Global Digital Store – Ebooks and Softwares

Tag: products

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

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

Sample from Latvia Sample from Latvia

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

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/

Read More
https://www.who.int/news-room/detail/07-05-2020-medical-product-alert-n-5-2020

Views: 0
May 9, 2020
Statement on the third meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of coronavirus disease (COVID-19)
The third meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) (IHR) regarding the coronavirus disease (COVID-19), took place on Thursday, 30 April 2020, from 12:00 to 17:45 Geneva
time (CEST).

Proceedings of the meeting

Members and advisors of the Emergency Committee were convened by teleconference. Membership of the Emergency Committee was expanded
to reflect the nature of the pandemic and the need to include additional areas of expertise.

The Director-General welcomed the Committee, thanked them for their commitment to enhancing global public health, and provided an overview of the major achievements in the COVID-19 response since the last Emergency Committee meeting on 30 January 2020.
Representatives of the legal department and the Department of Compliance, Risk Management, and Ethics (CRE) briefed the members on their roles and responsibilities.

The Ethics Officer from CRE provided the members and advisers with an overview of the WHO Declaration of Interest process. The members and advisers were made aware of their individual responsibility to disclose to WHO, in a timely manner, any interests
of a personal, professional, financial, intellectual or commercial nature that may give rise to a perceived or direct conflict of interest. They were additionally reminded of their duty to maintain the confidentiality of the meeting discussions and
the work of the committee. Only those committee members and advisers who were not considered to have any perceived or direct conflict of interest participated in the meeting.

The Secretariat turned the meeting over to the Chair, Professor Houssin. He also welcomed the Committee and reviewed the objectives and agenda of the meeting.

The WHO Regional Emergency Directors and the Executive Director of the WHO Health Emergencies Programme (WHE) provided regional and the global situation overview. After ensuing discussion, the Committee unanimously agreed that the outbreak still constitutes
a public health emergency of international concern (PHEIC) and offered advice to the Director-General.

The Director-General declared that the outbreak of COVID-19 continues to constitute a PHEIC. He accepted the advice of the Committee to WHO and issued the Committee’s advice to States Parties as Temporary Recommendations under the IHR.

The Emergency Committee will be reconvened within three months or earlier, at the discretion of the Director-General. The Director-General thanked the Committee for its work.

