- Jennifer Middleton, MD, MPH
The world of herbal dietary supplements can feel murky to physicians, as many supplements have limited rigorous data to back their efficacy and safety. Despite physicians' common reservations, though, an estimated 40.6 million US adults used these supplements in 2012. The authors of a current AFP article on Common Herbal Dietary Supplement-Drug Interactions cite studies showing that only 1 in 3 patients taking a supplement have informed their physician. If we are to help patients navigate the world of supplements safely, we first must know what they are taking.
Several studies have attempted to categorize which patients are more and less likely to discuss their supplement use with physicians. Women are more likely to inform their physicians of supplement use than men, and adults aged 45-64 are more likely to inform than adults aged 18-24. Asian Americans and Hispanic Americans are less likely to inform their physicians than other US ethnic groups. Patients who believe that supplements are safer than conventional medicine and/or not do consider them "medications" are unlikely to report their use as well. Unfortunately, patients are often unaware of the risks that may exist with supplements.
Knowledge of herbal dietary supplements among physicians is varied, as are attitudes about their use. Physicians with negative views are more likely to advise patients against supplement use. Unfortunately, this advice can discourage patients from further disclosing supplement use at future visits. Physicians may also hesitate to broach the subject with patients because of their own limited knowledge, and, in general, physicians are willing to learn more about supplements and other complimentary medicine therapies given the opportunity.
Several potential solutions exist. Raising awareness of the prevalence of supplement use, and many patients' reticence to discuss it, is a necessary first step. Improving our knowledge of common therapies' safety and efficacy is another; the AFP article mentioned above includes a table (Table 3) with several useful resources, and there's also an AFP By Topic on Complimentary and Alternative Medicine. Since less than half of physicians ask patients about their supplement use, simply asking our patients at every visit is also important as most patients prefer for their physician to ask rather than bring up supplement use themselves. Demonstrating a nonjudgmental attitude may encourage patients to give us honest responses. Communication and cultural competence training may also help physicians more deeply understand and discuss varied health traditions with patients.
How do you discuss supplement use with patients? Are there resources that you have found especially useful?
Monday, July 31, 2017
Monday, July 24, 2017
How family physicians can push back against overpriced drugs
- Kenny Lin, MD, MPH
Sometimes missed in the headlines about the stratospheric costs of new specialty drugs is the contribution of price hikes for older, established drugs, including generics, to prescription spending increases. In an editorial in the July 1 issue of AFP, Dr. Allen Shaughnessy described several situations that drug manufacturers exploit to raise prices excessively (also known as price gouging):
- Limited to no alternatives
- Older products with few producers
- Same product, different use
- Single producer, no generic available
- Evergreening (minor changes to gain patent exclusivity)
- Pay for delay (paying generics manufacturers not to sell a generic version of an off-patent drug)
In the United States, Dr. Shaughnessy observed, "The biggest driver of the cost hike is, simply put, that pharmaceutical companies can charge whatever they want. Drugs cost what the market will bear. Many medications could be a lot less expensive, but because an insurance company, the government, or a patient is willing to pay the asking price, there is no push to lower the costs."
Price gouging has become such a problem for patients and insurers that the Maryland General Assembly recently passed legislation to discourage price gouging on essential off-patent or generic drugs. As explained by Drs. Jeremy Greene and William Padula in the New England Journal of Medicine:
The law authorizes Maryland’s attorney general to prosecute firms that engage in price increases in noncompetitive off-patent–drug markets that are dramatic enough to “shock the conscience” of any reasonable consumer. ... To establish that a manufacturer or distributor engaged in price gouging, the attorney general will need to show that the price increases are not only unjustified but also legally unconscionable. ... A relationship between buyer and seller is deemed unconscionable if it is based on terms so egregiously unjust and so clearly tilted toward the party with superior bargaining power that no reasonable person would freely agree to them. This standard includes cases in which the seller vastly inflates the price of goods.
