Shooting for Safety

Measles Outbreak Prompts Austin Regional Clinic to Adopt Vaccination Policy That Protects Vulnerable Patients

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Cover Story — September 2015 

Tex Med. 2015;111(9):22-30.

By Joey Berlin

Officials at Austin Regional Clinic (ARC) aren't trying to become trendsetters, nor are they aiming to take a stand against the vocal minority of parents who believe vaccinations are unsafe. They say they're simply trying to maximize safety for their patients.

At a press conference on June 30, seven white-coated physicians and ARC Chief Executive Officer Norman Chenven, MD, formed a backdrop behind Alison Ziari, MD, as she announced that beginning the next day, July 1, ARC would no longer accept new pediatric patients whose parents or guardians don't permit vaccinations.

Dr. Ziari, cochief of ARC's Pediatrics Department, explained to media that ARC expects the parents of patients already in its system to comply, as well, if they want their children to continue receiving medical care in the clinic system. She said ARC physicians would begin discussing vaccination concerns with those families, with the intent of convincing them to implement the U.S. Centers for Disease Control and Prevention's (CDC's) vaccination catch-up schedule.

"For those parents who are unwilling to commit to a vaccination schedule," Dr. Ziari said, "they will need to find a medical professional outside of ARC who is more aligned with their choice of medical care for their child."

ARC's new policy includes an exception for any patients who have adverse reactions to vaccines or those with severely compromised immune systems. But aside from those patients, ARC is working toward a near future with no unvaccinated pediatric patients.

It's an eye-opening step that seemingly few, if any, medical systems of ARC's size have undertaken, at least in Texas. But trends within ARC's patient population and the measles outbreak that began at Disneyland theme parks in California in late 2014 pushed the clinic to take action.

ARC pediatrician Kimberly Avila Edwards, MD, says the clinic's pediatrics leaders thoroughly weighed the risks and benefits for patients in deciding on the new policy.

"There was a lot of very thoughtful discussions that went into it," Dr. Avila Edwards said. "And just seeing the increases in non-vaccinators … I don't know how we [couldn't] have made that decision."

Policy Particulars

ARC's new policy aims to protect the clinic's most vulnerable patients, such as infants who aren't fully vaccinated, seniors, those who have compromised immune systems, and pregnant women.

"Only a small fraction of our patients are not in full compliance with the CDC vaccine schedule," Dr. Ziari said. "However, we know that it takes just one case to become a safety concern."

Physicians who tell patients to seek care elsewhere must ensure they're not violating Texas Medical Board (TMB) rules and abandoning patients. TMB rules list "termination of patient care without providing reasonable notice to the patient" as a violation of the Texas Medical Practice Act. The board's rules don't explicitly define reasonable notice, but TMB spokesperson Jarrett Schneider says the board generally accepts 30 days as a reasonable time window.

TMB takes physician abandonment seriously. If the board determines a physician abandoned a patient, the doctor could face penalties ranging from a remedial plan with a $500 fine to sanctions that could include continuing medical education requirements and an administrative penalty. In some cases of patient abandonment, depending on the facts, the board could revoke a physician's medical license. (See "Firing Patients," May 2012 Texas Medicine, pages 37-40.)

Dr. Ziari said patients who are already in the ARC system would have varying timetables to adhere to the catch-up schedule to continue treatment at ARC.

"It depends on how old the child is and how old he or she is when entering the catch-up schedule because there are rules about how vaccines are given, the intervals, and who gets which vaccines, depending on how old the child is," Dr. Ziari said. "So each physician will decide, looking at their CDC catch-up schedule and how old that child is."

Although ARC recommends the flu vaccine, it is not required.

Medicine Rallies Around ARC

When ARC announced its new vaccination requirement, it had the support of the Texas Medical Association and the Texas Pediatric Society (TPS). 

Austin gastroenterologist Pradeep Kumar, MD, president of the Travis County Medical Society (TCMS), spoke at the news conference to offer ARC support on behalf of TMA and TCMS.

