Minsa aprueba documento técnico que establece el uso de determinados fármacos en tratamiento de personas afectadas por Covid-19

31 de marzo de 2020 - 2:51 p. m.

El Ministerio de Salud aprobó la Resolución Ministerial Nº 139-2020/MINSA que adjunta el Documento Técnico: Prevención y Atención de Personas Afectadas por Covid-19 en el Perú, que establece acciones dirigidas a la prevención, diagnóstico y sobre todo, tratamiento de las personas afectadas.

Este dispositivo legal, refrendado por el titular de Salud, Víctor Zamora, toma en cuenta que si bien no hay tratamientos específicos dirigidos a pacientes con sospecha o confirmación de infección por el virus del Covid-19, se informa que existen estudios internacionales sobre el uso de fármacos en atención de pacientes Covid-19 que ofrecen un limitado nivel de evidencia.

Estos medicamentos son: Cloroquina, Hidroxicloroquina, Azitromicina, Lopinavir/ritonavir, entre otros. Y su uso solo será para el manejo de casos moderados y severos (solo pacientes hospitalizados).

El Minsa, a solicitud de las Sociedades Científicas Nacionales y en consenso con el Grupo de Trabajo Covid-19, acoge la propuesta de poner a consideración de los médicos especialistas tratantes, sobre la base de una evaluación individual del paciente y previo consentimiento informado, los esquemas de tratamiento que las Sociedades Científicas Nacionales sugieren.

El documento técnico encarga a la Dirección General de Intervenciones Estratégicas en Salud Pública la supervisión, monitoreo y difusión de lo dispuesto.

Gratuidad del tratamiento

La norma también establece los criterios técnicos y procedimientos para la prevención, diagnóstico y tratamiento de los pacientes con el nuevo coronavirus en un escenario de transmisión comunitaria, que es de aplicación obligatoria en las Instituciones Prestadoras de Servicios de Salud (IPRESS) o establecimientos de salud públicos del Minsa, a través de las Direcciones de Redes Integradas de Salud (Diris), Direcciones Regionales de Salud (Diresa) o Gerencias Regionales de Salud (Geresa), Seguro Social de Salud (EsSalud), de las Sanidades de las Fuerzas Armadas y de la Policía Nacional del Perú, así como de las IPRESS privadas.

Señala que estas instituciones públicas y privadas deben notificar la enfermedad de manera obligatoria, de acuerdo a la norma vigente emitida por el Centro Nacional de Epidemiología, Prevención y Control de Enfermedades del Minsa. En tanto, en todos los establecimientos de salud del ámbito nacional se garantiza la gratuidad en el diagnóstico, detección y tratamiento, en el marco del Aseguramiento Universal en Salud.

La medida normativa también brinda características principales del Covid-19, signos de alarma, factores de riesgo de la enfermedad, clasificación clínica (casos leve, moderado y severo), así como la evaluación y manejo de pacientes según dicha clasificación, con y sin factores de riesgo.

Protección del personal de Salud

El documento técnico establece que todo trabajador de sector salud deberá estar vacunado contra influenza estacional y neumococo, y se realizará la prueba rápida en caso de que presente síntomas respiratorios compatibles con Infección Respiratoria Aguda (IRA) o sea contacto de un caso sospechoso o confirmado de Covid-19, o haya participado directamente en la atención de estos pacientes.

Recomienda que los establecimientos implementen áreas administrativas y asistenciales diferenciadas para la atención de casos de Covid-19, con el objetivo de reducir la exposición a los trabajadores de salud. Y especifica el tipo de Equipo de Protección Personal con el que debe contar el personal de salud.

Responsabilidades

Este documento técnico delega responsabilidades específicas. La Dirección General de Intervenciones Estratégicas en Salud Pública (Dgiesp) se encargará de elaborar y proponer documentos normativos, brindar asistencia técnica y capacitación a nivel nacional, implementar y supervisar el seguimiento clínico a distancia y presencial de personas en aislamiento domiciliario y cuarentena, así como garantizar el abastecimiento y la distribución de medicamentos e insumos médicos para el diagnóstico y la atención de pacientes Covid-19, lo que incluyen los Equipos de Protección Personal y pruebas de laboratorio.

