Oral Rehydration Salts (ORS)

PRODUCT PROFILE

Potential Lives Saved/Year: Over 640,000 lives saved by 2015 in just four high-burden countries¹

Problem and Proposed Intervention

Children from Nankoma Primary School, Bugiri district, Uganda, in 2013.
© UNICEF/Nakibuuka

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.

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 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.

Oral Rehydration Salts (ORS) product characteristics:

Drug/product: Low Osmolarity Oral Rehydration Salts (L-ORS)
Proposed Indication: Diarrhea
Formulation: Sachets of powder for dilution in 200 ml, 500 mlm and 1 litre, appropriate flavor.  Airtight packet preferably made of aluminum laminate.
Dose: At no signs of dehydration: 50-100 ml (or a quarter to half a large cup of fluid) for children under 2 years; 100-200 ml (one half to one large cup of fluid) for children ages 2-10 years until diarrhea stops. At some dehydration: dosing scheme as indicated in WHO diarrhea treatment guidelines or the amount of the child’s weight (kg) multiplied by 75 ml.
Avg. Cost: Approximately US$ 0.08-0.11/ sachet3

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 * Clear normative guidance on ORS in the WHO EML[1] 174 and the Priority Medicines for Mothers and Children 20115 as recommended treatment for diarrhea.* The standard treatment guidelines for diarrhea are part of the WHO-UNICEF Integrated Management of Childhood Illnesses (IMCI) guidelines.6
National, Regional * ORS is already incorporated into Essential Medicine Lists for diarrhea treatment of children in most high-burden countries (including the top 10 priority countries).*ORS is registered as over-the-counter in most countries, allowing broad distribution and administration in the private sector. * Slow dissemination of policy changes around diarrhea treatment and translation into actual training modules and simple job aids, resulting in limited changes in health provider prescription behaviors.
Product specification & characteristics * Strong, safety profile allowing ORS to be distributed over-the-counter, without requiring a prescription.* ORS has no cold chain storage complications.

* Comprehensive production guidelines for low-osmolarity ORS and oral solutions have been developed by WHO and partners.7

* In its powder form, ORS must be mixed with water. Guidelines may need to include instructions for boiling water to ensure water quality.* Though much more effective than antibiotics, ORS (in combination with zinc) does not provide immediate relief of symptoms and may be negatively perceived by caregivers.

* A variety of package sizes often leads to confusion among providers/caretakers on appropriate dosing.

Financing, Procurement & Supply *A broad and diverse range of international and national manufacturers of ORS currently exists. Public sector:* There is a lack of clarity on financing sources and procurement mechanisms for ORS (and other essential medicines).

* Broader recurring supply chain management challenges limit availability (e.g., weak infrastructure, low staffing levels at district and facility level, etc.).

Private sector:

* ORS is considered a low-margin, relatively low-volume product creating an unattractive market for suppliers to invest in production, marketing, distribution & sales.

* Significant import duties and taxes, together with mark-ups along the supply chain, contribute to elevated prices of ORS at the consumer level.

Service Provision (Rational Use) * Over-the-counter status allows many countries to distribute and administer ORS at mostly all levels of health care provision, including at the community level.* Co-packaging of ORS and zinc has been used in various contexts (Benin, Cambodia, Nepal, Madagascar) with aim of streamlining distribution and improving convenience for care-seekers. * ORS dosing can be complex when a child has some dehydration, making it difficult for providers to closely follow dosing recommendations during administration to patients.* Misconceptions among service providers that antibiotics, prescription drugs, injections and syrups are more effective, reinforces the tendency to prescribe/use alternative, suboptimal treatments instead of ORS (combined with zinc).
Demand * Demonstrated success among well-executed programs focusing on generating awareness and demand for ORS. In Egypt, for example, ORS scale-up has increased awareness to 99% and actual use up to 60%.8  In Bangladesh, ORS coverage has reached 80%. * Overall demand for ORS is relatively low due to high demand for alternative treatments, and a general perception of diarrhea as common and easily self-diagnosed/self-treated condition.* Caregivers in some countries are resistant to treatments that require self-preparation.

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.

Oral Rehydration Salts