PHI FPX 3200 Assessment 2 Right to Experimental Drugs

PHI FPX 3200 Assessment 2

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Right to Experimental Drugs

The right to experimental drugs is also a topic of debate and people for the idea and against it have shared their views. To allow people who have done all that they can to get well and perhaps to help give them hope is the reason why they should be allowed to try new medicines that have not been used before. However, there are some concerns that some people may have towards the safety, effectiveness, and ethical concerns that may arise from the use of treatments that have not received approval from large trials (Bunnik, 2019). When discussing this topic, one has to consider the advantages and the disadvantages of the new drugs that have been developed. PHI FPX 3200 Assessment 2 patients must know and comprehend all the benefits, probabilities, and possibilities of the treatments they are going to undergo in order to give their approval. Other organizations such as Federal Drug Administration play a very significant role in ensuring that medicines that are out on the market are safe and effective (FDA, 2019). But the proponents argue that over-caution would render many patients helpless and unable to access efficient drugs while the opponents argue that the approval processes are necessary to safeguard the patients. The right to experimental drugs is an important and very diverse issue that requires a very careful consideration and discussion in ethical terms.

PHI FPX 3200 Assessment 2 Ethical Theories and Moral Principles

Ethical principles and moral theories are very crucial in the healthcare field because they assist individuals in identifying and finding solutions to issues. The theory that has been widely applied in health care is the ethical theory known as utilitarianism. It state that actions must be measured by their consequences and aim at bringing happiness or health to as many people as can be reached (Vearrier, 2021). On the other hand, deontological ethics state that the action should be evaluated on the basis of Duty, that is, the extent to which the action fulfills duties regardless of the consequences. At the core of virtue ethics, there is the focus on the development of certain character traits, whereby an action is evaluated based on how it corresponds to these character traits (Mathúna et al., 2020). Apart from the above ethical theories, there are other sets of ethical principles that are generally applied in the health care system. It entails the freedom that a patient has to decide on his or her health care. There is the principle of beneficence that requires healthcare workers to do what is best for their patients. People believe that nurses and doctors should protect their patients from harm that can be caused to them. Equity means that all individuals are provided with equal amounts of healthcare services and funds (Nandifa et al. , 2020).

 These are the moral theories and ethical theories that should be applied in the current scenario when it comes to healthcare issues such as medical confidentiality, patient autonomy, the right to die, and the usage of new drugs in the market. For instance, in a case whereby a doctor administers unapproved experimental drugs to patients, the principles of utilitarianism may evaluate the outcome of the drug to the patient as well as the rest of society while deontological ethics will consider the importance of respecting the patient’s right to make decisions concerning their bodies (Tseng, 2021). Virtue ethics might probably consider how to act kindly and sensitively to the patient in the process of decision-making. With the help of PHI FPX 3200 Assessment 2 ethical theories and moral principles, it is possible to make decisions and act in the proper and ethical manner in the sphere of healthcare.

Principle of Informed Consent

The informed consent is quite crucial, especially for experimental drugs in light of the fact that they are yet to be approved for use by everyone. It is important to note that prior to a patient or a subject being enrolled in a medical treatment or a research study, the former is made aware of the possible advantages and disadvantages he or she may experience. This is termed as ‘informed consent’. As explained by Dankar and his colleagues (2019), informed consent is even more crucial in experimental drugs because the trial participants are exposed to more risks than they would have been exposed to if they were taking standard medications.

 Such people must be aware of all the aspects of the drug that is being used in the clinical trials such as what the drug is, how it is administered, and what effects it can cause. The participants must also be informed about other forms of treatment that can benefit them and the consequences of not participating in the study. PHI FPX 3200 Assessment 2 means that patients have to be in a position to understand the information that is being communicated to them regarding new drugs and be able to make a decision on the same in order to give informed consent. It is for this reason that those who are to be involved in the trial should do so willingly and not under any pressure or influence and they should also have the freedom of withdrawing from the trial at any time during the trial (Varkey, 2021). In conclusion, informed consent is a very vital ethical consideration when it comes to the use of people in medical research particularly when testing new drugs. It ensures that those who participate in the treatment are well informed on the consequences of the treatment and whether they want to undergo the treatment or not.

Costs and Benefits of Unapproved Experimental Drugs

The issue of providing people with new drugs that are not yet approved by the FDA is a rather cumbersome and highly debated topic with arguments and reasons for and against. Those who are in support of the sale of drugs that have not been approved by the FDA state that it will give patients who have hopelessly sought for a cure a way of getting a possibly life-saving treatment option. It can also act as a motivation and assist the medical field in gaining more knowledge in the process (Feustel et al., 2019). Besides, it can assist people in getting care sooner, which is beneficial for those who cannot afford to go through the clearance process. However, this kind of business has many dangers and one of them is selling drugs that have not been approved. The drugs have not been tested a lot so it could have some serious adverse effects and may even be lethal. Also, new drugs are still being developed which may not necessarily be effective, and this means that people are offered treatment that may not help them. Also, the selling of drugs that have not been authorized by the FDA brings into question the treatment’s safety and efficacy and the patient’s right to information on the same (Madeddu et al. , 2021). The providers of medical care, the drug companies and all those who are involved in the sale of drugs that have not been approved could also be sued.

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PHI FPX 3200 Assessment 2 Unapproved Drugs

 This problem has many aspects and there are so many opinions about this problem and all of them are opposite. Others have pointed out that patients should be allowed to receive unapproved drugs to enable them receive treatment that may help them. Some people have noted that before unapproved drugs are administered to patient, they should not be released into the market until they are proven to be safe and effective. Finally, it is argued that whether to give out the prohibited substances should be done with consideration on individual cases, the evidence that is available and the advice of medical practitioners (Bendicksen et al., 2022).

