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  • Medical Product Alert N°5/2020 – 7 May 2020

    Medical Product Alert N°5/2020 – 7 May 2020

    Falsified and contaminated Defibrotide identified in WHO regions of Western Pacific, Europe and Eastern Mediterranean

    This alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION identified in Australia, Latvia and Saudi Arabia. This product is sold under the brand name Defitelio.

    On 13 March 2020, the WHO Global Surveillance and Monitoring System on Substandard and Falsified (SF) Medical Products was informed that falsified DEFIBROTIDE 200MG vials were identified at patient level in Australia, displaying batch number 0286 (see Table 1 below for full details).

    Following enquiries with stakeholders, on 8 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials had also been supplied to Saudi Arabia, displaying batch number 0286 and 0126 (see Table 1 below for full details).

    Following enquiries with stakeholders, on 9 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials, displaying batch number 0126, had also been identified in Australia and Latvia.

    DEFIBROTIDE is used to treat hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots. This can be caused by treatments prior to a stem cell transplantation.

    Laboratory analyses, conducted by national medicines regulatory authorities and the manufacturer of the genuine product, established that these falsified products do not contain any of the expected active ingredient. The solution in the vials is also contaminated with mould (Cladosporium sp. and Aspergillus niger).

    Information available to WHO indicates that both batches of falsified DEFIBROTIDE 200MG vials were present within the regulated supply chain in Latvia as early as January 2020 and were also handled by medicine wholesalers in the United Kingdom in February 2020. It is important to note that widespread vigilance is required from all countries, regardless of where the product was originally identified.

    Table 1: falsified defibrotide subject of WHO Alert n°5/2020, identified in Australia, Latvia and Saudi Arabia

    Medical Product Alert N°5/2020 - 7 May 2020 1

    The two products listed in Table 1 are confirmed falsified, on the basis that there is deliberate misrepresentation of their identity, composition and source.

    The genuine manufacturer of Defibrotide, GENTIUM S.R.L has also confirmed to WHO that:

    • They did not manufacture the above products.
    • Authentic DEFIBROTIDE 200MG VIALS with batch number 0286 were supplied to Argentina, Hong Kong, Malaysia, Singapore and Turkey.
    • Authentic DEFIBROTIDE 200MG VIALS with batch number 0126 were supplied to Australia, Jordan, Kuwait, Lebanon, New Zealand, Qatar, Singapore, Turkey and the United Arab Emirates. 

      For guidance and photographs, please refer to page 2 of this Alert n°5/2020.

    Photos of Falsified DEFIBROTIDE Batch number: 0286, with expiry date: 09/2021

    Medical Product Alert N°5/2020 - 7 May 2020 2         Medical Product Alert N°5/2020 - 7 May 2020 3
    Sample from Latvia       Sample from Latvia

    Photos of Falsified DEFIBROTIDE Batch number: 0126, with expiry date: 08/2021

    Medical Product Alert N°5/2020 - 7 May 2020 4           Medical Product Alert N°5/2020 - 7 May 2020 5
    Sample from Australia       Sample from Australia

    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 them. If you have used these falsified products, or if you suffer an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

    All medical products must be obtained from licensed, authorized and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

    National regulatory/health authorities are advised to immediately notify WHO if these falsified products are identified in their country(ies). 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: https://www.who.int/medicines/regulation/ssffc/en/ 

    Medical Product Alert N°5/2020 - 7 May 2020
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  • INFOSAN Quarterly Summary, 2020 #1

    Food safety incidents

    During the first quarter of 2020, the INFOSAN Secretariat was involved in 38 food safety incidents involving 109 WHO Member States and 9 territories of WHO Member States. There were 25 incidents involving a biological hazard (Salmonella spp. [8], Listeria monocytogenes [5], Norovirus [3] Shiga-toxin producing Escherichia coli [2], Clostridium botulinum [2] Bacillus cereus [2], Cronobacter spp. [1], Shigella sonnei [1], unspecified biological hazard [1]), 6 involving an undeclared allergen (milk [3], peanut (1), egg [1], gluten [1]), 5 involving a physical hazard (undetermined foreign matter [2], glass [1], metal [1], plastic [1]), one involving a chemical/toxin hazard (histamine), and one linked to an unspecified hazard.

