CT Center for Patient Safety
CT Center for Patient Safety Newsletter

August 2016
In This Issue
Is GlaxcoSmithKline untouchable?

About a year ago, I met a patient advocate, Wendy Dolin.  Wendy came to patient advocacy after her husband unexpectedly took his life as a result of drug induced akathisia (a side effect involving agitation, distress, and restlessness) only several days after he began taking Paroxetine, the generic version of the antidepressant Paxil.  She has since filed a lawsuit against against Mylan Inc., the generic drug maker who manufactured the drug her husband was taking and against GlaxoSmithKline (GSK) who sold the drug's branded versions and devised its labels.  The Food and Drug Administration requires labels to be devised by the brand name manufacturers and these labels are to be used by the generic manufacturers, yet the name brand manufacturer has no duty to warn patients taking generic versions of their drug of the side effects and contraindications of their drugs.  The interesting thing about this case is that in the US, generic drugs are presently protected against legal actions related to the labeling of their drugs due to the FDA rules that require them to follow the same warning language of their branded counterparts.  As a result, Mylan Inc was removed from the lawsuit.  However, an Illinois technicality has allowed the lawsuit to proceed against GSK.  This lawsuit is attracting the interest of many because it will be the first involving a suicide allegedly caused by a generic antidepressant, and the first to test whether a jury would actually hold a branded drug maker liable for a generic drug injury.
August Health Hint
New FDA Nutrition Labels
Highlights of the Final Nutrition Facts Label
  • A New Design that makes important information stand out.
  • Manufacturers must declare the actual amount, in addition to percent Daily Value of vitamin D, calcium, iron and potassium.
  • The footnote will better explain what percent Daily Value means.
  • Updated Information about "Added Sugars" will be included.
  • Information on Vitamin D and potassium will be required on the label. Vitamins A and C will no longer be required.
  • While continuing to require "Total Fat," "Saturated Fat," and "Trans Fat" on the label, "Calories from Fat" is being removed.
  • Daily values for nutrients like sodium, dietary fiber and vitamin D are being updated
  • Serving Sizes and Labeling Requirements for Certain Package Sizes will be based on amounts of foods and beverages that people are actually eating, not what they should be eating.
  • Manufacturers will need to use the new label by July 26, 2018 except those with less than $10 million in annual food sales who will have an extra year to comply.
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Dear Members, 
I hope that everyone is having a wonderful summer. At the Center, we are busy watching the health insurance situation in Connecticut and across the country.  We are also planning for our fall workshops with medical and other health science students, physicians and patients on interdisciplinary communication and patient safety strategies.  We continue to represent patients in our ongoing work with health policy leaders on issues such as infection tracking, the development of hospital patient and family advisory councils, health information technology and medical research.

Today, I want to bring to your attention a matter of great urgency. Requests to raise health insurance premiums in 2017 for Connecticut's residents have been submitted by insurers. The increases range from  6.6% to 28.2%.   The Insurance Department will be holding public hearings on August 3 and August 4 for three big insurers in the state: Anthem, ConnectiCare and Aetna.  All health insurer's rate requests will be reviewed, but next week's public hearings offer a chance for you and all residents to make sure your voice is heard loud and clear.   You can either contact your state representatives, attend the hearing in person and if you oppose the rate increase, you can sign a petition stating so.  The petition can be found at: http://bit.ly/2aBktaq.  The more people who sign by August 2, the more impact we can all have on August 3.

I also had the opportunity to attend the 7th annual International Institute for Patient and Family Centered Care conference last week.  There were many great ideas exchanged and many amazing patient advocates in attendance.  I picked up a lot of information that I brought back to Connecticut with me.  Person- and Family-Centered Care is definitely here to stay, however it is not yet fully understood or delivered by many of our providers and institutions. Our organization will continue working to support Connecticut healthcare providers and institutions in their efforts to embrace and provide person-centered care to all.

Lastly, I want to mention that I will be a speaker at the World Congress  Patient Engagement and Experience Summit in Boston this September.  I will be presenting during the session on Engaging Patients in Shared Decision Making to Improve Health Outcomes.  Shared decision making is a key component of person-centered care and good communication between clinicians and patients leading to lowering medical errors.

Lisa Freeman
CMS releases Overall Hospital 
Quality Star Ratings

Last week, CMS released their Overall Hospital Quality Star Ratings for hospitals.  They used 64 measures, that were previously posted to their Hospital Compare website including hospital-acquired infection and emergency room wait times.
These star rating programs are part of the Administration's Open Data Initiative which aims to make government data freely available and useful while ensuring privacy, confidentiality, and security. According to Kate Goodrich, MD, MHS, Director of Center for Clinical Standards and Quality, " researchers found that hospitals with more stars on the Hospital Compare website have tended to have lower death and readmission rates." 

Of 31 Connecticut hospitals that were included, none received five (5) stars, one received four (4) stars, seventeen received three (3) stars, nine received two (2) stars, and one received only one (1) star.  These results are disappointing at best and show that our hospitals have work to be done to improve the quality of their patient care.  Patients should look at the ratings on this and all rating programs and make sure that they understand what they are based on.  The value is in the details, even though the star system was designed to make it easier for consumers to compare hospitals to one another. 

The star ratings can be found at Hospital Compare at https://www.medicare.gov/hospitalcompare/.  For more details and background, Kaiser Health News wrote a very informative article.
Medicare and Medicaid changes affecting members of the LGBT community

Submitted by  Cecelia Sullivan, MS Ed., HTP
Care Partner & Family Advocate

LGBT people need to be aware of recent developments that change how Medicare and Medicaid work for them. First, the Supreme Court's legalization of same sex marriage in all states changed how Medicare and Medicaid evaluate the eligibility of same sex spouses for both programs. Depending on the program and the individual's circumstances, the changes can be positive or negative.  Additionally, Medicare has begun covering Gender Reassignment Surgery and issued new rules that protect transgender older adults from sex discrimination in healthcare.

Three new fact sheets can help consumers learn how these changes may affect them, whether they are LGBT individuals married to someone of the same sex, or transgender individuals needing to access health care. These fact sheets were produced in partnership with SAGE (Services & Advocacy for Gay, Lesbian, Bisexual, & Transgender Elders), the SHIP National Network (State Health Insurance Assistance Programs), and Administration for Community Living (ACL).

The three fact sheets are:
All are available for download at the National Resource Center for LGBT Aging