In January 2021, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2020. This report provides a summary of a number of approvals and highlights the novel therapies approved in 2020, continuing the generally upward trend in approval volume seen over the past decade, despite the impact of coronavirus disease 2019 (COVID-19). Compared to 2018 and 2019, in which CDER approved 59 and 48 new drugs, respectively, 53 novel agents were approved in 2020. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or biosimilar approvals. Once again, the number of approvals exceeded the average of 41 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

Despite the ongoing pandemic the FDA continued their strategic initiatives to expedite the safe review of treatments in 2020. With the unprecedented challenges incurred in 2020, the FDA acknowledged that maintaining their commitment to bringing forth innovative therapies was difficult. Remarkably, the numbers reported by the FDA do not include the several emergency use authorizations (EUAs) issued by the FDA for COVID-19.

Last year, all 53 novel drug approvals again met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2020, 40% were considered first-in-class, and 58% were approved for rare diseases (Orphan Drugs), the latter of which increased from 44% in 2019. Priority Review was granted to 57% of novel drugs, 23% received Accelerated Approval, 42% were designated as Breakthrough Therapy (up from 27% in 2019), and 32% garnered Fast Track designation. Overall, 68% of all drug approvals in 2020 used expedited development and review methods. In addition, 92% were approved in the first review cycle, and 75% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2020 is illustrated in Figure 2, with agents within the oncology spectrum representing over one-third of 2020’s novel approvals.

The notable 2020 approvals encompassed new advances for the treatment of infectious diseases, including a new medication class for the treatment of human immunodeficiency virus-1 (HIV-1). Garnering perhaps the most attention, the FDA also approved the first medication for hospitalized patients with COVID-19. Unique infectious diseases in the US also received attention, with a new drug for malaria, two new options for the Ebola virus, and a new treatment for Chagas disease approved in 2020. In the neurology arena, there were multiple approvals of agents for more common conditions, such as migraine or Parkinson’s disease. Moreover, there were significant advances for rare neurological conditions, including the first oral agent for spinal muscular atrophy and new treatments for rare seizure disorders. In addition, two immunological agents were approved for the treatment of neuromyelitis optica spectrum disorder. Additional treatment options emerged for several autoimmune conditions in 2020 as well. Not surprisingly, numerous advances were made within the oncology umbrella, including both novel approvals and new or expanded indications for several existing agents. With over half of the novel approvals being classified as Orphan Drugs, in 2020, the FDA has fortified their dedication to providing innovative and often targeted treatment options for all individuals.

Technological and scientific advancements have dramatically altered the treatment landscape in several disease states. These include orphan diseases and conditions that previously had no disease-modifying treatment options. These innovative therapies have also come with unprecedented costs, with some agents introduced at a price exceeding one million dollars for a single patient. Value-based purchasing arrangements (VBPs) have attempted to manage the initial cost of these agents. In a VBP, which is sometimes referred to as an outcome-based arrangement, the ultimate price that is paid for the drug is dependent on the clinical outcome. In addition to a plan’s traditional utilization management initiatives to maintain sustainability, this strategy aims to hold pharmaceutical manufacturers responsible for the result of their product. This is similar to other healthcare environments, such as when readmissions impact hospital reimbursement. Under VBPs, a pharmaceutical manufacturer would issue a reimbursement if their product failed to produce the desired clinical outcome. In addition, this strategy incentivizes the development of unique therapies that are more likely to have a clinically significant impact. Novel medications that improve outcomes would provide a greater healthcare value and could be priced higher in the market. Currently, volume is a large driver of cost, with discounts from pharmaceutical manufacturers often tied to the number of units dispensed. This is less helpful for niche-area pharmaceuticals and genuinely innovative treatments used for uncommon conditions.

Practical considerations of VBPs, such as a higher administrative burden (e.g., paperwork, electronic database access, automated retrieval of data), limit their application to all products. Since it can be expensive to measure outcomes in order to assess the worth of a product to an individual patient or plan, VBP concepts are most commonly applied only to the costliest medications. For instance, VBPs can have a significant impact on the pricing of agents like gene therapy or select oncology agents. Some of these agents can have a large clinical impact on disease progression, survival, or quality of life, but a drug may not have the same results in all patients. However, value-based or outcome-based pricing may provide an increased incentive to payers by decreasing their initial risk and providing more sustainable treatment coverage.

