Researchers in the lab

Photo by Rhoda Baer

ROME, ITALY—Interleukin-1β (IL-1β) is a crucial factor in the development of blood-induced cartilage damage, according to research presented at the European League Against Rheumatism Annual Congress (EULAR 2015).

This discovery suggests that therapeutically targeting IL-1β could provide a new way to protect cartilage after a joint bleed, which can occur after joint trauma, major joint surgery, or due to hemophilia.

Whatever the cause, joint bleeds are expected to lead to an inflammatory response in the joint and to significant destruction of joint cartilage. So a treatment that could limit the damage from a joint bleed could potentially minimize future disability.

“As therapeutic agents opposing the activity of IL-1β are readily available, further research is now warranted to investigate whether an IL-1β antagonist would be effective in preventing and treating joint damage as a result of bleeding into the joint,” said study investigator Simon Mastbergen, PhD, of the University Medical Centre Utrecht in the Netherlands.

“Findings also suggest that the quicker treatment is initiated, the less damage to the joint may be sustained.”

Dr Mastbergen and his colleagues presented these findings at EULAR 2015 as abstract OP0262.

The researchers had cultured healthy human cartilage samples for 4 days in the presence or absence of 50% whole blood. They then added an IL-1β monoclonal antibody (mAb), an IL-1 receptor antagonist (IL-1RA), or a TNF-α mAb during blood exposure and assessed subsequent cartilage damage.

The IL-1β mAb and IL-1RA protected cartilage from blood-induced damage in a dose- and time-dependent manner. Early administration after blood exposure was the most beneficial. And, when the treatments were given at higher concentrations, there was near-complete normalization of cartilage.

The researchers said these effects were accompanied by a reduction in IL-1β and IL-6 production. The level of IL-1β was 74 pg/mL in whole-blood culture, but levels were undetectable after the IL-1RA was added (P=0.028). The level of IL-6 was 21,347 pg/mL in whole-blood culture, 27 pg/mL after the IL-1RA was added, and 289 pg/mL after the IL-1β mAb was added (P=0.028 for both).

However, TNF-α levels were unaffected by the IL-1RA or IL-1β mAb. TNF-α levels wer 35 pg/mL in whole-blood culture and 37 pg/mL after the addition of the IL-1RA or IL-1β mAb (P=0.753 for both).

Of course, the TNF-α mAb inhibited the effects of TNF-α on cartilage, but the mAb had no significant effect on blood-induced cartilage damage.

“This would appear to rule out TNF-α inhibitors, a class of drug currently used to treat various forms of arthritis, for this new indication,” Dr Mastbergen said.

Researchers in the lab

Photo by Rhoda Baer

ROME, ITALY—Interleukin-1β (IL-1β) is a crucial factor in the development of blood-induced cartilage damage, according to research presented at the European League Against Rheumatism Annual Congress (EULAR 2015).

This discovery suggests that therapeutically targeting IL-1β could provide a new way to protect cartilage after a joint bleed, which can occur after joint trauma, major joint surgery, or due to hemophilia.

Whatever the cause, joint bleeds are expected to lead to an inflammatory response in the joint and to significant destruction of joint cartilage. So a treatment that could limit the damage from a joint bleed could potentially minimize future disability.

“As therapeutic agents opposing the activity of IL-1β are readily available, further research is now warranted to investigate whether an IL-1β antagonist would be effective in preventing and treating joint damage as a result of bleeding into the joint,” said study investigator Simon Mastbergen, PhD, of the University Medical Centre Utrecht in the Netherlands.

“Findings also suggest that the quicker treatment is initiated, the less damage to the joint may be sustained.”

Dr Mastbergen and his colleagues presented these findings at EULAR 2015 as abstract OP0262.

The researchers had cultured healthy human cartilage samples for 4 days in the presence or absence of 50% whole blood. They then added an IL-1β monoclonal antibody (mAb), an IL-1 receptor antagonist (IL-1RA), or a TNF-α mAb during blood exposure and assessed subsequent cartilage damage.

The IL-1β mAb and IL-1RA protected cartilage from blood-induced damage in a dose- and time-dependent manner. Early administration after blood exposure was the most beneficial. And, when the treatments were given at higher concentrations, there was near-complete normalization of cartilage.

The researchers said these effects were accompanied by a reduction in IL-1β and IL-6 production. The level of IL-1β was 74 pg/mL in whole-blood culture, but levels were undetectable after the IL-1RA was added (P=0.028). The level of IL-6 was 21,347 pg/mL in whole-blood culture, 27 pg/mL after the IL-1RA was added, and 289 pg/mL after the IL-1β mAb was added (P=0.028 for both).

However, TNF-α levels were unaffected by the IL-1RA or IL-1β mAb. TNF-α levels wer 35 pg/mL in whole-blood culture and 37 pg/mL after the addition of the IL-1RA or IL-1β mAb (P=0.753 for both).

Of course, the TNF-α mAb inhibited the effects of TNF-α on cartilage, but the mAb had no significant effect on blood-induced cartilage damage.

“This would appear to rule out TNF-α inhibitors, a class of drug currently used to treat various forms of arthritis, for this new indication,” Dr Mastbergen said.

Researchers in the lab

Photo by Rhoda Baer

ROME, ITALY—Interleukin-1β (IL-1β) is a crucial factor in the development of blood-induced cartilage damage, according to research presented at the European League Against Rheumatism Annual Congress (EULAR 2015).

This discovery suggests that therapeutically targeting IL-1β could provide a new way to protect cartilage after a joint bleed, which can occur after joint trauma, major joint surgery, or due to hemophilia.

Whatever the cause, joint bleeds are expected to lead to an inflammatory response in the joint and to significant destruction of joint cartilage. So a treatment that could limit the damage from a joint bleed could potentially minimize future disability.

“As therapeutic agents opposing the activity of IL-1β are readily available, further research is now warranted to investigate whether an IL-1β antagonist would be effective in preventing and treating joint damage as a result of bleeding into the joint,” said study investigator Simon Mastbergen, PhD, of the University Medical Centre Utrecht in the Netherlands.

“Findings also suggest that the quicker treatment is initiated, the less damage to the joint may be sustained.”

Dr Mastbergen and his colleagues presented these findings at EULAR 2015 as abstract OP0262.

The researchers had cultured healthy human cartilage samples for 4 days in the presence or absence of 50% whole blood. They then added an IL-1β monoclonal antibody (mAb), an IL-1 receptor antagonist (IL-1RA), or a TNF-α mAb during blood exposure and assessed subsequent cartilage damage.

The IL-1β mAb and IL-1RA protected cartilage from blood-induced damage in a dose- and time-dependent manner. Early administration after blood exposure was the most beneficial. And, when the treatments were given at higher concentrations, there was near-complete normalization of cartilage.

The researchers said these effects were accompanied by a reduction in IL-1β and IL-6 production. The level of IL-1β was 74 pg/mL in whole-blood culture, but levels were undetectable after the IL-1RA was added (P=0.028). The level of IL-6 was 21,347 pg/mL in whole-blood culture, 27 pg/mL after the IL-1RA was added, and 289 pg/mL after the IL-1β mAb was added (P=0.028 for both).

However, TNF-α levels were unaffected by the IL-1RA or IL-1β mAb. TNF-α levels wer 35 pg/mL in whole-blood culture and 37 pg/mL after the addition of the IL-1RA or IL-1β mAb (P=0.753 for both).

Of course, the TNF-α mAb inhibited the effects of TNF-α on cartilage, but the mAb had no significant effect on blood-induced cartilage damage.

“This would appear to rule out TNF-α inhibitors, a class of drug currently used to treat various forms of arthritis, for this new indication,” Dr Mastbergen said.

Anopheles gambiae mosquito

Photo courtesy of the CDC

Researchers say they have located a new, more precise target for a mosquito-based vaccine to block the transmission of malaria.

The team created a 3-D crystal structure of AnAPN1, a protein found in the gut of the Anopheles mosquito that is considered essential to malaria transmission.

In studying the entire protein, the researchers found that previous incarnations of a proposed vaccine included irrelevant regions of AnAPN1.

Rhoel R. Dinglasan, PhD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, and his colleagues described this work in Nature Structural & Molecular Biology.

AnAPN1 is found on the apical surface of the Anopheles gambiae midgut and is potentially a receptor for the Plasmodium parasite. As a vaccine antigen, AnAPN1 prompts antibody production, but only some of these antibodies block parasite transmission.

“This dilution of the overall antibody response to AnAPN1 is problematic,” Dr Dinglasan said. “To further improve vaccine immunogenicity at the preclinical stage, we need to immuno-focus the antibody response to only the critical, transmission-blocking regions of the protein.”

Using the Australian Synchrotron, the researchers were able to visualize the crystal structure of AnAPN1 for the first time. This allowed the team to pinpoint the binding site of AnAPN1 antibodies that can and cannot block parasite development.

“We now know much more about which parts of the AnAPN1 protein are involved in generating transmission-blocking antibodies and have a new hypothesis as to how they might work,” said Natalie Borg, PhD, of Monash University in Clayton, Victoria, Australia.

The researchers identified a particularly potent antibody, 4H5B7, and tested it in blood samples from children carrying the Plasmodium falciparum parasite. 4H5B7 exhibited “complete transmission-blocking activity” against these naturally circulating strains of P falciparum.

The team said their data indicate the mechanism underlying this activity is the recognition of a conformation-dependent epitope that is predominantly found on peptide 4, which is part of peptide 7 on domain 1 of AnAPN1.

These findings suggest that, previously, researchers were asking the immune system to target too many regions on AnAPN1, which diluted the response to the relevant regions of the protein.

Anopheles gambiae mosquito

Photo courtesy of the CDC

Researchers say they have located a new, more precise target for a mosquito-based vaccine to block the transmission of malaria.

The team created a 3-D crystal structure of AnAPN1, a protein found in the gut of the Anopheles mosquito that is considered essential to malaria transmission.

In studying the entire protein, the researchers found that previous incarnations of a proposed vaccine included irrelevant regions of AnAPN1.

Rhoel R. Dinglasan, PhD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, and his colleagues described this work in Nature Structural & Molecular Biology.

AnAPN1 is found on the apical surface of the Anopheles gambiae midgut and is potentially a receptor for the Plasmodium parasite. As a vaccine antigen, AnAPN1 prompts antibody production, but only some of these antibodies block parasite transmission.

“This dilution of the overall antibody response to AnAPN1 is problematic,” Dr Dinglasan said. “To further improve vaccine immunogenicity at the preclinical stage, we need to immuno-focus the antibody response to only the critical, transmission-blocking regions of the protein.”

Using the Australian Synchrotron, the researchers were able to visualize the crystal structure of AnAPN1 for the first time. This allowed the team to pinpoint the binding site of AnAPN1 antibodies that can and cannot block parasite development.

“We now know much more about which parts of the AnAPN1 protein are involved in generating transmission-blocking antibodies and have a new hypothesis as to how they might work,” said Natalie Borg, PhD, of Monash University in Clayton, Victoria, Australia.

The researchers identified a particularly potent antibody, 4H5B7, and tested it in blood samples from children carrying the Plasmodium falciparum parasite. 4H5B7 exhibited “complete transmission-blocking activity” against these naturally circulating strains of P falciparum.

The team said their data indicate the mechanism underlying this activity is the recognition of a conformation-dependent epitope that is predominantly found on peptide 4, which is part of peptide 7 on domain 1 of AnAPN1.

These findings suggest that, previously, researchers were asking the immune system to target too many regions on AnAPN1, which diluted the response to the relevant regions of the protein.

Anopheles gambiae mosquito

Photo courtesy of the CDC

Researchers say they have located a new, more precise target for a mosquito-based vaccine to block the transmission of malaria.

The team created a 3-D crystal structure of AnAPN1, a protein found in the gut of the Anopheles mosquito that is considered essential to malaria transmission.

In studying the entire protein, the researchers found that previous incarnations of a proposed vaccine included irrelevant regions of AnAPN1.

Rhoel R. Dinglasan, PhD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, and his colleagues described this work in Nature Structural & Molecular Biology.

AnAPN1 is found on the apical surface of the Anopheles gambiae midgut and is potentially a receptor for the Plasmodium parasite. As a vaccine antigen, AnAPN1 prompts antibody production, but only some of these antibodies block parasite transmission.

“This dilution of the overall antibody response to AnAPN1 is problematic,” Dr Dinglasan said. “To further improve vaccine immunogenicity at the preclinical stage, we need to immuno-focus the antibody response to only the critical, transmission-blocking regions of the protein.”

Using the Australian Synchrotron, the researchers were able to visualize the crystal structure of AnAPN1 for the first time. This allowed the team to pinpoint the binding site of AnAPN1 antibodies that can and cannot block parasite development.

“We now know much more about which parts of the AnAPN1 protein are involved in generating transmission-blocking antibodies and have a new hypothesis as to how they might work,” said Natalie Borg, PhD, of Monash University in Clayton, Victoria, Australia.

The researchers identified a particularly potent antibody, 4H5B7, and tested it in blood samples from children carrying the Plasmodium falciparum parasite. 4H5B7 exhibited “complete transmission-blocking activity” against these naturally circulating strains of P falciparum.

The team said their data indicate the mechanism underlying this activity is the recognition of a conformation-dependent epitope that is predominantly found on peptide 4, which is part of peptide 7 on domain 1 of AnAPN1.

These findings suggest that, previously, researchers were asking the immune system to target too many regions on AnAPN1, which diluted the response to the relevant regions of the protein.

The lead author of a new Journal of Hospital Medicine report says one step hospitalists can take toward reducing preventable rehospitalizations is identifying the common traits of frequently admitted patients.

Marilyn Szekendi, PhD, RN, director of quality research at University Health System Consortium (UHC) in Chicago, says learning the characteristics that lead to frequent admissions—defined as patients who are admitted five or more times within one year—can help identify solutions for preventing repeated hospitalizations. UHC is an alliance of nonprofit academic medical centers and their affiliated hospitals.

"The good news here is that this is very doable," Dr. Szekendi says. "Every hospital can run this analysis…and actually create a list of who these patients are, along with their names and medical record numbers, so you can look at their diagnosis, you can look at other characteristics of the patient, and do a real-time assessment of who they are."

For their report, Dr. Szekendi and colleagues studied 28,291 patients admitted 180,185 times to academic medical centers in the U.S. from 2011 to 2012. While the cohort comprised just 1.6% of all patients, it accounted for 8% of all admissions and 7% of direct costs.

