Bump in Non-Opioid Pain Prescriptions Following CDC's 2016 Guidelines

 Non-opioid pain medication prescribing increased after the CDC published guidelines on opioids for chronic pain in 2016, according to a cohort study using insurance claims data.

Among over 15 million individuals, logistic regression models showed that the odds of non-opioid pain prescriptions were higher following the release of the "Guideline for Prescribing Opioids for Chronic Pain" compared with pre-guideline pattern-based estimates:

• 3% higher in the first year (95% CI 2.6-3.3)
• 8.7% higher in the second year (95% CI 8.3-9.2)
• 9.7% higher in the third year (95% CI 9.2-10.3)

"This finding aligns with language in the 2016 CDC guideline advising caution when initiating opioids and avoiding their use as a default first-line therapy," wrote Jason E. Goldstick, PhD, of the University of Michigan in Ann Arbor, and colleagues in JAMA Network Open.

The magnitude of the post-guideline differences from the pre-guideline pattern varied by several clinical characteristics, including chronic pain, recent opioid exposure, anxiety disorder, and mood disorder, the authors noted.

Of note, there were greater increases in odds of non-opioid prescribing over the post-guideline years among those with opioid exposure versus those without exposure:

• Year 1: OR 1.06 (95% CI 1.05-1.06) vs OR 1.02 (95% CI 1.02-1.02), respectively
• Year 2: OR 1.11 (95% CI 1.10-1.12) vs OR 1.08 (95% CI 1.08-1.09)
• Year 3: OR 1.12 (95% CI 1.11-1.13) vs OR 1.09 (95% CI 1.09-1.10)

Similarly, those with chronic pain, anxiety disorder, and mood disorders showed larger relative increases in prescribing odds of non-opioids compared with those without these factors, Goldstick and team said. For instance, those with chronic pain had a 14.9% higher prescribing rate during the third year compared with the pre-guideline pattern estimates.

In addition, non-opioid medications were more likely to be prescribed for women versus men, and those with Medicare Advantage compared with those with commercial insurance plans.

Across the study period from 2011 to 2018, opioid prescription rates notably decreased throughout the full cohort, from 23.1% in 2012 to 17.6% in 2018. Non-opioid prescriptions were steady through 2015 (20.1%), but increased in each following year, rising to 22.2% by 2018.

"Identifying the best way to tailor treatment options and delivery to the individual is a new area of investigation. Innovations in clinical research, including pragmatic and adaptive clinical trials; stepwise treatments; responder analyses; and machine learning approaches to predictive modeling of the interaction of biopsychosocial factors in response to various treatments are poised to revolutionize the field," noted Stephanie A. Eucker, MD, PhD, of Duke University School of Medicine in Durham, North Carolina, and colleagues, writing in an invited commentary. "Until we collectively prioritize pain management to include comprehensive multimodal, person-centered treatments, the problem of chronic pain will continue to grow."

For their study, Goldstick and colleagues constructed seven annual cohorts using claims data from the Optum Clinformatics Data Mart Database for January 2011 through December 2018. The cohorts included adults with commercial insurance or Medicare Advantage plans, no cancer or palliative care claims, and 2 years of continuous insurance enrollment. Patients were allowed to be included in more than one cohort, and each cohort covered a 2-year period.

The first year in each cohort was considered the baseline period, used to measure opioid exposures and other clinical characteristics, while the second year was the follow-up period in which prescribing outcomes were measured. Out of the seven cohorts, four were studied before the 2016 guideline was published, and three were studied after.

Goldstick and team acknowledged some limitations to their study. The requirement of continuous enrollment in an insurance plan meant that participants likely fell within a particular socioeconomic range. The study was also unable to account for pain management for those without insurance, those on Medicaid, those using over-the-counter medications, and those with a secondary insurance plan.

In addition, any comorbidities prior to a participant's insurance coverage, as well as specialty clinic care, were not included. Some non-opioid pain medicines, such as skeletal muscle relaxants and lidocaine, were also left out of the study, they noted.

Disclosures

This study was funded by grants from the CDC.

The study authors and commentators reported no conflicts of interest.

Primary Source

JAMA Network Open

Source Reference: Goldstick JE, et al "Patterns in nonopioid pain medication prescribing after the release of the 2016 guideline for prescribing opioids for chronic pain" JAMA Netw Open 2022; DOI: 10.1001/jamanetworkopen.2022.16475.

Secondary Source

JAMA Network Open

Source Reference: Eucker SA, et al "Nonopioid treatments for chronic pain -- integrating multimodal biopsychosocial approaches to pain management" JAMA Netw Open 2022; DOI: 10.1001/jamanetworkopen.2022.16482.

https://www.medpagetoday.com/painmanagement/painmanagement/99183

Failing to practice weight neutral care can trigger distress or disordered behaviors in patients

 I vividly remember when I realized I had to change how I talk to patients about weight. I was a second-year resident, rotating in a rural practice. As I worked through my well visit routine, the mantra "growth chart, growth chart, growth chart" always rang in my head. Before starting a conversation about growth and nutrition, I examined the growth chart, then turned the computer towards my patient and their caretaker. I explained percentiles, where their child fell on the curve, and its meaning. I described my concerns if they were at the extremes, the labs they needed if they were at the higher end, and moved on for the kids in the middle, under the pressure of limited time. One day, when I gave this explanation to a young girl and her mother, thinking I was doing the right thing, she cried. I had not said anything rude or demeaning, but the message was received: "There is something wrong with my body; my body is not good enough."

I saw myself in that patient's tears. I gained weight during my high school years and tried to lose some of it in college. I went in for a physical and my internist praised my efforts, but when I returned the following year after regaining it all, an EPIC alert popped up, warning her of my significant weight increase. Seeing my "failure" highlighted made me cry. My doctor saw my tears. Yet, instead of offering words of comfort or reassurance, she said nothing and proceeded with the appointment. Realizing I had been trained to cause the same harm I had experienced hurt me deeply. I needed to change my approach for that young girl and my future patients.

I acknowledged my patient's tears. I told her there is nothing wrong with her body and celebrated the things it allows her to do, like learn, grow, and play. She told me she played sports regularly with friends and we reviewed her typical nutrition. In the end, I didn't have any advice -- she was doing all the right things and happened to gain weight in early puberty. I can only hope she does not remember that day.

This experience sparked a quest for me to learn a better way. In my work with eating disorders, I have heard several patient histories start with a doctor's comments that triggered disordered behaviors, such as restricting or binging/purging. In our intent to look after our patients' health, we can cause significant emotional and physical harm. I didn't want to go down this path.

From The Body Is Not an Apology, I learned about how society and its oppressive structures tell people, including those at higher weights, that our bodies are bad and calls on us to find radical self-love in spite of these forces. I learned about the Health at Every Size movement, which does not see weight as an indicator of health. In Body Respect I reviewed studies showing 90% of diets fail and yo-yo dieting leads to even higher weights than baseline. Fearing the Black Body helped me understand that fatphobia has racist origins; thinness became the standard for white women in the 18^th century to represent their restraint compared to enslaved Black people in larger bodies who were seen as out of control. It also described the origins of BMI charts, which were created by a mathematician for insurance policies, then later co-opted for healthcare. Belly of the Beast tied this all together by demonstrating how fatphobia, anti-Blackness, and transphobia are all perpetuated by systemic oppression and places the responsibility on institutions to tear it all down. These works have inspired me in my development of an affirming, weight-neutral approach to health.

There is discussion in adult medicine about not weighing patients unless relevant, or at least letting them opt-out. For pediatric and adolescent medicine, patients are still growing, so weight is a pivotal vital sign as a trend, not an isolated point. One of my attendings told me, "every change tells a story." We do not need to look further than the COVID-19 pandemic to see how circumstances impact weight. When I see weight significantly increase or decrease, I approach it with non-judgmental curiosity to understand what may be going on in that young person's life. I ask about recent food intake and physical activity as well as new or worsening symptoms to evaluate for medical causes, like thyroid disease or chronic pain. I also consider psychological factors, like mental health concerns, trauma, and stress, etc. If they report no changes, I believe them and investigate further to rule out or identify medical issues. Screening allows for identifying and addressing core issues.

