Project Report Study sites: Haryana (Palwal district) and Orissa - - PDF document

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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

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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

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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

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List of Contents

Content Page no

• 1. Background

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• 2. Study Rationale

6

• 3. Study Objectives and Research Questions

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• 4. Prototype

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• 5. Study methodology

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• 6. Key findings

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• 7. References

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• 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

• f 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

• f 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

• n the amoxicillin DT packaging because it is the current WHO recommendation and we are
• ptimistic 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.

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• 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.

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• 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.

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• 5. Study Methodology

5.1 Study Approach and Study Population This activity was a formative research. The results from this study shall be used to iterate the prototypes for future use. We used participatory qualitative research methodologies to obtain the

• pinion of various stakeholders from users, prescribers, distributors and public health program

persons to understand the current difficulties with medication packaging as well as what would be the most desirable features of a future package presentation. Additionally, we used the prototypes of the probable packages that we developed to receive feedback on areas for improvement. We adopted a combination of in-depth interviews and focus group discussions using semi- structured interview guides. 5.2 Study sites This study was undertaken in two countries India and Kenya following similar protocol. In India, the study was done in two districts of Haryana (District Palwal) and Orissa (District Khurda). Additionally, the state level public health program stakeholder opinion was also

• btained.

5.3 Sampling Strategy To answer the objectives, we have included related stakeholders including end users of childhood pneumonia medication, prescribers (both formal and informal), and drug dispensers to understand their current practices and receive feedback on the presentation prototypes for amoxicillin DT. Additionally, the state level program persons was also important to understand the current practices and challenges in management of pneumonia in children and suitability of the amoxicillin DT prototype packaging. It was considered critical to obtain information from all the groups as the success of using amoxicillin DT to treat childhood pneumonia relies on both prescribing and using the medication appropriately. Apart from adherence possible negative externalities of adherence, need for monitoring and assessment by health care providers were also explored from the stakeholders. The stakeholders included in the study for data collected are given below in Table 1. Table 1: Stakeholder selection for data collection Stakeholder Haryana(Palwal) Orissa(Khurda) Total In-depth Interviews State level

• RCH officer or child health consultant
• Officer in-charge of drug procurement

Total 2 1 1 Total 2 1 1 4 Doctors

• Public
• Private

Total 6 4 2 Total 6 4 2 12

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• ANM

Total 5 5 Total 5 5 10 Informal providers

• Informal/unlicensed practitioners
• Chemists

Total 6 3 2 Total 6 3 2 12 Stockist

• Drug stockiest/ distributor

Total 1 1 Total 1 1 2 Caregivers

• Mothers of under-five children

Total 5 5 Total 5 5 10 Focus Group Discussion Caregivers

• Mothers of under-five children

Total 2 2 Total 2 2 4 Thus a total of 24 in-depth interview and 2 FGDs per state were conducted. The stakeholders were purposively identified. All participants were interviewed only after

• btaining consent.

5.4 Data collection procedures Data was collected from study participants using an in-depth interview guide and a focus-group discussion guide. The study tools were approved by the INCLEN Ethics Committee. Interviews were scheduled in consultation with the stakeholders as per their convenience and conducted either at home or office of the stakeholders. The interviews were recorded using study tools for the specific stakeholder in local language as per the verbatim narrated by the stakeholder. Later the responses were translated into English in another schedule for the stakeholder. For the stakeholders who responded in English, the response was directly recorded. Participants were asked about their care seeking practices, perceptions about the prototypes, suitability and areas of improvement. 5.5 Data management and analysis procedures The data collected were reviewed by the team leader/investigators at each site. The data collected in Orissa were verified and completed before sending to INCLEN. At INCLEN the data was checked for completeness and consistency. The data translation was checked by another team before entry into database. Data entry was done in MS word by data entry operators. The data entered were saved in database with secured access. Data analysis and summarization was done by investigating team at INCLEN. All data were read followed by listing and coding. The data shall be summarized as per broad topics. 5.6 Quality assurance We ensured multilevel quality assurance measures during data collection. The research teams were trained by investigator to ensure consistency in understanding. During data collection Principal Investigator made field visits to observe the data collection quality and method of

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• interview. PATH team members also visited Palwal district (Haryana) and observed the data

collection procedure. 5.7 Ethical approval The proposal was submitted to INCLEN Independent Ethics Committee (IIEC) for review and

• approval. The proposal and study documents including the informed consent for were approved

by the ethics committee. After obtaining ethical approval, the data collection was initiated. 5.8 Study and timeline June July Aug Sept Oct Protocol developed for interviews Prototype designing Ethics approval Training of study team User interviews completed Data transcribed and translated Data analysis Report writing