Sometimes missed in the headlines about the stratospheric costs of new specialty drugs is the contribution of price hikes for older, established drugs, including generics, to prescription spending increases. In an editorial in the July 1 issue of AFP, Dr. Allen Shaughnessy described several situations that drug manufacturers exploit to raise prices excessively (also known as price gouging):
- Limited to no alternatives
- Older products with few producers
- Same product, different use
- Single producer, no generic available
- Evergreening (minor changes to gain patent exclusivity)
- Pay for delay (paying generics manufacturers not to sell a generic version of an off-patent drug)
In the United States, Dr. Shaughnessy observed, "The biggest driver of the cost hike is, simply put, that pharmaceutical companies can charge whatever they want. Drugs cost what the market will bear. Many medications could be a lot less expensive, but because an insurance company, the government, or a patient is willing to pay the asking price, there is no push to lower the costs."
Price gouging has become such a problem for patients and insurers that the Maryland General Assembly recently passed legislation to discourage price gouging on essential off-patent or generic drugs. As explained by Drs. Jeremy Greene and William Padula in the New England Journal of Medicine:
The law authorizes Maryland’s attorney general to prosecute firms that engage in price increases in noncompetitive off-patent–drug markets that are dramatic enough to “shock the conscience” of any reasonable consumer. ... To establish that a manufacturer or distributor engaged in price gouging, the attorney general will need to show that the price increases are not only unjustified but also legally unconscionable. ... A relationship between buyer and seller is deemed unconscionable if it is based on terms so egregiously unjust and so clearly tilted toward the party with superior bargaining power that no reasonable person would freely agree to them. This standard includes cases in which the seller vastly inflates the price of goods.
The scope of the Maryland law is limited. It restricts action to off-patent drugs that are being produced by three or fewer manufacturers, and requires that manufacturers be given an opportunity to justify a price increase before legal proceedings are initiated. It is too early to know if the law will be effective against price gouging, or if it will be copied by other states that are also struggling to contain prescription drug cost increases in their Medicaid programs.
In the meantime, what can family physicians do to help patients lower their medication costs? In a 2016 editorial on the why and how of high-value prescribing, Dr. Steven Brown recommended five sound strategies: be a healthy skeptic, and be cautious when prescribing new drugs; apply STEPS and know drug prices; use generic medications and compare value; restrict access to pharmaceutical representatives and office samples; and prescribe conservatively.
In the meantime, what can family physicians do to help patients lower their medication costs? In a 2016 editorial on the why and how of high-value prescribing, Dr. Steven Brown recommended five sound strategies: be a healthy skeptic, and be cautious when prescribing new drugs; apply STEPS and know drug prices; use generic medications and compare value; restrict access to pharmaceutical representatives and office samples; and prescribe conservatively.
Monday, July 17, 2017
Counseling families about social media
- Jennifer Middleton, MD, MPH
Counseling at well child visits about media use can easily fall by the wayside with so many other important topics to discuss. Our office's electronic health record (EHR) has several template options to choose from for well child exams that each include age-appropriate anticipatory guidance topics, but none of them, at any age, include media use. Adding that prompt may become imperative, especially given the American Academy of Pediatrics' (AAP) Use of Media by School-Aged Children and Adolescents guideline. A recent AFP issue reviewed this new guideline and reminds us of the importance of making time to discuss media use with families.
The AAP encourages physicians to screen for problems related to media use, such as sexting, cyberbullying, problematic internet use, and Internet gaming disorder, in children and adolescents. A recent survey of Texas high schoolers found that 28% of adolescents had texted a naked picture of themselves ("sexting"); in this study, teen girls who sexted were at higher risk of engaging in high risk sexual behavior. The authors of this study suggest asking all teens if they have ever sent, received, or been asked to text a naked picture and also note that the majority of teens are quite uncomfortable with participating in sexting.
