Jennifer G. Allen

The protection and immunity rate for serogroup B meningococcal vaccine Bexsero (4CMenB) may be lower than expected, recent research results suggest.

The study, which was published in the July 2016 issue of

investigated the 2013 meningitis B (MenB) outbreak at Princeton University and found that 34% of students vaccinated with 2 doses of Bexsero didn’t develop antibodies and therefore weren’t immune to MenB.

Although rates of meningococcal disease in the United States have been declining since the late 1990s, college students are among those at greatest risk because of their close living conditions and potentially risky behaviors.

From March 2013 to March 2014, the Princeton campus experienced 9 cases of MenB, including one that became fatal. With special FDA approval, all 6000 Princeton students were eligible to receive the Bexsero vaccine to protect them from the outbreak. Of those students, 89% received at least the first dose within 2 months.

Researchers collected blood samples from 499 students who had received both doses. Of that cohort, just 66% showed bactericidal activity against the strain of MenB that infected students on campus—although none of those students actually contracted MenB.

“This level of seropositivity was lower than expected, given the antigenic similarity between the outbreak strain and the components of the vaccine and given that the Meningococcal Antigen Typing System predicted that 4CMenB would induce responses against the outbreak strain,” the authors wrote.

At the time, Bexsero was only approved for use in Canada and Europe. The

for use in the United States in January 2015.

Prior to this special approval, the only other MenB vaccine approved by the FDA was a 3-dose vaccine called Trumenba. All other meningitis vaccines licensed in the United States protect against more common strains of meningococcus: groups A, C, W, and Y.

“We had the unique opportunity to test the vaccine before licensure in US,” said Nicole Basta, PhD, MPhil, assistant professor of epidemiology and community health at the University of Minnesota. “All students who were tested had an immune response to at least one strain contained in the vaccine, but one-third didn't have any response to the outbreak strain.”

For now, the CDC’s Advisory Committee on Immunization Practices recommendations state that a MenB vaccine may be administered to adolescents and young adults 16 to 23 years to provide short-term protection against most strains of serogroup B meningococcal disease.

“For a relatively uncommon but devastating infectious disease, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is deployed in the context of a systematic public health response,” wrote Jerome Kim, MD, in an accompanying editorial.

Even with those small numbers, Dr. Basta said she’d recommend Bexsero to teens and young adults, especially those heading to college. Many states require incoming college students to have a meningitis vaccination prior to arriving on campus, and retail clinicians should promote their clinic as a convenient place to receive needed immunizations.

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Meningitis B Vaccine Shows Disappointing Immune Response

Poor medication adherence habits constitute a major threat to public health and costs the United States between $100 billion and $289 billion annually.

revealed a significant disconnect between self-reported medication adherence rates from high-risk type 2 diabetes (T2D) patients compared with what’s observed and documented by a nurse practitioner (NP).

Researchers analyzed data from 430 adults with T2D at high risk for serious adverse events or death. Everyone in the cohort participated in the Southeastern Diabetes Initiative (SEDI), which consists of a home visit, physician assessment, survey, and direct observation of pill bottles and insulin administration.

“High risk” in this study was defined by the following factors: recent hospitalization, substance or tobacco use, or having multiple comorbidities that require multiple medications, such as chronic kidney disease, heart failure, hypertension, or coronary artery disease.

The self-reporting tool employed by this study was the Morisky Medication Adherence Scale (MMAS), a questionnaire administered by an NP that asks patients to recall their own medication adherence and other health behaviors. The authors noted that the MMAS has been shown to be a reliable measure among other patient populations. For example, previous research on patients with hypertension has shown a strong correlation between MMAS-measured medication adherence and blood pressure control.

In the case of high-risk T2D patients, however, the investigators believed that the MMAS lacks sensitivity to the number of comorbidities and associated medication regimens that often develop in T2D patients.

“In SEDI, factors that classified patients as high risk included recent hospitalizations, substance use, tobacco use and multiple comorbidities—including coronary artery disease, hypertension, heart failure or chronic kidney disease&mdash;all of which require complex medication regimens,” wrote Katherine Kelly, FNP, of the Duke University Health System, and colleagues. “As a result, patients may report that they are ‘getting enough medications’ daily, skewing self-reported results and suggesting that improvement in diagnostic measures is needed, particularly in illnesses with multiple comorbidities.”

Beyond medications, patients with T2D may have trouble  accurately measuring their medication adherence habits because of the number of behavioral factors they need to recall, including food intake, glucose levels, activities, or times of day.

“Regardless of the underlying reasons for lack of agreement between self-report and observed counts, every effort must be made to discover where, in this high-risk population, the breakdown occurs,” the authors concluded.

With the prevalence of TD2 increasing to almost 10% of the total US population, it is of great importance that patients and NPs alike reconcile differences in measuring and recalling medication adherence habits.

in patients with T2D because they may look and feel perfectly fine. It may be hard to fathom that they have a serious disease that can cause significant problems in the future. Sometimes, patients do not understand that many of these comorbidities can be better managed or even eliminated by adhering to treatment plans.

For instance, clinicians can consider the volume and frequencies of a patients’ prescription fills and not rely entirely on self-reports of medication adherence. Overall, a clinician’s role in counseling patients should be to (1) ensure that they have sufficient understanding, knowledge, and skill to follow their regimens and monitoring plans, and (2) motivate patients to take an active role in their health care.

Self-Reported Medication Adherence Rates Among Diabetes Patients Vary Greatly from NP Observations

A scientific statement from the American Heart Association (AHA) warns that unintended interactions among prescription drugs, OTC products, herbs, or nutritional supplements may trigger or worsen heart failure (HF).

, said certain medications can cause heart-related problems by:

• Being toxic to heart muscle cells or changing how the heart muscle contracts.

• Interacting with HF medications, which means some of their benefits are lost.

• Containing more sodium than advised for patients with HF.

A common problem with non-steroidal anti-inflammatory drugs like ibuprofen is that they can cause sodium and fluid retention, which in turn reduces to effectiveness of diuretics. OTC heartburn and cold medicines may have similar effects on HF patients, who are often restricted from consuming too much sodium.

“Patients have been taught to read food labels for sodium content, but they also need to read labels on over-the-counter medications and natural supplements,” said Robert L. Page II, PharmD, MSPH, chair of the writing committee for the new scientific statement.

Many common, natural ingredients interfere with one or more medications prescribed for HF, including green tea, danshen, hawthorn, ginseng, St. John’s wort, and ephedra. Ephedra is known to raise blood pressure.

The AHA noted that HF patients have 5 or more different medical conditions and take 7 or more prescription medications daily, on average. Pitfalls of this polypharmacy include increased risk of adverse drug events, drug-drug interactions, and medication nonadherence.

“Since many of the drugs heart failure patients are taking are prescribed for conditions such as cancer, neurological conditions, or infections, it is crucial but difficult for health care providers to reconcile whether a medication is interacting with heart failure drugs or making heart failure worse,” Dr. Page said. “…Ideally, there should be a ‘captain’ who oversees your medications. This person might be a physician, advanced practice nurse, nurse, or a pharmacist who is managing your heart failure.”

Clinicians are well positioned to review patients’ medication regimens to ensure that no offending drugs are listed. Their advanced knowledge of prescription and OTC medications, herbal supplements, and drug-drug interactions is a proven advantage for medical teams, and they effectively reduce polypharmacy.

In particular, clinicians should make sure patients are aware of the dangers contained in seemingly innocuous OTC remedies, herbs like St. John’s wort or ginseng, and even green tea.

A scientific statement from the American Heart Association warns that unintended interactions among prescription drugs, OTC products, herbs, or nutritional supplements may trigger or worsen heart failure.

Heart Failure Patients Must Be Wary of Drug Interactions with OTC Products

A recent study identified 10 risk factors that seem to account for 90% of strokes.

Stroke prevention has become a major public health priority, as the disease burden continues to rise. The 2 major types of stroke are ischemic stroke caused by blood clots, which accounts for 85% of strokes, and hemorrhagic stroke or bleeding into the brain, which accounts for the remaining 15%.

The good news is that the majority of the factors that contribute to an increased risk of stroke are modifiable behaviors. That finding came from an analysis of health data from the first phase of the INTERSTROKE study, which examined 27,000 individuals from developing countries on every continent.

Risk factors for stroke, in order of worldwide importance, were identified as:

Reducing high blood pressure can cut the risk of stroke in nearly half.

Healthy activity could reduce stroke risk by 36%.

Maintaining healthy cholesterol levels could reduce stroke risk by 27%.

Maintaining healthy diets could reduce stroke risk by 23%.

Maintaining healthy weight could reduce stroke risk by 19%.

Tobacco cessation could reduce stroke risk by 12%.

Addressing heart disease could reduce stroke risk by 9%.

Eliminating alcohol abuse could reduce stroke risk by 6%.

Successfully managing stress could reduce stroke risk by 6%.

Preventing diabetes could reduce stroke risk by 4%.

Although the study wasn’t designed to explore how risk factors vary by age, sex, ethnicity, or region, the investigators did find that the importance of some risk factors varies by region. For example, high blood pressure is an extremely important risk factor in Southeast Asia, where it accounts for almost 60% of strokes, but in North America, Western Europe, and Australia, it only accounts for about 39% of strokes.

“Our findings will inform the development of global population-level interventions to reduce stroke, and how such programs may be tailored to individual regions,” stated study co-leader Salim Yusuf, professor of medicine and executive director of the Population Health Research Institute.

Nurse practitioners and physician assistants working in retail clinics might be the most ideal providers to promote these behavioral changes because they are well placed to counsel the community at large and patients individually about the importance of maintaining an overall healthy lifestyle.

10 Easy Ways to Prevent Stroke

Young women who get all 3 doses of the human papillomavirus (HPV) vaccine have fewer cervical cell anomalies in the future, recent study results found.

Researchers looked at Alberta province health data on HPV vaccinations and cervical cancer screenings, looking for a possible link between immunizations and Pap test results.

identified 10,204 young women 18 to 21 years who had a Pap smear between 2012 and 2015. Of the study participants, 56% had never received an HPV vaccine, while 44% had received at least 1 dose of HPV vaccine through a school-based program initiated in 2008.

Of the women who had been vaccinated, 84% received 3 or more doses, although the intervals between shots varied and didn’t necessarily adhere to the minimum 6-month waiting period needed to develop lasting immunity. Among the unvaccinated women, 16.1% had cervical abnormalities in their pap smears, compared with 11.8% in the fully vaccinated group.

It’s believed that high-risk strains of HPV are responsible for virtually all cases of cervical cancer (>99%), as they can cause cell mutations that can lead to genital cancers in women and men. If the body clears the HPV infection, cells can return to normal. If not, cervical cells can continue to change abnormally into precancerous and cancerous stages.

Writing on behalf of the research team, Huiming Yang, medical director of screening programs at Alberta Health Services, said the school-based HPV immunization program “has demonstrated early benefits, particularly against high-grade cervical abnormalities, which are more likely to progress to cervical cancer.”

Although school requirements have traditionally helped promote high vaccination rates for other immunizations,

the HPV vaccine for adolescents. As a result, HPV vaccination coverage is well below the Healthy People 2020 goal of 80%.

The HPV vaccine is currently required in only Virginia and Washington, DC, with Rhode Island joining the duo this August. This contrasts greatly with the varicella vaccine, which is required in all states; the hepatitis B vaccine, which is required in 47 states and DC; and the meningococcal vaccine, which is required in 29 states and DC.

Consequently, CDC data reveal that only 37.6% of girls and 13.9% of boys received the 3-dose HPV series in 2013.

The HPV vaccine is designed for women aged 11 to 12 years, but clinicians should encourage women as old as 26 years to get immunized if they haven’t received it yet. Clinicians should also be sure

, as the vaccine has been recommended for males since 2011, and a 2015 study published in

argued that deriving the greatest benefit from a vaccine program requires a strategy targeted at both genders.

, PhD, “It is important to emphasize that the HPV vaccine is much more than a vaccine against cervical cancer, as it prevents a number of different cancers in both women and men.”

“In addition, vaccinated males provide indirect protection to their sexual partners, thereby increasing the population benefit of the vaccine,” he said.

 Young women who get all 3 doses of the human papillomavirus vaccine have fewer cervical cell anomalies in the future, recent study results found.

HPV Vaccine May Reduce Abnormal Pap Results for Young Women

The latest federal diabetes screening recommendations fail to catch 55% of adults at high risk for diabetes, a recent investigation found.

from the US Preventive Service Task Force (USPSTF) recommend diabetes screening for patients who are overweight and obese and between the ages of 40 and 70 years. Even in adult patients who are not overweight or obese, the USPSTF says screening may be appropriate in those who:

Have a history of gestational diabetes or polycystic ovarian syndrome, or

Belong to certain racial/ethnic groups (eg, African Americans, American Indians/Alaskan Natives, Asian Americans, Hispanics/Latinos, or Native Hawaiians/Pacific Islanders)

Previously, the USPSTF only recommended such screening in asymptomatic adults with a sustained blood pressure (either treated or untreated) of 135/80 mm Hg or higher.

Notably, since the Affordable Care Act requires all insurers to fully cover services recommended by the USPSTF, patients who do not meet these criteria likely would have to pay out of pocket for such screening.

The study, which was conducted by researchers from the Northwestern University School of Medicine and recently published in

used data from 50,515 electronic health records (EHR) for adult primary care patients at community health centers in the US Southwest and Midwest from 2008 to 2013. It found that among all patients who developed dysglycemia, only 54% of whites, 50% of African Americans, and 37% of Latinos qualified for screening under the new guidelines.

The researchers were not surprised by the racial disparities uncovered in their analysis.

“We were interested to do this study because of population trends that racial and ethnic minorities are developing diabetes at younger ages and lower weights than whites,” said lead study author Dr. Matthew O’Brien in a university press release.

Dr. O’Brien offered the following illustration: “Say I’m caring for an obese 32-year-old Hispanic woman with a family history of diabetes who had gestational diabetes with a previous pregnancy. She shouldn’t be screened, according to the guidelines, but she’s very likely to have either prediabetes or diabetes.”

The researchers noted that USPSTF guidelines are on the right track because they are based on the 2 most important risk factors for diabetes: weight and age. Yet, the results of their analysis suggest that additional risk factors are needed to capture a greater proportion of patients who should be screened for diabetes.

Moving forward, Dr. O’Brien and colleagues recommended some next steps to improve upon current procedures. First, they called on the USPSTF to select additional factors to qualify more patients for diabetes screening. Second, they suggested that EHRs be used to alert care providers to screen patients with qualifying risk factors.

For clinicians, expanding upon USPSTF recommendations may create a larger window of opportunity to prevent type 2 diabetes in at-risk patients.

“Preventing and treating diabetes early is very important, especially in this setting of community health centers, where many of their socioeconomically disadvantaged patients face barriers to following up regularly,” Dr. O’Brien continued, “If you miss someone now, it might be years before they come back, at which point they have overt diabetes and maybe even complications, like heart attacks or strokes.”