Common factors linked with frequent readmissions included having significantly more comorbidities (an average of 7.1 versus 2.5), and 84% of their admissions are to medical services. In addition, this patient population has higher rates of psychosis or substance abuse, the researchers note. Although frequently admitted patients are slightly more likely than other patients to be on Medicaid or to be uninsured (27.6% versus 21.6%), nearly three-quarters have private or Medicare coverage.

"We know that there are many other factors that we didn't have data for, [such as] housing status, patients' preexisting access to other kinds of medical care," Dr. Szekendi says. "If we could do some further look at factors that define these patients, both nationally and individually, hospitals then would have some additional, really useful information about the patients that would further inform their improvement efforts. Going beyond the data...is the next step.”

Visit our website for more information on hospitalists' role in preventing readmissions.

The lead author of a new Journal of Hospital Medicine report says one step hospitalists can take toward reducing preventable rehospitalizations is identifying the common traits of frequently admitted patients.

Marilyn Szekendi, PhD, RN, director of quality research at University Health System Consortium (UHC) in Chicago, says learning the characteristics that lead to frequent admissions—defined as patients who are admitted five or more times within one year—can help identify solutions for preventing repeated hospitalizations. UHC is an alliance of nonprofit academic medical centers and their affiliated hospitals.

"The good news here is that this is very doable," Dr. Szekendi says. "Every hospital can run this analysis…and actually create a list of who these patients are, along with their names and medical record numbers, so you can look at their diagnosis, you can look at other characteristics of the patient, and do a real-time assessment of who they are."

For their report, Dr. Szekendi and colleagues studied 28,291 patients admitted 180,185 times to academic medical centers in the U.S. from 2011 to 2012. While the cohort comprised just 1.6% of all patients, it accounted for 8% of all admissions and 7% of direct costs.

Common factors linked with frequent readmissions included having significantly more comorbidities (an average of 7.1 versus 2.5), and 84% of their admissions are to medical services. In addition, this patient population has higher rates of psychosis or substance abuse, the researchers note. Although frequently admitted patients are slightly more likely than other patients to be on Medicaid or to be uninsured (27.6% versus 21.6%), nearly three-quarters have private or Medicare coverage.

"We know that there are many other factors that we didn't have data for, [such as] housing status, patients' preexisting access to other kinds of medical care," Dr. Szekendi says. "If we could do some further look at factors that define these patients, both nationally and individually, hospitals then would have some additional, really useful information about the patients that would further inform their improvement efforts. Going beyond the data...is the next step.”

Visit our website for more information on hospitalists' role in preventing readmissions.

The lead author of a new Journal of Hospital Medicine report says one step hospitalists can take toward reducing preventable rehospitalizations is identifying the common traits of frequently admitted patients.

Marilyn Szekendi, PhD, RN, director of quality research at University Health System Consortium (UHC) in Chicago, says learning the characteristics that lead to frequent admissions—defined as patients who are admitted five or more times within one year—can help identify solutions for preventing repeated hospitalizations. UHC is an alliance of nonprofit academic medical centers and their affiliated hospitals.

"The good news here is that this is very doable," Dr. Szekendi says. "Every hospital can run this analysis…and actually create a list of who these patients are, along with their names and medical record numbers, so you can look at their diagnosis, you can look at other characteristics of the patient, and do a real-time assessment of who they are."

For their report, Dr. Szekendi and colleagues studied 28,291 patients admitted 180,185 times to academic medical centers in the U.S. from 2011 to 2012. While the cohort comprised just 1.6% of all patients, it accounted for 8% of all admissions and 7% of direct costs.

Common factors linked with frequent readmissions included having significantly more comorbidities (an average of 7.1 versus 2.5), and 84% of their admissions are to medical services. In addition, this patient population has higher rates of psychosis or substance abuse, the researchers note. Although frequently admitted patients are slightly more likely than other patients to be on Medicaid or to be uninsured (27.6% versus 21.6%), nearly three-quarters have private or Medicare coverage.

"We know that there are many other factors that we didn't have data for, [such as] housing status, patients' preexisting access to other kinds of medical care," Dr. Szekendi says. "If we could do some further look at factors that define these patients, both nationally and individually, hospitals then would have some additional, really useful information about the patients that would further inform their improvement efforts. Going beyond the data...is the next step.”

Visit our website for more information on hospitalists' role in preventing readmissions.

Clinical question: What is the impact of statin discontinuation in palliative care setting?

Background: There is compelling evidence for prescribing statins for primary or secondary prevention of cardiovascular disease for patients with long life expectancy, but there is no evidence to guide decisions to discontinue therapy in those with limited prognosis.

Study design: Multicenter, unblinded, randomized, and pragmatic clinical trial.

Setting: Academic and community-based clinical sites as a part of the Palliative Care Research Cooperative Group.

Synopsis: The study analyzed the outcomes of 381 patients who had received a prognosis of one-month to one-year life expectancy, with an average age of 74. The participants were divided into two groups: continued statin group and discontinued statin group. Of the 381 participants, 212 survived beyond 60 days.

There was no significant difference between the proportion of participants who died within 60 days, with 45 (23.8%) in the discontinued statin group and 39 (20.3%) in the continued statin group (90% Cl, -3.5%–10.5%; P=0.36). Total quality of life was better for the group discontinuing statin therapy (mean McGill QOL score 7.11 versus 6.85; P=0.04). The researchers estimated that surviving participants would save $3.37 per day and $716 per patient.

Because of a lack of formal guidelines for discontinuation of statin therapy in patients with life-limiting illness, the discontinuation of statin therapy is mostly based on patient-provider decisions.

The results from this study will help physicians have thoughtful patient-provider discussions regarding statin discontinuation.

Citation: Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015;175(5):691–700. doi:10.1001/jamainternmed.2015.0289.

Visit our website for more research reviews.

Clinical question: What is the impact of statin discontinuation in palliative care setting?

Background: There is compelling evidence for prescribing statins for primary or secondary prevention of cardiovascular disease for patients with long life expectancy, but there is no evidence to guide decisions to discontinue therapy in those with limited prognosis.

Study design: Multicenter, unblinded, randomized, and pragmatic clinical trial.

Setting: Academic and community-based clinical sites as a part of the Palliative Care Research Cooperative Group.

Synopsis: The study analyzed the outcomes of 381 patients who had received a prognosis of one-month to one-year life expectancy, with an average age of 74. The participants were divided into two groups: continued statin group and discontinued statin group. Of the 381 participants, 212 survived beyond 60 days.

There was no significant difference between the proportion of participants who died within 60 days, with 45 (23.8%) in the discontinued statin group and 39 (20.3%) in the continued statin group (90% Cl, -3.5%–10.5%; P=0.36). Total quality of life was better for the group discontinuing statin therapy (mean McGill QOL score 7.11 versus 6.85; P=0.04). The researchers estimated that surviving participants would save $3.37 per day and $716 per patient.

Because of a lack of formal guidelines for discontinuation of statin therapy in patients with life-limiting illness, the discontinuation of statin therapy is mostly based on patient-provider decisions.

The results from this study will help physicians have thoughtful patient-provider discussions regarding statin discontinuation.

Citation: Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015;175(5):691–700. doi:10.1001/jamainternmed.2015.0289.

Visit our website for more research reviews.

Clinical question: What is the impact of statin discontinuation in palliative care setting?

Background: There is compelling evidence for prescribing statins for primary or secondary prevention of cardiovascular disease for patients with long life expectancy, but there is no evidence to guide decisions to discontinue therapy in those with limited prognosis.

Study design: Multicenter, unblinded, randomized, and pragmatic clinical trial.

Setting: Academic and community-based clinical sites as a part of the Palliative Care Research Cooperative Group.

Synopsis: The study analyzed the outcomes of 381 patients who had received a prognosis of one-month to one-year life expectancy, with an average age of 74. The participants were divided into two groups: continued statin group and discontinued statin group. Of the 381 participants, 212 survived beyond 60 days.

There was no significant difference between the proportion of participants who died within 60 days, with 45 (23.8%) in the discontinued statin group and 39 (20.3%) in the continued statin group (90% Cl, -3.5%–10.5%; P=0.36). Total quality of life was better for the group discontinuing statin therapy (mean McGill QOL score 7.11 versus 6.85; P=0.04). The researchers estimated that surviving participants would save $3.37 per day and $716 per patient.

Because of a lack of formal guidelines for discontinuation of statin therapy in patients with life-limiting illness, the discontinuation of statin therapy is mostly based on patient-provider decisions.

The results from this study will help physicians have thoughtful patient-provider discussions regarding statin discontinuation.

Citation: Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015;175(5):691–700. doi:10.1001/jamainternmed.2015.0289.

Visit our website for more research reviews.

The Internet has changed many facets of modern life, and the practice of medicine has not gone untouched. Consider, for better or worse, the reliance of many patients on WebMD and various other sites for self-diagnosis before consulting with a physician. Even before the Internet, patients would self-diagnose their skin type (more than 80% of them get it wrong). The Internet allows them access to most cosmeceutical brands, the misuse of which leads to unintended consequences that can affect skin health. Clearly, patients who receive advice from a trained medical professional have better outcomes. One reason for this is that the doctor (or aesthetician) spends time with the patient, explaining what products to use and in which order to use them, and follows up with the patient to assess the outcome and adjust the regimen as needed. The problem arises when these patients decide to purchase the products from a source other than their treating physician. Only about 30% of patients buy refills from their doctor for second purchases, and just 15% purchase products from their doctor the third time around. Why is this? It is likely the convenience and the low cost that drive patients to purchase from sources other than their physician or aesthetician. This desire to save money carries significant risks. Many the products online are expired or counterfeit, or are old containers refilled with a different formulation. Patients should be cautioned to only buy products from a source they trust.

I have had dozens of patients bringing in counterfeit products in the last few months. It seems that the problem is becoming more common. I interviewed several companies about this to see whether others were experiencing the same trend. This is what I found:

Some companies report that they have seen their samples and trade size containers being sold on eBay. Joe Ragosta of Topix Pharmaceuticals reports that when his company has asked such sellers if they are obtaining these products – marked as samples – from the company, they hear a range of defensive responses, including: “I got it at a show” or “My doctor gave me samples, and I decided to sell them” and “I work at a doctor’s office, and they let me take products as needed.” Make sure that no one on your staff is taking samples and selling them online.

One example: NeoStrata is concerned about the fraudulent use of their products. They recommend that patients purchase their products only from a known physician, ideally from the physician’s office rather than the website. The company understands that customers may want to save money wherever they can and might prefer to buy products online. NeoStrata urges customers who opt to buy online to make such purchases through physician-affiliated websites, where the doctor is clearly identified. At the very least, the company urges patients to choose only sites where they can contact someone and obtain the name of a physician. Further, they strongly discourage using eBay or other auction sites, which do not vouch for the safety and authenticity of products sold through their services.

Other potential problems with skin care products sold online include the following.

Counterfeit products

Several reports have indicated that counterfeit skin products originating in other countries have made their way into the United States and, according to the article published on the website Fact Based Skin Care, pharmaceuticals and personal care products, including cosmetics, are among the top five types of products seized by U.S. Customs and Border Patrol agents (Coy, C. Dangers of Counterfeit Cosmetics, Aug. 4, 2014). Such products include old bottles refilled with inexpensive imitation creams or bottles made to look like legitimate products that in fact contain imitation creams. I once had a patient present with an adverse reaction to a retinol product, which she brought with her to the visit. I sent the bottle to the company, which confirmed my suspicion that the product was counterfeit – a different bottle with a similar label.

In February 2014, CBS New York ran a segment on the potential inclusion of carcinogenic and other harmful ingredients found in online personal care products touted for their low prices (CBS New York. Counterfeit Cosmetics May Be Harmful To Your Health. Feb. 27, 2014). Not even 2 weeks later, CNN reported on the arrest of two brothers in New York alleged to have masterminded a multimillion-dollar counterfeit health and beauty product ring (CNN. Zulueta A. Massive Fake Health and Beauty Supplies Ring Busted. March 9, 2014). ABC’s Good Morning America followed suit with a segment in April 2014 that exposed aspects of the use of knock-off cosmetic products (ABC News, Good Morning America. Online Beauty Bargains: Is It the Real Deal? April 3, 2014).

The Federal Bureau of Investigation has posted memos concerning counterfeit and potentially compromised and hazardous cosmetics and fragrances, offering tips aimed at readily identifying or avoiding unauthorized products.

Torie Hardee of EltaMD summarized that counterfeit products can sometimes be identified by lack of an expiration date on the bottle, discoloration or slightly different fonts on bottles and packaging, and the manufacturer’s address on the bottle.

Jan Marini Company representative Stuart Mohr noted that their company has received returns of products that they had not manufactured, as well as their own current or discontinued products returned years after the expiration date. The Jan Marini Co., and most other companies, will not guarantee any product purchased via nonauthorized resellers, because the authenticity and safety of such products cannot be verified.

“These unauthorized resellers are sophisticated, often even working in rings, and find it easy to hide their real identity,” said Mr. Mohr. “Addresses are often hidden or vague; emails are not linked to any specific person; and it’s easy to use false names. If a person is caught in an unauthorized online transaction, it’s easy to change the email address or name and start again,” he added.

©Ingram Publishing/Thinkstockphotos.com

FBI’s tips for spotting counterfeit cosmetics and fragrances

• The product is a sample size.

• The packaging differs slightly from the authentic brand (different color or font).

• The product’s wrapping appears haphazard.

• The product is being advertised as a “limited edition” even though the authentic manufacturer doesn’t offer it as a limited edition.

• The product is not listed on the manufacturer’s website.

• The price is drastically lower than the MSRP.

• The product’s consistency or texture doesn’t feel or look like the authentic brand.

• For fragrances, something seems off about the scent, and the color of the fluid in the bottle might be different than the original.

• They are being sold at nonauthorized retailers, including flea markets and discount stores.

• The label does not contain lot number, bar code, manufacturer’s address, or expiration date.

Expired products

Unscrupulous online retailers may slash prices on expired products and remove the expiration date from the package. In my practice, a patient experiencing an erythematous reaction brought in the “SkinMedica” product bottle, which looked suspicious to me. The packaging that the product was in had been discontinued 8 years earlier. It is important to remember that ingredients, particularly retinol, degrade with exposure to air, sun, and heat, and over time. This is most likely what caused my patient’s adverse reaction, and her initial savings from the product caused her several weeks of irritated skin.

Diverted products

SkinMedica reports that diverted products are a trickier issue than counterfeit products, because their packaging and formulas are sufficiently complex to make counterfeiting too difficult to be profitable. Instead, their products have been sold on the so-called gray market below the manufacturer suggested retail price (MSRP), typically online. In these cases, the company cannot help patients with returns or complaints because they cannot verify the chain of custody of the purchased product. They are addressing this problem, though, with an awareness campaign called “Authentic and Authorized.” Its goal is to alert patients and the physicians who dispense their products of the benefits of a physician-dispensed model of skin care, with best outcomes achieved when doctors are prescribing a skin care regimen. SkinMedica emphasizes that no website can guarantee outcomes comparable to a skin care professional and product quality and safety can only be enforced when dispensed through authorized channels.

Potentially illegal or toxic ingredients

Several products that have entered the United States marketed as skin lighteners, antiaging agents, and acne treatment products have been found to contain mercury, according to a consumer update from the FDA. Arsenic, lead, beryllium, and other harmful toxins as well as allergy-inducing fragrances or preservatives not approved as safe in the U.S. may also be found in such products of dubious origin.

Improper storage

Products purveyed online are often stored in hot warehouses. As mentioned above, heat degrades and alters ingredients, rendering compounds such as retinol, benzoyl peroxide, peptides, and ascorbic acid worthless. Extreme cold can also damage the chemical integrity of products. Notably, organic products are more vulnerable because they lack preservatives to gird them against temperature variations and microbes that grow in hot, damp environments.

Lookalike imposters

Generic formulations are packaged to piggyback onto the success of well-known products. Such products found in drugstores may be packaged to look like Cetaphil or Aveeno items, but cost less, and deliver less. While the ingredients on the copycats are identical to those found in the branded preparations, the order in which ingredients are added, the temperature, pH, and even when and how fast ingredients are stirred are part of the proprietary recipe of the company and play a significant role in the potential of the end product and the actions the product exerts on the skin.

Conclusion

Whether or not you sell skin care products in your office, there is much you can do to educate your patients about skin care product safety. Namely, the farther a consumer gets from the source of the product or from reliable endorsers of products, the greater the opportunity for encountering fraudulent or counterfeit products. Patients are best served by sources they can trust, such as their dermatologist. If you sell products in your office, encourage your patients to buy refills from you so they can be assured of the proper formulations. Finally, encourage your patients not to skimp when it comes to the health of their skin, reminding them that it may cost them much more in terms of time, skin irritation, improper treatment, and all related expenses to buy products cheaply from unreliable sources.

Give your patients a copy of this article so that they will understand the enormity of the problem.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever.

The Internet has changed many facets of modern life, and the practice of medicine has not gone untouched. Consider, for better or worse, the reliance of many patients on WebMD and various other sites for self-diagnosis before consulting with a physician. Even before the Internet, patients would self-diagnose their skin type (more than 80% of them get it wrong). The Internet allows them access to most cosmeceutical brands, the misuse of which leads to unintended consequences that can affect skin health. Clearly, patients who receive advice from a trained medical professional have better outcomes. One reason for this is that the doctor (or aesthetician) spends time with the patient, explaining what products to use and in which order to use them, and follows up with the patient to assess the outcome and adjust the regimen as needed. The problem arises when these patients decide to purchase the products from a source other than their treating physician. Only about 30% of patients buy refills from their doctor for second purchases, and just 15% purchase products from their doctor the third time around. Why is this? It is likely the convenience and the low cost that drive patients to purchase from sources other than their physician or aesthetician. This desire to save money carries significant risks. Many the products online are expired or counterfeit, or are old containers refilled with a different formulation. Patients should be cautioned to only buy products from a source they trust.

I have had dozens of patients bringing in counterfeit products in the last few months. It seems that the problem is becoming more common. I interviewed several companies about this to see whether others were experiencing the same trend. This is what I found:

Some companies report that they have seen their samples and trade size containers being sold on eBay. Joe Ragosta of Topix Pharmaceuticals reports that when his company has asked such sellers if they are obtaining these products – marked as samples – from the company, they hear a range of defensive responses, including: “I got it at a show” or “My doctor gave me samples, and I decided to sell them” and “I work at a doctor’s office, and they let me take products as needed.” Make sure that no one on your staff is taking samples and selling them online.

One example: NeoStrata is concerned about the fraudulent use of their products. They recommend that patients purchase their products only from a known physician, ideally from the physician’s office rather than the website. The company understands that customers may want to save money wherever they can and might prefer to buy products online. NeoStrata urges customers who opt to buy online to make such purchases through physician-affiliated websites, where the doctor is clearly identified. At the very least, the company urges patients to choose only sites where they can contact someone and obtain the name of a physician. Further, they strongly discourage using eBay or other auction sites, which do not vouch for the safety and authenticity of products sold through their services.

Other potential problems with skin care products sold online include the following.

Counterfeit products

Several reports have indicated that counterfeit skin products originating in other countries have made their way into the United States and, according to the article published on the website Fact Based Skin Care, pharmaceuticals and personal care products, including cosmetics, are among the top five types of products seized by U.S. Customs and Border Patrol agents (Coy, C. Dangers of Counterfeit Cosmetics, Aug. 4, 2014). Such products include old bottles refilled with inexpensive imitation creams or bottles made to look like legitimate products that in fact contain imitation creams. I once had a patient present with an adverse reaction to a retinol product, which she brought with her to the visit. I sent the bottle to the company, which confirmed my suspicion that the product was counterfeit – a different bottle with a similar label.

In February 2014, CBS New York ran a segment on the potential inclusion of carcinogenic and other harmful ingredients found in online personal care products touted for their low prices (CBS New York. Counterfeit Cosmetics May Be Harmful To Your Health. Feb. 27, 2014). Not even 2 weeks later, CNN reported on the arrest of two brothers in New York alleged to have masterminded a multimillion-dollar counterfeit health and beauty product ring (CNN. Zulueta A. Massive Fake Health and Beauty Supplies Ring Busted. March 9, 2014). ABC’s Good Morning America followed suit with a segment in April 2014 that exposed aspects of the use of knock-off cosmetic products (ABC News, Good Morning America. Online Beauty Bargains: Is It the Real Deal? April 3, 2014).

The Federal Bureau of Investigation has posted memos concerning counterfeit and potentially compromised and hazardous cosmetics and fragrances, offering tips aimed at readily identifying or avoiding unauthorized products.

Torie Hardee of EltaMD summarized that counterfeit products can sometimes be identified by lack of an expiration date on the bottle, discoloration or slightly different fonts on bottles and packaging, and the manufacturer’s address on the bottle.

Jan Marini Company representative Stuart Mohr noted that their company has received returns of products that they had not manufactured, as well as their own current or discontinued products returned years after the expiration date. The Jan Marini Co., and most other companies, will not guarantee any product purchased via nonauthorized resellers, because the authenticity and safety of such products cannot be verified.

“These unauthorized resellers are sophisticated, often even working in rings, and find it easy to hide their real identity,” said Mr. Mohr. “Addresses are often hidden or vague; emails are not linked to any specific person; and it’s easy to use false names. If a person is caught in an unauthorized online transaction, it’s easy to change the email address or name and start again,” he added.

©Ingram Publishing/Thinkstockphotos.com

FBI’s tips for spotting counterfeit cosmetics and fragrances

• The product is a sample size.

• The packaging differs slightly from the authentic brand (different color or font).

• The product’s wrapping appears haphazard.

• The product is being advertised as a “limited edition” even though the authentic manufacturer doesn’t offer it as a limited edition.

• The product is not listed on the manufacturer’s website.

• The price is drastically lower than the MSRP.

• The product’s consistency or texture doesn’t feel or look like the authentic brand.

• For fragrances, something seems off about the scent, and the color of the fluid in the bottle might be different than the original.

• They are being sold at nonauthorized retailers, including flea markets and discount stores.

• The label does not contain lot number, bar code, manufacturer’s address, or expiration date.

Expired products

Unscrupulous online retailers may slash prices on expired products and remove the expiration date from the package. In my practice, a patient experiencing an erythematous reaction brought in the “SkinMedica” product bottle, which looked suspicious to me. The packaging that the product was in had been discontinued 8 years earlier. It is important to remember that ingredients, particularly retinol, degrade with exposure to air, sun, and heat, and over time. This is most likely what caused my patient’s adverse reaction, and her initial savings from the product caused her several weeks of irritated skin.

Diverted products

SkinMedica reports that diverted products are a trickier issue than counterfeit products, because their packaging and formulas are sufficiently complex to make counterfeiting too difficult to be profitable. Instead, their products have been sold on the so-called gray market below the manufacturer suggested retail price (MSRP), typically online. In these cases, the company cannot help patients with returns or complaints because they cannot verify the chain of custody of the purchased product. They are addressing this problem, though, with an awareness campaign called “Authentic and Authorized.” Its goal is to alert patients and the physicians who dispense their products of the benefits of a physician-dispensed model of skin care, with best outcomes achieved when doctors are prescribing a skin care regimen. SkinMedica emphasizes that no website can guarantee outcomes comparable to a skin care professional and product quality and safety can only be enforced when dispensed through authorized channels.

Potentially illegal or toxic ingredients

Several products that have entered the United States marketed as skin lighteners, antiaging agents, and acne treatment products have been found to contain mercury, according to a consumer update from the FDA. Arsenic, lead, beryllium, and other harmful toxins as well as allergy-inducing fragrances or preservatives not approved as safe in the U.S. may also be found in such products of dubious origin.

Improper storage

Products purveyed online are often stored in hot warehouses. As mentioned above, heat degrades and alters ingredients, rendering compounds such as retinol, benzoyl peroxide, peptides, and ascorbic acid worthless. Extreme cold can also damage the chemical integrity of products. Notably, organic products are more vulnerable because they lack preservatives to gird them against temperature variations and microbes that grow in hot, damp environments.

Lookalike imposters

Generic formulations are packaged to piggyback onto the success of well-known products. Such products found in drugstores may be packaged to look like Cetaphil or Aveeno items, but cost less, and deliver less. While the ingredients on the copycats are identical to those found in the branded preparations, the order in which ingredients are added, the temperature, pH, and even when and how fast ingredients are stirred are part of the proprietary recipe of the company and play a significant role in the potential of the end product and the actions the product exerts on the skin.

Conclusion

Whether or not you sell skin care products in your office, there is much you can do to educate your patients about skin care product safety. Namely, the farther a consumer gets from the source of the product or from reliable endorsers of products, the greater the opportunity for encountering fraudulent or counterfeit products. Patients are best served by sources they can trust, such as their dermatologist. If you sell products in your office, encourage your patients to buy refills from you so they can be assured of the proper formulations. Finally, encourage your patients not to skimp when it comes to the health of their skin, reminding them that it may cost them much more in terms of time, skin irritation, improper treatment, and all related expenses to buy products cheaply from unreliable sources.

Give your patients a copy of this article so that they will understand the enormity of the problem.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever.

The Internet has changed many facets of modern life, and the practice of medicine has not gone untouched. Consider, for better or worse, the reliance of many patients on WebMD and various other sites for self-diagnosis before consulting with a physician. Even before the Internet, patients would self-diagnose their skin type (more than 80% of them get it wrong). The Internet allows them access to most cosmeceutical brands, the misuse of which leads to unintended consequences that can affect skin health. Clearly, patients who receive advice from a trained medical professional have better outcomes. One reason for this is that the doctor (or aesthetician) spends time with the patient, explaining what products to use and in which order to use them, and follows up with the patient to assess the outcome and adjust the regimen as needed. The problem arises when these patients decide to purchase the products from a source other than their treating physician. Only about 30% of patients buy refills from their doctor for second purchases, and just 15% purchase products from their doctor the third time around. Why is this? It is likely the convenience and the low cost that drive patients to purchase from sources other than their physician or aesthetician. This desire to save money carries significant risks. Many the products online are expired or counterfeit, or are old containers refilled with a different formulation. Patients should be cautioned to only buy products from a source they trust.

I have had dozens of patients bringing in counterfeit products in the last few months. It seems that the problem is becoming more common. I interviewed several companies about this to see whether others were experiencing the same trend. This is what I found:

Some companies report that they have seen their samples and trade size containers being sold on eBay. Joe Ragosta of Topix Pharmaceuticals reports that when his company has asked such sellers if they are obtaining these products – marked as samples – from the company, they hear a range of defensive responses, including: “I got it at a show” or “My doctor gave me samples, and I decided to sell them” and “I work at a doctor’s office, and they let me take products as needed.” Make sure that no one on your staff is taking samples and selling them online.

One example: NeoStrata is concerned about the fraudulent use of their products. They recommend that patients purchase their products only from a known physician, ideally from the physician’s office rather than the website. The company understands that customers may want to save money wherever they can and might prefer to buy products online. NeoStrata urges customers who opt to buy online to make such purchases through physician-affiliated websites, where the doctor is clearly identified. At the very least, the company urges patients to choose only sites where they can contact someone and obtain the name of a physician. Further, they strongly discourage using eBay or other auction sites, which do not vouch for the safety and authenticity of products sold through their services.

Other potential problems with skin care products sold online include the following.

Counterfeit products

Several reports have indicated that counterfeit skin products originating in other countries have made their way into the United States and, according to the article published on the website Fact Based Skin Care, pharmaceuticals and personal care products, including cosmetics, are among the top five types of products seized by U.S. Customs and Border Patrol agents (Coy, C. Dangers of Counterfeit Cosmetics, Aug. 4, 2014). Such products include old bottles refilled with inexpensive imitation creams or bottles made to look like legitimate products that in fact contain imitation creams. I once had a patient present with an adverse reaction to a retinol product, which she brought with her to the visit. I sent the bottle to the company, which confirmed my suspicion that the product was counterfeit – a different bottle with a similar label.

In February 2014, CBS New York ran a segment on the potential inclusion of carcinogenic and other harmful ingredients found in online personal care products touted for their low prices (CBS New York. Counterfeit Cosmetics May Be Harmful To Your Health. Feb. 27, 2014). Not even 2 weeks later, CNN reported on the arrest of two brothers in New York alleged to have masterminded a multimillion-dollar counterfeit health and beauty product ring (CNN. Zulueta A. Massive Fake Health and Beauty Supplies Ring Busted. March 9, 2014). ABC’s Good Morning America followed suit with a segment in April 2014 that exposed aspects of the use of knock-off cosmetic products (ABC News, Good Morning America. Online Beauty Bargains: Is It the Real Deal? April 3, 2014).

The Federal Bureau of Investigation has posted memos concerning counterfeit and potentially compromised and hazardous cosmetics and fragrances, offering tips aimed at readily identifying or avoiding unauthorized products.

Torie Hardee of EltaMD summarized that counterfeit products can sometimes be identified by lack of an expiration date on the bottle, discoloration or slightly different fonts on bottles and packaging, and the manufacturer’s address on the bottle.

Jan Marini Company representative Stuart Mohr noted that their company has received returns of products that they had not manufactured, as well as their own current or discontinued products returned years after the expiration date. The Jan Marini Co., and most other companies, will not guarantee any product purchased via nonauthorized resellers, because the authenticity and safety of such products cannot be verified.

“These unauthorized resellers are sophisticated, often even working in rings, and find it easy to hide their real identity,” said Mr. Mohr. “Addresses are often hidden or vague; emails are not linked to any specific person; and it’s easy to use false names. If a person is caught in an unauthorized online transaction, it’s easy to change the email address or name and start again,” he added.

©Ingram Publishing/Thinkstockphotos.com

FBI’s tips for spotting counterfeit cosmetics and fragrances

• The product is a sample size.

• The packaging differs slightly from the authentic brand (different color or font).

• The product’s wrapping appears haphazard.

• The product is being advertised as a “limited edition” even though the authentic manufacturer doesn’t offer it as a limited edition.

• The product is not listed on the manufacturer’s website.

• The price is drastically lower than the MSRP.

• The product’s consistency or texture doesn’t feel or look like the authentic brand.

• For fragrances, something seems off about the scent, and the color of the fluid in the bottle might be different than the original.

• They are being sold at nonauthorized retailers, including flea markets and discount stores.

• The label does not contain lot number, bar code, manufacturer’s address, or expiration date.

Expired products

Unscrupulous online retailers may slash prices on expired products and remove the expiration date from the package. In my practice, a patient experiencing an erythematous reaction brought in the “SkinMedica” product bottle, which looked suspicious to me. The packaging that the product was in had been discontinued 8 years earlier. It is important to remember that ingredients, particularly retinol, degrade with exposure to air, sun, and heat, and over time. This is most likely what caused my patient’s adverse reaction, and her initial savings from the product caused her several weeks of irritated skin.

Diverted products

SkinMedica reports that diverted products are a trickier issue than counterfeit products, because their packaging and formulas are sufficiently complex to make counterfeiting too difficult to be profitable. Instead, their products have been sold on the so-called gray market below the manufacturer suggested retail price (MSRP), typically online. In these cases, the company cannot help patients with returns or complaints because they cannot verify the chain of custody of the purchased product. They are addressing this problem, though, with an awareness campaign called “Authentic and Authorized.” Its goal is to alert patients and the physicians who dispense their products of the benefits of a physician-dispensed model of skin care, with best outcomes achieved when doctors are prescribing a skin care regimen. SkinMedica emphasizes that no website can guarantee outcomes comparable to a skin care professional and product quality and safety can only be enforced when dispensed through authorized channels.

Potentially illegal or toxic ingredients

Several products that have entered the United States marketed as skin lighteners, antiaging agents, and acne treatment products have been found to contain mercury, according to a consumer update from the FDA. Arsenic, lead, beryllium, and other harmful toxins as well as allergy-inducing fragrances or preservatives not approved as safe in the U.S. may also be found in such products of dubious origin.

Improper storage

Products purveyed online are often stored in hot warehouses. As mentioned above, heat degrades and alters ingredients, rendering compounds such as retinol, benzoyl peroxide, peptides, and ascorbic acid worthless. Extreme cold can also damage the chemical integrity of products. Notably, organic products are more vulnerable because they lack preservatives to gird them against temperature variations and microbes that grow in hot, damp environments.

Lookalike imposters

Generic formulations are packaged to piggyback onto the success of well-known products. Such products found in drugstores may be packaged to look like Cetaphil or Aveeno items, but cost less, and deliver less. While the ingredients on the copycats are identical to those found in the branded preparations, the order in which ingredients are added, the temperature, pH, and even when and how fast ingredients are stirred are part of the proprietary recipe of the company and play a significant role in the potential of the end product and the actions the product exerts on the skin.

Conclusion

Whether or not you sell skin care products in your office, there is much you can do to educate your patients about skin care product safety. Namely, the farther a consumer gets from the source of the product or from reliable endorsers of products, the greater the opportunity for encountering fraudulent or counterfeit products. Patients are best served by sources they can trust, such as their dermatologist. If you sell products in your office, encourage your patients to buy refills from you so they can be assured of the proper formulations. Finally, encourage your patients not to skimp when it comes to the health of their skin, reminding them that it may cost them much more in terms of time, skin irritation, improper treatment, and all related expenses to buy products cheaply from unreliable sources.

Give your patients a copy of this article so that they will understand the enormity of the problem.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). She has contributed to the Cosmeceutical Critique column in Dermatology News since January 2001. Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever.

While much has been written about the Center for Medicare & Medicaid Services (CMS) plan to shift its payment system away from fee for service and toward a “value-based” structure, most physicians in small and solo private settings have given little, if any, thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS plan is something called the Value-Based Payment Modifier (VBM), a component of the Affordable Care Act (ACA). The VBM has been off the radar of smaller private practices, because up until now it has applied only to groups with more than 10 providers. Starting this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBM “score.”

That score will be based on your “quality of care” (as defined by the CMS) and how much your care costs the system, compared with care provided by other physicians. The quality component will be calculated from measures reported through the Physician Quality Reporting System (PQRS). Your practice will then be “tiered” to determine whether your performance is statistically better, the same, or worse than the national mean. The CMS has not shared all the details of its “quality tiering” formula, but you can get an idea of their general criteria by reviewing the recently released “Quality Benchmarks for the 2015 Value Modifier” at CMS.org.

To calculate the cost component, the CMS will evaluate measures that include total overall costs per beneficiary, and total costs for a composite of chronic conditions, such as (for internists) chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes; no one has speculated on which diseases might be used for dermatology. Practitioners are eligible for a 1% bonus if their average score is in the top 25% of all scores nationwide. You can get some sense of where you stand in the national hierarchy by studying your Quality Resource and Use Report (QRUR), which gathers information about each practice’s quality and performance rates for the VBM. Reports for the first half of 2014 were released by the CMS in April, and can be downloaded from the QRUR section of CMS.gov.

The ACA requires that the program be budget neutral – which means that all bonuses to physicians in the highest 25% must be offset by penalties – “negative adjustments” – to those in the lowest 25%. The good news is that groups with two to nine providers, and solo practitioners who report successfully for PQRS, receive only the upward or neutral adjustment for 2017, with no downward adjustments. That means you will have at least one penalty-free year to determine where you stand in the VBM pecking order – and perhaps earn a bonus.

So in summary, here is what you have to do now, in 2015, to maximize your chances of earning that upward adjustment in 2017:

• If you haven’t already, make sure your practice data are correct in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). This is where CMS will gather data for the VBM and the Physician Feedback Reports.

• Study the Quality Benchmarks and download your practice’s QRUR, as mentioned.

• Report successfully for PQRS in 2015, which will also avoid an automatic penalty of 4% in 2017.

Are there serious potential consequences inherent in this unprecedented new system? I think so. For all the talk that the transition from fee-for-service to “value-based” reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing.

In essence, the VBM establishes arbitrary practice standards and spending ceilings. It creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. Physicians who have the temerity to practice medicine as they see fit, irrespective of the costs involved, will be punished.

Patients will certainly not welcome their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs, and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

All of that said, the VBM is a reality, and can no longer be ignored if you treat Medicare patients.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters.

While much has been written about the Center for Medicare & Medicaid Services (CMS) plan to shift its payment system away from fee for service and toward a “value-based” structure, most physicians in small and solo private settings have given little, if any, thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS plan is something called the Value-Based Payment Modifier (VBM), a component of the Affordable Care Act (ACA). The VBM has been off the radar of smaller private practices, because up until now it has applied only to groups with more than 10 providers. Starting this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBM “score.”

That score will be based on your “quality of care” (as defined by the CMS) and how much your care costs the system, compared with care provided by other physicians. The quality component will be calculated from measures reported through the Physician Quality Reporting System (PQRS). Your practice will then be “tiered” to determine whether your performance is statistically better, the same, or worse than the national mean. The CMS has not shared all the details of its “quality tiering” formula, but you can get an idea of their general criteria by reviewing the recently released “Quality Benchmarks for the 2015 Value Modifier” at CMS.org.

To calculate the cost component, the CMS will evaluate measures that include total overall costs per beneficiary, and total costs for a composite of chronic conditions, such as (for internists) chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes; no one has speculated on which diseases might be used for dermatology. Practitioners are eligible for a 1% bonus if their average score is in the top 25% of all scores nationwide. You can get some sense of where you stand in the national hierarchy by studying your Quality Resource and Use Report (QRUR), which gathers information about each practice’s quality and performance rates for the VBM. Reports for the first half of 2014 were released by the CMS in April, and can be downloaded from the QRUR section of CMS.gov.

The ACA requires that the program be budget neutral – which means that all bonuses to physicians in the highest 25% must be offset by penalties – “negative adjustments” – to those in the lowest 25%. The good news is that groups with two to nine providers, and solo practitioners who report successfully for PQRS, receive only the upward or neutral adjustment for 2017, with no downward adjustments. That means you will have at least one penalty-free year to determine where you stand in the VBM pecking order – and perhaps earn a bonus.

So in summary, here is what you have to do now, in 2015, to maximize your chances of earning that upward adjustment in 2017:

• If you haven’t already, make sure your practice data are correct in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). This is where CMS will gather data for the VBM and the Physician Feedback Reports.

• Study the Quality Benchmarks and download your practice’s QRUR, as mentioned.

• Report successfully for PQRS in 2015, which will also avoid an automatic penalty of 4% in 2017.

Are there serious potential consequences inherent in this unprecedented new system? I think so. For all the talk that the transition from fee-for-service to “value-based” reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing.

In essence, the VBM establishes arbitrary practice standards and spending ceilings. It creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. Physicians who have the temerity to practice medicine as they see fit, irrespective of the costs involved, will be punished.

Patients will certainly not welcome their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs, and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

All of that said, the VBM is a reality, and can no longer be ignored if you treat Medicare patients.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters.

While much has been written about the Center for Medicare & Medicaid Services (CMS) plan to shift its payment system away from fee for service and toward a “value-based” structure, most physicians in small and solo private settings have given little, if any, thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS plan is something called the Value-Based Payment Modifier (VBM), a component of the Affordable Care Act (ACA). The VBM has been off the radar of smaller private practices, because up until now it has applied only to groups with more than 10 providers. Starting this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBM “score.”

That score will be based on your “quality of care” (as defined by the CMS) and how much your care costs the system, compared with care provided by other physicians. The quality component will be calculated from measures reported through the Physician Quality Reporting System (PQRS). Your practice will then be “tiered” to determine whether your performance is statistically better, the same, or worse than the national mean. The CMS has not shared all the details of its “quality tiering” formula, but you can get an idea of their general criteria by reviewing the recently released “Quality Benchmarks for the 2015 Value Modifier” at CMS.org.

To calculate the cost component, the CMS will evaluate measures that include total overall costs per beneficiary, and total costs for a composite of chronic conditions, such as (for internists) chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes; no one has speculated on which diseases might be used for dermatology. Practitioners are eligible for a 1% bonus if their average score is in the top 25% of all scores nationwide. You can get some sense of where you stand in the national hierarchy by studying your Quality Resource and Use Report (QRUR), which gathers information about each practice’s quality and performance rates for the VBM. Reports for the first half of 2014 were released by the CMS in April, and can be downloaded from the QRUR section of CMS.gov.

The ACA requires that the program be budget neutral – which means that all bonuses to physicians in the highest 25% must be offset by penalties – “negative adjustments” – to those in the lowest 25%. The good news is that groups with two to nine providers, and solo practitioners who report successfully for PQRS, receive only the upward or neutral adjustment for 2017, with no downward adjustments. That means you will have at least one penalty-free year to determine where you stand in the VBM pecking order – and perhaps earn a bonus.

So in summary, here is what you have to do now, in 2015, to maximize your chances of earning that upward adjustment in 2017:

• If you haven’t already, make sure your practice data are correct in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). This is where CMS will gather data for the VBM and the Physician Feedback Reports.

• Study the Quality Benchmarks and download your practice’s QRUR, as mentioned.

• Report successfully for PQRS in 2015, which will also avoid an automatic penalty of 4% in 2017.

Are there serious potential consequences inherent in this unprecedented new system? I think so. For all the talk that the transition from fee-for-service to “value-based” reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing.

In essence, the VBM establishes arbitrary practice standards and spending ceilings. It creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. Physicians who have the temerity to practice medicine as they see fit, irrespective of the costs involved, will be punished.

Patients will certainly not welcome their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs, and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

All of that said, the VBM is a reality, and can no longer be ignored if you treat Medicare patients.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters.

In 2013, Rep. Tim Murphy (R-Pa.) proposed the Helping Families in Mental Health Crisis Act, H.R. 3717, as a response to the tragedy in Newtown, Conn. The legislation did not make it out of committee before the congressional session ended, and on June 4, a revised version of the bill – now H.R. 2646 – was introduced in Congress, cosponsored by Texas Democrat Rep. Eddie Bernice Johnson. The legislation is being framed as sweeping legislation “to fix America’s broken health system.” Those familiar with the original version may recall that controversial portions included a requirement for states to have legislation for outpatient civil commitment or lose funding, and allow caretakers to access information for mental health patients without patient consent. That version also proposed the shifting of funds from the Substance Abuse and Mental Health Services Administration (SAMHSA) to the National Institute of Mental Health (NIMH) to promote research.

The text of H.R. 2646 is 173 pages long, nearly 40 pages longer than the original version of the bill Even those who are well versed in these issues are having trouble deciphering the new proposals.

Let me start with a rather unusual disclaimer for someone writing about a piece of legislation: I haven’t read the bill. Instead, I read the blog of journalist/advocate Pete Earley, after he went to the effort of reading the text, soliciting the opinions of leadership at several organizations, and putting together a list of comparisons between the 2013 and 2015 versions of the proposed legislation. In a piece headlined, “Murphy Introduces Revamped Mental Health Bill: Will It Fly This Time Around?” Earley compares the new 2015 bill to the original legislation proposed in 2013.

I’m going to summarize the differences Earley noted, and I’ll add his caveat that he is not certain that his interpretations are correct; the wording of the bill is confusing, and there is not yet agreement on what the different components of the legislation mean. Because the issues around requirements for outpatient commitment have been so volatile, let me add that Earley did communicate with a staffer in Murphy’s office and confirmed that his understanding of that portion of the legislation is correct.

