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Amoxicillin

Product Profile

Amoxicillin

Potential Lives Saved/Year:

900,000 children under 5¹





Problem and Proposed Intervention

Pneumonia, diarrhea and malaria remain the three largest killers of children and together account for about 40% of deaths in children under five years of age worldwide2.  An estimated 1.36 million children die each year due to pneumonia alone2.  The majority of these child deaths (60%) occur in just 10 countries: India, Nigeria, Democratic Republic of Congo (DRC), Pakistan, Ethiopia, Tanzania, Uganda, Bangladesh, Kenya and Niger.[1]  Additional attention and investment is needed to scale up effective treatment of pneumonia and diarrhea, which has received limited consideration and funding to date.  Inexpensive means of diagnosis and treatment are available.  Antibiotics, such as amoxicillin, can prevent the majority of pneumonia deaths and cost only about $US 0.21-0.42 per treatment course3.  Despite the existence of this simple, inexpensive treatment, many children in need are often left behind: only 30% of children with suspected pneumonia receive an antibiotic4.  Research and pilot programs have demonstrated effective approaches to scaling-up treatments such as amoxicillin, and a growing number of countries are scaling up integrated community case management programs, but these programs require significant systems supports in order to reach the majority of children in need. Comprehensive and ambitious programs designed to build on these initial projects are essential to achieve Millennium Development Goal 4 (reduce by two-thirds, between 1990 and 2015, the under-five mortality rate).



[1] These countries were selected based on a number of criteria including (a) burden of disease, and (b) programmatic capacity and strength.

Amoxicillin product characteristics:

Drug:

Amoxicillin (Amoxi)

Proposed Indication:

Simple pneumonia

Formulation:

250 mg scored, dispersible tablet (DT) in a blister pack of 10

Dose:

40mg/kg/dose twice daily for 3 days in low HIV areas and for 5 days in high HIV areas5.

2-12 months = 1+1 DT Daily (10 DT Total). 1-5 years = 2+2 DT Daily8 (20 Total)

Avg. Cost:

~$0.21-0.42 USD per treatment course3



Read more below.



Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* WHO EML176 [1]  and Priority Medicines List for Children7 both recognize Amoxicillin 250 mg Scored, Dispersible Tablet as a first line product for treatment of pneumonia in children <5

* US Pharmacopeia monograph exists for dispersible tablet.  European and Indian Pharmacopeias general reference for tablets.

 

National, Regional

* Market for DT is more developed in Asia, where many brands include Amoxi DT in 125 mg and 250 mg. Still, the majority of products in the market are suspension and capsules.

 

* Limited national focus and action on pneumonia as a main cause of child mortality.

* Registration of Amoxi DT is limited in Africa. The majority of the market (as per number of products registered) is for powder for oral suspension and capsules. 

* Many countries still have cotrimoxazole indicated as the first-line pneumonia treatment for children <5 and so registration and policy revision is necessary.

* Use of 250 mg DT is rarely mentioned in national treatment guidelines, and is often not yet included in national EMLs.

* Amoxicillin and antibiotic distribution is usually limited to a certain trained cadre of health providers, limiting access and distribution/administration possibilities at the community level.  And yet, the evidence base exists to support the safety and efficacy of community-level administration.  

Product specification & characteristics

* Available mainly in 125 mg and 250 mg strength in various blister sizes (6-15 mg).  The target presentation has been defined as a blister of 10.

* Safe excipients

* Rather than creating patient packs, dispensing pouches could be customized in-country and used to deliver the blister(s) of amoxicillin DT and appropriate messages. This would reduce logistic problems of having patient packs for <1s and for 1 to 5 years and introduce flexibility in the supply chain.

* Amoxi 250 mg DT aligns well with the new WHO treatment guidelines5 and Community Health Worker training package8.

* Leaflet does not usually include specific treatment guidelines for pneumonia.

* Amoxi 250mg DT does not align well with the 2005 and 2008 Integrated Management of Childhood Illnesses international guidelines.  As currently presented, it either requires breaking tablets or going with 125 mg DT, which requires more tablets.

* There are product packaging challenges, given the difference in administration for < 1s vs. 1-5 year olds.  Different options each have different + and - related to sourcing, cost, logistics, dispensing and compliance.

Financing, Procurement & Supply

* Over 90 manufacturers of Amoxi Dispersible Tablets in strengths from 125 mg to 1000 mg. 79 manufacture 250mg (UNICEF Survey)

* Cost of DT is much lower than that of powder for oral suspension. The 250mg DT in blisters of 10 for pneumonia is easier to administer.  Cotrimoxazole is cheaper, but only if adult tablets are used.

