July, 2018 - Bill of Health

Buprenorphine and Naloxone Legislative Restrictions: A Compromise Towards Harm Reduction

July 11, 2018July 11, 2018 Stephen Wood 1 Comment

Limiting access to MAT can result in patient harm. Improving access using a bridge therapy model may help save lives.

There were approximately 64,000 deaths from opioid overdose in 2016, including deaths from both prescription and illicit drugs. The incidence of opioid overdose has continued to escalate despite a number of efforts. Increasing treatment beds, limiting opioid prescriptions, distribution of naloxone and other efforts have not demonstrated a significant impact on non-medical opioid use or on opioid-related deaths.

The continuing rise in opioid overdose and overdose death has resulted in the declaration by the current executive administration of the opioid epidemic as a “Public Health Emergency”.

Medication assisted treatment (MAT) with agents such as methadone or buprenorphine/naloxone has been demonstrated to be one of the more effective measures in the reduction in high-risk opioid use among individuals with substance abuse disorder. Specifically, treatment with buprenorphine/naloxone has demonstrated efficacy in harm reduction with the advantage of a reduced potential for abuse, a safer therapeutic profile than alternatives, and it can be safely prescribed in the outpatient setting. Use of this therapeutic however, is currently restricted to only certain licensed providers in certain clinical settings, limiting access to this important life-saving intervention.

Health and Human Services Secretary Alex Azar testifying in front of Congress

Setting Hard Limits: A Federal District Court Puts up Major Hurdle to the Reworking of Medicaid in Stewart v. Azar

July 9, 2018July 17, 2018 Carmel Shachar Leave a comment

Since the Republican controlled Congress failed to repeal the Affordable Care Act in 2017, the Trump administration has been trying to implement its more conservative vision of Medicaid through waivers. On June 29, 2018, however, the D.C. federal district court issued a decision in Stewart v. Azar which would make it significantly more difficult for an administration to rework Medicaid without a congressional mandate.

This case, should it survive subsequent appeals, will represent an important turning point in the ability the Department of Health and Human Services has to shrink or undermine Medicaid through the use of administrative waivers.

When All You Have is a DALY, Everything Looks Like Disease

July 6, 2018July 17, 2018 jhylton Leave a comment

Recently the Petrie-Flom Center’s annual conference brought together medical experts, bioethics scholars, and disability advocates to rethink how medical systems and public health policies can engage with disability.

During the many fascinating panels at “Beyond Disadvantage: Disability, Law, and Bioethics” one idea that sparked some debate was whether we should use quality/disability adjusted life years (QALY/DALY) to set priorities for who gets access to healthcare resources. Prof. Govind Persad, a bioethicist at Johns Hopkins and blogger for Bill of Health, suggested in his presentation that we should dramatically reduce the role of such utilitarian calculations in priority setting, instead focusing on the genesis of the disadvantage.

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

July 5, 2018July 5, 2018 Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Michael S. Sinha, and Aaron 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 relevant to current or potential future work in the division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the utilization of medical devices necessary to detect post-approval safety differences, to evidentiary standards and regulatory tradeoffs in the FDA’s expedited approval programs, to the president’s plan to address high drug prices. A full posting of abstracts/summaries of these articles may be found on our website.

Panelists discussed responses to the opioid crisis in a webinar

The Need for Institutional, Individual and Community Based Responses to the Opioid Crisis

July 5, 2018July 17, 2018 The Petrie-Flom Center Staff Leave a comment

By John Alexander Short

Dr. Monica Bharel, the Commissioner of the Massachusetts Department of Health, recently hosted a webinar panel to discuss the many consequences of the modern opioid epidemic on families.

Hosted jointly by the Association of State and Territorial Health Officials (ASTHO) and The Forum at the Harvard T.H. Chan School of Public Health, the event also included Dr. Stephen Patrick, Dr. Karen Remley, and Dr. Michael Warren who joined Bharel for a talk titled “State Health Leadership: Understanding & Responding to the Lifelong Effects of Opioid Exposure for Infants, Children & Families.”

The discussion offered insight into the complex nature of addiction and the need to understand the disease to craft effective solutions.

What is in America’s Medicine Cabinet? Everything.

July 1, 2018August 9, 2018 Stephen Wood Leave a comment

There were 240 million opioid prescriptions in the U.S. in 2016, a number that accounts for about 30 percent of the world’s opioid prescriptions, and is enough for one opioid prescription for every adult American.

Experts believe the overprescribing of opioids is at least somewhat responsible for the current opioid crisis. This led to a national discussion around prescribing stewardship, as well as the development of policy and regulation with regard to opioid prescribing. Included among this have been limits on the duration of therapy, partial fills, and requirements that providers access their state’s prescription monitoring program before prescribing. These policies have had some success and there has been a decline in the number of opioid prescriptions in the last several years.

This should be good news, but unfortunately, opioids aren’t the only thing filling America’s medicine cabinets. Looking again at 2016, there were more than 190,000 kilos of amphetamines, drugs like Adderall and Ritalin, produced for consumption in the United States. The estimates are that about 16 million adults and more than 3.5 million children are taking these stimulants.

Baby was receiving his scheduled vaccine injection in his right

Childhood Flu Vaccination and Home Rule in the Big Apple

July 1, 2018January 8, 2019 Nicholas J. Diamond Leave a comment

On June 28, the State of New York Court of Appeals upheld a New York City Board of Health requirement that children between the ages of 6 months and 5 years old attending city-regulated child care or school-based programs receive flu vaccinations.

While New York City is no stranger to progressive public health initiatives, this ruling in particular is significant on at least two accounts. First, it strengthens New York City’s ability to confer the public health benefits of flu vaccination to a wider segment of the adolescent population, consistent with current recommendations. Second, it stands as a reminder of the important role that local health authorities, like boards of health, can play in improving population health, if granted sufficient authority under state law.

Month: July 2018