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• 6. Key Findings

6.1 Care seeking practices According to mothers, the common reasons for care seeking were fever, cough, vomiting, diarrhea followed by urine, skin and ear infection. Most of the mothers seek opinion from their husbands and other family members. While mothers in Orissa preferred going to private hospital

• r doctor, mothers in Haryana used to visit to local practitioner (most of which are informal

practitioners). According to mothers, blood tests were advised to majority of the children in Orissa while only few children were advised for the same in Haryana. 6.2 Diagnosis of pneumonia by prescribers The symptoms and signs used by prescribers were reasonable according to the protocol, but few mentioned about the respiratory rate criteria used for diagnosis. Some of them advise for chest x- ray and blood tests for confirming diagnosis. Although most of the ANMs were trained, none mentioned about the respiratory rate criteria for diagnosing pneumonia. 6.3 Medication prescription and usage The mothers in Orissa remembered medicines correctly and all children received antibiotics during the last episode of illness. Mother in Haryana did not remember medicines (or antibiotics) received by their children during last illness. The duration of medicine advised were commonly for 4-7 days (range: 2-10 days). Many of the mothers in Haryana did not remember the instruction (for usage of medicine) given by the doctor/ prescriber, while most of the mothers in Orissa could recall. According to the mothers at both sites, the prescribers explained usage of medicines to them and they could remember the instructions when they were back at home. Most

• f the mothers expressed that they don’t face any significant problem in administering the

medicines (mostly syrup). But few mothers experienced vomiting by children after giving medicines. Some of the prescribers had perception that mother don’t give medicines regularly and complete the course. Most of the ANMs had also doubt about the adherence to dosage and completion of medication course by mothers. Almost all of the prescribers (doctors) advise amoxicillin as first line antibiotics for treating pneumonia in children. For dosage calculation, some used both age and weight while some used age of the child. When asked about per kg dose calculation, few of the prescribers could clearly mention the correct dosage. All the ANMs indicated that they advise Cotrimoxazole tablets for children with pneumonia as that is available with them from Government supply. They advise the dosage according to the age of the child. According to the chemists and drug distributors, most of the prescribers prescribe syrup form of

• antibiotics. Most of the chemists prescribe medicines to the patients and dispense amoxicillin.

But none of them was clear about the dosage of medicine.

[Type text] 12 Regarding the instruction, none of the currently available medicine package has any instruction for usage. All mothers expressed that pictorial instruction is better than written and it shall help in understanding the instruction better. 6.4 Medicine availability in public health system According to the government stakeholders, both Cotrimoxazole and Amoxicillin are available in the health system and both syrup and tablet forms are available for use in children. The procurement is mostly centralized from the manufacturers. The dispensing from public health system is for 2-3 days and requires patients to return back to get the subsequent doses. 6.5 Prototype and preference 6.5.1 General impressions Most of the mother found the prototype to be helpful and understandable. The components understood by themselves including dosage of tablets, dissolving process, tablets, timing of medicines use. Most of the prescribers appreciated the prototype. They were of opinion that these shall help mothers in giving the medicines properly, even the uneducated can understand. Some had some apprehension about acceptance tablets in place of syrups and for some mothers it may be clumsy. Few of the prescribers were willing to stick to syrup form of medicine for prescription. Most of the ANMs believed that Prototype was good and to be helpful to understand in better

• manner. Because it covers all the components such as dosage, time table, Signs and how to give

the medicines. But one of the ANM suggested syrup to be preferable than DT. The chemist and drug distributers felt that this would help mothers understand the drug administration better. They believed that this will be helpful to patient and even they do not need to take the help of doctors and pharmacist to make them understand it. They also suggested there should be instructions about the infection that may arise when mother give medicine to their

• child. This would assist also the drug dispenser to explain and reinforce the medicine dosage.

The health officials found it to be good and helpful. They indicated that the dosage is different from that in the national guideline (IMNCI). 6.5.2. Glass vs. spoon The opinion of mothers was mixed in this context. Most of the mothers were of opinion that spoon is better than glass/cup; although some of the mothers said that they may choose glass/cup for older children. The mothers suggested the quantity of water to be taken in glass/cup for dissolving the tablets. Most of prescriber said that spoon/Bela (Large spoon) is better than glass or Katori/cup. Most of ANMs preferred spoon over glass/cup for administration of medicine in children. They

• pined that glass may be used for older children, but spoon is useful in all children.

