Tag: Medicines

  • Chagas disease: providing free paediatric medicine can enhance diagnosis and treatment

    Documentation resulting in the donation of an important antiparasitic medicine for the treatment of Chagas illness to the World Health Organization (WHO) is within the ultimate stage of preparation.

    A 3-year settlement, between the Mundo Sano Foundation1 (Brazil) and WHO, is anticipated to make obtainable 108 000 tablets of the paediatric formulation of benznidazole2 – a first-line medicine towards Chagas illness. Treatment3 with benznidazole within the early levels of an infection can treatment Chagas illness.

    “Making benznidazole freely obtainable for the treatment of newborns till the age of 18 might be a game-changer within the battle towards Chagas illness” mentioned Dr Mwelece Ntuli Malecela, Director, WHO Department of Control of Neglected Tropical
    Diseases. “This is not going to solely save future generations from growing life-threatening and deadly issues however can even increase up diagnosis and treatment.”

    Each yr, an estimated 15 000 youngsters are born from contaminated moms. A freely obtainable paediatric presentation of benznidazole with correct dosage is essentially anticipated to contribute to deal with congenital infections.

    “Treating newborns and youngsters was the lacking hyperlink, as we transfer decisively to advocate for the mixing of diagnosis of an infection amongst pregnant ladies and women of child-bearing age into different surveillance programmes, together with HIV and syphilis” mentioned Dr Pedro Albajar Vinas, Medical Officer with WHO’s Department of Control of Neglected Tropical Diseases.  “Diagnosing and treating ladies of this age group earlier than being pregnant can increase successfully stop congenital transmission.” 

    The settlement

    The donation by Mundo Sano Foundation at some point of the settlement includes benznidazole:

    • 105,000 tablets of 100mg
    • 3,000 tablets of 12.5mg

    Furthermore, the Foundation might donate funds of as much as US$100 000 at some point of the settlement to help actions related to distribution of medicines and conferences. The Foundation additionally makes provision for an extension of this settlement past
    the required length of three years.

    The illness

    Chagas illness, often known as American trypanosomiasis, is a doubtlessly life-threatening sickness brought on by the protozoan parasite Trypanosoma cruzi (T. cruzi).

    Although appreciable progress has been achieved, significantly in decreasing vector transmission and screening of blood and organ provide, reaching and diagnosing individuals most affected has been a problem.

    Currently, under-diagnosis of Chagas illness instances is as excessive as 90% and under-diagnosis of congenital transmission is believed to be even greater.

    Globally, an estimated 6-7 million individuals are contaminated with T. cruzi.

    The illness is discovered primarily in endemic areas of 21 continental Latin American international locations4. But motion of individuals to city areas and to different continents has expanded its transmission by means of non vectorial routes, akin to blood transfusion, congenital
    transmission, organ transplants and oral meals contamination.

    Considering the illness as a rising public well being drawback in lots of international locations, the World Health Assembly – WHO’s decision-making physique – determined in May 2019 to commemorate World Chagas Disease Day on 14 April.

    The inaugural celebration occurs this yr.


    1 Mundo Sano is a nonprofit worldwide basis working with the general public and personal sectors, academia, and different worldwide organizations to supply options to the affected communities and generate scientific information. In 2012, it led a public-private consortium in 2012 to provide benznidazole in Argentina.

    2 In 2017, the United States Food and Drug Administration (FDA) accepted benznidazole for the treatment of kids aged 2–12, making it the primary treatment accepted within the United States for Chagas illness.

    3 Nifurtimox can be 100% efficient in curing Chagas illness if given quickly after onset of an infection, together with instances of congenital an infection. It is donated by Bayer who pledged greater than 7.5 million tablets for the interval 2012-2021.

    4 Argentina, Belize, Bolivia (Plurinational State of), Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, French Guiana, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay, and Venezuela
    (Bolivarian Republic of).

    Chagas disease: providing free paediatric medicine can enhance diagnosis and treatment
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  • Medical Product Alert N°3/2020

    This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. 

