Monday, September 19, 2022

The evidence is in: WIC improves maternal and child health

 - Kenny Lin, MD, MPH

Food insecurity is increasingly recognized as a modifiable social determinant of health. The American Academy of Family Physicians has endorsed "sustained funding for evidence-based policies and programs to eliminate disparities in healthy food access, including ... the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC)." In a 2019 editorial about interventions to reduce maternal mortality, Drs. Katy Kozhimannil and Andrea Westby recommended postpartum screening for food insecurity. But how strong is the evidence that WIC improves maternal and child health?

Since 2012, American Family Physician's Implementing AHRQ Effective Health Care Reviews feature has summarized dozens of primary care-relevant systematic reviews from the Agency for Healthcare Research and Quality's Effective Health Care Program with accompanying clinical commentaries. A team of investigators in this program recently reviewed maternal and child outcomes associated with WIC and published a synopsis of their report in Annals of Internal Medicine. Investigators identified 82 studies that examined associations between WIC participation and maternal, birth, infant, and child health outcomes.

Based on direct evidence from 49 studies, they concluded that WIC participation likely reduces the incidence of preterm birth, low birth weight, and infant mortality. Lower strength of evidence suggested WIC is associated with less inadequate gestational weight gain and alcohol use and better diet quality during pregnancy, and it may increase child preventive care visits and immunizations. WIC was not associated with differences in breastfeeding rates or premature (before 4 months) introduction of solid foods. Children of families receiving WIC had better diet quality, increased household purchasing of healthy foods compared to less healthy foods and beverages, and higher cognitive development than WIC-eligible children not receiving benefits. There was insufficient evidence that WIC reduced childhood obesity or affected health status or risk of hospitalization.

The U.S. Department of Agriculture (USDA) found that food insecurity in households with children declined to its lowest rate in two decades in 2021, despite the negative impact of the COVID-19 pandemic on the economy. The nonpartisan Center on Budget and Policy Priorities observed:

About 10.2 percent of U.S. households were food insecure in 2021, meaning they struggled to afford enough food for an active, healthy life year-round. That the rate held steady during the pandemic — when accounting for statistical noise it’s not significantly different from the 10.5 percent rate for 2019 and 2020 — is a testament to robust relief measures policymakers enacted. These include Economic Impact Payments, an expanded Child Tax Credit, improved unemployment insurance, and expanded food assistance, along with [the Supplemental Nutrition Assistance Program]'s built-in ability to respond to increased need.

On the negative side, food insecurity increased from 2020 to 2021 in households without children and for women and older people living alone. Households headed by Black, Hispanic, and American Indian / Alaska Native persons were more likely to experience food insecurity than other households. Finally, the expiration of temporary pandemic emergency relief measures, such as free meals for all children attending public schools, may worsen food insecurity in families ineligible for WIC.

Monday, September 12, 2022

COVID bivalent booster vaccines ("updated boosters") roll out across the US

 - Jennifer Middleton, MD, MPH

On August 31, the United States (US) Food and Drug Administration (FDA) authorized Pfizer and Moderna's new bivalent COVID booster vaccines, also described as "updated boosters." The FDA amended  Emergency Use Authorizations to authorize the Pfizer and Moderna bivalent vaccines for persons aged 12 years and older and 18 years and older, respectively. The bivalent vaccines "add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading." Bivalent/ updated booster vaccines are anticipated to be available later this fall for younger ages

Although Pfizer and Moderna ran trials in humans earlier this year with a bivalent vaccine designed to protect against both the original SARS-CoV-2 strain and the B.1 subvariant, the FDA asked both companies to switch their strategy to targeting the B.A.4/5 subvariants this spring. To fast track their vaccines and hopefully get them approved before the virus can mutate again, the FDA approved the use of data from mouse models only instead of waiting for further human trials:

Regulators [relied] on those results, along with the human neutralizing antibody data from the BA.1 bivalent booster studies, to decide whether to authorize the boosters....The companies will continue to gather more data from human studies; those results probably won't be available until late October or early November.