While there has been an increase in the use of VBPs by states, manufacturers, and other payers in order to control drug spending and tie patient outcomes to cost, uncertainty remains in developing novel VBPs. The Medicaid Drug Rebate Program (MDRP) created by Congress under the Omnibus Budget Reconciliation Act of 1990 ensures that Medicaid receives the lowest net price for a single source drug or innovator multiple source drug during the rebate period charged to any payer. Simply put, pricing net of all discounts, must be reported to Medicaid, and the best price would have to be offered to Medicaid as well. It is critical that Medicaid programs continue to receive the lowest price available for a single source drug or innovator multiple source drug.

On June 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that is aimed at promoting VBP flexibility for a variety of payers, including Medicaid, with a goal of maintaining a best price for Medicaid. CMS notes that best price creates challenges related to the availability of VBP arrangements. For example, under existing best price rules, if an individual fails to achieve the specified clinical outcome under the VBP arrangement, the drug manufacturer may be required to provide a discount or otherwise may not be entitled to payment for that patient. Thus, the best price of that drug for purposes of the MDRP could become zero. This possibility has stunted the development and proliferation of VBPs. This new proposal from CMS, which includes other regulatory revisions as well (e.g., minimum standards for Drug Utilization Review [DUR] programs), could ultimately lower healthcare costs and potentially limit spending on treatments with limited value over time.

The ultimate goal of a VBP is for all parties to have a vested interest in the outcomes of drug therapy and to share the risk related to healthcare costs. Specifically, it calls on manufacturers to have more “skin in the game.” Moreover, the change to the Medicaid market could have potential savings applicable to a variety of market segments, impacting all Americans. Regardless of the final outcome or any changes made to the current draft prior to its possible rollout, the proposal demonstrates readiness from CMS to pivot prior strategies to mitigate rising drug prices.

In contrast to the conventional drug approval pathway in which drugs are reviewed under a New Drug Application (NDA), approval of a biological product is done under a separate pathway known as the Biologics License Application (BLA). Examples of biologics include therapeutic proteins such as insulin, monoclonal antibodies, vaccines, and blood-derived products. While the NDA and BLA processes are similar, they are not identical. The typical generic drug provisions (e.g., same active ingredient, bioequivalence) do not apply to BLAs. Instead, the single biological product already approved by the United States (US) Food and Drug Administration (FDA) is referred to as the reference product; the new potential biosimilar is then compared to the reference product. For approval as a biosimilar, the manufacturer must demonstrate that the agent is highly similar with no clinically meaningful differences.

In July 2018, the FDA released their Biosimilar Action Plan, described by then FDA Commissioner Dr. Scott Gottlieb, as “aimed at promoting competition and affordability.” Then, in December 2018, the FDA announced the plan to transition biological products that were historically regulated as drugs and approved via NDAs to the biologics pathway, taking effect in March 2020. These products include insulin, human growth hormone, and glucagon, among others. This change was mandated by Congress in the 2009 Biologics Price Competition and Innovation Act, which allowed 10 years for the transition. When considered as drugs under the NDA pathway, it was virtually impossible to develop a generic equivalent due to the nature and the inherent variation in the manufacturing process of these products. On March 23, 2020, the FDA issued a statement noting that this change is now in effect.

However, in the US, even if an agent is determined to be biosimilar, it is not automatically interchangeable (a process by which a product can be substituted for another without the approval of the prescriber). For a biosimilar to be considered interchangeable by the FDA, it must meet even more rigorous requirements and be approved as interchangeable. For products that are biosimilar but not interchangeable, the prescriber still needs to write for the specific product. In addition, even if determined to be interchangeable by the FDA, state pharmacy laws may further regulate what substitutions may be made at the pharmacy level without the approval of the prescriber. Just as a listing of generic equivalents is available through the FDA in their Orange Book, the FDA lists biologics and any respective biosimilars in their Purple Book. Recently converted to an online database format, the Purple Book provides details on reference products, their corresponding approved biosimilars, and whether or not the biosimilar is interchangeable. To date, no biosimilar has been designated as interchangeable.

