End of our Pharmacy School Journey… What is next?

We come to the end of our pharmacy school journey, and we wonder what’s next? Individuals that have a pharmacy degree have a variety of career options, so being adaptable and well-rounded is very important in life. I have embarked on many different opportunities during my journey through pharmacy school. When I saw the email from my school about the RxPharmacist internship, I immediately wanted to apply. This internship stood out because of its unique opportunities. After completing the internship, I can honestly say that it was incredible and unique.

The RxPharmacist team is filled with individuals that are wonderful and very knowledgeable. They genuinely care about you and want you to succeed. I really enjoyed my time with the RxPharmacist team because, every day, I felt very motivated and excited about the next project or task I was about to complete. Every day I felt like I was truly part of the RxPharmacist team and a real contributing member. I utilized my skill sets, and I am grateful that this internship allowed me to give back to my pharmacy profession. It is amazing the way this internship is set up because it allows you to connect with so many individuals across America. I have learned so much from every single person I encountered and met so many people through this internship that I will never forget. During my internship, I focused on enhancing medical writing and, more specifically, technical writing skills. This internship exposed me to various areas, from pharmacy-related topics to post-graduate transition preparation to new career options. All the projects that I have completed have allowed me to grow as an individual, personally and professionally. I am excited about the future and very thankful to the RxPharmacist team for allowing me to be part of their first-ever fall internship program.

– Dagmara Z. 2022 RxPharmacist Medical Writer Intern

Overview of Drug Development Process: From the Idea to the Finished Product

Image: unsplash.com

Drug development is an extensive process that takes time to be completed. Depending on which therapeutic area the drug is being developed for, more specifically, which disease it is targeting, the process might be slightly faster or slightly slower. To give you an idea, on average, it can take over 10 to 15 years for a drug to be developed. Especially now, with new technology and innovative thinking, many of us don’t understand why it takes so long for a drug to be developed. To better understand this process, let’s take a look at some of these steps. There are 5 core stages of drug development: discovery and development, preclinical research, clinical research, Food and Drug Administration (FDA) drug review, and FDA post-market drug safety monitoring.

Discovery and Development

  • This is when the research and development begin. There is an idea that has been discovered and researchers go through research, experiments, and tests to gather information and identify the right compound.

Preclinical Research

  • Research must be done in vitro and in vivo to identify the toxicity of that compound before it can go on to be tested on people. In vitro means studies conducted in a glass or test tube, and in vivo means studies are performed on living things.

Clinical Research

  • This is where the clinical trial design is created, and the Investigational New Drug Process (IND) begins. The IND application is submitted to FDA before the clinical research begins. There are phases within the clinical research stage.
    • Phase 1
      • The purpose is safety, toxicity, and dosage.
      • The process takes about a few months and includes about 20 to 100 individuals that are healthy or people with the disease that the drug is targeting.
    • Phase 2
      • The purpose is efficacy, additional safety data, and identifying side effects.
      • The process takes about months to about two years and can include a couple of hundred people with the disease that the drug is targeting.
    • Phase 3
      • The purpose is efficacy, monitoring, and gathering a detailed side effect profile.
      • The process is about one to four years and includes anywhere from 300 to 3,000 volunteers with the disease the drug is targeting.
    • Phase 4
      • This phase is conducted after the drug has been approved. The purposes of this phase are continued monitoring of drug safety and efficacy.

FDA Drug Review

  • Once all the other stages are successfully completed and the drug demonstrates safety and efficacy, a New Drug Application (NDA) can be submitted to the FDA. This is where the drug is considered for FDA approval. This FDA review process can take about 6 to 10 months.

FDA Post-Market Drug Safety Monitoring

  • This process involves the FDA continually monitoring the drug’s safety and efficacy.

These stages show just how long the process and steps are for drug development. If you want to learn more in detail about each process, the FDA has a great section on the drug development process. Also, the FDA has a section on novel drug approvals. In that section, it includes the FDA’s Center for Drug Evaluation and Research (CDER) approval of many new drugs and biological products. That list doesn’t include approvals of all products, but it does include new molecular entities and new therapeutic biological products. It is an incredible list to see exactly how many drugs get approved yearly.

It is fascinating to witness how many drugs undergo development, especially in recent times. Hopefully, in the future, we will continue to see innovative processes that move medicine forward. Overall, drug development is an extensive process that includes many stages and phases which shows just how much time it takes for everything to be completed to have an end product that is safe and effective.

