Essential medicines


Essential medicines, as defined by the World Health Organization, are medicines that "satisfy the priority health care needs of the population". Essential medicines should be accessible to people at all times, in sufficient amounts, and be generally affordable. Since 1977, the WHO has published a model list of essential medicines, with the 2023 list for adult patients containing over 500 medicines. Since 2007, a separate list of medicines intended for child patients has been published. A new list was published in 2021, for both adults and children.
Several changes have been implemented since the 2021 edition, including that medication cost should not be grounds for exclusion criteria if it meets other selection criteria, and cost-effectiveness differences should be evaluated within therapeutic areas. The following year, antiretroviral agents, usually used in the treatment of HIV/AIDS, were included on the list of essential medicines.
The WHO distinguishes between "core list" and "complementary list" medications.
  • The core list contains a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment.
  • The complementary list lists essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities are needed. In case of doubt, medicines may also be listed as complementary on the basis of higher costs or less attractive cost-effectiveness in a variety of settings.
This list forms the basis of the national drugs policy in more than 155 countries, both in the developed and developing world. Many governments refer to WHO recommendations when making decisions on health spending. Countries are encouraged to prepare their own lists considering local priorities. Over 150 countries have published an official essential medicines list. Despite these efforts, an estimated 2 billion people still lack access to essential medicines, with some of the major obstacles being low supply, including shortages of inexpensive drugs. Following these shortages, the US Food and Drug Administration released a report in fall of 2019 with strategies to overcome and mitigate supply issues.

Theory and practice

The original WHO definition in 1977 was that they were medicines "of utmost importance, basic, indispensable, and necessary for the healthcare needs of the population". The concept was mentioned in one of the ten points of the 1978 Alma Ata Declaration on primary health care.
In 2002 the definition was changed to:
This remains the definition as of 2019.
The use of essential medicines lists has resulted in better quality of care and improved management of health resources in the most cost-effective manner. The lists serve as a baseline for health insurance entities to include or exclude the medication, and modify the dose based on clinical study evidence. To improve the accessibility of essential medicines for both children and adults, it is necessary to ensure the rational use of medicine while also being cost-effective.
In a 2023 study evaluating the availability, distribution, and progress of essential medicines in China, results showed that access to essential medicines is lower in comparison to the WHO's goal, with little progress in expansion over the years. This systematic review and meta-analysis study pooled studies that reported the availability of essential medicines in various regions of China from 2009 to 2019. The data supports the need to improve the access and distribution of medication across regions to ensure that the goal of universal health coverage is reached. Having essential medications be accessible to everyone is the foundation to a better health without financial hardships for the general public.
The goal of universal health coverage was set in place in 2015, where multiple countries have taken steps towards ensuring treatment, palliation, rehabilitation, and preventative health measures for everyone. Understanding that accessibility to appropriate and applicable essential medications within the region, is the first step towards reaching equitable and universal healthcare.

Selection

Items are chosen as essential medicines based on how common the disease that is being treated, evidence of benefit, the degree of side effects and the cost compared to other options. In order to explore the human rights law and WHO's essential medicines policies into national legislation regarding medicines, affordability and financing needs to be understood to enhance universal access to essential medicines. The intention of essential medicine lists is to provide appropriate use of treatment and not include medications that have been withdrawn from the market in other countries due to unfavorable benefit-to-harm balance. Despite many efforts from different countries, some individuals do not have their needs met and have to turn to an alternative plan called the judiciary in order to receive the medications required. The Judiciary also known as the "Judicialization of access to medicines," this involves technical, scientific, legal, and social aspects. Further research is needed to explore these aspects comprehensively.

Cost-to-benefit ratio

Medications can be priced differently, due to the fact that each medication can have many qualities and uses. Because various medicines have different costs, individual uses, and distinct advantages, it prompts the theory of cost effectiveness. Cost effectiveness is the subject of debate between producers and purchasers of drugs. It is estimated that access to essential medicines could save 10 million people a year. Access to essential medicine is a cornerstone of effective healthcare systems and a fundamental component of global health initiatives aimed at improving quality of life, reducing health disparities, and fostering sustainable development. Proper access to essential medicine can lower the need for more expensive treatments or hospitalizations by managing conditions early and effectively.

History

The WHO made the Model List of Essential Medicines in 1977 based on the idea that certain medicines are required more often than others and are often inaccessible to many different populations. As of 2018, 146 countries are using the Essential Medicines concept, which is also used to guide the reimbursement of medicines depending on the importance to public health, the efficacy, the safety, and the cost of the medicines. The goal of the Essential Medicine concept is that medicines that have the highest relevance in public health, meaning medicines that are used the most often, should be available equally to everyone in a population either for free or at a very affordable cost.
The WHO Model List of Essential Medicines has been updated every two years since 1977. The 23rd version was published in July 2023. Over that period, the number of medications has more than doubled, from the original 208 in 1977, to more than 500 in 2023. Medicines are then categorized as essential or non-essential based on their inclusion in each country's EML. results are then analyzed by WHO regions, World Bank income groups, wealth inequality, and therapeutic groups. The group for essential medicines availability was higher than non-essential medicines. But in the public sector, the median availability was 40% for essential medicines, compared to 6.6% for non-essential medicines. Thus, overall, the availability of essential medicines in the public sector is still suboptimal, indicating challenges in achieving equitable access.

Children's list

The first edition of the "WHO Model List of Essential Medicines for Children", was published in 2007, while the 9th edition was published in 2023. It was created to make sure that the needs of children were systematically considered such as availability of proper formulations. While the EML is intended for the population as a whole, the EMLc is intended for children up to 12 years old. The first edition contained 450 formulations of 200 different medications and the 2023 list contains 361 medications. The intention of creating an EML for children is to improve child survival and provide treatment options for mortality and morbidity causes.
WHO launched a "Make Medicines Child Size" campaign in 2007 with the purpose of creating appropriate regimens and formulations for children based on their weight and age. A 2021 study assessing the age-appropriateness of enteral formulations listed on the WHO Essential Medicine List for Children highlighted the dependence on factors such as dose adaptability, formulation flexibility, and the child's swallowing ability. Analysis of the EMLc between 2011 and 2019 revealed that most enteral medications were not age-appropriate for children under six years old, necessitating manipulation of the medicine prior to administration. This practice raises concerns regarding safety and efficacy. Consequently, the study emphasizes the urgent need for more comprehensive information and guidelines for selecting and developing age-appropriate essential enteral medicines for pediatric populations.
While the practice of maintaining separate lists for the general population and children under 12 years of age is beneficial in tailoring healthcare interventions, it inadvertently excludes adolescents from the latter category. This age-based cutoff may lead to an oversight of the unique healthcare needs of this demographic. It would be a good idea to create a list for adolescents as well. This is important as it allows healthcare providers to offer tailored care for each group. This differentiation ensures that treatments are appropriate for children's unique physiological needs.