Patient Safety and Clinical Risk in Neonatal Care

By John Tingle                                     

The CQC (The Care Quality Commission)  is the independent regulator of health and adult social care in England. They make sure that health and social care services provided to people are safe, effective, compassionate, high-quality care and they encourage care services to improve. The  CQC inspects health facilities and they have important statutory regulatory powers and sanctions.They have recently produced a report on neonatal care and  on  providing care for infants in the community who need respiratory support. As well as some positive findings, the report does reveal a number of major patient safety risks and failings.

In England, one in every nine babies is born needing care from neonatal services and  this is on the increase. The care process here can be challenging with sick babies with complex health needs receiving hospital care and then care at home and in the community. The care of the baby traverses’ distinct pathways or care areas and sometimes problems can occur:

A lack of consistency in care and communication across a pathway can result in poor outcomes for both babies and parents.” (p.3)

The report looks at current practice in three different aspects of care: Continue reading

Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. Continue reading

California the latest to pass a Death with Dignity law, 5th in US

Medical personnel are trained to “first do no harm.” In end-of-life treatment, that simple directive can be difficult to interpret, and the legal landscape has evolved in the United States over the past 25 years. In 1990, the US Supreme Court ruled that physicians and other health care providers could withhold medical treatment at the direction of a patient or the patient’s directed agent.

Most recently, a movement to provide patients’ help in dying has been termed “death with dignity” and “assisted suicide.” Federal law does not currently address euthanasia or “mercy killings” in terminal patients who seek a physician’s aid to end their own suffering. Rather, the patient’s right to obtain a physician’s or other health care provider’s help to end their life is established by state law. Continue reading

Healthcare complaints matter: the need to improve the system

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

Continue reading

Prior Authorization Policies for Pediatric ADHD Medication Prescriptions

According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.

In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.

In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.

The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

Continue reading

Looking Towards 2030 in Patient Safety

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Continue reading

Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.

 

Variability of US State Workplace Wellness Program Laws

A team of researchers led by Jennifer Pomeranz, JD, MPH, Clinical Assistant Professor of the College of Global Public Health at New York University, have released a new set of resources that detail characteristics of laws related to workplace wellness programs and identify trends in these laws across the United States: interactive maps for public and private employers at LawAtlas.org and a paper published in the American Journal of Public Health.

Workplace Wellness Program Laws in US

A few key findings:

  • Thirty-three states and the District of Columbia have laws related to workplace wellness programs.
  • Four states (Georgia, Indiana, Maine and Massachusetts) provide tax incentives for work place wellness programs.
  • State laws addressed public and private employers differently, for example, five states permit rewards (e.g., discounts, rebates and waivers) by public employers, whereas 16 states expressly permit positive rewards for participation in programs by private employers.

The research was funded by the Robert Wood Johnson Foundation’s Public Health Law Research Program.

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

Gallery

Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, … Continue reading

Changing How We Think (and Talk) About Public Health Law

By Scott Burris, JD

Marice Ashe, Donna Levin, Matthew Penn, Michelle Larkin and I have a new piece in the Annual Review of Public Health (also available on SSRN). We set out a “transdisciplinary model of public health law” that encompasses within the core of the field both the traditional public health law practice of lawyers and what we call “legal epidemiology” — all the important public health law functions (from policy design to evaluation) that are typically carried out by people without legal training. I hope you will take a look.

Why this article and a transdisciplinary model? The idea comes out of the experience that the authors have all had trying to promote public health law practice and research. We realized that in spite of the success of the field and its importance to public health, a lot of non-lawyers in public health training, practice and research were uncomfortable with law — even when their work had to do with enforcing it or evaluating its impact.

We realized that we as lawyers were making things worse, by adhering to a traditional view of public health law as purely a practice of lawyers. We found that acknowledging the work of non-lawyers in public health law, conceptualizing key public health law activities in scientific terms, and even borrowing some scientific practices for legal work, were effective ways to change attitudes and improve our impact. Many of us have articles in the pipeline on legal epidemiology, policy surveillance and “the five essential public health law services” that will show the model in action.

I don’t have to tell readers of this blog that public health law is a great field. I hope the concept of transdisciplinary model will help make it a truly integral part of public health.

Read the full article here.

Job Opportunity: Legal Research Associate

Come join our team!

The Public Health Law Research program is hiring legal research associates to work on our policy surveillance project. The legal research associate will conduct legal research using Lexis and Westlaw, build historical law using HeinOnline, and conceptualize legal domains for empirical research. The associate will also code law for the creation of quantitative legal datasets at LawAtlas.org, and write legal briefs and other materials for LawAtlas.org.