PHI FPX 3200 Assessment 2

Pre-approved Drug Usage for a Wider Patient Pool

PHI FPX 3200 Assessment 2 Pre-approved drugs should be allowed to be used by more patients but this is a rather sensitive issue and there are those who are for and against the idea. The proponents of this approach argue that this method can assist the patients to improve or even get cured. People have noted that if a drug has been approved for one disease and has been demonstrated to be safe and effective, then people with similar diseases can benefit from it (White, 2022). This could, therefore, lead to the decentralization of treatment options, which in turn may reduce the cost of treatment and relieve the health care system. On the other hand, the opponents of the method fear that this may lead to over-medication of the patients and unnecessary harm. There are people who theorize that a drug may be safe and effective for one disease but not for another, and by administering it to more people it may produce adverse results (Heydari et al., 2020). They may also not get to know some aspects of the patient management such as other forms of management and alteration in the daily routines if they only use the drugs that have been approved.

PHI FPX 3200 Assessment 2 Pre-Approved Drug

 It is useful to know what happens when a pre-approved drug is administered to many patients, for instance, the impact on the health of patients, costs, and quality of care (Quaranta et al., 2022). However, there is also one more question that comes to mind – what does this imply from the ethical perspective? Health care decision-making refers to the freedom that people have to make their own decisions and health care providers are obliged to respect those decisions. However, there may be cases when it is not the best to generalize and give pre-approved drugs to more people this may cause an ethical dilemma (Borysowski, 2019). In conclusion, it is important that if one wishes to make the right decisions regarding the use of pre-approved drugs for numerous patients, the best and fair method should be employed which should have the patient’s safety and happiness in mind.

Conclusion

In conclusion PHI FPX 3200 Assessment 2, the right to experimental drugs is an interesting and rather multifaceted issue that requires one to delve deeper into the ethical aspects of the topic. There is a high need to apply such principles as informed consent in ethical frameworks for the solution of present-day problems in health care. It is an act of giving unapproved drugs which can be a life-saving measure but it is a very risky decision and has to be thought through thoroughly. Finally, the decision to provide medications that have not been approved should be made with the consideration of the benefits that may be gained and the risks that are likely to be encountered by the patient. Thus, it becomes the responsibility of the regulatory groups to come up with the right treatments that can work without causing harm.

References

Amrutkar, S. S., Patil, S. B., & Mundada, A. S. (2022). Abbreviated new drug submission approval process: An overview. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 174113432211460. https://doi.org/10.1177/17411343221146094

Bendicksen, L., Kesselheim, A. S., & Rome, B. N. (2022). The vexing voyage of vasopressin. Chest, 162(2), 433–435. https://doi.org/10.1016/j.chest.2022.02.048

Borysowski, J., & Górski, A. (2019). European Journal of Internal Medicine, 65, 12–16. https://doi.org/10.1016/j.ejim.2019.04.008

Bunnik, E. M., & Aarts, N. (2019). What do patients with unmet medical needs want? BMC Medical Ethics, 20(1). https://doi.org/10.1186/s12910-019-0420-8

Cohen, P. A., Avula, B., Wang, Y. H., Zakharevich, I., & Khan, I. (2020). Neurology: Clinical Practice. https://doi.org/10.1212/CPJ.0000000000000960

Dankar, F. K., Gergely, M., & Dankar, S. K. (2019). Informed consent in biomedical research. Computational and Structural Biotechnology Journal, 17, 463–474. https://doi.org/10.1016/j.csbj.2019.03.010

FDA. (2019). Drugs. Fda.gov. https://www.fda.gov/drugs

Feustel, A. C., MacPherson, A., Fergusson, D. A., Kieburtz, K., & Kimmelman, J. (2019). Neurology, 94(1), e1–e14. https://doi.org/10.1212/wnl.0000000000008699

Heydari, M., Mehraeen, M., & Joulaei, H. (2020). Shiraz E-Medical Journal, 21(9). https://doi.org/10.5812/semj.97662

Experimental drugs for chemotherapy- and cancer-related anemia. Journal of Experimental Pharmacology, Volume 13, 593–611. https://doi.org/10.2147/jep.s262349

Nandifa, V. N. P., Jena, Y., & Joewana, S. (2020). Beneficence is the highest moral imperative of a doctor dealing with the poor quality of patient autonomy. Jurnal Pendidikan Kedokteran Indonesia: The Indonesian Journal of Medical Education, 9(1), 44. https://doi.org/10.22146/jpki.44511

O’Mathúna, D. P., Escartín, C. P., Roche, P., & Marlowe, J. (2020). Engaging citizen translators in disasters. Translation and Interpreting Studies. https://doi.org/10.1075/tis.20003.oma

Quaranta, A., D’Isidoro, O., Piattelli, A., Hui, W. L., & Perrotti, V. (2022). Illegal drugs and periodontal conditions. Periodontology 2000, 90(1), 62–87. https://doi.org/10.1111/prd.12450

Tseng, P.-E., & Wang, Y.-H. (2021). Deontological or utilitarian? An eternal ethical dilemma in outbreak. International Journal of Environmental Research and Public Health, 18(16), 8565. https://doi.org/10.3390/ijerph18168565

Varkey, B. (2021). Medical Principles and Practice, 30(1), 17–28. https://doi.org/10.1159/000509119

Vearrier, L., & Henderson, C. M. (2021). HEC Forum, 33(1), 45–60. https://doi.org/10.1007/s10730-020-09431-7

White, C. M. (2022). Continued risk of dietary supplements adulterated with approved and unapproved drugs: Assessment of the US food and drug administration’s tainted supplements database 2007 through 2021. The Journal of Clinical Pharmacology, 62(8), 928–934. https://doi.org/10.1002/jcph.2046

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