How Specials Can Deliver Value to the NHS

CASE STUDY 5 Quality of life in ADHD Background An unlicensed sleep disorder treatment is prescribed to many people in the UK and is heavily imported. Sleep disorders such as problems getting to sleep or staying asleep are more common in children with attention deficit hyperactivity disorder (ADHD). ADHD is estimated to affect up to 3% of school-age children and young people in the UK making it one of the most common behavioural disorders affecting this age group21. Although one sleep disorder treatment product is licensed for use in treating sleep disorders in the UK, it is not licensed for use in people aged under 5522. Immediate release preparations are often not suitable for ADHD. During 2011, melatonin was the third most imported drug and in 2012, the fourth most imported. These preparations, despite the quality assurance checks in place, could be sub-standard products produced in non-GMP environment with up to 13% tolerance on active ingredients. This sleep disorder treatment is used therapeutically for children with ADHD to aid sleep. Without availability the impact is wide-ranging, affecting the ability to learn as well as the wider family (lack of sleep, stress, inability to work, etc). A child was given an imported unlicensed product and the parents noted a lack of effectiveness within a week. The sleep disorder treatment no longer seemed to work. The pharmacist reviewed the imported source and changed to a UK-based unlicensed Special product. Control of the child’s ADHD was resumed and the melatonin worked once more. The child’s ADHD was treated effectively. Quality of life in ADHD LOWEST RISK/PREFERRED CHOICE UK-licensed medicine Licensed formulation not available Off-label use of UK-licensed medicine Imported product licensed in (approved) country of origin High cost of imported product to NHS UK-manufactured Special in MHRA-licensed facilities Child’s sleep was controlled with consistent dose An extemporaneously dispensed medicine An imported product not licensed in the country of origin Crushing or splitting licensed tablets or capsules A non-UK-made unlicensed medicine or food supplement 16 HIGHEST RISK/LAST CHOICE Adapted from RPS practical guidelines on supplying Specials Hierarchy may alter in particular patient groups; for example, neonates Low quality import had no effect resulting in severe lack of sleep for child and parents

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