    The Coronavirus disease (COVID-19) pandemic (caused by the virus SARS-CoV-2) has increased demand for medicines, vaccines, diagnostics and reagents, all related to COVID-19, creating an opportunity for ill-intended persons to distribute falsified medical products 

    Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the current crisis of, or related to, COVID-19. 

    1. FALSIFIED IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS 

    WHO has received multiple reports regarding falsified in vitro diagnostics (IVDs) and laboratory reagents for the detection of SARS-CoV-2. Please refer to WHO’s Emergency Use Listing for a list of diagnostics approved for clinical use by WHO. To date, eight countries (Australia, Brazil, Canada, PR China, Russian Federation, Singapore, Republic of Korea, United States of America) have listed IVDs for COVID-19 diagnosis based on expedited regulatory assessments. Please note that, in the European Union, regulatory compliance for SARS-CoV-2 diagnostics are self-declared by the manufacturer.  

    To assist Member States and stakeholders, WHO has published the links to these emergency lists, together with contact details. These links provide information on IVDs authorized for use in the jurisdictions of the International Medical Device Regulators Forum, as well as policies and guidance. WHO will provide updated versions as new information becomes available.

    End-users are encouraged to check the labelling against the information posted by regulatory authorities upon listing to ensure they are in possession of the genuine product. This information might include product name, product code, expiry date, instructions for use and manufacturer details. 

    Unregulated websites supplying medicines and/or vaccines, particularly those concealing their physical address or landline telephone number, are frequently the source of unlicensed, substandard and falsified medical products. WHO has been made aware of various unregistered websites claiming that products on sale can treat or prevent COVID-19. Such products are likely to be falsified medicines. In addition, some websites may appear to provide easy access to legitimate medicines that are otherwise not readily available. End-buyers and consumers should be especially wary of such online scams and exert due diligence when purchasing any medical product, whether online or not.

     2. FALSIFIED MEDICINES AND VACCINES

    At this stage, WHO does not recommend any medicines to treat or cure COVID-19. However, the SOLIDARITY trial, led by WHO, is reviewing potential treatments for COVID-19. 

    WHO requests increased vigilance from national health authorities, healthcare professionals, members of the public and supply chain stakeholders worldwide to prevent the distribution of these falsified medical products. Increased vigilance should focus on hospitals, clinics, health centres, clinical laboratories, wholesalers, distributors, pharmacies and any other suppliers of medical products. All medical products must be obtained from authentic and reliable sources. Their authenticity and condition of the product should be carefully checked. Consumers are advised to seek advice from a healthcare professional in case of doubt. 

    National health authorities are requested 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: https://www.who.int/medicines/regulation/ssffc/en/ 

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    https://www.who.int/news-room/detail/31-03-2020-medical-product-alert-n-3-2020

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  • Medical Product Alert N°2/2020

    Medical Product Alert N°2/2020

    This Medical Product Alert relates to a confirmed falsified human immunodeficiency virus (HIV) in vitro diagnostic medical device (IVD) that has been identified circulating in Guyana and Kenya.

    Through its Global Surveillance and Monitoring System (GSMS) for substandard/falsified medical products,
    WHO was informed that at least 8,240 falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at end-user level. The product is Uni-Gold™ HIV and claims to be manufactured by
    Trinity Biotech plc. Subsequent reports
    revealed that the same falsified product is also circulating in Kenya.

    Uni-Gold™ HIV is a single-use rapid diagnostic test – an immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma and whole blood. Uni-Gold™ HIV is intended for use in point of care settings as an aid
    in diagnosis of HIV-1 and HIV-2 infection.

    The WHO testing strategy recommends three HIV reactive test results to confirm an HIV-positive status in a
    patient. The use of this falsified Uni-Gold™ HIV, subject of WHO medical product alert n°2 of 2020, is likely to lead to delayed diagnosis of HIV status.

    Table 1: Specific details of the falsified product Uni-Gold™ HIV, subject of WHO Medical Product Alert n°2 of 2020

    Product Name

    Uni-Gold™ HIV

    Lot Number

    HIV7120026

    Expiry Date

    5 DEC 2020

    Stated manufacturer

    Trinity Biotech

    The packaging of this falsified HIV test kit is in English.

