Depression: A Look at Some Novel Treatments

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Depression Overview

The World Health Organization estimates that approximately 5.0% of the world’s population suffers from depression.1 Depression is highly complex and arises from biological, environmental, and social factors. Although depression can happen at any age, the usual onset occurs during early adulthood. Sometimes, it is even common for depression to affect an individual in late adulthood as well.2  The PHQ-9 (Patient Health Questionnaire) is a widely used diagnostic tool for depression and can be accessed on the my HealthyVet VA website.

Depression is often diagnosed by psychiatrists, licensed therapists, or psychologists and is dependent on certain criteria. Depression must be present for at least two weeks consecutively, and a patient must have five or more of these symptoms2:

  • Loss of interest or pleasure in daily activities (must be present for depression diagnosis)
  • Feelings of sadness, hopelessness, or emptiness (must be present for depression diagnosis)
  • Increased or decreased appetite
  • Increased or decreased sleeping patterns
  • Decreased or slowed thinking, speaking, or movement
  • Feelings of constant guilt and worthlessness
  • Difficulty thinking or making decisions
  • Feelings of tiredness or energy loss
  • Frequent thoughts of suicide with or without a plan

These symptoms may occur every day or most of the day and must cause an individual lots of distress or interference of daily functioning. A depression diagnosis should not be attributed to the following:

  • substance use disorders,
  • adverse effects of other medications,
  • manic or hypomanic episodes, or other mental disorders such as schizophrenia, delusional disorder, or schizophreniform disorder.2

Depression can be brought about due to certain life events (loss of employment, financial loss) and tragedies (serious illness, loss of a loved one). Sometimes, there is no clear reason for what causes someone to develop depression. Depression may be transient or lifelong and it is important to discuss treatment options with providers as therapy is unique to each individual.

The usual side effects of antidepressants are diarrhea, constipation, sexual dysfunction, fatigue, and sleep disturbances. It is also very important to note that antidepressants carry a black box warning for increased thoughts of suicidality in children, adolescents, and young adults. Common treatments for depression at listed below. For a complete list of specific FDA-approved medications for depression, visit the FDA website.

  • SSRIs (Selective Serotonin Reuptake Inhibitors)
  • SNRIs (Serotonin Norepinephrine Reuptake Inhibitors)
  • NDRIs (Norepinephrine Dopamine Reuptake Inhibitors)
  • TCAs (Tricyclic Antidepressants)
  • MAOIs (Monoamine Oxidase Inhibitors)
  • Neurosteroids (Gamma-Aminobutyric Acid Modulators)
  • Psychotherapy
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Novel Treatments for Depression: A Breakthrough in Psychopharmacology

Recently, psychedelicshave been making headlines in the mental health world and so far, many signs are telling us they might be here to stay. As many as two-thirds of patients will not initially respond to an antidepressant, and there is increasing evidence to show that psychedelics may provide the answer that most clinicians have been searching for. In a recent United States survey, many Americans showed their support for the use of psychedelics if they were proven to be more effective than the standard treatment for mental disorders.4

Esketamine

The first psychedelic approved for treatment-resistant depression was esketamine (Spravato). Esketamine is an S-enantiomer of ketamine and an NMDA (N-methyl-D-aspartate) receptor antagonist. Granted FDA approval in 2019, esketamine’s efficacy and safety were evaluated in three parallel-group studies. All three studies looked at the Montgomery–Åsberg Depression Rating Scale (MADRS) scores. The MADRS is scored from 0 to 60 (scores on the higher end show more depressive symptoms). Patients in these studies received a new antidepressant at the start of the trial (for ethical purposes) and either placebo or esketamine treatment.

Results demonstrated that there was a significant reduction in MADRS scores compared to patients’ normal baseline readings.5 Because of esketamine’s potential for abuse, the FDA conducted a withdrawal study before a new drug application was sent out for submission.

Esketamine also has a REMS (Risk Evaluation and Mitigation Strategy) program for patient understanding of how benefits may outweigh risks.

