Zinc supplementation in the treatment of diarrhoeal disease

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Zinc supplementation in the treatment of
diarrhoeal disease
Incorporating new global recommendations into
country-level policy and action
Paulo Froes, MD, MPH, PgD OH S UNICEF/TACRO,
Health and Nutrition/Immunization Plus
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Zinc supplementation clinical evidence

• Randomised placebo-controlled clinical trials
  evaluating the impact of zinc supplementation
  during acute and persistent diarrhoea
• WHO meeting in New Delhi, India, 2001 convened to
  reviewh the results of all studies available

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Zinc in acute diarrhea

• Reduces duration of diarrhoea episode by up to
  25
• Decrease by about 25 the proportion of episodes
  lasting more than seven days
• It is associated with a 30 reduction in stool
  volume
• Conclusion significant beneficial impact on the
  clinical course of acute diarrhoea reduces both
  severity and duration

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Zinc in persistent diarrhoea

• Zinc-supplemented children had
• 24 lower probability of continuing diarrhoea
• 42 lower rate of treatment failure or death
• Conclusion zinc supplementation reduces the
  duration and severity of persistent diarrhoea

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Zinc in bloody diarrhoea

• Positive impact of the prevalence of dysentery in
  the month following the supplementation
• Improves seroconversion to shigellaciddal
  antibody response and increases the proportions
  of circulating B lymphocytes and plasma cells and
  the IgA-specific immunoglobulin response
• Conclusion zinc supplementation should be given
  as an adjunct to antibiotic treatment of bloody
  diarrhoea

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Cost-effectiveness studies

• zinc supplementation significantly improved the
  cost-effectiveness of standard management of
  diarrhoea for dysenteric as well as
  non-dysenteric illness.
• Sufficient evidence to recommend the inclusion of
  zinc into standard case management of both types
  of acute diarrhoea

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The new WHO-UNICEF recommended policies for
health professionals on the treatment of diarrhoea

• Counsel mother to begin administering suitable
  home fluids immediately upon onset of diarrhoea
  in a child
• Treat dehydration with new low osmolarity ORS
  solution (or with intravenous electrolyte
  solution in cases of severe dehydration)
• Emphasize continued feeding or increased
  breastfeeding during, and increases feeding
  after, the diarrhoeal episode
• Use antibiotics only when appropriate, i.e., in
  the presence of bloody diarrhoea or shigellosis,
  and abstain from administering anti-diarrhoeal
  drugs
• Provide children with 20 mg per day of zinc
  supplementation for 10-14 days (10 mg per day for
  infants under six months old)
• Advise mothers of the need to increase fluids and
  continue feeding during future diarrheoal episodes

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Zinc and Low-osmolarity ORS effective, safe and
available
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Incorporating the new recommendations into the
countrys health policy I

• Identifying and obtaining commitment and support
  from key stakeholders
• Appropriate departments of MoH (leadership role)
  interprogrammatic coordination is key
• Ministry of Planning and Finance
• Professional Organizations Medical and
  Pediatrics Associations Nurses Association
  Pharmacists Association
• Private sector Manufacturers of zinc and ORS,
  importers and wholesalers, private hospitals and
  pharmacies, drug shops, traditional healers
• Collaborating partners such as NicaSalud, PATH,
  UNICEF, PAHO/WHO, World Bank, USAID, other NGOs

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Incorporating the new recommendations into the
countrys health policy II

• Gathering clinical and scientific evidence
• Endorsing the new recommendations
• Revising/updating existing policies

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Available in English, Spanish and French
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Implementation issues new ORS and zinc
supplementation

• Product issues
• Supply management issues
• Technical
• Operational
• Monitoring and evaluation

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Product issues

• Dosage
• Each individual dose of zinc should contain 10 mg
  or 20 mg of elemental zinc
• For syrups, the concentration of elemental zinc
  should be either 10 mg/5 ml or 20 mg/5 ml
• For tablets, each tablet should contain either 10
  mg of 20 mg of elemental zinc. Tablets containing
  20 mg of elemental zinc should be scored.
• Zinc salt used in to prepare syrups or tablets
  for use in the management of diarrhoea should be
  soluble in water
• Zinc sulphate
• Zinc acetate
• Zinc gluconate
• Type of tablets for use in infants and young
  children it is essential that the tablets be
  dispersible. It means that the tablets should b e
  completely disaggregated in about 30 seconds or
  less than 60 seconds in 5 ml of tap water or
  breast milk
• Taste-masking it is essential that the metallic
  taste be totally masked
• Costing it is important to keep the cost of the
  zinc dose as low as possible. Arbitrarly, it has
  been suggested that one dose of zinc not exceed
  US 0.02
• Packaging tablets and syrups should be packaged
  to provide a full treatment of 10-14 daily doses
  of zinc (i.e, for syrups containing 20 mg/5 ml
  bottles should contain 50-75 ml of syrup for
  tablets, a blister should contain 10-14 tablets).
• Shelf life The zinc product should have a shelf
  life of at least two years

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Supply management issues I

• Technical
• Revision of medicine regulation
• Revision of the Essential Medicines List (new ORS
  included in WHO EML in 2003 zinc salts included
  in WHO EML in 2005)
• Review of Integrated Management of Childhood
  Illness (IMCI) guidelines (WHO/UNICEF)
• Training and supervision of health professionals
• Programme communication
• introduction of new treatment which providers and
  patients have little or no experience requires
  considerable planning for behaviour change
  strategies and capacity building at all levels
• Multiple approaches to raising public awareness
  is recommended
• Adhrerence is key with zinc treatment (10-14
  days)
• Instructions and job aids are strongly
  recommended to caregivers

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Supply management issues II

• Operational issues
• Replacement of old ORS no need to withdraw
  stocks. Just matter of planning introduction of
  new oRS in such a way that both products are not
  in circulation concurrently (just to prevent
  confusion). Existence of old ORS should not be a
  barrier for initiating zinc supplementation
• Plan phase-in of zinc treatment phased or
  immediate nationwide rollout. Phased lower
  costs, ability to test implementation strategies
  and correct issues with materials or methods,
  uptake of new recommendations in the health
  facilities can be monitored and modelled

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Supply management issues III

• Operational issues
• Forecasting of demand and quantification
• Forecasting demand for zinc in the absence of
  good morbidity data tentative link with
  procurement of ORS, e.g., one patient two
  sachets of ORS and 10-14 tablets of 20 mg zinc.It
  could underestimate true requirements if
  majoroity of cases makes use of home fluids
  instead of ORS
• Forecasting demand should include team approach
• Local production or international procurement?
• Distribution
• Stock management
• Private sector distribution
• Quality assurance (product efficacy, product
  safety pharmacovigilance product quality and
  post-marketing surveillance

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Monitoring and Evaluation

• Process indicators
• of health care staff trained in the management
  of diarrhoea including new ORS and 10-14 day
  treatment with zinc
• Zinc and new ORS available at the central storage
  facility
• of health facilities, storage facilities and
  private sector outlets with ORS and zinc
  available
• of facilities with the revised treatment
  guidelines
• of cases of diarrhoea in children under five
  prescribed of sold zinc and the new ORS
• Outcome indicators
• of cases od diarrhoea in children under five
  treated with a course of zinc supplementation for
  10-14 days, in addition to ORS
• Knowledge, attitudes and practices indicators
• of caregivers who are aware that zinc is an
  appropriate treatment for diarroeal disease
• of medical providers who believe that zinc is
  an effective treatment for diarrhoea in children
  under the age of five

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Muito Obrigado!