Earley noted eight main points:

1. Rather than removing funding from SAMHSA and shifting it to the NIMH, the new bill gives oversight for mental health care and funding to an assistant secretary for mental health and substance abuse treatment within the Department of Health and Human Services. The bill stipulates that the position must be held by a psychiatrist or psychologist.

2. In H.R. 2646, this funding would be provided only for programs recognized as evidence-based practices; it does not target specific SAMHSA programs for elimination.

3. States that implement outpatient civil commitment would receive a 2% increase in block funding grants. In the original version, states without this legislation would lose federal funding.

4. The new bill allows psychiatrists to share only specific information with caretakers without patient consent: diagnoses, treatment plans, and information about medications but not psychotherapy notes.

5. Murphy’s bill would repeal the so-called IMD (institutions for mental disease) exclusion for facilities with more than 16 beds as long as a facility kept patients less than an average of 30 days.

6. In the original version of the bill, Murphy wanted to eliminate funding to protection and advocacy agencies charged with protecting patients’ rights. The 2015 version bill would limit the powers of advocates by restricting their authority to the investigation of abuse and neglect, and would forbid these agencies from lobbying and from “counseling an individual with a serious mental illness who lacks insight into their condition on refusing medical treatment or acting against the wishes of such individual’s caregiver.”

7. The newer version eliminates the 190-day lifetime cap on inpatient psychiatric hospitalizations in Medicare.

8. H.R. 2646 encourages funding and support for peer-to-peer programs, but sets standards for peers and requires their work to be monitored by a mental health professional.

Obviously, legislation of this length includes much more, but these were the differences Earley identified in his comparison to text of the first version. His Website includes more detail and explanation of these points, and I encourage you to visit PeteEarley.com.

Days after the introduction of the bill, now known as the Murphy-Johnson Act, American Psychiatric Association President Renée Binder and CEO Saul Levin wrote a letter of support for the bill. The letter outlines some of the major issues that the legislation addresses, including increases to the psychiatric workforce. In it, they note: “This is historic legislation that would, for the first time in decades, bring systemwide reforms and improvements to care for our patients and for those who currently lack access to needed treatment.”

A hearing will be held on the bill today.

With thanks to Pete Earley who allowed me to hijack his article.

Dr. Miller is coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011). Follow Dr. Miller on Twitter @shrinkrapdinah.

In 2013, Rep. Tim Murphy (R-Pa.) proposed the Helping Families in Mental Health Crisis Act, H.R. 3717, as a response to the tragedy in Newtown, Conn. The legislation did not make it out of committee before the congressional session ended, and on June 4, a revised version of the bill – now H.R. 2646 – was introduced in Congress, cosponsored by Texas Democrat Rep. Eddie Bernice Johnson. The legislation is being framed as sweeping legislation “to fix America’s broken health system.” Those familiar with the original version may recall that controversial portions included a requirement for states to have legislation for outpatient civil commitment or lose funding, and allow caretakers to access information for mental health patients without patient consent. That version also proposed the shifting of funds from the Substance Abuse and Mental Health Services Administration (SAMHSA) to the National Institute of Mental Health (NIMH) to promote research.

The text of H.R. 2646 is 173 pages long, nearly 40 pages longer than the original version of the bill Even those who are well versed in these issues are having trouble deciphering the new proposals.

Let me start with a rather unusual disclaimer for someone writing about a piece of legislation: I haven’t read the bill. Instead, I read the blog of journalist/advocate Pete Earley, after he went to the effort of reading the text, soliciting the opinions of leadership at several organizations, and putting together a list of comparisons between the 2013 and 2015 versions of the proposed legislation. In a piece headlined, “Murphy Introduces Revamped Mental Health Bill: Will It Fly This Time Around?” Earley compares the new 2015 bill to the original legislation proposed in 2013.

I’m going to summarize the differences Earley noted, and I’ll add his caveat that he is not certain that his interpretations are correct; the wording of the bill is confusing, and there is not yet agreement on what the different components of the legislation mean. Because the issues around requirements for outpatient commitment have been so volatile, let me add that Earley did communicate with a staffer in Murphy’s office and confirmed that his understanding of that portion of the legislation is correct.

Earley noted eight main points:

1. Rather than removing funding from SAMHSA and shifting it to the NIMH, the new bill gives oversight for mental health care and funding to an assistant secretary for mental health and substance abuse treatment within the Department of Health and Human Services. The bill stipulates that the position must be held by a psychiatrist or psychologist.

2. In H.R. 2646, this funding would be provided only for programs recognized as evidence-based practices; it does not target specific SAMHSA programs for elimination.

3. States that implement outpatient civil commitment would receive a 2% increase in block funding grants. In the original version, states without this legislation would lose federal funding.

4. The new bill allows psychiatrists to share only specific information with caretakers without patient consent: diagnoses, treatment plans, and information about medications but not psychotherapy notes.

5. Murphy’s bill would repeal the so-called IMD (institutions for mental disease) exclusion for facilities with more than 16 beds as long as a facility kept patients less than an average of 30 days.

6. In the original version of the bill, Murphy wanted to eliminate funding to protection and advocacy agencies charged with protecting patients’ rights. The 2015 version bill would limit the powers of advocates by restricting their authority to the investigation of abuse and neglect, and would forbid these agencies from lobbying and from “counseling an individual with a serious mental illness who lacks insight into their condition on refusing medical treatment or acting against the wishes of such individual’s caregiver.”

7. The newer version eliminates the 190-day lifetime cap on inpatient psychiatric hospitalizations in Medicare.

8. H.R. 2646 encourages funding and support for peer-to-peer programs, but sets standards for peers and requires their work to be monitored by a mental health professional.

Obviously, legislation of this length includes much more, but these were the differences Earley identified in his comparison to text of the first version. His Website includes more detail and explanation of these points, and I encourage you to visit PeteEarley.com.

Days after the introduction of the bill, now known as the Murphy-Johnson Act, American Psychiatric Association President Renée Binder and CEO Saul Levin wrote a letter of support for the bill. The letter outlines some of the major issues that the legislation addresses, including increases to the psychiatric workforce. In it, they note: “This is historic legislation that would, for the first time in decades, bring systemwide reforms and improvements to care for our patients and for those who currently lack access to needed treatment.”

A hearing will be held on the bill today.

With thanks to Pete Earley who allowed me to hijack his article.

Dr. Miller is coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011). Follow Dr. Miller on Twitter @shrinkrapdinah.

In 2013, Rep. Tim Murphy (R-Pa.) proposed the Helping Families in Mental Health Crisis Act, H.R. 3717, as a response to the tragedy in Newtown, Conn. The legislation did not make it out of committee before the congressional session ended, and on June 4, a revised version of the bill – now H.R. 2646 – was introduced in Congress, cosponsored by Texas Democrat Rep. Eddie Bernice Johnson. The legislation is being framed as sweeping legislation “to fix America’s broken health system.” Those familiar with the original version may recall that controversial portions included a requirement for states to have legislation for outpatient civil commitment or lose funding, and allow caretakers to access information for mental health patients without patient consent. That version also proposed the shifting of funds from the Substance Abuse and Mental Health Services Administration (SAMHSA) to the National Institute of Mental Health (NIMH) to promote research.

The text of H.R. 2646 is 173 pages long, nearly 40 pages longer than the original version of the bill Even those who are well versed in these issues are having trouble deciphering the new proposals.

Let me start with a rather unusual disclaimer for someone writing about a piece of legislation: I haven’t read the bill. Instead, I read the blog of journalist/advocate Pete Earley, after he went to the effort of reading the text, soliciting the opinions of leadership at several organizations, and putting together a list of comparisons between the 2013 and 2015 versions of the proposed legislation. In a piece headlined, “Murphy Introduces Revamped Mental Health Bill: Will It Fly This Time Around?” Earley compares the new 2015 bill to the original legislation proposed in 2013.

I’m going to summarize the differences Earley noted, and I’ll add his caveat that he is not certain that his interpretations are correct; the wording of the bill is confusing, and there is not yet agreement on what the different components of the legislation mean. Because the issues around requirements for outpatient commitment have been so volatile, let me add that Earley did communicate with a staffer in Murphy’s office and confirmed that his understanding of that portion of the legislation is correct.

Earley noted eight main points:

1. Rather than removing funding from SAMHSA and shifting it to the NIMH, the new bill gives oversight for mental health care and funding to an assistant secretary for mental health and substance abuse treatment within the Department of Health and Human Services. The bill stipulates that the position must be held by a psychiatrist or psychologist.

2. In H.R. 2646, this funding would be provided only for programs recognized as evidence-based practices; it does not target specific SAMHSA programs for elimination.

3. States that implement outpatient civil commitment would receive a 2% increase in block funding grants. In the original version, states without this legislation would lose federal funding.

4. The new bill allows psychiatrists to share only specific information with caretakers without patient consent: diagnoses, treatment plans, and information about medications but not psychotherapy notes.

5. Murphy’s bill would repeal the so-called IMD (institutions for mental disease) exclusion for facilities with more than 16 beds as long as a facility kept patients less than an average of 30 days.

6. In the original version of the bill, Murphy wanted to eliminate funding to protection and advocacy agencies charged with protecting patients’ rights. The 2015 version bill would limit the powers of advocates by restricting their authority to the investigation of abuse and neglect, and would forbid these agencies from lobbying and from “counseling an individual with a serious mental illness who lacks insight into their condition on refusing medical treatment or acting against the wishes of such individual’s caregiver.”

7. The newer version eliminates the 190-day lifetime cap on inpatient psychiatric hospitalizations in Medicare.

8. H.R. 2646 encourages funding and support for peer-to-peer programs, but sets standards for peers and requires their work to be monitored by a mental health professional.

Obviously, legislation of this length includes much more, but these were the differences Earley identified in his comparison to text of the first version. His Website includes more detail and explanation of these points, and I encourage you to visit PeteEarley.com.

Days after the introduction of the bill, now known as the Murphy-Johnson Act, American Psychiatric Association President Renée Binder and CEO Saul Levin wrote a letter of support for the bill. The letter outlines some of the major issues that the legislation addresses, including increases to the psychiatric workforce. In it, they note: “This is historic legislation that would, for the first time in decades, bring systemwide reforms and improvements to care for our patients and for those who currently lack access to needed treatment.”

A hearing will be held on the bill today.

With thanks to Pete Earley who allowed me to hijack his article.

Dr. Miller is coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University Press, 2011). Follow Dr. Miller on Twitter @shrinkrapdinah.

The last time I spoke with my 70-year-old mother in Rhode Island, I asked her how she made out at her latest dermatology appointment. She burst forth: “Don’t get me started! The doctor spent the whole time with his face in the computer screen. He hardly examined me!” It went downhill from there.

I feel both her pain and his. As a Gen-X physician, I’m in a unique position. I trained in the pre-EHR age with the Dr. Marcus Welby–type physicians my parents knew and admired. I have also embraced the digitization of medicine and the advances this affords. At Kaiser Permanente, I help run one of the country’s most robust telemedicine programs, and I answer dozens of patient e-mails each week. Yet I too experience the frustration of having to split my attention between my screens and my patients.

At conferences and in articles, it seems the chasm between physicians who eagerly embrace the new digital world of medicine and those who long for the way things used to be is expanding rather than shrinking. Too often, there is insufficient dialogue between these two groups. Dr. Robert Wachter hopes to change that.

Professor and associate chair of the department of medicine at the University of California, San Francisco, Dr. Wachter has authored six books, has developed the concept of the “hospitalist,” and has been a leader in patient safety. His latest book, “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age,” (McGraw-Hill, 2015) has been hailed as a “must read” for physicians and other health care practitioners. I agree.

Medicine is in the midst of profound change that is as frightening as it is exciting. Dr. Wachter captures this tension through memorable patient stories and interviews. He argues that technology has made medicine both better and worse. It has enabled clinicians to improve diagnostics and health care delivery. Consider the explosive growth of “big data” in health care and of patient empowerment (e-mailing, texting, Skyping, OpenNotes). Yet, an astute observer acknowledges technology’s shortfalls. For example, what happens when information is incorrectly entered in an EHR? What are physicians to do with the massive patient data we receive?

To illustrate his theme, Dr. Wachter examines EHRs in depth. He argues that the most brilliant engineers can create the most complex computer systems, but if they’re not implemented and funded systemically, how will they be successful? Why would private practice physicians want to relinquish their “tried-and-true paper prescription and record system for an expensive and complex EHR?” And what happens when EHRs don’t talk to one another?

Despite their obvious advantages, EHRs have several drawbacks, including poor usability, time-consuming data entry (that adversely affects the doctor-patient relationship), the high cost of implementation, and decreased satisfaction among physicians with their jobs, Dr. Wachter notes. Who has the solution to these problems? Is it Silicon Valley? Or did they create the problem? (Dr. Wachter spends a great deal of time interviewing key players from that region.) Ultimately, he determines that the EHR, despite its brilliant advantages, wasn’t designed to give both physicians and patients what they really want.

The most compelling patient story that Dr. Wachter shares concerns a teenage boy who nearly died from an overdose of an antibiotic. He shows with devastating clarity how one wrong click of the keypad can lead to tragedy. No one – physicians, nurses, nor pharmacists – caught the error (the patient was administered 38.5 tablets instead of 1 tablet). Why? Dr. Wachter blames our “blind trust” in computers, which causes us to not question when something seems wrong. Moreover, multiple warnings went unheeded by nurses, who probably suffered from “alert fatigue,” desensitization to warning alarms (think of the ubiquitous car alarms sounding and how no one reacts to them), he says.

This leads to Dr. Wachter’s dive into the “complex interface between technology and people.” At what point do computers stop assisting physicians and begin replacing them? While he clearly believes that the human component of the doctor-patient relationship is irreplaceable, he does acknowledge through interviews with people such as Vinod Khosla, cofounder of Sun Microsystems, that computers will continue to “displace” much of the physician’s diagnostic and prescription work.

As Dr. Wachter seesaws through both sides of this argument, he finds himself “stick[ing] up for my teams: humans and the subset of humans called doctors.” After all, isn’t diagnostic skill at the core of an astute clinician’s arsenal? How do we relinquish it to computers?

What about technologies like OpenNotes that empower patients? How will this affect the doctor-patient relationship? What are we to do about patients who make bad choices, opt for high copays to save money up front, or choose Minute Clinics for all their health care needs? Will patients be harmed by such openness? The jury is still out.