Dr. Kumar says a policy like ARC's aims to eliminate the risks of having an unvaccinated child in the waiting room with other pediatric patients. He says the effectiveness of illness prevention rests not in 100-percent vaccine effectiveness but in the concept of "herd immunity." That is, even though vaccines aren't effective in every single person who receives them, "we still can eradicate these viruses in a community by the entire population becoming vaccinated, because it doesn't have a place to harbor. The virus doesn't have a place to infect because there are not enough hosts to be vulnerable." 

Dr. Kumar, who doesn't work for ARC, says that when ARC approached TCMS with the news that it was going to implement the policy, it sought the medical society's help in finding treatment options for displaced patients. TCMS surveyed pediatric groups in the county, then formed a task force to analyze the results of those surveys to help determine the medical society's approach.

Dr. Kumar says TCMS contemplated a process by which it would steer patients to other practices that might accept them.

"We entertained a host of other options, and at the end of the day, we agreed that we would be there for moral support," he said. "But because of insurance reasons — and also the volume of patients, which is unknown — we thought that it was inappropriate and out of place for the county medical society to be channeling these patients who were displaced.

"[For] both ARC and the county medical society, the idea is not that we have a stick and we're trying to beat people into vaccinating," Dr. Kumar added. "It's quite the opposite. It's [that] we're trying to protect those patients who [aren't] vaccinated from being infected with a vaccine-preventable illness."

In a letter addressed to Dr. Ziari, Fort Worth-area pediatrician Jason Terk, MD, TPS president, praised Dr. Ziari and ARC for their courage in taking steps to ensure patient safety.

"We are very familiar with the challenges of addressing concerns from parents who are vaccine-hesitant, and we agree that a dialogue must occur between parents who have questions and their pediatricians who have answers to those questions," Dr. Terk wrote.

The Final Straw

ARC officials had been thinking about instituting a strict vaccination policy even before the measles outbreak that began at Disneyland last December, but Dr. Ziari says that reinforced the potential negative health impact an unvaccinated population can unleash.

The California Department of Public Health finally declared that outbreak over in April, crediting it with 131 measles cases in the Golden State. Reports pegged the total number of resulting cases in the United States at 147, plus 159 others in Quebec, Canada, after one Disneyland visitor returned to a religious community with a low vaccination rate.

On July 2, the Washington State Department of Health reported that an autopsy on a Clallam County woman who had died in the spring revealed she had died from measles-caused pneumonia. Although the state health department did not connect the woman's death to the Disneyland outbreak, her illness was the sixth case of measles in Clallam County in 2015 and the first confirmed measles death in the United States since 2003.

Nationally, CDC reported 178 cases of measles from the start of 2015 through June 26, including 117 tied to the Disneyland outbreak.

"That's a huge group of people who were at Disneyland at that moment, but yet so many of them got sick because these diseases are incredibly, incredibly infectious," Dr. Ziari said.

Dr. Chenven, who said at the news conference that he's old enough to remember the days of polio epidemics, recalled a lecture he received as a medical school student after the advent of the measles vaccine.

"The lecturer stood up in front of 200 medical students in the audience, and he said that the aggregate IQ of this audience would be higher if we had this vaccination 20 years ago," Dr. Chenven said. "Measles is not a benign disease — it's not just a rash and a fever. It can be encephalitis, and it can be death from measles. So these are all serious, serious conditions."

Discredited Science Looms Large

Although vaccination skeptics long predate the work of British physician Andrew Wakefield, MD, his now-discredited 1998 study raising the possibility of a link between the measles, mumps, and rubella (MMR) vaccine and autism was the catalyst for much of today's movement to eliminate vaccination requirements. (See "Bad Science," March 2011 Texas Medicine, pages 27-32.)

After publishing the findings in the British journal The Lancet, Dr. Wakefield theorized that administering the separate vaccines for those three illnesses might be safer than the three-in-one shot. Many concerned parents in Britain and elsewhere latched on to the implications of that research. 

