Pharmacy

Too good to be true? An internship program full of a lifetime of learning

After finding out about the RxPharmacist Graduate Transitions Program through my school advisor, I had a strong interest in joining the program. I definitely thought it was too good to be true, to earn income while studying for your boards, but it has truly been a mutually beneficial experience! With a fellowship position already in place, I wanted to join the summer internship to enhance my work experiences and further build my skillset before beginning my fellowship in July. The program is very unique in that it specifically caters to graduating fourth year students and gives them an opportunity to edit or create MPJE/NAPLEX material of the student’s interest. Since I attended pharmacy school in Florida, I had no experience with the Massachusetts MPJE material, but I wanted to be licensed in the state for my fellowship. After editing the Massachusetts guide, I found the whole experience to be very effective and helpful in learning the material. I feel very prepared to take my MPJE exam and pass on the first time easily.

The RxPharmacist Graduate Transitions Program is very flexible and really cares about the success of the intern. I was able to create my own schedule and work on my own time. Throughout the program, I have learned valuable skills through the workshops offered on topics such as LinkedIn and writing effective cover letters through RxPharmacist’s, “How to get a Job Series” program that all interns get free access to. I have also expanded on my previous writing experiences that I know will be very beneficial to my career in the pharmaceutical industry. Another perk of the program is being matched with a mentor to support you through your projects and help you further your professional development. I enjoyed my sessions with my mentor and being connected with other professionals within the pharmaceutical industry. I cannot recommend this program enough, you need to definitely apply!

LeDea B., Florida A&M University

Stumbling upon a new opportunity to transform and be ready for this new economic climate of pharmacy

I stumbled upon RxPharmacist from a dear friend of mine who kindly forwarded the email she received about their internship programs over to me. I remember taking a quick glance out of confusion then rereading everything as it sounded too good to be true! It turns out I was right, it WAS too good to be true! RxPharmacist has a noble mission of not only helping pharmacy students pass their boards, but also earn some cash in the process. On top of everything, there are optional sessions for career growth, mentorship, and interviewing tips. For me, this was a once in a lifetime opportunity that helped me answer some of my own dilemmas and pursue my true passion. Questions such as should I pursue a regular pharmacist job out of graduation, or can I be able to strive for an entry level position in the pharmaceutical or medical writing industry? After all, the skills you gain here will take you as far as you let them. This internship program by RxPharmacist is designed to help each one of us [the interns] establish a solid foundation that will set us apart in today’s competitive workforce.   

My favorite part about this internship is the flexibility you are given when it comes to balancing your schedule. This is beneficial as I felt that I needed to practice having more of a “work-life balance” and there was no better way of doing so than with a fully remote work environment. RxPharmacist has been doing 100% remote work since 2016! For anyone seeking a non-traditional pharmacy role, this is the way to go as it may help some people realize if this path is even right for them and discover what they truly want out of a job and their life. This is why I highly recommend this internship for anyone seeking to challenge themselves, help future pharmacists, and gain new skills in a relatively short amount of time. Reflecting on my experience, I have learned more about my work and learning styles, as well my inspirations. I am more driven than ever to achieve my goals thanks to this exclusive experience I shared with my mentors and fellow interns. I hope that anyone out there who feels lost or unsure of what the future holds for them after pharmacy school explores this unique opportunity to experience it for themselves.

Shery S., University at Buffalo

The Role of the Pharmacist During the COVID-19 Pandemic

 

Image: unsplash.com

Current Trends During the COVID-19 Pandemic and the Pharmacist’s Perspective

The COVID-19 pandemic has affected everyone at some point. From job displacement to the loss of a loved one, COVID-19 has definitely changed the way we function in society. As some states are adopting to relax COVID-19 masking policies, the pandemic that began two years ago is not over yet. The CDC estimates that over 930,000 people in the United States have died from COVID-19.1 As we approach the unfortunate million number milestone, there are an estimated 130,000 weekly cases of COVID-19 as of February 2022.1


 

Source and Image: Centers for Disease Control. Available at: https://covid.cdc.gov/covid-data-tracker/#trends_totaldeaths

 

Source and Image: Centers for Disease Control. Available at: https://covid.cdc.gov/covid-data-tracker/#trends_dailycases

Some challenges that we have seen during these trying times have been especially taxing for healthcare professionals. Surges in COVID-19 hospital admissions, medical staff shortages, and usually long hours behind the pharmacy counter have left some providers with a sense of mental burnout. As a result, the “great resignation” has led numerous people to jump ship from their current jobs in search of finding that work-life balance that many once had prior to the pandemic. Some retail pharmacists are even moving to nontraditional careers such as remote opportunities amid the shortages of help and reduction of pharmacy store hours.2,3,4 Some common stressors pharmacists face are listed in the chart below.

Common COVID-19 Stressors Pharmacists Experience5
Facing Uncertainty
Staffing Issues
Increased Workload
PPE Shortages
Updated/Changing Guidelines
Family Health Concerns
Lack of Role Clarity
Threat to Professional Identity 
PPE = Personal Protective Equipment

On the other hand, roles for pharmacists, pharmacy students, and pharmacy staff have greatly expanded throughout the COVID-19 pandemic, creating a kind of incentive for pharmacists to provide vital and necessary patient care.6 Some examples of these role expansions have been: 

  • Creating community pharmacies that serve as COVID-19 testing sites
  • Permitting emergency pharmacist authority for pharmacist refilling (in some states)
  • Allowing pharmacy student volunteering while under pharmacist supervision
  • Granting pharmacy technicians the rights to administer vaccines, conducting remote data entry tasks, and taking new orders (in some states)

 

Image: unsplash.com

The Pharmacist’s Role Concerning Vaccinations, Home Testing Kits, and Personal Protective Equipment 

The general public who visit the pharmacy may have several questions or reservations concerning COVID-19 vaccines. We’ve all seen and heard the vast amounts of misinformation regarding vaccines out there on social media, and it is important for pharmacists to intervene and educate patients about certain misconceptions. The public may ask these questions for themselves, for their family members, or for their own children. Some common COVID-19 vaccination concerns are outlined below. For more information regarding frequently asked vaccination questions, please refer to the CDC website.