* Despite the existence of manufacturers, the# is limited in comparison to powder for suspension, capsules and tablets.

* Market for amoxicillin formulations is mainly for capsules, followed by oral suspension and tablets. A recent report9 indicates that the market potential for DT as replacement of oral suspension and syrup only would not be large compared to that of capsules.

Service Provision (Rational Use)

* Amoxicillin is a common drug known by service providers.

* The introduction of malaria Rapid Diagnostic Test (RDT) test kits in facilities may help to promote proper diagnosis of malaria versus other illnesses, such as pneumonia.

* Pneumonia is often misdiagnosed as malaria until it develops into severe pneumonia.  Prescriptions often include antibiotics and ACTs, which is a waste of resources, or do not include pneumonia treatment until it is too late.

* Over-prescription of non-first-line treatments, especially IV/injections, syrups, and expensive 3rd generation antibiotics that provide a higher profit margin in the private sector.

Demand

 

* Pneumonia is often self-misdiagnosed by caregivers as malaria, resulting in irrational drug use and minimal care-seeking until it develops into severe pneumonia.

* Irrational drug use is also due to preference for syrups, injections or non-first-line treatments.

* Limited easy, cost-effective prevention options for pneumonia.

* Insufficient care-seeking behavior.



 

Country Context and Diarrhea & Pneumonia Working Group

Recently, there has been growing recognition that additional investment is needed to scale up effective treatment of pneumonia and diarrhea, which has received limited attention and funding to date. Inexpensive treatment is available for these conditions, and significant progress in scaling up treatment coverage can be made, especially in reaching those who currently receive suboptimal medicines.  Research and pilot programs have demonstrated effective approaches to scaling-up these treatments. However, these programs are typically small-scale. Comprehensive and ambitious programs designed to build on these initial projects are essential to achieve significant increases in access in the coming years.

In light of this opportunity, a high-level working group has come together to support the 10 high-burden countries (India, Nigeria, Democratic Republic of Congo, Pakistan, Ethiopia, Tanzania, Uganda, Bangladesh, Kenya and Niger)  to develop, finance, and implement ambitious plans to scale-up effective treatment for diarrhea and pneumonia. The Initiative, led by UNICEF and the Clinton Health Access Initiative (CHAI), includes the Bill and Melinda Gates Foundation (BMGF), John Snow Inc. (JSI), Population Services International (PSI), the United Nations Secretary General Special Envoy for malaria (UNSE), and the World Health Organization (WHO), among others, and aims to achieve universal access of diarrhea and pneumonia treatment through both the public and private sectors.  In order to capitalize on the growing focus on pneumonia and diarrhea, this Initiative started working in the fall of 2011, before the Overlooked Commodities Commission was fully conceptualized and launched. 

The Initiative is pursuing multiple, simultaneous efforts at the global and country levels to support the development and implementation of these plans. The timeline for these efforts is ambitious – with the goal of finalizing comprehensive, costed national plans by early 2012.  This will allow the execution of plans to begin in 2012, driving towards universal coverage of appropriate treatments for diarrhea and pneumonia in children by 2015 across these 10 focal countries. 

Country_Map_coverage_and_deaths_03Apr2012



Coming soon: Read the full case study (PDF).


[1] Theodoratou E, Al-Jilaihawi S, Woodward F Feguson J, et al.  The effect of case management on childhood pneumonia mortality in developing countries.  International Journal of Epidemiology 2010;39:i155–i171.  Applied CHERG estimate of 70% reduction in U5 pneumonia deaths due to case management of pneumonia

[2] Black, R. et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet, 2010: 375. State of World Children 2011.

[3] 2010 UNICEF Supply Division catalogue.  Cost is presented excluding freight.

[4] UNICEF global databases 2011 based on DHS, MICS and other national surveys.

[5] WHO.  Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations: newborn conditions, dysentery, pneumonia, oxygen use and delivery, common causes of fever, severe acute malnutrition and supportive care.  Geneva, Switzerland.  ISBN 978 92 4 150282 5

[6] WHO. WHO Model List of Essential Medicines (March 2011), 17th edition.  Available at:  http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  Accessed March 26,2011

[7] WHO. Priority Medicines for Mothers and Children 2011, 3rd edition. http://www.who.int/medicines/publications/A4prioritymedicines.pdf (Accessed March 2012).

[8] WHO and UNICEF.  Integrated management of childhood illness: caring for newborns and children in the community.  Geneva, Switzerland. ISBN 978 92 4 154804 5

[9] Amoxicillin Market Research Report: Overseas Market of Amoxicillin Based on Official Trade Data. www.infobanc.com/market_reports/amoxicillin-export-market-analysis.pdf