The onset of the new calendar year brings with it a sense of hope and an urgent need for improved health outcomes. To help keep abreast with current health events, it is helpful to be informed about events of the recent past. This news roundup discusses a few of the key news releases that were announced during the month of December 2020 that affected the world of pharmacy and public health.

The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19, this discussion has a heavy emphasis on pandemic-related content.

There has been a plethora of news releases that have been announced in December 2020. To help summarize, five of the most relevant stories from the month are described below. 

Pfizer-BioNTech COVID-19 Vaccine Obtains Emergency Use Authorization (EUA)

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

Following a thorough yet succinct approval process, the Pfizer-BioNTech COVID-19 vaccine obtained an EUA after data showed that the vaccine is safe and effective in the described patient population. A future Pharmacist Consult article will discuss the logistics of how the vaccine was granted an EUA through a general process called ‘trial stacking’. 

Following the issuance of the EUA, FDA Commissioner Dr. Stephen M. Hahn stated “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world. Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

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Moderna COVID-19 Vaccine Obtains EUA

Seven days after announcing the issuance of an EUA for the Pfizer-BioNTech COVID-19 vaccine, the FDA announced the issuance of a second COVID-19 vaccine on December 18, 2020 from biotechnology company Moderna. This second vaccine is indicated for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. 

Although the Moderna COVID-19 vaccine has a different minimum age requirement than the Pfizer-BioNTech COVID-19 vaccine, the two are considered to be equally effective. 

 In an additional press briefing, FDA Commissioner Dr. Stephen M. Hahn stated: “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day. Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

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FDA Approves Second Treatment for Ebola Virus 

The Ebola virus obtained significant attention in the media throughout the 2010 decade, but it has a history dating back to 1976. Although the virus has fallen out of the media’s focus during 2020, it remains an issue that is impacting individuals across multiple countries. 

On December 21, 2020, the FDA approved Ebanga (ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.

This is the second medication approved by the FDA to treat Ebola. The first Ebola treatment, Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), was approved by the FDA on October 14, 2020. 

Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, and tissues of infected people or wild animals, and through surfaces and materials, such as bedding and clothing, contaminated with these fluids.

Ridgeback Biotherapeutics, a company based in Miami, FL, produces the therapy. It was granted an Orphan Drug designation, which provides incentives to assist and encourage drug development for rare diseases. Additionally, the FDA granted Ebanga a Breakthrough Therapy designation.

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U.S. Sues Walmart, Alleging Role in Fueling Opioid Crisis

On December 22, 2020, the United States and the Trump administration sued Walmart, accusing the retailer of helping to fuel the nation’s opioid crisis by inadequately screening for questionable prescriptions despite repeated warnings from its own pharmacists. This is a currently developing situation. 

The Justice Department’s lawsuit claims that Walmart “sought to boost profits” by understaffing its pharmacies and pressuring employees to fill prescriptions quickly. That made it difficult for pharmacists to reject invalid prescriptions, enabling widespread drug abuse nationwide, the suit argues.

Walmart Corporate issued a statement on December 22, 2020 in response to the news. “There are a lot of problems with the lawsuit—as we will explain in court, it is wrong on the law and riddled with factual inaccuracies, mischaracterizations and cherry-picked documents taken out of context. And it is outrageous the Department is trying to shift blame for DEA’s own well-documented failures in policing the very doctors it gave permission to prescribe opioids,” the Walmart press release described. 

As this situation progresses, additional news will be released. 

Related Links: 

Emerging SARS-CoV-2 Variants

Throughout the month of December 2020 and in months prior, there has been discussion of SARS-CoV-2 variants that have appeared in multiple countries worldwide. 

Variant of Concern (VOC) 202012/01 (a.k.a. B.1.1.7), was first noted in the UK in September 2020. Since December 20, 2020, several countries have reported cases of the UK VOC 202012/01, including the United States and Canada. The first 2 cases of the variant in the United States were reported to be in Colorado and cases have also been reported in California. Other variants have also been identified, per the CDC, in Nigeria and South Africa.

However, there is no evidence that the UK-based variant will impact vaccinations in any way, per the US Surgeon General. As COVID-19 vaccines become more and more available to individuals through the planned distribution phases, it is important for individuals to receive the 2-dose vaccine series as soon as they are able. 

To help combat this, the CDC is emphasizing the importance of strain surveillance. The CDC posted a statement related to this: “National SARS-CoV-2 Strain Surveillance (“NS3”): Since November 2020, state health departments and other public health agencies have been regularly sending CDC SARS-CoV-2 samples for sequencing and further characterization. This system is now being scaled to process 750 samples nationally per week. One strength of this system is that it allows for characterization of viruses beyond what sequencing alone can provide.”

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Pharmacist Consult

To stay up-to-date with current health events and ongoings, it is helpful to be informed about events of the immediate past. This news recap discusses a sampling of key news releases that were announced during the month of February 2021 that affected the world of pharmacy and public health.

The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19, this discussion has a heavy emphasis on pandemic-related content.

There has been a plethora of news releases that have been announced in February 2021. To summarize, six of the most relevant stories from the month are described below. 

Emergency Use Authorization (EUA) Given for Third COVID-19 Vaccine in United States

Image courtesy of Shutterstock

On February 27^th, following a positive meeting conducted by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the United States Food & Drug Administration (FDA) authorized the Janssen COVID-19 vaccine as the third COVID-19 vaccine authorized for use in the United States. This vaccine is now authorized alongside the Pfizer-BioNTech and Moderna COVID-19 vaccines. 

The Pfizer-BioNTech and Moderna COVID-19 vaccines are mRNA vaccines, but the Janssen COVID-19 vaccine uses a type of virus called adenovirus type 26 (Ad26) instead of mRNA.

Additionally, unlike the two mRNA COVID-19 vaccines that require two doses, the Janssen COVID-19 vaccine is a single-dose vaccine. The Janssen COVID-19 vaccine is approved for use in individuals 18 years or older. 

According to the FDA and analyzed clinical trial data, the Janssen COVID-19 vaccine is “67% effective [at] preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine [is] approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.”

Janssen Pharmaceuticals is a subsidiary company of Johnson & Johnson. Thus, when the terms ‘Johnson & Johnson COVID-19 vaccine’ and ‘Janssen COVID-19 vaccine’ are mentioned, they are one in the same. 

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Updated CDC Mask Recommendations

Image courtesy of CDC

Ever since the early days of the COVID-19 pandemic, individuals have adapted to the now-customary practice of wearing face masks to help protect against the spread of COVID-19.

Initially, there were no strict requirements regarding face masks – there were no mask mandates issued by various levels of government and there were no mask types specifically recommended. However, in early February, the CDC updated its masking recommendations. 

It is recommended to now layer with masks, and there are two possible ways to layer. One method would be to wear one cloth mask with multiple layers of fabric. Another method would be to wear a disposable mask beneath a cloth mask.

Additionally, the CDC recommends to wear a mask with a nose wire to make masks more secure to the wearer’s face, to use a mask fitter or brace when possible, and to tighten ear straps when possible to make the mask-face seal more secure. 

It is important to not combine two disposable masks. Additionally, KN95 masks should not be worn at the same time as other masks. 

Related links:

• Your Guide to Masks
• Masks Protect You & Me
• Types of Masks

Increasing Cases of COVID-19-Linked Syndrome Noted in Children

Image courtesy of Johns Hopkins Medicine

Cases of multisystem inflammatory syndrome in children (MIS-C), a possible complication of COVID-19, have spiked over the past several weeks and increasing numbers of patients have become critically ill or passed after developing the condition. 

According to the CDC, the specific cause of MIS-C is still being investigated. However, MIS-C can occur as a complication of an acute illness such as COVID-19. It is considered to be an exaggerated inflammatory reaction that can affect many different parts of the body.

If a child is thought to have MIS-C based on described symptoms and is not already under the care of a healthcare provider, the child should seek care as soon as possible. Emergency services are warranted typically if a child is experiencing troubled breathing, pain or pressure in the chest that does not go away, sudden confusion, inability to stay awake, pale/gray/blue-colored skin, lips, or nail beds, and/or severe stomach pain.

Ever since May 2020, the CDC has been tracking cases of MIS-C. Between May 2020 and February 2021, 2,060 cases of MIS-C have been reported across 48 states, New York City, Washington DC, and Puerto Rico. 

Related links:

Updated Transportation and Storage Conditions for Pfizer-BioNTech COVID-19 Vaccine

Image courtesy of Pfizer

When the Pfizer-BioNTech COVID-19 vaccine was initially authorized for use by the FDA in December 2020, a significant part of the vaccine that commanded worldwide media attention was the need for storage at ultra-frozen temperatures. This is troubling from a logistical standpoint as standard freezers are not able to reach ultra-frozen temperatures. 

Initially, the preferred storage and transportation states of undiluted Pfizer-BioNTech COVID-19 vaccine vials were at ultra-frozen temperatures between -112ºF and -76ºF (-80ºC to -60ºC). However, since then, Pfizer has obtained additional data about its vaccine’s stability at warmer temperatures than those initially described. 