Los hospitales e institutos, a su vez, ejecutarán las normas y procedimientos técnicos dispuestos, organizarán la atención en áreas especializadas destinadas para los pacientes con Covid-19, desde los casos moderados hasta los severos. También deberán elaborar e implementar el Plan de Control de Infecciones y de Bioseguridad, asimismo garantizar el abastecimiento de medicamentos y insumos médicos para una atención más óptima y eficiente.

Además, precisa las funciones del Laboratorio de Referencia Nacional de Virus Respiratorios del Instituto Nacional de Salud (INS), encargado de conducir la red de laboratorios en el ámbito nacional. Este realizará la transferencia tecnológica sobre los métodos de diagnóstico, supervisará el control de calidad de pruebas rápidas y consolidará la información del país relativa a exámenes realizados por los Laboratorios de Referencia Regional (LRR).

El documento deja sin efecto la Resolución Ministerial Nº 084-2020/MINSA, que aprobaba el Documento Técnico: Atención y Manejo Clínico de Casos Covid-19, escenario de transmisión focalizada.

In one particularly incomprehensible act, the government of India, a poor country of 1.3 billion people, locked down its people. As Quartz India reported on April 22, "Coronavirus has killed only around 700 Indians ... a small number still compared to the 450,000 TB and 10,000-odd malaria deaths recorded every year."

One of the thousands of unpaid garment workers protesting the lockdown in Bangladesh understands the situation better than almost any health official in the world: "We are starving. If we don't have food in our stomach, what's the use of observing this lockdown?" But concern for that Bangladeshi worker among the world's elites seems nonexistent.

The lockdown is "possibly even more catastrophic (than the virus) in its outcome: the collapse of global food-supply systems and widespread human starvation" (italics added). That was published in the left-wing The Nation, which, nevertheless, enthusiastically supports lockdowns. But the American left cares as much about the millions of non-Americans reduced to hunger and starvation because of the lockdown as it does about the people of upstate New York who have no incomes, despite the minuscule number of coronavirus deaths there. Or about the citizens of Oregon, whose governor has just announced the state will remain locked down until July 6. As of this writing, a total of 109 people have died of the coronavirus in Oregon.

An example of how disinterested the left is in worldwide suffering is made abundantly clear in a front-page "prayer" by a left-wing Christian in the current issue of The Nation: "May we who are merely inconvenienced remember those whose lives are at stake."

"Merely inconvenienced" is how the Rev. Dr. William J. Barber II, a Protestant minister and president of the North Carolina NAACP, describes the tens of millions of Americans rendered destitute, not to mention the hundreds of millions around the world rendered not only penniless but hungry. The truth is, like most of the elites, it is Barber who is "merely inconvenienced." Indeed, the American battle today is between the merely inconvenienced and the rest of America.

Michael Levitt, professor of structural biology at Stanford Medical School and winner of the 2013 Nobel Prize in chemistry, recently stated, "There is no doubt in my mind that when we come to look back on this, the damage done by lockdown will exceed any saving of lives by a huge factor."

To the left, anyone who questions the lockdown is driven by preference for money over lives. Typical of the left's moral shallowness is this headline on Salon this week:

"It's Time To Reject the Gods of Commerce: America Is a Society, Not an 'Economy,'" with the subhead reading, "America Is About People, Not Profit Margins."

And, of course, to smug editors and writers of The Atlantic, in article after repetitive article, the fault lies not with the lockdown but with President Donald Trump. The most popular article in The Atlantic this week is titled "The Rest of the World Is Laughing at Trump." The elites can afford to laugh at whatever they want. Meanwhile, the less fortunate -- that is, most people -- are crying.

Editor's Note: Want to support Townhall so we can keep telling the truth about China and the virus they unleashed on the world? Join Townhall VIP and use the promo code WUHAN to get 25% off VIP membership!

Dennis Prager is a nationally syndicated radio talk-show host and columnist. His latest book, published by Regnery in May 2019, is "The Rational Bible," a commentary on the book of Genesis. His film, "No Safe Spaces," came to theaters fall 2019. He is the founder of Prager University and may be contacted at dennisprager.com.

