In this episode, we will discuss all things peripheral arterial disease – definitions, staging, clinical presentation, risk factors, goals of therapy, and guideline-directed medication therapy recommendations including the newest evidence for the use of DOACs.

Key Concepts

1. Addressing modifiable risk factors (weight loss, smoking cessation, blood pressure and blood glucose control, dyslipidemia, structured exercise program, etc.) are recommended for the treatment of PAD.
2. Single antiplatelet therapy with either aspirin 81 mg or clopidogrel 75 mg daily are recommended in patients to reduce stroke, MI and other vascular deaths in symptomatic (1A) and asymptomatic patients (IIa- C-EO).
3. Rivaroxaban 2.5 mg BID, when added to aspirin 81 mg daily, is superior to aspirin alone in preventing composite outcome of stroke, MI, and CV death in PAD patients with recent revascularization surgery for PAD but increases the risk of major bleeding.
4. In the absence of heart failure, cilostazol is effective in improving symptoms, quality of life, and increasing walking distance in patients with intermittent claudication. 

References

• Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e686–e725. https://doi.org/10.1161/CIR.0000000000000470
• Criqui MH, Matsushita K, Aboyans V, et al. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021;144:e171–e191. https://doi.org/10.1161/CIR.0000000000001005
• Alonso-Coello P, Bellmunt S, McGorrian C, Anand SS, Guzman R, Criqui MH, Akl EA, Vandvik PO, Lansberg MG, Guyatt GH, Spencer FA. Antithrombotic therapy in peripheral artery disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e669S-e690S. doi: 10.1378/chest.11-2307. PMID: 22315275; PMCID: PMC3278062.
• Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017; 377:1319-1330. https://www.nejm.org/doi/full/10.1056/nejmoa1709118
• Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in peripheral arterial disease after revascularization. N Engl J Med. 2020; 382:1994-2004. https://www.nejm.org/doi/full/10.1056/nejmoa2000052

In this episode, we review the management of a patient with hypokalemia, including both inpatient and outpatient supplementation with potassium chloride supplements and what dosage forms are available for potassium repletion.

Key Concepts

1. Most diets will provide sufficient potassium to avoid hypokalemia. Hypokalemia usually occurs due to drug therapy (such as diuretics) or GI losses from severe vomiting or diarrhea.
2. In patients with chronically low potassium, supplements are dosed to increase dietary intake of potassium by about 20-40 mEq per day. For acute repletion, 10 mEq of potassium should increase serum potassium by about 0.1 mEq/L.
3. Over-the-counter potassium (as potassium gluconate) contains a very small amount of potassium (2.5 mEq). Potassium chloride powders and liquids (like salt substitutes) taste terrible and are poorly tolerated. Most patients will replete potassium via slow-release tablets (Klor-Con or Klor-Con M) or via potassium chloride IV infusions.
4. Most IV fluids do not contain any potassium at all (or very little potassium). Patients receiving these IV fluids who are NPO will eventually become hypokalemic. Certain maintenance fluids do contain potassium – most patients will receive about 40 mEq of potassium per day with these IV fluids.

In this episode, we will define Digital Health, its categories and examples, describe how pharmacists are involved in DH practice, opportunities and limitations and future of DH. We will also discuss what implications DH has for educators, educational institutions, student pharmacists, pharmacists, and practice of pharmacy in general.

Key Concepts

1. Digital Health is currently a broad umbrella category that uses mobile health, telehealth, web-based platforms, personalized medicine, and IT to provide scalable patient care.
2. There are several focused areas within DH that would impact pharmacy practice by warranting pharmacist oversight or collaborative insights.
3. There is positive data for pharmacist-led DH interventions using mobile apps and web-based tools, but the use of telehealth modality has mixed results.
4. Pharmacists need to stay current in their knowledge and skills for utilizing DH tools in integrative and collaborative patient care.

References

• Aungst TD, Franzese C, Kim Y. Digital health implications for clinical pharmacists services: A primer on the current landscape and future concerns. J Am Coll Clin Pharm. 2020;4(4):514-524. DOI: 10.1002/jac5.1382. https://accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jac5.1382
• American Association of Colleges of pharmacies. Digital Health Workshop - Resources. https://www.aacp.org/resource/digital-health-workshop-resources (Lists resources from Digital Therapeutics Alliance and Digital Medicine Society)
• Park T, Muzumdar J, Kim H. Digital Health Interventions by Clinical Pharmacists: A Systematic Review. Int J Environ Res Public Health. 2022 Jan 4;19(1):532. doi: 10.3390/ijerph19010532. PMID: 35010791; PMCID: PMC8744767.