The compiled data was interpreted and deemed acceptable by the FDA, so now the Pfizer-BioNTech COVID-19 vaccine can be transported and stored at temperatures found in standard freezers for up to 2 weeks. This news is promising to help alleviate certain logistical, transportation-based concerns while concurrently helping to reduce vaccine waste due to temperature excursion issues.

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FDA Approves 6 Novel Drugs in February 2021

Image courtesy of TG Therapeutics

The month of February 2021 was a hectic one for the FDA. Their hands were incredibly full with COVID-19 work alone, but their other workstreams were carrying on in their customary capacity as well. 

Throughout the month of February, a total of 6 novel drugs were approved by the FDA: Tepmetko (tepotinib), Ukoniq (umbralisib), Evkeeza (evinacumab-dgnb), Cosela (trilacicilib), Amondys 45 (casimersen), and Nulibry (fosdenopterin). 

Tepmetko (tepotinib), made by EMD Serono, is used to treat non-small cell lung cancer. Lung cancer is noted to be one of the most deadly and common types of cancer, so this is a welcome addition to current treatment options for patients fighting non-small cell lung cancer. To learn more about non-small cell lung cancer, consider referencing this resource from the American Cancer Society. 

Ukoniq (umbralisib), made by TG Therapeutics, is used to help treat certain subsets of patients with marginal zone lymphoma and follicular lymphoma. Marginal zone lymphoma and follicular lymphoma are two types of lymphoma – a cancer of the lymphatic system. To learn more about lymphoma, consider referencing this resource from the American Cancer Society.

Evkeeza (evinacumab-dgnb), made by Regeneron Pharmaceuticals, is used to treat patients with homozygous familial hypercholesterolemia (HoFH). Patients with HoFH have markedly high levels of cholesterol, specifically low-density lipoprotein (LDL). To learn more about HoFH, consider referencing this resource from FH Foundation. 

Cosela (trilacicilib), made by G1 Therapeutics, is used to help control myelosuppression (a decrease in bone marrow activity) caused by chemotherapy in adults with small cell lung cancer. Myelosuppression is a common side effect of many different anticancer treatments and often times it is an effect that can cause treatment delays or stoppages in therapy. By minimizing the incidence of myelosuppression when possible, patients with small cell lung cancer have a better chance to obtain their cancer treatments as scheduled. To learn more about myelosuppression, consider using this resource from the International Myeloma Foundation. 

Amondys 45 (casimersen), made by Sarepta Therapeutics, is used to treat Duchenne muscular dystrophy (DMD). DMD is a genetic disorder that causes muscle weakness and breakdown over time. To learn more about DMD, consider referencing this resource from the Muscular Dystrophy Association (MDA). 

Nulibry (fosdenopterin), made by Origin Biosciences, is used to treat molybdenum cofactor deficiency (MoCD) Type A. This is the first treatment approved to treat MoCD Type A; MoCD Type A is a rare genetic mutation that can cause severe and rapid neurologic deterioration. To learn more about MoCD, consider referencing this resource from MedLine Plus. 

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Mourning the Loss of a Pharmacy Legend: Dr. Joseph A. Oddis

Image courtesy of ASHP

On February 24^th, the world of pharmacy mourned the loss of Dr. Joseph A. Oddis. Dr. Oddis, 92, was a longtime CEO of the American Society of Health-System Pharmacists (ASHP) from 1960 to 1997. Throughout this time period, Dr. Oddis was one of the trailblazers that helped lead the charge of advancing pharmacy practice during this progressive time period for pharmacy. 

For reference’s sake, ASHP is a professional organization for pharmacists, pharmacy technicians, and pharmacy students. The purpose of ASHP is to support the practice of pharmacy in various hospitals and health systems. 

The current CEO of ASHP, Paul W. Abramowitz, released the following statement following Dr. Oddis’ passing: “This is an extremely sad day for the profession of pharmacy. Dr. Oddis’ contributions to pharmacy practice in the United States and globally are innumerable and have touched every corner of the profession. He embraced pharmacists’ societal roles as the medication experts and committed his life to advancing that vision. Dr. Oddis believed that pharmacists could improve the lives of patients through the safe and optimal use of medications. Dr. Oddis was a visionary who imagined ASHP as a professional organization that would offer the highest-caliber continuing education, pharmacy residency training, evidence-based drug information, pharmacist-led research, and so much more. He had that unique ability to articulate his vision, achieve consensus around it, and lead its highly successful implementation.”

Dr. Oddis will be missed. The profession of pharmacy would be entirely different without the strikingly positive influence of Dr. Oddis. 

Related links: 

Sexually transmitted infections (STIs) are common reasons patients seek health care in the United States. Unfortunately, cases are on the rise. Since 2014, cases of gonorrhea and chlamydia have increased 63% and 19%, respectively.

Previously, Pharmacist Consult covered common first-line treatment options for a variety of STIs. Since that article was published in July 2020, a few things have changed. Specifically, the treatment of gonorrhea.

On December 18, 2020, the Centers for Disease Control and Prevention (CDC) published an update to the 2015 treatment guidelines for gonococcal infection (gonorrhea). The changes could have a noticeable impact on how clinicians and patients approach treatment of this common STI.

Gonorrhea is caused by a bacteria called Neisseria gonorrhoeae. Patients with gonorrhea typically do not have just gonorrhea. Co-infection with another bacteria, Chlamydia trachomatis (you guessed it, the cause of chlamydia), is also common.

Previously, the first-line recommended treatment for gonorrhea was a combination of two antibiotics – ceftriaxone and azithromycin. These two antibiotics were given once: ceftriaxone as a single injection into the muscle (intramuscular injection) and azithromycin as a single oral dose. This was recommended as a strategy to prevent N. gonorrhoeae from becoming resistant to ceftriaxone (rates of resistance among similar antibiotics prior to the recommendation were increasing) as well as to treat any possible co-infection with C. trachomatis – two birds with one stone.

N. gonorrhoeae has become resistant to a variety of antibiotics. In the 1980s, penicillin and tetracycline became no longer recommended for treatment due to resistance. In 2007 and again in 2012, ciprofloxacin and cefixime became no longer recommended. Thus, penicillin, tetracycline, ciprofloxacin, and cefixime are no longer recommended. However, ceftriaxone has retained its activity (able to be used for treatment) up to this point.

Though N. gonorrhoeae resistance to ceftriaxone has remained relatively low, N. gonorrheoae and other bacteria have demonstrated increased resistance to azithromycin (Figure 1), and this increase began around the time this dual-therapy recommendation was implemented.

Studies have connected increased resistance to azithromycin with increased exposure to azithromycin via treatment of patients with gonorrhea. In an effort to preserve the effectiveness of azithromycin for other infections, the updated guidelines have removed azithromycin from the treatment of gonorrhea. Additionally, studies of ceftriaxone doses that demonstrate optimal treatment of the bacteria has led to a larger recommended dose from 250 mg to 500 mg. This results in a new recommendation of a single dose of ceftriaxone 500 mg intramuscularly for the treatment of gonorrhea (Table 1).

Table 1. Changes to Gonorrhea Treatment Recommendations

Abbreviations: g, gram; IM, intramuscular injection; mg, milligram

Great! This means that patients only need a single drug instead of two to treat their STI – but what about patients with unknown or potential chlamydia co-infection?

Previously, clinicians and patients did not need to worry – azithromycin adequately treated chlamydia. Clinicians simply needed to monitor culture results to ensure that if chlamydia was present that it would be susceptible to azithromycin – the patient’s end of the bargain (aside from abstaining from sexual contact) was more or less complete.

If co-infection with chlamydia cannot be ruled out, it is recommended to treat with doxycycline 100 mg by mouth 2 times daily for 7 days. Although this an effective treatment (especially with directly observed therapy), this new recommendation raises concerns for real-world compliance and successful treatment.

Figure 1. Percentage of Neisseria gonorrhoeae isolates with elevated minimum inhibitory concentrations (MICs) to ceftriaxone, cefixime, and azithromycin — Gonococcal Isolate Surveillance Project, United States, 2009–2018

This updated recommendation means that two main strategies for further treatment can take place after patients receive their dose of ceftriaxone:

1. Sending patients home without a prescription and calling one into their pharmacy after the test is positive.
2. Sending patients home with a physical prescription or calling one into their pharmacy before the test is positive.

In an effort to streamline workflow, clinicians may opt for strategy number 2. However, due to a potential lack of health literacy, this leaves the possibility of patients mistakenly filling and taking their doxycycline despite a negative result for chlamydia.

But what’s the big deal?

Patients must do this all the time for other medications. True, but chlamydia is a communicable disease. If it is not treated properly, it can spread to other people leading to an increase in cases. It is imperative that it is treated appropriately so as to prevent unnecessary treatment in other individuals. Although it is not the intention of this recommendation, if not executed properly by clinicians and patients, it is plausible that rates of resistance to doxycycline (as well as treatment failures of chlamydia) may increase if non-compliance is high.

Successful treatment now relies significantly on patient compliance. Both effective education and coordination with patients will be key. Clear verbal and written instructions and expectations will need to be communicated to patients to ensure successful treatment.