In a routine appointment, I ask all adolescents if they want to know their weight. I explain it is just a number on a chart that in itself has little meaning to me. If they decline, I will not mention it. Regardless of where they fall on the growth chart, we talk about the behaviors that contribute to health. I use "physical activity" and "nutrition," instead of "diet" and "exercise" to reduce stigma. We talk about how they feel about their bodies and if they have ever tried to change their weight through disordered eating because eating disorders can impact anyone of any size, gender, race/ethnicity, or socioeconomic background. Through motivational interviewing, I help anyone create goals for improvement, such as eating breakfast before school or getting 8 hours of sleep.

In my counseling, I use "nutrition-sensitive," not "obesity-related," to describe conditions like diabetes, high blood pressure, or high cholesterol. I also acknowledge the role that genetics, racism, and oppression play in health to counter the assumption that patients are solely responsible for their health outcomes. Even when a patient has abnormal labs indicating a nutrition-sensitive condition, I never recommend weight loss. After instituting lifestyle changes, the labs often change before weight. Weight loss is not necessary for management. If a patient still desires to lose weight, I explore the reasons behind their goals. I offer referrals that will provide support without emphasizing weight, such as therapists for those who struggle with body image or want to process traumatic experiences, and dietitians for those desiring nutrition guidance. I refer to an obesity specialist if they express interest in learning about medical management.

I am always learning new languages and approaches, but the gratitude I have seen from patients and families at feeling celebrated and not shamed during these conversations is the confirmation I need to know that I am on the right track.

Rebekah Fenton, MD, is a graduating adolescent medicine fellow based in Chicago, and an adolescent health advocate.

https://www.medpagetoday.com/opinion/second-opinions/99174

EU drug regulator: mRNA COVID vaccines do not cause absence of menstruation

 Available data suggest that mRNA COVID-19 vaccines do not cause an absence of menstruation, the European Union's health regulator concluded on Friday.

The assessment was prompted by reports of menstrual disorders after receiving one or two shots of either the Moderna or the Pfizer-BioNTech vaccines.

Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.

Absence of menstruation is defined as no bleeding for a period of 90 days or more.

Meanwhile, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is still investigating cases of heavy menstrual bleeding with the two vaccines.

Reports of heavy periods - bleeding characterised by increased volume and/or duration that interferes with the quality of life - were highlighted as a potential concern after a study in Norway suggested an uptick in instances of the phenomenon following inoculation.

On Friday, the PRAC said it had reviewed all available data on the possible risk but had requested vaccine makers to provide an updated cumulative review of cases.

https://finance.yahoo.com/news/eu-drug-regulator-mrna-covid-160202989.html

White House Says Delta to Ship UK Baby Formula Starting June 20

 Delta Air Lines Inc will start transporting 3.2 million bottles of Kendamil baby formula on June 20, the White House said on Friday in announcing the sixth shipment of overseas formula to help quell a U.S. shortage.

Delta will ship about 212,000 pounds of the British formula maker's product from London to Boston and Detroit, where it will then get to retailers, the White House said in a statement.

Separately, the U.S. Food and Drug Administration said Abbott Laboratories would have 16.5 million bottles of its Similac infant formula ready to be shipped from Spain this month.

It did not say when the bottles would be shipped into the United States, but said the government was looking at options to get the product to the U.S. "as quickly as possible".

The shipments are the latest in a string of Operation Fly Formula flights aimed at restocking U.S. shelves after Abbott, a major U.S. infant formula supplier, saw a key factory in Michigan shut down earlier this year and recalled its product.

U.S. President Joe Biden this week said nearly 10 million bottles of safe infant formula would be brought into the country to be sold nationwide in the next two weeks.

His administration is also securing overseas formula made by Nestle SA and Bubs Australia.

The bay formula shortage comes as Biden grapples with high inflation, gun violence and other issues before November congressional elections.

https://www.usnews.com/news/top-news/articles/2022-06-10/delta-to-move-british-baby-formula-to-u-s-starting-june-20-white-house

U.S. seeks to expand monkeypox testing as cases rise

 U.S. health officials are working to expand capabilities to test for monkeypox beyond a narrow group of public health labs, heeding calls from infectious disease experts who say testing for the virus needs to become part of routine care.

