doctor holding clipboard.

Learning from Clinical Negligence Claims: The New NHS Patient Safety Syllabus

By John Tingle

As part of its patient safety strategy, the National Health Service (NHS) in England has created the first system-wide patient safety syllabus, training, and education framework.

Education and training are fundamental prerequisites for creating a patient safety culture in any health care system. This new patient safety syllabus is both innovative and reflective, combining systems and human factors thinking.

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NHS building

Health Care Providers’ Legal Duty to Be Open and Honest with Patients

By John Tingle

Last September, the first ever prosecution of a National Health Service (NHS) trust for failure to comply with the regulation concerning duty of candor was adjudicated.

University Hospitals Plymouth NHS Trust was ordered to pay a total of £12,565 after admitting it failed to disclose details relating to a surgical procedure and to apologize following the death of a 91-year-old woman.

Duties of candor require that patients be informed of adverse events as soon as possible after they occur. These duties serve as mechanisms to help balance power dynamics in health care and to advance patient rights. In England, duties of candor are contained in the professional codes of ethics of doctors and nurses, and in statutory regulations.

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Busy Nurse's Station In Modern Hospital

What’s in a Name? The Value of the Term ‘Never Events’

By John Tingle 

The Healthcare Safety Inspection Branch (HSIB) in England, which conducts independent investigations of patient safety concerns relating to the country’s National Health Service (NHS), has just published a learning report that examines the findings of investigations they have carried out on incidents classified as “Never Events.”

England’s NHS defines Never Events as “patient safety incidents that are wholly preventable,” in accordance with the implementation of “guidance or safety recommendations that provide strong systemic protective barriers.”

In the National Health Service’s policy and framework, Never Events are listed under the following headings: surgical, medication, mental health, and general. These headings include incidents such as overdose of certain medications, failure to remove a foreign object used during a procedure, and transfusion of incompatible blood.

The investigations for the HSIB report cover seven of the 15 types of Never Events listed in the National Health Service (NHS) Never Events policy and framework published in 2018. These seven categories account for over 96% of the total Never Events recorded in 2018 – 2019.

Controversially, the HSIB report recommends that NHS England and NHS Improvement revise the Never Events list to remove several which don’t have “strong and systemic safety barriers.” “These events,” the report states, “are therefore not wholly preventable and do not fit the current definition of Never Events.”

This suggestion is, arguably, not in the spirit of advancing the patient safety agenda in the NHS in England.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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doctor holding clipboard.

The Inherent Value of Patient Safety Reports as Key Educational Tools

By John Tingle

Many patient safety adverse events across the National Health Service (NHS) in England have common causes, which exist regardless of clinical specialty, such as failures in communication, poor record keeping, and poor staffing levels.

This commonality of cause means that patient reports emanating from various clinical areas can have general, health system-wide value, relevance, and application. From these reports, it is possible to extrapolate generally applicable patient safety themes that can apply in a wide range of health care settings.

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Empty hospital bed.

The Inevitability of Error in Health Care

By John Tingle

A recent publication by the World Health Organization (WHO), a first draft of a global patient safety action plan 2021-2030, seems to have rekindled conversations about the “inevitability of error” in the field of patient safety.

The “inevitability of error” argument indicates that mistakes in health care do inevitably happen; that they are the consequences of the complex nature of health care treatment. Nursing and medicine depend on people, and nobody is infallible — we all make mistakes.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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