[Type text] 13 Chemists and drug distributors opined that use of glass in young children can lead to wastage. They suggested spoon is better as it can be used for all age groups. 6.5.3. Dark vs. light images of people/child None of mother had any issue with the colour of the image of child or mother Most of prescriber opined that they have no issue with any color but white color is good than black color. They say that white color of child is a presenting more attractive then black. ANMs had also no issue with color. Chemists and drugs distributors have no issue with any color, but felt a colourful child picture may be useful/ attractive. 6.5.4. Sun/moon (day and night) Many of mother felt that it was difficult to differentiate between day night based on the current picture According to them it shall be better if the sun be coloured red and moon be white, Additionally they suggested for indicating the day and night in writing. Prescribers opined that morning and evening (Day/Night) should be written along with sun and moon’s pictures. Some ANMs suggested that day and night along with time should be mentioned with sun and moon sign. Chemist and drug distributer say that day and night is clear in green images 6.5.5. Bacterial load Most of the mother found that bacterial load image is understandable and to be useful. They found it convincing for completing the course. Most of prescriber found that picture of bacterial load to be useful for mothers in understanding and completing course of medicine. They also felt that it will be helpful to them in explain to mothers. Most of ANMs felt that bacterial load is useful and shall assist them while explaining the

• mothers. Also this shall help mothers to understand and complete full course

Chemists and drug distributors suggested that there should be some instruction about hygiene which guide the mother how to wash the hand, use of safe water while giving medicine to the child. 6.5.6. Waiting time to dissolve They opined that there should be information about amount of water to be used for dissolving

• tablet. The time taken for dissolving the tablet should be indicated.

[Type text] 14 Most had no issue with the time needed to dissolve. Few prescribers opined that the mother may not wait for 2 minutes and check whether the tablet has dissolved fully or not. 6.5.7. Clarity of instructions Many of the mother felt need for written information also along with sign/pictute, especially for more than one times tablets is to be dissolved and administered. Prescribers suggested there should be instruction about when to take dose before/after taking

• meals. Although most of them felt that instruction were adequate.

They found the instruction to be adequate and clear enough. They found it adequate but also felt some components are to be clearer about use of safe water, clean spoon and glass, exact time of taking medicines etc. 6.5.8. Colors According to the mothers, prescribers and ANMs there was no issue with colours of the prototype as they felt the main focus is on the tablet and medicine. Some chemist felt that colourful child’s picture may be attractive. 6.5.9. Potential use of packaging Most of the mothers did express usefulness of the packaging instruction. The prescribers felt that this packaging shall be useful for both mother in understanding and prescribers in explaining the instruction. The ANMs felt that this packaging shall be useful for both mother in understanding and ANMs in explaining the instruction. Most of the ANMs opined to have the instruction on the package/wrapper pack of the tablets not on the tablet strip. 6.5.10. Combined vs. separate instructions Majority of mothers preferred prototypes with combined instruction as it covers both age groups in single package. However some of the mothers felt that combined prototype may lead to confusion so separate prototype for specific age group will be better. More than half of the prescribers opined combined prototypes as better. Some of them felt that separate instruction was good to avoid confusion among mothers especially the illiterate ones. While half of the ANMs preferred the combined instruction prototype, the other half preferred separate instruction prototypes. The opinions of chemist and drug distributers were divided with equal share of preference towards combined instruction prototype and separate.

[Type text] 15 6.5.11. First and last preference of prototypes Overall majority of mothers preferred the prototype-4(combined instruction) as the best and prototype-3(single instruction with glass) as the worst one. Majority of the prescribers preferred the prototype-1 as the best and prototype-4 (combined instruction) as worst one. Most of the ANMs preferred the prototype-4(combined instruction) as the best and prototype-3 (single instruction with glass) as the worst one. Health system officials preferred the prototype-4(combined instruction) as the best and prototype-3(single instruction with glass) as the worst one. 6.5.12. Other comments Majority of prescribers suggested all these instruction to be on a packet/ cover so that it is not cut into pieces while dispensing medicine or torn while using by patients /families. Some of them suggested for indicating administration in relation to food/meal, what to do if child develop diarrhea or vomits the medicines. Few prescribers had apprehension of overdose with 250 mg dosage for younger children. ANMs suggested for clearer prototype to be printed on wrapper and must be marked by the

• doctors. Medicines are to be shown in colored form, the symptom of disease to be included.

Time-table indicating medicine is to be taken before/ after the meals. In addition, Instruction about hygiene, clean spoon, safe water etc is to be included. A message about expiry date of the medicine or not to useful after the period may be helpful. Instruction should indicate to use boiled water and washing before handling medicines and administration. 6.6. Challenges Protocol: The public health system protocol has not still adopted the amoxicillin for use by the ANMs for treating pneumonia at community level. The facility level the prescribers are using amoxicillin as the first line antibiotics for pneumonia. Procurement: The cost of adding this instruction to the packaging of amoxicillin is expected to increase the cost (the extent is unknown at this moment) and absorption of this additional cost into the public health system is to be considered. Acceptance: The mothers and family members accepting amoxicillin DT in place of syrup shall need some reinforcement from the prescribers and counseling. Prototype instruction: There are not many challenges expected.

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