Kaiser Permanente

Five Reasons Why You Should Probably Stop Using Antibacterial Soap

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As the FDA recently noted, antibacterial products are no more effective than soap and water, and could be dangerous

antibacterial soap

A few weeks ago, the FDA announced a bold new position on antibacterial soap: Manufacturers have to show that it’s both safe and more effective than simply washing with conventional soap and water, or they have to take it off the shelves in the next few years.

 About 75 percent of liquid antibacterial soaps and 30 percent of bars use a chemical called triclosan as an active ingredient. The drug, which was originally used strictly in hospital settings, was adopted by manufacturers of soaps and other home products during the 1990s, eventually ballooning into an industry that’s worth an estimated $1 billion. Apart from soap, we’ve begun putting the chemical in wipes, hand gels, cutting boards, mattress pads and all sorts of home items as we try our best to eradicate any trace of bacteria from our environment.

But triclosan’s use in home over-the-counter products was never fully evaluated by the FDA—incredibly, the agency was ordered to produce a set of guidelines for the use of triclosan in home products way back in 1972, but only published its final draft on December 16 of last year. Their report, the product of decades of research, notes that the costs of antibacterial soaps likely outweigh the benefits, and forces manufacturers to prove otherwise.

Bottom line: Manufacturers have until 2016 to do so, or pull their products from the shelves. But we’re here to tell you that you probably shouldn’t wait that long to stop using antibacterial soaps. Here’s our rundown of five reasons why that’s the case:

1. Antibacterial soaps are no more effective than conventional soap and water. As mentioned in the announcement, 42 years of FDA research—along with countless independent studies—have produced no evidence that triclosan provides any health benefits as compared to old-fashioned soap.

“I suspect there are a lot of consumers who assume that by using an antibacterial soap product, they are protecting themselves from illness, protecting their families,” Sandra Kweder, deputy director of the FDA’s drug center, told the AP. “But we don’t have any evidence that that is really the case over simple soap and water.”

Manufacturers say they do have evidence of triclosan’s superior efficacy, but the disagreement stems from the use of different sorts of testing methods. Tests that strictly measure the number of bacteria on a person’s hands after use do show that soaps with triclosan kill slightly more bacteria than conventional ones.

But the FDA wants data that show that this translates into an actual clinical benefit, such as reduced infection rates. So far, analyses of the health benefits don’t show any evidence that triclosan can reduce the transmission of respiratory or gastrointestinal infections. This might be due to the fact that antibacterial soaps specifically target bacteria, but not the viruses that cause the majority of seasonal colds and flus.

2. Antibacterial soaps have the potential to create antibiotic-resistant bacteria. The reason that the FDA is making manufacturers prove these products’ efficacy is because of a range of possible health risks associated with triclosan, and bacterial resistance is first on the list.

Heavy use of antibiotics can cause resistance, which results from a small subset of a bacteria population with a random mutation that allows it to survive exposure to the chemical. If that chemical is used frequently enough, it’ll kill other bacteria, but allow this resistant subset to proliferate. If this happens on a broad enough scale, it can essentially render that chemical useless against the strain of bacteria.

This is currently a huge problem in medicine—the World Health Organization calls it a “threat to global health security.” Some bacteria species (most notably, MRSA) have even acquired resistance to several different drugs, complicating efforts to control and treat infections as they spread. Health officials say that further research is needed before we can say that triclosan is fueling resistance, but several studieshave hinted at the possibility.

3. The soaps could act as endocrine disruptors.  A number of studies have found that, in rats, frogs and other animals, triclosan appears to interfere with the body’s regulation of thyroid hormone, perhaps because it chemically resembles the hormone closely enough that it can bind to its receptor sites. If this is the case in humans, too, there are worries that it could lead to problems such as infertility, artificially-advanced early puberty, obesity and cancer.

These same effects haven’t yet been found in humans, but the FDA calls the animal studies “a concern”—and notes that, given the minimal benefits of long-term triclosan use, it’s likely not worth the risk.

4. The soaps might lead to other health problems, too. There’s evidence that children with prolonged exposure to triclosan have a higher chance of developing allergies, including peanut allergies and hay fever. Scientists speculate that this could be a result of reduced exposure to bacteria, which could be necessary for proper immune system functioning and development.

Another study found evidence that triclosan interfered with muscle contractions in human cells, as well as muscle activity in live mice and minnows. This is especially concerning given other findings that the chemical can penetrate the skin and enter the bloodstream more easily than originally thought. A 2008 survey, for instance, found triclosan in the urine of 75 percent of people tested.

5. Antibacterial soaps are bad for the environment. When we use a lot of triclosan in soap, that means a lot of triclosan gets flushed down the drain. Research has shown that small quantities of the chemical can persist after treatment at sewage plants, and as a result, USGS surveys have frequently detected it in streams and other bodies of water. Once in the environment, triclosan can disrupt algae’s ability to perform photosynthesis.

The chemical is also fat-soluble—meaning that it builds up in fatty tissues—so scientists are concerned that it can biomagnify, appearing at greater levels in the tissues of animals higher up the food chain, as the triclosan of all the plants and animals below them is concentrated. Evidence of this possibility was turned up in 2009, when surveys of bottlenose dolphins off the coast of South Carolina and Florida found concerning levels of the chemical in their blood.

What Should You Do?

If you’re planning on giving up antibacterial soap—like Johnson & Johnson, Kaiser Permanente and several other companies have recently done—you have a couple options.

One is a non-antibiotic hand sanitizer, like Purell, which don’t contain any triclosan and simply kill both bacteria and viruses with good old-fashioned alcohol. Because the effectiveness of hand-washing depends on how long you wash for, a quick squirt of sanitizer might be more effective when time is limited.

Outside of hospitals, though, the CDC recommends the time-tested advice you probably heard as a child: wash your hands with conventional soap and water. That’s because while alcohol from hand sanitizer kills bacteria, it doesn’t actually remove dirt or anything else you may have touched. But a simple hand wash should do the trick. The water doesn’t need to be hot, and you’re best off scrubbing for about 30 seconds to get properly clean.

Ulcer pills linked to B12 deficiency

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Medication used to treat stomach ulcers may cause potentially harmful vitamin B12 deficiency, say experts.

A US study of 200,000 people in the Journal of the American Medical Association found the link.

People who took tablets known as proton pump inhibitors (PPIs) or histamine antagonists (H2RAs) were more likely to lack enough vitamin B12 for good health.

Left untreated, B12 deficiency can lead to dementia and neurological problems.

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Only a minority of patients on long term proton pump inhibitors showed evidence of vitamin B12 deficiency”

Prof Mark Pritchard of the British Society of Gastroenterology

The study authors say doctors should still prescribe these medicines, but that they should weigh possible harms against any benefits in patients who need the drugs for prolonged periods of time.

More investigations are needed to fully evaluate the risk which appears to be in people who take these medications for two or more years, they say.

Link not proof

The Kaiser Permanente researchers found that the link with B12 deficiency increased with dose and was stronger in women and younger age groups.

But the overall risk was still low.

PPIs and H2RAs are commonly prescribed for patients with symptoms of stomach ulcers such as heartburn and indigestion.

The tablets are also widely available to buy without a prescription, ‘over-the-counter’ at pharmacies.

They work by reducing the amount of acid made by your stomach.

Stomach acid is needed for us to absorb vitamin B12 from our food, such as meat, fish and dairy.

If identified, most cases of B12 deficiency can be easily treated by giving supplements or an injection of vitamin B12.

But symptoms, such as lethargy, can be vague and overlooked.

Prof Mark Pritchard of the British Society of Gastroenterology said people should not be concerned by the findings.

“Only patients who had taken these tablets for more than two years were at risk and only a minority of patients on long-term proton pump inhibitors showed evidence of vitamin B12 deficiency.”

He said people taking ulcer medications could ask their GP for a simple blood test to measure vitamin B12 levels if they are worried.

System-Wide Effort Improves Hypertension in 80% of Patients.

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When Kaiser Permanente Northern California (KPNC) initiated a program to control hypertension in its patient population in 2001, less than half of patients diagnosed with hypertension had their blood pressure under control. Nine years later, 80% of KPNC hypertensive patients had blood pressures lower than 140/90 mm Hg, an improvement rate that exceeded both state and national trends.

Marc G. Jaffe, MD, from the Department of Endocrinology, Kaiser Permanente South San Francisco Medical Center, California, and colleagues tracked data from KPNC, 1 of 8 divisions of the integrated managed care organization, Kaiser Permanente, as it adopted a system-wide program employing several strategies to improve blood pressure control. They published the results of the program in the August 21 issue of JAMA.

In the quality improvement program, patients were identified each quarter for inclusion in a hypertension registry based on diagnostic codes, pharmacy data, and hospital records. Hypertension control rates were generated every 1 to 3 months for each KPNC medical center and distributed to center directors. The group used those data to identify practices associated with higher control rates, which they disseminated to other centers.

A hypertension control algorithm, based on emerging evidence, was updated every 2 years, suggesting a step-wise approach to hypertension medications for blood pressure control. In addition, in 2005, single-pill combination therapy of lisinopril-hydrochlorothiazide was incorporated into the regional guideline as first-line medication. In 2007, KNPC added patient follow-up visits with medical assistants 2 to 4 weeks after a medication adjustment to monitor medication control success.

Between 2001 and 2009, the KPNC hypertension registry population grew from 349,937 patients (15.4% of the adults in KPNC) to 652,763 patients (27.5% of the adults in the system).

By 2009, the hypertension control rate for KPNC was 80.4% (95% confidence interval [CI], 75.6% – 84.4%) compared with the initial control rate of 43.6% (95% CI, 39.4% – 48.6%) in 2001 (P < .001 for trend).

In comparison, the Healthcare Effectiveness Data and Information Set national mean hypertension control rate improvement failed to meet statistical significance, rising from 55.4% to 64.1% (P = .24 for trend) during the same period. The increase across California, available only since 2006, also failed to reach statistical significance, rising from 63.4% to 69.4% (P = .37 for trend).

Moreover, the KPNC hypertension control rate has continued to rise in years after the study, climbing to 83.7% in 2010 and 87.1% in 2011, the authors report.

Abhinaval Goyal, MD, MHS, assistant professor of medicine, Division of Cardiology, Emory School of Medicine, Atlanta, Georgia, and William A. Bornstein, MD, PhD, chief quality and medical officer, Emory Healthcare, Atlanta, authors of an accompanying editorial, call the KPNC study “an important contribution to the science of improving systems of care to detect and treat community-based hypertension.”

Dr. Goyal and Dr. Bornstein write that fee-for-service environments are less likely to implement approaches such as those used in the KNPC study because of the dual risks of increased costs and decreased reimbursements. “Fully integrated health systems (such as KPNC) that assume full responsibility by both insuring and delivering health care are particularly invested in managing risk factors to reduce downstream costs,” they write.

However, a transition to value-based models in all health sectors and the growth of accountable care organizations and shared savings models could ultimately make this kind of approach more widespread.

 

Source: JAMA.

Telehealth Follow-up in Lieu of Postoperative Clinic Visit for Ambulatory Surgery.

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Importance  Telehealth encounters can safely substitute for routine postoperative clinic visits in selected ambulatory surgical procedures.

Objective  To examine whether an allied health professional telephone visit could safely substitute for an in-person clinic visit.

Design  Prospective case series during a 10-month study period from October 2011 to October 2012 (excluding July and August 2012).

Setting  University-affiliated veterans hospital.

Patients  Ambulatory surgery patients who underwent elective open hernia repair or laparoscopic cholecystectomy during the 10-month study period.

Interventions  Patients were called 2 weeks after surgery by a physician assistant and assessed using a scripted template. Assessment variables included overall health, pain, fever, incision appearance, activity level, and any patient concerns. If the telephone assessment was consistent with absence of infection and return to baseline activities, the patient was discharged from follow-up. Patients who preferred a clinic visit were seen accordingly.

Main Outcomes and Measures  Percentage of patients who accepted telehealth follow-up and complications that presented in telehealth patients within 30 days of surgery.

Results  One hundred fifteen open herniorrhaphy and 26 laparoscopic cholecystectomy patients had attempted telehealth follow-up. Seventy-eight percent (110) of all patients were successfully contacted; of those, 70.8% (63) of hernia patients and 90.5% (19) of cholecystectomy patients accepted telehealth as the sole means of follow-up. Complications in the telehealth patients were zero for cholecystectomy and 4.8% (3) for herniorrhaphy. Nearly all patients expressed great satisfaction with the telephone follow-up method.

Conclusions  Telehealth can be safely used in selected ambulatory patients as a substitute for the standard postoperative clinic visit with a high degree of patient satisfaction. Time and expense for travel (7-866 miles) were reduced and the freed clinic time was used to schedule new patients.

Delivery of surgical care that is more efficient and cost-effective and has a high degree of patient satisfaction with excellent outcomes is a necessary evolution of the current surgical practice model. An in-person postoperative clinic evaluation is the “gold standard” throughout the United States. Some practices such as Kaiser Permanente use allied health care providers in lieu of surgeons to see the postoperative patients (N. Baril, MD, oral communication, December 12, 2012). The Veterans Health Care System provides care to eligible patients who come from sizeable catchment areas. The patients often must travel significant distances, which represent an investment on their part of time, missed work, and travel costs for a postoperative clinic visit that is typically quite brief. Therefore, as a quality initiative, we examined whether an allied health professional telephone visit could safely substitute for an in-person clinic visit.

For this pilot study, we defined a telehealth visit as a telephone call performed by a trained allied health care provider. This alternative has not been extensively studied, but a review of the literature demonstrates good patient satisfaction without compromise of overall patient care.1– 4 Several studies have shown that patients appreciate the ability to speak with their physicians or a physician’s surrogate by telephone and are highly satisfied with this mode of communication.1– 4 Advantages of telephone contact are the omission of clinic wait times and the elimination of the costs associated with traveling for an in-person clinic visit.2 Studies using telephone follow-up have been conducted in acute and chronic medical and surgical settings,4outpatient anorectal surgery,5 outpatient laparoscopic cholecystectomy,6 and pediatric adenotonsillectomy.7 These reports demonstrate that telephone encounters are safe for the patient and give the opportunity to provide advice and education and selectively identify individuals in need of actual in-person postoperative visits.2,4,8

Elective open hernia repairs and laparoscopic cholecystectomies are ambulatory procedures where potential complications are well characterized and infrequent.9– 10 The majority of postoperative clinic visits are often perfunctory with patients not having substantive issues that need acute medical attention. When there are complications, many of these patients present outside of the clinic visit with either a telephone call to the surgeon or to the emergency department. Therefore, these patients seemed to be the ideal cases that could be used for a pilot study before expanding to other ambulatory cases such as laparoscopic hernia repairs. Advantages to the patient would be convenience, no need to travel, and no loss of time. Advantages to the surgical service would be increased clinic access slots for new patients and decreased cost in the delivery of care.

DISCUSSION

Telehealth follow-up has been investigated and reviewed in various medical settings.1– 5,7– 8 Despite its demonstrated efficacy, there has not been widespread adoption in surgical practices. Our pilot study successfully demonstrates that patients who underwent elective open herniorrhaphy and laparoscopic cholecystectomy can be followed up safely by telehealth. Moreover, this approach has demonstrated acceptable complication assessment rates. Complications will occur after surgical procedures but the critical question to ask is whether there were any delays in diagnosis or worsened outcomes because of the lack of an in-person clinic visit. All but 1 of the hernia complications within 30 days were minor wound issues; the single serious complication of hematoma presented acutely and represented to the emergency department a second and third time even while being closely followed up in the clinic. No missed morbidity or mortalities were found on 30-day medical record review.

This pilot project was received very positively by our surgical staff and convincingly demonstrated to them that the vast majority of selected ambulatory patient follow-up could be done by telephone, with referral to the clinic based on the telephone evaluation. In the pilot, we learned that a process was necessary to facilitate completion of return-to-work or disability forms outside of a clinic visit. Our hospital is trying to expand the role of telehealth in the care of patients in our large catchment area. The director of the hospital telehealth program now recommends that a formal telehealth appointment be scheduled to set patients’ expectations. The 110 clinic slots that were opened up by use of this program were able to be used for new patients and helped improve clinic access and wait-time issues. We cannot provide any hospital cost data but a 10-minute physician assistant telephone call compared with a 5- to 10-minute surgeon visit in the clinic would most likely show a cost savings. More important is the savings of the patient’s time and resources to drive to the hospital for a brief and often cursory visit. In the cohort that accepted the telehealth visit, 51% had a round-trip driving distance of greater than 100 miles and 71% had a greater than 1 hour total commute.

Greater than 70% of patients contacted via telehealth willingly accepted this mode of communication for their postoperative care and no complaints were received. The observed low complication rate, none of which were directly tied to the lack of a postoperative clinic visit, helps demonstrate that patient care and outcomes were not compromised. It is our belief that this is applicable to non–veterans hospital practices. In general, people appreciate respecting their time, and elimination of a low-impact clinic visit while still maintaining patient contact through a telephone call should result in overall high patient satisfaction.

A potential weakness is the inference of cost savings to the system because a formal cost analysis was not performed. Since this was a pilot program, we can only infer conclusions about the true impact on health care costs. Overall, patients expressed satisfaction for our telehealth services, saving them from driving long distances and clinic wait times.

