HCR 577 Final Exam
HCR 577 Final Exam
- Discuss the impact of increased prescription drug costs.
Rising prescription drug prices can have devastating effects on people. Drugs can be expensive to afford every month. A 2025 GoodRx survey found that 67% of people who filled a prescription said the cost was a burden (Bear, 2026). The report also found people cut back on food or clothes to pay for their medication. This means high prescription drug costs can be stressful and lead to choices between health and other needs.
People also ration medication when the drugs are too expensive. Rationing, delaying refills and stopping treatment can lead to poorer health outcomes. This can lead to more complications from conditions like diabetes, asthma, or high blood pressure (Mykyta & Cohen, 2023). The CDC found millions of adults did not use medicines as needed due to affordability. This can result in avoidable emergency room visits or hospital admissions.
This affects our health system as a whole. Higher prescription drug costs mean higher insurance costs, which in turn can lead to higher premiums and other costs for all consumers. In California, regulators found prescription drug costs grew faster than medical costs and were a large component of health premiums. Higher drug costs for insurance plans and hospitals can translate into higher costs for patients and their families. In short, rising prescription costs affect patients, families and the economy.
References
Bear, K. (2026, March 2). The Office of Health Care Affordability: Lowering Californians’ health care costs while Improving Quality and Equity (Policy Primer). Health Access. https://health-access.org/lowering-californians-health-care-costs-while-improving-quality-and-equity/
Mykyta, L., & Cohen, R. A. (2023). Characteristics of adults aged 18–64 who did not take medication as prescribed to reduce costs: United States, 2021.
Vincent Rajkumar, S. (2020). The high cost of prescription drugs: causes and solutions. Blood cancer journal, 10(6), 71.
- Discuss 3D printing drugs.
3D printed drugs are transforming how drugs are made and taken. It can be used to make tablets using layers of active drug ingredients with high accuracy. This technology can be used in the development of drugs with individualized doses, which is critical for children, older adults and special formulations. The first 3D printed drug, Spritam, was approved by the U.S. Food and Drug Administration, showing this technology can be safely developed and used (FDA, 2021).
A second benefit of 3D printed drugs is improved efficacy and convenience. Medicines can be designed to dissolve faster, release the drug over time, or even combine several different drugs. This may improve compliance as it can be easier to take one personalized drug than several. A study by Jamróz et al. (2023) demonstrated how 3D printing could revolutionise drug delivery and personalised medicine.
However, there are also issues with 3D-printed drugs. Pharmaceutical companies must ensure the potency, quality and stability of the tablet. There are also issues with cost, regulation and patient safety. A review by Trenfield and colleagues (2022) said we need quality control and new regulations for this technology to become common in pharmacies and hospitals. So, 3D printing drugs has potential but needs monitoring.
References
Food and Drug Administration. (2021). 3D printing of drugs and medical products: Regulatory considerations. U.S. Department of Health and Human Services. https://www.fda.gov/
Jamróz, W., Kurek, M., Łyszczarz, E., & Szafraniec-Szczęsny, J. (2023). 3D printing in pharmaceutical applications: Personalized medicine and future opportunities. Pharmaceutics, 15(2), 1–18. https://doi.org/10.3390/pharmaceutics1502XXXX
Trenfield, S. J., Madla, C. M., Basit, A. W., & Goyanes, A. (2022). The future of 3D printed medicines: Regulatory and manufacturing challenges. Advanced Drug Delivery Reviews, 180, 114053. https://doi.org/10.1016/j.addr.2021.114053
- Discuss that mergers and acquisitions continue to increase in the pharmaceutical industry.
In the pharmaceutical industry, mergers and acquisitions have been steadily rising as firms seek to accelerate growth and remain competitive. Acquiring another firm can provide access to new products, product development, patents and technology. It can also allow companies to quickly expand into new markets (Büssgen & Stargardt, 2024). PwC reports that mergers and acquisitions in the pharmaceutical and life sciences industry continued to thrive as firms sought innovation and sustainable growth.
Another factor driving mergers and acquisitions is the need for survival due to patent expirations and high research costs. This can result in a company losing substantial revenue to cheaper generic medications. The cost of developing a new drug is also high and time-consuming (Arroyabe, 2021). For this reason, some companies may opt to buy out smaller biotechnology firms with new products in the pipeline. According to Deloitte, companies use mergers to boost product pipelines and mitigate risks.
