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      Accessibility of Medicines for Children: A Systematic Review

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          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.

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          Most cited references28

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          Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis.

          WHO and Health Action International (HAI) have developed a standardised method for surveying medicine prices, availability, affordability, and price components in low-income and middle-income countries. Here, we present a secondary analysis of medicine availability in 45 national and subnational surveys done using the WHO/HAI methodology. Data from 45 WHO/HAI surveys in 36 countries were adjusted for inflation or deflation and purchasing power parity. International reference prices from open international procurements for generic products were used as comparators. Results are presented for 15 medicines included in at least 80% of surveys and four individual medicines. Average public sector availability of generic medicines ranged from 29.4% to 54.4% across WHO regions. Median government procurement prices for 15 generic medicines were 1.11 times corresponding international reference prices, although purchasing efficiency ranged from 0.09 to 5.37 times international reference prices. Low procurement prices did not always translate into low patient prices. Private sector patients paid 9-25 times international reference prices for lowest-priced generic products and over 20 times international reference prices for originator products across WHO regions. Treatments for acute and chronic illness were largely unaffordable in many countries. In the private sector, wholesale mark-ups ranged from 2% to 380%, whereas retail mark-ups ranged from 10% to 552%. In countries where value added tax was applied to medicines, the amount charged varied from 4% to 15%. Overall, public and private sector prices for originator and generic medicines were substantially higher than would be expected if purchasing and distribution were efficient and mark-ups were reasonable. Policy options such as promoting generic medicines and alternative financing mechanisms are needed to increase availability, reduce prices, and improve affordability.
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            Paediatric pharmacokinetics: key considerations.

            A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware of anatomical and physiological changes that affect pharmacokinetic profiles of drugs to understand consequences of dose adjustments in infants and children. Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and perception of pain in children resulting from blood sampling. There are alternative sampling techniques that can minimize the invasive nature of such trials. Population based models can also limit the sampling required from each individual by increasing the overall sample size to generate robust pharmacokinetic data. This review details key considerations in the design and development of paediatric pharmacokinetic clinical trials.
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              Availability, prices and affordability of the World Health Organization’s essential medicines for children in Guatemala

              Background Several World Health Organization (WHO) initiatives aim to improve the accessibility of safe and effective medicines for children. A first step in achieving this goal is to obtain a baseline measure of access to essential medicines. The objective of this project was to measure the availability, prices, and affordability of children’s medicines in Guatemala. Methods An adaption of the standardized methodology developed by the World Health Organization and Health Action International (HAI) was used to conduct a cross sectional survey to collect data on availability and final patient prices of medicines in public and private sector medicine outlets during April and May of 2010. Results A subset of the public sector, Programa de Accesibilidad a los Medicamentos (PROAM), had the lowest average availability (25%) compared to the private sector (35%). In the private sector, highest and lowest priced medicines were 22.7 and 10.7 times more expensive than their international reference price comparison. Treatments were generally unaffordable, costing as much as 15 days wages for a course of ceftriaxone. Conclusions Analysis of the procurement, supply and distribution of specific medicines is needed to determine reasons for lack of availability. Improvements to accessibility could be made by developing an essential medicines list for children and including these medicines in national purchasing lists.
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                Author and article information

                Contributors
                Journal
                Front Pharmacol
                Front Pharmacol
                Front. Pharmacol.
                Frontiers in Pharmacology
                Frontiers Media S.A.
                1663-9812
                05 August 2021
                2021
                : 12
                : 691606
                Affiliations
                [ 1 ]Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China
                [ 2 ]Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China
                [ 3 ]Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, China
                [ 4 ]West China School of Pharmacy, Sichuan University, Chengdu, China
                [ 5 ]West China School of Medicine, Sichuan University, Chengdu, China
                [ 6 ]Academic Division of Child Health, Derbyshire Children’s Hospital, University of Nottingham, Derby, United Kingdom
                Author notes

                Edited by: Irene Lenoir-Wijnkoop, Utrecht University, Netherlands

                Reviewed by: Aukje K. Mantel-Teeuwisse, Utrecht University, Netherlands

                Faris El-Dahiyat, Al Ain University, United Arab Emirates

                *Correspondence: Lingli Zhang, zhanglingli@ 123456scu.edu.cn
                [†]

                These authors have contributed equally to this work

                This article was submitted to Drugs Outcomes Research and Policies, a section of the journal Frontiers in Pharmacology

                Article
                691606
                10.3389/fphar.2021.691606
                8375435
                34421594
                27eca93a-d42e-421f-ab71-8a7beed24525
                Copyright © 2021 Chen, Li, Zeng, Liu, Zhang, Choonara and Zhang.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 07 April 2021
                : 29 July 2021
                Categories
                Pharmacology
                Systematic Review

                Pharmacology & Pharmaceutical medicine
                children,medicine,accessibility,systematic review,availability,price,affordability

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