Does FDA&#39;s &quot;compassionate use&quot; program allow doctors to prescribe drugs to themselves under Emergency Use? Does the &quot;compassionate use&quot; program allow doctors to prescribe drugs for themselves that have been approved under an FDA emergency use authorization?
TL;DR: Most likely, for certain drugs. Self-prescribing was never illegal under Federal Law; it is regulated to varying degrees by the states, and discouraged by professional organizations like the American Medical Association. Pharmacists can refuse to fill prescriptions they are uncomfortable filling, and many will not fill self-prescriptions. It's not clear if, as originally written, this question is referring to the FDA's Expanded Access Program, which was created under FDA's regulatory authority (ergo it is not a law) and is colloquially called compassionate use; or the Right to Try Act, which was signed into law by President Trump in 2018. I am going to take a few moments to give an overview of both and then get to the question of self-prescribing. Expanded Access has been around for about 30 years, when it began as a way to make experimental HIV drugs available to patients during the HIV/AIDS epidemic. It has been used since them to make drugs available for a variety of diseases (like cancer), and most recently for COVID-19. The Right to Try Act is similar in that it makes experimental drugs available to patients before they have received full regulatory approval. The mechanism for that availability is a different, and it has since it is a law it has the explicit approval of Congress. Here are a journal article and a very good table breaking down the differences between Right to Try and Expanded Access. Neither of these modify the patient/doctor relationship, so they do not effect whether a prescriber can write their own prescriptions either way. A doctor could probably prescribe COVID-19-related treatments for themselves approved for widespread use under Expanded Access; they would likely be unable to self-prescribe other more medically-complex, higher-risk treatments like chemotherapy. See below. Self-prescribing is legal under federal law. As noted by the Emergency Care Research Institute: Under federal law, physicians in the United States are not prohibited from self-prescribing medications. State laws governing physicians, however, vary greatly, and some may prohibit physicians from prescribing, dispensing, or administering certain medications to themselves or family members. Restrictions vary by state. Most (perhaps all) states prohibit a prescriber from self-prescribing Schedule II controlled substances, with some providing an exception for an emergency. Many prohibit prescribing of Schedule II drugs to family members. I have found several sources that claim some states outright prohibit self-prescribing, but whenever I follow those back to the actual statute they only apply to Schedule II drugs. Professional organizations like the American Medical Association strongly discourage their members self-prescribing, stating in their Code of Ethics that &quot;treating oneself or a member of one's own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.&quot; The greatest barrier to self-prescribing lies at the pharmacy, where pharmacists are able to refuse prescriptions when they question the medical necessity or standard of care that lead to the prescription.
No. HIPAA places no limits on who you may share your medical records with - only on those with who your doctors (et al) can share. The HIV laws you refer to, place a positive obligation on you to share the information.
We can look at Missouri law as an example. Missouri Statutes §577.029 says A licensed physician, registered nurse, phlebotomist, or trained medical technician, acting at the request and direction of the law enforcement officer under section 577.020, shall, with the consent of the patient or a warrant issued by a court of competent jurisdiction, withdraw blood for the purpose of determining the alcohol content of the blood, unless such medical personnel, in his or her good faith medical judgment, believes such procedure would endanger the life or health of the person in custody. Blood may be withdrawn only by such medical personnel, but such restriction shall not apply to the taking of a breath test, a saliva specimen, or a urine specimen. In withdrawing blood for the purpose of determining the alcohol content thereof, only a previously unused and sterile needle and sterile vessel shall be utilized and the withdrawal shall otherwise be in strict accord with accepted medical practices. Upon the request of the person who is tested, full information concerning the test taken at the direction of the law enforcement officer shall be made available to him or her. &quot;Shall&quot; means &quot;must&quot; – if there is a warrant (we assume there is no consent). Then the question is, what happens if the phlebotomist (etc) refuses? First, §577.031 immunizes the medical-person from legal liability when they act in compliance with a request from a LEO (a simple request, not necessarily accompanied by a warrant). §577.033 says that being dead, unconscious or otherwise incapable of refusing does not constitute withdrawal of consent (which is implied, by law). No specific penalty is prescribed for refusal to administer a court-ordered blood draw. There is no penalty for complying, there is no prescribed criminal penalty for refusing to comply with a court order (there is the possibility of a finding of contempt of court). Not every state is Missouri: I understand that Utah is different.
Yes, it’s legal Homeopathic “medicines” contain no active ingredients so they are effectively placebos. Placebo work for some patients some of the time but they don’t work if the patient knows what they are. For them to be effective they have to be kept secret. Most doctors from time-to-time and for various reasons prescribe placebos. The ethics of this practice is debatable but the legality isn’t - it’s totally legal.
