JAMA Medical News & Perspectives highlights the FDA Sentinel Initiative

A new Journal of the American Medical Association (JAMA) article highlights the Food and Drug Administration’s (FDA) Sentinel Initiative.  The JAMA Medical News & Perspectives piece focuses on the progress to date with Sentinel, which was designed to identify potential safety issues by using electronic data to evaluate the safety of marketed drugs, devices, and biologics. Sentinel’s coordinating center is located at the HPHC Institute and led by DPM Chair Richard Platt, MD, MS. 

Dr. Alison Galbraith featured on Minnesota Public Radio’s “The Daily Circuit”

On February 3, 2015, Alison Galbraith, MD, MPH of the Center for Child Health Care Studies was featured on Minnesota Public Radio’s program “The Daily Circuit” to discuss high-deductible health plans (HDHPs), which offer lower premiums and higher deductibles than traditional health plans. Dr. Galbraith discussed the affordability of HDHPs for families of varying income levels, and the difficulties many people face when assessing the affordability of different health care options. Listen to the full program here.

Public Health “Emergency”?

In a NEJM Perspective, DPM Fellow Rebecca Haffajee, JD, MPH and colleagues discuss a recent declaration by the Massachusetts governor that the state’s opioid-addiction epidemic constitutes a public health emergency.  
 
With this declaration, the state public health commissioner was able to use emergency powers to implement several actions including: expanding access to naloxone, an opioid antagonist that can reverse overdoses; developing a plan to accelerate the mandatory use of prescription monitoring by physicians and pharmacists; and prohibiting the prescribing and dispensing of an FDA-approved hydrocodone-only medication (Zohydro, Zogenix).
 
Once a public health emergency is declared, actions -- such as military deployment, restricting freedom of movement, or suspension of civil rights -- can be implemented without normal legislative approval or other checks and balances.  Public health emergency powers are typically deployed if the scenario is exigent, if there is a high potential for catastrophic harm, and if avoidance of harm through ordinary means is not possible, such as with an Ebola outbreak or Anthrax attack.
 
The authors discuss whether or not it was appropriate to invoke emergency powers in the case of the opioid-addiction epidemic, since usual legislative procedures -- such as prescription-monitoring mandates and the drafting of related bills -- were already in process.  Moreover, sidestepping the usual legislative process can result in legal actions under federal law. Zogenix, the manufacturer of Zohydro, brought such a challenge, stating that the governor’s ban on its product was unconstitutional and a federal judge ruled in their favor. Finally, although not clearly a concern with the Massachusetts opioid public health emergency declaration, overuse of this tool can infringe upon private business and individual rights, as well as compromise public trust in the government’s use of public health powers.
 
The authors believe that, although the governor’s declaration recommended prudent measures to ameliorate the opioid-addiction crisis in Massachusetts, it sets a disturbing precedent for the use of emergency powers to address certain public health problems.
 
For more interesting discussion and additional details on this topic, access the full article by clicking here.

The Role of Primary Care in Cancer Survivorship Programs

Since the 2006 Institute of Medicine report focusing on the transition of cancer survivors from oncology to primary care settings, there has been growing interest in evaluating the readiness to care for this patient population by primary care providers (PCPs) and the mechanisms that may be used to facilitate the transition from oncology settings. Study findings have shown that although PCPs are often willing to care for cancer survivors, they may lack confidence and skills.
 
Larissa Nekhlyudov, MD, MPH, Associate Professor, has authored an article in Oncologist discussing the role of general internists in the management of cancer patients. Specifically, the article proposes 4 models for integrating primary care into cancer survivorship programs and has outlined the advantages and disadvantages of each model.
 
Models range from survivorship care “expert” PCPs offering either comprehensive continuity of care or consultative care in a cancer center, to designated PCPs in local practices, to community-based PCPs without specific survivorship expertise.
 
According to Dr. Nekhlyudov, the increasing population of cancer survivors necessitates more efficient management of their cancer and noncancer-related needs and would benefit from the involvement of primary care providers. Evaluation of innovative models of cancer survivorship care is clearly needed.
 
To read a subsequent interview with Dr. Nekhlyudov in the ASCO Post click here.

Barriers to Care Among Low-Income Pediatric Asthmatics

DPM researchers and colleagues conducted a telephone survey in 2012 with parents of asthmatic children about their experiences during the prior year within an integrated health care delivery system. Respondents included 769 parents of children aged 4 to 11 years with asthma. Of these, 25.9% of children received public subsidies; 21.7% were commercially insured with household incomes at or below 250% of the federal poverty level (FPL),  and 18.2% had higher cost-sharing levels for all services (e.g., ≥$75 for emergency department visits). Asthmatic children were classified based on (1) current receipt of a subsidy (ie, Medicaid or Children’s Health Insurance Program) or potential eligibility for the Affordable Care Act low-income cost-sharing or premium subsidies in 2014 and (2) cost-sharing levels for prescription drugs, office visits, and emergency department visits.
 
The main outcome measures included switching to cheaper asthma drugs, using less medication than prescribed, delaying/avoiding any office or emergency department visits, and financial stress (e.g., cutting back on necessities) because of the costs of asthma care.
 
Study results demonstrated that commercially-insured families with higher levels of cost-sharing and with incomes at or below 250% of the FPL, were significantly more likely to delay or avoid office or emergency room visits for their child’s asthma or to borrow money to pay for their child’s care. Higher-income families and low-income families with lower levels of cost-sharing through existing subsidies (Medicaid and Children’s Health Insurance Program) were less likely to report these behaviors. 
 
DPM study authors Alison Galbraith, MD, MPH and Ann Wu, MD, MPH, and their colleagues note that expanded insurance subsidies starting in 2014 could offer some protection from cost barriers and financial stress but, due to a family glitch, these subsidies are unavailable to millions of dependents for whom employer-sponsored family coverage might be unaffordable. Clearly, to inform policy refinements, work is needed to assess the effects of the Affordable Care Act and possible gaps in subsidy access.
 
To read the study abstract in JAMA Pediatrics, click here.

 

Increased Concern About Inability of Elderly to Afford Medications

Medicare Part D was implemented to make prescriptions more affordable for senior citizens.  But a new study by Harvard Pilgrim Health Care Institute researchers published in Health Affairs found that many seniors, particularly those with multiple chronic conditions, continue to have difficulty paying for prescriptions in the years since Medicare Part D was first offered. As a result, some cease taking medication altogether, skip pills, or forgo other basic needs to pay for them.   
 
Huseyin Naci, lead author of the study and a fellow at the Harvard Pilgrim Health Care Institute at Harvard Medical School and the research team found that medication affordability improved after implementation of Medicare Part D in 2006, and continued to improve for several years (2007-09), but that these gains eroded during 2009-11.
 
There are several possible reasons for recent worsening trends.  They may be due to accumulating effects of weak economic conditions in the US or increasingly restrictive coverage rules among private Part D plans. Researchers concluded that elderly beneficiaries with four or greater chronic conditions had the hardest time paying for their medications.  For example, 17% of the sickest elderly reported cost-related medication nonadherence in 2011, versus 8.4% among healthier elderly beneficiaries.  The sickest elderly were also about 3 times more likely than others to report going without other basic needs in order to afford their medications in 2011. By 2011, the risk of skimping on other basic needs in order to pay for pills was no longer significantly better among the sickest elderly than it had been prior to Part D. The study was based on data from the Medicare Current Beneficiary Survey, an annual survey administered by the Centers for Medicare and Medicaid Services. 
 
To read the full article in Health Affairs click here.

Potential Benefits of Calorie Labeling in Restaurants

Jason Block, MD and his colleague share their perspective on the potential benefits of menu labeling in a recent Journal of the American Medical Association (JAMA) Viewpoint article.  Provisions in the 2010 Affordable Care Act will require chain restaurants with 20 or more US locations to display calorie information on their menus, including drive-through menu boards. The US Food and Drug Administration released preliminary regulations in April 2011, and the long-delayed final regulations are expected soon, perhaps as early as summer 2014. The documented effects of menu labeling on consumer and restaurant industry behavior suggest that menu labeling will likely encourage some consumers to eat more healthfully some of the time, and the policy is likely an important first step toward improving the public’s eating habits.
 
To read the full JAMA Viewpoint article, click here.

Leukotriene antagonists may have similar effectiveness as inhaled steroids for asthma

In a study recently published in The Journal of Allergy and Clinical Immunology: In Practice, Ann Wu, MD, MPH and colleagues set out to determine the likelihood of asthma exacerbations after initiation of controller medications among children with asthma—under real-life conditions. Using electronic data from TennCare Medicaid and five large health plans (Harvard Pilgrim Health Care, HealthPartners, Kaiser Permanente Northern California, Kaiser Permanente Northwest, and Kaiser Permanente Georgia), Wu and colleagues studied a total of 26,191 children ages 4-17 years with uncontrolled asthma. The main outcome measures were asthma-related emergency department visits or hospitalizations, or oral corticosteroid use in the year after filling a controller medication.
 
Wu and colleagues found that overall adherence to controller medications was low. In patients with allergic rhinitis, subjects in TennCare Medicaid who were treated with leukotriene antagonists were less likely to experience emergency department visits compared to subjects treated with inhaled corticosteroids. For all other groups, the risk of emergency department visits, hospitalizations, and oral corticosteroids did not differ between children who initiated leukotriene antagonists and inhaled corticosteroids. These findings may be explainable by leukotriene antagonists having similar effectiveness as inhaled corticosteroids in real-life usage, by residual confounding by indication, or other unmeasured factors.

Great Potential for Shared Health Data Networks

Four existing health data networks are demonstrating that national patient databases are an invaluable tool in advancing research on America’s health.  An article by DPM researchers and colleagues discusses the experience of four featured programs --  FDA’s Mini-Sentinel (which focuses on medical product safety), the National Patient-Centered Clinical Research Network (comparative effectiveness research), the National Institute of Health (NIH) Distributed Research Network (biomedical research), and ESPnet (public health surveillance).
 
To date, data from these large networks has been available for research studies on:
 
  • assessing the potential for angioedema, an adverse reaction associated with some antihypertensive drugs used by millions
  • identifying risk of intussusception (intestinal blockage) following rotavirus vaccination in infants
  • monitoring the occurrence of influenza-like illnesses
 
Lessons have been learned in developing these initial national networks for use in secondary research. First, the networks are largely composed of data created by health systems or health plans as electronic health records or claims data.  The sensitivity of the data requires careful consideration of issues such as privacy, security, ethics and governance. Before it can be used for research, there needs to be a clear understanding of the data’s limitations.  Researchers must also understand how the data was collected and coded, and also where there may be gaps. Lastly, plans to maintain and update the networks are also needed to keep them robust for future studies.
 
According to paper co-author Richard Platt, MD, MS, who has led the coordination of the Mini-Sentinel, Collaboratory, and ESPnet, with the right development and controls in place, large data networks can make a significant contribution to evidence-based practice.
 
To read the article abstract in Health Affairs, click here.

 

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