Additionally, these updated guidelines leave healthcare providers wondering: what do these gonorrhea recommendations mean for patients who are positive for chlamydia and negative for gonorrhea?

The guidelines for chlamydia treatment are not yet updated and the first-line recommendation still includes a one-time dose of azithromycin 1 g. A natural extension of the gonorrhea guidelines would imply that doxycycline for 7 days will now be the preferred treatment for chlamydia. An update to the chlamydia guidelines is now very much needed to clarify this.

Though some may view this update as controversial, it will still require a change in many clinicians’ approach to treatment. Emergency departments, primary care offices, and STI clinics will all need to re-think how to best provide proper care for these patients. The choice of drug for treatment will certainly take these guideline recommendations into account, however other patient-specific factors will also be determinants. There will certainly still be situations where azithromycin will be used, but the ultimate goal of this recommendation is to reduce overall use.

Table 2. Hypothetical Pro/Con Positions on Updated CDC Recommendations

These updated guidelines represent compromise and an attempt to strike a delicate balance between individual treatment success, convenience, public health, and antimicrobial stewardship. And though these recommendations may complicate gonorrhea/chlamydia treatment, they are absolutely necessary to curb the rise of drug resistant gonorrhea.

References:

1. Sexually Transmitted Disease Surveillance 2018. Centers for Disease Control and Prevention (CDC). Accessible via: https://www.cdc.gov/std/stats18/default.htm. Last updated 28 July 2020.
2. Murdock, JL. Common First-Line STD Treatment Options. Pharmacist Consult. Accessible via: https://www.pharmacistconsult.com/common-first-line-std-treatment-options/. Published 27 July 2020.
3. Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020. Morbidity and Mortality Weekly Report (MMWR). Accessible via: https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm?s_cid=mm6950a6_w. Published 18 December 2020.
4. Dicker LW, Mosure DJ, Berman SM, et al. Gonorrhea Prevalence and Coinfection With Chlamydia in Women in the United States, 2000. Sexually Transmitted Diseases: May 2003 – Volume 30 – Issue 5 – p472-475. Accessible via: https://journals.lww.com/stdjournal/fulltext/2003/05000/gonorrhea_prevalence_and_coinfection_with.16.aspx#:~:text=Chlamydial%20Coinfection,-The%20median%20chlamydia&text=The%20median%20chlamydia%20positivity%20in,(IQR%2042.5%E2%80%9352.9%25).
5. Drug Resistant Neisseria Gonorrhoeae. Centers for Disease Control and Prevention (CDC). Accessible via: https://www.cdc.gov/drugresistance/pdf/threats-report/gonorrhea-508.pdf
6. Wind CM, de Vries E, Schim van der Loeff MF. Decreased Azithromycin Susceptibility of Neisseria gonorrhoeae Isolates in Patients Recently Treated with Azithromycin. Clinical Infectious Diseases, Volume 65, Issue 1, 1 July 2017, Pages 37–45, https://doi.org/10.1093/cid/cix249. Accessible via: https://academic.oup.com/cid/article/65/1/37/3828521. Published 24 March 2017.
7. Bacteria Culture Test. MedLine Plus | US National Library of Medicine. Accessible via: https://medlineplus.gov/lab-tests/bacteria-culture-test/. Last updated 30 July 2020.
8. Geisler WM, Uniyal A, Lee JY, et al. Azithromycin versus Doxycycline for Urogenital Chlamydia trachomatis Infection. N Engl J Med; 373:2512-252. doi: 10.1056/NEJMoa1502599. Accessible via: https://www.nejm.org/doi/full/10.1056/NEJMoa1502599#:~:text=For%20the%20treatment%20of%20chlamydia%20infection%2C%20the%20Centers%20for%20Disease,twice%20daily%20for%207%20days. Published 24 December 2015.
9. Understanding Health Literacy. Centers for Disease Control and Prevention (CDC). Accessible via: https://www.cdc.gov/healthliteracy/learn/Understanding.html. Last updated 24 November 2020.
10. Biggest Threats and Data -Antibiotic / Antimicrobial Resistance (AR / AMR). Centers for Disease Control and Prevention (CDC). https://www.cdc.gov/drugresistance/biggest-threats.html. Last updated 28 October 2020.

David M. Kaylor, PharmD is a PGY1 Pharmacy Resident at UofL Health – UofL Hospital, Louisville, KY

Heart disease. Cancer. Infant and maternal mortality. COVID-19. When we think of those things, we know how devastating they can be to people across people from all walks of life in the United States.

Heart disease has been the leading cause of death in the US for over 80 years, and cancer is slowly trending towards surpassing it. Infant mortality (death) is alarmingly prevalent in the US – the US ranks 33^rd of 36^th amongst developed nations in infant deaths per 1,000 live births, according to the United Health Foundation’s “America’s Health Rankings”. And, of course, we all know the impacts that the COVID-19 pandemic has had everywhere, including on even our own loved ones.

However, what may not be immediately clear to some is the striking statistical differences in health outcomes that exist amongst Black, indigenous, and people of color (BIPOC) living in this country.

As highlighted in Table 1, there are stark contrasts in death associated with major health conditions when comparing BIPOC to white Americans. For example, Black women are over 3 times more likely to die of pregnancy-related complications than white women, and the infant mortality rate is nearly double. As a whole, these numbers have trended down over the years alongside the progression of modern medicine. But, the rate at which they have decreased is much slower than that of white Americans.

Table 1: Mortality Rates of Common Causes of Death in Different Racial/Ethnic Groups

Table source links:
1) https://www.cdc.gov/nchs/hus/spotlight/HeartDiseaseSpotlight_2019_0404.pdf 2) https://seer.cancer.gov/explorer/application.html?site=1&data_type=2&graph_type=2&compareBy=sex&chk_sex_1=1&race=3&age_range=1&advopt_precision=1&advopt_display=1#graphArea 3) https://www.cdc.gov/mmwr/volumes/68/wr/mm6835a3.htm?s_cid=mm6835a3_w

The story goes much further than just mortality rates – risk factors for a myriad of health conditions show the same trend.

For example, Black adults over the age of 20 years are 21% more likely than white adults to have high blood pressure. Hispanic adults are about 9% more likely to develop diabetes and obesity than white adults. BIPOC may be more likely to live in areas with increased exposure to harmful environmental chemicals such as radon, which has been linked to lung cancer. These comorbidities (multiple health conditions) contribute significantly to the risk of pregnancy-related complications, which may be a direct reason for higher maternal and infant mortality amongst Black women.

It is evident through available data that BIPOC are disproportionately affected when it comes to treatable health conditions. Mental health conditions, inflammatory bowel disease, end-stage renal (kidney) & liver disease, strokes, hepatitis B are all examples of more disease states that show higher incidence and/or mortality among BIPOC compared to white Americans.

So, this begs the question: why do we see such shocking disparities in health for BIPOC? To even begin to answer that question, we must first understand history. Medical mistreatment – and the long-term consequences of it – against communities of color, namely Black Americans, has endured over several generations. This is critical in understanding the health disparities we see today.

A Long History of Mistreatment

After a young Black woman named Henrietta Lacks gave birth to her son Joseph at Johns Hopkins Medical Center in 1951, she had a severe hemorrhage (internal bleed). This resulted in a cervical biopsy, amongst other tests, being performed to help determine an underlying cause. A few days later, the results returned with devastating news – cervical cancer. She was treated with radium and told to follow up several days later. During these treatments, samples of cells were taken from her cervix to be studied by cancer researchers. However, no hospital staff asked Henrietta for her permission to collect these cells and experiment with them. Nobody even informed her that her cells were taken at all, and 6 months later she died at the age of 31 years.

These tissue samples eventually led to the discovery of the very first immortalized human cell line (called HeLa cells). They have turned out to be one of the most important cell lines in medical history, reproducing infinitely when placed under certain conditions. Cancer, AIDS, gene mapping, and countless other scientific endeavors have been researched and discovered using HeLa cells.

Although it was not yet common practice or law at the time to obtain informed consent from a patient when collecting tissue samples for research, the story of Henrietta Lacks still serves a crucial purpose. It demonstrated the medical mistreatment of Black Americans, as Ms. Lacks or her family were never told that she had tissue samples taken – or that they led to an incredibly important scientific discovery – until nearly 20 years after she had passed.

Around the same time as Henrietta Lacks, arguably the most infamous biomedical research study in US history – the Tuskegee Syphilis Study – was conducted in Tuskegee, Alabama. It ran from 1932 to 1972 and its purpose was to observe the natural history and progression of untreated syphilis. It was proposed to the 600 enrollees – who were all impoverished Black sharecroppers – as an opportunity to receive free medical care from the federal government. The study was run by the US Public Health Service, the CDC, and The Tuskegee Institute.

Of the men in the study, 399 of the 600 had latent syphilis – however, these men were never actually informed of their diagnosis. Patients were given “treatment” that consisted of placebos such as aspirin or mineral supplements. Additionally, unnecessary and dangerous diagnostic procedures were performed, such as spinal taps, and they were disguised as cures. In addition, the men were told that the study would last 6 months, but it ended up lasting 40 years.  About halfway through the study, penicillin was developed. It became standard of care for syphilis by 1947; however, investigators not only neglected to treat participants with this potentially life-saving drug, but also prevented them from going to other legitimate penicillin treatment centers in the area.

