Abstract

Introduction
Children with neurodevelopmental conditions, such as autism and other neurodivergence, commonly experience sleep difficulties [1]. This can have a significant impact on the child’s cognition, behaviour and on the quality of life of other family members. Melatonin has been shown to improve sleep in autistic children and be a lifeline for parents and caregivers [2]. However, little is known about the accessibility of this treatment.
Aim
To understand the variation in guidance for prescribing Melatonin between Integrated Care Systems (ICS’s) in England
Methodology
A systematic approach was used to identify the status of melatonin prescribing in formularies across England using Google search. This included using key phrases to identify the Area Prescribing Formulary (APFs) for the 42 ICS areas across England. Searches were conducted independently by two authors. Once identified, a data extraction form was used to collect data from the formulary relating to Melatonin prescribing. Formularies listed Melatonin as a ‘Green’, ‘Amber’ or ‘Red’ drug, where Green drugs can be prescribed in primary care, Amber drugs must be initiated by specialists and then a Shared Care Agreement is used so prescribers in primary care can continue the medication; and Red drugs must only be prescribed by hospital specialists. Data was pooled, cleaned and analysed using descriptive statistics to identify patterns, similarities and differences in information included in APFs about melatonin. Ethical approval was not required for this study.
Results
Regional guidance was identified in 40/42 areas. Thirty-six areas listed Melatonin as an Amber drug, requiring a Shared Care Agreement (SCA) to access in primary care. Four areas listed melatonin as a ‘Red’ drug, only prescribable hospital specialist. Only one area listed melatonin as a Green drug. One area did not have a commissioned pathway for prescribing; one had no agreed prescribing guidance; and one area only allowed prescription for up to three months but did not report a status. Two areas had specially commissioned sleep services, but did not mention Melatonin prescribing. Recommended formulations varied widely across areas too. Initiation was mostly by a specialist through initiation periods varied considerably, between 2 weeks and 3 months. Clinical governance also varied, with 40 areas, 57.5% (n = 23) recommended a ‘drug holiday’ every 6–12 months with a sleep diary and 32% (n = 13) provided information about transition from paediatric to adult services at 18 years, with most suggesting a break prior to 18th birthday.
Discussion
The status of melatonin in formularies varies substantially across England. This is important, as patients with neurodevelopmental disability may face a postcode lottery when trying to access this critical medicine in primary care. A limitation of the study is that formulary status may not always reflect clinical prescribing behaviours (prescribing can be off-formulary or formularies can be out of date) although on the whole, formularies does restrict prescribing. More research is needed to understand Melatonin prescribing patterns to allow equality of access across the country.