    The genuine manufacturer (Trinity Biotech plc) has confirmed that:

    • They did not manufacture the falsified product in Table 1.
    • Genuine lot HIV7120026 was made by Trinity Biotech plc and expired in 2019.
    • The expiry date is incorrect and does not correspond with their batch manufacturing records.

    Photographs and advice to the public are available below.

    Figure 1 – Falsified Uni-Gold™ HIV, lot number HIV7120026, displaying falsified expiry date

     

    Falsified UniGold HIV Images 1 and 2 Alert

    Figure 2 – Falsified Uni-Gold™ HIV, displaying labelling inconsistencies

    Falsified UniGold HIV Image 3 Alert

     

    Advice on action to be taken by end-users:

    • Please check to see if any Uni-Gold™ HIV test kits in your facility have lot number HIV7120026.
    • If you are in possession of these falsified test kits with lot number HIV7120026:
    1. Please do not use.
    2. Please immediately contact the organization that supplied you with the product (either your HIV testing programme, nongovernmental organization or local distributor).
    3. Please contact Trinity Biotech plc

    Phone : +353 1 276 9800

    E-mail : hiv@trinitybiotech.com

    1. Please contact your national health authorities

    All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked.

    Advice on action to be taken by national health authorities:

    WHO requests increased scrutiny within the supply chains of all countries, particularly at testing sites (health facilities, community-based), clinical laboratories, medical stores/warehouses, and at the facilities of relevant economic operators (agents,
    authorized representatives, distributors, wholesalers, etc.).

    If these falsified test kits with lot number HIV7120026 are discovered, please do not use.

    National health authorities are asked to immediately inform WHO, if these falsified products are discovered in their country using the WHO IVD complaint form.

    If you have any information concerning the manufacture, distribution, or supply of this product, 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°2/2020
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  • New WHO Guide to help countries expand access to essential medicines

    New WHO Guide to help countries expand access to essential medicines

    WHO’s   new user guide for countries, ‘Selection of medicines at country level’, is based on the WHO Model List of Essential Medicines. It sets out the key actions countries should undertake to develop and update their own
    national essential medicines lists based on the treatment needs of their populations and their capacity to reimburse payments for medicines.

    The document also aims to support countries in progressing towards universal health coverage. Today, approximately half of the world’s population is unable to  access essential medicines. The large majority of these people live in poorer countries,
    but rising prices of new medicines are also becoming a challenge for health systems in wealthy countries.

    A careful selection of essential medicines is the first step in ensuring a population can obtain the quality-assured medicines it needs at an affordable price.  Countries need to do more to ensure that all people and communities can access highly
    effective medicines. WHO’s new manual is a resource to do just that. 

    The document, intended for policy makers in charge of national medicines and reimbursement lists, aims to increase transparency on how essential medicines are selected. Most national lists of essential medicines have several differences when compared
    with WHO’s model list, which lists only medicines of proven safety and efficacy. Some national lists include medicines that bring little extra benefit to patients. Decision-makers should refer to the WHO global list to gauge the public health
    value of listing certain medicines for their populations.

    The essential medicines concept 

    Essential medicines are: 

    • those that satisfy the priority health care needs of the population
    • selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness
    • intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and community can afford.  

    The essential medicines concept is global and forward-looking. It incorporates the need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure drug quality; and the need for continued
    development of better medicines, medicines for emerging diseases and medicines to meet changing resistance patterns.

    Achieving universal health coverage and equity in public health depends on access to essential, high-quality and affordable health related technologies for all. To achieve access for all by 2030, at least two billion more people will need to have access
    to essential health services by 2030.

    In an effort to make the Model List of Essential Medicines more readily accessible, WHO recently developed an electronic version of the list, bringing the traditional EML to computer screens, tablets and smartphones in a freely accessible, downloadable,
    online database.