Psilocybin

Another psychedelic treatment that is currently garnering attention for treatment-resistant depression is psilocybin. Compass Pathways, a mental healthcare company, recently completed a phase 2 double-blind, randomized controlled trial with favorable results.

The investigators of the trial compared the efficacy of psilocybin (COMP360) at 25mg, 10mg, and 1mg in 233 patients who randomly received these doses along with psychological support. Results using MADRS scores as the primary endpoint indicated that the majority of patients showed response or remission after receiving the 25mg dose by the third week.6 In addition, patients who were taking the 25mg dose were able to maintain their response at the end of the third month.6 Phase 3 is set to begin in mid 2022.7

MDMA

MDMA (3,4-methylenedioxymethamphetamine) is a derivative of amphetamine and has gained some traction for the treatment of post-traumatic stress disorder (PTSD) in phase 3 trials. For the indication of depression, MDMA shows signs of having its place in therapy.

In a systematic review of various psychedelics used for patients with terminal illnesses, preliminary open-label results revealed a significant reduction in depression in patients taking MDMA. Although the sample size was relatively small with 13 patients receiving 125mg – 187.5mg of MDMA and 5 patients receiving placebo, depressive symptoms in patients were greatly diminished, even up to one year later.8 Other observational studies have also presented positive outcomes with MDMA reducing major depressive episodes.9 Overall, more clinical trials must be conducted to get a clearer picture of how MDMA plays a role in depression therapy.

Depression can affect the lives of many but there are lots of treatments out there that can help. From the standard treatments of SSRIs to newly approved psychedelics like esketamine, there is hope in getting better and feeling better. As we look to the future with several breakthroughs in research, it is possible that one day depression might become less and less prevalent. With psychedelics constantly on the rise in the mental health world, these treatments may become the new standard of care for patients. Until these novel treatments become the norm, it is important for healthcare workers everywhere provide quality and compassion care to those suffering from depression.

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. Depression. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/depression. Published September 13, 2021. Accessed February 20, 2022. 
  2. American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). Washington, DC: APA, 2013.
  3. Inc. DH. Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD. https://www.prnewswire.com/news-releases/survey-finds-majority-of-affected-americans-approve-of-psychedelics-as-an-alternative-treatment-to-address-anxiety-depression-and-ptsd-301462380.html. Published January 18, 2022. Accessed February 23, 2022. 
  4. Kim J, Farchione T, Potter A, Chen Q, Temple R. Esketamine for treatment-resistant depression — first FDA-approved antidepressant in a new class. New England Journal of Medicine. 2019;381(1):1-4. doi:10.1056/nejmp1903305 
  5. Compass Pathways announces positive topline results from groundbreaking phase iib trial of investigational COMP360 psilocybin therapy for treatment-resistant depression. Compass Pathways. https://compasspathways.com/positive-topline-results/. Published November 9, 2021. Accessed February 25, 2022. 
  6. Psilocybin found to rapidly improve depressive symptoms in clinical trial. Columbia University Department of Psychiatry. https://www.columbiapsychiatry.org/news/psilocybin-found-rapidly-improve-depressive-symptoms-clinical-trial. Published November 18, 2021. Accessed February 25, 2022. 
  7. Schimmel N, Breeksema JJ, Smith-Apeldoorn SY, Veraart J, van den Brink W, Schoevers RA. Psychedelics for the treatment of depression, anxiety, and existential distress in patients with a terminal illness: A systematic review. Psychopharmacology. 2021;239(1):15-33. doi:10.1007/s00213-021-06027-y 
  8. Jones GM, Nock MK. Lifetime use of MDMA/ecstasy and psilocybin is associated with reduced odds of major depressive episodes. Journal of Psychopharmacology. 2022;36(1):57-65. doi:10.1177/02698811211066714 

The Role of the Pharmacist During the COVID-19 Pandemic

 

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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)

 

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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 


Long-Acting Injectable Antipsychotics: Selecting the Right Treatment for the Right Patient

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History and Overview of Long-acting Injectable Antipsychotics