Dagmara Zajac

RxPharmacist Team

References:

  1. Mohs RC, Greig NH. Drug discovery and development: Role of basic biological research. Alzheimers Dement (N Y). 2017;3(4):651-657. Published 2017 Nov 11. doi:10.1016/j.trci.2017.10.005
  2. In Vivo vs In Vitro: Definition, Pros and Cons. Drug Discovery from Technology Networks. https://www.technologynetworks.com/drug-discovery/articles/in-vivo-vs-in-vitro-definition-pros-and-cons-350415#:~:text=The%20etymological%20origins%20of%20in,test%20tube%20or%20petri%20dish. Accessed December 29, 2022.
  3. Commissioner Oof the. Step 1: Discovery and Development. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development. Accessed December 29, 2022.
  4. Commissioner Oof the. Step 2: Preclinical research. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research. Accessed December 29, 2022.
  5. Commissioner Oof the. Step 3: Clinical research. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Accessed December 29, 2022.
  6. Commissioner Oof the. Step 4: FDA Drug Review. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review. Accessed December 29, 2022.
  7. Commissioner Oof the. Step 5: FDA Post-Market Drug Safety Monitoring. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring. Accessed December 29, 2022.
  8. Center for Drug Evaluation and Research. Novel drug approvals for 2022. U.S. Food and Drug Administration. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022. Accessed December 29, 2022.

How to handle the transition from being a student to being a full-time employee

Image: unsplash.com

When you start school, most of us only think about how far the end is to attain that degree, but as cliche as this might sound, the future is closer than we feel it is. For some of us, we might know what we want to do with the degree that we are trying to achieve. Then there are others who hope that education will steer them toward a career path during school. Either way, it is good to start thinking about how to make the transition from school to a full-time job. At the end of the day, even though some of us might be ahead of others by knowing what our end goal is, we are all going to heavily rely on our transferable skills to make that transition smoother.

What are transferable skills?

Transferable skills help you adjust to a new position or setting in your career. These are the general core skills that you have gained throughout all of your life experiences that you can apply to that new step in your life.

These are some examples of transferable skills, but depending on the environment of your previous experiences, jobs, education, etc., you’ll attain different transferable skills.

One of the first questions that might come up when thinking about transitions in life is, “How do I know what skills I will need so I can prepare myself to be successful,” or “How do I know what I want to do with my degree?”

  • If you are starting your undergraduate or graduate coursework, look for the skills you need to attain to be ready after you graduate. This, of course, will require doing some research. Some helpful places to start are job descriptions and individual testimonials on websites.
  • If you know what education you want to attain but are still deciding the area you want to be in after you graduate, then look for reasons that excite you about your field of education and places you could be in with that degree. After that, see what opportunities, internships, or volunteer work you can possibly do to build connections with other individuals within the area you want to be in. At the end of the day, you never know what you’ll get out of that experience and how much it’ll shape your future.
  • What has helped many individuals during school is being open-minded. You may have a very general idea of what you want to do, but until you do it yourself or see it with your own eyes, you may not know if a certain career is or isn’t for you. For example, writing essays in undergrad might not have been your favorite thing to do, but that does not mean you won’t want to be a professional medical writer. Even though you are writing in both settings, it’s much different.

Prepare yourself ahead of time. Extracurriculars are one way that can help you attain skills while doing things outside of your coursework that exposes you to possible job prospects. It is important to take advantage of all the opportunities you can because once you graduate, it is not the same as when you are a student. Being a student, you have a special advantage that some forget to utilize to learn things from others. Remember that everything you did when you were a student has shaped you become a full-time employee. Make sure to strategically approach those years, so you can get the most out of them.

Often, we hear that connections are very important. Well, this is one example where your connections might help you. If you’re going into an entry-level job, residency, or fellowship, people before you had to go through the change from being a student to a full-time employee. Don’t forget to reach out to your connections to hear how they handled their transitions. Even though your post-graduate plans may be unique or your road in life is different from others, don’t disregard others’ experiences and opinions. Connecting with others makes you more educated about life. At the end of the day, what you do will be what’s best for you.  

Overall, transferable skills and preparing yourself ahead of time for that transition will help you in the long run. In the future, others may reach out to you to understand how you handled your career transition. You will be able to share your story at that time, and in sharing those experiences, you will be able to set the stage for other people’s success in their journey of finding their ideal career.

Dagmara Zajac

RxPharmacist Team

References:

  1. Transferable skills: How to use them to land your next job. Coursera. https://www.coursera.org/articles/transferable-skills. Accessed December 27, 2022.
  2. Tauchman ER. Great Student, great employee: How to make the transition. Default. https://www.comptia.org/blog/great-student-great-employee-how-to-make-the-transition. Published December 19, 2022. Accessed December 27, 2022.

