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[e-drug] How to handle products for Severe Acute Malnutrition?

E-DRUG: How to handle products for Severe Acute Malnutrition?

Dear e-Druggers,

Our consultancy company hera (www.hera.eu) is involved in a multi-country study 
on products used to treat children with Severe Acute Malnutrition (SAM).

The following products are used for the treatment of SAM in children of 6 to 59 

1. Low-protein milk-based formula diet Formula-75 (F-75) and Formula-100 (F-100)
2. Ready-to-Use Therapeutic Food (RUTF)
3. Low-sodium oral rehydration solution (ReSoMal)

ReSoMal is a pharmaceutical product, a special ORS to be used only under strict 
supervision of a skilled health worker.  

However, Formula's and RUTF are food products. 
WHO Guidelines (http://www.who.int/elena/titles/transition_feeding_sam/en/) 
state that use of F-75, F-100 or RUTF should always be monitored by a skilled 
health worker. 

One could argue that this practice makes these food products pharmaceutical 
products which subsequently should comply with existing medicines regulatory 
arrangements, such as medicines registration. Another argument for this is that 
these food products are often being distributed through the central medicines 
stores and hospital pharmacies. 

What I could find on the internet is that UNICEF, USAID, MSF, WPF and other 
agencies are in agreement on the specifications used for the two Formulas and 
RUTF (UNICEF Supply Catalogue at (http://www.supply.unicef.dk/catalogue/). It 
seems these are not treated as pharmaceutical products as the specifications 
refer to international, regional or national standards for food products. 

International standards for food are to found in the *Codex Alimentarius*. 
Regulations in the EU, USA and other countries refer to Control Authorities 
that are linked to Ministries of Agriculture or Industry and Commerce and are 
specialized in the control of food products.

We have the following questions:

1. We like to know if all these products should be regarded as food products or 
medicines with regard to their quality assurance.

2. What are existing regulations and controls in your country and what is the 
practice? Are the Formulas and RUTF being controlled by authorities that are 
charged with food inspection or are these products under control of the 
medicines regulatory authority in your country?

3. Is any laboratory testing being done, pre- or post-shipment? What would be 
best practice and for what reason? 

4. Do the existing practices ensure quality and safe use of these products or 
are extra measures needed?

We would appreciate any inputs you can give us.

Kind regards,

Rob Verhage, pharmacist
hera Senior Partner / Pharmaceutical Systems Consultant
Tawajakoerastraat 4
Tel +597 438966

[Please send your suggestions directly to rob.verhage@hera.eu who will then 
summarize the collated responses later. Thanks, WB]

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