Monthly Archives: October 2017

Learning Module Improves Community Hospital Anaphylaxis IQ

Proper dosing, administration of epinephrine most commonly missed
by Molly Walker, Staff Writer, MedPage Today October 30, 2017

Action Points
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

BOSTON — Provider education on the dosing and administration of epinephrine improved knowledge among healthcare professionals at three community hospitals in Cleveland about how to properly treat life-threatening allergic reactions, a researcher found.
Mean test scores for knowledge of anaphylaxis increased 31% from baseline among attending physicians, residents, medical students, and nurses, reported John Johnson, DO, of University Hospitals Cleveland Medical Center.
At a presentation at the American College of Allergy, Asthma & Immunology annual meeting, Johnson said that anaphylaxis is often misdiagnosed because there is no definitive diagnosis, and errors in epinephrine dosage, concentration, and treatment route are common, even among healthcare professionals.
Johnson said “observations from our inpatient consult service” suggested there were problems. “We want to have epinephrine ready to go for patients, but we often get the wrong vial sent to us by pharmacy for the proper concentration of epinephrine,” he said.
He added that he’d observed many emergency departments were not ordering a tryptase test, which can help confirm a diagnosis of anaphylaxis, and “by the time someone thinks of ordering it, the patient was way past the 2-hour mark.”
A pre-test, learning module and post-test to track knowledge improvement were administered to 91 nurses, 51 residents, 31 medical students and 16 attending physicians at St. John Medical Center, Richmond and Bedford Hospitals, all affiliated with University Hospitals Cleveland.
The pre- and post-test did not have the same questions. He added that because “not everyone goes to medical school,” they made the language of the questions “friendly to all” — for example “stomach cramping” instead of “abdominal pain.”
Multiple-choice questions addressed the following:
• Time to onset and signs and symptoms of anaphylaxis
• Least likely causes of anaphylaxis
• Route of administration for epinephrine
• Proper dosing of epinephrine
Overall, a little under two-thirds of questions were answered correctly on the pre-test, while 93% of questions were answered correctly on the post-test. Johnson’s team noted that pre-test scores were positively correlated with years of experience among both physicians and physicians-in-training. However, all groups of healthcare professionals had significant improvements on their post-test scores — with groups ranging from a 27% to a 32% improvement in scores.
Proper dosing of epinephrine (1: 1,000 [intramuscular] IM route) was the question that was most commonly answered incorrectly among all groups. Route of administration was also a point of contention, with attending physicians and nurses preferentially choosing intravenous over intramuscular epinephrine for anaphylaxis, “if a patient already had intravenous access.” However, the authors added that selecting the correct dose and administration route on the pre-test did not improve with years of experience.
At the presentation, one clinician said education is thought to be the least effective method of quality improvement, and asked if “another add-on” might be needed.
Johnson said that “continued persistence” was the answer — including doing grand rounds and having greater prevalence in the communities.
“It’s going to be on us to educate people. We’ve been doing this for years and you’d think this would’ve had to change, but it hasn’t,” he commented.
Johnson said that he hoped to go back and reassess these hospitals after a 6 month period to see if the learning module made a difference in the community and improved the overall care that patients are getting. Another next step would be to try and expand this program into other areas of the community, like the school system.
“We want people to be exposed in the proper way and not have this sterile environment that we’re living in where everyone is developing allergies,” he said.

Johnson disclosed no conflicts of interest.
• Primary Source
American College of Allergy, Asthma & Immunology
Source Reference: Johnson JA, et al “Common misconceptions in the recognition and treatment of anaphylaxis in community hospital-based medical professionals” ACAAI 2017; Abstract OR003.

Patients Who Claim Penicillin Allergy Often Aren’t Allergic

Penicillin skin test feasible in ‘real-world’ office setting, researchers say
by Molly Walker, Staff Writer, MedPage Today October 30, 2017

Action Points
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

BOSTON — A large majority of patients at an allergy clinic who said they were allergic to penicillin had negative responses to the agent in skin testing, researchers reported here.
Of the 66 patients who underwent a penicillin skin test, 58 (88%) tested negative, while the most common reason for refusing a penicillin skin test was that the patient was on interfering medications, according to Allison Ramsey, MD, and S. Shahzad Mustafa, MD, both of Rochester Regional Health in Rochester, New York.
While 10% of the U.S. population reports being allergic to penicillin, 90% are not allergic, and less than 0.1% of the 25 million patients who are allergic to penicillin undergo penicillin skin testing annually, Ramsey noted in a presentation at the American College of Allergy, Asthma and Immunology meeting.
“Patients end up on more costly second-line antibiotics that carry more adverse effects. This has implications for antimicrobial resistance,” she noted.
From April to June 2017, two allergy physicians at the Rochester health system, which sees about half pediatric and half adult patients, obtained a detailed penicillin allergy history of 987 patients. This was an average of about 12 half-day sessions per week.
A penicillin skin test (PST) was then offered to all patients with an appropriate history, as well as a timed PST plus amoxicillin challenge in negative patients. The average time for penicillin skin test and challenge was about 71 minutes.
About 60% of patients were women, with an average age of 32, and were about evenly split between first-time and follow-up visits. Penicillin or multiple drug allergy was the chief complaint in about a quarter of patients, followed by asthma (23%), allergic/rhinoconjunctivitis (21%), and food allergy (17%).
Overall, 155 patients (15.7%) reported a penicillin allergy. Nearly half said it had been more than 10 years since they last had a reaction to the drug. Ramsey said that was particularly important because “it’s come up during discussion today that allergy may be one that tends to resolve over time.”
A little over half of patients reported a general non-specific rash as an allergic reaction to penicillin, with about 30% reporting hives and about 6% who didn’t know their reaction history. Six patients were de-labeled based on their history, and a direct challenge was performed in two patients. Around 43% of patients who reported an allergy to penicillin had a PST.
If a skin test was not performed, patients were asked to give a reason why. About a quarter of patients cited interfering medications with antihistaminic properties. There were 16% who said no based on time constraints, but 14% who were scheduled for skin test or a direct challenge at a future time, and only 7% who expressed anxiety about needle testing.
Ramsey said that the study provides a “real-world representation” of how feasible it is to do PST in an outpatient allergy office, regardless of a patient’s chief complaint.
“We’ve seen a lot of great data coming out of inpatient antimicrobial stewardship programs, and this is a model of how penicillin skin testing can be improved with initiatives like this,” she said. “These patients are coming through our doors every day.”

• Primary Source
American College of Allergy, Asthma and Immunology
Source Reference: Ramsey AC and Mustafa SS “A penicillin skin testing initiative in an outpatient allergy practice” ACAAI 2017; Abstract OR005.

New Cards Mean New Medicare Scams

The FTC warns seniors to hang up if they receive calls from individuals claiming to be from Medicare and asking for Social Security or bank information.

Debra Shute, October 25, 2017

New Medicare cards will be mailed out automatically, starting April of 2018, and are free to all 57 million Americans on Medicare, the Federal Trade Commission (FTC) has reminded seniors in response to a new wave of scams related to the update.
The new cards—required under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015—will assign each beneficiary a unique, randomly assigned number, known as a Medicare Beneficiary Identifier (MBI), which replaces the current Social Security Number–based Health Insurance Claim Number (HICN).
The purpose of the change is to reduce identity theft.
But aiming to take advantage of misinformation and confusion among seniors during the transition, scammers are calling seniors and telling them that they must pay for their new Medicare card. According to a Reuters news service report, the senior that filed the complaint was asked for checking account information and Medicare card numbers.
The FTC has verified this report and tells beneficiaries: “Is someone calling, claiming to be from Medicare, and asking for your Social Security number or bank information? Hang up. That’s a scam.”

Debra Shute is the Senior Physicians Editor for HealthLeaders Media.

6 Tips for Preventing ED Falls

As simple as encouraging patients to use the call button
by Laura Kinsella, BSN, RN, CEN October 29, 2017

The emergency department (ED) presents a set of unique challenges for patient care, not the least of which is unstable patients who are at great risk for falls. I once heard a nurse educator proclaim: “Everyone is a fall risk in an ED.” From the elderly to the acutely ill, most patients in the department are at possible risk of falling, whether due to their age, their complaint, or the medications and treatment they are receiving. Additionally, many EDs do not have bed or chair alarms available for gurneys to assist with patient falls. Fall prevention is almost solely in the hands of the busy ED nurse.
Here are six ways you can help prevent patient falls in the emergency setting.
1. Use universal falls precautions.
All patients — from the 30-year-old with abdominal pain to the 65-year-old post–total knee replacement — are at risk of falling. In your own practice, using universal falls precautions can be helpful. Treating all patients as though they have the same risk for falls is a good start. Additionally, performing individual fall risk assessments on each patient at the beginning of his or her visit is important to both assessing risk and documenting that risk in the medical record. If completing a falls risk assessment is not mandatory at your facility, consider printing out the Morse Fall Scale and attaching it to your ID badge for quick reference. A standardized tool can help you quickly quantify the risk of patient falls so you can intervene accordingly.
2. Plan your interventions.
My personal favorite fall prevention intervention is the call light. On patient care whiteboards in the ED rooms, I write my name and the phrase, “Please use your call bell for ANY reason” on the board. I orient patients to the call bell immediately and make sure that it is in reach. I explain to them why both side rails need to stay up. Additionally, you may place fall risk socks (or grippy non-skid socks) on your patient as soon as you get them undressed into a gown. Use a fall risk yellow arm band if they’re available to you.
3. Orient your patient.
“I’m going to be your nurse today, and the best way we can work together is for you to help me keep you safe.” I remind patients that even if they feel fine, that trying to get up after laying down or after receiving high-risk pain medications can cause them to feel weaker or dizzier than they might imagine. I encourage patients to use the call bell so I can help assist them out of bed for any reason, but it is also important to set expectations. “It may take me a few minutes to respond, but I will be there as soon as I can.” Try to point out IV lines and oxygen tubing to patients as well as their EKG cables and monitoring leads to remind them that they will need to stay in bed and cannot get up without assistance.
4. Active toileting.
One of the biggest reasons that patients fall is because they have to use the bathroom. For male patients I always place “just in case” urinals at the bedside, and I encourage female patients to use the call bell as soon as they think they have to use the restroom. It is also recommended that you offer toileting as frequently as possible so that you are able to prevent the “have to go right now” urge that draws patients out of their beds.
5. Teamwork works.
It would be impossible for a nurse to be able to be in all of his or her patients rooms at all times, especially within the environment of the ED. If you have a patient who is a high fall risk, who perhaps has dementia or is uncooperative, notify your charge nurse and your colleagues on the unit. Try to move the patient to a room in sight of the nurses’ station or near a hallway. Keep the curtains to the room open if possible to allow as much sight as possible from passersby. If staffing allows, perhaps you could request a safety sitter to help watch the patient to keep them safe.
6. Speak up.
If there are conditions on your unit that continually put patients at risk for falls, report them to your manager and supervisors. It is everyone’s responsibility to help prevent patient falls.

Laura Kinsella, BSN, RN, CEN, is an emergency room nurse in Washington, D.C. This story was originally published by Daily Nurse, a trusted source for nursing news and information and a portal for the latest jobs, scholarships, and books from Springer Publishing Company.

Flu Vax May Improve Outcomes in Other Illnesses

Vaccinated patients hospitalized with flu had lower risk of AKI development
by Michael Smith, North American Correspondent, MedPage Today October 29, 2017

Action Points
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

TORONTO — Even when the flu vaccine doesn’t prevent disease, it can ease some of the consequences, researchers said here.
In a small single-center study, vaccinated patients admitted to hospital with the flu were significantly less likely to need mechanical ventilation and to suffer acute kidney injury, according to Twinkle Chandak, MBBS, of the Berkshire Medical Center in Lenox, Massachusetts.
And for several other adverse outcomes, there was a trend favoring vaccination, Chandak reported at CHEST, the annual meeting of the American College of Chest Physicians.
Chandak said most vaccine studies tend to look at how well the drug prevents disease, but in the case of seasonal vaccines protection is never complete, so it’s important to know about critical disease outcomes in the presence or absence of vaccination.
But the findings are probably not completely unexpected for clinicians, commented CHEST session co-moderator Keith Wille, MD, of the University of Alabama at Birmingham.
“I think we feel that the vaccine helps,” although it’s nice to have data to support that suspicion, he told MedPage Today, adding that responses to the vaccine are known to be highly variable.
Chandak’s group noted that the predominant circulating strain of influenza in the 2015-2016 flu season was the pandemic strain — H1N1pdm09 — that first emerged in 2009-2010 and has been part of seasonal vaccines every year since.
The investigators took advantage of that fact to evaluated outcomes among vaccinated and unvaccinated patients who were admitted to their 300-bed community teaching hospital from September 2015 through April 2016.
Chandak’s group was interested in outcomes of H1N1pdm09 flu because during the pandemic season, the virus caused some 274,000 hospital admissions and 12,470 deaths in the U.S., according to CDC estimates, and preferentially affected younger people.
During that outbreak, 31% of patients were treated in intensive care and 11% died, she noted.
In 2015-2016, the hospital admitted 72 patients with flu confirmed by rapid polymerase chain reaction testing. Of those, 51 were shown to have disease caused by the H1N1pdm09 strain, even though 38 (76%) of them had been vaccinated, she told MedPage Today.
The analysis showed some significant differences, as well as trends that did not reach significance, in favor of vaccination, she said. Specifically, the risk of acute kidney injury was 35% in unvaccinated patients and 6% in the vaccinated, a difference that was highly significant.
Also, non-invasive ventilation was significantly higher the vaccinated group (41% and 6%), something that Chandak said was likely explained by the trend toward greater use of mechanical ventilation and multi-organ dysfunction syndrome among those who were not vaccinated (12% vs 6% for each).
ICU admission was 21% among the unvaccinated patients and 12% among those who got the shot, and they stayed 1.7 days on average versus 0.2 days, although the differences did not reach significance.
Some 44% of unvaccinated and 24% of vaccinated patients suffered from sepsis, although again, the difference was not significant.
On the other hand, in both groups, 6% of patients died and 12% went into shock and needed vasopressors.
Chandak cautioned that the study was small and the results need validation in larger patient populations.

Chandak and co-authors disclosed no relevant relationships with industry.
• Primary Source
CHEST
Source Reference: Chandak T, et al “H1N1 Influenza (2015-2016): Critical Illness Outcomes in Vaccinated vs Unvaccinated Patients” CHEST 2017.

Gout Equals Diabetes in Stroke Risk

Gout is a known risk factor for cardiovascular disease but not for MI and stroke
by Leo Robert, Rheumatology Network October 28, 2017

Gout is a risk equivalent to diabetes for incident stroke, but that is not the case for incident myocardial infarction (MI).
Having both gout and diabetes confers incremental risk for both incident MI and stroke compared with diabetes alone.
In a study in Arthritis Research & Therapy, researchers at the VA Medical Center in Birmingham and the University of Alabama at Birmingham noted that gout is a known risk factor for cardiovascular disease, cardiovascular mortality, and all-cause mortality but that associations between gout and specific cardiovascular outcomes, MI, and stroke are unclear.
The team therefore assessed whether gout is as strong a risk factor as diabetes for incident MI and incident stroke. The aim was also to estimate the increased cardiovascular risk with gout for women and men in various age groups and examine whether gout is additive to diabetes for cardiovascular risk.
The Study
The investigators used U.S. claims data from 2007 to 2010 that included private and public health plans for the retrospective study. Four mutually exclusive cohorts were identified: (1) diabetes only, (2) gout only, (3) gout and diabetes, and (4) neither gout nor diabetes. Patients with gout, diabetes, or both were slightly older and more likely to be men and have rates of comorbidities higher than in the cohort of patients who had neither condition.
Acute MI and stroke with hospitalization were the outcomes. The researchers compared the age- and sex-specific rates of incident MI and stroke across the four cohorts and assessed multivariable-adjusted hazard ratios (HRs).
Results
The key results were as follows:
• The incidence of acute MI was lowest in patients who had neither gout nor diabetes, followed by patients who had gout alone, diabetes alone, and both
• Among men older than age 80, the rates/1,000 person-years for these cohorts were 14.6, 25.4, 27.7, and 37.4, respectively
• Similar trends were noted for stroke and in women
• The rates for MI and stroke increased with age in all four cohorts
• Compared with diabetes only, gout was associated with a significantly lower adjusted HR of incident MI but a similar risk of stroke
• HRs for incident MI and stroke were higher in patients who had both gout and diabetes compared with patients who had diabetes only
Implications
The researchers cited the following as the main implications for clinicians:
• Recognition of gout as a cerebrovascular risk equivalent to diabetes implies that primary, secondary, and tertiary prevention of stroke may be needed in patients who have gout to reduce the increased risk
• Screening for risk factors for stroke (hypertension, diabetes, hyperlipidemia) and aggressive treatment may be warranted in patients who have gout
• Whether physicians may consider empiric use of lipid-lowering agents in a subgroup of patients with gout at high risk for cardiovascular events remains to be seen
• Optimal treatment of gout that targets both hyperuricemia and systematic inflammation may be needed to reduce stroke risk in patients who have gout
• To what extent each of these strategies reduces the risk of stroke in patients who have gout might be determined in large-sample observational studies or randomized trials of high-risk patients
• Cardiovascular disease prevention and treatment strategies that are in place for patients with diabetes may be applicable to patients who have gout
• By showing that gout is a cerebrovascular risk equivalent of diabetes for stroke, which is associated with high cardiovascular mortality, this study supports the previous finding that linked gout to higher overall mortality.
Conclusions
“As an inflammatory disease commonly associated with high comorbidity load (hypertension, diabetes, hyperlipidemia, obesity, renal failure) and systemic inflammation, gout can be effectively treated with inexpensive generic medications,” the authors concluded.
“On the basis of our study results, the presence of gout should alert physicians to screen, diagnose, and promptly treat cardiovascular risk factors (hypertension, hyperlipidemia), similar to the approach used in patients with diabetes.”

This article originally appeared on our partner’s website Rheumatology Network, which is a part of UBM Medica. (Free registration is required.)
last updated 10.27.2017
• Primary Source
Arthritis Research & Therapy
Source Reference: Singh JA, et al. “Is gout a risk equivalent to diabetes for stroke and myocardial infarction? A retrospective claims database study.” Arthritis Res Ther 2017 DOI: 10.1186/s13075-017-1427-5.

Combined Adequate Vitamin K and D Could Improve Knee OA

Post-hoc analysis of trial data suggests benefit
by Diana Swift, Contributing Writer October 27, 2017

Action Points
• Note that this observational study suggested worse physical performance in osteoarthritis among those with insufficient vitamin K and D levels.
• Whether this is causative remains up for debate — low vitamin levels may be a marker of poor overall health.

The combination of sufficient serum vitamin K and vitamin D status was associated with improved lower-extremity function in two knee osteoarthritis (KOA) cohorts, according to findings published online in Arthritis Care & Research.
Having adequate serum levels of both nutrients was variously linked to better function, faster gait, and faster chair stand times at baseline and over time, suggesting that dual supplementation may benefit some KOA patients, whereas vitamin D supplements alone have not.
“These findings merit confirmation in vitamin K and D co-supplementation trials,” wrote M. Kyla Shea, PhD, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, and colleagues.
While epidemiologic data have suggested that low vitamin D is associated with more radiographic OA and progression, most trials of KOA vitamin D supplementation alone have not shown improved structural or functional outcomes. Last year, for example, Nigel Arden et al reported that vitamin D supplementation did not slow the rate of KOA joint space narrowing or produce reductions in pain, stiffness, and functional loss over a 3-year period, leading the authors to conclude that vitamin D supplementation has no role in managing KOA.
Randomized controlled clinical trials of co-supplementation might alter that view, said Shea and colleagues. Using a single measurement, they evaluated baseline K and D sufficiency (as circulating phylloquinone/25-hydroxy vitamin D) and lower-extremity function in the Health, Aging Body Composition Knee OA Sub-study (Health ABC) cohort and then replicated the analysis in the Osteoarthritis Initiative (OAI). These two nutrients are mechanistically linked, because the expression of vitamin K-dependent proteins in joint tissues requires the 25(OH)D, active form of vitamin D.
The 1,069 participants in Health ABC had a mean age of approximately 75, and more than 60% were female. Patients’ function was based on the Short Physical Performance Battery (SPPB) and their usual 20-meter gait speed.
Dietary intakes of both vitamins were assessed by the Block Brief 2000 Food Frequency Questionnaire. Sufficient vitamin K intake was defined according to the Institute of Medicine recommendations of ≥90 mcg/day for women and ≥120 mcg/day for men. Sufficient vitamin D intake was defined as ≥600 IU/day for men and women younger than 70 and ≥800 IU/day for men and women 70 and over. The vitamin D included was that from both food and supplements, while vitamin K was restricted to food sources.
In Health ABC, participants with adequate levels of both vitamins were more likely to be male and/or white. In the 4,475 participants in the OAI cohort, those reporting sufficient intakes of both nutrients were more likely to be female and/or Caucasian. In OAI participants with the lowest levels of both nutrients, the mean Healthy Eating Index score was 66, rising to 71 in those with the highest combined levels.
In terms of education, 24% of those with less than a high school education were in the top level of the combined vitamins, whereas 44% in that category had a college education or higher.
Health ABC participants with sufficient plasma vitamin K (≥1.0 nmol/L) and serum 5(OH)D (≥50 nmol/ L) generally had better SPPB and Health ABC-PPB scores and faster 20-meter gait speed at baseline and over 4-5 years of follow-up (P≤0.002) . In the OAI analysis, sufficient combined intake correlated with overall faster usual gait speed and chair stand completion time over follow-up (P≤0.029).
The effect of higher combined nutrient status on lower-extremity function was additive, the team found. For example, in Health ABC those with circulating phylloquinone ≥1.0 nmol/L combined with 25(OH)D ≥50 nmol/L had, on average, a 0.04-0.07 meter per second (m/s) faster 20-meter gait speed (adjusted for confounders) than those with phylloquinone <1.0 nmol/L or 25(OH)D <50 nmol/L.
In the Health ABC 400-meter walk test, circulating combined levels were not significantly associated either with completion time in those who completed the walk or with the ability to complete the walk at baseline.
Analyzing each nutrient separately, the investigators also observed a slight positive difference in 20-meter gait speed. The difference in participants with < or ≥ 1.0 nmol/L plasma phylloquinone was 0.02-0.03 m/s (17), and the difference between participants with < or ≥ 50 nmol/L serum 25(OH)D was also, on average, 0.02-0.03 m/s. (A 0.05 m/s difference is considered clinically meaningful.)
In the OAI cohort, sufficient combined K/D intake at baseline was associated with overall faster 20-meter gait speed, chair stand completion time, and 400-meter walk time among completers of the walk.
Asked for his perspective on the findings, Brett L. Smith, DO, of the East Tennessee Medical Group in Alcoa and not a participant in the study, told MedPage Today: “I think the findings are very intriguing because the vitamin D studies have typically failed. This is one of the first positive studies of adequate circulating vitamin D and K repletion where we actually see an improvement in lower-extremity function in the very common problem of KOA. Clinical trials should be done, because the observational data is very suggestive.”
Smith said he does not currently test for vitamin K levels in KOA patients or suggest an increase in intake because of the lack of supporting data and the absence of an established standard of care for vitamin K consumption. But he would consider conducting a small observational study in his practice to see if the nutrient improves function: “If I can get enough results, I could perhaps use them to propose a clinical trial.”
Shea and colleagues noted that limitations to their study are its observational design, which cannot determine causality; the one-time-only measurement of circulating vitamins, which could not capture nutritional changes over time; and patient self-reporting of dietary intakes. Other drawbacks were the lack of an established clinical measure of vitamin K status and the confounding potential that adequate serum levels of these vitamins might reflect just a generally healthy lifestyle.

The study was conducted by the Osteoarthritis Initiative, which is funded by a partnership between the National Institutes of Health and industry members, and by several nonprofit government or academic research-funding bodies.
The authors reported having no competing interests.
• Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner
• Primary Source
Arthritis Care & Research
Source Reference:
Shea MK, et al “Sufficient vitamin K status combined with sufficient vitamin D status is associated with better lower extremity function: a prospective analysis of two knee osteoarthritis cohorts” Arthritis Care Res 2017; DOI: 10.1002/acr.23451.

CDC recommends new shingles vaccine to replace older one

By Susan Scutti, CNN Thu October 26, 2017

(CNN) A new adult vaccine has received a double thumbs-up from the American federal health system.
On the heels of Friday’s Food and Drug Administration approval of Shingrix, a new vaccine from GlaxoSmithKline for the prevention of shingles, a federal committee of immunization experts voted Wednesday to recommend Shingrix for all Americans 50 and older.
Shingles, also known as herpes zoster, is a painful, itchy rash that develops on one side of the body and can last for two to four weeks. One in three Americans will develop shingles in their lifetime, with the risk increasing to half of adults over 85, according to the US Centers for Disease Control and Prevention.
The Advisory Committee on Immunization Practices, which advises the CDC on vaccine usage, also recommended that adults who received Zostavax, a shingles vaccine made by Merck, be revaccinated with Shingrix.
Additionally, the committee expressed its preference for Shingrix over Zostavax.
GlaxoSmithKline says Shingrix will be available “shortly.”
Zostavax was licensed and recommended by the committee in 2006 for people 60 and older, including those who have had an episode of shingles. Until now, it has been the only approved vaccine to protect against the virus.
Vaccine differences
Vaccines “teach” the body’s immune system how to identify and protect itself against a virus or microbe it has not come into contact with.
Shingles is caused by a reactivation of the varicella zoster virus, the same virus that causes chickenpox.
Zostavax, a live-attenuated vaccine, introduces a weaker (attenuated) version of the varicella zoster virus in order to stimulate the immune system.
By comparison, Shingrix is a non-live, subunit vaccine that works by introducing only an essential subunit of the actual microbe. The intention of using part rather than the whole pathogen is to reduce the possibility of the body having an adverse reaction.
Zostavax is a single-shot vaccine that is given once. Shingrix is also a one-time-only vaccine, yet two shots are given two months apart.
Between 10% and 18% of patients will experience a complication known as postherpetic neuralgia, which causes pain and lasts from three months up to several years, once the shingles rash is gone.
Studies presented to the committee show that Zostavax is 51% effective against shingles and 67% effective against postherpetic neuralgia.
In contrast, Shingrix is 97% effective against shingles for people between the ages of 50 and 69 and 91% effective for people 70 or older. It is 91% effective against postherpetic neuralgia for people 50 and older. These rates are based on evidence presented to the committee from clinical trials with over 38,000 total participants.
Both vaccines wane in effectiveness over time. Zostavax diminishes in effectiveness by 15% to 25% after the first year and shows no significant protection by the ninth year, according to research presented to the committee. Shingrix remained at or above 85% effectiveness up to four years after vaccination; longer-term effectiveness is unknown.
Committee considerations
About 31% of the US population age 60 and older — about 20 million people — has been vaccinated with Zostavax, which is considered high uptake for an adult vaccine, according to the CDC.
More than one committee member suggested that familiarity with shingles — and the serious pain it can cause — accounts for this unusually high rate of acceptance. There are an estimated 1 million cases of shingles in the nation each year, according to the CDC.
Deliberating before the vote, the committee examined the cost-effectiveness of the two vaccines by estimating the total price of each vaccine and the costs when people become ill and compared the relative economic impacts.
The committee also considered possible challenges to giving adults two shots of a vaccine instead of only one. Real world data on other two-dose vaccines suggest that some people do not get both doses.
With little fuss, the majority of the 15-member committee voted both to recommend Shingrix and revaccination with it.
The pre-vote debate became lively, though, when considering whether to prefer Shingrix over Zostavax for the prevention of shingles and related complications.
“It’s not so much a matter of not preferring (Shingrix); it’s a matter of not preferring this vaccine at this particular moment in time,” said Cynthia Pellegrini, the solo consumer representative on the committee.
Though eight members voted in favor of preferring Shingrix, Pellegrini and six others voted against the motion.
She would rather the committee “wait a year or two and get a little bit more data about the real-world uptake implications of this vaccine,” she said.
Pellegrini admitted that Shringrix has been studied “very extensively” for almost a decade.
Though the clinical studies included a large number of participants, she noted that participation rates among ethnic minorities were “quite low.” Different population groups, then, might have bad reactions to the vaccine not yet seen by the scientists, she said.
Though outvoted on the preference issue, she voted in favor of recommending Shingrix for everyone over 50 and revaccination for those who had received Zostavax.

Correction: This story has been updated to reflect that the FDA approved Shingrix on Friday, October 20.

Baby food and formulas tested positive for arsenic, lead and BPA in new study

Ashley May, USA TODAY , October 25, 2017

An alarming study released Wednesday found many baby food products test positive for arsenic, including 80% of infant formulas. And, that’s not the only dangerous contaminate found.
The Clean Label Project, a nonprofit advocating for transparent labeling, tested baby food, infant formulas, toddler drinks and snacks purchased within the past 5 months. The group looked at top-selling formulas and baby food using Nielson data, and also included emerging national brands. After about 530 baby food products were tested, researchers found 65% of products tested positive for arsenic, 36% for lead, 58% for cadmium and 10% for acrylamide. All of these chemicals pose potential dangers to developing infants.
Jennifer Lowry, pediatrician and toxicologist at Children’s Mercy Hospital in Kansas City, Mo., who is not affiliated with the research, said these chemicals can affect fine motor skills and cognition.
Mainstream brands including Gerber, Enfamil, Plum Organics and Sprout were among the worst offenders — scoring two out of five in the Clean Label Project’s report card for toxic metals. Plus, 60% of products claiming to be “BPA free” tested positive for the industrial chemical bisphenol A. The quantities of contaminates range, but some products tested positive for up to 600 parts of arsenic per billion. That’s far more than just trace amounts.
Arsenic was the most common contaminate spotted in the Clean Label Project study. Nearly 80% of infant formula samples tested positive for arsenic. The toxin is associated with developmental defects, cardiovascular disease, neurotoxicity, diabetes and even cancer, according to the World Health Organization.
Jaclyn Bowen, executive director of Clean Label Project and a food safety scientist, said rice-based baby food such as snack puffs had some of the highest levels of arsenic.
In 2016, the U.S. Food and Drug Administration proposed a limit of 100 parts per billion of arsenic in infant rice cereal, but isn’t enforcing that limit. Rice often absorbs arsenic from contaminated soil as it grows in the environment.
“It is important for consumers to understand that some contaminants, such as heavy metals like lead or arsenic, are in the environment and cannot simply be removed from food,” Peter Cassell, a FDA spokesperson.
Lead, also found in food tested by the Clean Label Project, has been found in baby food before. Just a few months ago, the Environmental Defense Fund found 20% of 2,164 baby food samples tested contained lead. No amount of lead is safe, but it’s not regulated.
Low levels of lead in children’s blood have been connected to lower IQs, slowed growth, behavioral problems, hearing issues and anemia, according to the Environmental Protection Agency.
The Clean Label Project posted a list of products it tested, along with a star-rating grade informed by the California Office of Environmental Health Hazard Assessment, on its website. Bowen said she hopes the data helps parents become better advocates for their children’s health, and creates change in the baby food business.
“The baby industry needs to do a better job in protecting America’s most vulnerable population,” Bowen said.

Tracy Loew, (Salem, Ore.) Statesman Journal contributed to this report.
© 2017 USATODAY.COM

Unlabeled Ingredients in ‘Herbal’ Supplements Seen Causing Liver Injury

Common culprits: body-building, weight-loss products
by Joyce Frieden, News Editor, MedPage Today October 24, 2017

WASHINGTON — Herbal products and supplements are frequently mislabeled and may contain unlisted ingredients that are harmful to the liver, researchers said here.
Of 272 herbal dietary supplements analyzed, 51% had inaccurate labels in which some or all of the listed ingredients were not detected in the product, Victor Navarro, MD, of the department of transplantation at the Einstein Healthcare Network, in Philadelphia, and colleagues found.
“Herbal supplements are a common cause of liver injury,” Navarro said at a press briefing at the annual meeting of the American Association for the Study of Liver Diseases. “There are lots of products that are difficult to identify what they are and what they’re used for.”
A group of investigators known as the Drug-Induced Liver Injury Network, supported by the National Institute of Diabetes and Digestive and Kidney Diseases, collects cases of drug-induced liver injury; in 20% of cases, the injury was caused by dietary supplements, said Navarro, a member of the network. Many of the products are sold as body-building supplements or weight-loss supplements.
“A lot of the literature tells us supplements can be mislabeled or adulterated” — the latter occurring when something is secretly included to support the purpose for which it is being marketed, such as for sexual enhancement, he added.
Members of the 14-year-old network, which comprises six clinical centers and a data coordinating center, documented drug-induced liver injuries in 1,775 patients from 2003 to 2015. Of those, 375 reported taking at least one dietary supplement, and 101 patients contributed 337 supplement samples for analysis.
Of those samples, 272 had labels and were suitable for chemical analysis. Within that group, 96 products, taken by a total of 71 patients, were determined to be causes of liver injury.
The investigators then analyzed the supplements using high-pressure liquid chromatography and mass spectrometry. Some were found to contain hepatotoxins including anabolic steroids or pharmaceuticals, Navarro said. “We could look at the cases and determine that the actual injury came from the unlabeled ingredient … The next step is to look more carefully at all of these cases [and] continue our chemical analysis.”
Dietary supplements are regulated very differently from drugs, and they are not tested for safety, he pointed out. “If you look at the definition of a dietary supplement, it implies there is a deficiency in the diet.” While he and his colleagues can’t name a specific supplement to avoid, “When a provider is asked which supplements someone should take, if there’s no dietary deficiency, there is no reason to recommend that a patient should take supplements,” said Navarro.
All of these injury cases have been reported to the FDA MedWatch database, he said. “Many products we have identified as having these ingredients are not even marketed any more, and that could [happen over] a matter of months … We’re at the leading edge of this; we’re going to have to tighten that association [between the products and the injuries] and that’s going to be a challenge. We’ve identified some products we’re convinced cause liver injury [but] right now it’s very circumstantial.”
One positive outcome of the study is that it highlights the fact that these herbal products contain ingredients that are unknown to the patients taking them, said Norah Turreault, MD, of the University of California San Francisco, who moderated the session where the research was presented. However, the researchers are being cautious because “establishing what’s in them that’s related to hepatotoxicity is where they’re really working to build a stronger causality argument … But some awareness that there are things in the products that are not labeled is an important message to get out.”
Navarro had no disclosures. Terrault disclosed relevant relationships with Dynavax, Gilead, Bristol Myers Squibb, Novartis, Merck, Intercept, Biotest, Vertex, AbbVie, and Eisai.