For those who like clear black-and-white answers, Dr. Wachter’s book will seem maddeningly gray. Yet as a practicing clinician, I found it enlightening and thought provoking, and hope you will, too. I also hope it prompts you to step away from the computer, walk next door to your colleague’s office, and start a real-life conversation.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

The last time I spoke with my 70-year-old mother in Rhode Island, I asked her how she made out at her latest dermatology appointment. She burst forth: “Don’t get me started! The doctor spent the whole time with his face in the computer screen. He hardly examined me!” It went downhill from there.

I feel both her pain and his. As a Gen-X physician, I’m in a unique position. I trained in the pre-EHR age with the Dr. Marcus Welby–type physicians my parents knew and admired. I have also embraced the digitization of medicine and the advances this affords. At Kaiser Permanente, I help run one of the country’s most robust telemedicine programs, and I answer dozens of patient e-mails each week. Yet I too experience the frustration of having to split my attention between my screens and my patients.

At conferences and in articles, it seems the chasm between physicians who eagerly embrace the new digital world of medicine and those who long for the way things used to be is expanding rather than shrinking. Too often, there is insufficient dialogue between these two groups. Dr. Robert Wachter hopes to change that.

Professor and associate chair of the department of medicine at the University of California, San Francisco, Dr. Wachter has authored six books, has developed the concept of the “hospitalist,” and has been a leader in patient safety. His latest book, “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age,” (McGraw-Hill, 2015) has been hailed as a “must read” for physicians and other health care practitioners. I agree.

Medicine is in the midst of profound change that is as frightening as it is exciting. Dr. Wachter captures this tension through memorable patient stories and interviews. He argues that technology has made medicine both better and worse. It has enabled clinicians to improve diagnostics and health care delivery. Consider the explosive growth of “big data” in health care and of patient empowerment (e-mailing, texting, Skyping, OpenNotes). Yet, an astute observer acknowledges technology’s shortfalls. For example, what happens when information is incorrectly entered in an EHR? What are physicians to do with the massive patient data we receive?

To illustrate his theme, Dr. Wachter examines EHRs in depth. He argues that the most brilliant engineers can create the most complex computer systems, but if they’re not implemented and funded systemically, how will they be successful? Why would private practice physicians want to relinquish their “tried-and-true paper prescription and record system for an expensive and complex EHR?” And what happens when EHRs don’t talk to one another?

Despite their obvious advantages, EHRs have several drawbacks, including poor usability, time-consuming data entry (that adversely affects the doctor-patient relationship), the high cost of implementation, and decreased satisfaction among physicians with their jobs, Dr. Wachter notes. Who has the solution to these problems? Is it Silicon Valley? Or did they create the problem? (Dr. Wachter spends a great deal of time interviewing key players from that region.) Ultimately, he determines that the EHR, despite its brilliant advantages, wasn’t designed to give both physicians and patients what they really want.

The most compelling patient story that Dr. Wachter shares concerns a teenage boy who nearly died from an overdose of an antibiotic. He shows with devastating clarity how one wrong click of the keypad can lead to tragedy. No one – physicians, nurses, nor pharmacists – caught the error (the patient was administered 38.5 tablets instead of 1 tablet). Why? Dr. Wachter blames our “blind trust” in computers, which causes us to not question when something seems wrong. Moreover, multiple warnings went unheeded by nurses, who probably suffered from “alert fatigue,” desensitization to warning alarms (think of the ubiquitous car alarms sounding and how no one reacts to them), he says.

This leads to Dr. Wachter’s dive into the “complex interface between technology and people.” At what point do computers stop assisting physicians and begin replacing them? While he clearly believes that the human component of the doctor-patient relationship is irreplaceable, he does acknowledge through interviews with people such as Vinod Khosla, cofounder of Sun Microsystems, that computers will continue to “displace” much of the physician’s diagnostic and prescription work.

As Dr. Wachter seesaws through both sides of this argument, he finds himself “stick[ing] up for my teams: humans and the subset of humans called doctors.” After all, isn’t diagnostic skill at the core of an astute clinician’s arsenal? How do we relinquish it to computers?

What about technologies like OpenNotes that empower patients? How will this affect the doctor-patient relationship? What are we to do about patients who make bad choices, opt for high copays to save money up front, or choose Minute Clinics for all their health care needs? Will patients be harmed by such openness? The jury is still out.

For those who like clear black-and-white answers, Dr. Wachter’s book will seem maddeningly gray. Yet as a practicing clinician, I found it enlightening and thought provoking, and hope you will, too. I also hope it prompts you to step away from the computer, walk next door to your colleague’s office, and start a real-life conversation.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

The last time I spoke with my 70-year-old mother in Rhode Island, I asked her how she made out at her latest dermatology appointment. She burst forth: “Don’t get me started! The doctor spent the whole time with his face in the computer screen. He hardly examined me!” It went downhill from there.

I feel both her pain and his. As a Gen-X physician, I’m in a unique position. I trained in the pre-EHR age with the Dr. Marcus Welby–type physicians my parents knew and admired. I have also embraced the digitization of medicine and the advances this affords. At Kaiser Permanente, I help run one of the country’s most robust telemedicine programs, and I answer dozens of patient e-mails each week. Yet I too experience the frustration of having to split my attention between my screens and my patients.

At conferences and in articles, it seems the chasm between physicians who eagerly embrace the new digital world of medicine and those who long for the way things used to be is expanding rather than shrinking. Too often, there is insufficient dialogue between these two groups. Dr. Robert Wachter hopes to change that.

Professor and associate chair of the department of medicine at the University of California, San Francisco, Dr. Wachter has authored six books, has developed the concept of the “hospitalist,” and has been a leader in patient safety. His latest book, “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age,” (McGraw-Hill, 2015) has been hailed as a “must read” for physicians and other health care practitioners. I agree.

Medicine is in the midst of profound change that is as frightening as it is exciting. Dr. Wachter captures this tension through memorable patient stories and interviews. He argues that technology has made medicine both better and worse. It has enabled clinicians to improve diagnostics and health care delivery. Consider the explosive growth of “big data” in health care and of patient empowerment (e-mailing, texting, Skyping, OpenNotes). Yet, an astute observer acknowledges technology’s shortfalls. For example, what happens when information is incorrectly entered in an EHR? What are physicians to do with the massive patient data we receive?

To illustrate his theme, Dr. Wachter examines EHRs in depth. He argues that the most brilliant engineers can create the most complex computer systems, but if they’re not implemented and funded systemically, how will they be successful? Why would private practice physicians want to relinquish their “tried-and-true paper prescription and record system for an expensive and complex EHR?” And what happens when EHRs don’t talk to one another?

Despite their obvious advantages, EHRs have several drawbacks, including poor usability, time-consuming data entry (that adversely affects the doctor-patient relationship), the high cost of implementation, and decreased satisfaction among physicians with their jobs, Dr. Wachter notes. Who has the solution to these problems? Is it Silicon Valley? Or did they create the problem? (Dr. Wachter spends a great deal of time interviewing key players from that region.) Ultimately, he determines that the EHR, despite its brilliant advantages, wasn’t designed to give both physicians and patients what they really want.

The most compelling patient story that Dr. Wachter shares concerns a teenage boy who nearly died from an overdose of an antibiotic. He shows with devastating clarity how one wrong click of the keypad can lead to tragedy. No one – physicians, nurses, nor pharmacists – caught the error (the patient was administered 38.5 tablets instead of 1 tablet). Why? Dr. Wachter blames our “blind trust” in computers, which causes us to not question when something seems wrong. Moreover, multiple warnings went unheeded by nurses, who probably suffered from “alert fatigue,” desensitization to warning alarms (think of the ubiquitous car alarms sounding and how no one reacts to them), he says.

This leads to Dr. Wachter’s dive into the “complex interface between technology and people.” At what point do computers stop assisting physicians and begin replacing them? While he clearly believes that the human component of the doctor-patient relationship is irreplaceable, he does acknowledge through interviews with people such as Vinod Khosla, cofounder of Sun Microsystems, that computers will continue to “displace” much of the physician’s diagnostic and prescription work.

As Dr. Wachter seesaws through both sides of this argument, he finds himself “stick[ing] up for my teams: humans and the subset of humans called doctors.” After all, isn’t diagnostic skill at the core of an astute clinician’s arsenal? How do we relinquish it to computers?

What about technologies like OpenNotes that empower patients? How will this affect the doctor-patient relationship? What are we to do about patients who make bad choices, opt for high copays to save money up front, or choose Minute Clinics for all their health care needs? Will patients be harmed by such openness? The jury is still out.

For those who like clear black-and-white answers, Dr. Wachter’s book will seem maddeningly gray. Yet as a practicing clinician, I found it enlightening and thought provoking, and hope you will, too. I also hope it prompts you to step away from the computer, walk next door to your colleague’s office, and start a real-life conversation.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Sad woman

Photo by Jiri Hodan

DUBROVNIK, CROATIA—Results of a large study suggest patients who develop a venous thromboembolism (VTE) may have more mental health problems than their healthy peers.

One in 5 patients in the study purchased psychotropic drugs within 5 years of developing a VTE, a rate that was more than double that of age- and sex-matched control subjects.

Anette Arbjerg Højen, of Aalborg University Hospital in Denmark, presented these findings at EuroHeartCare 2015 (abstract 22).

“We know that other chronic medical illnesses in youth can lead to emotional and behavioral problems,” Arbjerg Højen said. “However, until now, VTE has been considered an acute condition that occurs in older people. There is no follow-up of [young VTE] patients regarding their mental health, and no studies have been done on this issue.”

So she and her colleagues investigated the mental health prognosis of young VTE patients using data from 4 nationwide registries: the Danish Civil Registration System, the Danish National Patient Register, the Danish National Prescription Registry, and the Danish Medical Birth Registry.

The investigators identified 4132 patients, ages 13 to 33, who had a first VTE between 1997 and 2010. The team then matched these patients by sex and birth year to a control group of 19,292 people without VTE.

All study participants were followed for their first purchase of psychotropic drugs, including antidepressants, anti-anxiety medications, sedatives, and antipsychotics.

The researchers used the purchase of psychotropic drugs as a proxy measure for mental health status and compared the measure between the two groups. The team used regression analysis to exclude non-VTE-related causes of psychotropic drug purchase, such as postpartum depression.

Results showed the VTE patients were much more likely to purchase psychotropic drugs than control subjects. Among VTE patients, the risk of purchasing psychotropic drugs following their diagnosis was 7.1% after 1 year and 22.1% after 5 years.

The excess risk for VTE patients relative to the controls was 4.7% after 1 year and 10.8% after 5 years. When the investigators adjusted for the effect of recent pregnancy or recent provocations, the risk differences became 4.1% after 1 year and 9.6% after 5 years.

“Most of the drugs prescribed were antidepressants,” Arbjerg Højen said. “These young patients struggle a lot with the fear of VTE recurrence. They are scared that, if it strikes again, it could become a pulmonary embolism and they might die.”

“Our study only included patients who received a prescription for psychotropic drugs. There will be others who were not prescribed medication because of their young age, so the group with mental health problems could be much larger than what we found.”

“Our study looked at mental health up to 5 years and not just in the immediate period after the VTE event, suggesting that it is not just a short-term panic. We don’t know how long mental health problems in VTE patients last, but we do know that these patients will always be at high risk of recurrent VTE, so there is a possibility that their depression or anxiety could be life-long if untreated.”

“Most young VTE patients are monitored by their general practitioner for 3 to 6 months because they are on oral anticoagulant treatment, but, after that, there is generally no long-term follow up. Our study points to the need for treating VTE as a chronic condition with serious mental health consequences requiring specialist care.”

Sad woman

Photo by Jiri Hodan

DUBROVNIK, CROATIA—Results of a large study suggest patients who develop a venous thromboembolism (VTE) may have more mental health problems than their healthy peers.

One in 5 patients in the study purchased psychotropic drugs within 5 years of developing a VTE, a rate that was more than double that of age- and sex-matched control subjects.

Anette Arbjerg Højen, of Aalborg University Hospital in Denmark, presented these findings at EuroHeartCare 2015 (abstract 22).

“We know that other chronic medical illnesses in youth can lead to emotional and behavioral problems,” Arbjerg Højen said. “However, until now, VTE has been considered an acute condition that occurs in older people. There is no follow-up of [young VTE] patients regarding their mental health, and no studies have been done on this issue.”

So she and her colleagues investigated the mental health prognosis of young VTE patients using data from 4 nationwide registries: the Danish Civil Registration System, the Danish National Patient Register, the Danish National Prescription Registry, and the Danish Medical Birth Registry.

The investigators identified 4132 patients, ages 13 to 33, who had a first VTE between 1997 and 2010. The team then matched these patients by sex and birth year to a control group of 19,292 people without VTE.

All study participants were followed for their first purchase of psychotropic drugs, including antidepressants, anti-anxiety medications, sedatives, and antipsychotics.

The researchers used the purchase of psychotropic drugs as a proxy measure for mental health status and compared the measure between the two groups. The team used regression analysis to exclude non-VTE-related causes of psychotropic drug purchase, such as postpartum depression.

Results showed the VTE patients were much more likely to purchase psychotropic drugs than control subjects. Among VTE patients, the risk of purchasing psychotropic drugs following their diagnosis was 7.1% after 1 year and 22.1% after 5 years.

The excess risk for VTE patients relative to the controls was 4.7% after 1 year and 10.8% after 5 years. When the investigators adjusted for the effect of recent pregnancy or recent provocations, the risk differences became 4.1% after 1 year and 9.6% after 5 years.

“Most of the drugs prescribed were antidepressants,” Arbjerg Højen said. “These young patients struggle a lot with the fear of VTE recurrence. They are scared that, if it strikes again, it could become a pulmonary embolism and they might die.”

“Our study only included patients who received a prescription for psychotropic drugs. There will be others who were not prescribed medication because of their young age, so the group with mental health problems could be much larger than what we found.”

“Our study looked at mental health up to 5 years and not just in the immediate period after the VTE event, suggesting that it is not just a short-term panic. We don’t know how long mental health problems in VTE patients last, but we do know that these patients will always be at high risk of recurrent VTE, so there is a possibility that their depression or anxiety could be life-long if untreated.”

“Most young VTE patients are monitored by their general practitioner for 3 to 6 months because they are on oral anticoagulant treatment, but, after that, there is generally no long-term follow up. Our study points to the need for treating VTE as a chronic condition with serious mental health consequences requiring specialist care.”

Sad woman

Photo by Jiri Hodan

DUBROVNIK, CROATIA—Results of a large study suggest patients who develop a venous thromboembolism (VTE) may have more mental health problems than their healthy peers.