In recent news, Pfizer-BioNTech (Comirnaty®) and Moderna (Spikevax) COVID-19 vaccines have been approved by the FDA for the prevention of COVID-19 and authorized for emergency use.7,8 The Janssen (Johnson & Johnson) COVID-19 vaccine, however, does not yet have FDA approval but is authorized for emergency use.9

Each vaccine has different criteria (e.g., age, booster eligibility) for patients. If a patient is receiving their COVID-19 vaccination for the first time, it would be wise to go over the vaccination schedule with them to ensure proper follow up. So far, most individuals qualify for the normal vaccination series and a booster (See chart below). Currently, the push for a second booster is reserved for individuals who are severely immunocompromised per CDC updates

 

Image from: The Food and Drug Administration. Available at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/do-i-qualify-covid-19-vaccine-booster-and-which-one

In early 2022, the Biden-Harris Administration began the initiative to provide millions of Americans with free at-home COVID tests and N95 masks. This decision came after massive surges in COVID-19 cases and when the Centers for Disease Control’s updated its guidance on N95 masks, noting that these masks offer “the highest level of protection.”10

In pharmacies today, people are eligible for free at-home COVID-19 testing kits with or without insurance plans. Everyone is now able to claim at least 4 at-home tests per household. Pharmacists can direct the general public to this government website for free orders. Kits usually arrive in about 7 to 12 days and is delivered by the United States Postal Service. For information on N95 mask availability, individuals are advised to contact their local grocery stores, pharmacies or community centers. 

The Pharmacists Role in Advocating Mental Health

From day to day, pharmacists might be overwhelmed and preoccupied with consults, phone calls, medication reconciliations, issues with prior authorizations, or medication transfers to say the least. Understandably so, this makes sense since there are so many tasks to do in a short amount of time. Even though a great deal of work is handled behind the scenes, it is important to recognize situations where patients or even coworkers might need certain help, especially when it comes to mental health. 

Incidences of depression have unfortunately been on the rise during the pandemic. In a longitudinal study that followed groups of U.S adults 18 years and older from March-April of 2020 and March-April 2021, depression in representative samples showed an increasing trend.11 In this study, the 2020 March-April cohort reported 27.8% depressive symptoms (95% CI: 24.9, 30.9) while the 2021 March-April cohort reported 32.8% depressive symptoms (95% CI: 29.1, 36.8). Reasons for the recent increases in depression have been attributed to life stressors such as socioeconomic status and job loss.11

 

Signs and symptoms of depression are9

  • changes in appetite
  • sleeping too little or too much
  • suicidal ideation (with or without a plan)
  • feelings of worthlessness or guilt
  • depressed mood or loss in interest in things that are pleasurable
  • concentration disturbances 
  • energy loss
  • psychomotor agitation or slowing

If the pharmacist has reason to believe that an individual might be suffering from depression, they can offer suggestions or recommendations to assist others. Mental health stigma is still very much widespread and negative societal beliefs may prevent others from seeking any help at all. It is always important however, to approach mental health discussions with a welcoming, yet careful manner to open up conversations that might be uncomfortable at first. Referring someone to a provider, therapist, or counselor is a great start. For more resources, visit the National Institute of Mental Health website. 

Common resources utilized for immediate intervention are the following:

Pharmacists everywhere can do their part to help those who need it the most during the COVID-19 pandemic. For pharmacists who have stayed diligent in providing continued, exceptional healthcare during the pandemic, their role in helping patients has never been more crucial. Even though time constraints during the pandemic may be the biggest barrier in helping patients throughout the day, pharmacists can still exercise their judgements in helping patients who may need that extra care. Although we may not know what changes to expect during this pandemic, we can certainly adapt to provide exceptional healthcare to everyone. 

Dr. Joseph Suarez, Pharm.D. is a Medical Writer at RxPharmacist, LLC who resides in San Antonio, Texas. His interests are in psychopharmacology, psychotherapy, and reconciling healthcare disparities. Dr. Suarez is seeking opportunities to utilize his incredible medical writing talents. If you are looking to hire, you may contact Dr. Suarez via LinkedIn.

