DNP 840 Topic 3 DQ 2

How might health care leaders determine appropriate nursing and care delivery models to address rapidly changing populations?

Discuss two regulatory organizations that provide oversight within the health care delivery system. Contrast this with a country that does not have regulatory oversight of health care. What influence does the selected regulatory organization have on your DPI Project and patient outcomes?

The two regulatory organizations that provide oversight in health care delivery that would be discussed are the Food and Drug Administration (FDA) and the National Institute of Nursing Research. These two agencies like other regulatory organizations ensure quality and safety practices in healthcare delivery.

The FDA regulates and controls medications, biological and radiation products, food, and cosmetics made available to the public as the marketing approval of drug products in the U.S  through a rigorous review process to ensure the efficacy and safety of these products before reaching the patient’s use (McKee et al., 2010). Stern & Price (2020) added that the FDA regulatory exercise does not only ensure the safety and efficacy of medications and other health and biological products but ensures the efficacy of medical devices that incorporate software and the subset of those devices with machine learning (ML) capabilities such device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. The use of adequate and well-controlled investigation conducted by scientific well trained experienced experts with clinical investigative knowledge and experience as established in the 1938 Federal Food, Drug, and Cosmetic (FD&C) Act and amended in 1962 establishes a safety requirement by the FDA for new drugs. Inclusively, a sponsor must establish the effectiveness and safety of the product in well-controlled clinical trials in the patient population for which the drug/product is indicated (McKee et al., 2010).

The Nursing research acknowledged the strength and potential for uncovering new information for practice underpinning hence the need to increase scientific discoveries through nursing research that improve health outcomes for the populations that the nurses serve is paramount. Emphasis on nursing research in schools of nursing is essential (Cashion et al., 2016). NINR is a component of the National Institutes of Health and one of the 27 institutes at the National Institute of Health. They support clinical research to establish a scientific basis for the care of patients in general. The National Institute of Nursing Research (NINR) leads nursing research to solve pressing health challenges and inform practice and policy by optimizing health and advancing health equity into the future (National Institute of Health, n.d.).  These regulations are relaxed in most third-world countries. The issue of medication and drug policy control in most developing third-world countries is challenging. Drug and medication marketing may be found to be individualized or private for financial incentives. No stringent policy is attached to the distribution or marketing of medication making the market distribution porous and hard to control. Sometimes the medication is distributed and marketed label risking the lives of the consumers with no ownership or responsibility for adverse reactions.

Reference

Cashion, A. K., Gill, J., Hawes, R., Henderson, W. A., & Saligan, L. (2016). National Institutes of Health Symptom Science Model sheds light on patient symptoms. Nursing Outlook, 64(5), 499–506. https://doi.org/10.1016/j.outlook.2016.05.008

McKee, A. E., Farrell, A. T., Pazdur, R., & Woodcock, J. (2010). The role of the US Food and Drug Administration review process: clinical trial endpoints in oncology. The oncologist, 15(S1), 13-18.

National Institute of Health (n.d.). About National Institute of Nursing Research. Retrieved from https://www.ninr.nih.gov/aboutninr/who-we-are

Stern, A. D., & Price, W. N. (2020). Regulatory oversight, causal inference, and safe and effective health care machine learning. Biostatistics, 21(2), 363-367.

RESPOND HERE

It is true that the Food and Drug Administration (FDA) and the National Institute of Nursing Research are regulatory bodies in the healthcare sector. These two regulatory bodies have different roles and scope of practice. However, these two institutions are helpful in ensuring quality and safety practices in healthcare delivery (Lulijwa et al., 2020).FDA is mainly concerned with regulation and monitoring of controls medications, biological and radiation products, food, and cosmetics. This regulatory body has the mandate to ban food materials that are considered to be unfit for human consumption. Also, the organization inform and guide the public in case there is wrong medical and food materials in the market (Fauci et al., 2019). FDA follow different guidelines to either allow the material in the market or ban the commodity.  The U.S through a rigorous review process to ensure the efficacy and safety of these products before reaching the patient’s use. The National Institute of Nursing Research emphasizes on the important of research in nursing practice.

References

Fauci, A. S., Redfield, R. R., Sigounas, G., Weahkee, M. D., & Giroir, B. P. (2019). Ending the HIV epidemic: a plan for the United States. Jama, 321(9), 844-845. doi:10.1001/jama.2019.1343

Lulijwa, R., Rupia, E. J., & Alfaro, A. C. (2020). Antibiotic use in aquaculture, policies and regulation, health and environmental risks: a review of the top 15 major producers. Reviews in Aquaculture, 12(2), 640-663.  https://doi.org/10.1111/raq.12344

One healthcare regulatory organization in the United States is the Food and Drug Administration (FDA). The FDA protects public health by ensuring all drugs, biologics, and medical equipment are safe, secure and effective. The organization ensures the safety of cosmetics and food supply and regulates the production and distribution of tobacco products, radiation-emitting equipment, and veterinary products (FDA, n.d.). FDA helps speed up innovations to improve public health.

Another valuable regulatory authority is the Centers for Disease Control and Prevention (CDC), which protects public health through disease prevention and management. The CDC monitors and reports disease outbreaks and establishes measures minimize further spread (CDC, 2022). The organization creates and disseminates guidelines and recommendations for disease control, including treatment protocols and vaccination schedules. The CDC also ensures public laboratories meet quality standards and collaborates with FDA to regulate the production, importation, and utilization of biologics and medical equipment. Both FDA and the CDC have been instrumental in building public trust in the healthcare system, improving public health, ensuring health care is safe and of good quality. Even with its weaknesses, the U.S. healthcare system is better than many others, especially in the developing regions.

All countries have some form of regulatory authority for healthcare services. At the basic level, there is a health ministry tasked with formulating health policy and regulation, ensuring healthcare access, preventing and controlling communicable diseases, and conducting health-related research. Despite having a health ministry, insecurity, poor governance, and other disruptions, make it difficult to sustain quality healthcare regulation in a country like Somalia. According to the OHCHR (2022), healthcare access in Somalia is dangerously low. With only one hospital in the country’s capital, people are forced to seek services in private clinics that only a few afford. Compared to the United States, Somalia has less developed healthcare infrastructure, worse health outcomes, and limited access to medications. The situation could improve with the establishment of strong regulatory bodies.

References

CDC. (2022). Mission, role and pledge. https://www.cdc.gov/about/organization/mission.htm

FDA. (n.d.). What we do. https://www.fda.gov/about-fda/what-we-do

UHCHR. (2022). Somalia: UN expert warns health care standards “dangerously low”. https://www.ohchr.org/en/press-releases/2022/04/somalia-un-expert-warns-health-care-standards-dangerously-low

REPLY

it is true that the United States is the Food and Drug Administration (FDA) protect public health. The regulatory agencies examine all drugs, biologics, and medical equipment before their approval in the market and in healthcare facilities. However, this organization has detailed procedures of examining drugs, food materials and biologics (Dignam et al., 2019). The detailed routine ensures that the regulatory agency limits the entry of unwanted materials in the market. Similarly, FDA have experts in nutrition and healthcare matters. Therefore, the professional input helps in protecting the public health. The organization ensures the safety of cosmetics and food supply and regulates the production and distribution of tobacco products. Besides, some occasions may want the body to offer statement on matters within their jurisdiction (Shekhar et al., 2021). The Centers for Disease Control and Prevention (CDC) is another common regulatory authority. CDC partners with different players to accomplish their obligations. The regulatory agency protects public health through disease prevention and management.

References

Dignam, T., Kaufmann, R. B., LeStourgeon, L., & Brown, M. J. (2019). Control of lead sources in the United States, 1970-2017: public health progress and current challenges to eliminating lead exposure. Journal of public health management and practice: JPHMP, 25(Suppl 1 LEAD POISONING PREVENTION), S13. doi: 10.1097/PHH.0000000000000889

Shekhar, R., Sheikh, A. B., Upadhyay, S., Singh, M., Kottewar, S., Mir, H., … & Pal, S. (2021). COVID-19 vaccine acceptance among health care workers in the United States. Vaccines, 9(2), 119. https://doi.org/10.3390/vaccines9020119

According to the description by Jordana et al. (2018), the regulatory body is the executive part of the government with statutory authority to have oversight from a legislative point of view. They provide regulations and impose sanctions when the rules are infringed. Two of many regulatory bodies in the healthcare industry are Occupational Health and Safety Administration (OSHA) and Federal Drug Administration (FDA).  The OSHA forms an important phase in developing a new profession in tasks, education, training, certification, and regulation of its proponent across different countries. The OSHA Act was created in 1970 to ensure a safe and healthful work environment for workers, and they enforce standards by giving education, outreach, and assistance. Notably, OSHA programs could be conducted anywhere in the world. The international OSHA program enables workers outside the jurisdictions to access high-quality safety training within their jurisdiction. However, the benefits of the Department, when not available in certain countries such as Qatar, Kuwait Lebanon, to mention a few, become hazardous for workers in employment. In addition, those without the regulation of the FDA face challenges of adulterated drugs and food not fit for s consumption circulating the public, thereby bringing food and drug-borne diseases endemic to the population (Hale 2019). The FDA, on the other hand, according to Pazdur (2021), is involved in food and drug development and regulation to ensure the safety and efficacy of human biological products, veterinary, medical devices, s cosmetics, and food supply. They also monitor the effect of the products that emit radiation on the public’s health.