Advice to WHO

Coordination, planning, and monitoring
- Continue to lead and coordinate the global response to the COVID-19 pandemic in collaboration with countries, the United Nations (UN), and other partners.
- Work with fragile states and vulnerable countries that require additional technical, logistical and commodity support.
- Establish mechanisms to compile lessons learned from country and partner experiences and WHO missions and share the best practices and updated recommendations.
- Provide further guidance to countries about adjusting public health measures, taking into account the different epidemiological situations of the pandemic.
- Promote the inclusion of all interested countries, including low- and middle-income countries from all regions, in the Solidarity clinical trials for therapeutics and vaccines.
- Continue efforts with partners to obtain equitable access to personal protective equipment, diagnostics, and biomedical equipment essential to the pandemic COVID-19 response.
- Continue to coordinate global expert networks in epidemiology, laboratory, vaccines, clinical care, infection prevention and control, social sciences, and operational research; modelling; and other technical support.
One Health
- Work with the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO), and countries to identify the zoonotic source of the virus and the route of introduction to the human population, including
  the possible role of intermediate hosts. This should be accomplished through efforts such as scientific and collaborative field missions, which will enable targeted interventions and a research agenda to reduce the risk of similar events.
- Work closely with OIE and FAO to provide guidance on how to prevent SARS-CoV-2 infections in animals and humans and prevent the establishment of new zoonotic reservoirs.
- Work with partner organizations and countries to strengthen the global food supply chain, protect food workers, properly manage food markets, and mitigate possible disruptions to the food supply.
Essential Health Services
- Support countries to assess and manage the unintended consequences of public health measures implemented to control the COVID-19 pandemic, including gender-based violence and child neglect.
- Support countries to monitor their ability to provide and strengthen essential health services throughout a likely extended COVID-19 response. This should include, but is not limited to, essential prevention for communicable diseases, particularly
  vaccination; services related to reproductive health, including care during pregnancy and childbirth; care of vulnerable populations, such as young infants and older adults; provision of medications and supplies for the ongoing management of chronic
  diseases, including mental health conditions; continuity of critical inpatient therapies; management of emergency health conditions and common acute presentations that require time-sensitive intervention; and auxiliary services, such as basic
  diagnostic imaging, laboratory services, and blood bank services.
- Support countries to address shortages of essential medicines and health products, personal protective equipment, and other medical supplies and to establish sustainable risk management practices to prevent future shortages.
Risk communication and community engagement
- Continue risk communications and community engagement activities through the WHO Information Network for Epidemics (EPI-WIN) and other platforms to counter rumours and misinformation.
- Continue to regularly communicate clear messages, guidance, and advice about the evolution of the COVID-19 pandemic, how to reduce transmission, and save lives.
- Work with partners and countries to articulate potential long-term consequences of COVID-19 pandemic, emphasizing the need for strengthened cross-sectoral preparedness, transparency and global coordination.
Surveillance
- Clarify the testing strategy, support countries to increase testing capacity, and aim to provide equitable access to diagnostic tests and supplies in light of market failures and global shortages.
- Continue to provide guidance on monitoring disease trends using Severe Acute Respiratory Infections (SARI) and Influenza Like Illness (ILI) surveillance systems in anticipation of the co-circulation of influenza viruses.
- Develop qualitative and quantitative indicators that countries can use to assess and monitor SARS-CoV-2 transmission at all levels of public health response.
- Continue to support countries and partners by providing technical and operational guidance, training platforms, and tools such as Go.Data,to enhance case identification and contact tracing capacity, strengthen the public health workforce, and engage
  communities for contact tracing.
- Provide clear qualitative and quantitative indicators to monitor SARS-CoV-2 transmission to inform the adjustment of public health and social measures.
Travel and Trade
- Continue working with countries and partners to enable essential travel needed for pandemic response, humanitarian relief, repatriation, and cargo operations.
- Develop strategic guidance with partners for the gradual return to normal operations of passenger travel in a coordinated manner that provides appropriate protection when physical distancing is not feasible.
- Update recommendations on appropriate travel measures and analyze their effects on international transmission of COVID-19, with consideration of the balance between benefits and unintended consequences, including entry and exit screening, education
  of travelers on responsible travel behaviour, case finding, contact tracing, isolation, and quarantine, by incorporating evidence on the potential role of pre-symptomatic and asymptomatic transmission.
To all States Parties