Long-acting injectable (LAI) antipsychotics are commonly indicated for schizophrenia. Schizophrenia is characterized by positive, negative, and cognitive symptoms.1

Schizophrenia Symptoms
Positive SymptomsNegative SymptomsCognitive Symptoms
Hallucinations, Delusions, Disorganized thinkingAnhedonia, Alogia, Affect flattening, AvolitionAttention and memory impairment, Diminished executive functioning

The first LAI was introduced in 1966 with proven applicability and convenience for patients and healthcare providers alike.2 Before the turn of the century, many healthcare professionals such as psychiatrists and psychologists directly treated patients with schizophrenia and other similar mental illnesses in hospital settings.2

It wasn’t until the latter part of the 20th century where outpatient services vastly grew. With expansions in psychiatric healthcare, there was strong acknowledgement of the problem of nonadherence of antipsychotic medications prescribed in the long term. The recognition of the use and need of LAIs definitely demonstrated good patient outcomes despite early side effect profiles with first-generation antipsychotics (e.g., tardive dyskinesia, extrapyramidal symptoms). Subsequently, second-generation LAIs were then introduced in 2003, but also presented with its own side effect profiles in direct comparison to oral agents (e.g., QTc prolongation, sedation, weight gain).3 Choosing the right LAI for the right patient can be challenging when there are many factors to consider, but it is always important to have your patient’s best interest in mind.

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The Issue of Adherence

Long-acting injectable antipsychotics are largely prescribed for combating the issue nonadherence. LAIs are highly effective in preventing relapse of schizophrenia; however, there are numerous barriers that often prevent patients from staying on their appropriate LAI regimens. The common reasons for nonadherence of LAIs can be attributed to4:

  • stigma
  • serious adverse events
  • patient mistrust with healthcare professionals
  • lack of medical resources
  • patient denial of diagnosis
  • regimen issues

Most often than not, patients are nonadherent because their symptoms might simply “resolve” or “go away.” While on oral medication, patients might take their pills when their symptoms come back and these gaps in therapy might not be the best course of treatment patients. LAIs, however, fix this issue as patients are more likely to be adherent. This is mostly in part to longer dosing intervals and the elimination of oral overlap in some LAIs. Since the medication is slowly delivered over the course of weeks to months, it is likely that the patient will be more willing to continue therapy in the convenient setting of an outpatient clinic.

As always, it is important to discuss with patents the risks and benefits of LAIs. An informed patient will have the tools for better decision making in the long run. A summary of long-acting injectable antipsychotics is outlined below.5,6

MedicationLAI GenerationInjection Schedule
Haloperidol Decanoate HaldolFirst generationEvery monthNo PO overlap if loading dose is given
Fluphenazine Decanoate ProlixinFirst generationEvery 2 to 3 weeksNo PO overlap
Risperidone Risperdal ConstaSecond generationEvery 2 weeksPO overlap given 3 weeks after first injection
Paliperidone Palmitate Invega HafyeraSecond generationEvery 6 months; No PO overlap*
Paliperidone Palmitate Invega SustennaSecond generationEvery month; No PO overlap
Paliperidone Palmitate Invega TrinzaSecond generationEvery 3 months; No PO overlap
Olanzapine Pamoate Zyprexa RelprevvSecond generationEvery 2 weeks or every 4 weeks; No PO overlap
Aripiprazole Monohydrate Abilify MaintenaSecond generationEvery month; PO overlap given 2 weeks
Aripiprazole Lauroxil AristadaSecond generationEvery 1 to 2 months; PO overlap given 21 days after first injection
* =  Invega Hafyera (approved in 2021 for twice a year administration) is safely administered to patients who have been taking either Invega Sustenna or Invega Trinza. Oral paliperidone is needed when there is incomplete administration between doses. See package insert for more information.
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Long-acting Injectable Antipsychotics: First Generation vs Second Generation

The side effect profiles of first and second generation LAIs are unique to their respective classes. For example, First generation LAIs can cause more extrapyramidal symptoms (e.g., akathisia) than second generation LAIs. In addition, second generation antipsychotics can cause undesirable side effects such as metabolic issues (weight gain and hyperlipidemia), sedation, and hyperprolactinemia.5

Selection is everything. Second generation LAIs such as paliperidone and risperidone are known to have higher incidences of hyperprolactinemia than aripiprazole.3 With all things considered, depending on the patient’s comorbid conditions and specific risk factors (heart disease, sleep disturbances), certain LAIs may be given priority over others.