Doctors and Patients Are Pawns in a Dangerous Political Brinkmanship

Professor Raoult Comments on the Pandemic Evolution, the Disease Phases, the Available Treatments and … Media Delirium

In the interview, Professor Didier Raoult, ranked number 1 among the world’s infectious disease experts, comments on the media treatment of the early treatment he recommends.

“Hydroxychloroquine, chloroquine, these are incredibly used drugs … I don’t even know how the media could have gone mad around this story. It is a real madness disconnected from reality … It was just needed to speak to any doctor to know that the plaquenil is harmless … All of a sudden, we learn it’s a toxic product . It is appalling, it is completely delusional … We must return to reason, reason must regain its rights, and we must stop considering that this drug, which was discovered 80 years ago, and which has been used since, became toxic in 2020.”

For Professor Didier Raoult, the majority of doctors reacted very well to the need to treat the disease. However, concerning doctors who do not intervene quickly and let the disease progress without treating it, he says that it goes against the principles of medical practice since … Hippocrates.

Professor Raoult also commented on treatments in intensive care units, in intensive care in France: “Something has happened that is quite remarkable, absolutely extraordinary, it is the quality of care in intensive care units.”

Evolution of the Epidemic

In this new interview, the Professor first discusses the evolution of the epidemic.

that the COVID-19 epidemic follows the typical bell curve for epidemics that epidemics are disappearing, that humanity has not disappeared because of an epidemic, and that we do not know why epidemics disappear that ecosystem phenomena, that are not understood, are at the basis of the transmissibility of viruses he presents some graphs, where we can see the bell shape for Italy, Turkey, Germany, France he cites a study officially recognized in France which predicts that 99% of cases will have occurred by around May 19 he thinks that at that time, in May, the transmissibility of the virus will be lower he doesn’t think there will be a rebound, a second wave he doesn’t think 70% of the population should be immune to control the epidemic he thinks that these last two elements are kind of virtual, that they do not emanate from facts, from actual observations

The Phases of the Disease

Professor Raoult then comments on treatments for the coronavirus. He insists that now we know this disease well, and that there are several phases.

He first gives some figures:

25,000 people who have been tested at the IHU in Marseille; positivity rates peaked at 22%, it’s now down to 5 or 6% positive; among staff, about 3% have been infected, as this is equivalent to what is happening in the general population approximately 4000 patients were followed 3300 were followed in day hospital as outpatients 630 were hospitalized 1500 strains have been identified; 1300 are under culture 1900 low dose chest scans were performed, chest scans are very important because they show lung damage in people who are apparently not symptomatic 7,500 electrocardiograms were performed and supervised by cardiologists 434 genomes have been sequenced and 309 analyzed approximately 1400 dosages of hydroxychloroquine, 500 dosages of azithromycin and 300 dosages of zinc were carried out to understand the drugs and to avoid any overdose (Important to note here the appearance of Zinc in the dosages carried out)

Treatment of the Disease

>> A Reminder of Why Early Treatment is Essential Thanks to considerable experience with treatment and a database of 3,500 patients, here are Professor Raoult’s comments.

