Rethinking Amoxicillin Packaging
How can we simplify the administration of antibiotics to children to prevent pneumonia?
Pneumonia is the leading cause of under-five child mortality globally, accounting for an estimated 1.1 million child deaths each year (WHO, 2013). UNICEF’s innovation project sought to investigate how Amoxicillin could be packaged to match the recommended course of treatment and thus, simplify the administration of the antibiotics to children.
Pneumonia is the leading cause of under-five child mortality globally, accounting for 18 per cent (an estimated 1.1 million) of all deaths of children under five years, which is more than AIDS, malaria and tuberculosis combined (WHO, 2013). One of the Millennium Development Goals is to reduce child mortality by addressing the main causes of child deaths (WHO, 2013). Although child deaths have numerous causes, the majority are preventable. Research and experience have shown that almost 11 million children who die each year could be saved by low-tech, evidence-based, cost-effective measures such as vaccines, antibiotics, micronutrient supplementation, long lasting insecticidal bed nets and improved family care and breastfeeding practices. To achieve this goal, UNICEF seeks to improve health care practices and optimal management of childhood illnesses. With regard to pneumonia, providing health care supplies that optimally treat pneumonia in children could save the lives of up to 1.56 million children over five years (UNICEF).
Pneumonia accounts for 18 per cent of all deaths of children under five years globally, which is more than AIDS, malaria and tuberculosis combined.
Health care supplies that optimally treat pneumonia could save the lives of up to 1.56 million children over 5 years.
In 2011, WHO updated its recommendation for the treatment of pneumonia in community and replaced Co-trimoxazole with Amoxicillin (preferably in dispersible format) as the new first-line treatment for childhood pneumonia (WHO, 2011). Amoxicillin 250mg dispersible tablets (DT), scored is the most suitable format to treat childhood pneumonia in the community setup and especially in remote areas where there is no reliable sources of clean water and electricity. It is also cheaper and easier to store and to transport tablets compared storage and transportation of bottles of amoxicillin oral suspensions.
The community administration of oral amoxicillin 250mg DT in children under the age of five is either 10 or 20 tablets per treatment (given twice daily for 5 days) depends on the age and weight of the child. However, despite the availability of these inexpensive antibiotics, only a third of children with suspected pneumonia receive antibiotics as part of their treatment regimens.
In most countries, amoxicillin is prescribed and dispensed by medically qualified personnel. However, to improve access in the community, some countries allow low skilled community health workers to prescribe and dispense amoxicillin to treat childhood pneumonia in community case management set ups that integrate treatment of malaria, pneumonia and diarrhoea.
To adequately support community health workers in dispense amoxicillin accurately, the product packages of amoxicillin must therefore match the treatment guidelines outlined for children within certain age and weight ranges as presented by WHO guidelines 2011. Without amoxicillin DT in appropriate packages and instructions, community health workers face difficulties in administering the appropriate dosages to children and engage in practices that proxy the paediatric formulations of oral suspension (OS), such as breaking adult formulations and/or changing their method of administration. For instance, hard tablets are often cut, crushed and then mixed into a liquid; concentrated capsules are diluted; or injectable medications are taken orally (Every Woman Every Child, 2013).
INTRODUCING THE SOLUTION
The goal of this innovation project was to make Amoxicillin 250mg DT available in an innovative package that would simplify the administration of the right dosage of the antibiotics, and thereby ensure that low skilled community caregivers provide the right treatment to children suffering of pneumonia. An investigation was conducted to assess how Amoxicillin 250mg DT could be easily administered to children without the need to engage in proxy practices. This entailed designing an Amoxicillin pack that matched the treatment guidelines for children of different ages within the given weight range.
The investigation resulted in three different packs of 250mg amoxicillin DT; a patient pack with 1×10 tablets of 250mg amoxicillin DT and a depictive instruction leaflet (for children under one year), a patient pack with 2×10 tablets of 250mg amoxicillin DT and a depictive instruction leaflet (for children between ages 1 year and 5 years) and a multiple dispensing pack of 10×10 tablets of 250mg amoxicillin DT and a single depictive instruction leaflet (to be dispensed appropriately for all ages). However, it was established that the multiple dispensing pack is the most cost effective solution for procurement due to its low cost and ease of transportation and storage. However, the multiple dispensing pack still needed to be re-packaged at the dispensing entity in order to appropriately dispense the correct dosage and usage instructions.
The main challenges of the project were associated with the overall introduction of Amoxicillin DT 250mg into the national policies of countries. In terms of registration, many countries still listed Co-trimoxazole as their first-line of treatment for pneumonia in children under-five years of age. The adoption of Amoxicillin DT 250mg is conditioned on national Ministry of Health policy revision and national registration because the lack of medicine registration is a large barrier to introduction. Secondly, in terms of treatment guidelines, most countries still had to update their own national guidelines after the latest WHO recommendations, for which Amoxicillin DT 250mg is most relevant. Finally, it is predominantly the trained health care professionals that administer the antibiotics; however there is evidence to support that Amoxicillin 250mg DT can be administrated at the community level and this would be made increasingly possible by the present project (UNICEF Supply Division, 2013).
The Amoxicillin DT 250mg package requirement was for a product package that supplied the dispersible tablets in such a way that it matched the treatment regimens for children of different ages and weights suffering of pneumonia. In 2012, UNICEF launched a request for Proposal (RFP) to supply Amoxicillin 250mg DT in order to increase supply to countries in accordance with the new WHO protocol. Since 2011, UNICEF had supplied small quantities of Amoxicillin from three suppliers. However, following a 70 per cent increase in procurement in 2012 over 2011, and an increase of 300 per cent over 2012, procurement of the medicine needed to be increased. The current Amoxicillin options are a 10×10 blister pack, a 1×10 blister pack and a 2×10 blister pack. Depending on the pack, the costs vary and ease of dispensing the medicines to children of different weights varies, and thus, compliance to the recommended treatment also varies.
In 2012, the newly established UN Commission on Life-saving Commodities for Women and Children agreed that PATH would conduct further trials to determine whether the Amoxicillin dispensing packs could be improved to match the treatment guidelines for all children within the weight range without the need for re-packing at the dispensing entities in the field. The proposed solution in 2013 was a dispensing envelope and currently PATH is looking to conduct pilot studies, costing studies, and assess regulatory implications as well as evaluate what other work needs to be done.
The importance of understanding user behaviour during the development of a solution was emphasised during the course of the project, in particular because it operated in the area of medicines and antibiotics where compliance is important because improper medication may have negative consequences. High importance was therefore given to ensure that the community health worker needs and usage behaviour were in focus, so the final solution would make it possible for them to easily provide the right dosage to children and not have to engage in proxy practices. This learning is applicable to present as well as future projects concerning the packaging of medicines, as well as in other areas.
The importance of supplier cooperation was also found to be very important in the development of the packaging solutions because it was a challenge to obtain supplier feedback and buy-in to the project. This indicates that the establishment of a good relationship with suppliers is essential in the long run for the development of other package solutions and future innovation projects.
FOCUS ON THE FUTURE
This innovation is one solution in the battle against pneumonia. Other innovation projects will proceed to continue this fight. UNICEF is supporting an innovation for an appropriate pneumonia diagnostic aid device in resource-poor settings to improve accurate diagnoses and delivery of appropriate treatment.