Clinical research has shown that even though second-generation LAIs are fairly tolerable given their side effect profiles, differences in patient relapse outcomes are pretty much favorable just like their first generation counterparts.3 The ACLAIMS trial was a pivotal randomized controlled trial that examined the relapse differences in patients with schizophrenia who were administered either haloperidol decanoate or paliperidone palmitate. The primary outcome of efficacy failure in both groups was not statistically significant (HR = 0.98; 95% CI = 0.65-1.47).7 Given these clinical outcomes, LAI therapy is guided by patient factors rather than a certain medication.

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Other Considerations for Long-acting Injectable Antipsychotics

Some patients may have other conditions or diagnoses that might be a cause for concern. In any case, a comprehensive medication history is needed for the appropriate LAI treatment. The following considerations may be evaluated on a case-by-case basis8,9:

Patient Considerations for Long-acting Injectable Antipsychotics  
PregnancyPregnant patients may safely take an LAI unless:  
There is a known contraindication
There is a rational reason for discontinuation  

Pregnant patients may benefit from taking an LAI if:  
There is a history of nonadherence
There is a history of many hospitalizations
There is a history illicit drug use
There are unresolved symptoms during postpartum term
Differential DiagnosisPatients are candidates for LAIs if they also have these diagnoses:  
Bipolar disorder*
Schizoaffective disorder  
* = Certain LAIs are indicated for the maintenance treatment of bipolar I disorder. See individual package inserts for appropriate indications.
† = Schizoaffective disorder includes schizophrenia symptoms and can overlap with either bipolar or depressive type manifestations.

After selecting the right treatment for the right patient, long-acting injectable antipsychotics can be quite effective in treating patients with schizophrenia. The data out there is consistent with positive results with both LAI generation formulations. Despite these outcomes, adherence remains a widespread problem.3 Healthcare professionals should always advocate for their patients while reinforcing the advantages of therapy. With collaborative efforts, we will eventually see a step in the right direction.

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. American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). Washington, DC: APA, 2013.
  2. Johnson DAW. Historical perspective on antipsychotic long-acting injections. The British Journal of Psychiatry . 2009;195:s7-s12. doi: 10.1192/bjp.195.52.s7 
  3. Jann MW. Understanding long-acting injectable antipsychotics for better treatment adherence. Psychiatric Times. https://www.psychiatrictimes.com/view/understanding-long-acting-injectable-antipsychotics-better-treatment-adherence. Published March 19, 2020. Accessed February 7, 2022. 
  4. Correll CU, Lauriello J. Using long-acting injectable antipsychotics to enhance the potential for recovery in Schizophrenia. The Journal of Clinical Psychiatry. 2020;81(4):1-8. doi:10.4088/jcp.ms19053ah5c 
  5. Crimson ML, Smith T, Buckley PF. Schizophrenia. In: Pharmacotherapy: A Pathophysiologic Approach. 11th ed. New York: McGraw Hill Medical; 2020. 
  6. Invega Hafyera. [package insert]. Janssen Pharmaceuticals, Inc. Titusville, NJ. 2021.
  7. McEvoy JP, Byerly M, Hamer RM, et al. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia. JAMA. 2014;311(19):1978. doi:10.1001/jama.2014.4310 
  8. Reinstein SA, Cosgrove J, Malekshahi T, Deligiannidis KM. Long-acting injectable antipsychotic use during pregnancy. The Journal of Clinical Psychiatry. 2020;81(6):1-3. doi:10.4088/jcp.20ac13597 
  9. Pacchiarotti I, Tiihonen J, Kotzalidis GD, et al. Long-acting injectable antipsychotics (LAIS) for maintenance treatment of bipolar and schizoaffective disorders: A systematic review. European Neuropsychopharmacology. 2019;29(4):457-470. doi:10.1016/j.euroneuro.2019.02.003 