    Link to manual: Selection of essential medicines at country level

    Link to e-EML: Model List of Essential Medicines

    New WHO Guide to help countries expand access to essential medicines
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  • ‘Chloroquine’ used to treat Covid-19 patients since first wave: Health DG

    ‘Chloroquine’ used to treat Covid-19 patients since first wave: Health DG

    ‘Chloroquine’ used to treat Covid-19 patients since first wave: Health DG 1

    PUTRAJAYA: Chloroquine, a drug used for malaria, has been used to treat Covid-19 patients since the first wave of the outbreak in Malaysia and has shown its efficacy, according to Health director-general Datuk Dr Noor Hisham Abdullah (pix).

    He said the anti-inflammatory properties of the drug were effective in treating Covid-19 which caused inflammation in the lower respiratory tract.

    “When the Covid-19 virus attaches to the lower respiratory tract it causes inflammation and replication of the virus and this drug helps treat the inflammation,” he told a press conference, here today.

    Besides ‘Chloroquine’, Dr Noor Hisham said the combination of ‘Lopinavir and Ritonavir’ and Hydroxychloroquine have also been used by Ministry of Health (MoH) since the first wave of the outbreak.

    He said the drugs used in the first wave of the infection showed promising results in treating Covid-19, however, further research was still required.

    He explained that the number of deaths due to the virus had increased as the patients were either elderly, had comorbidities such as high blood pressure and kidney disease, or those who sought treatment at a later stage or after they began having breathing difficulties.

    “We have tried the drug and it is also part of a joint study with the World Health Organization called ‘Solidarity Trial’ involving many other countries,“ he added.

    He said besides those medicines, studies would also focus on the latest drug, ‘Remdesivir’ as announced yesterday.

    “This is only for research, and drugs that we have used off-label such as Lopinavir and Ritonavir, those we have been using since the first wave,“ he added. – Bernama

    ‘Chloroquine’ used to treat Covid-19 patients since first wave: Health DG
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  • WHO Director-General calls on G20 to Fight, Unite, and Ignite against COVID-19

    Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, addressed Heads of State at today’s extraordinary G20 Leaders’ Summit focused on COVID-19. 

    He told them, “You have come together to confront the defining health crisis of our time: We are at war with a virus that threatens to tear us apart – if we let it.“

    He welcomed the G20‘s initiative to find joint solutions and work together: “This is a global crisis that requires a global response.”

     “Fight, unite, ignite“

    Dr Tedros’ call was clear. First, he urged leaders to fight without excuses, without regrets – thanking countries who have already taken steps and urgently asking that they do more.

    Second, he encouraged them to unite, stressing that no country can fight this alone, and calling on all countries to build on the solidarity already sparked by the crisis.

    Third, he exhorted them to ignite a global movement to ensure this never happens again. 

    He welcomed G20 leaders‘ commitment “to do whatever it takes to overcome the pandemic” to protect lives and livelihoods, as well as restore confidence and shore up stability currently threatened in trade and other sectors, and to commit to take all necessary health measures and seek to ensure adequate financing to contain the pandemic and protect people, especially the most vulnerable.“

    The G20 committed to support and further strengthen WHO’s mandate in coordinating the response, and called for full funding of WHO‘s Strategic Preparedness and Response Plan.

    G20 members pledged to work together to increase research and development funding for vaccines and medicines, strengthen international scientific cooperation, and leverage digital technologies.

    In turn, they tasked WHO and other relevant organizations with assessing gaps in pandemic preparedness and report the findings of this assessment to the G20 Finance and Health Ministers, in order to establish a global initiative on pandemic preparedness and response together.

     

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    https://www.who.int/news-room/detail/26-03-2020-who-s-director-general-calls-on-g20-to-fight-unite-and-ignite-against-covid-19

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  • Edo Government Restricts Gatherings To 20 Persons

    Edo Government Restricts Gatherings To 20 Persons

    Edo Government Restricts Gatherings To 20 Persons 2

    Edo Government Restricts Gatherings To 20 Persons 3


    In a bid to curb the spread of Coronavirus in Edo State, the state government has reduced the number of persons allowed in any public gathering from 50 to 20.

    Other measures taken by the state government in the face of continuous spread of the virus in the country include the closure of markets with only sellers of food items, medicines and other vital commodities allowed to operate.