Coordination and Collaboration
- Support WHO leadership and continue to collaborate with WHO at all levels of the organization and with other countries to enable effective global COVID-19 pandemic preparedness and response.
- Participate in global solidarity efforts to enable access to essential supplies for all.
- Document and share lessons learned from efforts to control the pandemic, including the timing, pace, and sequencing of the application and lifting of public health measures.
Preparedness
- Strengthen preparedness for health emergencies, and build resilient health systems, incorporating lessons learned during different stages of the pandemic, and sharing experiences with other countries.
Surveillance
- Work with WHO and multisectoral partners to interrupt transmission by maintaining robust surveillance systems; enhancing capacities for case detection, testing, isolation of cases, contact tracing, quarantine of contacts, and rapid response; strengthening
  the public health workforce; and actively engaging communities for contact tracing, with a particular focus on high risk areas.
- In settings where testing a large proportion of suspected cases is not possible, monitor overall trends; undertake early detection through laboratory confirmation of a limited number of cases with a focus on health workers; and rapidly implement
  public health measures.
- Share with WHO all data necessary to conduct global risk assessments through data platforms, such as the Global Influenza Surveillance and Response System and the IHR mechanism. These data should include SARI and ILI where available.
- Use the WHO qualitative and quantitative indicators to assess and monitor SARS-CoV-2 transmission at all levels of public health response.
Additional Health Measures
- Avoid restrictions on international transport of food, medical and other essential supplies and permit the safe movement of essential personnel required for an effective pandemic response.
- Implement appropriate travel measures with consideration of their public health benefits, including entry and exit screening, education of travelers on responsible travel behaviour, case finding, contact tracing, isolation, and quarantine, by
  incorporating evidence on the potential role of pre-symptomatic and asymptomatic transmission.
- Implement and monitor case finding and contact tracing of travellers, using digital tools where appropriate.
- Continue to review travel and trade measures based on regular risk assessments, transmission patterns at origin and destination, cost-benefit analysis, evolution of the pandemic, and new knowledge of COVID-19.
- Engage in global efforts to respond to the challenges of COVID-19 in managing maritime vessels.
- Do not implement trade restrictions beyond those considered to be of public health importance in accordance with relevant international agreements.
- Continue to provide appropriate public health rationale to WHO for additional health measures in accordance with IHR.
Health Workers
- Prioritize the protection of the health workforce through access to training and provision of personal protective equipment, infection prevention and control measures, improved working conditions, application of WHO recommended testing strategies,
  and prevention of stigma and attacks on health workers.
Food Security
- Work with WHO and partners to strengthen the global food supply chain, protect food workers, properly manage food markets, and mitigate possible disruptions to the food supply, especially for vulnerable populations.
One Health
- Promote sound practices to manage risks of trade of live animals in food markets and regulate trade of exotic wildlife.
Risk Communications and Community Engagement
- Continue to engage communities to address rumours and misinformation and keep the public informed, with a focus on vulnerable populations.
Research and development
- Address research gaps such as: routes of transmission, including the role of asymptomatic and pre-symptomatic infection droplet, contact, fomite and aerosol transmission; and viral shedding; and animal source and intermediate hosts, in collaboration
  with partners.
- Continue to support and conduct COVID-19 research, in line with the WHO Research and Development Blueprint, and the road map for COVID-19 vaccines, diagnostics, and therapeutics.
- Continue sharing full genome sequences to increase global understanding of virus evolution and phylogenetics and their application to public health practices.
Essential Health Services
- Maintain essential health services throughout a likely extended COVID-19 response. This should include essential prevention for communicable diseases, particularly vaccination; services related to reproductive health, including care during pregnancy
  and childbirth; care of vulnerable populations, such as young infants and older adults; provision of medications and supplies for the ongoing management of chronic diseases, including mental health conditions; continuity of critical inpatient
  therapies; management of emergency health conditions and common acute presentations that require time-sensitive intervention; and auxiliary services, such as basic diagnostic imaging, laboratory services, and blood bank services.
- Continue to track and document the impact of COVID-19 on essential health services.
Read More
https://www.who.int/news-room/detail/01-05-2020-statement-on-the-third-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-coronavirus-disease-(covid-19)

Views: 0
May 9, 2020
Global leaders unite to ensure everyone everywhere can access new vaccines, tests and treatments for COVID-19

Heads of state and global health leaders today made an unprecedented commitment to work together to accelerate the development and production of new vaccines, tests and treatments for COVID-19 and assure equitable access worldwide.

The COVID-19 pandemic has already affected more than 2.4 million people, killing over 160,000. It is taking a huge toll on families, societies, health systems and economies around the world, and for as long as this virus threatens any country, the entire world is at risk.

There is an urgent need, therefore, while following existing measures to keep people physically distanced and to test and track all contacts of people who test positive, for innovative COVID-19 vaccines, diagnostics and treatments.

“We will only halt COVID-19 through solidarity,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Countries, health partners, manufacturers, and the private sector must act together and ensure that the fruits of science and research can benefit everybody.”