    The food categories that were most commonly involved in the 38 incidents during the first quarter of 2020 involved fish and other seafood (8), herbs and spices (4), legumes and pulses (4), milk and dairy products (3), nuts and oilseeds (3), snacks, desserts and other foods (3), cereals and cereal-based products (2), composite food (2), fruit and fruit products (2), meat and meat products (2), vegetables and vegetable products (2), products of special nutritional use (1), and food for infants and small children (1). One incident involved an unknown food source.

    During such international food safety incidents, the INFOSAN Secretariat relies on the swift action of national INFOSAN Emergency Contact Points to respond to requests for information. Rapid sharing of information through INFOSAN enables members to implement appropriate risk management measures to prevent illness in their respective countries.

    Geographic scope

    The outlined incidents involved Member States from all WHO regions: Europe (39), followed by the Americas (24), Africa (24), the Western Pacific (18), the Eastern Mediterranean (8) and South-East Asia (6).

    Recall in several countries of frozen spring roll sheets from Singapore due to the presence of an undeclared allergen

    In February 2020, the INFOSAN Secretariat was notified by the European Rapid Alert System for Food and Feed (RASFF) and INFOSAN colleagues in Australia of a recall in Australia and several European countries of frozen spring roll sheets due to the detection of an undeclared allergen (milk), imported from Singapore. In collaboration with RASFF, the INFOSAN Secretariat was informed that the implicated frozen spring roll sheets were distributed internationally to 46 Member States from four WHO regions and 4 territories in Europe and the Western Pacific. Moreover, through engagement with the INFOSAN Emergency Contact Point (ECP) in Singapore, the INFOSAN Secretariat also received details of further distribution of implicated products to additional WHO Member States from all WHO regions, taking the total number of Member States involved to 65. It was also reported that the products involved had been redistributed by some countries to Europe, the Americas and Africa. Consequently, several countries recalled the implicated products to relabel them and investigated the issue to identify illnesses related to the consumption of the implicated frozen spring roll sheets. No illnesses were reported to the INFOSAN Secretariat.

    This incident has highlighted undeclared allergens as an important category of hazards that can result in a largescale international response to implement risk management measures and prevent illness. In addition, it exemplified efficient communication among INFOSAN members and the Secretariat.

    Outbreak of Listeriosis in the United States of America linked to enoki mushrooms imported from the Republic of Korea

    In March 2020, the INFOSAN Secretariat was made aware by the United States (US) Centers for Disease Control and Prevention (CDC) of an outbreak of Listeriosis in the US linked to the consumption of enoki mushrooms, imported from the Republic of Korea. In total, 36 cases including 4 deaths have been reported in the US. Following investigations in Canada, carried out in collaboration with the US, the INFOSAN Secretariat was informed of 6 cases of Listeriosis between 2017 and 2019 in Canada potentially related by whole genome sequencing (WGS) to the ongoing outbreak in the USA. In addition, food isolates (from enoki mushrooms from the Republic of Korea) genetically associated with the cluster of cases have been collected in 2019 by authorities in Canada. The WGS information pertaining to the cases and food isolates were shared on the INFOSAN Community Website to assist the identification of cases in other countries.

    The INFOSAN Secretariat engaged the INFOSAN Emergency Contact Point (ECP) in the Republic of Korea to seek details on any further international distribution of the implicated enoki mushrooms. Investigations are ongoing. 

    News & activities

    Food Sector and the COVID-19 outbreak

    On 31 December 2019, WHO was alerted to several cases of pneumonia of unknown origin in the city of Wuhan, Hubei Province, China. The virus, a previously unknown coronavirus has been named SARS-CoV-2 and is the cause of the COVID-19 disease.

    The WHO Epidemic Information Network (EPI-WIN) aims to share information tailored to specific sectors, including food and agriculture. The INFOSAN Secretariat has recently developed a guidance document for food businesses with regards to COVID-19 and food safety which is now available online. The guidance has also been disseminated through EPI-WIN and presented during two webinars.

    Call for applicants: INFOSAN Train-the-Trainer Workshop

    In February, the INFOSAN Secretariat issued a call for applications for the INFOSAN Train-the-Trainer workshop. With the constant growth of the network, and the increased need for training that this entails, the INFOSAN Secretariat, in collaboration with the Canadian Food Inspection Agency (CFIA), has announced this workshop which aims to increase the human resources available to train INFOSAN members on a range of INFOSAN-related topics, online or in-person. As a result, it is expected that the understanding of the roles and responsibilities of INFOSAN members will be improved, resulting in greater participation that will enhance speed and efficiency during the response to food safety emergencies at the global level. The INFOSAN Secretariat, together with CFIA, look forward to hosting this important workshop later this year.