References

  1. CDC Covid Data tracker. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Accessed February 15, 2022. 
  2. McCausland P. Covid vaccinations are free – but they’re taking a toll on local pharmacies’ bottom lines. NBCNews.com. https://www.nbcnews.com/news/us-news/covid-vaccinations-are-free-they-re-taking-toll-local-pharmacies-n1260717. Published March 12, 2021. Accessed February 15, 2022. 
  3. The great resignation: How is it impacting the pharmacy industry? RXinsider. https://rxinsider.com/market-buzz/?p=10608-the-great-resignation-how-is-it-impacting-the-pharmacy-industry-. Published December 16, 2021. Accessed February 15, 2022. 
  4. Peebles A. Pharmacy Workers Are the Pandemic’s Invisible Victims. Bloomberg.com. https://www.bloomberg.com/news/articles/2022-01-26/overworked-pharmacy-employees-are-the-covid-pandemic-s-invisible-victims. Published January 26, 2022. Accessed February 12, 2022. 
  5. Langran C, Mantzourani E, Hughes L, Hall K, Willis S. “I’m at breaking point”; exploring pharmacists’ resilience, coping and burnout during the covid-19 pandemic. Exploratory Research in Clinical and Social Pharmacy. 2022;5:100104. doi:10.1016/j.rcsop.2022.100104 
  6. Merks P, Jakubowska M, Drelich E, et al. The legal extension of the role of pharmacists in light of the COVID-19 Global Pandemic. Research in Social and Administrative Pharmacy. 2021;17(1):1807-1812. doi:10.1016/j.sapharm.2020.05.033 
  7. Comirnaty® [package insert] Pfizer Inc., New York, NY. 2021.
  8. Spikevax [package insert] Moderna US, Inc. Cambridge, MA, 2022.
  9. Janssen. [package insert] Janssen Biotech, Inc. A Janssen Pharmaceutical Company of Johnson & Johnson Horsham, USA, PA. 2021.
  10. Masks and respirators. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html. Published January 28, 2022. Accessed February 15, 2022. 
  11. Ettman CK, Cohen GH, Abdalla SM, et al. Persistent depressive symptoms during COVID-19: A national, population-representative, Longitudinal Study of U.S. adults. The Lancet Regional Health – Americas. 2021;5:1-12. doi:10.1016/j.lana.2021.100091 


Post-traumatic Stress Disorder: Current and Future Treatment Options for Clinicians

All images in this article pulled from: unsplash.com

PTSD Overview

Post-traumatic stress disorder (PTSD) is a type of anxiety disorder that is more common than you might think. It is estimated that at least 60% of men and 50% of women will go through some sort of traumatic experience in their lifetime.1 Also, the one-year prevalence of PTSD in the United States is approximately 3.5 to 4.7 percent.2 PSTD has long been associated with the terms “shell shock,” “post-Vietnam syndrome,” and “combat fatigue” in veterans for years; however, PTSD can occur in all populations regardless of age, gender, race, or socioeconomic status.3 There are many treatments available for PTSD that have been proven effective and in recent years, there have also been innovative yet experimental approaches to treating PTSD.

In summary, PTSD occurs after a traumatic experience (e.g., car collision, sexual assault, witnessing a death, developing a serious medical illness) and can manifest in different ways months to years after the trauma has passed. Although every case of PTSD is unique, many people will experience hallmark symptoms or manifestations such as intrusion, hyperarousal, avoidance,and distortions in thinking. These symptoms must be present for at least a month and cause marked distress that impairs the person’s quality of life.3

PTSD Symptoms/Manifestations3
TermDefinitionExamples
IntrusionUnwanted and intrusive thoughts associated with trauma. This is also known as “re-living” the traumatic experience and can occur with constant flashbacks or nightmares. Certain noises, sights, and smells of a similar manner in which the trauma occurred can trigger strong, spontaneous emotions.A retired veteran wakes up from a recurring nightmare about an airstrike that occurred 30 years agoA woman has an instant flashback of a robbery that happened a year ago while hearing popping of balloons in a department store
HyperarousalThe state of being irritable, easily shaken, hypervigilant, self-destructive, distracted, or unreasonably aggressive after a traumatic experience occurs.A young man becomes overprotective of his 5-year-old daughter around dogs after a he suffered a vicious dog attack last month A woman flinches when people hug her during get-togethers after a close family friend sexually assaulted her years ago
AvoidanceEvading or going out of one’s way to avoid situations, places, discussions, activities, or objects that serve as triggers of past trauma.A man takes a shortcut on his way to work to avoid the construction site where he crashed into another car during a busy intersectionA girl avoids rollercoasters when she goes to amusements parks after her friend was ejected next to her on a ride with faulty safety equipment
Distortions in ThinkingIrrational, distorted, or negative thinking in one’s behavior, feelings or thoughts after experiencing trauma. This can lead to beliefs that oneself or other people are “untrustworthy” or “bad.” Sometimes there is also thinking that oneself or other people do not deserve happiness or the right to lead a normal life.A woman holds anger directed at all of her doctors after learning her primary care physician misdiagnosed her serious heart condition that caused a delay treatmentA man cuts off all communication with his friends and family after he was robbed at knifepoint while walking to the bus stop two years ago

As always, it is important that proper diagnosis from either a psychiatrist, physician assistant, nurse practitioner, or licensed therapist is confirmed before any treatments are started. Related conditions that can highly mimic PTSD are the following3:

  • social anxiety disorder
  • panic disorder
  • agoraphobia
  • separation anxiety disorder
  • social anxiety disorder,
  • acute stress disorder,
  • disinhibited social engagement disorder, adjustment disorder
  • reactive attachment disorder (in children)
Image: unsplash.com

Current Evidenced-based Treatments for PTSD

There are a wide array of treatments for PTSD that are backed by evidence-based science. PTSD patients can choose nonpharmacological, pharmacological, or a combination of both. At times patients can be hesitant to try a new medication and might want to explore other approaches first. Since patient situations and circumstances vary, the provider and patient will come up with a plan for the best course of treatment. Nonpharmacological treatments for PTSD psychotherapies involve cognitive behavioral therapy (CBT). The types of CBT that are promoted by the American Psychological Association (APA) guidelines and the Veterans Health Administration and Department of Defense (VA/DoD) guidelines are4,5:

  • Cognitive Processing Therapy (CPT) – A type of PTSD therapy that focuses on changing internal thoughts and feelings in order to eliminate current and future negative thoughts and actions. CPT encourages the patient to rationalize or “make sense” of the traumatic experience, and how it has changed their perceptions either about themselves or others around them. CPT is typically 12 sessions (once weekly) and the patient will learn tools to help them come to terms with their trauma and how to cope with everyday life.6
  • Prolonged Exposure (PE) – A type of PTSD therapy that involves “rechallenging” or gradual repeated exposure to a situation, place, or activity that was once the source of trauma for the patient. PET helps the patient to incorporate “emotional processing” to slowly process the events related to the trauma that was not processed initially. To help guide this process, in vivo and imagined exposure are incorporated into therapy. In vivo exposure encourages patients to go back to the event, situation, or activity to accomplish a sense of desensitization of the trauma. Imagined exposure helps patients with confronting thoughts, memories and feeling surrounding the traumatic experience.6
Image: unsplash.com

Another psychotherapy treatment for PTSD is Eye Movement Desensitization Reprocessing (EMDR). This involves the patient recalling the trauma and examining the patient’s current emotional state. The patient moves their eyes from side to side during the session and the patient slowly incorporates positive thoughts when the traumatic thoughts subside.6

The APA and the VA/DoD have recommended CPT and PE after extensive systematic and meta-analysis of these evidenced-based treatments.7 It is important to note that the APA guidelines on PTSD are for treating all individuals, while the VA/DoD guidelines are recommendations for providers working for the VA or the DoD.7 Currently the APA guidelines suggests the use of EMDR, however the level of evidence is conditional.4 It is unclear at this time if the level of evidence will be changed to “strong” in the not-too-distant future. This contrasts with the VA/DoD’s strong recommendation for use in patients with PTSD.5 Even though EMDR needs additional exploration to address some limitations (cultural differences, diverse clinical settings), EMDR is still widely used in patients with PTSD.7

Image from unsplash.com

Pharmacotherapy

Currently, only four medications are recommended for the treatment of PTSD: sertraline, paroxetine, fluoxetine, and venlafaxine. While only sertraline and paroxetine are FDA approved for the treatment of PTSD, the APA and the VA/DoD recommend all the aforementioned medications for use.4,5

Medication Recommendations for PTSD4,5,8
Medication/ClassIndicationFDA ApprovalAPA RecommendationsVA/DoD Recommendations
Sertraline (SSRI)PTSDYes  Conditional* GRADE A
Paroxetine (SSRI)PTSDYesConditionalGRADE A
Fluoxetine (SSRI)PTSD (off-label)NoConditionalGRADE A
Venlafaxine SNRI)PTSD (off-label)NoConditionalGRADE A
SSRI = Selective Serotonin Reuptake Inhibitor, SNRI = Serotonin-Norepinephrine Reuptake Inhibitor, * = Conditional recommendation indicates good outcomes, but evidence may not be robust (risks vs benefits may vary from patient to patient), † = The GRADE system examines four domains for strength recommendation: Outcomes (morbidity, mortality, quality of life), Evidence Quality (randomized controlled trials, meta-analysis), Patient Preferences (risks vs benefits for patients, certain beliefs or perspectives in approach to therapy) and Other Implications (resources and/or cost-effectiveness)

In patients with PTSD, the VA/DoD suggests the usage of trazodone (GRADE B evidence for adjunctive treatment) for sleep disturbances and prazosin (GRADE B evidence for adjunctive treatment) for nightmares. Currently, the APA does not have current recommendations for these medications two medications.4,5

As far as benzodiazepines are concerned, the APA does not make mention of any usage of this medication class in their guidelines. The VA/DoD however, strongly recommends (GRADE D) against the usage of benzodiazepines, citing insufficient evidence and adverse side effect profiles5,9

Image: unsplash.com

The Future of PTSD Treatments: Psychedelics

Recently, the use of psychedelic medications has been gaining worldwide attention. In 2019, esketamine, a dissociative hallucinogenic therapy, was approved by the FDA for treatment-resistant depression.10 Other psychedelics such as psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) have also followed suit for future FDA approval.

In 2021, psilocybin was granted FDA breakthrough therapy designation for depression after a phase 2, randomized, double-blind, placebo controlled trial.11 This trial compared baseline depression scale scores in those taking either escitalopram or psilocybin.12 Results showed little difference in the change in scores (2 points difference between both groups) but did implicate some promise for future use. Experts claim that psilocybin will likely gain FDA approval for depression in a couple of years.13 In the PTSD realm, the jury is still out on whether or not psilocybin has its own unique place in therapy.

Similarly, MDMA was granted FDA breakthrough therapy designation for the treatment of PTSD first in 2017 after a phase 2 trial, and more notably in 2021 after a phase 3, randomized, double-blind, placebo controlled trial.14,15 The 2021 phase 3 trial compared the remission rates of PTSD in those taking either MDMA or placebo. After 18 weeks, two-thirds (67%) of the participants taking MDMA demonstrated complete remission of PTSD as opposed to the 32% taking placebo.10 Even though head-to-head studies are needed to demonstrate superiority (sertraline vs MDMA), so far, this novel treatment is making strides on its own.15 FDA approval for the use of MDMA in patients with PTSD could be coming as soon as 2023.13

Possible uses of psilocybin and MDMA does come with its own disadvantages. Both medications do carry the potential for abuse, just like their predecessor esketamine. Another thing to consider is the limitations of the setting in which these psychedelics are taken. In other words, it is highly unlikely that both these medications will be administered in a place other than a controlled environment like a licensed facility.

Whether we want to accept it or not, psychedelics might be here to stay for the long haul. What was once viewed by many as dangerous, mind-altering drugs are now seen with gradual acceptance for the future in treating many mental illnesses including PTSD.

About the Author

Dr. Joseph Suarez, Pharm.D. is a Medical Writer at RxPharmacist, LLC who resides in San Antonio, Texas. His interests are in psychopharmacology, psychotherapy, and reconciling healthcare disparities. Dr. Suarez is seeking opportunities to utilize his incredible medical writing talents. If you are looking to hire, you may contact Dr. Suarez via LinkedIn.