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

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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)
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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

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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

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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

Why RxPharmacist Helps Professionals Truly Earn Their Stripes

Denzel Washington once wrote, “Show me a successful individual and I’ll show you someone who had real positive influences in his or her life. I don’t care what you do for a living — if you do it well I’m sure there was someone cheering you on or showing the way. A mentor.” [1]

Washington’s words ring true not only for himself but for everyone. It doesn’t matter if someone is an intern, contractor, associate, or director as a true mentor will always be invaluable to their development both professionally and personally throughout their career. 

RxPharmacist strives to help young professionals thrive through tailored mentorship which provides ample opportunity to paint a unique portfolio of accomplishments in their own image and color. This kind of experience is invaluable in not only helping develop those hard and soft skills, but has the additional benefit of sharpening them further into evolving and channeling a person’s unique self if they are already further along in their professional journey. 

RxPharmacist’s stellar mentorship model has benefited professionals in all walks of life. Interns are offered a wealth of support which include 1:1 mentoring, professional networking and hands-on projects which emphasize the healthy balance of teamwork and independent initiative needed to really shine in a typical workplace. Likewise, employees are consistently encouraged to try new things and venture outside their comfort zone to further refine and grow their abilities. It is not an understatement to say the bright, adventurous, and nurturing culture at RxPharmacist is the pinnacle of its success and family-like spirit. 

Anyone can develop their career anywhere, but it is the dedication and commitment of the RxPharmacist model to both personal and professional growth which sets it apart from other opportunities. At RxPharmacist, curiosity is not punished but eagerly rewarded and creativity is not pushed aside but highly embraced. There is a clear value and framework for inclusion at RxPharmacist which empowers and supports employees from all backgrounds to have a real sense of belonging and support. To earn one’s stripes is no simple feat, but with the right support and mentorship it can be just the beginning to a highly remarkable journey ahead.

Here at RxPharmacist we are always eager to welcome new interns and employees to our team, feel free to apply by submitting your information through our website. 

Bibliography 

1. Washington D. The Mentors He’ll Never Forget. Guideposts. https://www.guideposts.org/better-living/positive-living/the-mentors-hell-never-forget. Published 2007. Accessed January 26, 2022.

Helping to Find Focus and Clarity in a Cloud of Uncertainty

Being a part of RxPharmacist has been rewarding in many ways. Thanks to a colleague and friend, I was introduced to the RxPharmaicst Internship opportunity and applied. Prior to applying, I was really confused about professional plans after graduating from pharmacy school (May 2020). As on the verge of graduating with my pharmacy degree in 2020, I also had no plans for the next phase of my life. I later successfully passed the NAPLEX exam but found myself struggling to pass my state’s MPJE exam. At RxPharmacist, I served as a Data Analytic Informatics Intern, in charge of creating online MPJE content. While doing so, I was also able to study for the MPJE at my own pace and passed!

I have witnessed the profession of Pharmacy play a vital role in alleviating chronic and infectious diseases which stirred my intellectual curiosity. This was further reinforced when I witnessed my father having a diabetic attack, which almost led to a stroke. Barriers such as lack of affordable healthcare and medication non-adherence was the leading cause of his inability to properly manage his condition. This incident left a huge impression on me and re-established my desire to want to help engage underserved populations in better managing their disease condition through my public health expertise, pharmacy, and other clinical initiatives. From my personal experience, I can engage and empathize with healthcare providers, patients, and their families in understanding the outcomes that are important to them and co-creating sustainable solutions.

