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1e. Child Health: Assessing the Global Situation of Medicines for Children
Availability of Children’s Medicines in Africa, 2007
1University of Newcastle, Australia; 2World Health Organization, Geneva
Problem statement: Data on the availability and cost of paediatric medicines are limited.
Objectives: To assess availability and cost of children’s medicines in 14 African countries
Design: The 2007 survey included 17 different medicines (20 formulations), two metered-dose inhalers, and up to five country-specific paediatric medicines. Data collectors recorded if the medicines were included in national essential medicines lists (EMLs) and standard treatment guidelines (STGs), availability in selected public and private medicine outlets, and cost to the patient.
Setting: WHO-HAI pricing survey methods were used to select 12 capital city medicine outlets: 1 Central Medical Store (CMS), 1 NGO health facility, 1 teaching hospital, 1 district hospital, 3 primary health care clinics (PHCs), and 5 private or retail pharmacies (RPs).
Outcome measure(s): Proportions (i.e., percentage) of the 20 paediatric medicine formulations in national EMLs and STGs; proportions available in each country by facility surveyed
Results: Proportions of medicines in EMLs ranged 50–90% with a match between EML and STGs in four countries. Availability varied by country and medicine outlet: CMS (15–75%), NGO facility (10–65%), teaching hospital (15–70%), district hospital (10–80%), PHCs (18–48%), RPs (38–62%). Cost data were limited. Often medicines were free to children in public sector outlets. Variability in costs was greater and prices generally higher in the private sector. Survey tools and methods were acceptable and effective; little training and support for data collectors was required. Extending surveillance to regional and rural areas would add to survey costs but would provide more complete coverage of the country situation. Participants identified a large number of country-specific medicines that could be included in future surveys.
Conclusions: Availability of children’s medicines in these 14 countries was variable and generally poor. Surveys were conducted only in capital cities; this is likely to represent the most optimistic picture of medicines availability. Further work is required to understand both supply- and demand-side mechanisms operating in each country. Interventions to increase availability are needed as is a commitment to ongoing and regular surveys to measure improvements over time. This study has demonstrated the development of easy-to-use data collection tools that can be adapted to local circumstances. Costs of surveys should not preclude regular monitoring of country-specific circumstances. This study has led to the development of WHO guidance (2009) on methods for medicines availability and pricing surveys of children’s medicines. Methods propose not more than 30 medicines be surveyed (7 are country-specific); sectors are extended to include licensed drug shops and dispensing doctors, and scope increased to include urban, peri-urban, and rural regions.
Funding source(s): WHO, Geneva
Medication Among Children in Africa South of Sahara: Qualitative Systematic Review
University of Copenhagen, Denmark
Problem statement: The use of medicines is an important aspect of child health. Medication behaviour established in childhood and adolescence may track into adulthood. However, this topic has been sparsely dealt with in international research, not least in low-income societies.
Objective: To provide an overview of empirical evidence on children and medication in Africa south of Sahara
Design and material: Systematic literature review; searches were conducted in Medline, Embase, and Psychinfo without restrictions, applying the same terms and combinations in all databases. In all searches, “children” and “Africa, south of Sahara” were combined with medication defined by 80 different search terms. Children were defined as 0–18 years. Primary exclusion criteria were immunisation programmes; preventing mother-to-child transmission of HIV; traditional medicine; efficacy studies; and clinical trials with clinical endpoints. Secondary exclusion criteria after reading abstracts were drug abuse; purely diagnostic studies; purely economic studies; and mixed children-adults studies.
Data handling and extraction: Titles and abstracts were first assessed for eligibility. Next, relevant full-text articles were acquired and information extracted on data sheets, one for each study.
Setting: Africa south of Sahara
Outcome measures: Medication theme; dosage form; country; study design; data collection period; population; results; and quality of study
Results: 1530 potentially relevant references were identified including 719 duplicates; after secondary exclusion, 132 studies remained for analysis. The illnesses dealt with were primarily malaria (63 studies), diarrhoea (27), fever (13), ARI/pneumonia (9), asthma (4), HIV/AIDS/ART (3), and epilepsy (2). Studies were carried out in 24 countries, primarily Kenya (24), Nigeria (17), Tanzania (14), South Africa (11), Ghana (9), Ethiopia (8), and Uganda (8); 9 countries had 1 study only. Most studies recognised 2 or more sources of treatment; 55% of studies included solely children under 5 and 38 studies did not specify the age group. Gender was not an issue. Almost half of studies focused on appropriate prescribing and use, but we identified only 2 studies on dosage regimes, 2 on medicine use in the population, and 1 on compliance.
Conclusions: Studies on children and medication in Africa south of Sahara focus primarily on 2 symptoms/conditions (malaria/fever and diarrhoea) and primarily deal with children under 5. Major research gaps include medication issues specific to children over 5, the importance of dosage forms for children, and acute conditions, other than malaria/fever and diarrhoea.
Funding source: Copenhagen University’s Global Health Cluster temporary fund provided partial funding.
A Rapid Assessment Protocol for Improving Access (RAPIA) to Medicine and Care for Children living with a Chronic Condition (Congenital Adrenal Hyperplasia) in Vietnam
1CLAN (Caring & Living As Neighbours), Australia; 2IIF (International Insulin Foundation), United Kingdom; 3CHW (Children's Hospital Westmead), Australia
Problem Statement: Affordable access to medicine and care are major barriers to survival and quality of life for children with chronic health conditions in resource-poor countries. Congenital adrenal hyperplasia (CAH) is the most common adrenal condition of childhood, with cortisol and aldosterone replacement essential to survival. CLAN advocated for the inclusion of hydrocortisone and fludrocortisone tablets in the WHO essential medicine list for children (EMLc), approved October 2008, but the history of insulin suggests this alone will not achieve affordable access for all.
Objectives: The Diabetes RAPIA survey was conducted in Vietnam by the IIF in 2008 to explore barriers to insulin access and diabetes care. CLAN took this opportunity to implement an adapted protocol and clearly identify barriers to accessing medicine and care for children with CAH in Vietnam. Although the exact incidence of CAH in Vietnam is not yet known, initial newborn screening trials in 2007 suggest it may be higher in Vietnam (closer to 1:6000, as is found in the Philippines) than Australia, the United States, and the United Kingdom (generally around 1:18,000).
Design: Structured surveys and templates used in the Diabetes RAPIA were adjusted to specifically address CAH. The CAH RAPIA was not a statistical assessment of the Vietnamese health system, but rather a rapid collation of qualitative and quantitative data to analyse CAH in a low-income setting.
Setting: The CAH RAPIA was a multi-level assessment of factors influencing access to medicine and care for people living with CAH in Vietnam, and had three components: macro (ministerial levels, private sector), meso (provincial levels and health care settings), and micro (caregivers and people living with CAH). Data were collected in Hanoi, Ho Chi Minh City, Thai Nguyen Province, and Dong Nai Province.
Study Population: 204 interviews (for diabetes and CAH) were conducted. Participants were selected on the basis of role (ministerial and health sector) and convenience sampling (CAH families) from the four provinces (two mainly urban and two relatively wealthy and urban).
Policies: Key policy aspects focused on registration and importation of hydrocortisone and fludrocortisone and on the financial burdens on CAH families.
Outcome measure(s): Understanding key barriers to accessing medicines and care for people living with CAH in Vietnam
Results: Although health care workers interviewed stated that more young children with CAH were surviving what was striking was the lack of older children with CAH (over 90% of children with CAH were younger than 15). The majority of families (60%) identify financial burdens (cost of medicines in the main) as their greatest concern. Barriers to affordable access to hydrocortisone and fludrocortisone were a mix of national and international factors: neither drug included in the WHO EMLc, neither drug registered in Vietnam, and variable pricing and quality. Barriers to care included lack of access to trained health professionals, particularly beyond major centres; travel costs; health systems not developed for paediatric chronic disease; clinical infrastructure unavailable; and a mismatch between actual and insurance-approved referral pathways. CAH family support clubs were effective for education and support.
Conclusions: Since this assessment, access to hydrocortisone and fludrocortisone has improved in Vietnam, with both medicines now registered, imported, and available through public health facilities. Financial burdens on families remain the biggest threat to child survival and well-being. National and international efforts to promote affordable access to medication and care for children with chronic disease in resource-poor settings are needed to drive policies capable of effecting large-scale, sustainable, and systems-based change.
Funding source(s): The CAH RAPIA was funded by CLAN with generous practical support from David Beran of the IIF.
Medicine Use in Children Under 5: 20 Years of Practice Patterns and Intervention Effects
1World Health Organization, Regional Office S.E.Asia, India; 2World Health Organization, Geneva; 3Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, USA
Problem statement: Many low- and middle-income countries (LMIC) have tried to improve treatment of child acute illness, but scant evidence exists about progress.
Objectives: To undertake a systematic review of studies from 1990 to 2009 on medicine use in children under 5 years old in LMIC
Design and methods: From published and unpublished studies, we systematically extracted quantitative data on medicine use, details on study setting, methodology, and interventions. We limited this review to studies on children under 5. To estimate trends over time, we calculated the average of each indicator (limited to baseline data for interventions) by study year, region, facility ownership, and prescriber type. To estimate intervention impacts, we calculated summary effect sizes for studies meeting accepted design criteria (RCT, pre-post with control, time series). We examined the indicator with the greatest effect size (GES) and the median effect size (MES) over all indicators.
Setting: Pediatric primary care settings in LMIC
Study population: Providers and children under 5
Intervention(s): Different types of interventions commonly implemented to improve use of medicines
Outcome measure(s): Standard indicators of medicine use commonly reported in IMCI and disease control programs
Results: Data were extracted for studies conducted in 78 countries reporting data on 394 distinct study groups; 75% reported data from the public sector and 25% from the private-for-profit sector. In all, 226 studies (57%) reported interventions, but only 45 (20%) used adequate study design. From 1992 to 2009, we observed no improvements in percentage of pneumonia cases treated appropriately with antibiotics (varying over time from 49 to 67%), percentage of non-pneumonia cases receiving inappropriate antibiotics (45–59%), percentage of diarrhea cases treated with ORS (41–59%), or percentage of diarrhea cases treated inappropriately with antibiotics (32–54%). Use of antidiarrheals decreased from >40% of cases pre-1992 to 14% in 2001–03. Practices in all regions were similar, and public sector practices tended to be better than private sector. Multi-component interventions tended to have larger effects than single-component ones. The median GES indicated a 30% improvement in practice for studies examining community case management interventions and 15% for interventions using provider education alone, two common approaches; the median MES across all indicators had similar values (28% and 9%, respectively) for these two types of interventions.
Conclusions: Treatment of child illness remains suboptimal in LMIC, with only use of antidiarrheals showing substantial improvement. Although many well-designed interventions reported positive effects, there has been no observable improvement in practice.
Funding source(s): WHO