As described in a previous blog post, the cost of insulin has risen substantially, leading patients to take desperate measures. At a time of economic instability and health uncertainty, these access concerns are even larger. Now that these products have transitioned to the biologic approval pathway, once patent exclusivity has passed, biosimilars can be developed, evaluated, and approved. Moreover, biosimilars can be reviewed further and may be classified as interchangeable, which can further alleviate the burden by allowing substitution at the retail level depending on local laws. This landmark change can promote market competition, potentially driving increased availability and decreased cost. The FDA reports that even having one generic drug on the market can decrease prices to approximately two-thirds of the price without competition. Generally, initial list prices of launched biosimilars have been 15% to 35% lower than their reference products. Most importantly, in their announcement of this change on March 23, the FDA pledged that they are ready to review eligible applications to ensure efficient approval. Ultimately, this revised process will provide an opportunity for other manufacturers to introduce safe and effective product competition without clinically meaningful differences. While this may be challenging in light of the ongoing global pandemic, this change, 10 years in the making, offers hope for patients who use these medications.

In January 2020, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2019. This report provides a summary of a number of approvals and highlights the “game-changers” approved in 2019, solidifying the upward trend in approval volume initially seen in 2017. Compared to 2017 and 2018, in which CDER approved 46 and 59 new drugs, respectively, 48 novel agents were approved in 2019. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or the 10 biosimilar approvals. This far exceeds the average of 38 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

In 2019, the FDA continued its strategic initiatives, with additional approvals of biosimilars and generics (both first-time agents and those off-patent with limited competition), as well as a focus on the expedited approval process, particularly for rare diseases and agents supported by positive patient-reported outcomes. Notably, the FDA hosted a public meeting in April 2019 to receive input on how to tackle barriers associated with the development of treatments for rare diseases, and held another meeting to celebrate “Rare Disease Day” in February 2020. Moreover, this trend is likely to continue, with the FDA releasing several guidances on gene therapy. The new pathway for insulin approval under biologic license applications planned for March 2020 and the launch of internet-based repositories or apps to improve access to information for both providers and patients (e.g., CURE ID in 2019, antiretrovirals in 2020) also highlight strategic initiatives of the FDA.

Last year, all 48 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2019, 42% were considered first-in-class, and 44% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 58% of novel drugs, 19% received Accelerated Approval (more than doubling the rate of 7% last year), 27% were designated as Breakthrough Therapy, and 35% garnered Fast Track designation. Overall, 60% of all drug approvals in 2019 used expedited development and review methods. In addition, 90% were approved in the first review cycle, and 69% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2019 is illustrated in Figure 2, with approvals once again dominated by drugs in the expansive oncology spectrum.

Some of the notable 2019 approvals included new advances for the treatment of cystic fibrosis (CF), with the first triple combination therapy and expanded indications of existing CF therapy available to younger patients, and the first new medications in several years for sickle cell disease. Additionally, several approvals targeted rare conditions, such as erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, tenosynovial giant cell tumor, Duchenne muscular dystrophy, and systemic sclerosis-associated interstitial lung disease. Beyond treatments for rare disease and cancer, the FDA also approved agents for more common disorders, including multiple sclerosis, novel treatments for depression, migraine and cluster headaches, epilepsy, several autoimmune conditions, age expansions for diabetes therapy, and a drug-sparing regimen and new prophylaxis option for human immunodeficiency virus-1 (HIV-1). Although down slightly from 2018, the large number of approvals from 2019 represent a continued trend by the FDA to expedite and increase the quantity of annual approvals.

Drones have been a part of military operations for decades as they have engaged in drone warfare and performed reconnaissance and surveillance missions. Civilian drones are popular with drone enthusiasts of all ages. Whether it is to take a hobby such as aerial photography or drone golf to the next level, keep the kids entertained, or to simply enjoy flying these unmanned winged vehicles, drones continue to trend on the hottest gift lists.

Zero emission unmanned aerial vehicles (UAVs) are already being utilized across a number of industries including reshaping search and rescue operations. Scores of emergency services including volunteer rescue teams, police officers, and firefighters deploy drones to save lives in natural disasters and to ensure public safety. Commercial drones are now going airborne and transforming healthcare services delivery, including the delivery of prescription medications.

