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Model List of Essential Medicines Includes New Section for Dental Preparations

A new section for dental preparations has been included during the 2021 review of the World Health Organization’s (WHO) Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc).

This new section includes fluoride (previously under the section for vitamins and minerals as “sodium fluoride”) given its indication for dental caries and an initial selection of fluoride-containing and fluoride-releasing products: silver diamine fluoride and glass-ionomer cement. This development will be key in increasing access to these products and help to reduce the burden of dental caries – the most prevalent disease globally.

WHO’s model lists aim to identify those chemical agents, medicines, medical devices, and other medical products that everyone should always have access to, and that all governments should ensure are available and affordable to their populations. The EML and EMLc are currently used as a guide by more than 150 countries to determine which medical products to provide and fund, and this new section for dental preparations is an opportunity for governments to include fluoride, silver diamine fluoride and glass-ionomer cement to their own national essential medicines lists, increasing their availability and accessibility.

As reported by the 23rd WHO Expert Committee on the selection and use of essential medicines’ Executive Summary, “the burden of oral diseases, particularly untreated dental caries, represents a significant public health problem globally”. The establishment of a new section for dental preparations is a key development to tackle the burden of dental caries and oral health inequalities, ensuring oral health promotion and care are part of efforts to increase access to essential medical products.

Fluoride toothpaste and other fluoride formulations

The initial proposal for this new section and its applications was led by WHO’s Oral Health Programme and different WHO collaborating centres, and included the recommendation to have a new entry for fluoride toothpaste. FDI submitted a letter supporting this proposal and the potential opportunity to make fluoride toothpaste available widely at an affordable price.

The Expert Committee instead decided to add fluoride toothpaste (or cream or gel) as a formulation for fluoride rather than including it as a full entry, and it continues to indicate fluoride for dental caries in other appropriate topical formulations. The Executive Summary of the Expert Committee has also requested “WHO to identify and define the alternative fluoride containing formulations that are recommended for use in the prevention of dental caries” for the 2023 review. This may open the opportunity for inclusion of other cost-effective mechanisms (including topical and non-topical formulations) to increase exposure to adequate levels of fluoride and reduce inequalities.

The inclusion of all these dental preparations (fluoride through toothpaste and other means, silver diamine fluoride and glass-ionomer cement) in essential packages of care, medicines and supplies, such as the WHO-endorsed Basic Package of Oral Care, is indeed crucial to increase access to oral health promotion and care in line with FDI’s Vision 2030: Delivering Optimal Oral Health for All.

Moreover, FDI also urges WHO to regularly review the section for dental preparations to update it with full alternatives to dental amalgam that are as durable, accessible, affordable, and environmentally sound as they become available.

What’s next?

We call on national dental associations (NDAs) to inform their governments about this development and to consider the addition of these dental preparations within their own national medicines lists, if they are not already included. In addition, we ask NDAs to encourage future Expert Committees to review this section with other medicines, medical devices, and restorative materials for oral health as they become cost-effective and available.

Moreover, we believe these additions should also inform the future “best buys” and other recommended interventions for oral health management to be recommended by WHO in 2024. Thereby, advancing the implementation of WHO’s resolution on Oral health (WHA74.5) and the upcoming 2022 Global strategy on tackling oral diseases.

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