References:

  1. How Common is PTSD in Adults? PTSD: National Center for PTSD. https://www.ptsd.va.gov/understand/common/common_adults.asp. Published September 13, 2018. Accessed February 1, 2022. 
  2. Sareen J. Posttraumatic stress disorder in adults: Epidemiology, pathophysiology, clinical manifestations, course, assessment, and diagnosis. UpToDate. https://www.uptodate.com/contents/posttraumatic-stress-disorder-in-adults-epidemiology-pathophysiology-clinical-manifestations-course-assessment-and-diagnosis#H1824470698. Published September 20, 2021. Accessed February 1, 2022. 
  3. Torres F. What is posttraumatic stress disorder? What Is PTSD? https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd. Accessed February 1, 2022. 
  4. Clinical Practice Guideline for the Treatment of PTSD. American Psychological Association. https://www.apa.org/ptsd-guideline/ptsd.pdf. Published February 24, 2017. Accessed February 1, 2022. 
  5. VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. U.S. Department of Veteran Affairs. https://www.healthquality.va.gov/guidelines/MH/ptsd/VADoDPTSDCPGFinal012418.pdf. Published 2017. Accessed February 1, 2022. 
  6. Understanding PTSD and PTSD Treatment. PTSD: National Center for PTSD. https://www.ptsd.va.gov/publications/print/understandingptsd_family_booklet.pdf. Published 2019. Accessed February 1, 2022. 
  7. Watkins LE, Sprang KR, Rothbaum BO. Treating PTSD: A review of evidence-based psychotherapy interventions. Frontiers in Behavioral Neuroscience. 2018;12(258).doi:10.3389/fnbeh.2018.00258 
  8. Medications for PTSD. American Psychological Association. https://www.apa.org/ptsd-guideline/treatments/medications. Published May 2017. Accessed February 1, 2022. 
  9. Use of Benzodiazepines for PTSD in Veterans Affairs. PTSD: National Center for PTSD. https://www.ptsd.va.gov/professional/treat/txessentials/benzos_va.asp. Published August 23,2018. Accessed February 1, 2022. 
  10. FDA approves new nasal spray medication for treatment-resistant depression; available only at a Certified Doctor’s Office or clinic. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified. Published March 5, 2019. Accessed February 1, 2022. 
  11. Medications for PTSD. American Psychological Association. https://www.apa.org/ptsdguideline/treatments/medications. Published May 2017. Accessed February 1, 2022. 
  12. Carhart-Harris R, Giribaldi B, Watts R, et al. Trial of psilocybin versus escitalopram for depression. New England Journal of Medicine. 2021;384(15):1402-1411. doi:10.1056/nejmoa2032994 
  13. Expert: MDMA is very likely to be FDA-approved for PTSD by the end of 2023. Pharmacy Times. https://www.pharmacytimes.com/view/expert-mdma-is-very-likely-to-be-fda-approved-for-ptsd-by-the-end-of-2023. Published November 7, 2021. Accessed February 1, 2022. 
  14. Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for trauma treatment: Safety and efficacy of MDMA-assisted psychotherapy compared to Paroxetine and Sertraline. Frontiers in Psychiatry. 2019;10.doi:10.3389/fpsyt.2019.00650 
  15. Mitchell J, Harrison C, Lilienstein A, Bogenschutz M. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine. 2021;27:1025-1033. doi:https://doi.org/10.1038/s41591-021-01336-3 

Finding Your Footing After Years of Studies

Many of my peers may agree that we are often pushed and pulled in multiple directions during our education. Encouraged to find our place, we stress on discovering where we best fit in the field of pharmacy. We tend to try to tailor our interests based on the discussions with alumni, interactions with mentors, or academic experiences. However, this is still not enough. We may not immediately enjoy our first experience after earning our long-desired degree. We may regret it. Or we may feel lost if we don’t get the position we thought we’d always hoped for. Or we may feel overwhelmed because we couldn’t choose what we wanted to do. This is where I found myself after graduation. I’m sure I am not the only one who has or will be here too.

Instead of asking “what do I do now”, I changed my thinking into “what CAN I do now”. I reminded myself that I have a world of opportunities to dip into all of my interests. An area that I only had some exposure in was non-traditional pharmacy areas such as medical writing. Hence, I began exploring the roles I could have in this area by asking my classmates who had fellowships or went straight into the workforce, having phone and video calls with professionals with years of experience, and researching what they entailed. I had the pleasure to learn about RxPharmacist from a fellow peer who was an intern with the company right after we graduated. As someone who enjoys creating educational materials and staying updated on healthcare topics, medical writing seemed fitting for me and led me to apply for RxPharmacist. When I was welcomed into the company as an intern, I was happy to find a place where I could improve my proficiency in editing, quality checking, writing, and researching. Moreover, I feel lucky to have a boss and supervisor who has given me guidance in this relatively unknown area of pharmacy and motivates me to never settle for anything less than what is best for me. My mentor and preceptor were a pillar of support who I could share all my goals and obstacles with. They were instrumental in pushing me forward in my career and remain as valuable individuals that I am grateful for knowing. It is thanks to RxPharmacist that I could fully invest in all the interests that I’ve always wanted to.

-Julianne T., 2021-2022 RxPharmacist Graduate Intern

The Compounding Conundrum of Personalized Medicine

It is no wonder personalized medicine has been taking a rise, after all the one size fits all approach seen in manufactured medicine cannot work for everyone. For patients with unique healthcare needs, compounding can be incredibly useful but the catch is these medications do not actually go through a traditional approval process. Why is that important? It means these medications and products have not been reviewed, studied, and evaluated by a third party regulatory entity such as the Food and Drug Administration (FDA).

