CT Center for Patient Safety
CT Center for Patient Safety Newsletter

October 2016
Dear Members,

Last week, I had the pleasure of speaking at a national conference of healthcare industry leaders.  The conference was promoted as a patient engagement and experience summit. The attendees and most of the other presenters were from hospitals, health systems, and health plans and were there to discuss their experiences, innovations, and best practices that are in place to enhance the patient experience. Unlike many of the prior conferences that I have attended, this one focused heavily on the use of technology to achieve greater patient engagement, better communication and a more satisfying patient experience.  First, I want to say that I was encouraged by some of the innovations that were shared and are either currently available or on the horizon.

I was invited to represent a patient's perspective and to present on shared decision making and the importance of a person-centered culture in our healthcare systems.  I highlighted the value and importance of including patients and their families in all aspects of communication and decisions about their health care.  I shared my personal experience, the medical harm that my husband experienced, and a few of our experiences and outcomes where information was shared with us and some where it wasn't.  The messages that wound through my presentation were that patient preferences have to be discussed as a critical part of the decision making process and that patients and their families are the only ones who are there the whole time so their input is essential.  A number of attendees spoke with me after my presentation to thank me for sharing my narrative, our story, and how the communication that my husband and I experienced in different ways and on different occasions impacted his care and his experience.  Many of them also shared that they had never heard this topic discussed from a patient's perspective, and hearing my presentation caused them to look at things in a different way.

In addition to the strategies and information that I shared, an important take-away was confirming the power of patient narratives.  My story and your stories make a difference.  Our good experiences with healthcare as well as the stories of the times when our experiences were less than good and even tragically bad make a difference and make an impression.  They lead to teaching moments.  They help to drive change because others can relate to our experiences.  We have to make sure that patient stories continue to be shared throughout healthcare.  I hope that you, our members, will continue to speak up, to share your stories, and to post your comments on our Facebook page and elsewhere. I thank the many of you who have already shared with us and hope to encourage those who haven't to do so.  By doing so,  you are helping to drive the changes that we are working so hard to achieve.
Lisa Freeman
Medication Safety Tips

Whether you are an older adult or a millennial, medications can be very helpful in treating many conditions, and can be very dangerous if not taken as prescribed.  The following are some very simple medication tips and tools to help you keep track and take charge of your medication management.

Take Medicine as Prescribed by Your Health Care Provider
  • Don't skip doses
  • Ask your prescriber or pharmacist what to do if you miss a dose
  • Take the dose that was prescribed - more is not usually better.
  • Write down what you're taking and keep the list with you.
  • Include the medicine's name, the Prescriber, why you're taking the medication, the dosage, and how often you take it.
  • Sample list template is available here
Learn what the Potential Drug Interactions and Side Effects Are
  • Discuss this with your pharmacist or doctor.
  • Interactions can happen when:
    • One drug affects another drug;
    • A medical condition affects a certain drug;
    • An herbal preparation or supplement affects the action of a drug;
    • A food or non-alcoholic or alcoholic drink reacts or interacts with a drug;
Review Medications with Your Health Care Provider
  • You should discuss all of the prescription and over-the-counter medications and supplements that you take with your health care provider at each visit and minimally annually.
  • Are the medications and supplements still necessary and appropriate
  • Can you afford all of your medications and if not, are there less costly alternatives.
  • Are your medications producing the desired results?
The complete FDA Medication Safety Tips Consumer Update is available here: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM399867.pdf

CTCPS does not offer medical advice. The above are suggestions  for your consideration but we urge you to discuss this and any questions with your medical care provider.
Having your health data at your fingertips can help you stay healthy

As I mentioned in my initial letter at the top of the column, I was encouraged by some of the technological innovations that were shared at a conference that I recently attended. In spite of this, I also hear from many patients that they are still frustrated by how difficult it is for them to get their health data and that it is not yet being shared freely between their different providers.  

To help you understand the types of innovation that the Government is bringing about and that private enterprise is working on, I want to share a short HHS (Health and Human Services) Video with you.  The full blog from HHS can be read here: http://www.hhs.gov/blog/2016/09/27/giving-patients-and-providers-keys-their-health-data.html

HHS Whiteboard on Healthcare Data

Drug Prices are Still Raging Out of Control

Most of us have seen numerous news reports about the price of EPI pens and the pharmaceutical company Mylan who markets the product.  Interestingly, Mylan does not even manufacture the pens but buys them from a wholly owned Pfizer subsidiary.  Even more disturbing is that NBC news reported that " sources estimate Mylan pays no more than $30 per EpiPen" 

According to a recent  Kaiser Family Foundation tracking poll, there is bipartisan support for changes that will more effectively control drug prices.  Currently, the government is forbidden from negotiating lower prices for drugs used by Medicare patients as part of the law that created Medicare Part D, yet eight in ten Americans favor allowing the federal government to negotiate with drug companies.   M oving forward, it will be interesting to see what our Congress does to help Americans afford the medications that they are prescribed.

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In This Issue
Consumers, Conflict of Interest, and the FDA
Guest Contributor Kim Witczak, WoodyMatters.com

Most people have no idea how political the FDA drug approval system can be.  I know I didn't before my husband's unexpected death over 13 years ago from an undisclosed drug side effect of antidepressants.  Since then, I have been working on FDA and other pharmaceutical drug safety related issues.   

Earlier this year I was appointed to serve as Consumer Representative on the FDA Psychopharmacologic Drugs Advisory Committee.  This is an honor and something that I do not take lightly as there are real life consequences to the topics being discussed at these advisory meetings.   

Last month, the FDA convened a special joint meeting with the Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committees to consider Pfizer's request to remove the black box warning from the smoking cessation drug, Chantix. There have been numerous warnings on Chantix starting in 2008, a year after it had come to market. The current black box warning includes a link to serious neuropsychiatric symptoms including depression, violence/aggression, psychosis, and suicidal thoughts.  This was the second time Pfizer has tried to get the boxed warning removed. On October 16, 2014 they were unsuccessful and the 2014 Advisory Committee voted to keep the black box warning on the drug and wait for the results of a large safety study that was underway.   

Unfortunately, I was NOT allowed to serve at this particular advisory meeting on Chantix.  Five days before I was supposed to fly out to Washington, DC, I received an email from the FDA stating that I was disqualified from participating due to CR 502 - Federal Conflicts of Interest ruling.  They determined me to have a bias because of a lawsuit against Pfizer for an unrelated drug that resolved over 10 1/2 years ago.  I was the only member recused from participating on the committee.  

Much to the FDA and Pfizer's surprise, I still flew out to Washington, DC on my own dime to speak for 3 1/2 minutes during the open public comments portion of the meeting.  After all, I had devoted enormous amount of time reviewing the briefing materials in preparation for this meeting and wanted to make sure my voice was heard.  It was too big of a potential safety issue for consumers and their physicians not to show up.

Well, unfortunately the meeting didn't go as I had hoped. Despite numerous issues with the Pfizer-sponsored large safety study, the advisory committee voted to REMOVE the black box warning. This is an UNPRECEDENTED move as very few black box warnings have ever been removed. Time will tell if the FDA will actually follow the recommendation of the advisory committee.  Regardless, this is new territory for drug safety and will impact ALL of us.

This experience raised two major concerns for me:

1) The larger impact of drug companies being able to get black box warnings reversed.  What will be the unintended consequence to the public? Will people believe the drug is now safe?  How will Pfizer and the media, intentionally spin this? Neither the FDA nor the Advisory Committee heard from the 2,700+ victims who were silenced by Pfizer in their settlements by lawsuits brought on before these black box warnings were added. Were the 17,000+ real world serious adverse events reported to the FDA through its Medwatch system even considered?  Or the Citizen Petition filed by Consumer Reports, Public Citizen, the National Physicians Alliance, and the National Center for Health Research?  In my mind, ALL data must be carefully considered and weighed when a black box warning is removed.  

2) The influence of industry on the FDA advisory committees.  Intellectual or appearance bias is a relatively new form of conflict of interest that FDA uses selectively.  Who is deciding who has an intellectual bias?  Again, it wasn't until Pfizer brought my lawsuit from over 10 years ago to the attention of the FDA. The FDA was already aware of my previous statements on Chantix in 2014 and said it wasn't an issue. 
This is not the first time the "intellectual bias" has been used to have an advisory committee member removed from the committee.  In 2011, the FDA tried to remove Public Citizen's Sid Wolfe from serving as the Consumer Representative member of the FDA's Drug Safety and Risk Management Advisory Committee reviewing the controversial birth control YAZ.  The FDA's rationale for removing him was due to Public Citizen's recommendation in one of their newsletters warning of the drug being considered by the committee. Eventually after much discussion, Sid was allowed to participate in the deliberations of the meeting, however, was NOT allowed to vote.  
Advisory members possessing information and views on matters being discussed is not a conflict of interest. Most experts including consumer and patient representatives are likely to have developed views on a variety of subjects based on their professional experience, including their own research and review of the scientific data.  The fact that they have information and reached conclusions should not be a disqualifying factor.  

Excluding advisory committee members because they have differing views on scientific matters threatens the very role of FDA advisory committees. First, it robs the FDA of advice from the very experts most qualified to give it - those who have actual knowledge and research experience concerning the subject being discussed by the advisory committee. Second, it may discourage qualified people from participating out of concern that their expertise may become controversial.  And lastly, it encourages politicization as those with vested interests may try to exclude consumer, patient, and scientist experts whose views are inconvenient to them.

If intellectual conflict of interest means being informed and subsequently having opinions on a drug, many more members of FDA advisory committees, even without a financial conflict of interest, would have to be excluded because they know too much.  At the end of the day, we all lose as a result of this. 

I will continue to represent the real world voice and perspective on the national level. However, I have come to realize that the real change is not going to happen within the system. It's going to come from you and I waking up and saying enough.  

If you are concerned about the use of intellectual or appearance conflict of interest on FDA Advisory Committees, you can submit comments to the FDA at:  https://www.federalregister.gov/documents/2016/09/23/2016-22936/procedures-for-evaluating-appearance-issues-and-granting-authorizations-for-participation-in-food.  The public comment period has been extended until November 26, 2016.

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