On November 1, 2019, the United Parcel Service (UPS) drone delivery division, UPS Flight Forward (UPSFF), and CVS Pharmacy made the first commercial residential drone deliveries of prescription drugs in the United States (US). For the maiden flight, pharmacists loaded the drones with prescription medications at a CVS drugstore in Cary, NC. The Matternet M2 drones flew to nearby residences and slowly lowered the small packages to the ground from a hover height of about 20 feet over the properties. A remote drone operator was on standby to step in, if needed. One of the revenue-generating deliveries was made to a front lawn of a private home while the other to the public space at a nearby retirement home. Per UPS, one of the packages was delivered to a CVS customer with limited mobility, for whom traditional store pick up was a challenge. UPS drone deliveries are expected to fly on pre-planned routes, carry packages up to 5 pounds, and deliver in 5 to 10 minutes. Prior to these deliveries, UPS had deployed Matternet quadcopter drones in the hospital setting at the WakeMed Raleigh, NC hospital campuses for commercial transport of medical supplies. As of early November 2019, this business-to-business model had yielded over 1,500 revenue-generating deliveries at WakeMed, since launching in March 2019. UPS is already partnering with the drone logistics startup Matternet on its next iteration of delivery services to medical campuses.

What is remarkable about the UPS/CVS autonomous delivery in Cary, NC is that it was for prescription medications flown directly to a patient’s home. Wing, a drone delivery service owned by Google’s parent company Alphabet, has partnered with FedEx and Walgreens Pharmacy for a home delivery pilot for health and wellness products in the Christiansburg, VA community. In partnership with local merchants, Wing already has drone deliveries of goods available in select areas of Australia and Finland. In June 2019, Amazon’s drone operator system, Prime Air, announced its plans to launch a drone delivery service in the “coming months.” Amazon’s UAVs are expected to fly up to 15 miles and deliver packages under 5 pounds. According to Amazon, 75% to 90% of purchased items weigh less than 5 pounds. These drones will employ “sense and avoid” technology fueled with computer vision, machine learning algorithms, and artificial intelligence to navigate around obstacles such as trees, birds, power lines, people, and pets. Zipline, a CA drone startup, has been actively delivering lifesaving medical supplies including blood and vaccines in Rwanda and Ghana. Notably, Rwanda will be home to the world’s first “droneport” – an airport for drones.

“Drone-to-Door” delivery of prescription medications is a pharmacy quantum leap. This innovation opens the door to swiftly delivering medications at the point of need and can benefit an array of people. Immobility can be a barrier to getting medications for patients with disabilities or those who have sustained injuries because it can be difficult for these patients to get to the pharmacy. Likewise, it can be challenging for the elderly or parents with a sick child at home to make it to the pharmacy, and people who work or travel may not be able to conveniently access a pharmacy. Patients in assisted living facilities also benefit from drone delivery of life-saving medications directly to the site of need. With a number of independent pharmacies and smaller hospitals closing their doors, consumers in rural communities are left without access to vital prescription medications and medical supplies. Drones can rise to fill part of this void. CVS Pharmacy is exploring these options in rural, as well as suburban and urban, markets. Moreover, medication delivery by sustainable UAVs saves time and provides consumers with convenience.

While questions about safety, privacy, intrusiveness, theft, medication exposure, noise, and light pollution remain, there are still significant regulatory hurdles to overcome before drone delivery becomes commonplace. Drones require aviation regulation similar to commercial airplanes. In September 2019, UPS became the first company to receive full Part 135 Standard Certification by the Federal Aviation Authority (FAA) granting UPS its highest certification. This allows the carriers to fly at night and out of operator’s line of sight, to fly as many drones supported by as many operators as needed to meet customer demand, and to collect payment for drone deliveries. In April 2019, Wing received a similar but more restrictive certificate limiting it to a single pilot allowing it to only complete one flight at a time. The FAA guidelines to inform how UAVs will operate in US airspace are anticipated in 2021.

The ascent of “The Airborne Pharmacy” is an inflection point in the delivery of medications to consumers and provides an aerial glimpse of its mainstream future. When imagining that future, the sky’s the limit for real-world, everyday life applications of drone-centric technology. What originated as a part of military infrastructure can now change how life-saving medications reach patients at home or in the inpatient and outpatient settings. “Drone-to-Door” not only has the potential to reshape how medications are delivered but also to transform the consumer experience by providing convenience in an on-demand healthcare economy.

