The independent regulator for health and social care in England, the Quality Care Commission (CQC) has recently published its annual report on the real-time state of health and social care in England. It analyses trends, shares examples of outstanding, good, and poor health care care practices. It provides a true, unabashed account of issues facing the National Health Service (NHS) and health care delivery.
The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.
Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.
Fentanyl is a potent opioid analgesic and has been the center of the opioid and overdose epidemic. As an illicit agent, fentanyl is often in the form of a powder, which is then either insufflated (the fancy medical term for snorting) or dissolved in water and injected intravenously. It is fifty to one-hundred times more potent than heroin, the drug it replaced as the illicit opioid of choice. It can cause significant euphoria and analgesia, which is why it is so widely used. It can also cause respiratory depression or complete respiratory arrest, the reason it can be so deadly. It is readily absorbed when insufflated or injected and the actions are almost immediate. These are the facts.
In resource-constrained health care environments, it is important not to reinvent the wheel and waste money when existing, proven patient safety solutions already exist in other countries. Global patient safety knowledge sharing, and learning helps all countries, regardless of income level and this needs to be encouraged. Read More
The National Health Service in England has been trying for many years to get its complaints system right, but it has never succeeded. A great number of reports have been published on the system over the years, some dating back for at least a quarter of a century.
Wait times and length of stay in emergency departments are a hot topic and often result in a variety of identifiable harms that include medical error and failures to meet quality care measures. Patients with psychiatric conditions, including suicidal ideations, risk for harm to others, or psychosis, are particularly vulnerable to increased emergency department (ED) lengths of stay. The length of ED holds for psychiatric patients can be three-fold that of similar holds for medical patients. Lack of access to appropriate care, comorbid medical illness, or violent behavior can all contribute to this.
Increased length of stay impacts the efficiency of the ED itself, increasing wait times, utilizing human resources and physical space. It has a more important impact, however, on the patient. Patients may be held in a small room with constant observation for days with little or no access to natural light, bathing facilities or contact with family or friends. They may be dressed in paper gowns, told when to eat, when to sleep and confined to their room for days at a time, emulating the conditions in a maximum security prison. Emergency Departments, through no fault of their own, are becoming holding cells for patients who are both vulnerable and often marginalized.
Recent studies have highlighted the inherent susceptibility for medication errors by anesthesia providers in the perioperative environment. In a prospective survey at Massachusetts General Hospital, investigators identified a concerning potential error rate of 1 in 20 medication administrations, many of which resulted in patient harm.
To those of us who toil daily in the trenches of the operating room, this come as no surprise, for we are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels and administers the medications, independently and without secondary verification or use of technologic support. In one sense this may seem to be an advantage, for if there are fewer intermediaries, such as pharmacists or registered nurses, there are fewer humans to make a mistake. On the other hand, more intermediaries or additional verification might identify previously unrecognized errors. Read More
“Medical errors are the third leading cause of death in the United States,” says a new report by the World Health Organization. And in the United Kingdom, “recent estimations show that on average, one incident of patient harm is reported every 35 seconds.”
Patient safety remains an issue of concern for all countries across the globe. But by observing what other countries do and report about patient safety we can avoid the costly mistake of trying to reinvent the wheel when information is already available about important trends.
FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).
Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.
In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika. There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.
Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.
Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School
Lunch will be provided. This event is free and open to the public.