Compounding is defined as the process of “combining, mixing, or altering ingredients to create medications tailored to the needs of an individual patient”.1 For example, a patient with allergies to certain ingredients in a medication such as a preservative or dye can receive a modified compounded form instead.1 Another example is a patient who may require an alternate dosage form such as a liquid as opposed to a tablet which is especially prominent in pediatric or geriatric populations.1

Access to compounding services are invaluable for some patients, however, vigilance is critically important in this particular field of practice. In the absence of FDA review and approval, guaranteeing the safety, efficacy and quality of these medications can be tricky… so tricky you might even call it a compounding conundrum. The interactable module below outlines common pharmaceutical ingredients used in compounding.3

In 2012, a Massachusetts pharmacy caused more than 750 infections and more than 60 fatalities across 20 states due to fungal contamination.2 This event would lead to passing of the Drug Quality and Security Act (DQSA) which was officially enacted the following year.2 A prior blog post of ours outlined the need for REMS programs and Why We Can’t Be Hasty When It Comes to Drug Safety, the same is particularly true here as patients can be placed in serious harms way when appropriate measures or precautions are not taken in compounding. The following links below assembled by the United States Pharmacopeial (USP) Convention are highly useful in better understanding appropriate standards for compounding and have been linked below for your convenience: 

The FDA also provides a plethora of compounding guidance and resources found here as it is trying to gain a more involved approach given the recent deaths and news from a lack of quality assurance or sterility in compounded products causing patient harm. For example, there is a federal law that specifies a 5% limit on distribution for out of state drugs compounded by pharmacies and physicians under Section 503A of the FDCA. The FDA plans not to enforce this rule until after states sign and finalize the memorandum of understanding (MOU) as ultimately it is under the state jurisdiction and regulation to oversee compounding pharmacies. 

References

  1. U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  2. U.S. Food and Drug Administration. Compounding Laws and Policies. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  3. Ansel, HC, Loyd VA. Pharmaceutical Dosage Forms And Drug Delivery Systems. 10th ed. Lippincott-Williams & Wilkins; 2014.

Rising Rates of Asthma and the Hygiene Hypothesis

Many years ago, I came across a tale of The Wheezing Wolf and the Three Little Pigs , you could call it a breathless spin on a timeless children’s classic. It is also a tale that manages to very creatively highlight a disease state which affects a large number of children worldwide, specifically asthma. It is estimated more than 22 million people (~6 million children) in the United States have some form of asthma, a chronic but reversible condition which causes inflammation and bronchoconstriction of our airways.1

Although there is no magic bullet or cure for people who suffer from asthma, we do have a large variety of medications that allow for proper management to help prevent long term airway remodeling, permanent lung damage, hospital stays and emergency room visits.1 You might be wondering what causes people to acquire asthma. Data is gathered meticulously to better highlight trends in asthma for this very reason. For example, one trend already identified makes clear that African American and Hispanic children are generally more likely to experience mortality from asthma related causes.1 Below you will find several interactable modules which outline the rise in asthma cases over time and the demographic aggregation of cases across the United States.

One theory which has gained traction over the years to explain rising cases of asthma is called the hygiene hypothesis. This hypothesis suggests our post natal immune response is compromised by an ultra clean environment.3 There is evidence to suggest lower levels of the bacterial protein lipopolysaccharide (LPS) in a person’s home would predispose them to develop conditions like asthma (LPS helps our immune system grow and learn by switching on toll-like receptor 4 (TLR4) on T-cells).3 If you would like to learn more about how this may relate to the COVID-19 pandemic, the following article is a nice read: The hygiene hypothesis, the COVID pandemic, and consequences for the human microbiome.

As a whole, asthma attacks can vary in severity and in nature from one person to another. Common triggers include tobacco smoke, dust mites, pollen, air pollution, mold, a man’s best friend, perfumes, harsh cleaners/disinfectants and even acid reflux.2 It is important for patients who suffer from asthma to identify and avoid triggers. For example, encouraging tobacco cessation in households with smokers or using an air cleaner with a HEPA filter for people who may be allergic to their furry friends.2

Lastly, if there is one thing we know from the hygiene hypothesis, it’s that people love to clean their homes. It is especially true now perhaps more than ever before and we may very well see an even steeper rate of asthma cases moving forward, even if just from COVID sequelae alone. Here is a CDC guide for properly cleaning and disinfecting homes that patients (especially those sensitive to harsh detergents or cleaners) may find useful; it’s even COVID approved. 

References

  1. U.S. Food and Drug Administration. Asthma Fact Sheet. Accessed May 2, 2021. Retrieved from https://www.fda.gov/consumers/minority-health-and-health-equity/asthma-fact-sheet.
  2. Centers for Disease Control and Prevention. Common Asthma Triggers. Accessed May 2, 2021. Retrieved from https://www.cdc.gov/asthma/triggers.html.
  3. U.S. Food and Drug Administration. Asthma: The Hygiene Hypothesis. Accessed May 2, 2021. Retrieved from https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/asthma-hygiene-hypothesis.
  4. National Center for Health Statistics, Centers for Disease Control and Prevention. Asthma Data Visualizations. Accessed May 2, 2021. https://www.cdc.gov/asthma/data-visualizations/default.htm.

