Better Healthcare: The Role of Post Market Surveillance - Essay Sample

Introduction

Health remains one of the critical needs of humans on earth. Achieving better healthcare has been among the goals and objectives of nations and the world in general. In essence, affordable and better healthcare to the people is one way of development progress and improvement in terms of standards of living. Post Market Surveillance refers to the monitoring of drugs in the market in terms of their performance after they have been released for the first time (Azuma, 2015).

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The discovery of regenerate medicine in recently has raised both public and private interests. Individuals have been more concerned about the ability of the drugs to offer medication to different types of treatment on the patient's body. On the other hand, investors in the market have seen this an opportunity to maximize on by increasing high production that will meet the existing and rising demand in the industry (Azuma, 2015). Besides, there are a number of bodies that deal with the production and supply of the drug, yet they have not been tested in terms of market safety. This poses a threat to the end consumer of the product and thus, raises many questions on the roles of PMS on stem cells for regenerative medicine.

Background of the Problem

Regenerative medicine refers to an area of research that entails the application of mechanisms in biology to restore, repair, and maintain the functioning of tissues in the human body. The cell-based therapies need to be passed through several tests to ascertain the approved therapies that are safe for patients in the market (Azuma, & Yamanaka, 2016). Once the process has been investigated and approved by the regulatory bodies in the market like Health Canada, the European Medicine Agency (EMA), and US Food and Drug Administration (FDA), the therapies can be legally offered to patients in the market because of assurance of safety and quality of services in the market.

Currently, most markets around the world are being faced with the problem of quality health services that pose a higher risk to the patient. In most cases, patients are not aware of the dangers that they are exposed to, and thus, the presence of regulatory bodies will help keep surveillance on the market (Azuma & Yamanaka, 2016). In recent years, several unapproved cell-based therapies have been conducted on patients who have mainly been initiated by private clinics. This had increased several risks that patients were exposed to, leading to various complications. This is an existing problem in the market considering that the unapproved therapies and not regulated nor approved, leading to loss of high cash flow and putting patients at more significant risks (Griffin et al., 2013).

Besides, the marketing of these unproven therapies tends to create a broader gap in achieving various treatments associated with several diseases. In most cases, patients tend to keep on developing repeated infections because of the development of repeated conditions related to poor and low-quality treatment that has not been approved (Azuma & Yamanaka, 2016). Therefore, the safety of the patient remains a problem that needs to be looked upon by the government and other independent bodies that are concerned more about the health of citizens. In addition, the level of education in this field is quite lower, thus creating a knowledge gap on health practitioners to enable them to deliver quality services to patients. Also, there is a need to understand that traditional methods of regulating the market are now outshined calling for a replacement with new methods that will address unique safety, quality, and restore efficiency on regenerative medicine.

Ethical, Legal, and Social Issues

Ethical considerations refer to the moral standards in the market that producers are expected to consider when manufacturing their products for the interests of the customers. A business needs to observe ethical considerations in a number of aspects that range from prices and quality, among many other factors. Transparency and quality are some of the things that need to be considered ethically in the market (Caplan & West, 2014). The prevalence of low-quality products in the market is usually as a result of the lack of ethics in these companies and clinics offering the products and services. There is a need for clinics to consider offering clients the correct information and consent to ensure that they can make the right choices for their treatment. An organization or business that observes ethics can build trust in their customers because of their honesty practices. The entity is likely to benefit due to customer loyalty that is as a result of the company ethics. In brief, the importance of ethics cannot be undermined because of how it influences honesty between the parties in communication.

On the other hand, the use of ethics enhances the accuracy of the information that is delivered to the public. Accuracy is essential in technical communication because it helps the public gain the essential information that they might be in need. Also, it reduces the chances of the public being cheated on some aspects of the company. The ethical plan is essential because it is a way that we can use as an individual to stay in a morally upright manner. This usually acts as a guideline between what is right and what is wrong (Caplan & West, 2014). An ethical plan aids in the decision-making process. Decisions might be tricky at times and in this case, ethics play a role in informing the decision-maker what is right or wrong. Therefore, it is essential to observe moral ethics in life. Also, speaking out at times might be challenging, considering that it might be difficult to express views at times. Therefore, ethics are essential, and we need to learn more and understand how to maintain and observe moral, ethical standards.

On the other hand, observing the legal requirements set by the regulatory bodies remains a challenge as some organization is still being found guilty of various offences (Caplan & West, 2014). The increased number of deaths among patients in the past has been the core pillar for adjustment of legislation rules to prevent their welfare. One of the main objectives that need to be achieved in this area of research is to come up with the best therapy that will be authorized in the market and offered to patients as a better treatment in the future years to come (Caplan & West, 2014). Registration of any business offering the services in the market will help in streamlining the market and making it possible to achieve a better health environment for patients in the future years. However, with several limitations in the field of health that range to low facilities making it difficult in doing away with the unauthorized facilities.

Besides, ethics can be challenged, as well. This implies that in the life that we live at times, we might fail to adhere to the moral ethics. Ethics are fundamental in life because they ensure that we can tend to inform us of how we are expected to lead our lives. When ethics are challenged, we find that our voices might not be heard since we end up feeling inferior to others, making it difficult to express ourselves. Having a voice to speak out is essential in the sense that addressing oneself views will be more comfortable and this usually reduces the level of intimidation from others as well (Caplan & West, 2014).

On the other hand, I will focus heard to ensure that I can maintain qualities of having an excellent voice to speak out loud whenever I feel oppressed or even when I feel that at some point, I am not observing the best morals. Therefore, my goal is to maintain good ethics and ensuring that I can establish the challenges that I am facing in a bid to ensure that I can observe the morals of life. This is likely to change my thinking perspective and more so how I handle my affairs and deal with different situations.

Regulatory Framework

Regulations in the market refer to the measures that are put in place to ensure that the market operates in the best way without any party rights being violated.

• Limitations and Barriers (2 pages)
• Potential Benefits Associated with Stem Cell for Regenerative Medicine (2 pages)
• Threats Associated with Stem Cell for Regenerative Medicine (2 pages)
• Findings of the Study (3 pages)
• The solution to the problem (2 pages)
• Conclusion (1 page)
• Recommendations (2 pages)

References

Azuma, K. (2015). The regulatory landscape of regenerative medicine in Japan. Current Stem Cell Reports, 1(2), 118-128.

Azuma, K., & Yamanaka, S. (2016). New policies that support the clinical application of inducedpluripotent stem cell-based regenerative therapies. Regenerative Therapy, 4, 36-47.

Caplan, A. I., & West, M. D. (2014). Progressive approval: a proposal for a new regulatorypathway for regenerative medicine. Stem cells translational medicine, 3(5), 560-563.

Griffin, M. D., Elliman, S. J., Cahill, E., English, K., Ceredig, R., & Ritter, T. (2013). Concise review: adult mesenchymal stromal cell therapy for inflammatory diseases: how well arewe joining the dots?. Stem Cells, 31(10), 2033-2041.

McArdle, A., Senarath-Yapa, K., Walmsley, G. G., Hu, M., Atashroo, D. A., Tevlin, R., ... & Longaker, M. T. (2014). The role of stem cells in aesthetic surgery: fact or fiction?. Plastic and reconstructive surgery, 134(2), 193.