    Governor Godwin Obaseki disclosed the new measures during the inauguration of the Edo State COVID-19 Response Committee at Government House, Benin City, the state capital.

    He said, “We are reducing the number of persons allowed to gather in public places from 50 to 20 persons. 

    “Also, only markets where essential commodities like foodstuffs are sold should remain open for now.

    “The state government is working with the Irrua Specialist Teaching Hospital for mass production of hand sanitisers in drums that would be distributed to local government areas, palaces, markets and other government agencies for use in public places.”

     

    He directed transport unions to intensify sensitisation among members on the need to implement social distancing by reducing the number of passengers on their vehicles.

    The governor while tasking security agencies in the state on the enforcement of the new measures, disclosed that the state government would partner with Nigeria Medical Association to intensify public health services.

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  • CND accepts all WHO recommendations on the control of several psychoactive substances from the 42nd ECDD meeting

    CND accepts all WHO recommendations on the control of several psychoactive substances from the 42nd ECDD meeting

     

    During its 63rd session, the Commission on Narcotic Drugs (CND) accepted all recommendations from the 42nd meeting of the WHO Expert Committee on Drug Dependence (ECDD). This effectively brings twelve psychoactive substances, including eleven New Psychoactive Substances (NPS) and one medicine, under international control.  Given the potential for dependence or abuse and known adverse effects, these compounds pose a risk to public health and society and are largely without any therapeutic benefit.

       Based on an in-depth review of candidate compounds by the ECDD, an independent group of experts in the field of drugs and medicines, the WHO provides annual recommendations on substance scheduling to the CND, a policy-making body comprised of 53 UN Member States. This ECDD review includes a balanced consideration of potential for abuse, dependence and harm with therapeutic value. The CND then votes on whether or not the WHO recommendations for placing reviewed substances under international control should be endorsed.

          The 42nd ECDD recommendations included the addition of four synthetic cannabinoids and three synthetic stimulants to Schedule II of the 1971 Convention on Psychotropic Substances given similar action and adverse effects to other substances in this Schedule. These synthetic cannabinoids have been associated with impaired mental status, impaired driving, and fatalities, whereas the included synthetic stimulants have been linked to fatal intoxication. Similarly, two fentanyl analogues, with their opioid-like effects, were brought under Schedule I control (strict control) of the 1961 Single Convention on Narcotic Drugs given similar action and effects to other drugs in this Schedule. Two benzodiazepines including the medicine etizolam were brought under Schedule IV control of the 1971 Convention on Psychotropic Substances, both of which have been implicated in fatal and non-fatal intoxication and impaired driving. A hallucinogen was also recommended to be brought under control, specifically to Schedule I of the Convention on Psychotropic Substances of 1971, based on abuse potential and non-fatal and fatal intoxication. This is the first hallucinogen to be reviewed in many years, suggesting a potential shift in drug trends. For more information on these recommendations, please review the 42nd ECDD meeting report. .  

        In addition, the ECDD conducted a pre-review of several Schedule III opioid preparations, some of which can be accessed as over-the-counter options, such as codeine-based cough syrups, to consider their abuse potential.  The ECDD recommended a critical review be carried out at a later date.

    CND accepts all WHO recommendations on the control of several psychoactive substances from the 42nd ECDD meeting
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  • WHO teams with partners to mitigate the potential impact of the COVID-19 pandemic in malaria-affected areas

    The rapid spread of COVID-19 is testing the resilience of robust health systems around the world. WHO and its partners are taking measures to mitigate the potential impact of sustained transmission of the coronavirus in malaria-endemic settings –
    particularly in sub-Saharan Africa, which shoulders more than 90% of the global malaria burden.

    To date, a small proportion of the global COVID-19 cases have been identified in malaria-affected countries. However, as of 17 March, 25 countries in the African Region had reported cases of COVID-19, and local transmission of the disease had been detected
    in 6 countries (Algeria, Cameroon, Kenya, Rwanda, Senegal, South Africa).

    “At this point, we still don’t know what the COVID-19 pandemic will look like in sub-Saharan Africa,” said Dr Pedro Alonso, Director of the WHO Global Malaria Programme. “But we do know that when public health emergencies have
    hit parts of Africa with weak health systems and high malaria transmission, the impact on malaria disease and death has been very severe.”