The Importance of Medication Use Evaluation

Image: unsplash.com

The continued drug development expands the drugs available on the market for patients. How do we determine if patients are on the best drugs available? How do we determine if the drugs on the formulary for a given healthcare system are appropriate based on the market or trends seen within a healthcare system? The answer to these questions is in the importance of medication use evaluation (MUE). This type of evaluation does not provide answers to all the questions surrounding medication use but helps us get to a place of understanding, which can facilitate changes that are beneficial for patients in the long-term sense.

When discussing MUE, there are other processes needed to be addressed. Those processes are the drug utilization review (DUR) and the drug use evaluation (DUE). DUE and DUR are regarded as being synonymous with each other as these are ongoing drug therapy reviews. DUR is a quality assurance measure. For example, DUR encompasses three categories: prospective, concurrent, and retrospective. There are different categories for these drug therapy reviews depending on if we are addressing the drug review before dispensing, evaluating medication use during ongoing treatment, or reviewing therapy after treatment completion. Overall, DURs are put in place to ensure safety and efficacy of medication use.

DURs and DUEs are precursors to the MUE, which provides a more detailed performance tool for healthcare professionals. The difference that stands out about MUE from other processes is that it focuses on outcomes and quality of life. Well, the next question someone may ask is, “how do you know if an MUE needs to be initiated?” From the various MUE objectives, one can realize that the MUE process can begin for a variety of reasons. For example, it can be because of increased medication errors seen within a healthcare system, or the withdrawal of approved products. Depending on the objective to start an MUE, a therapeutic or process outcome is usually determined at the end. There are different types of MUE objectives, such as:

  • Patient safety improvement
  • Drug therapy optimization
  • Cost minimization
  • Innovative practices assessment

According to the American Society of Health System Pharmacists (ASHP), the framework one can utilize to begin the MUE process is FOCUS-PDCA:

  • Find
  • Organize
  • Clarify
  • Understand
  • Select
  • Plan
  • Do
  • Check
  • Act

Depending on the site utilizing this framework, the approach will differ. On the other hand, MUEs can have its limitations due to the lack of scope, poor documentation, or poor communication. Pharmacists are a very important component of these evaluations because of their expertise. Medication therapy management (MTM) is a big part of many pharmacists’ everyday jobs, and in the long run, MTM results in better patient outcomes. ASHP has a great guidelines documents for those interested in MUE and learning about its in-depth practices.

It is important to be aware of the various processes within systems that determine how patients are treated so they can ultimately receive the best outcomes. The MUE is a long process, but the findings from an MUE can help healthcare systems in various areas. As with any process, there are limitations, and for this reason it is important to have the right healthcare professionals assess these medication evaluations. 

Dagmara Zajac

RxPharmacist Team

References:

  1. ASHP guidelines on medication-use evaluation. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/medication-use-evaluation-current.ashx?la=en&hash=4927E9E8F085C17B19CA40AC0BAACBA229F47B07. Accessed December 23, 2022.
  2. Faley B, Fanikos J. Best Practices for Medication Utilization Evaluations in Postsurgical Pain Management. Curr Emerg Hosp Med Rep. 2017;5(1):33-40. doi:10.1007/s40138-016-0121-2
  3. Fanikos J, Jenkins KL, Piazza G, Connors J, Goldhaber SZ. Medication use evaluation: pharmacist rubric for performance improvement. Pharmacotherapy. 2014;34 Suppl 1:5S-13S. doi:10.1002/phar.1506
  4. Drug utilization review. AMCP.org. https://www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/drug-utilization-review. Accessed December 23, 2022.

Overview of the Direct Oral Anticoagulants

Image: unsplash.com

Direct oral anticoagulants (DOACs) are used to prevent thrombosis and are used for several different indications. This class of medication has stood out for several reasons, but the main reason was that this class of medication does not require regular laboratory monitoring compared to other anticoagulation drug classes. In many ways, anticoagulation guidelines and practices have changed with the addition of this therapeutic drug class. In 2010, the first DOAC dabigatran was approved by the Food and Drug Administration (FDA); since then, many more have been approved.

Dabigatran is categorized as the direct thrombin inhibitor DOAC compared to rivaroxaban and apixaban, which are categorized as the oral direct factor Xa inhibitor DOACs. By 2013, there were more prescriptions for DOACs compared to warfarin (vitamin K antagonist), which in previous years, was the commonly used form of anticoagulation by patients. The common FDA-approved indications for DOACs are the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), stroke prevention in nonvalvular atrial fibrillation (NVAF), prevention of recurrent DVT and PE, and many other indications. In addition, there are multiple off-label indications seen with this drug class as well.

There are considerations that need to be addressed when prescribing this class of medications. In terms of pharmacokinetics, there are comorbidities that may affect the efficacy of DOACs. For example, renal impairment, hepatic impairment, and body weight are all things to consider in patients initiating DOAC therapy. As mentioned previously, this drug class monitoring is different compared to previous methods of anticoagulation monitoring. Currently, there is no approved FDA-specific DOAC monitoring method; however, there are monitoring parameters that need to be performed in patients taking DOACs.

Patient education is critical when patients are beginning any anticoagulation medication. Anticoagulation medications are one of the therapeutic areas where a reversal agent for a class of medication is very beneficial due to the associated risk factors. When the first DOAC was approved, there was no reversal agent approved on the market. In 2015, FDA approved the first reversal agent for the first approved DOAC dabigatran. After that, in 2018, the next reversal agent was approved for apixaban and rivaroxaban.

For newer classes of medications, it is beneficial to be able to look at statistics to understand how receptive the healthcare systems and doctors are to adapting to new methods of treatment. The use of warfarin for atrial fibrillation between 2011 and 2020 decreased from 52.4% to 17.7%. In contrast, DOAC use for atrial fibrillation between 2011 to 2020 increased from 4.7% to 47.9%. It is apparent that these trends in oral anticoagulant use among patients with atrial fibrillation in community practice show an increased use of DOACs over warfarin.

In terms of anticoagulation methods for patients, DOACs have changed the standards of practice. Since the first DOAC was approved, there have been many advancements seen within this class of medications. This overview follows the current anticoagulant standards for patients. Perhaps in the near future, this drug class will continually expand and newer therapies will be introduced and implemented.

Dagmara Zajac

RxPharmacist Team

References:

  1. Chen A, Stecker E, A Warden B. Direct Oral Anticoagulant Use: A Practical Guide to Common Clinical Challenges. J Am Heart Assoc. 2020;9(13):e017559. doi:10.1161/JAHA.120.017559
  2. Navar AM, Kolkailah AA, Overton R, et al. Trends in Oral Anticoagulant Use Among 436 864 Patients With Atrial Fibrillation in Community Practice, 2011 to 2020. J Am Heart Assoc. 2022;11(22):e026723. doi:10.1161/JAHA.122.026723
  3. SavaysaÔ [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc., 2021.
  4. Direct oral anticoagulants (doacs). Blood Clots. https://www.stoptheclot.org/about-clots/blood-clot-treatment/direct-oral-anticoagulants/. Published October 4, 2018. Accessed December 20, 2022.

Pharmacy Entrepreneurs: A new career pathway in our uncertain economic climate

Image: unsplash.com

A pharmacy degree is a monumental stepping stone to opening your doors to a variety of jobs. There are three big job areas that pharmacists usually utilize their degree in, and that is a hospital, retail, or the pharmaceutical industry setting. The economic standpoint has influenced many to think outside the box and pursue areas that take more than just attaining a pharmacy degree. There are so many brilliant pharmacists that chose to take a different path, and many refer to that as the “nontraditional path.” These individuals have consequently changed the world job market and more importantly, changed the lives of patients because of their creativity, grit, and braveness.

There are individuals who chose to start their own pharmacies. Pharmacy is a growing field and individuals will require prescriptions, but it is not easy to compete against large chain pharmacies. Yet, individuals choose to go into that market because they see the good outcomesdespite the hurdles that they will most likely face along the way. From an economic standpoint, pharmacies are not usually affected by a recession, which makes it an appealing business market option. Other benefits of starting a business mean you can be your own boss, and there’s a work-life balance component seen in this field compared to others. There is a whole business factor to starting a pharmacy, but that has not discouraged people. They find ways to either educate themselves about it or partner with individuals to see their dream come to life.

An example of entrepreneurs that created something innovative and transformed the pharmacy business is TJ Parker and Elliott Cohen. Parker, after attending pharmacy school, worked for his father’s drug prepackaging business, and then met Cohen while working on an MIT contest. These individuals started PillPack, which prepackages patients’ medications by dosages and delivers it directly to them. PillPack was acquired by Amazon; they reportedly bought it for one billion dollars in cash. Overall, these individuals created something that, in the end, has helped many patients.