Work has already started. Since January, WHO has been working with researchers from hundreds of institutions to develop and test vaccines, standardize assays and standardize regulatory approaches on innovative trial designs and define criteria to prioritize vaccine candidates. The Organization has prequalified diagnostics that are being used all over the world, and more are in the pipeline. And it is coordinating a global trial to assess the safety and efficacy of four therapeutics against COVID-19.

The challenge is to speed up and harmonize processes to ensure that once products are deemed safe and effective, they can be brought to the billions of people in the world who need them. Past experience, in the early days of HIV treatment, for example, and in the deployment of vaccines against the H1N1 outbreak in 2009, shows that even when tools are available, they have not been equally available to all.

So today leaders came together at a virtual event, co-hosted by the World Health Organization, the President of France, the President of the European Commission, and the Bill & Melinda Gates Foundation. The event was joined by the UN Secretary General, the AU Commission Chairperson, the G20 President, heads of state of France, South Africa, Germany, Vietnam, Costa Rica, Italy, Rwanda, Norway, Spain, Malaysia and the UK (represented by the First Secretary of State).

Health leaders from the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI-the Vaccine Alliance, the Global Fund, UNITAID, the Wellcome Trust, the International Red Cross and Red Crescent Movement (IFRC), the International Federation of Pharmaceutical Manufacturers (IFPMA), the Developing Countries Vaccine Manufacturers’ Network (DCVMN), and the International Generic and Biosimilar Medicines Association (IGBA) committed to come together, guided by a common vision of a planet protected from human suffering and the devastating social and economic consequences of COVID-19, to launch this groundbreaking collaboration. They are joined by two Special Envoys: Ngozi Okonjo-Iweala, Gavi Board Chair and Sir Andrew Witty, former CEO of GlaxoSmithKline.

They pledged to work towards equitable global access based on an unprecedented level of partnership. They agreed to create a strong unified voice, to build on past experience and to be accountable to the world, to communities and to one another.

“Our shared commitment is to ensure all people have access to all the tools to prevent, detect, treat and defeat COVID-19,” said Dr Tedros. “No country and no organization can do this alone. The Access to COVID-19 Tools Accelerator brings together the combined power of several organizations to work with speed and scale.”

Health leaders called on the global community and political leaders to support this landmark collaboration and for donors to provide the necessary resources to accelerate achievement of its objectives, capitalizing on the opportunity provided by a forthcoming pledging initiative that starts on 4 May 2020. This initiative, spearheaded by the European Union, aims to mobilize the significant resources needed to accelerate the work towards protecting the world from COVID-19.

Read More
https://www.who.int/news-room/detail/24-04-2020-global-leaders-unite-to-ensure-everyone-everywhere-can-access-new-vaccines-tests-and-treatments-for-covid-19

Views: 0

May 9, 2020
Commitment and call to action: Global collaboration to accelerate new COVID-19 health technologies
Our Vision and Mission

Grounded in a vision of a planet protected from human suffering
and the devastating social and economic consequences of
COVID-19, we, an initial group of global health actors (BMGF,
CEPI, Gavi, Global Fund, UNITAID, Wellcome Trust, WHO) and
private sector partners and other stakeholders, are launching
a landmark, global and time-limited collaboration to accelerate the
development, production and equitable global access to new COVID-19 essential health technologies.

We know that as long as anyone is at risk from this virus, the entire
world is at risk – every single person on the planet needs to be
protected from this disease.

We agree that alongside evidence-based public health measures,
innovative COVID-19 diagnostics, therapeutics and vaccines are
needed – in record time and at record scale and access – to save
millions of lives and countless trillions of dollars, and to return
the world to a sense of ‘normalcy’.

We recognize the significant amount of critical work, investment
and initiatives already ongoing around the world to expedite
the development and deployment of innovative COVID-19 related
products and interventions.

We appreciate that while development and deployment of
innovative products is essential, it will not be enough. We must
simultaneously and urgently accelerate the strengthening of
sustainable health systems and capacities to enable delivery of
the new COVID-19 tools to those who need them and to mitigate
the knock-on impact on other diseases.