The AFP review of this guideline notes that cyberbullying can bring "social, academic, and health concerns" for both the victim and the bully. Several validated scales for screening both bullying victims and perpetrators can be found in this CDC document; although none explicitly mention social media use, several questions are vague enough to potentially include cyberbullying.
Validated scales do exist for screening for problematic internet use and Internet gaming disorder. The 18-item Problematic and Risky Internet Use Screening Scale (PRIUSS) can help identify adolescents and adults with problematic internet use. Many adolescents and young adults with problematic internet use also have depression, social anxiety, and/or attention deficit disorder, so a positive PRIUSS should prompt exploration of these other possible diagnoses. The Internet Gaming Disorder Test (IGDT-10) is a 10 question screen for Internet gaming disorder.
Besides screening for these 4 conditions, the AAP encourages physicians to discuss boundary setting regarding places and times where media use is and is not appropriate. Parents should role model appropriate media use, such as keeping electronic devices (including televisions) outside of the bedroom. Parents also should discuss online safety with their children, though some parents feel unprepared to do so; the AAP has a list of tips for parents here. There's also an AFP By Topic on Health Maintenance and Counseling that includes additional resources for well child (and adult) visits.
No data yet exists showing that screening for these conditions positively influences any patient-centered outcomes, but their associations with mental illness and risky behaviors is convincing enough for me to incorporate them into my well child visits. I'm going to get started by asking our EHR leadership to add "media use" to our anticipatory guidance templates. What step will you take to facilitate conversations about media use with families?
Counseling at well child visits about media use can easily fall by the wayside with so many other important topics to discuss. Our office's electronic health record (EHR) has several template options to choose from for well child exams that each include age-appropriate anticipatory guidance topics, but none of them, at any age, include media use. Adding that prompt may become imperative, especially given the American Academy of Pediatrics' (AAP) Use of Media by School-Aged Children and Adolescents guideline. A recent AFP issue reviewed this new guideline and reminds us of the importance of making time to discuss media use with families.
The AAP encourages physicians to screen for problems related to media use, such as sexting, cyberbullying, problematic internet use, and Internet gaming disorder, in children and adolescents. A recent survey of Texas high schoolers found that 28% of adolescents had texted a naked picture of themselves ("sexting"); in this study, teen girls who sexted were at higher risk of engaging in high risk sexual behavior. The authors of this study suggest asking all teens if they have ever sent, received, or been asked to text a naked picture and also note that the majority of teens are quite uncomfortable with participating in sexting.
The AFP review of this guideline notes that cyberbullying can bring "social, academic, and health concerns" for both the victim and the bully. Several validated scales for screening both bullying victims and perpetrators can be found in this CDC document; although none explicitly mention social media use, several questions are vague enough to potentially include cyberbullying.
Validated scales do exist for screening for problematic internet use and Internet gaming disorder. The 18-item Problematic and Risky Internet Use Screening Scale (PRIUSS) can help identify adolescents and adults with problematic internet use. Many adolescents and young adults with problematic internet use also have depression, social anxiety, and/or attention deficit disorder, so a positive PRIUSS should prompt exploration of these other possible diagnoses. The Internet Gaming Disorder Test (IGDT-10) is a 10 question screen for Internet gaming disorder.
Besides screening for these 4 conditions, the AAP encourages physicians to discuss boundary setting regarding places and times where media use is and is not appropriate. Parents should role model appropriate media use, such as keeping electronic devices (including televisions) outside of the bedroom. Parents also should discuss online safety with their children, though some parents feel unprepared to do so; the AAP has a list of tips for parents here. There's also an AFP By Topic on Health Maintenance and Counseling that includes additional resources for well child (and adult) visits.
No data yet exists showing that screening for these conditions positively influences any patient-centered outcomes, but their associations with mental illness and risky behaviors is convincing enough for me to incorporate them into my well child visits. I'm going to get started by asking our EHR leadership to add "media use" to our anticipatory guidance templates. What step will you take to facilitate conversations about media use with families?
