This Medical Product Alert pertains to a lot of confirmed falsified chloroquine merchandise circulating within the WHO area of Africa. Please observe that this Medical Product Alert n°4/2020 will likely be up to date as new studies of falsified chloroquine are obtained and validated by WHO.

Between 31 March and a couple of April 2020, the WHO world surveillance and monitoring system on substandard and falsified (SF) medical merchandise obtained 9 studies of confirmed falsified chloroquine merchandise from three international locations. All reported merchandise had been recognized at affected person stage and all have been confirmed as falsified.

This WHO medical product alert N°4/2020 refers to 9 completely different falsified chloroquine merchandise, with completely different shows (see Desk 1). It is very important observe that widespread vigilance is required from all international locations, no matter the place the product was initially recognized.

Desk 1: Record of recognized falsified chloroquine merchandise, topic of WHO Alert N°4/2020

All of the merchandise listed in Desk 1 are confirmed as falsified, on the premise that they intentionally/fraudulently misrepresent their id, composition or supply. Certainly, it may be famous that:

  • both: the merchandise don’t include the correct quantity of the energetic pharmaceutical ingredient, based mostly on the outcomes of preliminary or full compendial evaluation;
  • and/or: the merchandise weren’t produced by the producer whose identify is said on the product labels, and the variable knowledge (batch quantity and dates) of the above merchandise don’t correspond to real manufacturing information;
  • and/or: the producer whose identify is said on the product labels doesn’t exist.

Chloroquine phosphate or sulfate is referenced on the WHO Mannequin Record of Important Medicines for the therapy of Plasmodium vivax an infection (malaria). Massive scientific trials are beneath solution to generate the sturdy knowledge wanted to determine the efficacy and security of chloroquine and hydroxychloroquine within the therapy of COVID-19. These medicines are at the moment approved for malaria and sure autoimmune illnesses and it’s important that sufferers don’t face shortages attributable to stockpiling or use outdoors the approved indications. 
Each chloroquine and  hydroxychloroquine can have severe unintended effects, particularly at excessive doses or when mixed with different medicines.

The SOLIDARITY trial, led by WHO, is reviewing potential therapies for COVID-19. Please consult with  WHO medical product alert n°3/2020 for normal info on falsified medical merchandise in relation to the administration 
of COVID-19.

For images of merchandise listed in Desk 1, please consult with the WHO Medical Product Alert web site, and 
to the annex of this medical product alert n°4/2020 (see pages 3-7).

WHO requests elevated vigilance throughout the provide chains of nations more likely to be affected by these falsified merchandise. Elevated vigilance ought to embrace hospitals, clinics, well being centres, wholesalers, distributors, pharmacies and some other suppliers of medical merchandise.

If you’re in possession of the above merchandise, please don’t use. You probably have used these falsified merchandise, or in the event you undergo an opposed response/occasion having used these merchandise, you’re suggested to hunt quick medical recommendation from a certified healthcare skilled, and to report the incident to the Nationwide Regulatory Authorities/Nationwide Pharmacovigilance Centre.

All medical merchandise have to be obtained from licensed, genuine and dependable sources. Their authenticity and situation needs to be rigorously checked. Search recommendation from a healthcare skilled in case of doubt.

Nationwide regulatory/well being authorities are suggested to right away notify WHO if these falsified merchandise are found of their nation. You probably have any info regarding the manufacture, distribution, or provide of those merchandise, please contact: rapidalert@who.int. 

WHO International Surveillance and Monitoring System for Substandard and Falsified Medical Merchandise
For extra info, please go to: www.who.int/medicines/regulation/ssffc/en/ 

Annex: Pictures of falsified chloroquine merchandise circulating within the WHO area of Africa, Medical Product Alert N°4/2020

CAMEROON

Pictures of confirmed falsified Chloroquine Phosphate (100mg)
ChloroquinePhosphate250mgCameroon-1

Pictures of confirmed falsified Chloroquine Phosphate (250mg)
ChloroquinePhosphate250mgCameroon-2

Pictures of confirmed falsified Chloroquine Phosphate 250mg
ChloroquinePhosphate250mg-Cameroon 3

DEMOCRATIC REPUBLIC OF CONGO

Pictures of confirmed falsified CLOROQUINE 250MG
ChloroquinePhosphate250mgDRC1

Pictures of confirmed falsified Chloroquine Phosphate 250mg
ChloroquinePhosphate250mgDRC2

NIGER

Pictures of confirmed falsified Samquine 100 (100mg)

Samquine100-100mgNiger 1

Pictures of confirmed falsified Chloroquine phosphate tablets B.P 100mg

Chloroquine-phosphate-tabletsB.P100mgNiger2

Pictures of confirmed falsified Niruquine (100mg)
Niruquine00mgNiger3

 

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