As a result of never receiving treatment, 128 of the men in the study died. As for those who survived, they all suffered through severe complications of the disease. Blindness, brain damage, mental illness, heart disease, and bone deterioration were just some of the effects seen. Additionally, 40 of the men’s spouses contracted the disease and 19 of their children were born with congenital syphilis, a type of syphilis passed from a mother to a baby while in the womb.

In 1972, the details of the study were revealed to the public and it was quickly shut down. The following year, Congress reached settlements with the study’s surviving participants and families. New federal guidelines were created to protect human research subjects. However,, the damage to the trust of Black Americans in the US healthcare system had already been done.

It lingers to this very day.

The stories of Henrietta Lacks and the Tuskegee Experiment serve to illustrate the longstanding medical mistreatment of Black Americans in the US and the resulting distrust and hesitancy to receive care that we still see today. As we seek to understand and address health disparities within communities of color, it is increasingly important to recognize the history that helped to create them.

Health Disparities in the Age of COVID-19

As we now enter year 2 of the global pandemic COVID-19, over 500,000 American lives have been lost. We have seen the damage this disease can do on people, their families, and their livelihoods. And just as we have seen with health conditions such as heart disease and cancer, there are also stark differences in mortality of COVID-19 in communities of color, particularly Black and Hispanic Americans.

2.8 times is the rate at which Black and Hispanic Americans are dying from COVID-19 compared to white Americans. This is an alarming number, and it has drawn a lot of attention in both the medical community and society at large. We have already explored some more general health disparities as well as the history that perpetuated them. However, it is important to circle back to the current global health crisis at hand and analyze the uniquely devastating challenges that it has brought to BIPOC.

Although this is not meant to oversimplify a very complex issue, the reasons for higher COVID-19 mortality in BIPOC can be broken down into 3 main reasons:

1) More comorbidities/risk factors

2) Increased exposure to the virus

• More likely to live in densely populated cities or live with extended family members at home
• Black Americans represent 25% of public transit users
• Approximately 1/3^rd of bus drivers, food service workers, janitors, cashiers, and stockers (“essential employees”) are Black or Hispanic/Latino

3) Barriers to care lead to poor overall relationship between patient and provider

• Black patients often report unfair assumptions made about them (ex: Black patients are 22% less likely to receive adequate pain medications than white patients for the same diagnoses) which perpetuates medical mistreatment and mistrust
• Lack of education or awareness of language barriers (ex: 6 of 10 Spanish-speaking patients report having difficulty communicating important information with a healthcare provider)
• Implicit bias in medicine (most healthcare providers have implicitly positive attitudes towards white patients and negative attitude towards people of color) and lack of adequate training to overcome it

We know the COVID-19 pandemic has ravaged communities across the US and beyond. However, it is critically important to recognize the unique and difficult challenges that communities of color face with this pandemic and how we can move forward as a healthcare system to address them.

A Pharmacist’s Role

An article recently published in the American Medical Association’s Journal of Ethics highlighted the ways in which pharmacists and physicians can collaborate to help ensure health equity in underserved groups such as BIPOC. The article concludes by affirming that pharmacists’ skills in chronic disease state management/prevention, medication management, health and wellness, and patient advocacy should be capitalized on and utilized in a multidisciplinary approach to combat health inequity and disparities.

This is one of many examples of pharmacists taking initiative in the world of health equity, particularly for BIPOC.  Large professional pharmacy organizations such as ASHP and APhA have taken stances on combatting systemic racism, discrimination, implicit bias, and health disparities. This aligns with state and federal government goals, as well as a majority of health systems initiatives.

In all, pharmacists have not only an opportunity to better serve their patients of color, but a duty. It is written in the very oath that pharmacists take upon graduation: “I will consider the welfare of humanity and relief of suffering my primary concerns”.

As more awareness and education spreads on health disparities in communities of color, pharmacists can actively help by engaging in important discussions with peers & learners, supporting initiatives at their institutions in the field of Diversity, Equity, and Inclusion, and working to recognize and combat their own implicit biases. That is what our patients and communities deserve, and pharmacists are up to the task.

Resources to Utilize and Share

ASHP Task Force on Racial Diversity, Equity, and Inclusion

CDC Office of Minority Health & Equity

American Medical Association COVID-19 Health Equity Resources

Robert Wood Johnson Foundation Health Equity Resources  

CDC COVID-19 Racial and Ethnic Health Disparities

American Public Health Association Health Equity Guide

References:

1. United Health Foundation. America’s Health Rankings. 2018 Annual Report. Accessed 2/12/21.
2. Centers for Disease Control and Prevention. CDC Health Disparities & Inequalities Report (CHDIR). Published 2013. Accessed 2/15/21.
3. Centers for American Progress. Health Disparities by Race and Ethnicity. Published 5/7/20. Accessed 2/13/21 at https://www.americanprogress.org/issues/race/reports/2020/05/07/484742/health-disparities-race-ethnicity/.
4. Frakt A. The New York Times. Bad Medicine: The Harm That Comes From Racism. Updated 7/8/20. Accessed 2/12/21 at https://www.nytimes.com/2020/01/13/upshot/bad-medicine-the-harm-that-comes-from-racism.html.
5. Nuriddin A, Mooney G, White AIR. Reckoning with histories of medical racism and violence in the USA. Lancet. 03 Oct 2020;396(10256):949-951. doi: 10.1016/S0140-6736(20)32032-8.
6. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States; Baciu A, Negussie Y, Geller A, et al., editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The State of Health Disparities in the United States. 
7. Ray R. The Brookings Institution. Why are Blacks dying at higher rates from COVID-19? Published 4/9/20. Accessed 2/16/21 at https://www.brookings.edu/blog/fixgov/2020/04/09/why-are-blacks-dying-at-higher-rates-from-covid-19/.
8. Interaction Institute for Social Change, 2016. Equality vs equity. [image] Available at: [Accessed 24 February 2021].

DISCLAIMER: This article is provided as commentary and discussion, not direct medical advice. Before making any medical decision, consult with your medical provider.

In the Northern Hemisphere, the weather is getting warmer, days are getting longer, and more time is collectively being spent outside. Although sun exposure precautions should be considered year round, it is important to be especially mindful of these precautions during warmer months and when more time is being spent outside.

Although proper sun safety has many different components, one key component of sun safety is to wear sunscreen when feasible. 

Many questions can arise after someone inquires about which sunscreen product may be the best. Like all other over-the-counter products, this answer can vary depending on the person. At a minimum, it is important to consider sun protection factor (SPF), broad-spectrum protection levels, water repellant capabilities, product formulations, and active ingredients. 

The AAD recommends choosing a sunscreen product that is SPF 30 or higher, has broad spectrum protection (protects against both UVA and UVB), and is water resistant. However, SPF 15 or higher is also considered acceptable as that is the minimum count recommended by the Centers for Disease Control and Prevention (CDC). 

Oils, lotions, creams, gels, butters, pastes, ointments, and sticks are the sunscreen product formulations that are considered “GRASE” (generally recognized as safe and effective) by the United States Food and Drug Administration (FDA). 

Active ingredient(s) should also be evaluated prior to using a sunscreen product. This article entails a discussion of active ingredients to consider when deciding which sunscreen product to purchase and utilize. 

Alongside the CDC and FDA, the American Academy of Dermatology (AAD) is one of the premier organizations to reference when considering skin health at-large – this includes knowing which sunscreen product(s) to consider. This article discusses sunscreen active ingredients that are currently recommended for use by the AAD and FDA. 

The ingredients detailed below are all considered to be acceptable. However, prior to using any product, it is important to ask your dermatologist, primary care provider, pharmacist, or other healthcare provider about which sunscreen product may be most appropriate for you. 

Zinc Oxide

Zinc oxide is a naturally-occurring mineral that is commonly used in topical sunscreen products and a wide variety of other cosmetics. The FDA regulates the safety and effectiveness of zinc oxide in addition to other ingredients used in sunscreen products.

Considered to be a physical sunscreen, zinc oxide is often the single active ingredient in many sunscreen products. It also can be combined with titanium dioxide, which is mentioned below. Physical sunscreen products are occasionally called sunblock or mineral sunscreen products. 

Zinc oxide is recognized by the FDA as being GRASE. 

According to the AAD, “physical sunscreens work like a shield, sitting on the surface of your skin and deflecting the sun’s rays… opt for this [type of] sunscreen if you have sensitive skin.”

Image 1: Categorizing and Assessing Sunscreen Ingredients

Image courtesy of the EPA

In Image 1, zinc oxide is depicted in the bottom row of the table. Of all the listed sunscreen ingredients, zinc oxide is currently thought to be the most protective active ingredient against both UVA and UVB rays. Titanium dioxide is considered to be the next most protective ingredient against both UVA and UVB rays. 

In terms of strengths, a sunscreen product’s zinc oxide concentration can go up to 25%, according to the FDA. Acceptable zinc oxide concentrations typically range from 5% to 25%. If zinc oxide is combined with titanium dioxide in a product, the zinc oxide percentage is usually much lower than 25%.  If a product contains more than 25% zinc oxide, it should not be used.