    The 2014-2016 Ebola outbreak in Guinea, Liberia and Sierra Leone, for example, undermined malaria control efforts and led to a massive increase in malaria-related illness and death in the 3 countries.

    Joint action 

    To support malaria-affected countries, WHO has identified the need for a set of inter-related actions among global partners: 

    • generating, using and disseminating accurate information; 
    • mitigating against health system disruptions; and 
    • ensuring the continuity of routine malaria-specific interventions while also providing, where needed, additional emergency measures, such as mass drug administration, in health systems significantly impacted by COVID-19. 

    The Organization convened partners on 17 March to discuss areas of collaboration, coordination and next steps.

    WHO has begun monitoring the evolving geographic location of COVID-19 cases to understand the extent to which the coronavirus and malaria affect the same target groups. This information will reveal who is likely to be at greatest risk, where and when,
    and thus inform the need for malaria-specific interventions to save lives.

    In parallel, WHO is working across the 3 levels of the organization to ensure that any advice intended to curb coronavirus transmission and to guide COVID-19 disease management is appropriate in malaria-affected settings.  

    In recent days, there have been reports of disruptions, as a result of COVID-19, in the production and global supply chains of essential malaria commodities, such as the long-lasting insecticidal nets, diagnostic testing and antimalarial medicines. Coordinated
    efforts are required to ensure the availability of key malaria control tools – particularly in countries with a high burden of the disease – and that efforts to limit transmission of COVID-19 do not compromise access to malaria prevention,
    diagnosis and treatment services. 

    Malaria-affected countries may also experience disruptions in health systems in the coming months. A marked increase in febrile patients seeking treatment for COVID-19 at health facilities, for example, would present a significant challenge for a health
    workforce that may itself be depleted by the disease.

    Policy guidance

    WHO is developing guidance for national malaria control programmes and implementing partners to prepare them for the challenges they may face as result of COVID-19.  Among other areas, the guidance will address the mitigation of stockouts of
    malaria medicines and commodities; the use of preventive malaria therapy for health workers; the deployment of emergency measures in some settings; and the generation of information relating to the geographic distribution and populations affected
    by COVID-19 in malaria-endemic settings.  

    Restrictions around grouping people together – for training, social and behavior change communication activities, fixed-site distribution and clinical care – as well as the restrictions around movement of people in the country, will require
    significant adaptations in order to deliver quality interventions and care.

    All people living in malaria-affected areas are advised to follow same precautions as the general population, including: frequent hand-washing, respiratory hygiene, social distancing, seeking prompt medical care if symptoms arise (cough, fever,
    difficulty breathing), and other WHO-recommended actions. 

    WHO stands ready to work with countries and other stakeholders to mitigate the negative impact of the coronavirus on malaria responses worldwide and, where possible, contribute towards a successful COVID-19 response.  

    About COVID-19

    COVID-19 is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. Essential information on the COVID-19 pandemic can be found in
    a dedicated WHO site.

    About malaria

    Malaria is a preventable and treatable disease caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. In 2018, there were an estimated 228 million cases of malaria worldwide and
    405 000 malaria-related deaths. For more on malaria, visit: www.who.int/malaria

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  • Medical Product Alert N° 1/2020 (English version)

    Medical Product Alert N° 1/2020 (English version)

     

    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

    Medical Product Alert N° 1/2020 (English version) 4

    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 

    Medical Product Alert N° 1/2020 (English version) 5

    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)

    Medical Product Alert N° 1/2020 (English version) 6

     

    Medical Product Alert N° 1/2020 (English version) 7

    Medical Product Alert N° 1/2020 (English version) 8Medical Product Alert N° 1/2020 (English version) 9Medical Product Alert N° 1/2020 (English version) 10

    Medical Product Alert N° 1/2020 (English version) 11

     

    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/

     

    Medical Product Alert N° 1/2020 (English version)
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    https://www.who.int/news-room/detail/09-03-2020-medical-product-alert-n-1-2020-english-version

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