Pharmacy Learning-Conceptual Solutions

Medical Product Alert N°3/2020
Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
31 March 2020 Medical product alert Geneva
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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.

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.

At this stage, there is no vaccine to prevent COVID-19. Products claiming to be vaccines to prevent COVID-19 may be considered falsified and may pose significant risks to public health.

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.

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 [email protected].

Pretomanid, developed by the non-profit TB Alliance, has received U.S.
approval in combination regimen with bedaquiline and linezolid for people
with XDR-TB or treatment-intolerant/non-responsive MDR-TB

NEW YORK (August 14, 2019) Pretomanid, a novel compound developed by the
non-profit organization TB Alliance, was approved by the U.S. Food & Drug
Administration (FDA) today for treating some of the most drug-resistant
forms of tuberculosis (TB).1 The new drug was approved under the Limited
Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as
part of a three-drug, six-month, all-oral regimen for the treatment of
people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant
TB (MDR-TB) who are treatment-intolerant or non-responsive (collectively
'highly drug-resistant TB).1,2

The LPAD pathway was established by FDA as a tool to encourage further
development of antibacterial and antifungal drugs to treat serious,
life-threatening infections that affect a limited population of patients
with unmet needs.

'FDA approval of this treatment represents a victory for the people
suffering from these highly drug-resistant forms of the world's deadliest
infectious disease,'� said Mel Spigelman, MD, president and CEO of TB
Alliance. 'The associated novel regimen will hopefully provide a shorter,
more easily manageable and highly efficacious treatment for those in need.'�

Please see Full Prescribing Information at:
www.TBAlliance.org/pretomanid

Pretomanid and the BPaL Regimen Full Prescribing Information Pretomanid and the BPaL Regimen Pretomanid is an investigational tuberculosis (TB) drug developed by TB Alliance for use in combination with bedaquiline and line

Tackling Wasteful Spending on Health says that at a time when public budgets are under pressure worldwide, it is alarming that around one fifth of health expenditure likely makes no or minimal contribution to good health outcomes. In other words, governments could spend significantly less on health care and still improve patients' health. Efforts to improve the efficiency of health spending at the margin are no longer good enough.

According to the report:

* One in ten patients in OECD countries is unnecessarily harmed at the point of care.

* More than 10% of hospital expenditure is spent on correcting preventable medical mistakes or infections that people catch in hospitals.

* One in three babies is delivered by caesarean section, whereas medical indications suggest that C-section rates should be 15% at most.

* The market pe*******on of generic pharmaceuticals - drugs with effects equivalent to those of branded products but typically sold at lower prices - ranges between 10-80% across OECD countries.

* A third of OECD citizens consider the health sector to be corrupt or even extremely corrupt.

Strategies to reduce waste can be summed up as:
i) stop doing things that do not bring value: for example, unnecessary surgeries and clinical procedures; and
ii) swap when equivalent but less pricy alternatives of equal value exist: for example, by encouraging the use of generic drugs, developing advanced roles for nurses, or ensuring that patients who do not require hospital care are treated in less resource-consuming settings.

The report is available online at
www.oecd.org/health/tackling-wasteful-spending-on-health-9789264266414-en.htm