All of the ingredients listed in Image 1 will be further discussed below. 

Example zinc oxide products (not all inclusive)

Titanium Dioxide

Titanium dioxide is a naturally-occurring element that can be used as a topical sunscreen. It is also used in many other cosmetic products. The FDA regulates the safety and effectiveness of titanium dioxide in addition to other ingredients used in sunscreens. 

Titanium dioxide, similarly to zinc oxide, is recognized by the FDA as being GRASE. 

Also considered to be a physical sunscreen, titanium dioxide is commonly combined with zinc oxide in many sunscreen products. 

Image 2: Visual Representation of Sunscreen Protection Levels

Image courtesy of Project Sunscreen

Image 2 further drives home the message of Image 1. Zinc oxide is noted to provide the most protection against UVA1, UVA2, and UVB rays, but titanium dioxide also offers helpful protection. 

In terms of strengths, a sunscreen product’s titanium dioxide concentration can go up to 25%, according to the FDA. However, as titanium dioxide is typically used in combination with zinc oxide, this percentage is typically much lower. If a product contains more than 25% titanium dioxide, it should not be used. 

In regard to both zinc oxide and titanium dioxide, physical sunscreen products generally can be used for most skin types, including sensitive skin. After physical sunscreen products are applied, they are active immediately.

Physical sunscreen products typically need to be applied multiple times per day. At a minimum, the CDC recommends reapplying sunscreen after being exposed to the sun for more than two hours and/or after swimming, sweating, or toweling off. However, as many products are on the market, be sure to look at package directions for specific recommendations on how often a particular sunscreen product should be applied. 

Physical sunscreen summary: both zinc oxide and titanium dioxide are go-to active ingredients to consider using. There is typically not a preference between choosing a stand-alone zinc oxide sunscreen product versus choosing a zinc oxide/titanium dioxide combination sunscreen product. They are generally thought to be equally safe and effective. 

Example zinc oxide/titanium dioxide combination products: 

Avobenzone, Ensulizole, Homosalate, Octisalate, Octocrylene, Octinoxate, and Oxybenzone

Considered to be chemical sunscreens rather than physical sunscreens, avobenzone, ensulizole, homosalate, octisalate, octocrylene, octinoxate, and oxybenzone are active ingredients that can be used in combination with one another in many chemical sunscreen products. These active ingredients are commonly used in the United States. 

According to the AAD, “chemical sunscreens work like a sponge, absorbing the sun’s rays… these formulations tend to be easier to rub into the skin without leaving a white residue [compared to physical sunscreens].” 

To understand the difference between chemical and physical sunscreens, reference Image 3 below. 

Image 3: Comparing Chemical and Mineral Sunscreen Ingredients

Image courtesy of Water’s Edge Dermatology

After applying any chemical sunscreen, it is important to wait 15 to 30 minutes prior to exposure to sunlight. As these sunscreens absorb into the skin, there is a small lag time before they start working.

Chemical sunscreens are generally able to be used for most skin types as well, but they are more likely than physical sunscreens to potentially cause skin irritation. Chemical sunscreens are considered to be more water and sweat resistant to physical sunscreens, however, and may be more preferable for people with active lifestyles. 

Regardless of which sunscreen type is chosen, typically only one sunscreen should be applied at a time. A physical sunscreen should not be worn at the same time as a chemical sunscreen. 

Chemical sunscreen products, like physical sunscreen products, typically need to be applied multiple times per day. At a minimum, the CDC generally recommends reapplying sunscreen if someone is exposed to the sun more than two hours and/or after swimming, sweating, or toweling off. However, as many products are on the market, be sure to look at package directions for a specific recommendation on how often a particular sunscreen product should be applied. 

Separately and importantly, there are 12 specific active ingredients in chemical sunscreen products that are still being studied and evaluated by the FDA. The active ingredients still being fully evaluated for potential GRASE status by the FDA are avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, oxybenzone, octocrylene, padimate O, and sulisobenzone. Of these, cinoxate, dioxybenzone, meradimate, padimate O, and sulisobenzone are not commonly used in the United States. 

Nevertheless, chemical sunscreens products are still considered acceptable to use according to the AAD and FDA. But, as of now, the only sunscreen products that are listed as being GRASE are zinc oxide and titanium dioxide. 

In general, chemical sunscreens are an alternative option to physical sunscreens. Although current guidance generally favors the use of physical sunscreen products over chemical sunscreen products, both types can be used. 

Example chemical sunscreen products:

Key Takeaways

Both physical and chemical sunscreen products are available for use in the United States. Although the physical sunscreen active ingredients of zinc oxide and titanium dioxide may be generally favored, chemical sunscreen products are still a viable option to utilize. 

If anything, it’s helpful to also know which sunscreen product types should be avoided. Although the list below is not all-inclusive, it is a helpful list to start with.

• Avoid sunscreen-insect repellent combination products. These products are not considered to be safe and effective.
• Para-aminobenzoic acid (PABA) and trolamine salicylate are not considered to be safe and effective active ingredients for sunscreen products. 
• Oral sunscreen products should not be utilized. Only use topical sunscreens that are applied to the skin.
• Any sunscreens that have a SPF lower than 15-30 should not be used as these products likely will be ineffective. 
• Avoid sunscreens that are labeled “waterproof” or “sweat proof” as these claims cannot be validated. Claims such as “water resistant” are acceptable. 
• Any sunscreen products that are expired should be discarded. 

With all of this in mind, regulation advancements are forthcoming for the world of sunscreen products. Read on for a summary of a proposed FDA regulation to help make all sunscreen products even more safe and effective. 

Prior to using any product, it is important to ask your dermatologist, primary care provider, pharmacist, or other healthcare provider about which sunscreen product may be appropriate for you – regardless of type.

References:

The opioid epidemic is one of the most significant public health crises in the United States, affecting millions of individuals and communities across the nation. In 2023, there were an estimated 74,000 deaths from synthetic opioids with fentanyl being the primary agent. Over the past few decades, the widespread misuse and abuse of prescription pain medications, heroin, and synthetic opioids like fentanyl have led to a dramatic increase in overdose deaths, addiction, and related health problems. 

This crisis has strained healthcare systems, law enforcement agencies, and social services, highlighting the urgent need for comprehensive and effective solutions to address the complex issues associated with opioid addiction. Can a new pain medicine be the key to addressing pain management and the opioid epidemic? 

VX-548: A Potential Breakthrough in Pain Management

VX-548, also known as suzetrigine, is an investigational drug being developed by Vertex Pharmaceuticals, designed to provide relief from moderate-to-severe acute pain. Suzetrigine may offer a potential alternative to treating pain than traditional opioids.

How does it work? 

Suzetrigine is a selective sodium channel blocker that specifically inhibits NaV18. This particular channel is found in the peripheral nerves. The mechanism behind suzetrigine is unique due to the fact that it does not bind in the same way as opioids and therefore does not exert the same side effects that are widely experienced such as drowsiness and slow breathing. Furthermore, since it is considered a non-opioid analgesic, it will not contain the same risk of addiction as regular opioid medications. 

Source: Access Health International

What is the potential impact? 

So far phase-2 clinical trials have shown promising results with reducing pain and tolerability. However, it is still undergoing development and has not been approved by the FDA but their submission for New Drug Application (NDA) has been accepted. They have also been granted FDA Fast Track and Breakthrough therapy.  

If approved, suzetrigine can offer a groundbreaking alternative to opioids, especially those at risk for addiction or overdose.

Pharmacists’ Role in Combating Opioid Addiction

While new drug developments for treating both chronic and acute pain without opioids are still on the horizon, pharmacists are uniquely positioned to play a pivotal role in combating the opioid addiction crisis. There are some key strategies that can be implemented in practice.

Patient Education and Counseling

Educate patients about the proper use, storage of opioid drugs. Screen patients for risk factors of addiction and provide counseling accordingly. Furthermore, discuss non-opioid pain management options, such as physical therapy and over-the counter analgesics.

Prescription monitoring and flagging

 It is imperative to find ways to monitor prescription patterns to identify signs of abuse and diversion. If you notice any strangeness occurring, report suspicious activity to the appropriate authorities or patient’s healthcare provider.

Naloxone distribution

Stocking and dispensing naloxone can help prevent overdose. In addition, it is imperative to train patients and their families on administering naloxone.

Medication Management Therapy (MTM) Services

MTMs might not be ideal depending on the setting of your pharmacy but can provide enormous benefits in being able to identify issues in patients’ pain medication regimen. This can also help assist patients off of opioids when appropriate.

Collaborative with Healthcare Providers

Work collaboratively with physicians and other healthcare providers to develop comprehensive pain management plans. Refer patients to addiction treatment programs or mental health services as needed.

Community Outreach

Participate in community outreach programs to raise awareness about the opioid crisis and its consequences. Promote harm reduction strategies, such as needle exchange programs, to reduce the risks associated with opioid use.

Pharmacists can play a direct role in helping to combat the opioid and overall substance use epidemic in the United States. In addition to finding alternative ways to treat pain, it is important to also understand the role that fentanyl has played as well. Knowing these vital pieces will help with the treatment of substance abuse and aid in overcoming the opioid crisis in the country.