there are several stages to the disease. the first phase, which they call the incubation period, is between when the patient catches the virus and when he is symptomatic; the only thing at that the time of this incubation period is the virus, and sometimes people don’t even realize they have the virus the next period is the clinical period. There, the patients are sick, they have a fever. It’s the most common manifestation. from a therapeutic perspective, the virus is then the target, but needs to be treated relatively early. he says it’s known for the flu for example. Tamiflu works for the first, second day of the flu, and then it doesn’t work. we know that for viral infections, it is at the beginning that it is necessary to treat, after, the response against the virus is so strong that the problem is no longer the virus gradually, there is no longer a correlation between the viral load (the number of viruses) and the severity of the disease, and in the end, there are no more viruses. so there is a real sequence / evolution for the the disease, which is first a viral disease, then it becomes both viral and an immune response, and then it’s just a disease related to the immune response once the patient is healed, there is another risk, that of pulmonary fibrosis, which can make the lung no longer work at all, even when we thought the patient was cured each phase of the disease corresponds to a therapeutic phase in order to be able to treat people at the start, I always said, you have to deal with drugs that have anti-viral efficacy and are not toxic. There should not be too significant risks compared to the expected benefits. this is one of the reasons why drugs such as Remdesivir cannot be prescribed for this because their toxicity is too great; regarding Remdesivir, you can see it very well with the study which quickly disappeared from the WHO website … (note that this randomized study, which found that “remdesivir was not associated with statistically significant clinical benefits” is now public – see our article) the toxicity of Remdesivir means that it cannot be given for a disease which at first is mild what you can do is to give harmless drugs, and the Chinese have done it too. the first study led the Chinese to decide to choose hydroxychloroquine over Remdesivir, why hydroxychloroquine? Because it is not toxic, it is cheap and it is available, which was a reasonable choice if we thought that it was necessary treat people early. then things get worse, and there it’s the immune response that becomes important. there are no more viruses. There is no longer any need for antivirals at this point. Because antivirals no longer work. There are no more viruses. the problem at this point is the immune response, even if there probably remains a place for hydroxychloroquine, which is a modulator of immunity. Hydroxychloroquine, chloroquine, these are incredibly used drugs. I do not even know how the media could have gone mad around this story. It’s real madness out of touch with reality. They are sick. It would have been simple to speak to any doctor to know that plaquenil is harmless and that people are given that. before the crisis, 1.2 million boxes of plaquenil were sold in 2019, so 36 million tablets of plaquenil. and all of a sudden, we discover that plaquenil is a toxic, appalling product – it’s completely delusional. a recent study of people using plaquenil for arthritis shows an absence of heart problem how this madness took the world is something that is mysterious always be careful: chloroquine and hydroxychloroquine, if taken in sufficient doses, you can kill you we must return to reason: it is a drug that can be used if we respect the right dosage. as for azithromycin, it is the drug that has been most prescribed for respiratory infections, including those that are viral, because often there are secondary bacterial infections luckily azithromycin is particularly effective in combination with hydroxychloroquine we have already treated more than 3000 people with this. things are going very well. there have been no medication related accidents. we must return to reason, reason must resume its rights, and we must stop considering that this drug, which was discovered 80 years ago, and which has been used since, became toxic in 2020 people ate 36 million pills, just in the cities, because I’m not talking about those from the hospital, and it would have suddenly become a deadly thing? just ask your GP. everyone has already prescribed plaquenil. it’s not possible, it’s just an implausible thing that it suddenly become a deadly thing. what we forget is that this disease (COVID-19) causes damage to the heart – myocarditis. There are fatal myocarditis. Whether or not you are taking treatment, watch out as they can cause rhythm disturbances and death. we live in an era where we seek maximum safety, and it is legitimate to look at the things that are possibly associated with torsades de pointe: potassium base, co-medications, the length of the ECG QT interval, all of these are things you can do, and if you do that, you have no trouble; all this is very simple.

The Role of Medical Doctors

Regarding the role of medical doctors today in the crisis, here are the comments of Professor Didier Raoult.

I found that generally speaking, medical doctors react very well. I think I am in tune with most of the practitioners, who see the sick and who say: listen, something has to be done. A lot of people react like this, so we give azithromycin, we give macrolides, we treat patients like that. The idea that we can leave people until they have respiratory failure without giving them anything … medicine has never done that. Medical doctors treat people. We give them something. At least to reassure them, to say that we take care of them. You can’t say: people are sick, they are left in a bed until they can’t breathe, and there they go to the hospital. This is against all principles of medical practice since … Hippocrates. We can’t do that. We can’t validate that. He comments on the situation of Paris versus that of Marseille: they use more hydroxychloroquine and azithromycin in Paris than in Marseille. Perhaps the media, but Parisian doctors and patients, they are no crazier than the others: they want the medications. It’s a story of Parisian media. But Parisians are normal humans, and when they are sick, they want to be treated. And Parisian doctors, when their patients are sick, they want to treat them. These are humans – not aliens.