Learn more and apply today!

Second Amendment Rights and Mental Illness

By Mariam Ahmed, JD/MSPP (2016)

In recent years, there have been a multitude of state- and federal-level discussions about how to use law to minimize gun violence as active shooter events increase. During these deliberations, one point that has repeatedly been debated is whether people with mental illness should have their gun possession rights limited.

Here’s how the legal landscape currently looks.

Continue reading

Marriage Equality, Health, and Life Extension

Health care analysts have long studied the effects of relationships on health, e.g., married men live longer than unmarried.   Professor Debra Umberson, a sociologist at the University of Texas Sociology Department has researched deeply into these issues.  She opened my eyes recently with insights as to how denial of marriage equality is a public health hazard because of the beneficial effects of marriage on health and life extension.

Here is a link to her Huff Post essay on this topic and a word version of the same:

http://sites.la.utexas.edu/mharp/2015/06/09/one-benefit-to-same-sex-marriage-that-nobody-is-talking-about/

 In Sickness As In Health

As the U.S. Supreme Court decides whether the Constitution requires recognition of same-sex marriage, many have speculated about the real-world consequences of marriage equality.  On at least one front the answer is clear.  Extending marriage rights to same-sex couples will improve the nation’s health. Continue reading

A needle in a haystack – finding the elusive solution to Indiana’s HIV Outbreak

By Nicolas Wilhelm, JD

Scott County, Indiana, which only has a few thousand residents, has historically had an average of five HIV cases per year. Since December 2014, however, the county has seen an outbreak, with more than 140 newly diagnosed cases. Dr. Jonathan Mermin, the director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the Center for Disease Control (CDC) calls this “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Dr. Joan Duwve, the chief medical consultant with the Indiana State Department of Health, explained that the abuse of the prescription drug Opana was one of the catalysts for the increase in HIV cases, with some residents injecting it as frequently as 10 times a day, and sharing syringes with other members of their community.

HIV is mainly spread either by sexual contact with another person with HIV, or by sharing needles or syringes with someone who has HIV. One way to reduce the spread of the disease is to implement syringe exchange programs (SEPs) that reduce the transmission of blood-borne pathogens like HIV by providing free sterile syringes and collecting used syringes from injection-drug users (IDUs).

Continue reading

Building on 20 Years of Success: The Future Role of Law

By Scott Burris, JD

On this, the last day of National Public Health Week 2015, we’re looking forward by looking backward. There is nothing new about using law and policy to promote healthier environments, products and behavior. There is no good future for public health that does not include even more, and more effective, legal interventions.

Evan Anderson and I wrote in 2012 about the legal regulation of health-related behavior over the past half-century. The story we told offered several reasons for unabashed optimism about what law can do for health. The record is clear that law works, and works across a wide range of different health threats. We pointed to CDC lists of Great Public Health Achievements from the last century and the first decade of the 21st.   Every one of them — from high levels of vaccination, through motor vehicle safety and cancer prevention to maternal and child health – could not have been successful without law and policy. Continue reading

Making Connections & Collaborating for the Future of Public Health

As part of the Public Health Law Research program’s participation in National Public Health Week 2015, we have been sharing materials and resources under the daily themes. Today’s theme, Building Broader Connections, is about expanding partnerships and making connections to benefit public health.

We spoke with Laura Hitchcock, JD, Policy Research & Development Specialist for Public Health – Seattle & King County and the King County Executive/Department of Executive Services Partnerships Initiative Lead. We asked her to offer some insight from her work as a lawyer and researcher in a public health department.

PHLR: What role can researchers play in building partnerships with health departments and contributing to the policy-making discussion?

Laura Hitchcock, JD

Laura Hitchcock, JD

LH: Public health researchers can help to support development and refinement of evidence-based policies. Because policies are created in a political process, it is important for public health departments to continue to offer their scientific knowledge to support creation of effective policies, including repeal of ineffective policies or refinement of existing policies to better result in a healthy population by 2030. Health departments may need help to define local or state-focused areas for policy evaluation by working together with researchers, and should contribute to development of research agendas by identifying areas where policy makers, communities, medical professionals and others have concerns about the public’s health, and are likely to need support from researchers to know how to ‘plug in’ to research agenda development. Continue reading

FREE REGISTRATION! Families Matter: Ethically, Legally, and Clinically

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading