FDA Commissioner’s Letter to Health Care Professionals About H1N1 Vaccine Safety

Below we reproduce a letter from Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (FDA), to all U.S. health care professionals. It explains why the FDA (and most experts) believe the current H1N1 vaccine is as safe as any of the seasonal flu vaccines that are produced using the same process. Many nurses remain reluctant to get the vaccine, as are many patients. Some we’ve heard from have changed their minds as they’ve seen the sudden and devastating effects of this virus on patients in their hospitals. We hope this letter will provide some context for thinking about the current H1N1 vaccine, and for addressing the concerns of patients.

Dear Healthcare Professional,

I am writing first to thank you for your extraordinary efforts during the 2009 H1N1 influenza outbreak. 

As this new infectious disease sweeps through communities across the country, you must juggle your usual patient care responsibilities with a special role in influenza response.  Delays in vaccine delivery and the persistence of myths about vaccination have not made your job any easier.  Thank you for rising to this public health challenge.

I am also writing to provide information that can be helpful as you talk to patients about the 2009 H1N1 influenza vaccines — the best tools we have to prevent severe illness and death caused by the virus. 

As the Commissioner of the U.S. Food and Drug Administration (FDA), I am pleased to have this opportunity to communicate with you directly at this key moment in time.

The Department of Health and Human Services is working with influenza vaccine manufacturers and state and local public health officials to make these vaccines widely available.  So far, more than 41 million doses of the 2009 H1N1 vaccine have been allocated to the states for distribution across the country, and more is becoming available every day. 

Some of your patients may be asking how the FDA, the manufacturers, and the scientific community can have confidence in vaccines that were available just six months after the 2009 H1N1 virus emerged. Understanding more about the manufacturing and approval process for these vaccines should help you to answer their questions.

Every year, FDA and vaccine manufacturers follow a series of steps to make a new influenza vaccine targeted to the three main circulating strains of influenza. These steps have produced effective and very safe vaccines time and again, adding up to hundreds of millions of doses administered in the United States alone.

We followed this same path for the 2009 H1N1 vaccines.

Making the 2009 H1N1 Vaccine

First, scientists at laboratories in the United States and elsewhere modified the 2009 H1N1 virus into a version suitable to be used as the “seed” for the development of vaccines.  The process that was followed is similar in every respect to that which is employed every year for the preparation of seasonal influenza vaccines, as slightly different strains appear regularly each year. 

Overcoming Barriers to Kidney Transplantation

By Genevieve Coorey, BSN, MA(Ed.). Coorey is the quality assurance and program director at the National Kidney Foundation and was the lead author of “Barriers to Preemptive Kidney Transplantation,” published in the November issue of AJN.

 

Honoring a dad's gift of life

Talk with any nursing colleague who cares for people with a chronic, complex disease and you will hear about the resilience and patience with which they accept—even triumph over—the effects of their illness.  

Cheryl learned nine years ago that her kidneys were failing. “At one point, I was so weak from anemia and malnutrition I could barely lift a dinner plate. Walking through a grocery store was a struggle. I used a wheelchair briefly because my legs were so filled with fluid. My husband . . . had to carry me at times, because I was too weak to walk.” 

A long-time school friend gave Cheryl one of his kidneys. She took up biking when her recovery allowed and the next summer she rode a 69-mile segment of a huge annual bike ride across Iowa; two years later she rode all 500 miles. Now Cheryl is a seven-time gold medal winner at three separate National Kidney Foundation U.S. Transplant Games events and a two-time bronze medal winner at the World Transplant Games. Extraordinary.

Every year, thousands die while waiting for an organ transplant. Yet the compassion and selflessness of others—complete strangers in fact—may offer hope for some. This is illustrated by Linda’s story:

Saving SimBaby – Teaching Nurses to Speak Up

The baby’s condition is going downhill fast. A medical team surrounds the infant, tersely exchanging instructions. The gripping scenario has the participants’ hearts beating fast, but the baby on the table is SimBaby, a manikin with sophisticated robotics that’s used in health care simulation training.

As in a real situation, “there is adrenalin in a simulation,” explains Elaine Beardsley, MN, RN, clinical nurse specialist in the pediatric simulation program at Seattle Children’s Hospital. “Even though it is a simulated environment, people get nervous. People talk more.” However, Beardsley says, the structured communication training within the simulation “cuts the chatter.”

The November AJN Reports focuses on ways that SimBaby is helping teams of nurses and physicians at Seattle’s Children’s Hospital learn to avoid the kinds of communication breakdowns that, studies have shown, can lead to errors in stressful situations. The training includes creating a safe environment in which nurses and residents are encouraged to speak up to physicians “when they perceive mistakes being made.”

“Simulation, in my mind, is about getting us to communicate better,” says Jennifer Reid, MD, assistant professor of pediatric emergency medicine at the University of Washington School of Medicine and Seattle Children’s Hospital and codirector of the hospital’s ED simulation program. “Our training is such that physicians and nurses are usually educated, trained, and practice more or less in parallel. Simulation is an opportunity-a rare one-for us to learn and train together, working consciously on our communication skills. When else do I ask a nurse directly if she has any idea what I as the physician am thinking? When else do physicians and nurses actually sit face-to-face and talk about what it felt like to be a part of that team and the elements of communication that helped or frustrated them?”

Simulation training is increasingly big now in most nursing schools, as well as in some hospitals. Does it increase a team’s ability to work together and to make sure they are always on the same page? Can it help nurses become more confident about alerting a team to potential errors? And what, we wonder, will the future of simulation training look like just ten years from now?

‘Mercy,’ Revisited: A Nurse Goes from Harsh Critic to Fan

By Peggy McDaniel, BSN, RN

The new NBC television series Mercy is starting to grow on me. Like some other recent shows (Nurse Jackie and Hawthorne), this drama features nurses as the lead characters. As I explained here a while back, my response to the first episode was very negative. Disparaging comments made about nurses by other staff and by patients’ family members struck me as unnecessary and irritating. Lines like “what do you know, you’re only a nurse?” were hard for a real nurse to take. My first impression was that the characters could have been women in almost any career. The words and actions of Veronica, one of the lead characters, seemed harsh and inappropriate. The overall image of nursing was negative.

So now for my confession: I have continued to watch Mercy. And I’ve become less of a critic and more of a fan. We still get more dramatic effects than convincing reality. For example, in a recent episode, Veronica runs in and bangs a patient’s chest with her fist, an action which ultimately restarts the patient’s heart. I still miss the comparatively realistic practices depicted in ER; Mercy doesn’t attempt to get such details right. 

But recent story lines have shown our nurse heroines to be strong patient advocates. This is a true (believable, and inspiring) nursing role. Even if the story line takes liberties with what a real nurse would do—such as when a character visits a patient’s son at his home to encourage him to visit his dying mother—the point about patient advocacy is made and appreciated. Advocating for our patients and promoting their health and welfare is a nursing priority.

Have you continued to watch Mercy? Have your views of Veronica, Sonia, and Chloe altered as you’ve gotten to know them? What other nursing roles and tasks would you like to see portrayed? I am hoping for story lines that show off other important nursing roles, such as educator, role model, coordinator, among many others. Let’s hear your ideas. Maybe the network will listen!

Are Domestic Violence and Pregnancy Preexisting Conditions?

By Peggy McDaniel, BSN, RN

Kaiser Health News recently ran a story about an attorney who was denied private insurance coverage based on a “preexisting condition”—that is, treatment she’d received following a domestic abuse incident. A majority of states have passed laws prohibiting insurers from denying coverage based on treatment for domestic violence, but  eight states as well as the District of Columbia have no such legislation. It is a challenge to track the occurrence of such denials. Insurers often use alternative ways to find out about a history of domestic abuse. They have been known to search for protective orders at local courthouses, which is public information, and search through medical records for documentation of treatment related to such incidents. 

A bitter irony is that nurses are expected to be aware of and directly question patients about suspected abuse, yet in doing so we could be setting up patients for future loss or denial of coverage. 

Pregnancy, likewise defined as a preexisting condition, can also be used to deny coverage. Health reform bills under consideration would disallow the practice of basing insurance rates on gender, a practice which has in effect discriminated against women, particularly those of child-bearing age. 

The practice of denying private health insurance coverage based on these and other preexisting conditions must stop. As a nurse and a consumer, I believe that everyone should be able to buy health care at a reasonable price. A rate such as $1,000 per month for a family is not affordable. In the end we all pay if people do not have some kind of coverage, since the uninsured do eventually receive care—from ERs, which are mandated to provide this care. 

By moggs oceanlane, via Flickr

The very idea that a person can be denied health insurance coverage for a history of domestic violence should encourage us to look closely at reform efforts under discussion and actively join in the conversation. As nurses we are asked to support our patients and promote physical and mental health.  If the very support we give, such as a referral to a domestic violence support group, causes a patient to lose her insurance, we all fail.

An End to Interruptions: Nurses Preventing Medication Errors

By Christine Moffa, MS, RN, AJN clinical editor

By NathanF/via Flickr (Creative Commons)

I have a hard time focusing when I am repeatedly interrupted. How many times have you walked down the hall to get something, met with an unexpected request or encounter, and then found you couldn’t remember where you were going or why?

A few years ago I was working as float nurse in an outpatient facility. One of the specialties I floated to was the pediatric clinic. There were seven or eight nurses (a mix of RNs and LPNs) working at the same time, with half assigned to administering medication, mostly vaccines, and the others performing telephone triage and monitoring patients in the observation room.  I can now admit that I used to pray to get assigned to the triage section—not because giving injections was a problem, but because the setup of their system terrified me.

Nurses as Cheerleaders?

By Shawn Kennedy, MA, RN, AJN interim editor-in-chief

1906 Cheerleader Postcard/via Halloween Street, Flickr

While I was attending the Sigma Theta Tau International Honor Society of Nursing 40^th biennial convention at the Indianapolis Convention Center last weekend, it was obvious that there was another event going on in the complex. In contrast to the nurses (and we’re talking the experienced practitioners, educators, and researchers who, for the most part, are in the AARP-eligible segment), there were numbers of mothers and their teen and preteen daughters, most of whom were in make-up they’d never be allowed to wear to school. (Think heavy, blue eye-liner and sparkles.) No problem figuring out who was attending which conference.

I asked one woman walking with young girls in glitzy outfits what brought them to the convention center. She told me it was a cheerleading competition and then asked what I was there for. I told her it was a nursing conference. As she hurried off, she said, “Well, you’re like cheerleaders, but for sick people.”

At first I laughed, but then I wanted to grab her and straighten her out. Nurses are just like cheerleaders? Here I was, attending a meeting of nursing’s honor society, some of the best and brightest in nursing presenting the work they do to advance knowledge and practice to improve health care, and this woman likens nurses to the perky young things in skimpy costumes who excel at smiling, dancing, and yelling.

ANA Releases Letter Urging Nurses to Get Vaccinated

 

As the influenza season begins, the American Nurses Association (ANA) calls on all registered nurses to get the seasonal influenza vaccine. After all, as nurses, we have an ethical obligation not only to protect ourselves, but also to protect our patients and our families from influenza illness. ANA has long emphasized to nurses that vaccination is one simple step that everyone should take. Simultaneously, during the 2009-2010 influenza season, this nation is also facing a major health threat caused by the H1N1 virus.

 

The above is an excerpt from a letter by President Rebecca Patton, MSN, RN, CNOR, of the American Nurses Association (ANA) urging nurses to get vaccinated for both the seasonal flu and the H1N1 virus (swine flu). To read the full letter, click here: ANA Letter to Nurses.

Trauma in Pregnancy: An Expert’s Calm Look at What Nurses Need to Know

Anatomical changes in the third trimester of pregnancy. Illustration by Anne Rains.

By Sylvia Foley, AJN senior editor

In this month’s CE feature on Trauma in Pregnancy, author Laura M. Criddle takes a calm look at a distressing subject. After outlining possible mechanisms of injury, Criddle reminds readers that “trauma care priorities don’t change when the patient is pregnant.” Initial interventions will still focus on the “ABCs”—airway, breathing, and circulation. She also points out that the fetus’s best chance for survival is “vigorous resuscitation of the mother,” since most fetuses will not survive maternal death.

However, the normal changes of pregnancy can affect both the nature of injury and the body’s responses; this has important implications for nursing care. Among Criddle’s key points:

• Compression and displacement of various organs occur as pregnancy advances. This makes some injuries more likely, others harder to detect.
• The normal changes of pregnancy can mask the signs of decompensation.
• Pregnancy and its changes can also make complications after injury more likely.

Criddle provides several examples for each point. She also offers strategies for assessment and interventions for both mother and fetus.

Have you cared for pregnant trauma patients? What was the experience like? Please tell us in the comments.

Nurses Write, Right?

By Shawn Kennedy, MA, RN, AJN interim editor-in-chief

by karindalziel/ via Flickr Creative Commons

As nurses, we have great stories and insight. We see a side of life few other people see. We see people when they’re sick and tired and defeated by illness. We witness the intimacy of people when they’re most vulnerable, when all pretense has been stripped away. We also have a wealth of scientific knowledge about the effects of illness, how to prevent it and manage it, and what it takes to restore individuals to health or at least to the optimum health possible for them.

As an editor, I’m constantly seeking manuscripts. And I mean constantly—I sometimes feel like a beggar, asking people to “please write that as a case study,” or “please submit that (poignant, funny, revealing, uplifting) story,” or “consider doing an update on (name the problem) incorporating new evidence.” Maybe one out of four pieces materializes.

Nurses writing about nursing is vital to the profession. And it’s not just about writing about research. Research advances knowledge but we also need to know how practitioners are applying knowledge. We know “one size does not fit all”—how does practice need to change to meet the needs of diverse groups? What are the problems and issues aound practice? Is the nursing taught in the classroom connected to the nursing we actually do?

We need to document what we do, why we do it, and what are the outcomes. We need to do this not only to share information that can be helpful to colleagues, but also to share it with the wider health care community and the public. How else can other professions and the public know what we do and why it’s important?  

So think about what you have to say about what you do, what you’ve experienced, and what you know that would benefit your colleagues. And then write about it. We consider many types of articles, from research to opinion pieces to case studies to accounts of personal experiences. AJN’s author guidelines are at www.editorialmanager.com/ajn.