Perspective: Putting patients and their safety first
By Arvind M. Dhople, Ph.D., Professor Emeritus, Florida Tech
“First, do not harm” is the most fundamental principle of any health care service. Patient safety is defined as “the absence of preventable harm to a patient and reduction of risk of unnecessary harm associated with health care to an acceptable minimum.”
In April 2024, the U.S. Food and Drug Administration (FDA) announced plans to increase the regulatory vigilance of laboratory-developed tests. Laboratory-developed tests are increasingly used for a wide range of health-related assessments worldwide, including screening for risk of cancer and selecting cancer treatment, but are not subject to the same approvals as drugs, medical devices, and other diagnostic tests. As diagnostic and digital technologies advance rapidly, increased scrutiny is needed to ensure their safety. However, the right balance between regulatory rigors and fostering innovation is also essential to avoid delays in medical progress.
Separately, in April 2024, the World Health Organization (W.H.O., part of U.N.) launched the first ever Patient Safety Rights Charter to relineate patient rights regarding health and safety and to support the formulation of policies and guidelines to patient-centered health-care systems. The Charter includes ten rights that are fundamental to reducing inadvertent harm to patients, including the right to timely, effective, and appropriate care and the right to safe health=-care process and practices. In ever evolving cancer care, among the challenges of changing government policies, regulatory delays and staff and drug shortages, a steadfast commitment to patient safety and wellbeing is paramount.
And finally, in line with these goals, the European Cancer Organization continues to advocate for improvements in various aspects of cancer care. Since early 2024, the organization has had events in nine European countries to promote agendas particularly useful for tracking inequalities in cancer burden, preventing efforts, research expenditure, diagnosis, and treatment access by gender/socioeconomic status/and other social determinants. Awareness of these gapes is crucial to address specific policy changes to remedy areas of need and to ensure the ubiquitous provision of quality care.
In the U.S., the shortage of essential chemotherapeutics, pain management medicines, and other fundamental drugs is the highest it has been in 23 years. On April 17, 2024, oncology doctors across the U.S., led by the American Society for Clinical Oncology, demanded fast action from the U. S. Congress, reminding them of the severe consequences of drug shortages on cancer care and the difficult choices oncologists need to make. Urgent measures are needed to address the causes of this shortage, whether from few financial incentives for pharmaceutical companies, issues with raw materials and manufacturing international supply-chain problems, international market dynamics, or other unknown factors.
Heavy reliance on a global market leaves health-care systems vulnerable to disruptions caused by events such as natural disasters, geopolitical events, or pandemics. The COVID-19 pandemic emphasized the importance of local manufacturing capabilities. On April 25, 2024, WHO and the International Finance Corporation (Washington, DC) announced partnership to bolster local manufacturing of health products in low-income and middle-income communities worldwide to ensure preparedness for future pandemics and the ability to respond rapidly to surges in demand.
Perhaps a similar plan is needed to address some of the challenges in cancer care. All stakeholders – pharmaceutical companies, regulatory agencies, health-care producers, and government agencies – should unite and incentivize solutions that bolster the manufacturing capacities of essential cancer medicines and ensure reliable, continuous drug accessibility and availability for every patient.
Adherence to the fundamental rights of patients to safe, timely, and high-quality health care is not a matter of choice or debate. The pursuit of patient safety transcends borders and disciplines, requiring collective commitment to build health-care systems that leave no patient behind. Patients with cancer cannot wait – we must act now!
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