Tuesday, July 11, 2017
Self-monitoring doesn't improve control of type 2 diabetes
- Kenny Lin, MD, MPH
"Have you been checking your sugars?" I routinely ask this question at office visits involving a patient with type 2 diabetes, whether the patient is recently diagnosed or has been living with the disease for many years. However, the necessity of blood glucose self-monitoring in patients with type 2 diabetes not using insulin has been in doubt for several years.
A 2012 Cochrane for Clinicians published in AFP concluded that "self-monitoring of blood glucose does not improve health-related quality of life, general well-being, or patient satisfaction" (patient-oriented outcomes) and did not even result in lower hemoglobin A1C levels (a disease-oriented outcome) after 12 months. In their article "Top 20 Research Studies of 2012 for Primary Care Physicians," Drs. Mark Ebell and Roland Grad discussed a meta-analysis of individual patient data from 6 randomized trials that found self-monitoring improved A1C levels by a modest 0.25 percentage points after 6 and 12 months of use, with no differences observed in subgroups. Based on these findings, the Society of General Internal Medicine recommended against daily home glucose testing in patients not using insulin as part of the Choosing Wisely campaign.
Still, the relatively small number of participants in trials of glucose self-monitoring, and the persistent belief that it could be useful for some patients (e.g., recent type 2 diabetes diagnosis, medication nonadherence, changes in diet or exercise regimen), meant that many physicians have continued to encourage self-monitoring in clinical practice. In a 2016 consensus statement, the American College of Endocrinology stated that in patients with type 2 diabetes and low risk of hypoglycemia, "initial periodic structured glucose monitoring (e.g., at meals and bedtime) may be useful in helping patients understand effectiveness of medical nutrition therapy / lifestyle therapy."
In a recently published pragmatic trial conducted in 15 primary care practices in North Carolina, Dr. Laura Young and colleagues enrolled 450 patients with type 2 non-insulin-treated diabetes with A1C levels between 6.5% and 9.5% and randomized them to no self-monitoring, once-daily self-monitoring, or once-daily self-monitoring with automated, tailored patient feedback delivered via the glucose meter. Notably, about one-third of participants were using sulfonylureas at baseline. After 12 months, there were no significant differences in A1C levels, health-related quality of life, hypoglycemia frequency, health care utilization, or insulin initiation. This study provided further evidence that although glucose self-monitoring may make intuitive sense, it improves neither disease-oriented nor patient-oriented health outcomes in patients with type 2 diabetes not using insulin.
"Have you been checking your sugars?" I routinely ask this question at office visits involving a patient with type 2 diabetes, whether the patient is recently diagnosed or has been living with the disease for many years. However, the necessity of blood glucose self-monitoring in patients with type 2 diabetes not using insulin has been in doubt for several years.
A 2012 Cochrane for Clinicians published in AFP concluded that "self-monitoring of blood glucose does not improve health-related quality of life, general well-being, or patient satisfaction" (patient-oriented outcomes) and did not even result in lower hemoglobin A1C levels (a disease-oriented outcome) after 12 months. In their article "Top 20 Research Studies of 2012 for Primary Care Physicians," Drs. Mark Ebell and Roland Grad discussed a meta-analysis of individual patient data from 6 randomized trials that found self-monitoring improved A1C levels by a modest 0.25 percentage points after 6 and 12 months of use, with no differences observed in subgroups. Based on these findings, the Society of General Internal Medicine recommended against daily home glucose testing in patients not using insulin as part of the Choosing Wisely campaign.
Still, the relatively small number of participants in trials of glucose self-monitoring, and the persistent belief that it could be useful for some patients (e.g., recent type 2 diabetes diagnosis, medication nonadherence, changes in diet or exercise regimen), meant that many physicians have continued to encourage self-monitoring in clinical practice. In a 2016 consensus statement, the American College of Endocrinology stated that in patients with type 2 diabetes and low risk of hypoglycemia, "initial periodic structured glucose monitoring (e.g., at meals and bedtime) may be useful in helping patients understand effectiveness of medical nutrition therapy / lifestyle therapy."