We remember lessons from the past, which have shown that even
when effective tools are available to the world, too often some
are protected, while others are not. This inequity is unacceptable –
all tools to address COVID-19 must be available to all. In the fight
against COVID-19, no one should be left behind.

We understand we cannot do this alone, and that we need to
work together in unprecedented and inclusive partnership with all
stakeholders – political leaders, public and private sector partners,
civil society, academia, and all other stakeholders across society
– jointly leveraging our comparative strengths and respective
voices to drive towards collective solutions, an accelerated path,
and access for all. We are stronger, faster and more effective
working together.

Our Mission is not only accelerated development and availability
of new COVID-19 tools – it is to accelerate equitable global access
to safe, quality, effective, and affordable COVID-19 diagnostics,
therapeutics and vaccines, and thus to ensure that in the fight
against COVID-19, no one is left behind.

Our Commitment
1. We commit to the shared aim of equitable global
  access to innovative tools for COVID-19 for all.
2. We commit to an unprecedented level of partnership
  – proactively engaging stakeholders, aligning and
  coordinating efforts, building on existing collaborations, collectively devising solutions, and grounding
  our partnership in transparency, and science.
3. We commit to create a strong unified voice to
  maximize impact, recognizing this is not about
  singular decision-making authority, but rather
  collective problem-solving, interconnectedness and
  inclusivity, where all stakeholders can connect and
  benefit from the expertise, knowledge and activities
  of this shared action-oriented platform.
4. We commit to build on past experiences towards
  achieving this objective, including ensuring that
  every activity we undertake is executed through the
  lens of equitable global access, and that the voices
  of the communities most affected are heard.
5. We commit to be accountable to the world, to
  communities, and to one another. We are coming
  together in the spirit of solidarity, and in the service
  of humanity, to achieve our mission and vision.
Our Call

We ask the global community and political leaders to
support this landmark collaboration, and for donors to
provide the necessary resources to accelerate achievement
of the objectives of this global collaboration, capitalizing
on the opportunity provided by the rolling pledging
campaign that will start on 4 May 2020.

Read More
https://www.who.int/news-room/detail/24-04-2020-commitment-and-call-to-action-global-collaboration-to-accelerate-new-covid-19-health-technologies

Views: 0
May 9, 2020
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

Read More
https://www.who.int/news-room/detail/23-04-2020-infosan-quarterly-summary-2020-1

Views: 0

May 9, 2020
Tools for Maximizing Customer Relationships

Business is tough these days and the economy has caused companies of all sizes to rethink when and how to nurture their relationship with customers. While it may seem like an easy decision to cut back on investing in customer marketing, that may not be the wisest choice. As products and services continue to become commoditized, the only remaining differentiator becomes the vendor‐customer relationship. There?s no getting around that delighting customers and growing revenue will become more heavily based on how well you understand their evolving needs. This article explores three categories of tools used to engage customers and strengthen your relationship with them.

Read More
http://www.associationofmarketing.org/whitepapers/view.php?whitepaper_id=77

Views: 0

April 11, 2020
Speed of Covid-19 deaths shock doctors and nurses

NEW YORK: One medical worker called it “insane”, another said it induces paranoia – the speed with which patients are dying from the novel coronavirus is shocking even veteran doctors and nurses as they scramble to determine how to stop such sudden deterioration.

Patients “look fine, feel fine, then you turn around and they’re unresponsive”, said Diana Torres, a nurse at Mount Sinai Hospital in New York, the epicentre of the pandemic in the US where the virus has infected nearly 430,000 people and caused more than 14,700 deaths.

“I’m paranoid, scared to walk out of their rooms.”

It isn’t just the elderly or patients with underlying health conditions, who can be fine one minute, and at death’s door the next.

It can happen for the young and healthy, too, health professionals told Reuters.

A young woman died unexpectedly while nurse Laurie Douglas was on duty at Our Lady of the Lake Hospital in Baton Rouge, Louisiana.

After 34 years on the job, Douglas said she normally has “an intuition of who is going to fade and who may improve”.