The other answers have addressed the letter of the question you asked, but I wanted to correct a misconception in your question statement: ... It's bad enough to suffer some horrible side effect, but not even being able to seek compensation is just the last straw. Note that under the PREP Act, you can seek compensation from the government if you are injured by a covered vaccine, including (at this time) a COVID-19 vaccine: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration. The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures. The PREP Act declaration for medical countermeasures against COVID-19 states that the covered countermeasures are: any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured: a. to diagnose, mitigate, prevent, treat, or cure COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or b. to limit the harm that COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom, might otherwise cause; So it is incorrect to say that you would be unable to seek compensation if you were injured by Pfizer's COVID-19 vaccine. You would just have to seek compensation from the government rather than suing Pfizer. As noted in the other answers, this protection under the PREP Act will lapse by October 1, 2024. However, it is also entirely plausible that this vaccine will be recommended on a regular basis going forward, in which case it would end up being covered by the National Vaccine Injury Compensation Program instead. This program is designed to protect manufacturers of vaccines that are routinely administered to children and pregnant women, the idea being that the threat of costly lawsuits might otherwise dissuade manufacturers from making such vaccines. Your seasonal flu shot, for example, is covered under this program; if you sustained an injury from that shot, you would be able to file a claim for benefits under this program. If we end up in a situation where COVID-19 vaccines are required regularly for most people (which seems entirely plausible at this point), then I would wager that they would end up being folded into this program.
In this statement of &quot;Patient Rights &amp; Responsibilities from Nash UNC it is said that: A patient has the right to know the names and the jobs of his or her caregivers. But I do not find any actual law that establishes such a right. Hospitals usually have a policy that doctors and other caregivers must wear name-tags and identify themselves to patients, but that does not necessarily apply to questions after the fact, nor can I be sure that any law mandates such a policy.
tl;dr Spouse before adult child. Patient’s designated surrogate, and court appointed guardian, before both. Assuming your mom does not have an advanced directive or has not designated a proxy, then her husband would come before you. He can ask whoever he wants and in fact he should get the information he can to determine what she would want. The standard is what the decision maker believes the patient would want, not necessarily what the decision maker wants. For example, if the patient has for as long as anyone can remember said repeatedly “I’m not dying hooked up to machines- when the time comes, let me go.” And the next of kin is of the “try whatever is possible to try” mindset, they should still go with what they believe the patient wants. This can be very hard in real life. In Florida, the decision to withhold (e.g. DNR) or withdraw must be with evidence that that is what the patient would want or is in her best interests. You may recall this coming up in the Terry Schiavo case- husband (who was also court appointed guardian) takes precedence over parents, but parents challenged his decision in court. Florida law laws out the order: 765.401 The proxy.— (1) If an incapacitated or developmentally disabled patient has not executed an advance directive, or designated a surrogate to execute an advance directive, or the designated or alternate surrogate is no longer available to make health care decisions, health care decisions may be made for the patient by any of the following individuals, in the following order of priority, if no individual in a prior class is reasonably available, willing, or competent to act: (a) The judicially appointed guardian of the patient or the guardian advocate of the person having a developmental disability as defined in s. 393.063, who has been authorized to consent to medical treatment, if such guardian has previously been appointed; however, this paragraph shall not be construed to require such appointment before a treatment decision can be made under this subsection; (b) The patient’s spouse; (c) An adult child of the patient, or if the patient has more than one adult child, a majority of the adult children who are reasonably available for consultation; (d) A parent of the patient; (e) The adult sibling of the patient or, if the patient has more than one sibling, a majority of the adult siblings who are reasonably available for consultation; (f) An adult relative of the patient who has exhibited special care and concern for the patient and who has maintained regular contact with the patient and who is familiar with the patient’s activities, health, and religious or moral beliefs; or (g) A close friend of the patient. (h) A clinical social worker licensed pursuant to chapter 491, or who is a graduate of a court-approved guardianship program. Such a proxy must be selected by the provider’s bioethics committee and must not be employed by the provider. If the provider does not have a bioethics committee, then such a proxy may be chosen through an arrangement with the bioethics committee of another provider. The proxy will be notified that, upon request, the provider shall make available a second physician, not involved in the patient’s care to assist the proxy in evaluating treatment. Decisions to withhold or withdraw life-prolonging procedures will be reviewed by the facility’s bioethics committee. Documentation of efforts to locate proxies from prior classes must be recorded in the patient record. (2) Any health care decision made under this part must be based on the proxy’s informed consent and on the decision the proxy reasonably believes the patient would have made under the circumstances. If there is no indication of what the patient would have chosen, the proxy may consider the patient’s best interest in deciding that proposed treatments are to be withheld or that treatments currently in effect are to be withdrawn. (3) Before exercising the incapacitated patient’s rights to select or decline health care, the proxy must comply with the provisions of ss. 765.205 and 765.305, except that a proxy’s decision to withhold or withdraw life-prolonging procedures must be supported by clear and convincing evidence that the decision would have been the one the patient would have chosen had the patient been competent or, if there is no indication of what the patient would have chosen, that the decision is in the patient’s best interest.
You get a lab to test it You should clearly document the chain of custody (ideally with photos) from the unopened packaging to the lab. Any decent sized city will have several labs with the capability to tell you what’s in a pill and provide an expert report.