comorbid conditions (e.g. tic disorders,
Tourette’s syndrome, epilepsy—also, see below), adverse
effect profile, issues regarding compliance, the potential for
drug diversion (drugs being forwarded to others for non-
prescription use or misuse), and child or carer preference.
Methylphenidate hydrochloride p. 227 should be
considered for ADHD without significant comorbidity or
ADHD with comorbid conduct disorder. Methylphenidate
hydrochloride or atomoxetine p. 226 should be considered
when tics, Tourette’s syndrome, anxiety disorder, stimulant
misuse or risk of drug diversion are present. Atomoxetine
should be used if methylphenidate hydrochloride has been
tried and has been ineffective at the maximum tolerated
dose, or the child is intolerant to low or moderate doses of
methylphenidate hydrochloride p. 227.BNFC 2018 – 2019 Attention deficit hyperactivity disorder 225
Nervous system4