References:

1. Centers for Disease Control and Prevention. (2024, May 15). U.S. overdose deaths decrease in 2023, first time since 2018. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2024/20240515.htm#:~:text=The%20new%20data%20show%20overdose,psychostimulants%20(like%20methamphetamine)%20increased 
2. Jones, J., Correll, D. J., Lechner, S. M., Jazic, I., Miao, X., Shaw, D., Simard, C., Osteen, J. D., Hare, B., Beaton, A., Bertoch, T., Buvanendran, A., Habib, A. S., Pizzi, L. J., Pollak, R. A., Weiner, S. G., Bozic, C., Negulescu, P., & White, P. F. (2023). Selective inhibition of na            v            1.8 with VX-548 for acute pain. New England Journal of Medicine, 389(5), 393–405. https://doi.org/10.1056/nejmoa2209870  
3. Vertex announces FDA acceptance of New Drug Application for suzetrigine for the treatment of moderate-to-severe acute pain. Vertex Pharmaceuticals. (2024, July 30). https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-acceptance-new-drug-application-suzetrigine  
4. Bach, P., & Hartung, D. (2019, September 2). Leveraging the role of Community Pharmacists in the prevention, surveillance, and treatment of Opioid Use Disorders – Addiction Science & Clinical Practice. BioMed Central. https://ascpjournal.biomedcentral.com/articles/10.1186/s13722-019-0158-0#:~:text=Community%20pharmacists%20are%20ideally%20positioned,reduce%20the%20harms%20associated%20with  

Disclaimer added after article publication: Check with a healthcare professional before deciding if a probiotic may be appropriate for you. A recent, updated guidance made by the American Gastroenterological Association (AGA) recommends against the use of probiotics for most digestive conditions.

To potentially select a probiotic supplement, it is useful to first know the semantics differentiating probiotics, prebiotics, and synbiotics. 

Probiotics are living microorganisms that provide the intestines with bacteria that help an individual gain a positive health benefit. In order to function optimally, a person’s intestines need certain naturally-occurring bacteria to be present to aid functions like digestion, gut motility, chemical regulation, immune system function, drug metabolism, acid-base regulation, protective effects from certain harmful substances, etc. Probiotic foods, drinks, and supplements can help to provide these important bacteria if they are absent or deficient in a person.

In contrast, a prebiotic is a dietary substance that alters the composition or activity of the bacteria in the gut. However, prebiotics are not microorganisms themselves. Utilizing an analogy to gardening, prebiotics can be thought of as a soil fertilizer whereas probiotics can be thought of as seeds. 

A synbiotic is simply a combination product of a probiotic and prebiotic. It is acceptable to combine taking probiotics and prebiotics, but it is not typically necessary to take multiple probiotic supplements or prebiotics unless recommended by a pharmacist or physician. 

This article focuses on probiotics specifically. Details about prebiotics and synbiotics will be discussed in future Pharmacist Consult articles. Described below are five thoughts to think through prior to potentially purchasing a probiotic supplement online or at a pharmacy.

1. Consider Your Options

Probiotics are contained within a variety of everyday foods, drinks, and medicinal supplements. Typically, for more minor needs, individuals can supplement their gut bacteria by consuming foods or drinks that have a high probiotic content. For individuals who may require even more probiotic supplementation, it may be warranted to obtain a designated probiotic supplement. 

Individuals that need probiotic supplements typically have needs that extend beyond the scope of supplementation from foods or drinks alone. To determine if someone may be a candidate for a probiotic supplement itself (versus consuming certain foods or drinks), it is best to discuss with a local pharmacist or physician. A pharmacist or physician can help to determine what an individual’s specific needs are from a probiotic source.

For example, individuals that have diarrhea, ongoing antibiotic usage, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or are at high risk of hepatic encephalopathy commonly may be given a recommendation to take a probiotic supplement. Of note, probiotic supplements are not considered to be effective for acute pancreatitis or Crohn’s disease.

NOTE: For a thorough chart of different gastrointestinal conditions that may benefit from probiotic use, reference this chart provided by the American Academy of Family Physicians (AAFP).

2. Look Beyond the Brand Name

Similarly to how someone’s pain might respond better to Tylenol (acetaminophen) than Advil (ibuprofen), depending on the reason for a person taking a probiotic, one probiotic strain may be more appropriate than another strain. 

In order to choose the most appropriate probiotic for an individual, it is important to look at the back of a supplement’s packaging to see what probiotic strain specifically is contained inside of the product. The brand name of a probiotic does not usually indicate what strain of probiotic is contained inside of the product unless it is specifically known by the consumer.

Probiotic strain names consist of two to three words – genus, species, and sometimes a subspecies. For example, consider the name Bifidobacterium longum infantis. For this probiotic, the genus is Bifidobacterium, the species is longum, and the subspecies is infantis. All three of these words together describe the strain of probiotic. This is the strain inside of Align® probiotic capsules.

In the image above, the back of this box of Align® demonstrates the specific probiotic strain contained within each capsule. Although the full genus, species and subspecies isn’t listed, the number next to Bifidobacterium also helps to demonstrate the specific bacteria strain.

Table 1. Common Probiotic Examples

See Table 2 (below) for a more detailed breakdown of probiotic names and usages. 

3. Considering a Probiotic Supplement – Know the ‘Why’ 

Probiotics contain different strains of bacteria, and different medical studies have linked varying strains to different purposes. So, depending on a person’s specific need for a probiotic, it is important to choose a probiotic strain that corresponds with the medical need for supplementation. 

For example, if an individual is at risk of developing antibiotic-associated diarrhea after taking a certain antibiotic for a prolonged period of time, they may opt to take Bio-K, Culturelle, or Florastor (see Table 2). These three probiotics have evidence that display effectiveness for this condition.

Table 2. Probiotic Bacteria with High Evidence for Use (Not An All Inclusive List)

Note: For a more thorough chart of different probiotic strains that may be effective, reference this chart provided by the American Academy of Family Physicians (AAFP).

4. Helping To Optimize Your Dose

Dosing units for probiotics are different from most other medicines. Many medicines quantify their strengths in terms of grams (g) or milligrams (mg). However, probiotic doses are represented in terms of colony-forming units (CFUs). For example, one probiotic supplement capsule may represent 5 billion CFUs per capsule.

A probiotic’s dose effectiveness hinders upon the specific probiotic strain in combination with a person’s condition they are taking the probiotic for.

Note: for a specific list of recommended doses, please reference the fourth column of Table 2 above. Especially as the above table is not all inclusive, always confirm with a local pharmacist or physician that a dose of a probiotic is appropriate.

The dose of a probiotic supplement is typically described on the “Supplement Facts” section on the back of a product’s packaging. It is recommended to always follow the described dose and directions for use as listed on every product’s specific packing. 

5. Check In Consistently With a Pharmacist or Physician Throughout Probiotic Treatment

Simply put, digestive health needs change over time and they require ongoing maintenance and observation. At a minimum, checking in with a pharmacist or physician at least every 3 months is important to ensure that a probiotic supplement is still effective.

Similarly, pharmacists and physicians can also help to determine if a probiotic supplement may still be necessary to take if it is thought that an individual’s digestive health no longer requires the use of a probiotic supplement. 

Pharmacists are known as the most accessible healthcare provider. A quick, free phone call to a pharmacist is an easy yet important step to ensure that health outcomes are maximized over time.

References:

1. Guarner F, Sanders ME, Eliakim R, et al. World Gastroenterology Organisation Global Guidelines. Prebiotics and Probiotics – 2017. WGO Global Guideline.
2. Hungin AP, Mulligan C, Pot B, et al. The European Society for Primary Care Gastroenterology (ESPCG). Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice – an evidence-based international guide. Aliment Pharmacol Ther 2013; 38(8):864–86
3. Wilkins T, Sequoia J, Dorn WJB. Probiotics for Gastrointestinal Conditions: A Summary of the Evidence. Am Fam Physician. 2017 Aug 1;96(3): 170-178.

Probiotics have become increasingly popular with more and more patients seeking these out for various health concerns. Pharmacists, being the most accessible healthcare professional, are frequently asked about probiotic supplements. From understanding the different strains, the type of products, side effects and which conditions it can help, knowing the answers to these common probiotic questions might be an important factor for patients seeking to optimize their health. 

However, just like other supplements, it is also crucial to know who may benefit from these and who may not as they can pose significant health concerns for certain populations. This guide aims to equip you with the knowledge and tools to confidently navigate probiotic recommendations and effectively counsel patients on these supplements. 

What are probiotics? 

Probiotics are live bacteria and yeasts that work together (or synergistically) with your digestive system and organs associated with it. We usually think of bacteria and yeasts as germs that cause diseases. The human body is filled with trillions of microorganisms. Probiotics are often called “good” or “helpful” bacteria because they help keep your gut healthy.

These microscopic organisms live in your gut, also known as your gastrointestinal (GI) tract, and play an important role in digestion, nutrient absorption, and even immune function. A balanced gut microbiome, the community of microorganisms in your gut, is essential for overall health. Probiotics can help restore the balance of good and bad bacteria in your gut, which is often disrupted by illness, certain medications, and most importantly, the diet. 