In a recently published pragmatic trial conducted in 15 primary care practices in North Carolina, Dr. Laura Young and colleagues enrolled 450 patients with type 2 non-insulin-treated diabetes with A1C levels between 6.5% and 9.5% and randomized them to no self-monitoring, once-daily self-monitoring, or once-daily self-monitoring with automated, tailored patient feedback delivered via the glucose meter. Notably, about one-third of participants were using sulfonylureas at baseline. After 12 months, there were no significant differences in A1C levels, health-related quality of life, hypoglycemia frequency, health care utilization, or insulin initiation. This study provided further evidence that although glucose self-monitoring may make intuitive sense, it improves neither disease-oriented nor patient-oriented health outcomes in patients with type 2 diabetes not using insulin.
Monday, July 3, 2017
Adding an antibiotic to uncomplicated I&Ds may improve outcomes
- Jennifer Middleton, MD, MPH
Adding an oral antibiotic after incision and drainage of an uncomplicated skin abscess has been found, to date, to not improve clinical outcomes. The American College of Emergency Physicians (ACEP) even has a Choosing Wisely recommendation to this effect. A study published last week, however, found differently: adding an antibiotic after incision and drainage (I&D) of small skin abscesses resulted in better clinical healing.
The study authors prospectively enrolled 505 adults and 281 children at several sites across the United States who presented to urgent care clinics, Emergency Departments (EDs), and outpatient care sites with small skin abscesses (no greater than 5 cm in diameter for adults, no larger than 3 cm for children under 1 year of age, no larger than 4 cm for children aged 1-8 years) and randomized them to receive, after incision and drainage, either 10 days of clindamycin, trimethoprim/sulfamethoxazole (TMP/SMX), or placebo. 81.7% and 83.1% of the participants who received clindamycin or TMP/SMX, respectively, had a clinical cure 10 days after completing antibiotics, compared with only 68.9% of participants who received a placebo (95% confidence intervals 78.3-87.9, 76.8-86.7, and 62.9-74.9, respectively). When analyzed separately, the researchers found that clindamycin was more effective in the pediatric participants compared to TMP/SMX, while the difference between cure rates for adults for these 2 antibiotics was not significant.
New infections in the 30 days following treatment were more common in the placebo group than either antibiotic group; clindamycin was more effective than TMP/SMX in preventing recurrent infection, especially in pediatric participants. Adverse events were more common in the clindamycin group, though, and most commonly consisted of diarrhea and nausea; these were described as "mild or moderate and resolved without sequelae." 1 hypersensitivity reaction to TMP/SMX was described.
This study's findings contradict common practice and the ACEP's Choosing Wisely recommendation. A closer look at the references cited in the ACEP's Choosing Wisely recommendation, however, demonstrate that the evidence to date regarding treatment of uncomplicated skin abscesses has been a bit meager. They include a smaller randomized control trial (RCT) from 2010 that found placebo equivalent to TMP/SMX in 161 pediatric patients treated in EDs for uncomplicated abscesses; an RCT from 1985 that enrolled 50 adults and found no difference in clinical improvement between those treated with cephradine (a first-generation cephalosporin) and placebo; and, a 2011 cross-sectional study that examined differences in antibiotic prescribing habits across 3 separate pediatric EDs but did not examine clinical outcomes.
Additionally, the Infectious Diseases Society of America's 2014 Practice Guideline for the Diagnosis and Management of Skin and Soft Tissue Infections includes a "strong" recommendation against using antibiotics in uncomplicated skin abscesses but describes the quality of the evidence supporting this recommendation as "low." The more robust design of this new study, with its large number of participants and breath of geographic sites, makes its findings difficult to dismiss. It also builds on a 2016 RCT which found that, in care sites with a high prevalence of methicillin-resistant Staphylococcus aureus (MRSA), adding TMP/SMX to incision and drainage improved clinical cure rates in adults and teens with uncomplicated skin abscesses compared to placebo.