About Treatment in Intensive Care

something quite remarkable, absolutely extraordinary, has happened: the quality of care in intensive care units. I know it’s like that in Marseille. In Paris, my friends tell me the same thing. When there are these forms of respiratory distress, in general the mortality is more than 20 or 25%. In the American data series, what we see are absolutely considerable mortalities. what friends and colleagues tell us is that we have a much lower mortality: 9 or 10%. A colleague in Paris told me the same thing: 9 or 10%. this is because they have a network of intensive care specialists and they exchange information that they have as they go, and which are not yet published, in particular regarding coagulation there are big coagulation issues. They changed their therapeutic approach. They adapted it by giving anti-coagulants as soon as possible, to avoid pulmonary embolism, which can be a cause of sudden death. they also used “outside protocol” medication to control the immune response. when this immune response goes crazy, you have to control it, and there are drugs for that; such drugs should be used, even if there are no randomized studies, because this is about saving the lives of people in a situation that is compassionate; these tools must be used: when you have such severe situations, you have to use whatever you can to save people’s lives this approach there and the French ICUs amount to an incredible reaction, because the ICUs were overflowed, there are units that were installed in conditions that are almost war conditions – yet the result is quite exceptional. we could have had 30% more deaths, if it had not been for the quality of care in the ICUs. I think that is very good and that many people have been saved thanks to high quality ICU treatment. regarding the last phase, after intensive care, there are real questions, and pulmonologists will take care of that, for how to detect pulmonary fibrosis pulmonary fibrosis happened with people treated in ICU who have had this terrible inflammatory reaction, but also in other situations, which pose a real question for the future.

Coronavirus: The End of the Crisis?

Treatment Summary

The utilization of Hydroxychloroquine (HCQ) and Azithromycin (AZ) as a treatment for the coronavirus (COVID-19) is the subject of a study from the south of France issued March 18, 2020.[7] We understand that this study will be published in the International Journal of Antimicrobial Agents.[8] A copy of the study is attached. The study was performed under the direction of Didier Raoult, MD, PhD and Philippe Gautret, MD, PhD, both widely recognized infectious disease specialists.

In this study, HCQ and AZ were utilized to treat COVID-19 patients. The study involved 36 patients, which included 16 patients in a control group. The results showed patients prescribed both drugs were 100% virologically cured of COVID-19 within six (6) days. Patients that were not treated (control group) did not show significant improvement. As the authors of this study explained, “our study has some limitations including a small sample size…”. There were 20 patients that were treated: six (6) patients treated with HCQ and AZ, that resulted in the 100% virological cure and 12 patients treated with only HCQ, that showed substantial improvement but not as significant as when both drugs were used. Obviously, this is a small group, but the results appear promising. The authors ultimately “recommend that COVID-19 patients use [HCQ and AZ] to cure their infection and to limit the transmission of the virus...”.

Interestingly, the authors state these compounds could be useful “to prevent the transmission of the virus, especially for healthcare workers.” This raises the prospect for a preventative therapy. Didier Raoult MD, PhD and his team stated that, “[w]e think that it is not moral that this ... is not systematically included in the therapeutic trials concerning the treatment of Covid-19 infection ...”.[9] Additionally, Didier Raoult, MD, PhD and Philippe Gautret, MD, PhD have suggested that:

(1) individuals without symptoms who test positive for COVID-19 should be treated promptly with HCQ and AZ to limit or avoid symptoms and reduce the spread of infection,

(2) if the symptoms have already resulted in significant respiratory issues, such as permanent lung damage, it is unlikely HCQ and AZ would be able to reverse this damage, and

(3) it is important to test everyone as soon as possible, especially high-risk healthcare workers, and treat immediately before symptoms arise.[10]

Such a strategy would require increased tracking and testing for COVID-19. We understand that in China, and perhaps in South Korea, cell phones were used to trace people who were in recent contact with COVID-19 patients as a means to ensure thorough tracking and containment of the virus.

There is anecdotal information suggesting HCQ is currently part of the protocol for treating COVID-19 patients in South Korea and China and that hospitals in the United States are using HCQ for the treatment of COVID-19 patients. Daniel Dae Kim, a well-known actor from South Korea, recently shared his COVID-19 experience on social media, including his use of HCQ and AZ as treatment.

