Access to age-appropriate essential medicines: a retrospective survey of compounding of medicines for children in hospitals in Nigeria and implications for policy development

IntroductionThe WHO Essential Medicine List for children (EMLc) is used for promoting access to medicines. The age-appropriateness of enteral (oral and rectal) formulations for children depend on their adaptability/flexibility to allow age-related or weight-related doses to be administered/prescribed and the child’s ability to swallow, as appropriate. There is scant information on the age-appropriateness of essential enteral medicines for children.ObjectiveTo evaluate the age-appropriateness of enteral essential medicines.Materials and methodsAge-appropriateness of all enteral formulations indicated and recommended in the EMLc 3rd to 7th (2011–2019) editions were determined by assessing swallowability and/or dose adaptability for children under 12 years, stratified into five age groups.ResultsEnteral formulations in the EMLc were more age-appropriate for older children aged 6–11 years than for younger children. In the 3rd edition, for older children, 77%, n=342, of formulations were age-appropriate. For younger children, age-appropriateness decreased with age group: 34% in those aged 3–5 years, 30% in those aged 1–2 years, 22% among those aged 28 days to 11 months and 15% in those aged 0–27 days. Overall, similar proportions were found for the 7th edition. In contrast, the majority of medicines in the 7th list were age-appropriate in targeted diseases like HIV and tuberculosis.ConclusionMost recommended enteral essential medicines in EMLc 2011 and 2019 were not age-appropriate for children <6 years. Medicines which are not age-appropriate must be manipulated before administration, leading to potential issues of safety and efficacy. Evaluation of the age-appropriateness of formulations for medicines to be included in EMLc could improve access to better medicines for children in the future.

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Are age-appropriate antibiotic formulations missing from the WHO list of essential medicines for children? A comparison study

Archives of Disease in Childhood ◽

10.1136/archdischild-2016-311933 ◽

2017 ◽

Vol 102 (4) ◽

pp. 352-356

Author(s):

Verica Ivanovska ◽

Hubert G Leufkens ◽

Carin MA Rademaker ◽

Elizabeta Zisovska ◽

Mariëlle W Pijnenburg ◽

...

Keyword(s):

Essential Medicines ◽

Administration Routes ◽

Area Of Interest ◽

Oral Formulations ◽

Clinical Benefits ◽

Age Appropriate ◽

Therapeutic Needs ◽

Medicines For Children ◽

Dosing Accuracy ◽

Weight Groups

ObjectiveThere is a global call for formulations, which are better suited for children of different age categories and in a variety of settings. One key public health area of interest is age-appropriate paediatric antibiotics. We aimed to identify clinically relevant paediatric formulations of antibiotics listed on pertinent formularies that were not on the WHO Essential Medicines List for Children (EMLc).MethodsWe compared four medicines lists versus the EMLc and contrasted paediatric antibiotic formulations in relation to administration routes, dosage forms and/or drug strengths. The additional formulations on comparator lists that differed from the EMLc formulations were evaluated for their added clinical values and costs.ResultsThe analysis was based on 26 EMLc antibiotics. Seven oral and two parenteral formulations were considered clinically relevant for paediatric use. Frequently quoted benefits of oral formulations included: filling the gap of unmet therapeutic needs in certain age/weight groups (phenoxymethylpenicillin and metronidazole oral liquids, and nitrofurantoin capsules), and simplified administration and supply advantages (amoxicillin dispersible tablets, clyndamycin capsules, cloxacillin tablets, and sulfamethoxazole+trimethoprim tablets). Lower doses of ampicillin and cefazolin powder for injection could simplify the dosing in newborns and infants, reduce the risk of medical errors, and decrease the waste of medicines, but may target only narrow age/weight groups.ConclusionsThe identified additional formulations of paediatric antibiotics on comparator lists may offer clinical benefits for low-resource settings, including simplified administration and increased dosing accuracy. The complexity of both procuring and managing multiple strengths and formulations also needs to be considered.

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Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019

Pharmaceutics ◽

10.3390/pharmaceutics12040316 ◽

2020 ◽

Vol 12 (4) ◽

pp. 316 ◽

Cited By ~ 3

Author(s):

Jose-Manuel delMoral-Sanchez ◽

Isabel Gonzalez-Alvarez ◽

Marta Gonzalez-Alvarez ◽

Andres Navarro-Ruiz ◽

Marival Bermejo

Keyword(s):

Drug Product ◽

Essential Medicines ◽

World Health ◽

European Medicines Agency ◽

Drug Products ◽

United States Food ◽

Age Appropriate ◽

States Food ◽

Health Organization ◽

Medicines For Children

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities demand pediatric forms different to adult formulations. The objective of this study was to evaluate the authorization availability from United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) of oral essential medicines for children and analyze its age-appropriateness for oral administration in children. All oral drugs from 7th List of Essential Medicines for Children by World Health Organization (WHO) were selected. Availability of commercial drug products was collected from OrangeBook, Spanish drug product catalogue, British electronic Medicines Compendium, and the International Vademecum. Tablets, effervescent tablets, and capsules were considered as not age-appropriate forms. Liquid forms, powder for oral suspension, mini tablets, granules, and soluble films were considered as age-appropriate forms due to their flexibility. More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA. Nevertheless, around 50% of these formulations are not age-appropriate for most pediatric groups. This study shows the lack of age-appropriate medicines for children. More efforts are needed to improve development and approval of pediatric medicines.

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A critical comparison between the World Health Organization list of essential medicines for children and the Brazilian list of essential medicines (Rename)

Jornal de Pediatria (Versão em Português) ◽

10.1016/j.jpedp.2012.08.012 ◽

2013 ◽

Vol 89 (2) ◽

pp. 171-178

Author(s):

Helena Lutéscia L. Coelho ◽

Luís Carlos Rey ◽

Marina S.G. de Medeiros ◽

Ronaldo A. Barbosa ◽

Said G. da Cruz Fonseca ◽

...

Keyword(s):

World Health Organization ◽

Essential Medicines ◽

World Health ◽

Critical Comparison ◽

The World ◽

Health Organization ◽

Medicines For Children

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Essential medicines for children: Should we focus on a priority list of medicines for the present?

Journal of Pharmacology and Pharmacotherapeutics ◽

10.4103/0976-500x.77073 ◽

2011 ◽

Vol 2 (1) ◽

pp. 1 ◽

Cited By ~ 7

Author(s):

B Gitanjali

Keyword(s):

Essential Medicines ◽

Priority List ◽

A Priority ◽

Medicines For Children

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Persisting pain in childhood medical illness

Oxford Textbook of Paediatric Pain ◽

10.1093/med/9780199642656.003.0032 ◽

2013 ◽

pp. 319-327

Author(s):

Martha Mherekumombe ◽

John J. Collins

Keyword(s):

Pain Management ◽

World Health Organization ◽

Essential Medicines ◽

World Health ◽

Medical Illness ◽

Global Problem ◽

The World ◽

Health Organization ◽

Medicines For Children

Persisting pain in the context of medical illness has been recognized recently as a global problem by the World Health Organization (WHO, 2012). Whilst the epidemiology of medical illness varies throughout the world, the general principles of pain management are applicable to most medical illnesses in children and are effective. Successful pain management for most children is contingent on the availability of the WHO model list of essential medicines for children (WHO, 2011), although regrettably not all medicines are available in every country in the world.

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