Potential Lives Saved (ORS + zinc): Over 640,000 lives saved by 2015 in just four high-burden countries¹

Problem and Proposed Intervention

Children gather in Kere Kebele in Machakel Woreda in Amhara State of Ethiopia in July 2013.

Pneumonia, diarrhea and malaria remain the three largest killers of children and together account for about 40% of deaths in children under five worldwide.2 An estimated 1.5 million children die each year due to diarrhea alone.2 The majority of these child deaths (60%) occur in just 10 countries: India, Nigeria, Democratic Republic of Congo, Pakistan, Ethiopia, Tanzania, Uganda, Bangladesh, Kenya and Niger. The WHO-recommended treatment for diarrhea is ORS and zinc, products that are highly effective and affordable; ORS and zinc prevent a majority of deaths and costs less than $US 0.50 per treatment course. Zinc, in particular, shortens the duration of acute diarrhea by 25% and treatment failure or death in persistent diarrhea by 40%.3

Despite the existence of this simple, life-saving treatment, many children with diarrhea are not accessing these products in developing countries: only 38% of children receive ORS and less than 5% receive zinc.2 Although zinc, along with ORS, has been recommended by the WHO as the recommended treatment for pediatric diarrhea since 2004, awareness among care-seekers and service providers is limited. In addition, suboptimal products like antibiotics and anti-diarrheals continue to be used. Research and pilot programs have demonstrated success in scaling up ORS and zinc, but have primarily been small-scale. Additional attention and investment in comprehensive and ambitious programs can significantly scale up access to these simple, low-risk products and is essential to accelerating progress to Millennium Development Goal 4 of reducing child mortality by two-thirds by 2015.

Zinc product characteristics:

Drug: Zinc
Proposed Indication: Diarrhea
Formulation: 20mg scored taste masked dispersible tablet or oral solutions at concentration of 10mg/5ml
Dose: 20 mg daily for 10 days (or 10mg daily for 10 days for children >6 months)
Avg. Cost: Approximately US$ 0.31/10 tablets4

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.

Key issues related to product uptake

Strengths Challenges
Policy and Regulation
  1. Clear normative guidance on zinc in standard treatment guidelines.5
  2. WHO EML 176, [i] and WHO Priority Medicines for Mothers and Children 20117 specification as recommended treatment for diarrhea.
  1. Lack of a broadly endorsed minimum quality standard for zinc tablets.
  2. Need for clearer dosing guidance in WHO treatment guidelines for zinc (e.g., can now be administered as 10 or 14-day treatment course).
National, Regional Zinc already incorporated in national treatment guidelines and Essential Medicine Lists for diarrhea treatment of children in most high-burden countries (including the 10 priority countries).
  1. Inability for most countries to sell zinc as ‘over-the-counter’, limiting uptake through the private sector.
  2. Slow dissemination of policy changes around diarrhea treatment and translation into training modules/ job aids, resulting in limited changes in provider prescription behaviors.
Product specification & characteristics
  1. Strong safety profile allows zinc to potentially be classified as an over-the-counter drug, without requiring a prescription.
  2. Zinc has no cold chain storage complications.
  3. Comprehensive production guidelines for zinc tablets and oral solutions have been developed by WHO and partners.8
  1. Need for clearer dosing guidance in WHO treatment guidelines for suppliers to facilitate decisions around packaging and increase confidence on where to compete in the market.
  2. Lack of consistent specification of taste-masking requirements and corresponding recommendation.
  3. Syrups available in most countries, but are not preferable in terms of price and convenience (the preferred 10mg/5ml formulation is generally more expensive due to higher packaging and volume/transportation costs).
  4. Zinc, like ORS, does not provide immediate relief of symptoms. 
  5. When taken with ORS, the treatment dose required for zinc is 10-14 days compared to ORS treatment for only the first few days, increasing the chances for irrational use.
Financing, Procurement & Supply
  1. Zinc faces relatively minimal regulatory requirements compared to other key health commodities (e.g., ARVs, ACTs).
  2. Local manufacturers producing zinc tablets currently exist in India, Kenya, Bangladesh, and Tanzania.
  1. Despite an established pathway for zinc under the WHO Prequalification (PQ) Program (as of 2008), there are no WHO Prequalified manufacturers of zinc to date. Consensus on a broadly endorsed quality assurance and quality control standard is needed. Given Zinc’s widely accepted safety profile[1], alternatives to the WHO PQ pathway (e.g., WHO GMP, compliance with USP monograph) can be considered.

Public sector:

  1. Lack of clarity on financing sources and procurement mechanisms for zinc (and other essential medicines). Donors have financed and/or procured zinc, but on an ad hoc basis.  
  2. Stock expiration due to insufficient care-seeker demand/purchase.

Private sector:

  1. Low demand for zinc in Africa and Asia creates unattractive market for suppliers to invest in production, marketing, distribution & sales, thereby resulting in low availability.
  2. Significant import duties and taxes, together with mark-ups along the supply chain, contribute to elevated price levels of zinc at the consumer level.
Service Provision (Rational Use)
  1. Unlike malaria, HIV, TB, etc., there is no need for a diagnostic test.
  2. Co-packaging of ORS and zinc has been used in various contexts (Benin, Cambodia, Nepal, Madagascar) with the aim of streamlining distribution and improving convenience for care-seekers.
  1. Misconceptions among service providers that antibiotics, prescription drugs, injections and syrups are more effective reinforce the tendency to prescribe/use alternative, suboptimal treatments
  2. Limited awareness among service providers of the importance of zinc, so they do not prioritize prescribing or restocking it.
  1. Previous initiatives have demonstrated that zinc uptake is feasible and that it is generally accepted as a product for treating diarrhea. Over 83% of caregivers who use zinc for diarrhea indicate that they would use it again.9
  2. Free distribution of zinc at household level in pilot in western Kenya led to 62% usage levels.10
  1. Very low awareness of zinc, along with ORS, as recommended treatment for diarrhea among caregivers and health providers.
  2. Misconceptions among caregivers that antibiotics, prescription drugs, injections, and syrups are more effective reinforce the tendency to use/demand alternative, suboptimal treatments.
  3. Some countries have a preference for oral solutions (e.g., India).

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.