Based on the treatment procedure in the study described above and guidance compiled from hospitals like the University of Washington in Seattle[11], the following is a summary of treatment procedures (please consider that we are attorneys, not medical professionals, and are reporting from medical authorities):

Perform baseline EKG and address any cardiology risks and monitor EKG throughout entire treatment period[12] Determine patient allergies or potential for adverse reactions and contraindications to both drugs Administer 200 milligrams of Hydroxychloroquine sulfate, three (3) times per day (a total of 600 milligrams per day) for ten (10) days[13] Administer Azithromycin at 500 milligrams on day 1, followed by 250 milligrams per day for four (4) days[14]

Treatment Safety

HCQ has been widely available and used in medicine since 1955.[15] The primary approved uses of HCQ are for treatment of malaria, lupus and rheumatoid arthritis.[16] The safety profile of HCQ has become established over decades of learning and understanding the risks and side effects associated with its use alone and in combination with other drugs.

Similarly, AZ has a safety profile that has been established since its use beginning in 1991.[17] The most commonly known use of AZ is Zithromax or Z-Pak, which is approved for use to treat acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis and genital ulcer disease.[18]

Having a thorough understanding of the safety profiles of both of these drugs is crucial to the acceptance of their use as a potential treatment of COVID-19. Fortunately, we have decades of studies demonstrating the safety of these drugs, including one such study which states “[b]oth azithromycin and chloroquine have been safely administered individually in all trimesters of pregnancy.” The report concludes that “[t]he combination may be safely administered any time during pregnancy…”.[19] While these studies use chloroquine, rather than HCQ, it is understood that HCQ has a better safety profile than chloroquine.[20]

Legal Implications for Use of HCQ and AZ as Off-Label Drugs

In addition to the approval and marketing of prescription drugs in the United States, the Food and Drug Administration (FDA) also oversees labeling. All prescription drugs available in the United States today have their own FDA-approved label which contains important information including, among many others, the approved uses of the drug. When a medical practitioner prescribes the drug for a use that is not specified on the FDA-approved label it is considered an "off-label” use.

Currently, there is no authority limiting medical practitioners from prescribing off-label prescription drugs. The Agency for Healthcare and Research Quality, the lead Federal agency charged with improving the safety and quality of America's health care system, states that as many as one in five prescriptions written today are for an off-label use and that the practice is “legal and common.”[21] Indeed, the FDA website currently states, “[f]rom the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”[22]

A doctor’s need to prescribe drugs off-label stems from science and medicine moving faster than the FDA’s bureaucracy and regulation. The pace of medical discovery invariably runs far ahead of FDA’s regulatory machinery, and off-label use is frequently state-of-the-art treatment.[23] The editor of the Journal of the American Medical Association testified before Congress that for a product to have the most effective potential benefits, law and regulation should and must follow, not precede, science. There are too many variations in clinical circumstances and too much time delay in regulations to allow the government to impede the physician’s ability to practice in these regards when it is medically appropriate.[24]

While drug manufacturers are aware of the prevalence of off-label uses, many may lack an incentive to get approval for the off-label uses due to the expensive and lengthy FDA-approval process. With drugs that have been approved for as long as HCQ and AZ, there is little economic benefit for manufacturers to obtain FDA approval. This concept may also explain the wide use and acceptance of prescribing off-label drugs.

Despite a seemingly wide-spread use of off-label prescription drugs, medical practitioners should be confident they can be protected from potential malpractice claims. The law prescribes a number of ways a medical practitioner may seek to substantially reduce potential liability associated with prescribing off-label use prescription drugs.

Informed Consent in New York State

It is essential that a medical practitioner disclose to a patient the alternatives, risks and benefits associated with a particular treatment prior to administering such treatment. When a patient agrees to treatment, it is considered “informed consent.” The lack of informed consent can cause serious issues for a medical practitioner. New York Public Health Law § 2805-D addresses informed consent.[25] Below is a summary of New York Public Health Law § 2805-D in relevant part. A complete version of the statute is attached.