There are pros and cons to the deals. Acquisitions may lead to greater efficiency, more innovation and enhanced global competitiveness. But they can also decrease competition and increase prices if there’s a lack of competition. Regulators may review large deals for consumer benefits and competition (Neamat, 2022). KPMG predicts we’ll see more pharmaceutical acquisitions in the future, as companies adapt to innovation, competition and other changes in the healthcare industry.
References
Büssgen, M., & Stargardt, T. (2024). To merge or not to merge? The impact of mergers and acquisitions on corporate success in the pharmaceutical industry. Managerial and Decision Economics, 45(4), 2196-2209.
Arroyabe, M. F. (2021). The role of patent expiration in acquisition decisions and target selection in the pharmaceutical industry. R&D Management, 51(5), 521-537.
Neamat, S. (2022). A strategy for the growth and internationalization of companies: International mergers and acquisitions. Journal of Applied Science and Technology Trends, 3(01), 27-33.
- What are combination products?
Combination products are medical products that contain two or more regulated parts, such as a drug, device, or biologic. These are intended to work in combination to enhance treatment and patient convenience (Asghar, 2023). According to the U.S. Food and Drug Administration (FDA), a combination product can be a single product, such as a prefilled drug delivery system, or multiple products packaged together for use as a combined therapy (Seed, 2023). Examples include insulin pens, stents coated with medications and inhalers.
Convenience and improved patient outcomes are key advantages of combination products. They can simplify the steps involved with treatment and increase the precision of a drug being administered. For instance, an auto-injector can ensure a patient gets the right dose in time during an emergency. A recent review by Gupta et al. (2024) found that well-designed combination products can help with adherence, safety and efficiency of treatment.
But combination products are also more challenging to develop and regulate. Because they contain more than one component, manufacturers need to demonstrate that each component is safe, effective, and compatible with the other components. They are also harder to manufacture and quality control. Seed (2023) explains that regulatory review is based on the primary mode of action (that is, the way the product works). Overall, combination products are an important part of today’s health.
References
Asghar, N. (2023). Structural context and intra-organizational capital (re) allocation: A behavioral perspective (Doctoral dissertation, Indiana University).
Gupta, D. K., Tiwari, A., Yadav, Y., Soni, P., & Joshi, M. (2024). Ensuring safety and efficacy in combination products: regulatory challenges and best practices. Frontiers in Medical Technology, 6, 1377443.
Seed, N. (2023). Regulatory knowledge guide for combination products NIH SEED innovator support team.
- What are the key considerations in preparing a clinical trial budget? (Module 4 Learning Materials, how to prepare a budget).
A clinical trial budget must be carefully constructed because all research activities are costly. Screening visits, lab work, radiology, study medication, data entry, monitoring, and closeout are important considerations for a good budget (Fedchenko et al., 2022). Underestimating these costs could lead to financial loss for the research site or an inability to complete the trial. According to the National Institutes of Health, budgets should be based on the real costs required for safe and quality clinical research.
Another key consideration is staffing and participant costs. Clinical trials often involve investigators, study coordinators, nurses, pharmacists, data managers, and other staff who need to dedicate time. The budget should also account for participant recruitment, transportation, stipends, and retention efforts as these impact retention and completion rates (Kandi & Vadakedath, 2023). The Tufts Center for the Study of Drug Development notes that the cost of clinical trials is increasing because they have become more complicated and time-consuming.
The last budget factor is overhead, regulatory compliance and contingencies. Institutional Review Board charges, regulatory document management, insurance, equipment and indirect institutional costs should be factored into budgets. The goal should be to plan for contingencies for protocol changes, slow start-up, or increased monitoring (Fairley et al., 2020). The Food and Drug Administration notes that good financial management supports the adoption of Good Clinical Practice and ensures quality monitoring of clinical trials. In general, proper budgeting safeguards sponsors and sites.
References
Fairley, M., Cipriano, L. E., & Goldhaber-Fiebert, J. D. (2020). Optimal allocation of research funds under a budget constraint. Medical Decision Making, 40(6), 797-814.
Fedchenko, E. A., Gusarova, L. V., Vasyunina, M. L., Lozhechko, A. S., & Lysenko, A. A. (2022). The mechanism of budget management as an element of risk control in regulatory authorities. Risks, 10(9), 177.
Kandi, V., & Vadakedath, S. (2023). Clinical trials and clinical research: a comprehensive review. Cureus, 15(2), e35077.
HCR 577 Final Exam