“But these people are throwing that out the window.

“Last week, she was planning her wedding.

“This week, her family is planning her funeral,“ she said, referring to the deceased patient.

Patients might enter the hospital with strong oxygen levels and be engaged in happy conversation, said a resident emergency doctor at New York-Presbyterian Hospital, only to be “gasping for breath” and intubated a few hours later.

“The scary thing is there are no rules to it,“ the resident said on condition of anonymity.

These scenes are playing out everywhere as Covid-19 has infected more than 1.4 million worldwide and killed more than 85,000 as of Wednesday.

The quick turns for the worse are likely products of an “overly exuberant” reaction by the immune system as it fights the virus, said Dr Otto Yang, an infectious disease specialist at the UCLA Medical Centre in Los Angeles.

Called a cytokine storm, it occurs when the body overproduces immune cells and their activating compounds – cytokines – causing dangerously high blood pressure, lung damage and organ failure.

Emily Muzyka, 25, a nurse in the New York suburbs, said she reached her breaking point last week, when a relatively healthy 44-year-old woman needed sudden intubation.

“I had a meltdown that night,“ she said.

“I cried to my boyfriend.”

Intubation refers to inserting a tube into the mouth and through the airway of a Covid-19 patient struggling to breathe, so they can be hooked to a mechanical ventilator.

Journalist Anick Jesdanun, who was in good health and had run 83 marathons, died last week from Covid-19, according to a post on Facebook by his cousin Prinda Mulpramook.

Jesdanun, who was 51, at first didn’t need hospitalisation, according to the post.

He had begun to recover and showed clear lungs and strong vital signs during a doctor’s visit in late March. But “a sudden setback” sent him to the emergency room on April 1, and “13 hours later we lost him”, Mulpramook wrote.

A nurse at Mount Sinai’s intensive care unit recalled watching patients’ kidneys quickly shut down, adding that many require intravenous drips of the blood thinner Heparin.

“It’s insane how sick they get, how quickly.

“We’re really trying hard to figure out how to treat them.”

Some of those hospitals are experimenting with unproven drugs in hopes of helping patients, including the anti-malaria medication hydroxychloroquine.

“We’re essentially throwing the kitchen sink at these patients,“ a doctor said.

Read More
https://www.thesundaily.my/home/speed-of-covid-19-deaths-shock-doctors-and-nurses-AF2241516

Views: 0

April 10, 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

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)

Photographs of confirmed falsified Chloroquine Phosphate (250mg)

Photographs of confirmed falsified Chloroquine Phosphate 250mg

DEMOCRATIC REPUBLIC OF CONGO

Photographs of confirmed falsified CLOROQUINE 250MG

Photographs of confirmed falsified Chloroquine Phosphate 250mg

NIGER

Photographs of confirmed falsified Samquine 100 (100mg)

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

Photographs of confirmed falsified Niruquine (100mg)

Read More
https://www.who.int/news-room/detail/09-04-2020-medical-product-alert-n4-2020

Views: 0
April 10, 2020
Glossary of Youth: Its Education, Regimen, and Hygiene, by G. Stanley Hall

GLOSSARY

AGAMIC. Unmarried; unmarriageable, sometimes non-sexed.

AGENIC. Lacking in reproductive power; sterile.

AMPHIMIXIS. That form of reproduction which involves the mingling of substance from two individuals so as to effect a mixture of hereditary characteristics. It includes the phenomena of conjugation and fertilization among both unicellular and multicellular organisms.

ANABOLISM. See METABOLISM.

ANAMNESIC. Pertaining to or aiding recollection.

ANEMIC. Deficient in blood; bloodless.

ANTHROPOMORPHISM. The attributing of human characteristics to natural, supernatural, or divine beings.

ANTHROPOMETRY. Science of measurement of the human body.

ARTIFACT. Any artificial product.

APHASIA. Impairment or lose of the ability to understand or use speech.

ASSOCIATIONISM. The psychological theory which regards the laws of association as the fundamental laws of mental action and development.

