Falsified antimalarials in West and Central Africa displaying an outdated WHO Essential Drugs Programme logo
This Medical Product Alert relates to a series of confirmed falsified antimalarials circulating in West and Central Africa. Medicines subject of this alert display a similar logo to the outdated
WHO Essential Drugs Programme logo.
Since 2013, different falsified medicines, all displaying the outdated WHO Essential Drugs Programme logo, have been reported to the WHO Global Surveillance and Monitoring System by various stakeholders. The continued and widespread availability of these falsified medicines highlights a strong need for additional vigilance. WHO previously published two alerts on this issue (No.132 in Oct 2014, and No.131 in March 2014)
This WHO medical product alert N°1/2020 refers to falsified Quinine Sulphate 300mg presented in six different combinations of batch numbers, expiry and manufacturing dates (see Table 1). The fraudulent use of the outdated WHO Essential Drugs Programme logo may create a false sense of product quality.
Table 1: List of identified falsified Quinine Sulphate 300mg, subject of WHO Alert N°1/2020
Recently received results of analysed samples show they do not contain any of the expected active ingredients.
Quinine sulphate is referenced on the WHO Model List of Essential Medicines, to manage and treat severe malaria. At this stage, no adverse reactions attributed to these falsified products have been reported to WHO.
All the above falsified products claim to be manufactured by REMEDICA LTD – Cyprus and to contain 300mg of quinine sulphate. Remedica Ltd has confirmed that:
- they did not manufacture the above falsified products; and
- the variable data (batch number and dates) on the above products has never been used by Remedica.
These falsified medicines display the following common characteristics (please see photographs):
- grey or white plastic containers which contain 1000 loose circular tablets each;
- display the outdated WHO Essential Drugs Programme logo;
- English and French labelling with mistakes and inconsistencies; and
- discovered at patient level in both regulated and unregulated outlets.
Product details, photographs and advice to the public are available on the following pages.
Outdated WHO Essential Drugs Programme logo
Photographs of confirmed falsified Quinine Sulphate 300mg tablets subject of
Medical Product Alert N°1/2020
1. Falsified
Quinine Sulphate Tablets B.P 300mg identified
in Chad (Batch 44680)
WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products.
If you are in possession of the above products, please do not use. If you have used these falsified products, or if you suffer an adverse event having used these products, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre.
All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.
National health authorities are asked to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact rapidalert@who.int .
WHO Global Surveillance and Monitoring System
for Substandard and Falsified Medical Products
For further information, please visit our website: www.who.int/medicines/regulation/ssffc/en/
Read More
https://www.who.int/news-room/detail/09-03-2020-medical-product-alert-n-1-2020-english-version
Views: 0