The FDA emphasized that this strategy has been used successfully for many years to update annual influenza vaccination components and emphasized that they "'have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.'"

Persons who have not yet received their primary COVID vaccinations need to complete that series prior to receiving the bivalent/updated booster; the bivalent/updated boosters "come in booster-sized doses" and "contain less vaccine than the primary series." For persons eligible for a COVID vaccine booster, the EUA recommends only the use of the bivalent/updated booster vaccines going forward. They also recommend a minimum of 2 months' time between the final dose of the primary series and/or last monovalent booster prior to receiving the bivalent/updated booster. Persons recovering from recent COVID-19 infection may "consider waiting a minimum of 3 months."  Some infectious disease experts, though, are recommending longer intervals:

An advisory panel to the C.D.C. voted to recommend the same interval between doses, although several members voiced concerns that two months was too short. Doctors and immunologists said that in general, people should wait around four to six months after immunization or infection. "That’s because your body will probably not generate much of an immune response so soon after a previous encounter with the virus," Aubree Gordon, an epidemiologist at the University of Michigan, said. “Your immunity level is so high that you’ll just neutralize immediately the antigen that’s being produced — you kind of reach a ceiling."

The CDC has given the green light to co-administering the bivalent/updated booster with influenza and/or any other indicated vaccinations; injection sites should be separated by a minimum of 1 inch

The CDC encourages all eligible persons for the bivalent/updated booster to receive it to protect against severe illness, long COVID, and the risk of transmitting the disease to those more vulnerable. If your office or care site won't be stocking it, the vaccines.gov website provides a tool to search for COVID-19 vaccine providers by zip code. The AFP By Topic on COVID-19 will continue to be regularly updated, and this recent AFP Curbside Consultation on "Vaccine Disagreement Between Parents" provides guidance regarding vaccine hesitancy. 

Tuesday, September 6, 2022

Neurosyphilis, ocular syphilis, and otosyphilis are don't-miss diagnoses

 - Kenny Lin, MD, MPH

When a patient with a history of migraine headaches presents with a "severe frontal headache and left-eye blurred vision and pain," neurosyphilis is unlikely to be foremost in the differential. Even after she mentions a two-month history of a diffuse maculopapular rash, clinicians may feel reassured because it doesn't involve the palms and soles. But syphilis, the great imitator, was in fact the eventual diagnosis in this patient, the subject of a case report published in Cureus.

In the August issue of AFP, Dr. Jennifer Jones-Vanderleest reviewed detection and treatment of neurosyphilis, ocular syphilis, and otosyphilis, which can occur at any stage of syphilis regardless of immune status. Early neurosyphilis (within the first few years of infection) can present with "headache, dizziness, altered mental status, cranial neuropathies, motor and sensory deficits, meningitis, or stroke." Neurosyphilis is diagnosed with the combination of neurologic signs and symptoms and reactive syphilis serology and cerebrospinal fluid (CSF) tests. The 2021 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Infections Treatment Guidelines recommend that patients with neurosyphilis be treated with 18 to 24 million units of aqueous crystalline penicillin G per day for 10 to 14 days, administered as a continuous infusion or 3 to 4 million units intravenously every 4 hours. These patients should be tested for HIV and be offered HIV preexposure prophylaxis if HIV negative. After treatment, normalization of the serum RPR titer predicts normalization of CSF parameters; thus, repeated CSF sampling is not needed unless the patient is HIV positive and not receiving antiretroviral therapy.

As I discussed in a previous AFP Community Blog post, the incidence of syphilis in the U.S. has been rising for the past two decades due to stagnant health department funding for contact tracers and the recent impact of the COVID-19 pandemic. Far from being ancient history, "in 2020, 133,945 cases of all stages of syphilis were reported, including 41,655 cases of primary and secondary syphilis," according to the CDC. Although a disproportionate number of cases occur in men who have sex with men, rates in women have increased sharply since 2016.

A draft recommendation statement from the U.S. Preventive Services Task Force (USPSTF) reaffirmed screening nonpregnant adolescents and adults at increased risk for syphilis infection. The USPSTF recommends that all pregnant patients be screened for syphilis as early as possible in pregnancy. The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recommend rescreening women at high risk for syphilis at 28 weeks of gestation and again at delivery to prevent congenital syphilis.

Monday, August 29, 2022

Their time is (past) up: Vitamin D & omega-3 supplements

 - Jennifer Middleton, MD, MPH

Recent evidence continues to challenge the routine use of two common supplements: vitamin D and omega-3 fatty acids.

A quick web search on vitamin D finds Mayo ClinicUpToDate, and WebMD all extoling its benefits despite a lack of evidence to support its widespread use. Dr. Lin asked on the blog in 2016, "Is Vitamin D supplementation is good for anything?" Although there are a few clinical situations where vitamin D supplementation may be indicated (chronic kidney disease with secondary hyperparathyroidism, for example), vitamin D does not otherwise support mood or reduce the risk of osteoporotic fracture. An ancillary study of VITAL (Vitamin D and Omega-3 Trial) published last month in the New England Journal of Medicine randomized nearly 26,000 middle and older aged community-dwelling adults and found no benefit to vitamin D supplementation regarding fracture risk:

VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. 

An accompanying NEJM editorial declares VITAL's ancillary analysis a "decisive verdict on vitamin D supplementation." Of note, the original VITAL found no benefit for vitamin D to reduce the risk of cancer or cardiovascular disease (CVD), and it found no reduction in CVD from use of omega-3 fatty acid supplementation, either.

Another trial, REDUCE-IT, published in 2019 did find CVD benefit to omega-3 supplementation (specifically, 2 grams of icosapent ethyl daily) in persons with "elevated triglyceride levels despite the use of statins," but REDUCE-IT's findings are now being called into question. A recently published biomarker substudy found that REDUCE-IT's placebo, a pharmaceutical grade mineral oil capsule, may have increased CVD event risk among participants in the placebo group, creating a false appearance of benefit in the intervention group. These unintended harms from the study's placebo may explain why REDUCE-IT purportedly found benefit when multiple, large, previous studies have not. Like vitamin D, however, omega-3 fatty acid supplements continue to be used by millions of persons in the United States.

Changing clinical habits can be challenging. In this 2018 AFP editorial, Drs. Ebell, Shaughnessy, and Slawson describe several factors that contribute to this difficulty including practice inertia, emphasis on inductive (instead of patient-oriented, evidence-based) reasoning in medical training, and limited advertising for changes that don't benefit medical and/or pharmaceutical industries. They urge "physicians [to] accept that change is uncomfortable" and remind us that "[w]e need to remain flexible in our thinking if we are to meet our goal of doing our best when caring for every patient."

If you'd like to read more, this 2021 AFP Putting Prevention into Practice article reviews the current United States Preventive Services Task Force (USPSTF) "I" statement for vitamin D screening, and this 2019 AFP Medicine By the Numbers article reviews The NNT Group "red" rating for omega-3 fatty acid supplementation to prevent CVD.

Monday, August 22, 2022

Back to school & back to sleep: melatonin supplementation in children

- Lilian White, MD

As the end of summer approaches, children are making their way back to into the classroom. With this transition and possible changes in sleep-wake schedules, sleep disorders in children and adolescents may become more apparent. Parents may ask about the use of melatonin to treat insomnia during this transitional period.

Normal sleep duration and sleep patterns change as children age. Children 5 to 12 years old usually require 9-12 hours of sleep, and only 5 in 100 need daytime naps. Adolescents typically need 8-10 hours of nighttime sleep. Daytime napping in adolescents suggests insufficient sleep at night or a potential sleep disorder. Most high school students do not get enough sleep. This lack of sleep is associated with an increased risk of obesity, diabetes mellitus, injuries, poor mental health and attention/behavioral problems.

About 10-30% of children struggle with insomnia. Children may have difficulty initiating or maintaining sleep. They may be diagnosed with an insomnia disorder if this occurs at least 3 times per week for at least 3 months. Childhood insomnias are characterized as difficulty with sleep-association (e.g., require caregiver to be present to fall asleep) or limit-setting (e.g., absence of a regular bedtime routine). Behavioral interventions are considered first line treatment. In the Choosing Wisely campaign, the American Academy of Sleep Medicine recommends not prescribing medications to treat behavioral childhood insomnia.

Adolescents are more commonly affected by delayed sleep phase syndrome, a subtype of circadian sleep rhythm disorder. The prevalence is estimated to be 7-16%. Sleep onset and awakening are delayed by more than 2 hours for at least 3 months. A sleep diary may be helpful in making this clinical diagnosis. The most powerful influence on the circadian rhythm is light. Decreased morning light exposure and/or increased evening light exposure may worsen symptoms. Treatment of delayed sleep phase syndrome includes regular sleep-wake schedules, avoiding bright or blue light prior to bedtime, bright light therapy within the first 1-2 hours of awakening, and melatonin.

Melatonin helps the onset of sleep in the circadian rhythm. Melatonin is typically recommended at a dose of 0.3 to 5 mg taken 1.5 to 6.5 hours before bed for a short duration (i.e. days). Ideally, melatonin moves sleep onset earlier. However, if taken later – such as the middle of the night or at bedtime – it may move sleep onset later. Melatonin may be particularly helpful in children with neurodevelopmental conditions such as attention-deficit/hyperactivity disorder and autism if behavioral approaches are insufficient to improve insomnia.

Melatonin is generally well-tolerated. Adverse effects most commonly include headache, daytime sleepiness, dizziness, and nausea. The effects of long-term melatonin use in children are not well established; low-quality evidence suggests that it may affect the timing of puberty through potential downstream effects on sex hormones. More research is needed to explore this relationship.

Although melatonin may be purchased over the counter in the United States, it may be harmful if ingested at unintended high doses. Over the past few years, physicians have seen an increase in melatonin given to children, with one study noting a 7x increase. Poison control centers have reported an 530% increase in calls regarding melatonin ingestion (94% of which were unintentional). Melatonin is available in many child-friendly forms such as gummies or chewables. If melatonin use is recommended, physicians should caution parents to store melatonin in a safe place away from children.

While melatonin may present a helpful option to treat certain sleep disorders in children, behavioral interventions are still considered the most effective and first-line treatment. Additional tips for behavioral management of insomnia can be found in a recent AFP article on Common Sleep Disorders in Children and related patient education.

Monday, August 15, 2022

Guest post: A call for family physicians’ role in combating misinformation

Alex McDonald, MD, FAAFP, CAQSM 

For years, physicians have been discouraged from sharing information in the social media space, and, as a result, misinformation and disinformation has flourished.  Over half of younger adults get much, if not all, of their news and information from social media. Those individuals who get their information via social media channels are often only exposed to information that further aligns with their or their social circle’s own views. This phenomenon has real world consequences when it comes to an individual’s beliefs and subsequent health decisions. The average person spends 2 hours a day on social media, yet only 15 minutes four times a year with their physicians; as such, it can be challenging for physicians to correct health misinformation.

 

The COVID-19 pandemic has thrust this problem into the spotlight, leaving no easy answers or solutions. Drs. Shahjahan’s and Pasquetto's AFP editorial on “Countering Medical Misinformation Online and in the Clinic” is an excellent summary of the challenge of misinformation, both in the traditional medical setting and on social media, and also provides suggestions about how to combat it. Physicians are one of the most trusted and respected professions, and we no longer can ignore or avoid correcting or addressing misinformation when we confront it in the clinic or online. We must educate ourselves and our colleagues to learn the skills and understand the importance of consistent yet respective discourse with patients. We can no longer afford to simply avoid disagreement in the exam room or online.  These conversations are not always easy and often do not occur in a single setting, but speaking up and consistently correcting misinformation by all physicians can and will have an impact. 

 

The Federation of State Medical Boards made a strong statement in June 2021 condemning and threatening sections against licensed medical professionals who spread misinformation, yet there has been a noticeable lack of action, even for the most egregious offenders. I believe that health professionals spreading misinformation and disinformation are the most harmful and the hardest to address. As a medical community, we must find the will to confront colleagues or other medical organizations that are touting anecdotal or non-evidenced based information. There is not always a single right answer in medicine, but there are clearly wrong answers. We must not allow others to corrupt or misrepresent science for their own benefit, and we must not allow this to propagate or the trend to continue. There is often debate within the medical literature, and often evidence-based medicine begins with anecdote or case studies, but we must not mistake early emerging information, that warrants further investigation, with evidence-based science.  

 

Physicians, who specialize in relationships, trust, and understanding, are best equipped to tackle this challenge. Collaboration, connection, and compassion are all are key - who better to do this work than family physicians? A strong and trusted social media account is a tool in the bag of the 21st century physician to share accurate and trusted information beyond the walls of the clinic or hospital. We must each also acknowledge our own role in inadvertently spreading misinformation. We are human and we are all susceptible to the emotions and bias on which misinformation thrives. We must educate ourselves to spot misinformation when we see it, and not just hit the “like” or “share” button, to stop misinformation in its tracks. We must not comment or engage with misinformation as this only boosts its reach; instead, ignore, block and move on.


No single person or approach is going stem the tide of pervasive misinformation and disinformation. It’s going to take all of us to educate ourselves, our colleagues, and our patients. 

 

Additional Resources: 

 

Monday, August 8, 2022

Gestational diabetes is an increasingly common pregnancy complication

 - Kenny Lin, MD, MPH

A recent report from the Centers for Disease Control and Prevention documented a precipitous rise in the rate of gestational diabetes in the U.S. from 2016 to 2020, based on data collected from birth certificates. In 2020, gestational diabetes affected 7.8% of all pregnancies, reflecting a 13% increase since 2019 and a 30% increase since 2016. Prevalence increased with increasing age (2.5% in patients younger than 20 years and 15.3% in those aged 40 or older) and increasing pre-pregnancy body mass index (BMI). Both factors are likely driving the overall rise in gestational diabetes; the median age at which U.S. women gave birth reached an all-time high of 30 years in 2019 and only 2 in 5 women with a live birth in 2020 had a normal BMI prior to pregnancy.

The U.S. Preventive Services Task Force (USPSTF) recommends screening for gestational diabetes in asymptomatic pregnant patients at or after 24 weeks of gestation. Although the USPSTF did not identify a preferred test, a previously discussed study suggested that the two-step approach (a non-fasting 50 gram oral glucose challenge test followed by a fasting 100 gram glucose tolerance test if the first test is positive) "produces equivalent benefits, and fewer harms, than the one-step approach."

Adverse outcomes associated with gestational diabetes include gestational hypertension, preeclampsia, shoulder dystocia, macrosomia, and Cesarean delivery. Gestational diabetes also confers a 7-fold greater maternal risk of developing type 2 diabetes later in life and 1.5 times greater risk of the child being overweight in childhood or adolescence. Management of gestational diabetes begins with glucose self-monitoring and lifestyle modifications, followed by oral medication or insulin if target blood glucose levels are not achieved.

Prevention of gestational diabetes includes counseling on appropriate weight gain goals based on pre-pregnancy BMI, which can generally be achieved by averaging "350 to 450 calories per day above the previous intake (e.g., two slices of bread with half an avocado, ¾ cup of Greek yogurt or 1 cup of blueberries with two hard-boiled eggs)." Additionally, "patients should be encouraged to engage in moderate aerobic activity most days of the week for at least 20 to 30 minutes at a time, for a total of at least 150 minutes per week." In a previous AFP Community Blog post, Dr. Erin Fredrickson discussed strategies for facilitating exercise in pregnant patients. The USPSTF recommends offering behavioral counseling interventions for healthy weight and weight gain in pregnancy; effective interventions generally started at the end of the first trimester and varied in duration and intensity (from 15 to 120 minutes and from 1 to more than 12 total contacts).

Monday, August 1, 2022

Will vaccine hesitant US adults accept a more traditional COVID-19 vaccine?

 - Jennifer Middleton, MD, MPH

Earlier this month, the United States (US) Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax for adults aged 18 and older:

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual.

This technology is similar to more traditional vaccines, such as the influenza vaccine, and differs from the available mRNA COVID-19 vaccines from Pfizer and Moderna. It's currently authorized as a 2 shot series, with doses given 3 weeks apart. In the clinical trial data of 25,500 participants submitted to the FDA, Novavax reported that 2 doses of their vaccine were, overall, "90.4% effective in preventing mild, moderate or severe COVID-19....in the subset of participants 65 years of age and older, the vaccine was 78.6% effective." Several countries worldwide who have previously authorized the Novavax vaccine offer a booster 5 months after the 2nd shot, and Novavax is reportedly pursuing authorization in the US for both that booster as well as administration to adolescents aged 12-17. They are also testing boosters with protection against the omicron strain. Although Novavax was part of the US government's Operation Warp Speed in 2020, the company suffered "developing and manufacturing setbacks" as a smaller start-up which put it behind Pfizer and Modera in the race to an EUA. 

The speed of the mRNA vaccines' development, along with the newness of their technology, led some people to question their short- and long-term safety. Given this reluctance regarding mRNA vaccines, Novavax, which "has no genetic material, only proteins," may be a more comfortable option for some patients. Approximately 10% of the adult population in the US has yet to receive a first dose of any of the COVID-19 vaccines, and increasing vaccine uptake may help slow the development of new variants

As noted on the blog last year, helpful resources to discuss vaccine hesitancy with patients include these resources and talking points from the US Centers for Disease Control and Prevention (CDC) along with this article on "Helping Patients Make Healthy Decisions on COVID-19" found in the AFP By Topic on Coronavirus Disease 2019 (COVID-19).

Monday, July 25, 2022

What to tell patients about exercise in pregnancy

- Erin Fredrickson, DO, MPH

If we had a magic pill to reduce rates of pregnancy complications and improve the health of pregnant patients, we would prescribe it faster than Allyson Felix can sprint 400 meters. Exercise during pregnancy isn’t a magic pill, but the potential benefits of engaging in purposeful physical activity during all stages of the reproductive journey far outweigh the perceived risks. Family physicians have a unique opportunity to assess health behaviors of patients before, during, and after pregnancy and provide guidance around lifestyle changes in the context of families and communities.

Before discussing the benefits and considerations for leisure-time physical activity in pregnancy, it is important to note that not every pregnant patient has the privileges of time or safety required to include exercise in their daily routine. The burden of societal inequity, systemic racism, misogyny, and climate change falls hardest on Black, brown, Indigenous, and people of color, especially during pregnancy. Acknowledging these barriers, we can encourage patients through individual relationships while advocating for policy changes to support our communities.

All adults, including pregnant patients without contraindications, are recommended to engage in 150 minutes per week of moderate intensity physical activity for optimal health. Exercise in pregnancy is associated with lower rates of prenatal complications, better fetal outcomes, and gentler labor experiences and postpartum recovery. Studies have found lower rates of gestational diabetes and large for gestational age infants, gestational hypertension, and preterm delivery among exercising pregnant patients compared to those who did not exercise. One study found that people with higher physical activity levels during pregnancy had a shorter duration of active labor. Another systematic review and meta-analysis of 17 trials found a reduction in cesarean birth rate of 16% in the exercise group. Exercise is well-known to improve mood regulation and is associated with fewer symptoms of postpartum depression. Considering the biomechanical changes of pregnancy, at least 60% of pregnant patients experience musculoskeletal pain, but greater self-reported overall fitness is associated with lower levels of bodily pain, lumbar/sciatic pain, and reduced pain disability in the second and third trimester.

How should we talk to patients about exercise during pregnancy? Previously inactive patients can begin exercising with gradual increases in frequency and duration over time. Anyone physically active prior to pregnancy can continue throughout pregnancy, but will likely need to modify activities to adapt to physiologic and biomechanical changes over time. With the right support in place, elite athletes can partner with their care teams and coaches to prioritize a healthy pregnancy and athletic longevity. Almost all types of aerobic exercise are safe (walking, jogging, swimming, cycling), but pregnant patients should avoid activities with higher risk of blunt abdominal trauma. Patients should be counseled to take breaks when needed, get enough to eat and drink, avoid extreme heat, and stop exercise immediately if vaginal bleeding or contractions occur. Most people should aim for intensity <80% of their maximum heart rate (or <15 “hard” on the rating of perceived exertion scale).

People with certain obstetric and medical conditions, particularly cardiovascular/respiratory complications, should be more cautious with exercise during pregnancy and the primary obstetric care team should have a low threshold to consult with maternal-fetal medicine.

AFP has been discussing exercise in pregnancy before it was cool (1998), and the American College of Obstetricians and Gynecologists updated their clinical guidance in 2020 with helpful tables for counseling. Our July issue includes a FPIN Clinical Inquiry on reducing risk of hypertensive disorders of pregnancy with exercise and an article on care of the active female with recommendations for exercise in pregnancy and the postpartum period in this Table (subscription required). Encouraging and facilitating exercise during pregnancy, particularly for those with societally imposed barriers, is an important component of working toward health equity for pregnant patients.

**

Dr. Fredrickson is a third-year resident at the University of Washington Family Medicine Residency Program, Seattle and one of AFP's 2022 Resident Representatives.

Monday, July 18, 2022

Pharmacists can now prescribe Paxlovid

 - Jennifer Middleton, MD, MPH

The United States (US) Food and Drug Administration (FDA) recently modified its Emergency Use Authorization (EUA) for nirmatrelvir/ritonavir (Paxlovid) to "authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing." Although some physician organizations have previously expressed concern with expanding pharmacists' scope of practice, others argue that increased access to Paxlovid is necessary

Nirmatrelvir/ritonavir must be started within 5 days of symptom onset, and its EUA applies to outpatient adults at high risk for severe COVID-19 illness. It is effective at reducing the risk of hospitalization or death, with a number needed to treat (NNT) of 18 in unvaccinated persons, with early non-peer-reviewed data demonstrating efficacy in vaccinated persons as well. When first approved, supplies and access were limited, but now plenty of nirmatrelvir/ritonavir is available to meet demand, which has been increasing in the US as COVID-19 surges again. The challenge for many patients is access to a prescription within the short 5 day window; COVID-19 tests, especially home test kits, may not be positive on the first day or two of symptoms, and prescribing requires time to review medical records for underlying liver and kidney disease as well as medication lists for nirmatrelvir/ritonavir's many drug-drug interactions.

The FDA encourages patients seeking nirmatrelvir/ritonavir after a positive COVID-19 test to first "consider seeking care from their regular health provider" or look for a Test-to-Treat location nearby. If seeking nirmatrelvir/ritonavir from a state-licensed pharmacist, patients should bring records of liver and kidney labwork that are less than 1 year old along with a comprehensive list of their medications and supplements.

Pharmacists' expertise can benefit patients and physicians. This 2021 FPM article reviews how in-office pharmacists can help with medication safety reviews, assist with tobacco cessation, and improve diabetes and hypertension control. "Interventions that involve pharmacists" increase medication adherence in patients with multiple chronic health conditions. Compared to physicians, pharmacists' management of warfarin results in improved INR readings and safety outcomes, and pharmacists can safely manage uncomplicated urinary tract infections (UTIs). The Choosing Wisely campaign urges us to "[not] continue medications at transitions of care without a pharmacist...performing a comprehensive medication review."

The AAFP recognizes these benefits of collaborative agreements with pharmacists, but it also warns about fragmentation of care when pharmacist prescribing is decoupled from a patient's primary care physician. Ensuring adequate communication with primary care offices when a pharmacist prescribes nirmatrelvir/ritonavir will be necessary to minimize the risk of this fragmentation. Looking beyond the COVID-19 pandemic, family physicians should think creatively about how to maximize collaboration opportunities with pharmacists, especially since, on average, patients access their community pharmacists much more frequently than their primary care physician. 

Monday, July 11, 2022

Advances in peanut allergy prevention and treatment

 - Kenny Lin, MD, MPH

People with severe peanut allergy are at risk of life-threatening anaphylaxis from unintentional ingestion of small amounts of peanuts. A recent new drug review in AFP discussed oral immunotherapy with peanut allergen powder, which increases tolerance for ingesting the amount of peanut protein in a single peanut by 63% but has important downsides: 1 in 10 patients need to use epinephrine after administration (compared to 1 in 20 in a placebo group); common short-term adverse effects include abdominal pain, throat irritation, and oral pruritus; and a price of approximately $3000 annually.

Although it was once believed that children should not consume peanuts early in life, a United Kingdom randomized trial in infants 4 to 11 months of age at high risk of developing peanut allergies (described in this Practice Guidelines summary) found that early consumption of peanuts reduced the risk of developing peanut allergy by age 5 years by 80% (absolute risk reduction=14%, NNT=7). This finding led the National Institute of Allergy and Infectious Diseases to recommend in 2017 that peanut-containing foods be introduced into the diet of infants with severe eczema, egg allergy, or both at 4 to 6 months of age. In 2021, a consensus document on the primary prevention of food allergy from three North American professional allergy societies recommended introducing peanut-containing products to all infants around 6 months of age, regardless of their risk of developing peanut allergy.

A similar change to infant feeding guidelines in Australia occurred in 2016, recommending that all infants be introduced to peanuts before age 12 months. A study in JAMA last week evaluated changes in feeding practices and the prevalence of peanut allergy across two population-based cross-sectional samples recruited in 2007-2011 and 2018-2019. Although infants in the later sample were much more likely to have consumed peanuts before 12 months than infants in the earlier sample (86% vs. 22%), overall there was no statistical difference in peanut allergy prevalence. Noting that East Asian ancestry is considered a risk factor for peanut allergy, the authors hypothesized that the increased representation of infants with parents from East Asia in the later sample may have contributed to finding no effect. Another possible explanation is that early introduction of peanut-containing foods does not significantly modify peanut allergy development in infants not at high risk.

In a previous paper on identifying and using clinical practice guidelines, Dr. David Slawson and I observed: "The ultimate test of a good guideline is whether or not it has been prospectively validated; that is, has its adoption been shown to improve patient-oriented outcomes in real-world settings?" Based on the JAMA study, infant feeding recommendations to prevent peanut allergies have not yet passed this test. On the other hand, an accompanying editorial argued that "given the potential for benefit and the low risk of harm, the [study results] should not dissuade clinicians from following current consensus guidance that recommends early peanut introduction for infants." The challenge of identifying children at increased risk for peanut allergy (as noted in the consensus document, definitions have varied across studies and guidelines) and the inherently artificial nature of previous guidance restricting what an infant would otherwise naturally eat make this a reasonable course of action in the face of imperfect evidence.