ATAVISTIC. Pertaining to reversion through the influence of heredity to remote ancestral characteristics.

ATAXIC. Pertaining to inability to coördinate voluntary movements; irregular.

CALAMO-PAPYRUS. Reed papyrus or pen-paper.

CATABOLISM. See METABOLISM.

CATHARSIS. Purgation or cleansing. Aristotle’s esthetic theory that little renders immune for much.

CEREBRATION. Brain action, conscious or unconscious.

CHOREA. St. Vitus’s dance; a nervous disease marked by irregular and involuntary movements of the limbs and face.

CHRESTOMATHY. A collection of extracts and choice pieces.

CHRISTENTHUM. The Christian belief; the spirit of Christianity.

COMMANDO EXERCISES. Gymnastic exercises whose order is dependent upon the spoken command of the director.

CORTEX. The gray matter of the brain, mostly on its surface.

CORTICAL. Pertaining to the cortex.

CRANIOMETRY. The measurement of skulls.

CRYPTOGAMOUS. Having an obscure mode of fertilization; or, of plants that do not blossom.

CULTUS. A system of religious belief and worship.

DEUTSCHENTHUM. The spirit of the German people.

DIATHESIS. A constitutional predisposition.

EPHEBIC. Pertaining to the Greek system of instruction given to young men to fit them for citizenship; adolescent.

EPIGONI. Successors; followers who only follow.

EPISTEMOLOGY. The theory of knowledge; that branch of logic which undertakes to explain how knowledge is possible and to define its limitations, meaning, and worth.

EUPEPTIC. Having good digestion.

EUPHORIA. The sense of well-being; of fullness of life.

EVIRATION. Emasculation; loss of manly characteristics.

FERAL. Wild by nature; untamed; undomesticated.

FORMICARY. An artificial ants’ nest.

GEMÜTH. Disposition; the entire affective soul and its habitual state.

HEBETUDE. Dullness; stupidity.

HEDONISTIC. Relating to hedonism, that form of Greek philosophy which taught that pleasure is the chief end of existence.

HETAERA. A Greek courtesan. This class was often highly trained in music and social art, and represented the highest grade of culture among Greek women.

HETEROGENY. (1) The spontaneous generation of animals and vegetables, low in the scale of organization, from inorganic elements. (2) That kind of generation in which the parent, whether plant or animal, produces offspring differing in structure or habit from itself, but in which after one or more generations the original form reappears.

HETERONOMOUS. Having a different name.

HOROLOGY. The science of measuring time and of constructing instruments for that purpose.

HYGEIA. The Greek goddess of health; health.

HYPERMETHODIC. Methodic to excess; overmethodic.

HYPERTROPHY. Excessive growth.

INDISCERPTIBLE. Incapable of being destroyed by separation of parts.

INHIBITION. Interference with the normal result of a nervous excitement by an opposing force.

IRRADIATION. The diffusion of nervous stimuli out of the path of normal discharge which, as a result of the excitation of a peripheral end organ may excite other central organs than those directly connected with it.

KINESOLOGICAL. Pertaining to the science of tests and measurements of bodily strength.

KINESOMETER. An instrument for measuring muscular strength.

MEDULLATION. The investment of nerve fibers with a protective covering or medullary sheath, consisting of white, fat-like matter.

MERISTIC. Pertaining to the levels or spinal and cerebral segments of the body.

METABOLISM. The act or process by which, on the one hand, dead food is built up into living matter—anabolism, and by which, on the other, the living matter is broken down into simpler products within a cell or organism—catabolism.

METAMORPHOSIS. Change of form or structure; transformation.

METEMPSYCHOSIS. The doctrine of the transmigration of the soul from one body to another.

MONOPHRASTIC. Pertaining to or consisting of a single phrase.

MONOTECHNIC. Pertaining to a single art or craft.

MORPHOLOGY. The science of form and structure of plants and animals without regard to function.

MYOLOGY. The scientific knowledge of the muscular system.

