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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WHO flag.

A Dose of Perspective on World Patient Safety Day

By John Tingle

The second World Health Organization (WHO) World Patient Safety Day was held on September 17th, 2020.

WHO made a call for global support, commitment, and collective action by all countries and international partners to improve patient safety. The theme for the year is “health worker safety: a priority for patient safety.”

The annual WHO World Patient Safety Day campaign is a welcome one, especially in the context of the COVID-19 pandemic.

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Vaccine.

The Ethics of COVID-19 Vaccine Trials in Developing Countries

By Sunnie Ning

As more COVID-19 vaccine candidates enter clinical trials, many developing countries are being tapped to participate.

But the history of clinical trials in developing countries is fraught with ethics violations and discrimination. In June, several protests broke out in South Africa over the University of Oxford’s COVID-19 vaccine trial. Demonstrators held signs that said: “We are not guinea pigs.”

In this post, I explore some of the ethics issues of clinical trials conducted by groups in developed countries but carried out in developing countries.

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NHS building

The Enormity of the Patient Safety Challenges Facing the NHS in England

By John Tingle

Adding to the enormity of the challenges facing the NHS in developing a patient safety-focused culture, NHS Resolution and the Care Quality Commission (CQC) have recently produced important reports on NHS litigation and poor care. The analysis of these reports will help to reveal the full nature and extent of the NHS’s patient safety problems.

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NHS building

The Long and Winding Road of NHS Complaints System Reform

By John Tingle

Sadly, the NHS (National Health Service) has not been able to get its complaint system right, even after decades of trying.

Despite several reports published over two and half decades detailing the challenges the complaint system faces, as well as potential solutions, it still is not fit for purpose. Most recently, the Parliamentary Health Service Ombudsman (PHSO) has produced a report on complaint handling with a focus on the NHS. It is a good, hard-hitting report, which spells out clearly the problems, difficulties, and opportunities to put things right with NHS complaints.

It is, however, another good NHS complaint system reform report in a long line of others. The other reports failed to change adequately the NHS complaints culture and there is little evidence to suggest that this one will succeed where the others have failed.

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NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

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Photograph of a gavel in front of a British flag

A New Litigation Crisis on the Horizon: Negligent Delays for Non-COVID-19 Patients

By John Tingle

As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.

Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.

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Busy Nurse's Station In Modern Hospital

COVID-19 Clinical Negligence and Patient Safety Update

By John Tingle

Health care law is evolving particularly rapidly during the COVID-19 pandemic.

For example, as the COVID-19 pandemic continues, families in England who have lost loved ones to the virus are considering filing clinical negligence claims. And there have even been calls in some quarters to bring global lawsuits against China for breaches of international health regulations over its handling of COVID 19.

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