One in 5 patients in the study purchased psychotropic drugs within 5 years of developing a VTE, a rate that was more than double that of age- and sex-matched control subjects.

Anette Arbjerg Højen, of Aalborg University Hospital in Denmark, presented these findings at EuroHeartCare 2015 (abstract 22).

“We know that other chronic medical illnesses in youth can lead to emotional and behavioral problems,” Arbjerg Højen said. “However, until now, VTE has been considered an acute condition that occurs in older people. There is no follow-up of [young VTE] patients regarding their mental health, and no studies have been done on this issue.”

So she and her colleagues investigated the mental health prognosis of young VTE patients using data from 4 nationwide registries: the Danish Civil Registration System, the Danish National Patient Register, the Danish National Prescription Registry, and the Danish Medical Birth Registry.

The investigators identified 4132 patients, ages 13 to 33, who had a first VTE between 1997 and 2010. The team then matched these patients by sex and birth year to a control group of 19,292 people without VTE.

All study participants were followed for their first purchase of psychotropic drugs, including antidepressants, anti-anxiety medications, sedatives, and antipsychotics.

The researchers used the purchase of psychotropic drugs as a proxy measure for mental health status and compared the measure between the two groups. The team used regression analysis to exclude non-VTE-related causes of psychotropic drug purchase, such as postpartum depression.

Results showed the VTE patients were much more likely to purchase psychotropic drugs than control subjects. Among VTE patients, the risk of purchasing psychotropic drugs following their diagnosis was 7.1% after 1 year and 22.1% after 5 years.

The excess risk for VTE patients relative to the controls was 4.7% after 1 year and 10.8% after 5 years. When the investigators adjusted for the effect of recent pregnancy or recent provocations, the risk differences became 4.1% after 1 year and 9.6% after 5 years.

“Most of the drugs prescribed were antidepressants,” Arbjerg Højen said. “These young patients struggle a lot with the fear of VTE recurrence. They are scared that, if it strikes again, it could become a pulmonary embolism and they might die.”

“Our study only included patients who received a prescription for psychotropic drugs. There will be others who were not prescribed medication because of their young age, so the group with mental health problems could be much larger than what we found.”

“Our study looked at mental health up to 5 years and not just in the immediate period after the VTE event, suggesting that it is not just a short-term panic. We don’t know how long mental health problems in VTE patients last, but we do know that these patients will always be at high risk of recurrent VTE, so there is a possibility that their depression or anxiety could be life-long if untreated.”

“Most young VTE patients are monitored by their general practitioner for 3 to 6 months because they are on oral anticoagulant treatment, but, after that, there is generally no long-term follow up. Our study points to the need for treating VTE as a chronic condition with serious mental health consequences requiring specialist care.”

Enterococcus species account for about 110,000 urinary tract infections (UTIs) annually in the U.S.¹ The most common species isolated are Enterococcus faecalis and Enterococcus faecium (E faecium). Amoxicillin is the drug of choice for the treatment of enterococcal UTIs. Second-line therapies include vancomycin and nitrofurantoin. Alternative therapies include daptomycin and linezolid; however, these newer agents ideally would be reserved for more serious infections to preserve activity.²

Increased E faecium resistance to ampicillin and vancomycin has limited the therapeutic options. The results of a study by Zhanel and colleagues assessed the prevalence of resistant enterococcal urine isolates in North America.³ Of the 658 E faecium urine isolates, about 96% were resistant to ampicillin and 94% were resistant to vancoymcin.³ Nitrofurantoin has much lower resistance rates; however, its use is contraindicated in patients with a creatinine clearance (CrCl) < 60 mL/min.⁴ Data supporting the contraindication are limited, but the results of a study by Oplinger and Andrews suggested that using nitrofurantoin in patients with a CrCl ≥ 40 mL/min may be safe and effective.⁵ A therapeutic dilemma may occur when resistant E faecium UTIs are encountered and viable treatment options are limited due to intolerances, administration difficulties, lack of susceptibility data, or cost.

Related: Antimicrobial Stewardship in an Outpatient Parenteral Antibiotic Therapy Program

Based on the current Clinical and Laboratory Standards Institute standard, Enterococcus species with a minimal inhibitory concentration (MIC) ≥ 16 μg/mL are considered ampicillin resistant. Microbiology laboratories use the same breakpoint regardless of the site of infection.⁶ Amoxicillin concentrates in the urine; therefore, urinary concentrations are much higher than serum concentrations. The mean serum peak concentration after a single dose of oral amoxicillin 500 mg is 7.6 μg/mL.⁷ After a single dose of oral amoxicillin 500 mg, the average concentration in pooled urine collected over 6 hours was 1,100 μg/mL.⁸

In 2002, Williamson and colleagues analyzed 30 ampicillin- resistant E faecium urine isolates. Reported MICs were 128 μg/mL (30%), 256 μg/mL (60%), and 512 μg/mL (10%).⁹ A more recent retrospective analysis analyzed 234 ampicillin-resistant E faecium urine isolates. The MIC ranged from 32 to 1,024 μg/mL, with a median MIC of 256 μg/mL. Only 5 isolates had an MIC value > 1,000 μg/mL, but each of these isolates was within 1 dilution of 512 μg/mL.¹⁰ Because penicillins exhibit time-dependent killing, an optimal response will occur as long as the urine concentration is above the MIC for at least 50% of the dosing interval.¹¹ Therefore, therapeutic doses of amoxicillin are expected to produce urine concentrations that exceed the MIC of resistant E faecium urine isolates. The purpose of this study was to determine if amoxicillin was a viable treatment option for ampicillin-resistant E faecium UTIs based on this in vitro theory.

Methods

Veterans aged ≥ 18 years with a positive urine culture for ampicillin- resistant E faecium who received antibiotic therapy for cystitis at the Jesse Brown VA Medical Center (JBVAMC) from January 1, 2005, through June 22, 2010, were evaluated in this retrospective cohort study. Exclusion criteria were the presence of any other organisms in the initial urine culture, prostatic involvement, and the presence of E faecium in a blood culture. Subjects treated with multiple antibiotics concurrently and with sequential treatment of different antibiotics with no evaluation of efficacy between courses were also excluded.

Related: Urologist Workforce Variation Across the VHA

All included subjects were evaluated for resolution of symptoms; improvement in leukocyte esterase count and white blood cell (WBC) count from urine analysis (UA); and eradication of E faecium from a repeat urine culture. The response to treatment was classified as cure, presumed cure, or failure. The criteria for cure were based on the following: resolution of symptoms if present at baseline; repeat UA indicating improvement from the initial positive UA (if obtained); and eradication of E faecium in a repeat urine culture (if obtained).

At least 1 of the aforementioned criteria must have been met to be classified as cure. If more than 1 of the aforementioned criteria was present, then each one must have been met to be classified as cure. To be evaluated for presumed cure, the subject must have had symptoms at baseline. No documentation of ongoing symptoms in subjects who had an appropriate follow-up but did not have a repeat UA or urine culture indicated presumed cure. Persistence or worsening of pretreatment symptoms, a repeat UA without improvement from the initial positive UA, or a repeat urine culture demonstrating continued presence of E faecium indicated failure. The primary endpoint for the study was to determine whether amoxicillin was effective for the management of ampicillin-resistant E faecium UTIs. This study was conducted in compliance with the University of Illinois at Chicago Institutional Review Board and JBVAMC Human Subjects Research Committee requirements.

Results

This study included 20 positive urine cultures for ampicillin-resistant E faecium in 19 subjects. Nine cases were treated with amoxicillin, and 11 cases were treated with nitrofurantoin. At baseline, the mean age was 75 years, mean duration of therapy was 14 days, and all the subjects were male. The baseline characteristics of the 2 groups were similar with the exception of an older population, shorter duration of therapy, and increased incidence of chronic kidney disease in the amoxicillin treatment group, P = .02, .03, and .01, respectively.

Symptoms were documented in 8 of 9 (89%) cases at the time of the positive culture in the amoxicillin treatment group and 5 of 11 (45%) cases in the nitrofurantoin treatment group (Table). The asymptomatic amoxicillin treatment group case and 5 of the 6 nitrofurantoin treatment group asymptomatic cases received treatment prior to a urologic procedure in accordance with the Infectious Diseases Society of America (IDSA) guidelines for the treatment of asymptomatic bacteriuria. The urologic procedures included transurethral resection of a bladder tumor, cystoscopy, urethral dilation, cystometrogram, and transurethral resection of the prostate. One asymptomatic subject in the nitrofurantoin group did not have any documentation to support an appropriate indication for treatment. All positive cultures were > 100,000 colonies/mL except for 1 culture in the nitrofurantoin treatment group, which was 45,000 colonies/mL, but because the subject was symptomatic, treatment was administered and a repeat urine culture was negative.

There were 8 cases classified as cure, 1 presumed cure, and no failures in the amoxicillin group. In the nitrofurantoin group, 7 cases were classified as cure, 1 presumed cure, and 3 failures. The presumed cures were excluded from the statistical analysis due to inability to ensure these cases were truly cured. Also excluded from the statistical analysis was one of the failures in the nitrofurantoin group, because the subject was asymptomatic with no known indication for treatment. This left 8 cases classified as cure and no failures in the amoxicillin group compared with 7 cases classified as cure and 2 failures in the nitrofurantoin group, P = .47 (Figure). Statistical analysis was performed using the Fisher exact test.

Discussion

There was no statistically significant difference between amoxicillin and nitrofurantoin for the treatment of ampicillin-resistant E faecium UTIs. There were no failures in the amoxicillin group despite all isolates displaying resistance based on current breakpoints, supporting the theory that higher urine concentrations of amoxicillin may overcome the MIC of resistant isolates.

Related: Novel Therapy for Treating Complicated UTIs

Of the 11 cases treated with nitrofurantoin, 3 were classified failures. The first failure in the nitrofurantoin group was an asymptomatic subject who did not have a repeat urine culture but had a repeat UA, which showed a persistent elevation in WBC and leukocyte esterase count. This subject was removed from the statistical analysis, as treatment was not indicated per IDSA guidelines. No reason could be identified for the second failure, as a repeat culture demonstrated continued presence of E faecium. Chronic kidney disease (CKD) contributed to the third failure in the nitrofurantoin treatment group; the subject’s CrCl was about 17 mL/min. After treatment, the subject had a repeat urine culture, which indicated the continued presence of E faecium. The subject was later successfully treated with amoxicillin. Both cultures in the same subject were included in the final analysis per protocol, as the subject had an adequate evaluation of efficacy between courses. Four additional cases with CKD were treated with nitrofurantoin; however, their CrCl ranged from 40 to 55 mL/min, and all were classified cure or presumed cure.

Limitations

There were several limitations to this study. Due to the strict inclusion and exclusion criteria, a limited number of subjects were evaluated. Given that this was a retrospective study, it is possible that symptoms were reported by a subject but not appropriately documented. Another significant limitation of this trial was that MICs were not determined due to the retrospective nature of the study. External validity was also limited due to a predominately elderly and male population. Safety data regarding different therapies were not collected, as this study evaluated only the efficacy of therapies.

Conclusion

Although this was a very small retrospective analysis, to the authors knowledge this is the first clinical study supporting the in vitro theory that amoxicillin (500 mg every 8 hours) may overcome the MIC of resistant isolates due to achievement of higher urinary concentrations. Because this was a small retrospective analysis, more prospective evidence is needed to confirm these results.

Acknowledgements
Heather Kim, biostatistician, University of Illinois at Chicago. CCTS Support: UL1RR029879.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Enterococcus species account for about 110,000 urinary tract infections (UTIs) annually in the U.S.¹ The most common species isolated are Enterococcus faecalis and Enterococcus faecium (E faecium). Amoxicillin is the drug of choice for the treatment of enterococcal UTIs. Second-line therapies include vancomycin and nitrofurantoin. Alternative therapies include daptomycin and linezolid; however, these newer agents ideally would be reserved for more serious infections to preserve activity.²

Increased E faecium resistance to ampicillin and vancomycin has limited the therapeutic options. The results of a study by Zhanel and colleagues assessed the prevalence of resistant enterococcal urine isolates in North America.³ Of the 658 E faecium urine isolates, about 96% were resistant to ampicillin and 94% were resistant to vancoymcin.³ Nitrofurantoin has much lower resistance rates; however, its use is contraindicated in patients with a creatinine clearance (CrCl) < 60 mL/min.⁴ Data supporting the contraindication are limited, but the results of a study by Oplinger and Andrews suggested that using nitrofurantoin in patients with a CrCl ≥ 40 mL/min may be safe and effective.⁵ A therapeutic dilemma may occur when resistant E faecium UTIs are encountered and viable treatment options are limited due to intolerances, administration difficulties, lack of susceptibility data, or cost.

Related: Antimicrobial Stewardship in an Outpatient Parenteral Antibiotic Therapy Program

Based on the current Clinical and Laboratory Standards Institute standard, Enterococcus species with a minimal inhibitory concentration (MIC) ≥ 16 μg/mL are considered ampicillin resistant. Microbiology laboratories use the same breakpoint regardless of the site of infection.⁶ Amoxicillin concentrates in the urine; therefore, urinary concentrations are much higher than serum concentrations. The mean serum peak concentration after a single dose of oral amoxicillin 500 mg is 7.6 μg/mL.⁷ After a single dose of oral amoxicillin 500 mg, the average concentration in pooled urine collected over 6 hours was 1,100 μg/mL.⁸

In 2002, Williamson and colleagues analyzed 30 ampicillin- resistant E faecium urine isolates. Reported MICs were 128 μg/mL (30%), 256 μg/mL (60%), and 512 μg/mL (10%).⁹ A more recent retrospective analysis analyzed 234 ampicillin-resistant E faecium urine isolates. The MIC ranged from 32 to 1,024 μg/mL, with a median MIC of 256 μg/mL. Only 5 isolates had an MIC value > 1,000 μg/mL, but each of these isolates was within 1 dilution of 512 μg/mL.¹⁰ Because penicillins exhibit time-dependent killing, an optimal response will occur as long as the urine concentration is above the MIC for at least 50% of the dosing interval.¹¹ Therefore, therapeutic doses of amoxicillin are expected to produce urine concentrations that exceed the MIC of resistant E faecium urine isolates. The purpose of this study was to determine if amoxicillin was a viable treatment option for ampicillin-resistant E faecium UTIs based on this in vitro theory.