MYTHOPOEIC. Producing or having a tendency to produce myths.

NOETIC. Of, pertaining to, or conceived by, mind.

NUANCE. Slight shade; difference; distinction; degree.

ORTHOGENIC. Pertaining to right beginning and development.

ORTHOPEDIC. Relating to the art of curing deformities.

OSSUARY. A depository of dry bones.

PALEOPSYCHIC. Pertaining to the antiquity of the soul.

PANTHEISTIC. Relating to that doctrine which holds that the entire phenomenal universe, including man and nature, is the ever-changing manifestation of God, who rises to self-consciousness and personality only in man.

PATRISTICS. That department of study occupied with the doctrines and writings of the fathers of the Christian Church.

PHOBIA. Excessive or morbid fear of anything.

PHYLETICALLY. In accordance with the phylum or race; racially.

PHYLETIC. Pertaining to a race or clan.

PHYLOGENY. The history of the evolution of a species or group; tribal history; ancestral development as opposed to ontogeny or the development of the individual.

PHYLUM. A term introduced by Haeckel to designate the great branches of the animal and vegetable kingdoms. Each phylum may include several classes.

PICKELHAUBE. The spiked helmet of the German army.

PLANKTON. Sea animals and plants collectively; distinguished from coast or bottom forms and floating in a great mass.

POLYGAMIC (LOVE). Pertaining to the habit of having more than one mate of the opposite sex.

POLYPHRASTIC. Having many phrases; pertaining to rambling, incoherent speech.

POST-SIMIAN. Pertaining to an age later than that in which simian or monkey-like forms prevailed.

PRENUBILE. Pertaining to the age before sexual maturity or marriageability is reached.

PRIE DIEU. A praying desk.

PROPEDEUTIC. Preliminary; introductory.

PROPHYLACTIC. Any medicine or measure efficacious in preventing disease.

PSEUDOPHOBIAC. Pertaining to a morbid condition in which the subject is continually in fear of having said something not strictly true.

PSYCHOGENESIS. The origin and development of soul.

PSYCHONOMIC. Pertaining to the laws of mind.

PSYCHOSIS. Mental constitution or condition; any change in consciousness, especially if abnormal.

PUBERTY. The age of sexual maturity.

PUBESCENT. Relating to the dawning of puberty.

PYGMOID. Of pygmy size and form.

RABULIST. A chronic wrangler; one who argues about everything.

SCHEMA. A synopsis; a summary. In the Kantian sense, a general type.

SCHEMATISM. An outline of any systematic arrangement; an outline.

SUPERFOETATION. A second conception some time after a prior one, by which two foetuses of different age exist together in the same female. Often used figuratively.

TEMIBILITY. (From Italian temibile, to be feared.) The principle of adjustment of penalty to crime in just that degree necessary to prevent a repetition of the criminal act.

TIC. A nervous affection of the muscles; a twitching.

TRANSCENDENTAL. In the Kantian system having an a priori character, transcending experience, presupposed in and necessary to experience.

TRAUMATA. Wounds.

TRAUMATISM. A wound; any morbid condition produced by wounds or other external violence.

VERBIGERATION. The continual utterance of certain words or phrases at short intervals, without reference to their meaning, as seen in insane Gedankenflucht or rapid flight of thought.

Extract from Youth: Its Education, Regimen, and Hygiene, by G. Stanley Hall

Views: 0

April 9, 2020
5 Reasons Why You Should Do a Product Launch That Have Nothing To Do With Selling That Product

When most entrepreneurs decide to launch a product, they’re mostly thinking about how many products they’re going to sell or how much money they’ll make during the launch. Now while that’s a great reason to have a product launch, it’s actually not the only reason. In fact, I may go as far to say it’s not even the most important reason. Let’s take a moment and go through the top 5 reasons to have a launch that have nothing to do with selling that particular product.

Read More
http://www.associationofmarketing.org/articles/view.php?article_id=5392

Views: 0

April 9, 2020