E-DRUG: Medical Product Alert Falsified Meningococcal ACWY Vaccine in West Africa
------------------------------------------------------------------------------------------------------
Medical Product Alert N° 1/2017
Falsified Meningococcal ACWY Vaccine circulating in West Africa
http://www.who.int/medicines/publications/drugalerts/drug_alert1-2017/en/
Medical Product Alert relates to the circulation of a confirmed falsified
Meningococcal ACWY Vaccine discovered in Niger.
PRODUCT DETAILS
This product is used to immunise against Meningococcal disease serogroups
A, C, W, and Y. Meningococcal meningitis vaccine is listed as a WHO
Essential Medicine.
On 31 May 2017, the manufacturer Bio-Manguinhos/Fiocruz informed WHO that
a falsified version of the following product was available in Niger:
http://www.who.int/entity/medicines/publications/drugalerts/meningocACWY_
vaccine_table01.JPG Click to enlarge
jpg, 52kb
The label on the product claims that it is manufactured by
Bio-Manguinhos/Fiocruz and is presented in vials of 10 doses each.
Photographs of the falsified vaccine are available in annex. This falsified
product has not yet been subject to laboratory analysis.
The manufacturer Bio-Manguinhos/Fiocruz has stated that:
They do not manufacture Polysaccharide Meningococcal ACWY Vaccine
Based on examination of the photographs they can confirm that this packaging is falsified
No adverse events following immunisation attributed to this falsified
vaccine are known to have been reported at this stage.
On the basis of the above information, any Meningococcal ACWY
Vaccine claiming to be manufactured by Bio-Manguinhos/Fiocruz, should be
considered falsified and reported.
ADVICE TO HEALTH CARE PROFESSIONALS, PATIENTS AND NATIONAL AUTHORITIES
If you are in possession of this vaccine, please do not use. Contact a
healthcare professional as soon as possible for advice and report the
incident to your local Ministry of Public Health / National Medicines
Regulatory Authorities/ National Pharmacovigilance Centre.
Please seek immediate advice from a qualified healthcare professional if
you have been immunised with this falsified vaccine, or if you suffer an
adverse event following its immunisation, and report the incident as
indicated above.
Members of the public who are aware of falsified medical products sold by
various retailers should report to their national health authorities.
It is necessary to ensure that all medical products are obtained from
authentic and reliable sources. Their authenticity and origin should be
carefully checked and verified with manufacturers before use. WHO requests
increased vigilance for the supply chains of countries likely to be
affected by these falsified products. Vigilance should include hospitals,
clinics, pharmacies and any other suppliers of medical products.
Authorities are asked to immediately notify WHO if these falsified products
are discovered in their country. If you have any information on their
supply and/or distribution please contact
rapidalert@who.int
WHO will issue Medical Product Alerts to ensure a timely, proportionate,
accurate and consistent response to health events arising from substandard
and falsified medical products which represent a significant threat to
international public health. Alerts will be published on the WHO website,
and will remain on the website for a period of 5 years before archiving.
Alerts may also be disseminated to the current known networks of National
Medicines Regulatory Authorities dealing with defective medicines,
International Health Regulation Focal Points, substandard and falsified
surveillance and monitoring focal points and National pharmacovigilance and
vaccine networks.
Links to PHOTOGRAPHS
http://www.who.int/entity/medicines/publications/drugalerts/meningococcal_
poly1.JPG
http://www.who.int/entity/medicines/publications/drugalerts/meningococcal_
poly2.JPG
WHO Surveillance and Monitoring Rapid Alert
Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) Medical
Products
All WHO Drug Alerts are available at the following link:
http://www.who.int/medicines/publications/drugalerts/en/
Posted by Carinne Bruneton
Moderator of E-med - french sibling of e-drug
Bruneton Carinne <carinne.bruneton@gmail.com>