"I think that movement, at the very base, is not data-driven," Dr. Kumar said of the vaccination skepticism. "It's not scientifically sound. It's based on anecdote and fear. Medicine is not based on that; medicine is data-driven."

The American Academy of Pediatrics (AAP) maintains a list of vaccination-related studies on its website. The studies AAP links to in the documents find vaccines to be safe and effective and don't support the research suggesting links to autism.

For example, a 2002 study that appeared in the New England Journal of Medicine looked at all children born in Denmark between 1991 and 1998. Researchers obtained vaccination data on each infant from the Danish National Board of Health and got data on each child's autism status from the country's Psychiatric Central Register.

The study accounted for 537,303 children, 82 percent of whom had received the MMR vaccine. Out of those children, the study identified 316 children with autism and 422 others diagnosed with autistic spectrum disorders. Researchers concluded that the results provided "strong evidence against the hypothesis that MMR vaccination causes autism."

Exemption Boom in Texas

A recent University of Michigan poll suggests more parents are becoming firmer supporters of vaccinations. The poll, which researchers conducted in May, measured changes in parents' attitudes toward vaccination between 2014 and 2015. About one-third of respondents, 34 percent, said they now perceived more benefits to vaccines than they had before, and 35 percent also said they were more supportive of vaccination requirements for school and day care entry. One quarter of parents said they perceived vaccines to be safer than they did a year earlier. A majority of parents said they had the same views as a year ago on vaccines' effectiveness and safety.

Still, skeptics worried about potential harmful effects of vaccinations continue to fight against efforts to implement stricter laws and policies, often using social media to reach new eyes. Not even an event as far-reaching as the Disneyland outbreak will change some minds. On the same day ARC announced its new vaccination policy, California Gov. Jerry Brown signed a controversial bill that barred exemptions from school-required vaccinations based on religious and personal beliefs. Governor Brown approved Senate Bill 277 over loud protests from groups opposing mandatory vaccinations for public schoolchildren, who said they would challenge the law in court, according to reports.

Cook Children's Health Care System, in which Dr. Terk practices, has required its pediatric patients to receive vaccinations for about six years. Pediatricians and family physicians for the Austin Diagnostic Clinic also do not accept patients from families who choose not to immunize their children.

Dr. Terk says parent vaccination opposition is at a considerably higher level today than it was when Cook first implemented its policy.

"The timbre of the conversation has changed," he said. "I think things are a bit more at a fever pitch because of what has happened with outbreaks of disease, and there's the hardening of the fringes of this culture war, basically. I don't think [it was] the same dynamic that exists now."

The results of that culture war may be showing up in data Texas schools submit to the state's Department of State Health Services (DSHS). The state's data show child vaccination exemptions for conscientious reasons are still an overwhelming minority, but also a growing one. 

Texas law allows vaccination exemptions for schoolchildren if a physician provides a written statement that the injection would be harmful or injurious to the child or a member of the child's household, or if a parent or guardian chooses to be exempt for "reasons of conscience," including religious beliefs.

Each fall, DSHS collects self-reported immunization data from the state's public schools and accredited private schools and compiles the information into the department's Annual Report of Immunization Status. The 2014-15 annual report shows a little more than 41,000 students, or just 0.79 percent of total reported enrollment, had a conscientious exemption filed at their school,.

That exemption percentage, however, is significantly higher than the one DSHS collected for the 2003-04 report, which showed 2,314 students, or 0.08 percent of enrolled students, with conscientious exemptions. And conscientious exemptions are nearly four times as common as they were in the 2007-08 school year, when the report accounted for 10,400 students with the exemption. (See "Vaccination Exemptions on the Rise.")

Dr. Ziari says ARC began noticing an increase in unvaccinated pediatric patients more than a year ago, although she says ARC doesn't have hard data on how many more patients were unvaccinated. ARC treats around 400,000 patients of all ages and employs about 350 physicians, 70 of whom are pediatricians.

"I really can't give you a good number, and the reason is because we actually see lots of patients, for example in our after-hours, [for] whom we're not the primary care doctor, and so it's hard to quantify," she said. "I'll tell you that talking [to] the doctors in our group, we know that the number of unvaccinated children is going up."

Changing Minds

Of course, not every physician will take the same route as ARC.

Austin family physician Guadalupe Zamora, MD, says he believes in immunizing every child and that the studies have shown that vaccinations don't cause autism. Dr. Zamora, who doesn't practice at ARC, says he understands where ARC is coming from with its new hard line on immunization.

But he also feels parents have the right to decline vaccinations, and he says he'll continue seeing patients whose parents feel that way.

"Those children need to be seen. I'm not going to turn them away. I'm going to see those children," he said. "If there's even a hint that a child may have a preventable disease, we're going to bring that child in through the office right away, bring equipment in an exam room where we can isolate and see the child, and then get the child home."

Dr. Zamora says he tries to educate parents as much as he can about the potential ramifications of unvaccinated children.

"I have several families for whom, in their eyes, one of their children was well, and after immunization, that's when the child had a neurological decline," he said. "So they're fearful of another child having the same problem. I understand that … and I can agree with them that if they want to decline, it's fine. It's their risk, and I always tell them that."

Dr. Terk believes vaccine-hesitant parents fall into three general categories: 

  1. Parents who have heard about the perceived potential effects of vaccinations and simply want to ask questions, and "if you answer their questions in a respectful way, they're going to be comfortable with it"; 
  2. Parents convinced that vaccines pose potential harm but who will often consent to vaccination once a physician respectfully uses the evidence to push back against their concerns; and 
  3. The most challenging category for physicians, parents who are inflexibly antivaccine. 

"They're absolutely convinced there is a pharmacy/medical/government conspiracy, and you're not going to reach those people," Dr. Terk said. "So I think you have to understand your audience. You have to understand whom you're dealing with to be able to have a chance of success."

Dr. Terk adds the third group of parents may "self-select themselves out after a time because they'll understand that you're not going to be in an environment that's friendly to maintaining nonvaccinated kids or kids who will be vaccinated according to a nonstandard schedule."

The Early Reaction

One week after ARC implemented its new policy, Dr. Avila Edwards says she had spoken to one mother who historically had objected to a particular vaccine. Dr. Avila Edwards says she had always been open with the family about her lack of support for their decision to forego that immunization, which she declined to identify.

"I've always known for this specific vaccine, they didn't feel it was necessary. But getting to the crux of exactly why never had really come out," she said.

She adds that the family was considering the vaccine and planning to make a decision at press time. 

Other than that, Dr. Avila Edwards says so far, the overwhelming reaction from patient families has been "thank-you."

From past experience testifying to the state legislature on behalf of TMA and TPS, she said, "I'm just very aware that parents who choose not to vaccinate are very vocal, and so I was expecting probably a lot more outspoken members of our community to speak on their disapproval of it, and I have not heard anything. I have been pleasantly surprised at the support of this decision from the outside."

Although she was waiting to hear more about family-pediatrician conversations, Dr. Ziari says a few patients had requested transfers, "which we knew was going to happen."

"Certainly, the media part of it has been fairly positive," she said. "I mean, certainly there have been some negatives, but … the majority have been positive on social media and on our website and Facebook posts. We have an informational number; [reaction there] has been generally positive."

Other practices and groups could follow ARC's lead.

"Really, every group, every individual pediatrician out there … even large groups, they have to consider what's best for their patients," Dr. Ziari said. "And we're not trying to create policy for other people. We really just want to protect the 400,000 whom we take care of."

Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.


Be Wise — Immunize Physician Resources

The TMA Foundation funds the Be Wise — ImmunizeSM initiative, which strives to improve vaccination rates in Texas through education and hands-on clinics. Be Wise helps educate physicians, office staff, and patients about vaccinations. It offers patient education materials and physician toolkits for children and adolescents to help doctors talk to parents about fears of and objections to vaccination. 

Learn more about Be Wise, and find links to download the educational materials and physician toolkits at www.texmed.org35782.html.

Be Wise ― Immunize is a service mark of the Texas Medical Association.

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