Another regulatory body in the health industry is Continuous professional development (CPD). This is a critical component in supporting high-quality patient care as newer models of data-driven healthcare delivery emerge. It is directed towards Integrating data-driven methodologies in the healthcare environment. This regulatory venture has been accelerated during COVID-19. There is a need for CPD practices to meet the requirements when self-assessing their performance. National CPD accreditation bodies and professional associations have moved towards integrating practice data in performance-based CPD, resulting in CPD strategic frameworks linking learning and practice data to enhance the quality of care. Physicians use data for clinical duties to help strengthen knowledge and patient outcomes (Wiljer et al., 2023). The CPD ensures the safety of data use and the privacy of patients. In countries without regulatory data services, there is a lack of transparency regarding how data is used. Poor data quality adds confusion and misrepresentations. There is no clarity and guidance on the purpose of data and to what extent these decisions affect care delivery. For example, clinicians are skeptical about whether sufficient resources and guidelines are available. The OSHA and FDA significantly influence my selected DPI since I will work on the clinic’s Human papillomavirus vaccine. The population must trust the approval of the Gardasil 9 shot and have proven evidence of its efficacy in preventing human papillomavirus infection in adulthood. It is, therefore, imperative to have researched the newest evidence-based literature articles with factual statistics to that effect.

Wiljer, David, Tavares, Walter, Charow, Rebecca, Williams, Spencer, Campbell, Craig, Davis, Dave, et al. (2023). A Qualitative Study to Understand the Cultural Factors That Influence Clinical Data Use for Continuing Professional Development. Journal of Continuing Education in the Health Professions, 43, 34-41. https://doi.org/10.1097/CEH.0000000000000423

Hale, A. (2019). From national to European frameworks for understanding the role of occupational health and safety (OHS) specialists. Safety science, 115, 435-445.

Jordana J, Fernández-i-Marín X, Bianculli A (2018). “Agency proliferation and the globalization of the regulatory state: Introducing a data set on the institutional features of regulatory agencies”. Regulation & Governance. 12 (4): 524–540. doi:10.1111/rego.12189. hdl:10230/46637.

Pazdur, R. (2021). FDA and Its Role in Drug Development. Journal of the Advanced Practitioner in Oncology, 12(3), 293.

RESPOND HERE

I consider these regulatory bodies as institutions established to maintain professionalism in the healthcare sector. The U.S. health sector has many regulatory agencies assigned different roles. However, collectively these regulatory organizations help healthcare facilities to improve on their service delivery. Most of regulatory bodies permitted to operate are recognized by the authority (Chen et al., 2020). Occupational Health and Safety Administration (OSHA) and Federal Drug Administration (FDA) are among regulatory agencies in the U.S.  The OSHA Act of 1970 played a significant role in the development of the regulatory body.  The OSHA forms an important phase in developing a new profession in tasks. Other same-minded healthcare players support the institution to attain its goals. FDA is a common regulatory agency that is in charge of examining biologics, medical supplies, cosmetics, and food materials before they are allowed in the market (Iglesias-Lopez et al., 2019). The organizations bar unfit commodities from accessing the market. FDA has professionals as members. These individuals use their competence to examine goods before entering the market.

References

Chen, J. A., Chung, W. J., Young, S. K., Tuttle, M. C., Collins, M. B., Darghouth, S. L., … & Huffman, J. C. (2020). COVID-19 and telepsychiatry: Early outpatient experiences and implications for the future. General hospital psychiatry, 66, 89-95. https://doi.org/10.1016/j.genhosppsych.2020.07.002

Iglesias-Lopez, C., Agustí, A., Obach, M., & Vallano, A. (2019). Regulatory framework for advanced therapy medicinal products in Europe and United States. Frontiers in pharmacology, 10, 921. https://doi.org/10.3389/fphar.2019.00921