This is a very controversial issue. Patients who are likely to be prescribed off-label unproven drugs for COVID-19 management e.g. HCQS and Azithromycin , may also develop serious adverse effects due to the drugs (e.g QT prolongation, arrhythmia etc ) . The situation can lead to more controversy if the patients are having mild or asymptomatic disease and they land up into drug toxicity. This can lead to many medico-legal and ethical issues. This type of situation demands that there should be a thorough discussion (regarding pros and cons of such drugs) between the doctor and the patient (and/or their relatives) , before prescribing any unproven drug for COVID-19 treatment. It can be considered to obtain a written inform consent from patients or their relatives. Your views will be appropriated.
Informed consent is required, in particular when participating in a clinical trial.
Informed consent is required, in particular when participating in a clinical trial.
Do COVID 19 patients have an alternative..if they refused to sign the informed/ written consent.
Ethical research practice requires agreeing first to participate in any clinical trials. Written informed consents are crucial and should be applied.
Amina Sultan..they must be informed about the adverse effects of the drugs which are not even supported by the evidence well. And most important point is that not every COVID -19 patients need these drugs.. Generally these are restricted for COVID-19 patientz with severe pneumonia.
Christian G Meyer..yes that's very important but here I am talking about clinical practice not clinical trials
Conviene por ética profesional, y por la salud de las personas infectadas,disponer del consentimiento informado, Para tratar con medicamentos no probados como eficaces a causa del CONAVI 19.Sería un error ignorar un instrumento que puede ser muy útil, al momento de evaluar la eficacia o no de esos medicamentos.Cada ser humano decide acerca de lo que le conviene o no, la verdad del profesional ante todo.Revisar protocolo judicial en estos casos, qué dice la ley de ejercicio profesional? Exito en su investigación.
Informed consent must b approved in case of use of unapproved drug in clinical practise... n such use shud b limited only in sitatuon like COVID.. which lacks any approved drugs
The use of compassionate - non-registered - drugs in clinical practice needs informed written consent. Otherwise the doctor is liable in case of unfavourable outcome.
Rimple Jeet . Yes this is exactly what I thought before posting this question
It is not required to obtain Informed Consent from patient to prescribe a drug off-label for COVID-19 endemic because:
1) During Informed Consent Procedure doctors have to explain the alternatives of the current treatment (if patient deny than what is available) as there is no alternative treatment available for COVID -19 and this is an health emergency situation so keeping in mind the safety of patient doctors have to prescribed the best available treatment to patients.
2) There are no other approved therapies/treatment or drug available as of now.
3) HCQs and Azithromycin are the drug of choice as they boost immunity and have some sort of role to curb infection (literature support this theory).
Vinay Singh . Thanks for your response but I do not agree with you on many points . 1st of all HCQS -AZ combination does not boost immunity . Earlier published articles on HCQS and AZ have many methodological flaws and latest evidence does not support your statement (see this https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2 and https://retractionwatch.com/2020/04/06/hydroxychlorine-covid-19-study-did-not-meet-publishing-societys-expected-standard/ ).
Coming to point no. 2, yes there are no approved therapies, HCQS -AZ are also not approved but can lead to harm as well and use is unproven, in that case if inform consent is missing, it can lead to many medico legal issues. Although I agree with you on emergency use. But they are not best available therapies , but yes something is better than nothing.
@Harmanjit Singh
Please go through it: HCQs have shown beneficial effects in several diseases
Savarino A, Boelaert JR, Cassone A, Majori G, Cauda R (2003) Effects Savarino A, Boelaert JR, Cassone A, Majori G, Cauda R (2003) Effects of chloroquine on viral infections: an old drug against today’s diseases? Lancet Infect Dis 3(11):722–727
Though it is seen in recent studies ( COVID-19) that it does not have any beneficial effect but when nothing is available you have to choose what is available which have at least some promising result rather than leave your patient untreated.
Vinay Singh. I have gone through all these articles. I am not saying that it should not be given...my question is entirely different. That old paper you are showing has nothing to do with covid and since then hcqs is only used in SLE and RA and not approved for any viral illness. It has many disadvantages which must be communicated to the patient and that might arise the need of a consent also. If you talk about Indian recommendations for use of hcqs And AZ, they are saying that this is off label and only to be used in serious covid patients. Hcqs has anticytokine effect, so your claim of boosting immunity is not justified.
https://www.researchgate.net/publication/340448998_Azithromycin_promising_medicine_for_COVID_19_in_early_stage_by_effecting_on_mTOR_and_immune_system
https://www.nejm.org/doi/full/10.1056/NEJMoa2012410
According to new article published in NEJM, HCQ does not lead to any benefit in COVID patients
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