A medical practitioner must obtain informed consent in those cases involving either (a) non-emergency treatment, procedure or surgery, and (b) a diagnostic procedure which involved invasion or disruption of the integrity of the body.[26] A medical practitioner’s failure to obtain informed consent from a patient in these situations can lead to malpractice liability.

For medical practitioners, it shall be a defense to any malpractice action based upon an alleged failure to obtain such an informed consent that: (i) the patient assured the medical practitioner he/she would undergo the treatment regardless of the risk involved, or the patient assured the medical practitioner that he/she did not want to be informed of the matters to which he would be entitled to be informed; or (ii) consent by or on behalf of the patient was not reasonably possible.[27] Notably, under New York law, a medical practitioner likely need not obtain informed consent in an emergency. [28]

Thus, prior to prescribing HCQ and AZ, or any off-label use medication, medical practitioners should be certain that their patients are fully informed of the risks associated with the proposed treatment. Medical practitioners can prove informed consent was obtained prior to the administration of an off-label treatment in the following ways:

Provide the patient with ample written literature on the drugs in a format that can be easily read and comprehended by the patient. Written literature should be available in a variety of languages. Have the patient provide an ink signature on a form wherein the patient acknowledges that the use of HCQ and AZ in the treatment of COVID-19 is an off-label use and states that the patient fully understands the procedure, as well as, the potential for risks, benefits, side effects and alternatives (including no treatment) associated with the treatment and authorizes the medical practitioner to proceed with such treatment. The form itself should stat the treatment procedure, as well as, the potential for risks, benefits, side effects and alternatives specific to the individual patent. Have the treating medical practitioner engage in an oral conversation with the patient about the treatment wherein the potential risks, benefits, side effects and alternatives are thoroughly explained to the patient in a manner that is simple enough for the patient to understand. Also, allow the patient to: (1) ask questions to his/her satisfaction and (2) confer with family advisors, if desired. Medical practitioners should seek to have a witness present during this discussion, as well as, a translator if necessary.

Assumption of Risk Defense in New York State

New York law recognizes assumption of risk defense in negligence tort liability actions. This can also be applicable in a malpractice case. Assumption of risk can be expressed or implied. The New York Court of Appeals stated that, “[e]xpress assumption, which was held to preclude any recovery, resulted from agreement in advance that [medical practitioner] need not use reasonable care for the benefit of [patient] and would not be liable for the consequence of conduct that would otherwise be negligent.”[29] “Implied assumption was founded not on express contract, but on plaintiff's voluntarily encountering the risk of harm from defendant's conduct with full understanding of the possible harm to himself or herself.”[30]

The Court of Appeals for the Second Circuit has stated, “[e]xpress assumption of risk is a total bar to recovery.”[31] Quoting an earlier Second Circuit decision, the Court states, “[i]n Schneider, we stated that "[w]hile a patient should be encouraged to exercise care for his own safety, we believe that an informed decision to avoid surgery and conventional chemotherapy is within the patient's right `to determine what shall be done with his own body.'" 817 F.2d at 995 (citations omitted). This conclusion led us to hold that a patient may expressly assume the risk of malpractice and dissolve the physician's duty to treat a patient according to the medical community's accepted standards.”[32]

The bottom line is that “[t]he standard for proving negligence in a malpractice case is whether the treatment deviates from accepted medical standards.”[33] However, even when deviating from accepted medical standards, medical practitioners can substantially limit or potentially eliminate their liability. Thus, is it critical that medical practitioners use discretion in their decision to administer HCL and AZ and as to the sufficiency of their disclosure and informed consent practices with their patients. This practice should be applied to the prescription of all off-label uses of drugs.

Conclusion

As we continue into this unchartered territory that is COVID-19, we are hopeful that medical practitioners can rest assured of the legal protections in place that are associated with the prescription of an off-label drug use. Medical practitioners should use their discretion on a case by case basis, but the objective is that they should not feel inhibited by what might be considered an off-label use stigma. These unprecedented times call for unprecedented actions, but we must still be logical and rational in our actions.

Please do not regard this paper as medical or legal advice. The authors of this article are not medical practitioners. Appropriate legal and medical professionals should be consulted for each specific situation.

Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020 FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine.