Seeking out global patient safety research

By John Tingle

Unsafe health care is a problem of global proportions .The remedies and solutions to many patient safety problems are unlikely to be found in just one countries health care system. Health is one of the world’s great generics, it transcends countries borders, we are all dealing with the health of human beings which is the common denominator. Whilst country contexts may change the subject matter, the patient, remains constant. WHO state:

“Ensuring the safety of patients is a high visibility issue for those delivering health care – not just in any single country, but worldwide. The safety of health care is now a major global concern. Services that are unsafe and of low quality lead to diminished health outcomes and even to harm. The experience of countries that are heavily engaged in national efforts clearly demonstrates that, although health systems differ from country to country, many threats to patient safety have similar causes and often similar solutions (p.1).

Continue reading

Cottage Food and Food Freedom Laws – New LawAtlas data

The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.

Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.

These laws are quickly becoming an increasing area of debate at the state level.  Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to.  At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.

Continue reading

Maps Outlining State Fair Housing Laws, State Landlord-Tenant Laws, and City Nuisance Property Laws are Now Available on LawAtlas

Three new datasets covering housing related laws were published today on LawAtlas.org, the Center for Public Health Research website dedicated to empirical legal datasets. The three datasets are:

Each dataset is publicly available. You can explore the data using the site’s mapping tool that allows you to explore the elements of the law across jurisdictions or download the data as an excel spreadsheet without any cost. Each dataset is accompanied by a codebook, a research protocol, and a summary report.

State Fair Housing Protections

The federal Fair Housing Act, passed as part of the Civil Rights Act of 1968, prohibits discrimination in housing-related transactions for individuals who are members of a protected class — these include race, color, national origin, religion, sex, familial status, and disability. Forty-nine states and D.C. have adopted their own fair housing laws to expand upon these federal protections, such as prohibiting discrimination based on an individual’s sexual orientation, gender identity, or source of income. These laws regulate which protected classes are included, the types of discriminatory actions that are prohibited, and when discrimination is exempt under the law.

Continue reading

Civil Commitment and the Opioid Epidemic: A Call for Research

By Scott Burris, JD

There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.

With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.

The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Continue reading

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Continue reading

New data: Baby-Friendly Hospital Laws

The Baby-Friendly Hospital Initiative (BFHI) is a global initiative of UNICEF and the World Health Organization aimed at promoting hospital policies that encourage and support breastfeeding. Baby-Friendly USA, the organization primarily responsibile for implementing BFHI in the United States, has outlined 10 evidence-based practices that hospitals can implement to support breastfeeding — called the 10 Steps to Successful Breastfeeding. These include written breastfeeding policies, staff training, rooming-in, and educating mothers about the benefits and management of breastfeeding.

Several states have enacted statutes or regulations encouraging or requiring hospitals to adopt one or more of these “baby-friendly practices.”

The newest map on LawAtlas.org, which was created and is maintained by ChangeLab Solutions, identifies key features of state laws and regulations regarding recommendations or requirements for hospitals related to any of the 10 Steps to Successful Breastfeeding. It also includes state laws recommending or requiring certain hospital discharge practices related to breastfeeding.

In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices

In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices.

As of October 1, 2016, 18 states had enacted laws or regulations that encourage and support breastfeeding initiation and continuation. In 15 of these states, hospitals must follow one or more baby-friendly practices.

Explore the maps and download the data at LawAtlas.org.

The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

Continue reading

New Research: Legal Epidemiology in the Literature

It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:

Legal Epidemiology: The Science of Law
T Ramanathan, R Hulkower, J Holbrook, M Penn – The Journal of Law, Medicine and Ethics

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws
L Barraza, C Schmit, A Hoss – The Journal of Law, Medicine & Ethics

Legal Mapping Analysis of State Telehealth Reimbursement Policies
KE Trout, S Rampa, FA Wilson, JP Stimpson – Telemedicine and e-Health

Expanding Access to Care: Scope of Practice Laws
K Hoke, S Hexem – The Journal of Law, Medicine & Ethics

Health in All Policies: Unfunded mandate?

By Joshua Waimberg, JD

Beginning in the early 2000s, there was a push in the public health world for jurisdictions and localities in the United States to adopt a Health in All Policies (HiAP) approach similar to recent initiatives in Europe. At its core, HiAP is a collaborative approach to improve the public’s health by incorporating health into decision-making across sectors and policy areas.

According to the Public Health Institute, HiAP is centered around five core elements: promoting health and equity, supporting intersectoral collaboration, creating co-benefits for multiple partners, engaging stakeholders, and creating structural or process change. It can be adopted at all levels of government, and jurisdictions that adopt HiAP approaches do so to ensure that all decision-makers and stakeholders work together to improve the health of their communities.

The Policy Surveillance Program, with support from the Health Impact Project, a collaboration of the Robert Wood Johnson Foundation and The Pew Charitable Trusts, has just published that detail state-level HiAP bills and laws that were proposed or passed between the start of 2012 and the end of 2016. Continue reading

Webinars: ASPPH Two-Part Series on PHLR

CPHLR is joining forces with the Association of Schools and Programs of Public Health (ASPPH) for a free, two-part webinar series on public health law research and policy data evaluation.

Public Health Law Research Part I: Creating and Using Open-Source Policy Data for Public Health Evaluation Research
March 29 @ 12:00 pm – 1:00 pm
Will introduce participants to the practice of Policy Surveillance and the various law and policy datasets available through LawAtlas and other open-source portals.
REGISTER >>

Public Health Law Research Part II: Developing and Implementing a Policy Evaluation Using Open-Source Legal Data
April 12 @ 12:00 pm – 1:00 pm
Will introduce participants to the theory, design and implementation of a policy evaluation using policy surveillance datasets.
REGISTER >>

Biosimilars – In The Pipeline or Still a Pipe Dream?

By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.

The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.

Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.

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

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

Medical Marijuana Delivery May Not Be As “Eazy” As It Seems

By Arielle Lusardi

As state medical marijuana laws proliferate throughout the country, companies are trying to secure their own piece of the action. In July 2014, a San Francisco-based start-up company, called Eaze, launched a mobile application that facilitates the delivery of medical marijuana in California. Continue reading

Being Blunt About Product Safety: The problems with the lack of uniformity in medical marijuana laws

By Holly Jones, BA, JD candidate

How can the federal government ensure consumer safety in an industry that distributes a substance the federal government classifies as an illegal drug? The federal government effectively banned the use of marijuana nationwide with the Controlled Substance Act of 1970, classifying marijuana as a Schedule I substance according. Regardless of this federal prohibition, 23 states and Washington, DC have legalized marijuana for medical use. A lack of federal legalization allows states to independently enact their own distinct medical marijuana laws.

In a dataset released yesterday on LawAtlas.org, the distinctions become clear — there are currently 24 variations of medical marijuana program product safety guidelines in the United States, some of which bear little, if any, resemblance to one another. While some states, like Connecticut and Massachusetts, provide incredibly comprehensive guidelines for their medical marijuana programs, others provide skeletal legislation and instead grant a great deal of autonomy to local jurisdictions.

While variation may allow researchers to more effectively evaluate the approaches, from a patient-safety perspective, uniformity has its advantages. Continue reading