scholarly journals Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective

Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 423
Author(s):  
Davide Ferorelli ◽  
Lorenzo Spagnolo ◽  
Maricla Marrone ◽  
Serena Corradi ◽  
Maria Silvestre ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Large Scale ◽  
Ethical Issues ◽  
Political Influence ◽  
Legal Aspects ◽  
Off Label Use ◽  
Off Label ◽  
Drug Regulatory Agencies ◽  
Multiple Drugs ◽  
Label Use

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.

Survey on Off-Label Use of Antineoplastic Agents in Pediatric Patients using a Large-scale Medical Database in Japan

2020 ◽  
Vol 51 (6) ◽  
pp. 307-316
Author(s):  
Mayuko KURODA ◽  
Ayaka NAKAMURA ◽  
Nanae TANEMURA ◽  
Masayoshi NAKAKUNI ◽  
Junko SATO ◽  
...  
Keyword(s):  
Antineoplastic Agents ◽  
Large Scale ◽  
Pediatric Patients ◽  
Off Label Use ◽  
Medical Database ◽  
Off Label ◽  
Label Use

A systematic analysis of off-label drug use in real-world data (RWD) across more than 145,000 cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18031-e18031 ◽  
Author(s):  
Jonathan McCafferty ◽  
Kartikey Grover ◽  
Li Li ◽  
Zhiqiang Li ◽  
Marc Y. Fink ◽  
...  
Keyword(s):  
Drug Use ◽  
Clinical Response ◽  
Cancer Patients ◽  
Hormonal Therapy ◽  
Clinical Studies ◽  
Off Label Use ◽  
Systematic Analysis ◽  
Off Label ◽  
Multiple Drugs ◽  
Label Use

e18031 Background: Off-label drug use is common in cancer treatment (tx) due to limited approved tx options. Systematic analysis of RWD for off-label drug use facilitates hypothesis generation and design of clinical studies for new indications. Methods: We analyzed systemic tx data of > 145,000 cancer patients at Mount Sinai hospitals for 60 chemotherapy, 80 targeted, 16 hormonal therapy drugs, and 6 immune checkpoint inhibitors (CPIs). Off-label use was determined when patients received a drug for cancer indications that had not received regulatory approval, and the tx was not in a clinical trial setting. Clinical response to off-label tx was assessed using time to treatment discontinuation (TTD) as a surrogate endpoint. Results: Chemotherapy drugs were used off-label more frequently than targeted and hormonal agents. Across all cancer tx regimens involving a chemotherapy drug , 31% were off-label. In contrast, for tx regimens involving targeted and hormonal therapy drugs, only 11% and 6.7%, respectively, were used off-label. Further investigation revealed that chemotherapy often combines multiple drugs, where the combinations may include one or more drugs not approved for the disease. For example, cisplatin is approved only for bladder, ovarian and testicular cancers, but is widely used in combination to treat other cancers. Consequently, we observed an 84% off-label use of cisplatin. Several targeted drugs and CPIs were used off-label at high frequencies. 53% of nivolumab tx was off-label, primarily for treating hepatocellular carcinoma (before FDA approval) and relapsed/refractory multiple myelomas (RRMM). Trametinib targeting MEK and venetoclax targeting Bcl-2 were used off-label at a frequency of 84% and 89%, respectively, mainly in RRMM. In MM patients treated with trametinib (n = 91) and venetoclax (n = 121), 14 (15%) and 42 (35%), respectively, had TTD > 120 days. Conclusions: Off-label uses of novel targeted and immunotherapy drugs are likely based on disease mechanisms and when clinical trials deliver early, encouraging results. A thorough chart review would help us better understand clinical response as well as adverse events in these patients and potentially guide future clinical studies.

scholarly journals Ethical dimensions in randomized trials and off-label use of investigational drugs for COVID-19 treatment

2021 ◽  
pp. 147775092110114
Author(s):  
Pooja Dhupkar ◽  
Seema Mukherjee
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Off Label Use ◽  
Off Label ◽  
Investigational Drugs ◽  
Number Of Patients ◽  
The Impact ◽  
Label Use

Coronavirus disease 2019 (COVID-19) is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, despite a lack of evidence of efficacy in COVID-19. In this review, we highlight the potential ethical issues that should be addressed during the use of investigational drugs with little prior evidence as a treatment options during a pandemic. We discuss the impact of design of randomized clinical trials using LOTUS trial as an example and that of off-label use of drugs like chloroquine/hydroxychloroquine (CQ/HQ) on the safety of patients during COVID-19. We conclude that the adaptive randomized clinical trial designs offer a flexible and efficient approach, enabling patients to quickly switch to successful treatments, while minimizing the number of patients on standard of care. Randomized clinical trial design should consider blinding of investigators and only representative patients who can provide consent should be included. We also conclude the emergency approvals of drugs should be carefully issued and off-label use should be restricted in pandemics. Streamlined regulatory guidelines for emergency drug use in a pandemic can also help in providing benefit and minimizing harm to patients in the future.

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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