Pill pack.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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Doctors performing surgery.

The Need to Go Back to Basics in Patient Safety

By John Tingle and Amanda Cattini

In the hustle and bustle of our daily professional lives, it is sometimes all too easy to forget about the basics. In terms of health care practice and patient safety, these underpinning basic, foundational concepts include the need for proper patient communication strategies.

The consequences of failures in patient communication can be devastating. There is a need to go back to this basic issue at regular intervals.

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Empty nurses station in a hospital.

The AMA Can Help Fix the Health Care Shortages it Helped Create

By Leah Pierson

Recently, Derek Thompson pointed out in the Atlantic that the U.S. has adopted myriad policies that limit the supply of doctors despite the fact that there aren’t enough. And the maldistribution of physicians — with far too few pursuing primary care or working in rural areas — is arguably an even bigger problem.

The American Medical Association (AMA) bears substantial responsibility for the policies that led to physician shortages. Twenty years ago, the AMA lobbied for reducing the number of medical schools, capping federal funding for residencies, and cutting a quarter of all residency positions. Promoting these policies was a mistake, but an understandable one: the AMA believed an influential report that warned of an impending physician surplus. To its credit, in recent years, the AMA has largely reversed course. For instance, in 2019, the AMA urged Congress to remove the very caps on Medicare-funded residency slots it helped create.

But the AMA has held out in one important respect. It continues to lobby intensely against allowing other clinicians to perform tasks traditionally performed by physicians, commonly called “scope of practice” laws. Indeed, in 2020 and 2021, the AMA touted more advocacy efforts related to scope of practice that it did for any other issue — including COVID-19.

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Physical therapist helps person in wheelchair.

Balancing Patient Rights and Costs in Medical Malpractice Claims

By John Tingle and Amanda Cattini

The issue of the high and increasing costs of clinical negligence (medical malpractice) in the National Health Service (NHS) in England has long been a contentious one. There are common themes in the debate. The economic arguments supporting reform explain that the NHS is spending a considerable amount of money out of its health budget on malpractice claims, which otherwise could be put into front line health care services.  While the economic arguments are important, others contend that the patient’s voice must be heard more widely in the reform debate. They emphasize that it is important to look deeper as to what compensation means to victims of clinical negligence, and caution against unnecessarily fettering patients’ reasonable pursuit of claims.

Two recently published reports provide several key perspectives on these issues.

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Doctor in white coat neck down

Buzzwords in Patient Safety: Some Preliminary Thoughts

By John Tingle and Amanda Cattini

Every profession, service, or industry maintains what can be termed, “buzzwords.” A “buzzword” can be defined as transient, flavor-of-the-month-type word, which describes a concept than can be seen to direct policy and practice until it becomes less topical and eventually fades away from general use. These terms come and go and are often refined and come back into use. In the National Health Service (NHS) in England, we have seen such pervading terms as clinical governance, patient empowerment, controls assurance, and patient advocacy.

Today there is what can arguably be called a new buzzword, “decolonization.” This word seems very much to be the term of the day. It pervades vast areas of academic and professional life and discourse. In terms of health law and patient safety research, the decolonization of national and global patient safety systems and structures seems an interesting perspective to further peruse.

One benefit of adopting decolonization perspectives to patient safety is that we can utilize the concept as a disrupter of established thinking and seek to establish new foundations of knowledge.

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Picture of Ivermectin tablets.

Legal and Ethical Analysis of Court-Ordered Ivermectin Treatment for COVID-19

By Jennifer S. Bard

A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.

The patient’s prescription came from a doctor who has no authority to treat patients at this particular hospital, although he is licensed to prescribe medicine in Ohio.

This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.

The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.

There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.

This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.

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doctor holding clipboard.

The Latest on Never Events in the NHS in England

By John Tingle

Never Events” — medical errors that should never occur — are a major and recurring problem in health care in England.

When they do occur, they sap confidence and trust in the health care system, and can result in significant injury or death to the patient. They can result in expensive litigation. There is also a significant financial cost to the NHS, which is always short of financial resources. The patient, their relatives, and all those involved in the incident bear emotional costs, too.

In the National Health Service (NHS), Never Events are defined and listed. The list includes such incidents as a foreign body being left in a patient, wrong implant/prosthesis, and wrong site surgery, among others. Sadly, the incidence of Never Events in the NHS is still too high.

Never Events are also a major patient safety metric that helps regulators such as the Care Quality Commission (CQC) and the public judge the safety of a hospital or other health care facility.

Recent publications highlight that Never Events remain a critical and a stubbornly persistent problem for the NHS to address.

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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.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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