Looking at the future, we need to realize that pharmacy, like other healthcare fields, is being revolutionized because of entrepreneurs. Another entrepreneur took his degree and used it in another way to revolutionize the world with a healthy option for individuals. That individual is  Kun Yang, who graduated from pharmacy school and wanted something more than the regular 9 to 5 job in the long-term sense. Yang, along with a group of individuals, started and founded Pricklee. It is a drink that’s made from a cactus and is filled with antioxidants and electrolytes. This group, like others, identified an area that was missing something and created a beneficial product for many individuals.

There are so many things that have been discovered because of entrepreneurs who have the right innovative visions. With the ever-changing economic climate, for some, entrepreneurship is an appealing market to go into. Entrepreneurs must take all their skills and experiences and bring them forward to start something new. There are many ways to define pharmacy entrepreneurs, but in the overall sense, the common factor that drives these individuals to pursue entrepreneurship is their devoted passion to help others.

Dagmara Zajac

RxPharmacist Team

References:

  1. Desk N. Why opening a pharmacy is a good business choice. Advisory Excellence. https://www.advisoryexcellence.com/why-opening-a-pharmacy-is-a-good-business-choice/. Published June 30, 2022. Accessed December 16, 2022.
  2. Tindera M. 32-year-old founder sells his pharmacy startup to Amazon. Forbes. https://www.forbes.com/sites/michelatindera/2018/06/28/32-year-old-founder-sells-his-pharmacy-startup-to-amazon/amp/. Published June 28, 2018. Accessed December 16, 2022.
  3. Your medication, sorted and delivered. PillPack. https://www.pillpack.com/. Accessed December 16, 2022.
  4. Landi H. Making pharmacy more ‘amazon-like’: PillPack founder details Tech Giant’s push into drug delivery. Fierce Healthcare. https://www.fiercehealthcare.com/tech/making-pharmacy-more-amazon-like-pillpack-founder-details-tech-giant-s-push-into-drug-delivery. Published May 13, 2021. Accessed December 16, 2022.
  5. Paul S. Entrepreneurship and pharmacy: Is it possible? LinkedIn. https://www.linkedin.com/pulse/entrepreneurship-pharmacy-possible-sue-paul. Published February 20, 2021. Accessed December 16, 2022.
  6. Kun Yang: Superfruit and celebrating the small wins. YouTube. https://www.youtube.com/watch?app=desktop&v=2unvWHiDT8E. Published November 30, 2019. Accessed December 16, 2022.

Overview of Irinotecan and Topotecan: The Topoisomerase I Inhibitors

Image: unsplash.com

For DNA replication and cellular division to occur, topoisomerase I is required. It is an enzyme that creates and helps repair strands of DNA. In cancer cells, it has been shown that there is an increased activity of topoisomerases. This is why topoisomerase inhibitor medications have been used in many cancer therapies. Mainly topoisomerase I is responsible for relaxing supercoiled double strands of DNA, which then allows for replication to occur. The most common topoisomerase I inhibitor medications are irinotecan and topotecan.

In 1996, irinotecan and topotecan were approved for use in the United States. Camptothecin is another topoisomerase I inhibitor, and irinotecan and topotecan were originally derived from it. Camptothecin was isolated from the Camptotheca acuminata, which is a Chinese tree. Since its discovery and use, there have been fewer toxic analogues made.

Depending on the drug, indications can vary. Commonly, they are used in advanced colorectal, ovarian, and small-cell lung cancer. There are multiple regimens, and dose administration is dependent on the specific regimen cycle it is being used for. Irinotecan has been used with other therapies, such as 5-fluorouracil (5-FU) and leucovorin (LV). Hepatic adjustments may be seen with irinotecan because it is metabolized by the liver. Compared to topotecan, it is renally eliminated, which may result in possible renal adjustments in patients. Moreover, dosage and administration can sometimes vary based on the regimen, body weight, and other patient-specific factors.

What are the differences and similarities between liposomal irinotecan and irinotecan?

  • Liposomal form of irinotecan has a lipid bilayer
  • SN-38 is an active metabolite of both medications
  • The lipid bilayer prolongs irinotecan half-life, and it prevents it from converting to its active metabolite quicker
  • The liposomal form is used for treatment in patients with metastatic adenocarcinoma of the pancreas
  • These are not interchangeable medications

There are many chemotherapeutic medications that have extensive side effect profiles or adverse reactions associated with them. It is important to distinguish that there are acute and delayed adverse reactions. To overcome these acute and delayed adverse reactions, patients are pre-medicated. For example, the most notable toxicity seen with irinotecan is diarrhea, which is usually delayed. To overcome this, some patients will receive loperamide. Another example associated with irinotecan is its acute cholinergic syndrome, which can be treated with atropine. Overall, not all patients will be pre-medicated with the same regimens because there are patient-specific factors to account for prior to selecting treatments that mitigate and prevent adverse effects seen with these chemotherapeutic medications. The noticeable toxicities in topoisomerase I inhibitors are typically hematologic and gastrointestinal.