U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky said during a conference call on Friday that her agency is working with the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS) to expand testing capacity to include commercial laboratories.

The CDC did not respond to a request for further details.

Currently, preliminary monkeypox testing in the United States is done through a network of 69 public health laboratories, which send results to the CDC for confirmation.

There have been 45 confirmed monkeypox cases in 16 U.S. states so far, with the bulk of the current outbreak outside of Africa, where the virus is endemic, occurring in Europe.

The United States has conducted roughly 300 monkeypox tests. While testing for the virus rose by 45% last week, that needs to increase dramatically if the outbreak is to be contained, infectious disease experts said.

"There is not enough testing going on now for monkeypox in the United States," said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security.

"The commercial labs are used to working with healthcare providers from across the country, moving samples around quickly, reporting results quickly in a way that providers understand and expect," he said.

Large commercial U.S. testing companies include Quest Diagnostics and Labcorp.

For commercial labs to do this testing, they need access to monkeypox samples to validate their tests, regulatory guidance from the FDA and commercial billing codes set by CMS, said Inglesby, a former senior White House adviser for the COVID-19 response.

"My sense is all of that is moving forward," he said.

https://finance.yahoo.com/finance/news/u-seeks-expand-monkeypox-testing-191721089.html

COVID June 10, 2022: Cases, Hospitalizations and Deaths Increasing

 On COVID (focus on hospitalizations and deaths):

COVID Metrics
	Now	Week Ago	Goal
Percent fully Vaccinated	66.7%	---	≥70.0%1
Fully Vaccinated (millions)	221.6	---	≥2321
New Cases per Day3🚩	106,874	99,715	≤5,0002
Hospitalized3🚩	23,292	22,043	≤3,0002
Deaths per Day3🚩	291	262	≤502
1 Minimum to achieve "herd immunity" (estimated between 70% and 85%). 2my goals to stop daily posts, 37-day average for Cases, Currently Hospitalized, and Deaths 🚩 Increasing 7-day average week-over-week for Cases, Hospitalized, and Deaths ✅ Goal met.

Click on graph for larger image.

This graph shows the daily (columns) and 7-day average (line) of deaths reported.

New cases have quadrupled from the recent low.  Hospitalizations and deaths are now increasing.

Average daily deaths bottomed in July 2021 at 214 per day.

https://www.calculatedriskblog.com/2022/06/covid-june-10-2022-cases.html

FDA says Moderna COVID vaccine safe and effective for young children

 Reviewers at the Food and Drug Administration (FDA) said in briefing documents released on Friday that Moderna’s COVID-19 vaccine is both effective and safe for children under 6 years old.

The analysis comes ahead of several advisory committee meetings next week to weigh giving approval to Moderna’s and Pfizer’s vaccines for young children.

“Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” staff at the FDA wrote. 

The FDA staff noted that rates of adverse reactions were found to be similar between young adults and those aged between 12 and 17 years old. 

“In children 6 months through 11 years of age, rates of solicited local and systemic adverse reactions were generally lower compared to those observed in adolescents and in previous clinical trials with young adults, with the exception of fever which was reported more frequently in the younger age groups compared to adolescents and adults,” FDA staff said.

The FDA’s analysis of the Moderna vaccine is promising news for parents who are anxious to vaccinate younger children. So far, children aged 5 years and older can only receive the Pfizer vaccine, and no vaccine has been authorized for children under 5 years old.

An FDA advisory committee is set to meet Wednesday to weigh allowing Moderna’s vaccine for children between the ages of 6 months and 5 years old and Pfizer’s vaccine for children under 5.

If the advisory committee recommends approval the vaccines for young children, approval from the Centers for Disease Control and Prevention and FDA authorization could follow soon after.

The advisory committee will also meet Tuesday to discuss changing emergency use authorization for the Moderna vaccine so children and adolescents aged 6 to 17 years can receive it.

https://thehill.com/policy/healthcare/3519696-fda-says-moderna-covid-vaccine-safe-and-effective-for-young-children/