Accessibility of Medicines for Children: A Systematic Review

Abstract

Background: Accessibility of medicines for children is a matter of global concern. Medicines prescribed for children are often off-label. To formulate appropriate policies and undertake necessary interventions to improve access to medicines for children, it is necessary to evaluate the accessibility of medicines for children. However, there is no systematic review of the medicine accessibility for children.Methods: Relevant studies were identified through searching Pubmed, Embase, CNKI, Wanfang, VIP, World Health Organization website, and Health Action International website. Besides, the references of included studies as a supplementary search were read. We extracted the basic information of articles (the first author, published year, the name of journal, research institution, etc.), the basic study characteristics (survey area, survey time, survey method, survey medicine lists, the number of medicine outlets surveyed, etc.), and the study results (the current situation of the accessibility of medicines for children, including the availability, price, and affordability of medicines for children, etc.). Two reviewers independently selected studies and extracted the data. Descriptive analysis methods to analyze the current situation of the accessibility of children’s medicines were used.Results: A total of 18 multicenter cross-sectional studies were included in this systematic review, which were from low-income and middle-income countries. Seventeen studies (17/18, 94.4%) used the WHO/Health Action International (HAI) medicine price methodology to investigate the accessibility of medicines for children. Fifteen studies (15/18, 83.3%) were selected to investigate medicines based on the WHO Model List of Essential Medicines for Children (WHO EMLc). In the public sectors, the availability of originator brands (OBs) ranged from 0 to 52.0%, with a median of 24.2%, and the availability of lowest-priced generics (LPGs) ranged from 17.0 to 72.6%, with a median of 38.1%. In the private sectors, the availability of OBs ranged from 8.9 to 80%, with a median of 21.2%. The availability of LPGs ranged from 20.6 to 72.2%, with a median of 35.9%. In most regions, the availability of OBs in the private sectors was higher than in the public sectors. Collectively, in the price of medicines for children, the median price ratio (MPR) of the OBs in the public sectors and private sectors were much higher than that of the LPGs. And the affordability of the LPGs in the public sectors and private sectors was higher than that of originator brands (OBs).Conclusion: The availability of medicines for children is low in both the public sectors and private sectors in low-income and middle-income countries. The MPR of originator brands (OBs) is higher than that of lowest-priced generics (LPGs), and the most lowest-priced generics (LPGs) have better affordability.

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

“…[2][3][4][5][6] Several studies have shown that low availability, high prices and poor affordability have kept medicines out of reach for children, as well as lack of age-appropriate formulations, adequate dosing and administration instructions in the product labelling. [7][8][9][10][11] Over many decades, paediatric drug development has been hindered by various factors. They include a common notion to protect children from research, little appreciation of paediatric pharmacology, recruitment challenges and low market pressure.…”

“…Unfortunately, the availability of medicines for children is low and this is a significant public health problem, whereby off‐label prescribing remains high 2–6 . Several studies have shown that low availability, high prices and poor affordability have kept medicines out of reach for children, as well as lack of age‐appropriate formulations, adequate dosing and administration instructions in the product labelling 7–11 …”

Accessibility of Essential Medicines for Children in Sichuan Province of China: A Cross-Sectional Study

“…Nowadays, a systematic review has identified 18 multicentre studies evaluating the accessibility of essential medicines for children ( Chen et al, 2021 ). The majority of studies used the WHO/HAI standardized methodology ( World Health Organization and Health Action International, 2008 ), which was jointly developed by WHO and HAI in 2000 for standardizing studies on the accessibility of medicines.…”

“…The WHO/HAI standardized methodology estimates the accessibility of medicines by investigating medicine availability, price, and affordability. The results have shown that the availability of essential medicines for children is generally low in low-income and middle-income countries, the median price ratios of originator brands was higher than that of lowest-priced generics, and the most lowest-priced generics had better affordability ( Chen et al, 2021 ).…”

Drug Delivery Formulations and Devices Tailored for Paediatric and Older Patients

“…Trials in "average" patients aim to determine if a medicine will be safe and efficacious, but drugs are also required for patients that lie outside of the average, including paediatrics and older persons. Few drugs have undergone clinical trials in paediatric patients, so in the absence of specific formulations, physicians can opt to use such drugs off-label and/or in an unlicensed fashion (Chen et al, 2021). Off-label use is one when a licenced product is used outside the specifics of the license or label granted by the national regulator.…”