While there have been significant drug shortages in the past as a result of unforeseen circumstances, such as Hurricane Maria’s effect on Puerto Rico’s drug manufacturing facilities in 2017, drug shortages often crop up and continue despite no obvious reason. The ongoing shortage of vincristine, an older, traditional chemotherapy agent used for several cancers, has compelled tough decisions by providers and families. In some cases, there are few other treatment options for patients or the treatment regimen is incomplete without vincristine. Other shortages, including those for heparin, critical antimicrobials, and immunoglobulin, have also made national news. The United States (US) Food and Drug Administration (FDA) monitors and reports drug shortages and has historically worked with manufacturers and public health partners to mitigate the impact of shortages. For instance, during Hurricane Maria, the FDA allowed temporary importation of certain products from select manufacturers and worked to expedite reviews of drug applications that could alleviate shortages of affected medications. According to the FDA, the biggest causes for drug shortages are quality or manufacturing issues (37%), lack of raw materials (27%), and manufacturing delays and capacity concerns (27%).

Due to the ongoing issues associated with drug shortages and prompting from a bipartisan Congressional group in June 2018, the FDA developed an interagency Drug Shortages Task Force. This group was tasked with studying shortages, determining their root causes, and developing strategies to limit the occurrence and widespread effect of drug shortages. The Task Force evaluated products that were affected by a shortage between 2013 and 2017 and solicited public and key stakeholder feedback. In late October 2019, the FDA issued a press release announcing the publication of a report from the Task Force entitled, “Drug Shortages: Root Causes and Potential Solutions.” Notably, the Task Force confirmed that drug shortages not only persist but also have continued to rise again recently since falling from their peak in 2011. As an example of their impact, the group highlighted select medications whose shortages have had a significant clinical impact (e.g., pediatric oncology medications, medications for septic shock). Of the 163 drugs in shortage they analyzed, 63% were sterile injectables and 67% were products available as a generic. The median time since first approval was nearly 35 years and most were considered relatively “cheap,” as they were several years off-patent (median price of $2.27/unit for oral drugs and $11.05 for injectables).

The Task Force identified 3 root causes associated with drug shortages: (1) lack of incentives for manufacturing less profitable drugs; (2) lack of recognition and incentives for mature quality and production management, as well as production contingency plans; and (3) logistical and regulatory hurdles that limit production responsiveness. Moreover, the Task Force proposed solutions to alleviate the impact of drug shortages. The first recommendation is to create a shared understanding of the impact of drug shortages, including quantifying costs, frequency, persistence, and intensity, as well as improving transparency of contracted price and stipulations. The group also recommends the development of a rating system to incentivize a manufacturer’s investment in maturing quality management, beyond the minimum threshold of Current Good Manufacturing Practices (CGMPs), to improve voluntary transparency. Finally, the group recommends the promotion of sustainable private sector contracts. This recommendation would involve providing incentives for manufacturers that would mitigate the financial risk of introducing or keeping products on the market, in addition to quality-based manufacturing financial incentives. The Task Force further identified legislative proposals that could limit product availability interruptions (including improved data sharing), risk assessment to identify vulnerabilities, and additional expiration date/shelf-life data. Likewise, the Task Force also stated that the FDA plans to publish guidance for the industry. These would be regarding FDA notification of permanent or temporary manufacturing of a product and risk management plans to prevent and limit shortages.

In addition, other legislation has been proposed, such as the Mitigating Emergency Drug Shortages (MEDS) Act, introduced to legislation by Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN). According to Collin’s office, shortages can add approximately $230 million in drug costs and $216 million in labor costs annually in the US. Key priorities of the Act include strengthening transparency to disclose causes, expected impact, and estimated durations of shortages; extending reporting requirements to include active ingredients (not only the finished product); requiring contingency and redundancy plans for critical medications; and incentivizing manufacturing of products in shortage. Furthermore, the proposed legislation would require the Department of Health and Human Services (DHHS) and Department of Homeland Security (DHS) to conduct a risk assessment associated with shortages of critical drugs that could affect national security. So far, the MEDS Act has support from several healthcare organizations, including the American Pharmacist’s Association (APhA), American Society of Health-System Pharmacists (ASHP), American Society of Clinical Oncology (ASCO), and the American Hospital Association (AHA).

In the meantime, drug shortages continue to creep into national news. While a lack of drug accessibility is often linked to cost, drug shortages are a reminder that cost is not the only roadblock to treatment. Despite the innovation of the US healthcare system, and the novel drug and biologic discoveries that have dramatically altered care, some Americans, because of a variety of factors and causes, still find themselves scrambling to obtain routine or essential medications.

