{"id":34429,"date":"2024-11-26T16:16:07","date_gmt":"2024-11-26T16:16:07","guid":{"rendered":"https:\/\/bnssghealthiertogether.org.uk\/?page_id=34429"},"modified":"2025-01-15T22:47:12","modified_gmt":"2025-01-15T22:47:12","slug":"evidence-to-support-the-joint-formulary-group-jfg-uses-of-melatonin","status":"publish","type":"page","link":"https:\/\/bnssghealthiertogether.org.uk\/tr\/integrated-care-board\/research-and-evidence\/impact-case-studies\/evidence-to-support-the-joint-formulary-group-jfg-uses-of-melatonin\/","title":{"rendered":"Melatonin Kullan\u0131mlar\u0131 Hakk\u0131nda Ortak Form\u00fcler Grubu&#039;nu (JFG) Destekleyen Kan\u0131tlar"},"content":{"rendered":"<div class=\"assembler_default-group assembler_module_group assembler_default-group_1 assembler_module_group_1\"><div class=\"assembler_module_area assembler_module_area_1\"><div class=\"assembler_text-module assembler_module assembler_text-module_1 assembler_module_1  transparent\"><a tabindex=\"-1\" title=\"Mod\u00fcl-1 ba\u015fl\u0131kl\u0131 b\u00f6l\u00fcm\" id=\"module-1\" href=\"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages\/34429\/#module-1\" class=\"anchor\"><span class=\"hidden\">Mod\u00fcl-1 ba\u015fl\u0131kl\u0131 b\u00f6l\u00fcm<\/span><\/a><!-- Template found for text-module - Template: template-text - Matched: _only --><section class=\"w-full mx-auto max-w-content pt-12 sm:pt-24 pb-12 sm:pb-24\">\r\n  <div class=\"entry-content w-full !px-0 max-w-small\">\r\n        <h1>Melatonin Kullan\u0131mlar\u0131 Hakk\u0131nda Ortak Form\u00fcler Grubu&#039;nu (JFG) Destekleyen Kan\u0131tlar<\/h1>\n<p>The Medicines Optimisation team at NHS Bristol, North Somerset, and South Gloucestershire ICB coordinate the Joint Formulary Group (JFG).\u00a0 The JFG includes representatives from primary and secondary care covering all prescribing across Bristol, North Somerset and South Gloucestershire.<\/p>\n<p>The Joint Formulary sets the requirements for cost-effective prescribing in the locality.\u00a0 Any drug not listed in the Formulary is considered to be Non-Formulary and is not to be routinely prescribed. Please see the <a href=\"https:\/\/remedy.bnssg.icb.nhs.uk\/\" rel=\"noopener\">Bristol, North Somerset and South Gloucestershire Joint Formulary website<\/a> Daha fazla bilgi i\u00e7in.<\/p>\n<p>The ICB Clinical Effectiveness team were asked to support the JFG in response to applications made for three different indications for melatonin. The applications were for use as follows:<\/p>\n<ol>\n<li>Melatonin for treating sleep disorders in adult patients with dementia once physical\/psychological causes are ruled out, and sleep hygiene measures have failed<\/li>\n<li>Melatonin for aiding the onset of sleep in children in a Paediatric Intensive Care Unit (PICU) or Paediatric High Dependency Unit (PHDU) when sleep hygiene measures have failed<\/li>\n<li>Melatonin for treating sleep disorders in patients with Attention Deficit Hyperactivity Disorder (ADHD), Learning Disability (LD), and\/ or Autistic Spectrum Disorder (ASD) once physical\/psychological causes are ruled out, and sleep hygiene measures have failed.<\/li>\n<\/ol>\n<h2><strong>Clinical Effectiveness Team\u2019s Input<\/strong><\/h2>\n<p>The ICB Clinical Effectiveness (CE) team undertook three evidence reviews, one for each of the proposed melatonin uses listed above to support the JFG\u2019s decision-making.<\/p>\n<p>In these evidence reviews, as far as possible, the following points were addressed to aid discussion in the JFG:<\/p>\n<ul>\n<li>Quality and strength of the evidence<\/li>\n<li>Patient safety<\/li>\n<li>Efficacy and clinical effectiveness<\/li>\n<li>Cost-effectiveness and resource impact.<\/li>\n<\/ul>\n<h2><strong>Impact of \u2018Melatonin for sleep outcomes in dementia\u2019<\/strong><\/h2>\n<p>The evidence review demonstrated a paucity of good quality research evidence examining the use of melatonin for sleep outcomes in dementia.\u00a0 The available evidence focussed predominantly on Alzheimer&#8217;s Disease rather than other types of dementia.<\/p>\n<p>The outcome of the JFG discussion about this use of melatonin was that, based on a lack of evidence, it <strong><em>would not be<\/em><\/strong> added to the formulary at this time. However, considering the dearth of studies examining this indication yet the considerable anecdotal evidence of benefit, where it had been used \u2018off-formulary\u2019 in Bristol, North Somerset and South Gloucestershire, a local study was commissioned to develop an evidence base for the area.<\/p>\n<p>The results of this study will inform decision-making for future JFG applications for the use of melatonin in treating sleep disorders in adult patients with dementia.<\/p>\n<p>As a decision was reached and ratified shortly after the JFG meeting, this evidence review was considered appropriate for sharing on the <a href=\"https:\/\/future.nhs.uk\/system\/login?nextURL=%2Fconnect%2Eti%2FWEAHSNevidence%2FgroupHome\" rel=\"noopener\">WEAHSN Evidence Repository<\/a>.