    Developing the new INFOSAN Community Website

    The INFOSAN Community Website (ICW) continues to be an effective tool for the network to disseminate information during food safety emergencies. Over the past year, through the INFOSAN member survey, the Secretariat has gained a better understanding of how members use the ICW and how it can be improved to enhance information sharing. The information collected, together with the experience of members of the Secretariat, has provided numerous innovative ideas to guide the development of the new ICW. The Secretariat is pleased to announce that the competitive process to select the vendor that will develop the new INFOSAN Community Website has concluded and the work on the creation of the new ICW has begun. 

    Voice of an active network member

    voice-5-2020

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  • Medical Product Alert N°4/2020

    Medical Product Alert N°4/2020

    This Medical Product Alert relates to a number of confirmed falsified chloroquine products circulating in the WHO region of Africa. Please note that this Medical Product Alert n°4/2020 will be updated as new reports of falsified chloroquine are received and validated by WHO.

    Between 31 March and 2 April 2020, the WHO global surveillance and monitoring system on substandard and falsified (SF) medical products received nine reports of confirmed falsified chloroquine products from three countries. All reported products were identified at patient level and all have been confirmed as falsified.

    This WHO medical product alert N°4/2020 refers to nine different falsified chloroquine products, with different presentations (see Table 1). It is important to note that widespread vigilance is required from all countries, regardless of where the product was originally identified.

    Table 1: List of identified falsified chloroquine products, subject of WHO Alert N°4/2020
    table1

    All the products listed in Table 1 are confirmed as falsified, on the basis that they deliberately/fraudulently misrepresent their identity, composition or source. Indeed, it can be noted that:

    • either: the products do not contain the correct amount of the active pharmaceutical ingredient, based on the results of preliminary or full compendial analysis;
    • and/or: the products were not produced by the manufacturer whose name is stated on the product labels, and the variable data (batch number and dates) of the above products do not correspond to genuine manufacturing records;
    • and/or: the manufacturer whose name is stated on the product labels does not exist.

    Chloroquine phosphate or sulfate is referenced on the WHO Model List of Essential Medicines for the treatment of Plasmodium vivax infection (malaria). Large clinical trials are under way to generate the robust data needed to establish the efficacy and safety of chloroquine and hydroxychloroquine in the treatment of COVID-19. These medicines are currently authorized for malaria and certain autoimmune diseases and it is important that patients do not face shortages caused by stockpiling or use outside the authorized indications. 
    Both chloroquine and  hydroxychloroquine can have serious side effects, especially at high doses or when combined with other medicines.

    The SOLIDARITY trial, led by WHO, is reviewing potential treatments for COVID-19. Please refer to  WHO medical product alert n°3/2020 for general information on falsified medical products in relation to the management 
    of COVID-19.

    For photographs of products listed in Table 1, please refer to the WHO Medical Product Alert website, and 
    to the annex of this medical product alert n°4/2020 (see pages 3-7).

    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 reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

    All medical products must be obtained from licensed, authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

    National regulatory/health authorities are advised 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 more information, please visit: www.who.int/medicines/regulation/ssffc/en/ 

    Annex: Photographs of falsified chloroquine products circulating in the WHO region of Africa, Medical Product Alert N°4/2020

    CAMEROON

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

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

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

    DEMOCRATIC REPUBLIC OF CONGO

    Photographs of confirmed falsified CLOROQUINE 250MG
    ChloroquinePhosphate250mgDRC1

    Photographs of confirmed falsified Chloroquine Phosphate 250mg
    ChloroquinePhosphate250mgDRC2

    NIGER

    Photographs of confirmed falsified Samquine 100 (100mg)

    Samquine100-100mgNiger 1

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

    Chloroquine-phosphate-tabletsB.P100mgNiger2

    Photographs of confirmed falsified Niruquine (100mg)
    Niruquine00mgNiger3

     

    Medical Product Alert N°4/2020
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    https://www.who.int/news-room/detail/09-04-2020-medical-product-alert-n4-2020

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