The Drug Shortages Task Force’s report may be found here: https://www.fda.gov/media/131130/download.

In 1989, one survey of the general public found that more than half of respondents believed lack of discipline was a possible cause of mental illness. The survey found that, at that time, Americans were more likely to receive information about mental illness from mass media than from medical providers or psychologists. Thirty years later, with the availability of information on the internet, the public should theoretically have a more accurate and balanced perspective of mental illness. But is the public obtaining their information from science-based sources? While there is still much to learn about mental illness, scientists have identified several factors that can play a role in mental health, including genetics, environmental exposure, altered brain chemistry, significant stress, and comorbid medical conditions. With the availability of misinformation on the internet and on social media websites in particular, are we really any better educated on mental health than we were 30 years ago?

The National Institute of Mental Health (NIMH) reports that approximately 1 in 5 adults experiences mental illness annually, with approximately 1 in 25 experiencing mental illness that substantially interferes with or limits 1 or more major life activities. Based on data from the 2018 National Survey on Drug Use and Health, approximately 19% have an anxiety disorder, 2.8% live with bipolar disorder, and fewer than 1% have schizophrenia in the United States (US) adult population. In addition, 7.2% of adults have experienced at least 1 major depressive episode in the last year. Unfortunately, only about 43.3% of adults with a mental health condition received mental health services within the past year, and of those with a serious mental illness, only 64.1% received mental health services within the past year. Even the indirect costs of mental health have a significant impact. Serious mental illnesses have been estimated to cost over $193.2 billion in lost earnings per year in the US, and mental illness has been predicted to cost the global economy $16 trillion by 2030.

Much has changed in the treatment of mental illnesses in the past 30 years. Key treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and newer serotonin-norepinephrine reuptake inhibitors (SNRIs), have mitigated some of the limitations of earlier antidepressants (e.g., drug-food interactions or select adverse effects). Even in the past year, novel approvals for treatment-resistant depression (TRD) and postpartum depression (PPD) have emerged. For those with schizophrenia, the availability of newer generation antipsychotics has significantly altered care as well. Although testing for genetic alterations to better identify the best medication choice for a patient is in its relative infancy, the role of pharmacogenomics is rapidly expanding, too. These advances offer promise for individuals with mental illness, but no medication is without risks, and a discussion with a licensed medical provider is essential to establish an appropriate treatment regimen. In addition to medications, the role of nonpharmacologic treatment has expanded in the past 30 years as well, with additional treatment modalities beyond the advancements in psychotherapy alone (e.g., modern cognitive behavioral therapy, interpersonal therapy). A more holistic approach, incorporating lifestyle changes (e.g., diet, exercise) and non-traditional medicine (e.g., meditation, acupuncture), is also gaining in popularity; however, it is critical to understand that herbal or “natural” treatments can have adverse or toxic effects and drug interactions. These should only be used in consultation with a healthcare provider.

Mental illness can contribute to the risks for suicide. Unfortunately, the Centers for Disease Control and Prevention (CDC) reports that suicide rates have increased by approximately 30% from 1999 to 2016. Notably, suicide is rarely caused by a single factor, and the National Alliance on Mental Illness (NAMI) reports that approximately 54% of those who die by suicide do not have a diagnosed mental health condition. Regardless, this leaves a significant portion of patients with known mental health conditions where intervention may have been helpful. Moreover, NAMI also reports that approximately 90% of those who die by suicide show symptoms of a mental health condition. The CDC includes several warning signs on their website and offers advice to several groups ranging from laypersons to the government to healthcare providers. One component the CDC emphasizes to healthcare systems is the need for affordable and effective mental and physical healthcare where people live. In addition, the Zero Suicide Institute provides a framework for continuous quality improvement in health and behavioral healthcare systems aiming to prevent suicide.

Of late, the public seems particularly concerned with the risk of violence in those with a mental illness. A 2006 survey found that 32% and 60% of Americans thought people with depression and schizophrenia, respectively, were likely to act violently toward someone else; however, research has demonstrated that there are several factors that contribute to violence, and that when accounting for these additional factors, the presence of a mental illness is only a modest contributor (at best) to violence. According to the 2018 National Survey on Drug Use and Health, approximately 19.4% of those over 12 years of age have used an illicit drug in the past year and 3% had at least 1 illicit drug use disorder. Additionally, 3.7% of adults reported dual diagnosis (both any mental illness and substance use disorder). Studies of patients with substance abuse or dual diagnosis have found higher correlations with violence compared to mental illness alone. Most importantly, adequate treatment has demonstrated improved outcomes.