Irinotecan and topotecan have been used for a long time. It is important to notice that even though these medications are in the same drug class, they are not interchangeable. These medications are utilized for many different cancer types, such as advanced colorectal, ovarian, and small-cell lung cancer. Overall, staying up to date with new findings and the most current literature is important to ensure that patients receive the best-individualized therapy.

Dagmara Zajac

RxPharmacist Team

References:

  1. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Topoisomerase Inhibitors. [Updated 2020 Sep 12]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548372/
  2. Topoisomerase inhibitor. Topoisomerase Inhibitor – an overview | ScienceDirect Topics. https://www.sciencedirect.com/topics/neuroscience/topoisomerase-inhibitor#:~:text=Topoisomerase%20I%20inhibitors%20include%20irinotecan,etoposide%2C%20doxorubicin%2C%20and%20epirubicin. Accessed December 13, 2022.
  3. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Irinotecan. [Updated 2018 Apr 27]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548037/
  4. CAMPTOSAR®Dosage and Administration (irinotecan hcl). CAMPTOSAR® Dosage and Administration (irinotecan HCl) | Pfizer Medical Information – US. https://www.pfizermedicalinformation.com/en-us/camptosar/dosage-admin. Accessed December 13, 2022.
  5. Baker DE, Levien TL. Irinotecan Liposome Injection. Hosp Pharm. 2017;52(2):144-150. doi:10.1310/hpj5202-144
  6. HYCAMTIN® (topotecan) for injection, for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020671s023lbl.pdf. Accessed December 13, 2022.

Pseudomonas aeruginosa: An Overview of Transmission, Resistance, and Treatment

Image: unsplash.com

Pseudomonas aeruginosa is a type of bacteria that causes a variety of different infections. In 2012, there were roughly 46,000 individuals hospitalized due to multidrug-resistant Pseudomonas aeruginosa. Similarly in 2017, there were roughly 32,600 hospitalizations due to infections caused by this bacterium, and roughly 2,700 deaths occurred. It has been shown that between 2012 and 2017, the infections of multidrug-resistant Pseudomonas aeruginosa infections have been decreasing due to the continued efforts to prescribe the correct antibiotics.

Pseudomonas aeruginosa is an aerobic, gram-negative, non-sporing forming rod. It can be found in freshwater and the environment. Anyone can acquire this type of infection, but more commonly, it does affect individuals with weakened immune systems or those in hospital settings. The most common risk factors for patients in the hospital setting are catheters, surgery, and breathing machines. Individuals that are commonly infected are patients with cystic fibrosis, AIDS, neutropenia, burns, cancer, and organ transplantation. Overall, these bacteria can spread through contaminated surfaces, equipment, or by touching contaminated hands.

Antibiotics are used to treat these types of infections. This type of bacteria is affected by antibiotic resistance. Most commonly, patients are started on a broad-spectrum antibiotic. Local antibiograms should be used to determine the correct empiric therapy. If a patient has one or more risk factors for multi-drug resistant organisms, septic shock, respiratory failure with mechanical ventilation, or intensive care unit admissions, they may require double pseudomonal coverage. The drug classes commonly used are carbapenems, cephalosporins, aminoglycosides, fluoroquinolones, and others.

The specimen is sent off to the laboratory to confirm the exact type of bacteria that is growing. After that, the specific bacteria will be tested against all the antibiotics to determine which antibiotic it is susceptible. Next, narrowing down the antibiotic for the patient will ensure coverage of only that specific bacterium that is growing. Once the results come back, the antibiotic selection will be made based on the susceptibilities, the area where the bacteria are growing, and other patient-specific factors.

For this type of infection, it is important to make sure that the patient not only receives the appropriate antibiotic, but also the appropriate duration and dosage form as well. Oral and IV antibiotics selection is usually dependent on the infection itself and the site of infection. Patients might be required to be on extended courses of antibiotics to ensure that all the bacteria are killed. Sometimes, antibiotics are not the only form of action needed to get rid of the infection. If the infection is deep, patients may be required to take extended intravenous (IV) antibiotics and undergo surgical debridement. This is when interprofessional healthcare teams are important to select the appropriate treatments to make sure that the infection will be gone entirely.