In this episode, we invite Dr. Amir Ali, PharmD, BCOP to discuss with us the pathophysiology, risk factors, prevention, and treatment clinical pearls of tumor lysis syndrome TLS).

Key Concepts

1. TLS is caused by rapid cell death of cancerous cells that results in intracellular contents “spilling” into the blood – this leads to high serum uric acid, high serum potassium, high serum phosphate, and LOW calcium.
2. These laboratory abnormalities cause acute kidney injury (via crystal formation in the kidney), arrhythmias (from hyperkalemia), and seizures (from high phosphate and low calcium).
3. Patients at highest risk for TLS are those with hematologic malignancies (lymphomas and leukemias), especially if WBC or LDH labs are very high.
4. Prevention is the Key! The primary prevention approach for TLS is hydration, allopurinol, and sometimes a low dose of rasburicase. The treatment of TLS involves more aggressive hydration and rasburicase.

References

• Coiffier B, Altman A, Pui CH, Younes A, Cairo MS. Guidelines for the management of pediatric and adult tumor lysis syndrome: an evidence-based review [published correction appears in J Clin Oncol. 2010 Feb 1;28(4):708]. J Clin Oncol. 2008;26(16):2767-2778. doi:10.1200/JCO.2007.15.0177
• Cairo MS, Coiffier B, Reiter A, Younes A; TLS Expert Panel. Recommendations for the evaluation of risk and prophylaxis of tumour lysis syndrome (TLS) in adults and children with malignant diseases: an expert TLS panel consensus. Br J Haematol. 2010;149(4):578-586. doi:10.1111/j.1365-2141.2010.08143.x
• Jones GL, Will A, Jackson GH, Webb NJ, Rule S; British Committee for Standards in Haematology. Guidelines for the management of tumour lysis syndrome in adults and children with haematological malignancies on behalf of the British Committee for Standards in Haematology. Br J Haematol. 2015;169(5):661-671. doi:10.1111/bjh.13403

In this episode, we review Paxlovid (nirmatrelvir/ritonavir) from the perspective of its pharmacology, efficacy, safety, pharmacists’ authority to prescribe, drug interactions, and rebound symptoms after Paxlovid therapy.

Key Concepts

1. Paxlovid is the preferred outpatient therapy for COVID-19 in patients at high risk for progressing to severe COVID-19. It likely has similar efficacy to IV monoclonal antibodies and IV outpatient remdesivir but differences in vaccination rates and patient populations makes a direct comparison difficult.
2. The 5-day course of Paxlovid is generally well tolerated. “Paxlovid mouth” (dysgeusia) is relatively common and is characterized by a terrible metallic or garbage-like taste in the mouth during therapy.
3. As of July 2022, licensed pharmacists have the authority to assess patients for Paxlovid and prescribe the therapy; however, Medicare/Medicaid reimbursement has not clearly established how reimbursement of clinical services can occur.
4. “Rebound” COVID-19 symptoms may or may not be due to Paxlovid (versus the natural course of the disease). If rebound symptoms occur, they are almost always mild or asymptomatic in nature and do not require additional treatment.

References

• DailyMed - PAXLOVID- nirmatrelvir and ritonavir kit (nih.gov). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bdddfba-bd31-44cb-ba9e-23a4e17a4691
• Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals. CDC. June 15, 2022. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
• EPIC-HR Study: Hammond J, Leister-Tebbe H, Gardner A, et al. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022;386(15):1397-1408. doi:10.1056/NEJMoa2118542. https://www.nejm.org/doi/full/10.1056/NEJMoa2118542
• COVID-19 Rebound After Paxlovid Treatment. CDC Health Alert Network. May 24, 2022. https://emergency.cdc.gov/han/2022/han00467.asp
• FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. Administration for Strategic Preparedness & Response (ASPR). July 6, 2022. https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-06July2022.aspx
• PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers. https://www.fda.gov/media/158165/download

In this episode, we will discuss mechanism, pharmacokinetics, efficacy, safety, and possible place in therapy for tirzepatide (Mounjaro), a new treatment for type 2 diabetes.

Key Concepts

1. Tirzepatide is a novel GIP and GLP-1 receptor agonist resulting in glucose-dependent secretion of insulin and a decrease in glucagon secretion.
2. This medication was FDA approved in May 2022 for the treatment of type 2 diabetes as an adjunct to diet and exercise. It is available as a long-acting once weekly pen injection to be administered subcutaneously.
3. Current efficacy data exist from a 40-week trial which showed that tirzepatide was superior to semaglutide in A1c reduction and weight loss.
4. The most common adverse effects of tirzepatide include GI concerns such as nausea, vomiting, and diarrhea as well as hypoglycemia.

