The State of Care in Mental Health Services in England 2014-2017

By John Tingle

The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. They have recently published a report of inspections on specialist mental health services. The  report is very thorough and detailed and reveals both good and bad practices. When reading the report however the poor practices identified eclipse the good ones.

Patient safety concerns

Concerns about patient safety are a constant and overarching theme in the report. The CQC biggest concern in this care area is patient safety:

“For both NHS and independent mental health services overall, and for eight of the 11 core services, safe was the key question that we most often rated as requires improvement or inadequate. At 31 May 2017, 36% of NHS core services and 34% of independent core services were rated as requires improvement for safe; a further 4% of NHS core services and 5% of independent core services were rated as inadequate for safe “(29).

Continue reading

The Rising Cost of Clinical Negligence: Who Pays the Price?

By John Tingle

The Medical Protection Society (MPS) have recently published a report arguing that the rising costs of clinical negligence needs to be urgently controlled. They state that the NHS is struggling under the increasing burden of clinical negligence costs and suggest some reforms.The report is detailed and thorough and raises some good and interesting points but in reading it, it should be remembered that there is also a very good contrary position that can be advanced by those who act for patients in clinical negligence litigation. This report puts the issues to test.

The Report

The report begins by looking at the increasing costs of clinical negligence claims. Costs have increased over the years and the figures are stark. The report quotes figures from NHS Resolution, the new name for the NHS LA (National Health Service Litigation Authority) who estimates that the provision for future clinical negligence costs, relating to claims arising from incidents that have already occurred, stands at £56.1 billion:

“Expenditure on clinical claims by NHS Resolution increased by 72% (11.5% a year on average) over the five years to 2015/16. Should this trend continue it risks becoming wholly unsustainable for the NHS and wider society, which ultimately pays for these cost. Last year alone, nearly £1.5billion was spent and, put into context, this equates to the cost of training over 6,500 new doctors.(p4).” Continue reading

How should we organize consent to research biobanking in the hospital?

By Alena Buyx, MD PhD

Ever wondered what happens to the biological material you leave behind when you check out of the hospital? Nothing much, is the usual answer. However, the little bits of blood, tissue, and urine are potentially valuable for medical research; miniscule amounts of it may already allow sophisticated analyses, including genetic ones. Thus, in an approach termed ‘healthcare-embedded biobanking’, healthcare providers have started collections of leftover patient materials to create resources for future research.

However, unlike traditional research, healthcare-embedded biobanking is not done with a clear research question in mind. The materials are simply left-overs from diagnosis or treatment and, at the time of collection, the scientific projects for which they may be used eventually are entirely unclear.

This approach leads to an ethical conundrum. Established research ethics frameworks found here and here require that patients be asked for their consent and that they are given  all the information they need to make an informed decision about whether to donate their material (and its associated data) or not.  This includes, in particular, the research goals as well as the potential benefits and risks. However, this provision of information is not possible in healthcare-embedded biobanking: the risks and benefits can only be described in very broad terms, and the goals and timing of future research are usually unknown. Indeed, the materials may even not be used at all. Continue reading

Making Health Care Safer: What Good Looks Like

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Continue reading

Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

I am very happy to host yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:

Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk

This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.  

The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Continue reading

WHO: Global Patient Safety Leadership

By John Tingle

The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:

“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”

Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Continue reading

The Global Virome Project: Understanding Our Viral Enemies to Create a Safer World

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

By Ana S. Ayala

There is no doubt that viruses, emerging and re-emerging, have become an imminent global health threat. Starting in 2014, we saw the decimation of West African countries as a result of the Ebola epidemic. Soon after came the Zika outbreak that continues to pose a threat to countries in the Americas and around the world. Since December 2016, Brazil has been experiencing a rise in yellow fever cases , and deaths, among humans and monkeys alike. Colombia and Peru have already reported probable cases. As a response to rising human cases of the H7N9 bird flu, China just ordered the closure of all poultry markets in the eastern province of Zhejiang to stop the trade of live poultry.

Experts warn that the question is not whether but when a pandemic will hit. Unknown or little-known viruses currently looming in animal populations undetected pose a especially dangerous risk–we have little to no experience with them, we do not know whether or when they will spill over to humans, and we do not know where they will emerge next. Continue reading

Emergency Preparedness: Is Quarantine All We Have to Offer?

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy K. Mariner

On August 1, 2014, while Ebola raged in Guinea, Liberia, and Sierra Leone, Donald Trump tweeted: “The U.S. cannot allow Ebola infected people back! People that go to faraway places to help out are great-but must suffer the consequences.”  Most experts agree that epidemics are best avoided where the population is educated, well-nourished, and resilient, with access to effective medical and public health resources. Yet, too often, the first response to the threat of an epidemic is to keep people out of the country or quarantine them. It is worth considering why this is so, and how we can do better.

