[Type text] Project: Assessment of User-Friendly Product Presentation for Amoxicillin Dispersible Tablets in the Treatment of Childhood Pneumonia in Low-Resource Settings Project Report Study sites: Haryana (Palwal district) and Orissa (Khurda district), India 1
[Type text] Investigating Team India Principal Investigator Dr Manoja Kumar Das Director Projects The INCLEN Trust International F1/5, Okhla Industrial Area Phase-I, New Delhi-110020, INDIA Co-Investigator Dr Samarendra Mahapatro Professor of Pediatrics Hi-Tech Medical College Bhubaneswar, Odisha-751006, INDIA Overall PATH Dr Amy Ginsburg PATH 2201 Westlake Avenue, Suite 200, Seattle, WA 98121,USA Ph. no. - 206.285.3500; Fax no. - 206.285.6619 Email: aginsburg@path.org 2
[Type text] Research Team Members Haryana (Palwal District) Dr Manoja Kumar Das (Principal Investigator and Director Projects, INCLEN) Dr Abhishek Yadav (Program Officer) Dr Mandeep Mandloi (Program Officer) Mr Mahboob Alam (Research Assistant) Mr Shahbaaz Minaz (Research Assistant) Mr Tuhiram (Field worker) The INCLEN Trust International F1/5, Okhla Industrial Area Phase-I, New Delhi-110020, INDIA Orissa (Khurda District) Dr Samarendra Mahapatro (Co-Investigator) Dr Rajib Roy (Associate Professor, Pediatrics) Dr Lisa Sadangi (Associate Professor, Community Medicine) Dr Brajakishor Behera (Research Assistant) Dr Sourajit Routray (Research Assistant) Dr Monalisa Patra (Research Assistant) Hi-Tech Medical College Bhubaneswar, Odisha-751006, INDIA Data Entry Team Mr Samar Yadav Mr Arun Kumar 3
[Type text] List of Contents Content Page no 1. Background 5 2. Study Rationale 6 3. Study Objectives and Research Questions 6 4. Prototype 7 5. Study methodology 8 6. Key findings 11 7. References 16 4
[Type text] 1. Background Pneumonia is the leading cause of death in children worldwide, accounting for more childhood deaths than AIDS, malaria, and measles combined. Each year, pneumonia kills an estimated 1.6 million children under the age of five and is responsible for 18% of all deaths of children under five years of age globally. 1 Almost all these deaths are preventable if pneumonia is appropriately identified and treated. Community-acquired bacterial pneumonia can be cured and the majority of pneumonia deaths prevented with antibiotics such as amoxicillin. 2,3 In India also amoxicillin is being used commonly for childhood pneumonia in practice and recommended as alternative antibiotics under IMNCI. Despite the existence of this simple, inexpensive treatment, many children in need are not treated: only 30% of children with suspected pneumonia receive an antibiotic. 4 Of the children who do receive amoxicillin, many do not know how to take the medication appropriately and do not complete the recommended course. This can lead to inadequate treatment and the potential to develop drug resistance. The WHO Model List of Essential Medicines and Priority Medicines List for Children both recognize amoxicillin 250 mg scored dispersible tablet (DT) as a first-line product for treatment of childhood pneumonia. 6,7,8 However, the majority of countries are still using the non- dispersible tablet form. Although 500 mg tablets are available, they are often not the appropriate strength for children. Oral suspension is another treatment option; however, there are often problems with dispensing amoxicillin suspension in low resource settings including limited access to clean water. Although amoxicillin DT strength 125mg is available in market for purchase, the same is not available in public health system distribution. The packaging is standard 10 tablets (DTs) per strip. Based on demand from parents and caretakers, the chemists dispense the tablets by cutting strips, which compromise the adherence for full treatment. Additionally, dispensing by the private practitioners in small fractions of the dosage, per day basis also influences the adherence and completion of full course. Will appropriate packaging of amoxicillin DT tablets either 125 mg or 250 mg for full course with usage instruction for parents improve the adherence and completion of therapy? Will the packaging and if yes, which packaging is likely to be acceptable for the public health system, considering the storage and logistics issues? What are the instructions to be mentioned on the package, which shall make the parents and caretakers comfortable in using the full course of the therapy? We will be focusing on the amoxicillin DT packaging because it is the current WHO recommendation and we are optimistic that countries will begin to transition to this treatment in the next several years. In India under IMNCI amoxicillin is part of the pneumonia management protocol, as second line management. User-friendly product presentation that enables appropriate distribution by the provider and provides clear instructions to the caregiver on how to administer a complete course of amoxicillin has the potential to increase adherence, ensuring proper treatment of childhood pneumonia. In this activity, product presentation refers to packaging, either secondary or primary, as well as instructional inserts. 5
[Type text] 2. Study Rationale Appropriate adherence to drug regimens is vital when treating childhood pneumonia. Lack of adherence can lead to treatment failure and the development of drug-resistant strains of pneumonia. It is well documented in the literature that product presentation, including clear instructions, plays a large role in the compliance of patients taking medications. The development of product presentations that enable appropriate administration of amoxicillin DT for the treatment of childhood pneumonia is necessary for improving medication adherence. We tried that the product presentations are appropriate for the context in which they are to be used, including both use-case scenario and end user. In India special packaging with instructions are not in use for domiciliary treatment of diseases like pneumonia. We hope that this formative research shall inform planning packaging of drugs to improve compliance. 3. Study Objectives and Research Questions This study was undertaken with the following objectives: Objective 1: Develop prototypes of potential package presentations for amoxicillin DT to encourage adherence to the full antibiotic treatment. 1. What visual cues improve understanding of instructions in health interventions? 2. What information is important to parents and caregivers of patients regarding adherence to treatment? 3. How can this information be integrated while maintaining flexibility of packaging for different dosages? Objective 2: Explore end user perceptions of the prototypes including acceptability, usability, and feasibility of uptake. 1. How do providers and caregivers perceive current packaging and instructions for amoxicillin prescriptions or other treatment packaging for childhood pneumonia? 2. What would be important features in future product presentations for amoxicillin DT? 3. How can we improve the prototypes? a. What is easy to understand about the instructions? What is difficult? 4. What are the opinions of the providers on whether or not improved instructions will lead to better adherence? 5. Will providers and caregivers utilize these instructions if provided? Objective 3: Identify opportunities for improvement of the package presentations using subjective feedback from end users and incorporate these into new iterations of the product presentations. 6
[Type text] 4. Prototype The prototypes developed for this study targeted two age group children as per the dosage needed: Infants aged >2 months to 12 months: Amoxicillin 250 mg, 1 tablet twice a day Children aged >1 year to 5 years: Amoxicillin 250 mg, 2 tablets twice a day The prototype had the following features: Primarily pictorial with some written instructions Dosage: number of tablets to be given each time: one tablet for infants and two tablets for children Frequency: twice a day with pictorial indication for day/morning and night/evening Days: total of five day schedule Mode of administration: how to mix the tablets (using spoon and glass) and giving by spoon and glass Colour: different colours of prototypes for the infants and children to allow easy differentiation. Bacterial load: a pictorial representation of bacterial load and reduction over days to emphasize the need for full course adherence Four prototypes were developed and finalized for testing by the PATH team and shared with us. The four prototypes were as follows. Prototype 1 Prototype 2 Prototype 3 Prototype 4 These four prototypes were used for obtaining the opinion of the stakeholders during interviews and focus group discussions. 7
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