Pseudomonas aeruginosa can cause serious types of infections. It most commonly affects patients in the hospital setting or immunocompromised patients. There are various antibiotics that can be used to treat these types of infections. Due to multidrug resistance seen with these bacteria, it is important to send off the specimen to the laboratory to ensure that physicians or other healthcare professionals can narrow the antibiotic that is susceptible so that it can get to the site of action. Sometimes in certain cases, antibiotics may not be the only form of treatment used for patients to get rid of these infections, which is why interprofessional teams in these situations are very beneficial in considering all specific factors to ensure patients receive the best care possible.

Dagmara Zajac
RxPharmacist Team

References:

  1. Wilson MG, Pandey S. Pseudomonas Aeruginosa. [Updated 2022 Aug 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557831/
  2. Pseudomonas aeruginosa infection. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/organisms/pseudomonas.html. Published November 13, 2019. Accessed December 10, 2022.
  3. 2019 antibiotic resistance threats report. Centers for Disease Control and Prevention. https://www.cdc.gov/drugresistance/biggest-threats.html. Published November 23, 2021. Accessed December 10, 2022.

Why is Antibiotic Stewardship Important?

Image: Unsplash.com

Antibiotics are commonly prescribed. In 2021, there were 211.1 million oral antibiotic prescriptions given by healthcare professionals in the outpatient setting. In other terms, that is an estimated 636 oral antibiotic prescriptions per 1000 individuals. To compare this to previous year’s statistics, in 2020, there were 201.9 million oral antibiotic prescriptions given by healthcare professionals in the outpatient setting, meaning 613 oral antibiotic prescriptions per 1000 individuals. Clearly, this shows that the number of antibiotic prescriptions keeps increasing.

Figure 1. Unnecessary Antibiotic Prescribing

According to the Centers for Disease Control (CDC), about 30 % of antibiotics are prescribed unnecessarily in the outpatient setting (See Figure 1). With that being said, it is crucial to discuss and understand the issue of antimicrobial resistance. Due to increased unnecessary prescribing of antibiotics, antimicrobial resistance is on the rise and it has become a serious matter and threat to not just local health, but also global public health. Since the pharmaceutical industry isn’t providing new drugs on the market to make up for the increase in antibiotic resistance, then what has been done to address this growing problem? One answer to that question is antibiotic stewardship programs. 

According to CDC 2021 annual report, the top 5 most common oral antibiotic classes prescribed in the United States were:
Figure 2. Percentages of the Top 5 Most Commonly Prescribed Oral Antibiotics

Due to antimicrobial resistance, antibiotics lose their effectiveness in fighting off infections. This has led to other implications, such as prolonged hospital stays, increased costs, treatment failures, and much more. On average, patients will be in the hospital for 13 days due to antimicrobial resistance. Therefore, multidrug resistance (MDR) has become a significant challenge in healthcare and has worsened the antimicrobial resistance issue. For example, globally, 500,000 new cases of MDR tuberculosis are diagnosed yearly. On top of everything, it has been shown that the COVID-19 pandemic has set to increase the threat of antimicrobial resistance as well. Overall, pharmaceutical companies have drifted away from this drug development area, which is why there has been a decrease in new antibiotic development for many years.

Antibiotic stewardship programs aim to help this growing problem by improving the use of antibiotics. Physicians and pharmacists have led the majority of antibiotic stewardship programs. These programs ensure that clinicians prescribe antibiotics only when it is necessary, prescribe antibiotics that cover the necessary infection, and do not expose patients to unnecessary antibiotics. To be in accordance with the Centers for Medicare and Medicaid Services, the Joint Commission made it a requirement for hospital settings to have antibiotic stewardship programs implemented. This is a huge win in reducing inappropriate antibiotic use. Antibiotic stewardship programs can be found in various settings, such as hospital settings, outpatient settings, nursing homes, and resource-limited settings. The CDC website has a page with core elements designated to each antibiotic stewardship program setting to understand that each program may differ depending on its location.

Antibiotic resistance has been on the uptrend for quite a while. It is important to know why antibiotics must be carefully prescribed. Antibiotic stewardship programs are one way that this growing problem is being addressed. Hopefully, we will see that antibiotic stewardship efforts have decreased the issue of antibiotic resistance over time.