A New Foreign and Interstate Quarantine Rule

On January 19, 2017, the day before Trump’s inauguration as President, the Centers for Disease Control and Prevention (CDC) issued final regulations for detaining individuals suspected of harboring a “quarantinable” communicable disease (QCD). Why would the Obama Administration issue new rules? The explanation in the Federal Register offers 2 reasons: (1) responding to the Ebola epidemic and outbreaks like MERS and measles; and (2) clarifying and codifying “current practice” “to make the public aware of their use.” Continue reading

When a Nurse Needs an Attorney: US Quarantine Policy

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Kaci Hickox, MPH, MSN, RN

As new cases of Ebola in the Democratic Republic of Congo (DRC) are announced, I am reminded of the importance of applying lessons learned from U.S. quarantine policies during the 2014 West Africa Ebola outbreak. I watched the suffering of entire families and communities facing the largest Ebola outbreak in history. During my Ebola training in Brussels, I will never forget hearing an Ebola expert explain, “Remember to have compassion because this disease turns peoples’ loved ones into a biological hazard.” I remember the moment I understood Ebola with my heart, not merely my head, when a young woman admitted to the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Treatment Unit in Bo, Sierra Leone, explained, “Nineteen of my family members have died of Ebola.”

Yet, in the midst of extreme fear and suffering, I also witnessed the profound courage of the staff responding to stop the outbreak. On my last day in the unit we had celebrated the discharge of 39 Ebola survivors. Offering isolation, testing, and treatment for persons who developed symptoms of Ebola was necessary to stop disease transmission and finally, after two years of response, the outbreak was declared over in December 2015! In this globalized world, we must be prepared to react not only to Ebola, but to any infectious disease threat with courage instead of fear, science instead of politics.

How do we ensure courageous responses to infectious disease threats? Continue reading

New Blog Symposium: Between Complacency and Panic – Legal, Ethical and Policy Responses to Emerging Infectious Diseases

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy E. Parmet and Jennifer L. Huer

Public health is often invisible. In contrast to health services, public health interventions usually operate behind the scenes, reducing risks to broad populations. No one can say who was saved, what deaths were prevented.

For public health, this invisibility presents political and budgetary challenges. Without clear beneficiaries, public health has lacked the political support and dollars allocated to health services. This challenge may be even more formidable today as the Trump Administration seeks enormous cuts to public health programs, while questioning settled public health science.

In the face of such challenges, it may be tempting for public health advocates to emphasize the dangers of emerging infectious diseases. Over the last forty years, a multitude of new or previously tamed infectious diseases such as HIV/AIDS, SARS, Ebola, and Zika have emerged, wrecking morbidity and mortality, and causing panic around the globe. During these outbreaks, public health’s importance becomes, at least briefly, all-too-apparent. Continue reading

The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Continue reading

Patient Safety in the NHS: The Culture Change Agents

By John Tingle and Jen Minford 

It is important to take a broad holistic approach when looking at patient safety policy development and practice in the NHS. There cannot be a one size fits all approach and a number of possibly quite disparate organisations and stakeholders in the NHS and beyond must be consulted and involved so that effective and positive culture change takes place.

The  CQC (Care Quality Commission) is a major patient safety culture change agent whose job is to ensure that health and social care services provide people with safe, effective, compassionate and high-quality care. The CQC encourages care service providers to be on an upward trajectory of improvement. They have recently produced a report to analyse what impact they have on quality and improvement in health and social care. The report provides evidence that the CQC is having a significantly positive impact  on regulating care and ensuring good standards.

A majority of new providers and registered managers responding to a CQC survey said that their guidance and standards are clear. The CQC approach to regulation and their standards have an influence on how some providers measure their own quality. CQC inspection reports were also said to be useful. Continue reading

Factory farming, human health, and the new WHO Director General

By Nir Eyal

Last week, over 200 experts called on the next Director General of the World Health Organization to prioritize factory farming in an open letter. Announced in articles in the New York Times and The Lancet, the letter argues that factory farming is a major barrier to better global health. The letter does not make this argument on animal rights grounds – although this argument is certainly strong – but instead focuses on factory farming’s contribution to antibiotic resistance, climate change, and the rise of chronic diseases. These three issues formed the core of the last Director General’s agenda, although limited attention was paid to factory farming, which the authors argue, “connects the dots among them.”

One of the authors is Scott Weathers, a Global Health and Population MSc student at the Harvard T.H. Chan SPH. The other is Sophie Hermans, a doctoral student from Cambridge U. Their letter received overwhelming response. On twitter, their announcement of the letter was the #1 trending tweet on all relevant hashtags for the recent World Health Assembly.

Congratulations, Scott and Sophie!

(I am among the letter signatories.)