In conclusion, this pilot study demonstrated that a scripted telehealth visit by an allied health professional can be safely and effectively used for the postoperative care of open herniorrhaphy and laparoscopic cholecystectomy patients. There were no complications that resulted from the substitution of telehealth for a “gold standard” clinic visit. Expansion of telehealth follow-up to other selected procedures with low morbidities will be expanded within our service. The net results of increased clinic slots for new patients; patient satisfaction with avoiding travel; hospital cost savings by not using clinic space, resources, and staffing; and cost shifting the follow-up care from a physician to an allied health professional should all positively impact the cost of care for both the patient and the hospital. Evolution of care needs to continue with the aim of providing outstanding outcomes, at the lowest cost, and with a high degree of patient satisfaction. This program appears to satisfy all of these goals and is a direction that should be considered by other high-volume ambulatory practices, with care taken to select the correct mix of procedures.

 

Source: JAMA

Online Access to Personal Health Records Increases Use of Services .

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Patients with online access to personal health records unexpectedly increased their use of most clinical services, according to a JAMA study. Previous studies found the opposite effect.

The retrospective cohort study involved some 44,000 users of Kaiser Permanente Colorado‘s MyHealthManager who were matched to members who did not establish accounts. Matching was based on members’ history of office visits.

Compared with nonusers, users had an increased rate of office visits in the year following activation of their MyHealthManager account, a difference of 0.7 per member per year. Similarly, telephone encounters, after-hours clinic visits, emergency department visits, and hospitalizations all rose significantly. Among patients with coronary artery disease, use of services did not increase.

Editorialists call the findings “sobering for patient portal enthusiasts.” They speculate that the reason for the discrepancy between this and earlier studies may have to do with regional differences in healthcare delivery.

Source: JAMA

Depression significantly increased risk for dementia in diabetic patients.

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Depression in patients with diabetes doubled their risk for developing dementia, data showed.

Study researcher Wayne Katon, MD, of the University of Washington School of Medicine, told Healio.com that health care providers are actively trying to address depression in this patient population.

“Health care systems are developing health services interventions to improve screening and quality of treatment for depression in patients with chronic medical illnesses such as diabetes,” Katon said.

Katon and colleagues analyzed data collected on 19,239 patients aged 30 to 75 years with type 2 diabetes. The patients were part of the Kaiser Permanente Northern California Diabetes Registry, a multiethnic cohort of insured patients with diabetes.

Clinically significant symptoms of depression were determined using DSM-IV criteria, and incident cases of clinically recognized dementia were identified based on the presence of one or more ICD-9-CM codes of uncomplicated senile dementia. Patients with evidence of one or more dementia diagnoses prior to baseline were excluded from the study. The researchers estimated the association between depression and incident dementia diagnosis in years 3 through 5 of follow up.

During the 3- to 5-year period, 2.1% of patients with comorbid depression and diabetes (incidence rate of 5.5 per 1,000 person-years), compared with 1% of patients with diabetes alone (incidence rate of 2.6 per 1,000 person-years), had one or more ICD-9-CM diagnoses of dementia. Patients with comorbid depression had a 100% increased risk of dementia during the 3 to 5 years after baseline (AHR=2.02; 95% CI, 1.73-2.35).

Patients who took insulin, with or without oral hypoglycemic treatment, had a substantially lower risk of dementia associated with depression (HR=1.59; 95% CI, 1.17-2.18), compared with patients not treated with insulin (HR=2.82; 95% CI, 2.33-3.42).

Results also showed that patients aged younger than 65 years had a substantially higher risk for dementia associated with depression (HR=4.42; 95% CI, 3.11-6.29), compared with patients aged more than 65 years (HR=2.01; 95% CI, 1.65-2.45). The researchers said this finding is troubling from a public health and cost perspective. “The temporal patterning underscores the importance of developing early interventions to potentially reduce the incidence of dementia,” they wrote.

There are a number of biologic mechanisms that could link depression with dementia, according to the researchers.

“Depression severity has been associated with a higher risk of biologic abnormalities such as hypothalamic-pituitary axis dysfunction,” they wrote. “Dysregulation of the hypothalamic-pituitary axis associated with depression has been linked to higher glucocorticoid production and impaired negative feedback. Dysregulation of cortisol may damage brain areas involved in cognition such as the hypothalamus as well as decrease neurogenesis in key brain areas.”

For more information on programs targeting depression in patients with chronic illnesses like diabetes, visit www.teamcarehealth.org.

Disclosure: Dr. Katon’s relevant financial activities outside of the study include board membership for Eli Lilly and Wyeth and honoraria for lectures for Eli Lilly, Wyeth, Pfizer and Forest.

Source: Endocrine Today.