The "child size medicines" concept: policy provisions in Uganda

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The "child size medicines" concept: policy provisions in Uganda

Abstract

Background: In two thousand seven, the World Health Organization launched the 'make medicines child size' campaign by urging countries to prioritize procurement of medicines with appropriate strengths for children's age and weight and, in child-friendly formulations of rectal and flexible oral solid formulations. This study examined policy provisions for MMCS recommendations in Uganda.

Methods: This was an in-depth case study of the Ugandan health policy documents to assess provisions for MMCS recommendations in respect to oral and rectal medicine formulations for malaria, pneumonia and diarrhea, the major causes of morbidity and mortality among children in Uganda- diseases that were also emphasized in the MMCS campaign. Asthma and epilepsy were included as conditions that require long term care. Schistomiasis was included as a neglected tropical disease. Content analysis was used to assess evidence of policy provisions for the MMCS recommendations.

Results: For most medicines for the selected diseases, appropriate strength for children's age and weight was addressed especially in the EMHSLU twenty twelve. However, policy documents neither referred to 'child size medicines' concept nor provided for flexible oral solid dosage formulations like dispersible tablets, pellets and granules- indicating limited adherence to MMCS recommendations. Some of the medicines recommended in the clinical guidelines as first line treatment for malaria and pneumonia among children were not evidence-based.

Conclusion: The Ugandan health policy documents reflected limited adherence to the MMCS recommendations. This and failure to use evidence based medicines may result into treatment failure and or death. A revision of the current policies and guidelines to better reflect 'child size', child appropriate and evidence based medicines for children is recommended.

Introduction

The need for appropriate medicines for children has attracted attention worldwide. It is argued that appropriate medicine formulations should be the basis for drug therapy for children to ensure efficacy and safety. Unsuitable formulations may lead to the child not taking the medicines, or receiving inappropriate doses leading to adverse reactions or ineffective treatment, needless to mention death. Many formulations used for children, especially tablets, are inappropriate for dosing,

dispensing and administering. For example, tablets for adults have traditionally been split and given to children, resulting in inaccurate doses in view of the children's weight, age, physiological and cognitive conditions.

The World Health Organization in two thousand seven, launched the 'make medicines child size' campaign to ensure that children receive the right medicine in the right dose. The MMCS initiative defined 'child size medicines' as those with: appropriate strengths and, child-friendly characteristics such as suppositories, solutions and flexible solid oral dosage formulations. The United Nations member states were urged to make the procurement and supply of 'child size medicines' a priority and also ensure that there are corresponding legislative and regulatory measures for safe medicine use among children. WHO also accentuated the importance of children's medicines being based on the recent evidence of efficacy and safety for treating the specified children. Flexible solid oral dosage forms are considered most suitable for children at the global level especially for developing countries. The flexible solid oral dosage forms include tablets that are dispersible and can be used for preparation of oral liquids suitable for the younger age groups, powders, granules and pellets. Evidence based medicine has been defined by Dickerson and others as a healthcare practice that is based on integrating knowledge gained from the best available research evidence, clinical expertise, patients' values and circumstances. In two thousand eleven, WHO, with support from the United Nations Fund for Population Activities and United Nations International Children's Emergency Fund proposed a list of lifesaving priority medicines for mothers and children to reduce maternal, new born and under five morbidity and mortality.

The role of policy provisions in increasing children's access to appropriate medicines, as recommended by the MMCS campaign, cannot be underestimated. The need for country level reviews about the status of pharmaceutical policies, practices and the degree to which these policies are adhered to has been underscored. It has been argued that evaluation of national medicine policies has potential for creation of evidence that other countries can use to formulate similar policies in their settings.

A study of provisions for priority medicines for mothers and children in the national essential medicines' lists concluded that countries need to urgently amend their lists to provide all priority medicines as part of the efforts to improve maternal and child health. Studies about the implementation of 'child size medicine' policies at country levels have been scarce. A survey by WHO in fourteen African countries recommended an improvement of access to medicines for children. In Tanzania, it was reported that caretakers experienced problems in administering tablets whereby the children either disliked the taste or vomited the medicines. A study on provisions for safe medicines for children in Nigeria, on the other hand, found that there was a lack of pediatric focus in the essential medicines lists, a lack of access to up-to-date medicine information and weak national level policies.

There have been variations in the definition of policy. However, policy is commonly referred to as: formal authorization norms, values and power or 'course of action that affects a set of institutions, organizations, services and funding arrangements'. This study collectively refers to policy statements, strategies,

lists of essential medicines and clinical guidelines as 'policy documents'.

In Uganda, the essential medicines management program has been in place since nineteen eighty-five and has been influential in determining the medicines that are procured by public health facilities. Over the years, this program has evolved and is the origin of policy provisions like the essential medicines lists and clinical guidelines. Prior to and after the launch of the MMCS campaign, no studies tailored to policy provisions for child size medicines in Uganda existed. Although the medicine policy reforms affecting essential medicines lists and clinical guidelines have been introduced, it is not clear to what extent they have addressed the MMCS recommendations. The objective of this study was to investigate the policy provisions for MMCS campaign by WHO in Uganda and make recommendations on how to address the policy gaps, if any.

Methods Study setting

Study design

Data analysis

Ethical considerations

Results Historical overview of the reforms

The essential medicines lists

Child-friendly medicines

Appropriate medicine strengths for children

VEN classification

The Uganda clinical guidelines

Recommendation of splitting of adult medicines to give to children

Evidence based medicines

Discussion

The WHO recommendations on child-size medicines remain an unfinished business

Medicine strengths for children

Evidence based medicines

Study strengths and limitations

Policy implications

Conclusion

Recommendations

Overview

This document examines the adherence of Ugandan health policy to the "child size medicines" recommendations by the WHO, revealing gaps in policy provisions that could impact the treatment of childhood diseases. The study analyzes policy documentation to recommend necessary reforms for improved access to child-appropriate medicines.

Key Points

1The WHO launched the 'make medicines child size' campaign in 2007 to prioritize age-appropriate medicines for children
2The study found limited adherence to policy provisions for child size medicines in Uganda
3Many recommended treatments in clinical guidelines were not evidence-based
4A revision of policies is needed to ensure evidence-based and child-appropriate formulations are available for children
5The research highlights the importance of child-centered medicine formulations to enhance treatment efficacy and safety.

Details

Authors: Xavier Nsabagasani, Jasper Ogwal-Okeng, Anthony Mbonye, Freddie Ssengooba, Rebecca Nantanda, Herbert Muyinda, Ebba Holme Hansen
Category: Health and Medicine

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