With the discussion of mental health in the press and the plethora of inaccurate information on mental health online, it is difficult for the public to develop a truthful foundation on mental illness. While public access to information and scientific discovery have advanced in the past 30 years, the most critical component for the proper diagnosis, effective treatment, and safety of those with mental illness remains consultation with a healthcare provider and/or team.

If you or someone you know may be at risk for suicide, contact the free and confidential Suicide Prevention Lifeline at 1-800-273-TALK (8255). It is available to anyone 24 hours a day, 7 days a week.

Nearly 2 decades after measles was declared “eliminated” in the United States (US), we find ourselves in the midst of an unprecedented measles outbreak in the modern era of vaccination. As of July 25, 2019, a total of 1,164 active cases of measles have been confirmed in 30 states. As one of the most contagious human diseases, measles can lead to serious health complications such as pneumonia, encephalitis, and even death. Given its highly contagious nature, the measles resurgence has public health officials on high alert.

Once relegated to the history archives thanks to a widely effective immunization program, measles is an acute respiratory illness spread through coughing or sneezing. The virus can linger for up to 2 hours after an infected person leaves an area. Symptoms typically begin 1 to 2 weeks after a person becomes infected. High fever, cough, runny nose, and red/watery eyes are followed after a few days by the hallmark red rash. Patients are considered contagious from 4 days before and after the rash appears. It is so contagious that following exposure, about 90% of unprotected individuals will develop measles.

According to the Centers for Disease Control and Prevention (CDC), the measles outbreak has proliferated due to factors including international travel and unvaccinated individuals. Unfortunately, measles is common in many parts of the world, and Europe is experiencing an ongoing spike, which is contributing to the measles surge in the US. In late April 2019, the CDC reported that, of the 44 “imported measles” cases that came into the US this year, 34 cases were in primarily unvaccinated US residents traveling abroad. The majority of imported measles cases in the US have been from popular travel spots such as the Philippines, Ukraine, Israel, Thailand, Vietnam, and Germany. In June 2019, the CDC issued a Level 1 Global Measles Outbreak Notice, alerting US travelers to the current situation and reminding them to check their immunizations before traveling internationally. Regardless of destination, the CDC recommends visiting their “destinations” site to view valuable traveler’s health updates to safely plan for travel.

Insufficient measles vaccination coverage, the other culprit in this outbreak, has also been fueling US circulation of the disease. The majority of measles cases in the US have been among unvaccinated individuals. CDC statistics show that there are pockets of unvaccinated close-knit communities in certain US jurisdictions, such as in parts of New York, experiencing an outbreak. Measles spreads quickly through these populations, making it difficult to limit transmission. Personal and religious beliefs, complacency, and unproven risks thought to be associated with vaccines, are among the reasons behind vaccine hesitancy and avoidance, leading to undervaccination in vulnerable communities. Moreover, unfounded concerns regarding vaccines and autism, which have been refuted by scientific evidence, have also led to skepticism in select groups.

In the pre-vaccine era, an estimated 3 to 4 million people in the US contracted measles each year, resulting in significant deaths and hospitalizations. In modern times, a vaccine is the strongest weapon to combat measles. For best protection, 2 doses of the measles, mumps, and rubella (MMR) vaccine are recommended and are approximately 97% effective at preventing measles; 1 dose is roughly 93% effective. The MMR vaccine is part of routine childhood immunizations. Measles vaccine recommendations for all age groups, as well as for international travelers, are available on the CDC website.

The CDC deems a disease “eliminated” after 12 continuous months of no active transmissions. If the current outbreak, which started in New York in October 2018, is not contained by October 2019, the US risks losing its measles elimination status. Whether traveling abroad or enjoying a summer staycation, individuals and communities should guard against the measles virus. The best protection against the “21^st century measles outbreak” is immunization. Armed with awareness, education, and appropriate vaccinations, this preventable disease can once again be banished to the history books.

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you are in need of medical advice, please contact your healthcare provider.