Given all of the attention on inappropriate antibiotic use these last few weeks on the blog, it's admittedly a bit tough to digest a study that suggests adding antibiotic treatment to a condition that didn't previously warrant it. It will be interesting to see if other researchers attempt to replicate this result or, perhaps, perform a systematic review of all of the data on this topic.
Will this study change how you care for patients after incision and drainage of an uncomplicated skin abscess?
Adding an oral antibiotic after incision and drainage of an uncomplicated skin abscess has been found, to date, to not improve clinical outcomes. The American College of Emergency Physicians (ACEP) even has a Choosing Wisely recommendation to this effect. A study published last week, however, found differently: adding an antibiotic after incision and drainage (I&D) of small skin abscesses resulted in better clinical healing.
The study authors prospectively enrolled 505 adults and 281 children at several sites across the United States who presented to urgent care clinics, Emergency Departments (EDs), and outpatient care sites with small skin abscesses (no greater than 5 cm in diameter for adults, no larger than 3 cm for children under 1 year of age, no larger than 4 cm for children aged 1-8 years) and randomized them to receive, after incision and drainage, either 10 days of clindamycin, trimethoprim/sulfamethoxazole (TMP/SMX), or placebo. 81.7% and 83.1% of the participants who received clindamycin or TMP/SMX, respectively, had a clinical cure 10 days after completing antibiotics, compared with only 68.9% of participants who received a placebo (95% confidence intervals 78.3-87.9, 76.8-86.7, and 62.9-74.9, respectively). When analyzed separately, the researchers found that clindamycin was more effective in the pediatric participants compared to TMP/SMX, while the difference between cure rates for adults for these 2 antibiotics was not significant.
New infections in the 30 days following treatment were more common in the placebo group than either antibiotic group; clindamycin was more effective than TMP/SMX in preventing recurrent infection, especially in pediatric participants. Adverse events were more common in the clindamycin group, though, and most commonly consisted of diarrhea and nausea; these were described as "mild or moderate and resolved without sequelae." 1 hypersensitivity reaction to TMP/SMX was described.
This study's findings contradict common practice and the ACEP's Choosing Wisely recommendation. A closer look at the references cited in the ACEP's Choosing Wisely recommendation, however, demonstrate that the evidence to date regarding treatment of uncomplicated skin abscesses has been a bit meager. They include a smaller randomized control trial (RCT) from 2010 that found placebo equivalent to TMP/SMX in 161 pediatric patients treated in EDs for uncomplicated abscesses; an RCT from 1985 that enrolled 50 adults and found no difference in clinical improvement between those treated with cephradine (a first-generation cephalosporin) and placebo; and, a 2011 cross-sectional study that examined differences in antibiotic prescribing habits across 3 separate pediatric EDs but did not examine clinical outcomes.
Additionally, the Infectious Diseases Society of America's 2014 Practice Guideline for the Diagnosis and Management of Skin and Soft Tissue Infections includes a "strong" recommendation against using antibiotics in uncomplicated skin abscesses but describes the quality of the evidence supporting this recommendation as "low." The more robust design of this new study, with its large number of participants and breath of geographic sites, makes its findings difficult to dismiss. It also builds on a 2016 RCT which found that, in care sites with a high prevalence of methicillin-resistant Staphylococcus aureus (MRSA), adding TMP/SMX to incision and drainage improved clinical cure rates in adults and teens with uncomplicated skin abscesses compared to placebo.
Given all of the attention on inappropriate antibiotic use these last few weeks on the blog, it's admittedly a bit tough to digest a study that suggests adding antibiotic treatment to a condition that didn't previously warrant it. It will be interesting to see if other researchers attempt to replicate this result or, perhaps, perform a systematic review of all of the data on this topic.
Will this study change how you care for patients after incision and drainage of an uncomplicated skin abscess?
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