References:

  1. Majumder MAA, Rahman S, Cohall D, et al. Antimicrobial Stewardship: Fighting Antimicrobial Resistance and Protecting Global Public HealthInfect Drug Resist. 2020;13:4713-4738. Published 2020 Dec 29. doi:10.2147/IDR.S290835
  2. Barlam TF. The state of antibiotic stewardship programs in 2021: The perspective of an experienced stewardAntimicrob Steward Healthc Epidemiol. 2021;1(1):e20. Published 2021 Aug 5. doi:10.1017/ash.2021.180
  3. Measuring outpatient antibiotic prescribing. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/data/outpatient-prescribing/index.html. Published October 5, 2022. Accessed December 1, 2022.
  4. Outpatient antibiotic prescriptions — United States, 2021. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/pdfs/Annual-Report-2021-H.pdf. Published October 7, 2021. Accessed December 1, 2022.
  5. Outpatient Antibiotic Prescriptions – United States, 2020. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/pdfs/Annual-Report-2020-H.pdf. Published October 7, 2021. Accessed December 1, 2022.
  6. Core elements of antibiotic stewardship. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/core-elements/index.html. Published April 7, 2021. Accessed December 1, 2022.

Common Beta Blockers: A Refresher

Image: Unsplash.com

There are roughly 30 million adults on a beta blocker in the United States. Beta-blockers have been around for a very long time. This class of medications has both been used for on and off-label purposes. Over the years, their usage has evolved and has been seen in various disease states. Overall, the indications that this class of medications have been utilized in, are heart failure, glaucoma, hypertension, anxiety, migraines, and many others. This beta blocker refresher will provide you with the overview that will potentially spark your interest to dive deeper into each medication discussed.

Most common beta-blockers have been recognized for being either selective beta blockers or non-selective beta-blockers:

Depending on which specific beta-blocker a patient is prescribed, it is important to provide education on that specific drug’s adverse effects. Individuals taking non-selective beta blockers may experience some side effects that are not seen with selective beta blockers due to their mechanism of action. For example, sotalol has a risk for QT prolongation because it blocks potassium channels. The adverse effects are dependent on the specific drug, but there are overall common side effects seen within this class of medications, such as fatigue, hypotension, dizziness, and bradycardia. The less common side effects that individuals should be aware of are insomnia, weight gain,  hepatotoxicity, and bronchospasm. Historically, beta-blockers have been contraindicated in patients with asthma due to their mechanism of action. Also, beta-blockers may mask the signs of hypoglycemia. Patients who have diabetes should be educated on what to do when on a beta blocker just in case they experience hypoglycemia. Beta-blockers, however, have their useful places in therapy. To illustrate, this class of medication has been utilized for its anxiolytic effect. An example is propranolol, which is often prescribed off-label for anxiety or to help with stage performance to reduce some peripheral symptoms associated with anxiety.

Other beta-blocker class pertinent details:
  • Individuals should monitor their blood pressure and heart rate while on this medication.
  • There are multiple formulations available on the market.
    • The most common routes of administration are oral, intravenous, or ophthalmic.
  • The dosage of these medications depends on the specific drug.
    • Some of these medications come in immediate release or extended release.
    • For example, propranolol ranges from 80 mg/day to 320 mg/day, which can be split into multiple doses daily due to its half-life.
  • Patients can be on this medication for an extended period of time.

Overall, this class of medication has been on the market for a long time; it is well-established compared to other classes of medications in terms of indications and side effect profiles. It is important to differentiate between selective and non-selective beta-blocker medications to understand their mechanism of action and their respective indications. A large patient population utilizes this class of medications, so it is extra important to keep up with new findings and updates. Hopefully, this refresher on beta-blockers has helped to provide you with beneficial information to continue delivering the best care in your own pharmacy setting.

Dagmara Zajac

RxPharmacist Team

References:

  1. Beta-blockers: Types, uses and side effects. Cleveland Clinic. https://my.clevelandclinic.org/health/treatments/22318-beta-blockers. Accessed November 28, 2022.
  2. What you should know about beta blockers. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/beta-blockers/art-20044522. Published August 13, 2021. Accessed November 28, 2022.
  3. Oliver E, Mayor F Jr, D’Ocon P. Beta-blockers: Historical Perspective and Mechanisms of Action. Rev Esp Cardiol (Engl Ed). 2019;72(10):853-862. doi:10.1016/j.rec.2019.04.006
  4. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Beta Adrenergic Blocking Agents. [Updated 2018 Jun 3]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548127/
  5. Farzam K, Jan A. Beta Blockers. [Updated 2022 Jul 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532906/
  6. Srinivasan AV. Propranolol: A 50-Year Historical Perspective. Ann Indian Acad Neurol. 2019;22(1):21-26. doi:10.4103/aian.AIAN_201_18