The Fault in Our EGFRs

The Fault in Our Stars is a novel written by John Green. Since its release in both print and film, the moving story has managed to strangle hearts around the world as it explores many colorful yet melancholic themes of life, cancer being among them. One example is a clever nod to Shakespeare’s Julius Caesar, specifically the following line by Caddius: “The fault, dear Brutus, is not in our stars, but in ourselves, that we are underlings”. 6

Of all the literary works I’ve read and enjoyed over the years, this line is especially memorable. Caddius implies fate (or stars for that matter) is a negligible force, for it is supposedly a person’s own fault alone if their life falls short of their expectations. By titling his book The Fault in Our Stars it is clear Green disagrees, at least as it pertains to cancer and our dear protagonists in the novel.

Although cancer can certainly be acquired through environmental means such as smoking or radiation, it can also be genetic. In fact, if we want to get a little more technical, for a select group of people their undoing could specifically be a fault in their epidermal growth factor receptor or EGFR (HER1/ErbB1) gene.2 EGFR positive lung cancer is most common in people who have adenocarcinoma, never/rarely smoked, women, young adults and people of asian or east asian heritage.2 Additionally, adenocarcinoma is a subtype of non-small cell lung cancer (NSCLC) which causes nearly 80-85% of all lung cancers.4 Risk of acquiring adenocarcinoma is increased for patients who smoke, inhale second hand smoke, and are exposed to radon gas, asbestos or other cancer-causing agents in their daily lives.4

If we are dealing with an EGFR positive case of lung cancer and wish to decide on a medication, it makes sense we would attempt targeted therapy as opposed to standard chemotherapy in order to directly inhibit the EGFR receptor. Therefore, NSCLC EGFR+ patients can typically be administered EGFR inhibitors as outlined above.

I have included some other potential mutations and their therapies as a bonus. Note they all end in -nib, as they are all tyrosine kinase inhibitors (TKIs) and the bolded drugs are preferred. Medications ending in ‘-mab’ denote monoclonal antibodies which are biologic type medications as they are usually therapeutic proteins and large structures chemically. Medications ending in ‘-nib’ are usually small molecules, think of this as a car versus an airplane which are ‘-mabs’ for size.

You should anticipate a rise in biosimilar oncology medications on the market. Overall, the Food and Drug Administration (FDA) has approved 29 biosimilar medications so far, and almost all of them have a role to play in oncology therapeutics. If you are interested in a much deeper dive into oncology and many more disease state topics, check out our CPJE Study Guide. Additionally, here are some useful resources on cancer you can also reference:

References

  1. American Cancer Society. What Causes Cancer? Accessed April 17, 2021. https://www.cancer.org/cancer/cancer-causes.html.
  2. Lung Cancer Foundation of America. EGFR Mutation and Lung Cancer: What is it and how is it treated? Accessed April 17, 2021. https://lcfamerica.org/lung-cancer-info/types-lung-cancer/egfr-mutation/.
  3. American Cancer Society. What Is Lung Cancer? Accessed April 17, 2021. https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
  4. Harvard Health Publishing. Adenocarcinoma of the lung. Accessed April 17, 2021. https://www.health.harvard.edu/a_to_z/adenocarcinoma-of-the-lung-a-to-z.
  5. American Cancer Society. Non-Small Cell Lung Cancer Targeted Drug Therapy: Lung Cancer Drugs. Accessed April 17, 2021. https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/targeted-therapies.html.
  6. Shakespeare W, Mowat, BA, Werstine, P. The tragedy of Julius Caesar. New York: Washington Square Press; 2005.
  7. Green, J. The Fault in Our Stars. Penguin Books; 2013.

Five Varieties of Insulin and Why We Need Them

An estimated 34.2 million people in the United States have some form of diabetes (⅕ of which are entirely unaware), and in the last 20 years the number of diagnosed adults has more than doubled in size.1 The significance of this disease state is paramount from a public health perspective, especially as diabetes has been identified as the number one cause of kidney failure, lower limb amputations and microvascular complications.1 You can think of diabetes as a metabolic disease which is generally broken down into four categories: type one diabetes, type two diabetes, gestational diabetes (onset during pregnancy) and prediabetes (elevated blood glucose levels which are yet to be considered entirely diagnostic of active disease).1

The following video is an excellent visual resource for understanding diabetes and its associated consequences on the human body.6 Both type one and type two diabetes cause an accumulation of glucose in the bloodstream, however, it is the etiology that differentiates them. Type one diabetics essentially experience autoimmune destruction of their pancreatic beta cells which diminishes endogenous insulin production (type one is usually diagnosed in younger people and makes up 5-10% of diabetics).1 In comparison, type two diabetics can produce insulin just fine but their body is unresponsive due to built up insulin resistance over time (type two is usually diagnosed in adults and makes up 90-95% of diabetics).1

The tricky thing about insulin is it must be injected because it is easily broken down and digested in an oral form.2 All patients with type one diabetes will be dependent on exogenous insulin for survival, and some type two diabetics may also require insulin for adequate control. There is a highly interesting concern in type two diabetes management surrounding a delay in insulin initiation, typically dubbed clinical inertia. You can read more about clinical inertia in the following literature review: Clinical inertia is the enemy of therapeutic success in the management of diabetes and its complications: a narrative literature review.

Insulins can be deadly when used inappropriately. It is important to understand and be familiar with the onset, peak and duration of insulins as seen in the figures above so an appropriate personalized regimen or adjustment can be made for each patient’s needs and goals. Generally, rapid and short acting insulins are intended for bolus purposes, whereas intermediate and long acting insulins are intended for basal purposes. We can also categorize and identify insulins via the five categories above. Note that Afrezza is inhaled as opposed to injected and can be given at the start of each meal which may be a great option if a patient is looking for something non-injectable.