How can you get probiotics? 

Probiotics can be obtained mainly in two major ways: either through certain foods or through supplements. 

Foods that contain probiotics: 

• Yogurt. Yogurt in general has many health benefits, but what makes them special is the fact that they contain live microorganisms that are good for the gut. And may be beneficial for those lactose intolerant since the bacteria can help break down the lactose. However, it is important to tell patients to read the food labels to ensure that there are live bacteria and to try to stay away from products with high sugar and fat content. Fat free Greek yogurt, with nut butter and fruit can help satisfy a sweet tooth.  
• Kefir. Kefir is a fermented probiotic milk drink that contains several major bacteria and yeast strains that are supportive to the gut and is actually a better source than yogurt. 
• Sauerkraut. Sauerkraut are finely shredded cabbage that has been fermented by lactic acid or bacteria. It has a salty, sour taste but it does contain fiber along with the vitamins C and K, as well as other important vitamins and minerals. Best way to eat sauerkraut is to top it with sausages, like a hotdog, or eat it as a side dish. 
• Temph. Tempeh is a fermented soybean product that forms a firm patty. It also contains a numerous amount of protein which can be used as a meat substitute for those that are vegetarian or vegan. 
• Kimchi. Kimchi is a fermented dish originating from Korea. It is mostly made from cabbage but it can be made from other vegetables as well. It is then flavored with red chili flakes, garlic, ginger, scallion and salt. 
• Miso. Miso is a Japanese seasoning which is made from fermented soybeans with salt and fungus (or koji). It is also a good source of protein and fiber. Add miso in water with seaweed and tofu for a nutritious and delicious soup. 
• Kombucha. Kombucha is a fermented black or green tea that contains a good amount of bacteria and yeast. 
• Pickles. Pickles are cucumbers that have been preserved in salt and water then are left to ferment. These are a great source of probiotics. It is important to note that the ones made with vinegar do not have live bacteria and therefore do not have probiotic effects. 
• Traditional buttermilk. Traditional buttermilk is leftover liquid from making butter and contains some probiotics. But before your patients rush to the grocery store to buy the buttermilk used to cook or fry their foods, they should know that cultured buttermilk, that is mainly used for this purpose, does not contain any probiotic effects. 
• Natto. Natto is a fermented soybean product similar to tempeh and miso which contains a bacterial strain. It is also rich in protein and Vitamin K2.

Supplements:

Probiotics are also available in supplement form as capsules, tablets, powders, and even chewable gummies. These supplements contain concentrated amounts of specific probiotic strains.

Probiotics and health conditions

Probiotics have been studied for a wide range of health conditions. While research is ongoing for some, there are others that have better evidence. 

Although probiotics may seem like a better treatment option than conventional medicine for certain conditions and diseases, there needs to be more conclusive results in order to fully support the idea as a mainstream treatment.  

Who should not use Probiotics?

While probiotics are typically safe for most people, there are certain circumstances where they might not be suitable for patients. 

• Individuals with compromised immune system:
  • People undergoing chemotherapy or radiation
  • People that have HIV/AIDS
  • Individuals with severe burns or other critical illnesses
• Infants with short bowel syndrome
• People with central venous catheters
• Premature infants 
• Pregnant and breastfeeding patients 
• Allergies 

What are the side effects of probiotics? 

Though probiotics are generally well-tolerated in most individuals, others might experience mild side effects, especially if they are just starting to take them regularly. Gas, bloating and abdominal discomfort are the common effects that may occur, but they will eventually go away after the first few days of use. 

It is important to note that if these effects are persistent or become severe, patients should be advised to stop taking them and consult with their doctor. 

What are the common probiotic strains? 

Probiotics can be complex, with numerous strains offering various benefits. There are a few strains that are commonly found in foods and supplements. 

• Lactobacillus acidophilus: Often found in yogurt, it supports digestive health.  
• Lactobacillus casei: Can help with digestive issues and immune function.  
• Lactobacillus rhamnosus: Known for its potential to support gut, immune function and vaginal health.  
• Lactobacillus plantarum: May help with digestive issues and skin health.  

Lactobacillus is the most commonly used strain and are often found in many supplements. 

• Bifidobacterium animalis: Commonly found in dairy products, it supports digestive health.  
• Bifidobacterium longum: May help with digestive issues and immune function.  
• Bifidobacterium bifidum: Can contribute to gut health and immune support.  

• Saccharomyces boulardii: A type of yeast often used to treat diarrhea.  
• Bacillus subtilis: A spore-forming bacteria that can survive stomach acid.

Top 11 Tips to Give Patients

Overall, probiotics can be a great addition for patients wanting to be the healthiest version of themselves. It can be further useful when combined with a healthy diet, regular exercise and high quality sleep. Here are some tips to discuss with patients when helping them to find the right probiotics for their goals. 

1. Consult Your Healthcare Provider: Always discuss probiotic use with your doctor, especially if you have underlying health conditions or are taking medications.
2. Identify Your Goal: Determine what you hope to achieve with probiotics (e.g., digestive health, immune support, skin conditions).
3. Understand Probiotic Strains: Different strains have different benefits. Research specific strains linked to your desired outcome.
4. Look for Colony-Forming Units (CFUs): This indicates the number of live bacteria in the product. Higher CFUs generally mean more potency.
5. Prioritize Quality: Choose reputable brands that adhere to quality standards and testing. Here is a great source for finding quality supplements. 
6. Consider Storage: Many probiotics require refrigeration to maintain potency. Check the label for storage instructions.
7. Pay Attention to Expiration Dates: Ensure the product is fresh and effective.
8. Start Low, Go Slow: Begin with a lower dose and gradually increase if needed.
9. Be Patient: It may take several weeks to experience the full benefits of probiotics.
10. Diversify Your Gut Flora: Incorporate probiotic-rich foods like yogurt, kefir, and sauerkraut into your diet.
11. Don’t forget prebiotics: Prebiotics are the fuel needed for your bacteria to flourish. They are fibers that our bodies cannot digest. Common foods that contain prebiotics are whole grains, legumes, fruits (i.e. bananas, apples, berries), and vegetables.

In addition to discussing with patients about their probiotics, it is important to try to have a basic understanding of these supplements and how they can be used. To dive into a deeper knowledge, refer back to one of our past articles on choosing probiotic supplements and also consider utilizing this probiotic chart. Various resources can aid in helping your patients make the best decisions in their overall health. 

Resources: 

1. U.S. Department of Health and Human Services. (n.d.). Probiotics: What you need to know. National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/health/probiotics-what-you-need-to-know  
2. Amara, A. A., & Shibl, A. (2015). Role of probiotics in health improvement, infection control and disease treatment and management. Saudi Pharmaceutical Journal, 23(2), 107–114. https://doi.org/10.1016/j.jsps.2013.07.001 
3. U.S. Department of Health and Human Services. (n.d.). Probiotics: What you need to know. National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/health/probiotics-what-you-need-to-know  
4. Person. (2022, January 31). Do probiotics reduce the risk of Clostridioides difficile colitis?. AAFP. https://www.aafp.org/pubs/afp/afp-community-blog/entry/do-probiotics-reduce-the-risk-of-clostridioides-difficile-colitis.html 
5. Yang, Y., Olah, P., Radai, Z., Maia, G., Salava, A., Salo, V., Barker, J., Lauerma, A., Andersson, B., Homey, B., Fyhrquist, N., & Alenius, H. (2024). Exploratory multi-omics analysis reveals host-microbe interactions associated with disease severity in psoriatic skin. eBioMedicine, 105, 105222. https://doi.org/10.1016/j.ebiom.2024.105222  
6. Satish Kumar, L., Pugalenthi, L. S., Ahmad, M., Reddy, S., Barkhane, Z., & Elmadi, J. (2022). Probiotics in Irritable bowel syndrome: A review of their therapeutic role. Cureus. https://doi.org/10.7759/cureus.24240  
7. Wiciński, M., Gębalski, J., Gołębiewski, J., & Malinowski, B. (2020). Probiotics for the treatment of overweight and obesity in humans—a review of clinical trials. Microorganisms, 8(8), 1148. https://doi.org/10.3390/microorganisms8081148  
8. Madabushi, J. S., Khurana, P., Gupta, N., & Gupta, M. (2023). Gut biome and mental health: Do probiotics work? Cureus. https://doi.org/10.7759/cureus.40293  
9. Chatfield, S., & Chatfield, S. (2024, January 23). The 10 most common types of probiotics (and their benefits). Omni. https://omnibioticlife.com/blogs/blog/types-of-probiotics#:~:text=The%20most%20common%20types%20of,they%20act%20in%20the%20body. 
10.  Lactobacillus acidophilus. Mount Sinai Health System. (n.d.). https://www.mountsinai.org/health-library/supplement/lactobacillus-acidophilus#:~:text=The%20primary%20dietary%20sources%20of,cultures%2C%20miso%2C%20and%20tempeh.  
11. GoodRx. (n.d.). 8 tips for choosing safe & high-quality supplements. GoodRx. https://www.goodrx.com/well-being/supplements-herbs/how-to-know-if-youre-buying-a-good-supplement-brand  
12. Probiotic chart. (n.d.). https://usprobioticguide.com/?utm_source=intro_pg&utm_medium=civ&utm_campaign=USA_CHART

Heart Disease. A condition often associated with aging is now becoming a concern in younger populations. Heart disease has become the leading cause of death in people living in the United States as one person dies every 33 seconds from cardiovascular issues. However, while older adults remain at higher risk, alarming trends are showing rising cases of heart disease among the young. 

Heart Disease Facts 

It is crucial to understand the overall importance of cardiovascular disease in general and its effects on the country. 

According the CDC: 

• 1 out 5 people (695,000) died from heart disease in 2021.
• Between 2018 to 2019 heart disease costs the United States about $239.9 billion each year which includes health care services and medicines. 
• Coronary artery disease is the most common type of heart disease as 1 in 20 people have this condition. It has also killed over 375,000 people in 2021. 
• Over 800,000 people in the U.S. have heart attacks, with 1 of 5 being considered “silent” where the person is not aware of it. 

Causes of Heart Disease in Young People 

There are a variety of risk factors that can cause heart disease in young people. 

In general, people with diabetes are twice as likely to develop heart disease than people who do not have diabetes. This has increased substantially in those ages 20 to 44 years from 2009 to 2020. Having high blood glucose damages blood vessels resulting in more fat buildup in the arteries thus causing atherosclerosis.  

Obesity has become another huge factor in young people developing heart disease (from 32.7% of those from 20-44 in 2009 to 40.9% in 2020). Carrying extra weight puts more strain on the heart to have to work harder and puts more people at a significant risk for heart disease.  Furthermore it leads to other chronic conditions such as hypertension, high cholesterol and diabetes. 

Smoking cigarettes is one of the top risk factors of developing heart disease. In fact, the risk of heart attacks doubles in those that smoke one or more packs of cigarettes a day compared to nonsmokers. 

However, cigarettes are not the only things that put you at risk of heart attacks, E-cigarettes or vapes (which are used more in young adults and in 1 in 20 Americans), can also put those in risk of developing a heart attack. The nicotine content accelerates the heart rate and can raise blood pressure as well leading to heart disease. In addition, some vape juices contain Vitamin E acetate, an oily chemical which helps to dilute or thicken vape liquids, that can cause lung related illnesses. 

Illicit drugs such as cocaine or methamphetamine can raise your heart rate and increase your chances of developing a heart attack. Although marijuana is still being researched, daily use may raise the risk of developing heart failure, stroke or heart attacks. 

Between increasing demands of work, events happening both nationally and globally, and other stressors of life, it is no coincidence that stress has a huge impact on the heart. Chronic stress and anxiety elevates blood pressure further contributing to heart disease. It also increases inflammation throughout the body which leads to other chronic conditions such as certain skin, joint and nerve diseases. 

Although not talked about often, family history plays a big role in developing heart disease. About one-third to one-half chances of developing heart conditions, specifically coronary heart disease, is rooted in the genes. 

In fact, in 2022, a large-scale genome study of heart disease used a quarter million cases from a variety of participants that were white, Black or Hispanic. This research showed the region of DNA where the “heart attack” region was located. However, further research to determine its effects on various populations is needed to determine a solid conclusion of the genes found. 

Poor dietary habits, a sedentary lifestyle, excessive alcohol use can also contribute to early onset of heart disease. 

Complications that often results from heart disease, especially in young people tend to be premature deaths (as death is the first indication of heart problems); reduced quality of life (can limit ability to enjoy experiences and daily life); and financial burden that can take a toll due to medical expenses, lifestyle adjustments and if severe enough, lacking the ability to work. 

Why are Healthy Young People getting heart disease? 

Sometimes it might be easy to see a young person that is overweight with high blood pressure and diabetes and not be surprised if they develop heart disease. But when it occurs suddenly in a young person who is seemingly healthy, it often leaves a lot of people stunned, especially since it happens without warning. 

Sudden cardiac death used to occur mainly in older adults, but these days it is becoming increasingly seen in young adults especially those who are athletes. It is estimated that 1 in 50,000 to 1 in 80,000 young athletes die of sudden cardiac death each year. This is mainly seen the most in black male athletes. 

There are a few heart conditions that can contribute to death in this population. 

• Thickened heart muscle (hypertrophic cardiomyopathy)
• Heart rhythm disorders: QT prolongation is a common one that can cause sudden heart death. 
• Blunt chest injury or trauma: Sometimes a hard hit to the chest causes sudden cardiac death which can change the signaling of the heart. 
• Congenital heart defect (CHDs): These are heart structure defects that are present at birth. Some can be mild and others can be severe (or critical). Critical CHDs occur in 1 in 4 babies with surgery being needed within the first year of their life. 

What are some prevention strategies? 

Although heart disease has been occurring suddenly in young people without warning, there can be preventative measures that can be taken to minimize the risks of serious complications. 

Encouraging a balanced diet rich in vegetables, fruits, lean proteins and healthy fats along with physical activity can help reduce the risk of heart disease. 

Monitoring blood pressure, blood glucose, cholesterol levels and other risks factors that might be associated with heart disease is an important approach to preventing cardiac and other chronic conditions. 

Steering clear of smoking, excessive alcohol consumption and illicit drug use is crucial for improving overall health. 

Implementing stress reduction techniques such as mindfulness, meditation and regular exercise can help lower the risk of heart disease. 

How can pharmacists be more involved? 

There is no doubt that pharmacists are one of the most trusted and easily accessible healthcare professionals. We play a crucial role in the medical system and can be involved in the care of young people. 

Providing medication counseling on prescriptions and overall health education are important parts that can help patients understand their conditions and adhere to any medications they are taking. This leads to greater prevention of chronic conditions from forming or worsening over time.

Giving over-the-counter (OTC) medication recommendations that are safe and effective for these patients is also another service that can be provided in order to avoid potential drug interactions and give the best product advice for their current condition. We can also educate young people about risks associated with drug and alcohol use and provide resources for those that might be struggling. 

Collaborative care is also a fundamental part of our profession as we can work together with other allied healthcare professionals to ensure coordinated and comprehensive care for young patients. This can involve medication therapy management (MTM), medication reconciliation, and follow up for optimizing treatment outcomes. Also another care we can provide as pharmacists can be conduct healthcare screenings that involves monitoring blood pressure, cholesterol and blood glucose.  

Takeaway 

Young patients might appear healthy on the surface, but these individuals can develop heart disease due to a combination of genetic predisposition, unhealthy life choices, underlying health conditions and other risk factors. It’s essential for young people to prioritize heart health by implementing regular exercise, a balanced diet, stress management and a healthy lifestyle. 

Patients should also try to reduce their risks by knowing their birth and family history, if possible, and frequently obtaining checkups and screenings for heart disease. Utilizing pharmacists can also help them to manage any medications they are taking and allow them to get recommendations that will best support their overall health. 

Heart disease in young people may not always be known or may come without warning, but there are approaches that can be taken now to prevent further cardiac damage and helping to reduce the risks of other chronic conditions can help them live a long, fulfilled life. 

1. Centers for Disease Control and Prevention. (2023, May 15). Heart disease facts. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/facts.htm
2.  U.S. Department of Health and Human Services. (n.d.). Diabetes, heart disease, & stroke – NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/heart-disease-stroke 
3. Aggarwal, R., Yeh, R. W., Joynt Maddox, K. E., & Wadhera, R. K. (2023). Cardiovascular risk factor prevalence, treatment, and control in US adults aged 20 to 44 years, 2009 to March 2020. JAMA, 329(11), 899. https://doi.org/10.1001/jama.2023.2307 
4. ScienceDaily. (2019, March 7). E-cigarettes linked to heart attacks, coronary artery disease and depression. ScienceDaily. https://www.sciencedaily.com/releases/2019/03/190307103111.htm 
5. Boudi, F. B., Patel, S., Boudi, A., & Chan, C. (2019). Vitamin E acetate as a plausible cause of acute vaping-related illness. Cureus. https://doi.org/10.7759/cureus.6350 
6. Marijuana use linked with increased risk of heart attack, heart failure. American Heart Association. (n.d.). https://newsroom.heart.org/news/marijuana-use-linked-with-increased-risk-of-heart-attack-heart-failure#:~:text=DALLAS%2C%20Nov.%206%2C%202023,at%20the%20American%20Heart%20Association%27s 
7. Genes involved in heart disease are similar across all populations, VA study finds. (2022, August 3). https://www.research.va.gov/currents/0822-Genes-involved-in-heart-disease-are-similar-across-all-populations-VA-study-finds.cfm#:~:text=The%20genes%20involved%20in%20coronary,are%20rooted%20in%20their%20genes 
8.  Liu, B., & Quertermous, T. (2018). Genome-wide association studies for coronary artery disease risk. Science Trends. https://doi.org/10.31988/scitrends.40870 

https://www.nhlbi.nih.gov/news/2023/researchers-explore-high-rate-sudden-cardiac-arrest-black-male-athletes