Transcript Zinc supplementation in the treatment of diarrhoeal disease Incorporating new global recommendations into countrylevel policy and action Paulo Froes, MD, MPH, PgD OH.

Zinc supplementation in the
treatment of diarrhoeal disease
Incorporating new global recommendations into countrylevel policy and action
Paulo Froes, MD, MPH, PgD OH & S
UNICEF/TACRO, Health and
Nutrition/Immunization Plus
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
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
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
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
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
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
Zinc and Low-osmolarity ORS:
effective, safe and available
Incorporating the new recommendations
into the country’s 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
Incorporating the new recommendations
into the country’s health policy II
• Gathering clinical and scientific evidence
• Endorsing the new recommendations
• Revising/updating existing policies
Available in English,
Spanish and French
Implementation issues: new ORS
and zinc supplementation
• Product issues
• Supply management issues
– Technical
– Operational
• Monitoring and evaluation
Product issues
1. Dosage
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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.
2. Zinc salt used in to prepare syrups or tablets for use in the management of
diarrhoea should be soluble in water:
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Zinc sulphate
Zinc acetate
Zinc gluconate
3. 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
4. Taste-masking: it is essential that the metallic taste be totally masked
5. 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
6. Packaging: tablets and syrups should be packaged to provide a full treatment of 1014 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).
7. Shelf life: The zinc product should have a shelf life of at least two years
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
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
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
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Local production or international procurement?
Distribution
Stock management
Private sector distribution
Quality assurance (product efficacy, product safety –
pharmacovigilance – product quality and post-marketing
surveillance
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
Muito Obrigado!