Current Newsletter
Editorial
27th Edition
Welcome to GPED's 27th Newsletter!
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We are excited to introduce the new issue of the Global Pediatric Endocrinology and Diabetes (GPED) newsletter!
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What's Inside This Issue?
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GPED First Annual Meeting
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Webinar Highlights
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Spotlight on Newborn Screening in Indonesia
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Changing Diabetes in Children (CDiC) Initiative
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Click here to read the Newsletter. Please remember to subscribe to our GPED Newsletter email list to receive the most up-to-date GPED information!
Bisphosphonates for the management
of osteogenesis imperfecta (OI) in Kenya
In April 2022, GPED collaborated with the Center for International Health (CICH) at British Columbia Children’s Hospital in Vancouver to facilitate the delivery of much needed zoledronic acid to children at Machakos Orthopaedic Clinic in Kenya.
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The clinic provides affordable care and surgery to patients in rural eastern Kenya, including many children with paediatric orthopaedic conditions such as osteogenesis imperfecta (OI). OI is a genetic disorder, also known as brittle bone disease, that causes pain, frequent fractures that can lead to significant disability if not treated. Zoledronic acid is effective in treating children with OI by strengthening the bones and decreasing the number of fractures. However, medications like zoledronic acid are not covered by Kenya’s National Hospital Insurance Fund (NHIF) and are out of reach for most healthcare facilities.
These life-changing medicines were provided by Health Partners International of Canada’s (HPIC) Access to Medicine program which aims to improve access to medicine in vulnerable communities that are challenged in accessing quality healthcare. HPIC provides Humanitarian Medical Kits to support Canadian volunteers and healthcare professions, such as GPED, to be able to provide these medicines.
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GPED had 23 vials sent to Kenya thanks to a visitor who accepted to carry the medicines. Dr Speciosa Mbula Nguku Anaesthesiologist/Pain Specialist at Machakos Center oversaw the distribution of zoledronic acid. She made sure she had a full ward (see picture). Several children were given the injection on the same day, making the best use of this limited resource. She says: “One vial goes so far. Children were admitted overnight and the fellowship they had together was amazing. They met other parents who have the same challenges. Conversations happened. One mum now wants to take her son to school. She had thought that the son couldn't join school. You have given these families hope”.
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As pediatric endocrinologists know, biphosphonates not only prevent fractures in patients with OI but also decrease pain very effectively. GPED has put in contact Dr Mbula Ngulu with a patient advocate in Kenya and we are hoping that this will lead to advocacy for better access to zoledronic acid in patients with OI in Kenya in the future.
For more information, please contact:
Dr Speciosa Mbula Nguku
Anaesthesiologist/Pain Specialist
Acumen EA Fellow 2015; www.machakos-orthopaedics.org; Twitter: @machakosortho
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Request for Proposals for Diagnostics gap analysis and national EDL
in ASEAN countries
WHO published the first edition of the Model List of Essential In Vitro Diagnostics (EDL) in May 2018. This was followed by two further editions, in 2019 and 2021 (See GPED Newsletter Issue 19, May 2021). EDL is important to pediatric endocrinologists: it includes an increasing number of diagnostic tests relevant to endocrinology and diabetes and helps national health authorities to prioritize the availability of tests for universal health coverage (UHC) and health emergencies and to promote healthier populations, which are the three strategic priorities of the WHO Thirteenth General Programme of Work (2019–2023).
On 22 July 2022, WHO published a Request for Proposals for Diagnostics gap analysis and national EDL in ASEAN countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam).
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The Request for Proposals is published on the United Nations Global Market website: https://www.ungm.org/Public/Notice/178866
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Please help us to identify possible consulting companies in the ASEAN region.
For more information, please contact: EDLsecretariat@who.int
The WHO 2021 lists of essential medicines for adults (EML) and children (EMLc) now include long-acting analogues of insulin as therapeutic alternatives to human insulin
Every 2 years, WHO publishes a revised List of Essential Medicines for adults (EML, since 1977) and children (EMLc, since 2007). The EMLc is intended for use in children up to 12 years. Human insulin (vials) has been included in the WHO EML since its first edition, in 1977. The most recent EML and EMLc, released in 2021, now include long-acting insulin analogues (insulins detemir, degludec and glargine) for potential inclusion in national EMLs.
The addition of long-acting insulin analogues was proposed on several occasions over the last few years but had always been rejected on the basis of an unfavourable cost benefit ratio. Several reviews have shown modest but definite clinical benefits (i.e. small decrease in HbA1c, decrease in nocturnal hypoglycemia) in patients with Type 1 diabetes, less so in patients with Type 2 diabetes. The concern expressed by several experts in the field is that inclusion of long-acting analogues in the WHO EML could make insulin further out of reach for patients in LMICs. Indeed, especially in low- and middle-income countries, insulin analogues are much more expensive to the patient than human insulins despite a manufacturing cost that is grossly similar. However, in many high-income countries, where patients can afford insulin analogues, the reality is that pediatric endocrinologists are presently using insulin analogues as first line treatment.
GPED successfully advocated for prequalification of insulin analogues by WHO
Insulin analogues are now included in the EML and EMLc. The next step is to decrease their price and increase access (see next article).
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Link to EML and EMLc:
Children: www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.03
Adult: www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
In 2019, the World Health Organization (WHO) piloted a prequalification program for human insulin, with the hope that it would increase the number of players in the field (beyond the three major manufacturers, Sanofi, Novo Nordisk and Eli-Lilly, that together account for >95% of all insulin prescribed in the world). Unfortunately, so far, prequalification of human insulin did not attract applications by new manufacturers.
In May 2022, the International Consortium for Pediatric Endocrinology (ICPE, http://intpedendo.org/index.php) and NCD Child (https://www.ncdchild.org/), following a recommendation by Global Pediatric Endocrinology and Diabetes (GPED, www.globalpedendo.org) wrote to Dr Bente Mikkelsen to request that prequalification of insulin be extended to insulin analogues. Dr Mikkelsen is Director, NCD Department, Division for Universal Health Care/Communicable Diseases and Non Communicable Diseases, World Health Organization. We are delighted to let you know that this process is now approved!
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It is hoped that this opportunity to prequalify insulins with the WHO will attract smaller manufacturers interested in reaching out to new markets, increase the number of insulin brands marketed in a country and, ultimately, improve access and decrease the price of insulin in general and insulin analogues in particular.
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Pediatric endocrinologists in LMICs can play a key role by promoting this information to their health authorities and to local manufacturers.
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For more information, please see:
2nd Invitation to Manufacturers of human insulin and insulin analogues to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs). https://extranet.who.int/pqweb/sites/default/files/documents/EOI_Insulin_V2_May2022.pdf
Previous Newsletters
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Newsletter Issue 8, November 2017
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Newsletter Issue 6, April 2017
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Newsletter Issue 5, January 2017
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Newsletter Issue 4, October 2016