As an aside, one important public health issue as it relates to insulins is actually affordability. Supposedly one in four diabetic patients cannot afford their insulin altogether.4 The issue is complex and significant enough to have its own dedicated gofundme page as for many patients insulins are a non-negotiable lifeline. You can read more about the black market dedicated to the insulin trade here, but remember there are resources for patients who need them should you ever directly encounter this issue in the community. Some patients may also obtain over the counter insulin from Walmart’s ReliOn insulin program.

References

  1. Centers for Disease Control and Prevention. What is Diabetes? Accessed April 6, 2021. https://www.cdc.gov/diabetes/basics/diabetes.html.
  2. American Diabetes Association. Insulin Basics. Accessed April 6, 2021. https://www.diabetes.org/healthy-living/medication-treatments/insulin-other-injectables/insulin-basics.
  3. Insulin and diabetes. Accessed April 6, 2021. https://www.diabetes.org.uk/guide-to-diabetes/managing-your-diabetes/treating-your-diabetes/insulin.
  4. About Mealtime Insulin. Accessed April 6, 2021. https://www.humalog.com/fast-acting-mealtime-insulin.
  5. Teare, K. One in four patients say they’ve skimped on insulin because of high cost. Accessed April 6, 2021. https://news.yale.edu/2018/12/03/one-four-patients-say-theyve-skimped-insulin-because-high-cost.
  6. Diabetes UK. Diabetes and the body | Diabetes UK. Published September 3, 2013. Accessed April 6, 2021. https://www.youtube.com/watch?v=X9ivR4y03DE.

Why We Can’t Be Hasty When It Comes to Drug Safety

To be, or not to be?

When it comes to drug safety, it is up to the U.S. Food and Drug Administration (FDA) to decide if a medication may be, or not be. The Risk Evaluation and Mitigation Strategy (REMS) requirement was set up by the FDA for select prescription medications which pose a high potential for serious adverse effects. As its name suggests, the REMS program is concerned with drug safety and in ensuring the benefits of a certain drug outweigh the risk.1

REMS does not only oversee adverse effects alone, but seeks to “prevent, monitor and manage” any medication the FDA expects could potentially violate safe medication practices.1 Although the FDA is in charge of determining whether REMS must be enforced for a medication, it is the manufacturer who is in charge of the program and submission of assessment reports for quality improvement or assurance efforts.2 Appendix 4 from A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS is a tool provided by the FDA which can be useful if you ever find yourself counselling a patient on a REMS classified drug.4

Drug safety efforts and their importance in public health can be seen as early as 1937. The antibiotic sulfonamide would result in hundreds of deaths due to the toxic excipient diethylene glycol supposedly claimed as being inert, you can read more about the incident via the June 1981 issue of the FDA Consumer magazine titled “sulfonamide disaster”.3 Later in the 1960s thalidomide was used for antiemetic effects in pregnant women, but resulted in severe teratogenic adverse effects made clear when babies were born with missing or deformed extremities.3

Science Museum Group. Thalomid (thalidomide) capsules. 2000-590 Science Museum Group Collection Online. Accessed March 13, 2021. https://collection.sciencemuseumgroup.org.uk/objects/co498098/thalomid-thalidomide-capsules-thalidomide.

Science Museum Group. Pair of artificial arms for a child, Roehampton, England, 1964. 1999-579 Science Museum Group Collection Online. Accessed March 13, 2021. https://collection.sciencemuseumgroup.org.uk/objects/co476754/pair-of-artificial-arms-for-a-child-roehampton-england-1964-artificial-arm.

The difference between these two events, however, is significant from the perspective of the United States. You see, after the sulfonamide tragedy the FDA mandated the 1938 Food, Drug, and Cosmetic Act (FDCA). At this point, pharmaceutical companies were required to conduct studies proving a drug is safe before becoming readily available to the general public.3 As such, thalidomide was never approved in the United States due to data suggesting deformities in animal models despite lobbying and immense political pressure against the clinical director at the time.3 

This brief dive into history barely scratches the surface on the importance of pharmacovigilance but is helpful in understanding what can happen if we get a little too hasty when it comes to drug safety, which brings us back to REMS. You can view a list of all current REMS medications on the FDA website alongside their associated goals, materials and a comprehensive timeline of program updates. Additionally, if you want to go really deep into the U.S. regulations for REMS, visit this helpful FDA slidedeck.

References

  1. Center for Drug Evaluation, Research. Risk Evaluation and Mitigation Strategies (REMS). Accessed March 13, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
  2. Center for Drug Evaluation, Research. FAQs about REMS. Accessed March 13, 2021. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems.
  3. Alshammari TM. Drug safety: The concept, inception and its importance in patients’ health. Saudi Pharmaceutical Journal. 2016;24(4):405-412.
  4. A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS. U.S. Food and Drug Administration https://www.fda.gov/files/about%20fda/published/A-Framework-for-Benefit-Risk-Counseling-to-Patients-About-Drugs-with-a-REMS.pdf.
  5. Science Museum Group. Thalomid (thalidomide) capsules. 2000-590 Science Museum Group Collection Online. Accessed March 13, 2021. https://collection.sciencemuseumgroup.org.uk/objects/co498098/thalomid-thalidomide-capsules-thalidomide.
  6. Science Museum Group. Pair of artificial arms for a child, Roehampton, England, 1964. 1999-579 Science Museum Group Collection Online. Accessed March 13, 2021. https://collection.sciencemuseumgroup.org.uk/objects/co476754/pair-of-artificial-arms-for-a-child-roehampton-england-1964-artificial-arm.
  7. Science Museum Group. Pair of artificial arms for a child, Roehampton, England, 1964. 1999-579 Science Museum Group Collection Online. Accessed March 13, 2021. https://collection.sciencemuseumgroup.org.uk/objects/co476754/pair-of-artificial-arms-for-a-child-roehampton-england-1964-artificial-arm.
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