Health in the Factory: The Historical Roots of Italian Citizen Science

This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. In this post, Giulia Frezza and Mauro Capocci offer a historical look at how workers and scientists shaped a new approach to occupational and environmental health in Italy, asking if current practices of citizen science share the lineages of such radical movements. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Giulia Frezza and Mauro Capocci

The radical movement  critique of science in the turbulent decades of 1960s-70s in Italy, is a significant episode that can be useful for a critical reappraisal of contemporary definitions of the scope and the aims of Citizen Science (CS).

In those years, the deep social transformation of Italian society also involved a new perception of science and technology which emphasized that science was not neutral. Far from being a tool for workers’ empowerment, it became apparent that science and technology were ideologically determined. Trespassing the orthodox boundaries of Marxism, a group of scientists advocated a new relationship between science and society, while at the same time workers understood that they needed a new alliance with scientists in order to foster real social progress. An early result of this movement was the involvement of researchers and health professionals in the struggle for better working conditions within the factory. Through their personal experience and developing hegemonic power, workers criticized the traditional notions of risk management and health protection by actively collecting data and pointing to flaws in the existing industrial systems and the science behind them. Eventually, this activism resulted in a widespread science-based “Health in the Factory” movement. At the same time, a large number of sympathetic physicians and epidemiologists engaged in social efforts to create groups and associations that lent scientific support to activists. This proved to be of paramount importance when tragic accidents happened, such as the Seveso and Manfredonia chemical explosions that occurred within the span of a few months in 1976. Such tragedies proved instrumental for breaking “the illusory boundary” separating the factory and the outside world; the impact of what took place inside the production sites was far-reaching. Industrial accidents eventually connected local ecology, the city environment, families, citizens, scientists studying harmful substances in the lab, and society as a whole. These events were a turning point for spreading social awareness, allowing local struggles to turn into national developments, and resulting in the evolution of the public health system and regulations of risk prevention (exposure thresholds, health assessment of working conditions, prevention and management of industrial accidents). Continue reading

A Quarter of the Work Force: International Medical Graduates and the Lives They Save

By Wendy S. Salkin

On Monday, May 1, 2017, International Workers’ Day, thousands took to the streets across the United States to demonstrate in support of immigrants’ rights in the United States and against immigration policies recently rolled out by President Trump.

Among the Presidential Actions taken by President Trump during his first hundred days in office has been the issuance of his “Buy American and Hire American” Executive Order, issued just two weeks ago on April 18, 2017, in which the President states that “[i]t shall be the policy of the executive branch to buy American and hire American.” What is meant by “hire American” is detailed in section 2(b) of the Executive Order:

Hire American. In order to create higher wages and employment rates for workers in the United States, and to protect their economic interests, it shall be the policy of the executive branch to rigorously enforce and administer the laws governing entry into the United States of workers from abroad, including section 212(a)(5) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(5)).

Continue reading

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading

The Economics of Patient Safety: Adopting a Value-based Approach

By John Tingle

The OECD (Organisation for Economic Co-operation and Development) have recently published a report on the economics of patient safety.The report is in two main sections, section 1, the cost of failure and section 2, reducing harm effectively and efficiently.

Section 1 focuses on a review of the literature in the area. The reports begins by making the point that health care has always been and continues to be, a risk-laden activity:

“While modern medical sciences can certainly do more, the risks of complication, error and harm are commensurately greater.” (p.9)

The report states that adverse health care events can happen at any point of the patient’s journey and can vary between care settings. Similar causative factors can be attributed to most types of harm.On the world patient safety stage, the report states that despite global efforts to reduce the burden of patient harm in developing countries, the situation does not appear to have changed over the past 15 years. WHO data is cited from 2000 which indicates that two –thirds of all adverse events occurred in low-and middle income countries. The risk of patient death as a result of an adverse event appears to be much higher in developing countries with some estimates suggesting that as many as one in three adverse events result in the patient’s death. The report does suggest some ways forward in avoiding adverse health care events in developing countries. Continue reading

Reforming the approach to clinical negligence in the National Health Service (NHS)

By John Tingle

The Department of Health in England  have just published a consultation paper on the Governments proposal to introduce a Rapid Resolution and Redress Scheme (RRR) – a voluntary administrative compensation scheme for families affected by severe avoidable birth injury. Action against Medical Accidents (AvMA) the UK charity for patient safety and justice cautiously welcomes the stated intentions of the scheme but state that more thought needs to be given to the proposals. There needs to be more detail of the scheme and  some serious concerns are expressed.

The case for change

There are central three policy objectives behind the (RRR) scheme:

  • Reducing the number of severe avoidable birth injuries by encouraging a learning culture.
  • Improving the experience of families and clinicians when harm has occurred; and
  • Making more effective use of NHS resources.

In the consultation paper, a leading policy justification for the (RRR) scheme is the success of a Swedish initiative called, ‘The Safe Delivery Care Project’ which shows evidence of a reduction of claims for severe neurological birth injury. Continue reading

The National Health Service (NHS) in England is standing on a burning platform?

By John Tingle

In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:

“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)

This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Continue reading

NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

Continue reading