Methods

Veterans aged ≥ 18 years with a positive urine culture for ampicillin- resistant E faecium who received antibiotic therapy for cystitis at the Jesse Brown VA Medical Center (JBVAMC) from January 1, 2005, through June 22, 2010, were evaluated in this retrospective cohort study. Exclusion criteria were the presence of any other organisms in the initial urine culture, prostatic involvement, and the presence of E faecium in a blood culture. Subjects treated with multiple antibiotics concurrently and with sequential treatment of different antibiotics with no evaluation of efficacy between courses were also excluded.

Related: Urologist Workforce Variation Across the VHA

All included subjects were evaluated for resolution of symptoms; improvement in leukocyte esterase count and white blood cell (WBC) count from urine analysis (UA); and eradication of E faecium from a repeat urine culture. The response to treatment was classified as cure, presumed cure, or failure. The criteria for cure were based on the following: resolution of symptoms if present at baseline; repeat UA indicating improvement from the initial positive UA (if obtained); and eradication of E faecium in a repeat urine culture (if obtained).

At least 1 of the aforementioned criteria must have been met to be classified as cure. If more than 1 of the aforementioned criteria was present, then each one must have been met to be classified as cure. To be evaluated for presumed cure, the subject must have had symptoms at baseline. No documentation of ongoing symptoms in subjects who had an appropriate follow-up but did not have a repeat UA or urine culture indicated presumed cure. Persistence or worsening of pretreatment symptoms, a repeat UA without improvement from the initial positive UA, or a repeat urine culture demonstrating continued presence of E faecium indicated failure. The primary endpoint for the study was to determine whether amoxicillin was effective for the management of ampicillin-resistant E faecium UTIs. This study was conducted in compliance with the University of Illinois at Chicago Institutional Review Board and JBVAMC Human Subjects Research Committee requirements.

Results

This study included 20 positive urine cultures for ampicillin-resistant E faecium in 19 subjects. Nine cases were treated with amoxicillin, and 11 cases were treated with nitrofurantoin. At baseline, the mean age was 75 years, mean duration of therapy was 14 days, and all the subjects were male. The baseline characteristics of the 2 groups were similar with the exception of an older population, shorter duration of therapy, and increased incidence of chronic kidney disease in the amoxicillin treatment group, P = .02, .03, and .01, respectively.

Symptoms were documented in 8 of 9 (89%) cases at the time of the positive culture in the amoxicillin treatment group and 5 of 11 (45%) cases in the nitrofurantoin treatment group (Table). The asymptomatic amoxicillin treatment group case and 5 of the 6 nitrofurantoin treatment group asymptomatic cases received treatment prior to a urologic procedure in accordance with the Infectious Diseases Society of America (IDSA) guidelines for the treatment of asymptomatic bacteriuria. The urologic procedures included transurethral resection of a bladder tumor, cystoscopy, urethral dilation, cystometrogram, and transurethral resection of the prostate. One asymptomatic subject in the nitrofurantoin group did not have any documentation to support an appropriate indication for treatment. All positive cultures were > 100,000 colonies/mL except for 1 culture in the nitrofurantoin treatment group, which was 45,000 colonies/mL, but because the subject was symptomatic, treatment was administered and a repeat urine culture was negative.

There were 8 cases classified as cure, 1 presumed cure, and no failures in the amoxicillin group. In the nitrofurantoin group, 7 cases were classified as cure, 1 presumed cure, and 3 failures. The presumed cures were excluded from the statistical analysis due to inability to ensure these cases were truly cured. Also excluded from the statistical analysis was one of the failures in the nitrofurantoin group, because the subject was asymptomatic with no known indication for treatment. This left 8 cases classified as cure and no failures in the amoxicillin group compared with 7 cases classified as cure and 2 failures in the nitrofurantoin group, P = .47 (Figure). Statistical analysis was performed using the Fisher exact test.

Discussion

There was no statistically significant difference between amoxicillin and nitrofurantoin for the treatment of ampicillin-resistant E faecium UTIs. There were no failures in the amoxicillin group despite all isolates displaying resistance based on current breakpoints, supporting the theory that higher urine concentrations of amoxicillin may overcome the MIC of resistant isolates.

Related: Novel Therapy for Treating Complicated UTIs

Of the 11 cases treated with nitrofurantoin, 3 were classified failures. The first failure in the nitrofurantoin group was an asymptomatic subject who did not have a repeat urine culture but had a repeat UA, which showed a persistent elevation in WBC and leukocyte esterase count. This subject was removed from the statistical analysis, as treatment was not indicated per IDSA guidelines. No reason could be identified for the second failure, as a repeat culture demonstrated continued presence of E faecium. Chronic kidney disease (CKD) contributed to the third failure in the nitrofurantoin treatment group; the subject’s CrCl was about 17 mL/min. After treatment, the subject had a repeat urine culture, which indicated the continued presence of E faecium. The subject was later successfully treated with amoxicillin. Both cultures in the same subject were included in the final analysis per protocol, as the subject had an adequate evaluation of efficacy between courses. Four additional cases with CKD were treated with nitrofurantoin; however, their CrCl ranged from 40 to 55 mL/min, and all were classified cure or presumed cure.

Limitations

There were several limitations to this study. Due to the strict inclusion and exclusion criteria, a limited number of subjects were evaluated. Given that this was a retrospective study, it is possible that symptoms were reported by a subject but not appropriately documented. Another significant limitation of this trial was that MICs were not determined due to the retrospective nature of the study. External validity was also limited due to a predominately elderly and male population. Safety data regarding different therapies were not collected, as this study evaluated only the efficacy of therapies.

Conclusion

Although this was a very small retrospective analysis, to the authors knowledge this is the first clinical study supporting the in vitro theory that amoxicillin (500 mg every 8 hours) may overcome the MIC of resistant isolates due to achievement of higher urinary concentrations. Because this was a small retrospective analysis, more prospective evidence is needed to confirm these results.

Acknowledgements
Heather Kim, biostatistician, University of Illinois at Chicago. CCTS Support: UL1RR029879.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Enterococcus species account for about 110,000 urinary tract infections (UTIs) annually in the U.S.¹ The most common species isolated are Enterococcus faecalis and Enterococcus faecium (E faecium). Amoxicillin is the drug of choice for the treatment of enterococcal UTIs. Second-line therapies include vancomycin and nitrofurantoin. Alternative therapies include daptomycin and linezolid; however, these newer agents ideally would be reserved for more serious infections to preserve activity.²

Increased E faecium resistance to ampicillin and vancomycin has limited the therapeutic options. The results of a study by Zhanel and colleagues assessed the prevalence of resistant enterococcal urine isolates in North America.³ Of the 658 E faecium urine isolates, about 96% were resistant to ampicillin and 94% were resistant to vancoymcin.³ Nitrofurantoin has much lower resistance rates; however, its use is contraindicated in patients with a creatinine clearance (CrCl) < 60 mL/min.⁴ Data supporting the contraindication are limited, but the results of a study by Oplinger and Andrews suggested that using nitrofurantoin in patients with a CrCl ≥ 40 mL/min may be safe and effective.⁵ A therapeutic dilemma may occur when resistant E faecium UTIs are encountered and viable treatment options are limited due to intolerances, administration difficulties, lack of susceptibility data, or cost.

Related: Antimicrobial Stewardship in an Outpatient Parenteral Antibiotic Therapy Program

Based on the current Clinical and Laboratory Standards Institute standard, Enterococcus species with a minimal inhibitory concentration (MIC) ≥ 16 μg/mL are considered ampicillin resistant. Microbiology laboratories use the same breakpoint regardless of the site of infection.⁶ Amoxicillin concentrates in the urine; therefore, urinary concentrations are much higher than serum concentrations. The mean serum peak concentration after a single dose of oral amoxicillin 500 mg is 7.6 μg/mL.⁷ After a single dose of oral amoxicillin 500 mg, the average concentration in pooled urine collected over 6 hours was 1,100 μg/mL.⁸

In 2002, Williamson and colleagues analyzed 30 ampicillin- resistant E faecium urine isolates. Reported MICs were 128 μg/mL (30%), 256 μg/mL (60%), and 512 μg/mL (10%).⁹ A more recent retrospective analysis analyzed 234 ampicillin-resistant E faecium urine isolates. The MIC ranged from 32 to 1,024 μg/mL, with a median MIC of 256 μg/mL. Only 5 isolates had an MIC value > 1,000 μg/mL, but each of these isolates was within 1 dilution of 512 μg/mL.¹⁰ Because penicillins exhibit time-dependent killing, an optimal response will occur as long as the urine concentration is above the MIC for at least 50% of the dosing interval.¹¹ Therefore, therapeutic doses of amoxicillin are expected to produce urine concentrations that exceed the MIC of resistant E faecium urine isolates. The purpose of this study was to determine if amoxicillin was a viable treatment option for ampicillin-resistant E faecium UTIs based on this in vitro theory.

Methods

Veterans aged ≥ 18 years with a positive urine culture for ampicillin- resistant E faecium who received antibiotic therapy for cystitis at the Jesse Brown VA Medical Center (JBVAMC) from January 1, 2005, through June 22, 2010, were evaluated in this retrospective cohort study. Exclusion criteria were the presence of any other organisms in the initial urine culture, prostatic involvement, and the presence of E faecium in a blood culture. Subjects treated with multiple antibiotics concurrently and with sequential treatment of different antibiotics with no evaluation of efficacy between courses were also excluded.

Related: Urologist Workforce Variation Across the VHA

All included subjects were evaluated for resolution of symptoms; improvement in leukocyte esterase count and white blood cell (WBC) count from urine analysis (UA); and eradication of E faecium from a repeat urine culture. The response to treatment was classified as cure, presumed cure, or failure. The criteria for cure were based on the following: resolution of symptoms if present at baseline; repeat UA indicating improvement from the initial positive UA (if obtained); and eradication of E faecium in a repeat urine culture (if obtained).

At least 1 of the aforementioned criteria must have been met to be classified as cure. If more than 1 of the aforementioned criteria was present, then each one must have been met to be classified as cure. To be evaluated for presumed cure, the subject must have had symptoms at baseline. No documentation of ongoing symptoms in subjects who had an appropriate follow-up but did not have a repeat UA or urine culture indicated presumed cure. Persistence or worsening of pretreatment symptoms, a repeat UA without improvement from the initial positive UA, or a repeat urine culture demonstrating continued presence of E faecium indicated failure. The primary endpoint for the study was to determine whether amoxicillin was effective for the management of ampicillin-resistant E faecium UTIs. This study was conducted in compliance with the University of Illinois at Chicago Institutional Review Board and JBVAMC Human Subjects Research Committee requirements.

Results

This study included 20 positive urine cultures for ampicillin-resistant E faecium in 19 subjects. Nine cases were treated with amoxicillin, and 11 cases were treated with nitrofurantoin. At baseline, the mean age was 75 years, mean duration of therapy was 14 days, and all the subjects were male. The baseline characteristics of the 2 groups were similar with the exception of an older population, shorter duration of therapy, and increased incidence of chronic kidney disease in the amoxicillin treatment group, P = .02, .03, and .01, respectively.

Symptoms were documented in 8 of 9 (89%) cases at the time of the positive culture in the amoxicillin treatment group and 5 of 11 (45%) cases in the nitrofurantoin treatment group (Table). The asymptomatic amoxicillin treatment group case and 5 of the 6 nitrofurantoin treatment group asymptomatic cases received treatment prior to a urologic procedure in accordance with the Infectious Diseases Society of America (IDSA) guidelines for the treatment of asymptomatic bacteriuria. The urologic procedures included transurethral resection of a bladder tumor, cystoscopy, urethral dilation, cystometrogram, and transurethral resection of the prostate. One asymptomatic subject in the nitrofurantoin group did not have any documentation to support an appropriate indication for treatment. All positive cultures were > 100,000 colonies/mL except for 1 culture in the nitrofurantoin treatment group, which was 45,000 colonies/mL, but because the subject was symptomatic, treatment was administered and a repeat urine culture was negative.

There were 8 cases classified as cure, 1 presumed cure, and no failures in the amoxicillin group. In the nitrofurantoin group, 7 cases were classified as cure, 1 presumed cure, and 3 failures. The presumed cures were excluded from the statistical analysis due to inability to ensure these cases were truly cured. Also excluded from the statistical analysis was one of the failures in the nitrofurantoin group, because the subject was asymptomatic with no known indication for treatment. This left 8 cases classified as cure and no failures in the amoxicillin group compared with 7 cases classified as cure and 2 failures in the nitrofurantoin group, P = .47 (Figure). Statistical analysis was performed using the Fisher exact test.

Discussion

There was no statistically significant difference between amoxicillin and nitrofurantoin for the treatment of ampicillin-resistant E faecium UTIs. There were no failures in the amoxicillin group despite all isolates displaying resistance based on current breakpoints, supporting the theory that higher urine concentrations of amoxicillin may overcome the MIC of resistant isolates.

Related: Novel Therapy for Treating Complicated UTIs

Of the 11 cases treated with nitrofurantoin, 3 were classified failures. The first failure in the nitrofurantoin group was an asymptomatic subject who did not have a repeat urine culture but had a repeat UA, which showed a persistent elevation in WBC and leukocyte esterase count. This subject was removed from the statistical analysis, as treatment was not indicated per IDSA guidelines. No reason could be identified for the second failure, as a repeat culture demonstrated continued presence of E faecium. Chronic kidney disease (CKD) contributed to the third failure in the nitrofurantoin treatment group; the subject’s CrCl was about 17 mL/min. After treatment, the subject had a repeat urine culture, which indicated the continued presence of E faecium. The subject was later successfully treated with amoxicillin. Both cultures in the same subject were included in the final analysis per protocol, as the subject had an adequate evaluation of efficacy between courses. Four additional cases with CKD were treated with nitrofurantoin; however, their CrCl ranged from 40 to 55 mL/min, and all were classified cure or presumed cure.

Limitations

There were several limitations to this study. Due to the strict inclusion and exclusion criteria, a limited number of subjects were evaluated. Given that this was a retrospective study, it is possible that symptoms were reported by a subject but not appropriately documented. Another significant limitation of this trial was that MICs were not determined due to the retrospective nature of the study. External validity was also limited due to a predominately elderly and male population. Safety data regarding different therapies were not collected, as this study evaluated only the efficacy of therapies.

Conclusion

Although this was a very small retrospective analysis, to the authors knowledge this is the first clinical study supporting the in vitro theory that amoxicillin (500 mg every 8 hours) may overcome the MIC of resistant isolates due to achievement of higher urinary concentrations. Because this was a small retrospective analysis, more prospective evidence is needed to confirm these results.

Acknowledgements
Heather Kim, biostatistician, University of Illinois at Chicago. CCTS Support: UL1RR029879.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
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