Over the years of schooling obtaining a Master’s in Public Health: Epidemiology and Biostatistics, and Doctor of Pharmacy degree, I’ve acquired the necessary research, analytical and statistical skills including methods to test hypothesis for association or causality of different risk factors and health outcomes in different populations, as well as build clinical knowledge to effectively promote and deliver optimal healthcare. In addition, I have been able to work within teams to evaluate the clinical effectiveness and value of the Pneumococcal vaccine in pediatrics in the state of Maryland, working with the Maryland Emerging Infections Program and Active Bacterial Core Surveillance team at Johns Hopkins University in collaboration with the Centers for Disease Control and Prevention (CDC). The research was a case-control study that evaluated the effectiveness of the 13-valent Pneumococcal Conjugate Vaccine (PCV13) against invasive Pneumococcal disease (IPD) in children 2-59 months living in Baltimore. Clinical endpoints were not assessed for the new antigens, which led us to conduct a post-licensure matched case-control study to assess vaccine effectiveness.

Joining RxPharmacist gave me better insight on how to constructively figure out my life goals while helping other students succeed to prepare for their NAPLEX, MPJE, and BCPS exams.  The internship later convinced me that the next stage of my learning may lay in the field of public health professionally as a pharmacist. The internship led to an opportunity to continue my development as a Public Health professional, serving as an Epidemiologist. I later plan to combine my public health and pharmacy efforts linking disease prevalence and drug utilization, to enable development of effective health policies, as well as allow disease prevention to be placed within a larger context. At RxPharmacist, I found being in an environment that’s right for me in terms of performing tasks that allow for personal enjoyment and professional growth.

-Catherine W., 2021 RxPharmacist Intern

A new beginning- RxPharmacist Intern Testimonial

Transitioning to a brand new career in pharmacy was daunting for me, especially after graduating pharmacy school. When I found out about RxPharmacist, LLC through my pharmacy school, I knew it was my last chance to take a leap of faith before venturing to a new path of my own. As we are all facing this devastating COVID-19 pandemic, I knew that being open to new opportunities instead of being selective would help me in the long run, and I am glad that RxPharmacist was there when I needed them the most.

In a sense I knew what I wanted in a career, but I felt I didn’t quite have my skills refined just yet. As soon as I found out there was a medical writing position available through RxPharmacist, LLC, I immediately took the position and gave it my best that I had. During this program I had a chance to improve my medical and technical writing skills as well as my time management. I also worked beside amazing people who had my best interests in mind and their mentorship was the best I have experienced as a pharmacist.

My specific project with RxPharmacist, LLC was working on a Board Certified Pharmacist Specialist® guide to help thousands of seasoned pharmacists pass their boards. This project exceedingly expanded my knowledge of pharmacotherapy beyond what my studies encompassed in pharmacy school and that knowledge is transferable in whatever capacity I will end up in. Currently, I am pursuing a PGY-1 residency program and the valuable skills I have taken with me from RxPharmacist, LLC will undoubtedly help me achieve my goal of entering into a program that is the perfect fit for me. I recommend RxPharmacist, LLC to any pharmacy student or graduate who needs to refine any skills needed for success and am grateful that I chose RxPharmacist, LLC to allow me to be a part of their team.

– Joseph S.

University of North Texas Health Science Center at Fort Worth, 2021 PharmD Graduate

2021 Intern Testimonial!

Intern Testimonial

Before my internship with RxPharmacist, I really had no idea what was possible with medical writing in the field of pharmacy. Now I’ve learned that it can really just be whatever you make of it. If you’re interested in a certain aspect of pharmacy, no matter how niche, there’s bound to be others just like you who are willing to read your work on it. I personally am interested in compounding and veterinary pharmacy, and was able to work on RcPharmacist’s first compounding guides!

The biggest thing I appreciated about this internship is how mutually beneficial it is. I got to work on projects that interested me and was given the opportunity to improve my own writing skills. RxPharmacist got to have content by pharmacists, for pharmacists. Everyone in the field of pharmacy benefits from the work put out by RxPharmacist. Like pretty much every new graduate, I had to also study for the NAPLEX and MPJE while working the internship. They understand this and will work with you and your schedule to make sure you feel comfortable and are successful!