<\/p>\n<h2><strong>Impact of \u2018Melatonin for sleep outcomes on PICU\/PHDU\u2019<\/strong><\/h2>\n<p>The evidence review demonstrated a notable lack of evidence on the effectiveness of the use of melatonin in PICU and PHDU environments. However, there was evidence that melatonin has a good safety profile in paediatric populations and may be beneficial for sleep outcomes in children more broadly.<\/p>\n<p>Furthermore, there was evidence that \u2018off-formulary\u2019 prescriptions for melatonin in PICU\/PHDU were increasing internationally.<\/p>\n<p>The outcome of the JFG discussion about this use of melatonin was that given the safety profile of melatonin use with paediatrics and the short-term duration of melatonin administration (i.e., only whilst the child is on PICU\/PHDU), it <strong><em>would be<\/em><\/strong> added to the formulary.\u00a0 There is an expectation that being used \u2018on-formulary\u2019 will enable better local data collection on the use of melatonin for this purpose.<\/p>\n<p>As a decision was reached and ratified shortly after the JFG meeting, this evidence review was considered appropriate for sharing on the <a href=\"https:\/\/future.nhs.uk\/system\/login?nextURL=%2Fconnect%2Eti%2FWEAHSNevidence%2FgroupHome\" rel=\"noopener\">WEAHSN Evidence Repository<\/a>.<\/p>\n<h2><strong>Impact of \u2018Use of melatonin for sleep outcomes in ADHD\/ LD\/ ASD\u2019<\/strong><\/h2>\n<p>The evidence review demonstrated a considerable volume of clinical evidence examining the use of melatonin for sleep outcomes in patients with ADHD, LD, and\/ or ASD.\u00a0 However, despite this, much of the evidence was limited by variable quality due to methodological heterogeneity, populations assessed,\u00a0 and risk of bias.<\/p>\n<p>The review showed there may be more evidence for the use of melatonin for LD and ASD, rather than ADHD.<\/p>\n<p>The outcome of the JFG discussion about this use of melatonin was that it <strong><em>would not be<\/em><\/strong> added to the formulary for ADHD but <strong><em>may be<\/em><\/strong> added for LD and ASD.<\/p>\n<p>Further work is required before a decision can be made about making these changes due to additional financial costs that would be incurred by the system.<\/p>\n<h2><strong>Additional Reflections on Impact<\/strong><\/h2>\n<p>When asked for their reflections on the impact of CE team support on the JFG decision process, members of the Medicines Optimisation team indicated it was very helpful to outsource the evidence reviews to the CE team for several reasons:<\/p>\n<ol>\n<li>The independence of the CE team from the JFG decision-making process was considered to have added rigour to its assurance process by providing unbiased reviews of the evidence<\/li>\n<li>The Medicine\u2019s Optimisation team neither had the capacity nor the skill set available to conduct evidence reviews, with a sufficient level of depth and critical appraisal, to enable objective decisions about adding melatonin to the formulary for the indications listed previously<\/li>\n<li>The application process can be emotive with passionate stakeholders sharing anecdotal evidence as to why they believe their formulary request should be successful. However, disinterested evidence reviews enabled the JFG to position and weigh the different forms of evidence in a more detached manner.<\/li>\n<\/ol>\n<p>Since these reviews were conducted, the CE team has supported the Medicines Optimisation team with more evidence reviews to support new applications for formulary additions.<\/p>\n  <\/div>\r\n  <\/section><\/div><!-- .assembler_text-module.assembler_module.assembler_text-module_1.assembler_module_1..transparent --><\/div><!-- .assembler_module_area.assembler_module_area_1 --><\/div><!-- .assembler_default-group.assembler_module_group.assembler_default-group_1.assembler_module_group_1  -->","protected":false},"excerpt":{"rendered":"<p>Section titled module-1 Evidence to support the Joint Formulary Group (JFG)- Uses of Melatonin The Medicines Optimisation team at NHS Bristol, North Somerset, and South Gloucestershire ICB coordinate the Joint Formulary Group (JFG).\u00a0 The JFG includes representatives from primary and secondary care covering all prescribing across Bristol, North Somerset and South Gloucestershire. The Joint Formulary [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":32870,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-34429","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages\/34429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/comments?post=34429"}],"version-history":[{"count":3,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages\/34429\/revisions"}],"predecessor-version":[{"id":36079,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages\/34429\/revisions\/36079"}],"up":[{"embeddable":true,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/pages\/32870"}],"wp:attachment":[{"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/media?parent=34429"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bnssghealthiertogether.org.uk\/tr\/wp-json\/wp\/v2\/tags?post=34429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}