Another thing I greatly enjoyed about the internship was the mentorship and networking that happened on the side. My mentor acted as the editor for my guide, and was always supportive and willing to give feedback. They try to match your mentor to your interests, and while my interests were sort of niche, my mentor was still a great source of information and mentorship. One of my mentors knew other pharmacists who were currently working in the fields that I’m interested in, and helped me connect with them to further network. I had some of the nicest mentors a new graduate could ask for.

-Christina I., 2021 RxPharmacist Intern

University of Texas at Austin

Using literature in medicine: An overview on clinical study types

In healthcare, collaboration and the sharing of information is vital to the expansion of knowledge. Different types of studies are conducted to confirm or build upon key concepts, such as the efficacy of a drug, the safety of an intervention, or the superiority of a specific treatment. In this blog, we will briefly review different study types that are used to answer clinical questions in the healthcare setting.

Quantitative studies1

Clinical guidelines are based upon evidence-based medicine (EBM), which is primarily derived from quantitative studies. Quantitative studies can either be descriptive or analytical.

A descriptive study does not try to establish a relationship between variables, and instead, simply describes the data that was found. Descriptive studies include case reports and case series.

An analytical study tests a hypothesis in a group of people to determine if there is a specific cause or relationship between variables. A hypothesis can be tested one of two ways: through the use of an intervention (an experimental study) or by observing the effect without directly applying an intervention (an observational study). Analytical studies include case-control, cohort, or randomized controlled studies, as well as those of a factorial design.

Below the different subtypes of studies are summarized.

Some studies pool together information from a variety of quantitative studies. Meta-analyses focus on pooling data to conduct further statistical analyses with increased power to support conclusions5. Forest plots are a tool typically utilized by meta-analyses. A systematic review focuses on answering a clinical question by summarizing data from other studies, without doing a separate statistical analysis5.

Qualitative studies6

While quantitative research is needed to justify consensus for EBM, qualitative studies are a major component of health care practice, particularly in the fields of academia and community health. If you are part of a non-profit organization looking to apply for grant funding, qualitative data can help to justify the needs of your population of interest.

The methodology of qualitative studies is based upon the information needed.

The _________ qualitative method…asks the question(s)…
Phenomenology  How do people experience a certain event?  
Grounded theoryWhat is the theoretical framework for a particular behavior, thought process, etc.?
EthnographyWhat are the important cultural aspects of a particular community?
HistoricalHow can the past events affect the future for this group?
Narrative inquiryWhat are the unique perspectives or lived experiences of this specific (often marginalized) group of people?
Action researchWhat approach does this specific (often marginalized) group of people propose for addressing groups like themselves? How can we get this group involved in the process?
Case studyWhat is the experience of a particular entity (individual, community, organization, etc.)?

Methods for achieving these types of studies are focus groups, interviews, surveys, and observation.

These study types can help to answer various questions within the healthcare setting. Although each type has the ability to elicit different information and outcomes, they all share in the common goal of expanding knowledge, and ultimately, improving patient care.

-Gabriela O., 2021 RxPharmacist Intern

References:

  1. Ranganathan P, Aggarwal R. Study designs: Part 1 – An overview and classification. Perspect Clin Res. 2018;9(4):184-186. doi:10.4103/picr.PICR_124_18
  2. Ranganathan P, Aggarwal R. Study designs: Part 3 – Analytical observational studies. Perspect Clin Res. 2019;10(2):91-94. doi:10.4103/picr.PICR_35_19
  3. Aggarwal R, Ranganathan P. Study designs: Part 4 – Interventional studies. Perspect Clin Res. 2019;10(3):137-139. doi:10.4103/picr.PICR_91_19
  4. Aggarwal R, Ranganathan P. Study designs: Part 2 – Descriptive studies. Perspect Clin Res. 2019;10(1):34-36. doi:10.4103/picr.PICR_154_18
  5. Haidich AB. Meta-analysis in medical research. Hippokratia. 2010;14(Suppl 1):29-37
  6. Qualitative study design: Qualitative study design. LibGuides. https://deakin.libguides.com/qualitative-study-designs. Accessed August 20, 2021.
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