References

1. Frias JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021;385:503-515. https://www.nejm.org/doi/full/10.1056/NEJMoa2107519
2. Mounjaro. Package insert. Elli Lilly and Company. 2022. 

In this episode, we will discuss the rationale behind the FDA approval of two new pneumococcal conjugate vaccines (PCV20 and PCV15), the characteristics of these vaccines, their place in therapy as recommended by the ACIP, and subsequent CDC immunization schedule changes.

Key Concepts

1. Pneumococcal disease is mainly caused by various serotypes of Streptococcus pneumoniae and presentation can vary from mild forms (sinusitis, otitis media) to more severe (pneumonia, bacteremia, or meningitis).
2. Previously we used PCV13 and PPSV23 vaccines for adults ages 18 years and older for prevention of pneumococcal disease, but the recommendations were rather complicated based on age, underlying condition/immune status, and vaccination status. 
3. Two new conjugate-type pneumococcal vaccines, PCV20 (Prevnar 20) and PCV15 (Vaxneuvance) are now approved by the FDA and were recently added to the CDC’s adult immunization schedules.
   These updated recommendations are more simplified where adults with high-risk conditions and those ages 65 years and older should receive either 1 dose of PCV20 vaccine or 1 dose of PCV15 and then 1 dose of PPSV23 a year later to complete their pneumococcal vaccine series.  
4. PCV15 is now FDA approved for children and updated recommendations for children have been voted upon by the Advisory Committee on Immunization Practices (ACIP) and will be final once it is made official policy by the CDC.

References and Resources

• Kobayashi M, Farrar JL, Gierke R, Britton A, Childs L, Leidner AJ, et al. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. 2022;71(4);109–117. https://www.cdc.gov/mmwr/volumes/71/wr/mm7104a1.htm?s_cid=mm7104a1_w
• Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Hall E., Wodi A.P., Hamborsky J., et al., eds. Washington DC: Public Health Foundation; 2021.
• Goldblatt D, O’Brien KL. Pneumococcal Infections. In: Loscalzo J, Fauci A, Kasper D, Hauser S, Longo D, Jameson J. eds. Harrison's Principles of Internal Medicine 21e. McGraw Hill; 2022. Accessed August 04, 2022.
• Wagner AL, Boulton ML. Pneumococcal Infections. In: Boulton ML, Wallace RB. eds. Maxcy-Rosenau-Last Public Health & Preventive Medicine, 16e. McGraw Hill; 2022. Accessed August 04, 2022.
• CDC’s PneumoRecs VaxAdvisor mobile app: https://www.cdc.gov/vaccines/vpd/pneumo/hcp/pneumoapp.html
• CDC’s Pneumococcal vaccine timing for adults: https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf

In this episode, we “deep dive” into diltiazem, describing its most important drug facts, pharmacology and medicinal chemistry, pharmaceutics, AB compatibility, and important medication safety issues.

Key Concepts

1. Diltiazem is a non-dihydropyridine calcium channel blocker (CCB). This type of CCB reduces both heart rate and blood pressure whereas dihydropyridine CCBs only reduce blood pressure.
2. Diltiazem has numerous dosage forms (IV, immediate release tablets, and extended-release products). Extended-release products are always dosed once or twice daily. Historically there were a significant number of extended-release capsules with a variety of brand names and AB-compatibility. Today, only a few branded products still exist in the US market (Cardizem CD, Cartia XT, Cardizem LA, Tiazac, Taztia XT).
3. The FDA Orange Book describes “AB” compatibility, which outlines whether one formulation is therapeutically equivalent to another formulation. Depending on state law, pharmacists can use AB compatibility codes to automatically substitute formulations without notifying the prescriber.
4. The numerous dosage forms of diltiazem is a medication safety issue. Remember that immediate release diltiazem is always dosed TID/QID (3-4 times per day) whereas extended-release formulations are always dosed once daily. A twice-daily extended-release product was previously on the market but has since been discontinued.

In this episode, the hosts of the HelixTalk reflect back on the history and making of HelixTalk to commemorate the 150th episode. We review each of our three favorite episodes and with a brief reflection on the episode content. We have come a long way from where we began and it is all thanks to the wonderful listeners and contributors who have a common thing in mind: a quest and thirst for knowledge!

Links to Previous Episodes:

1. #50 - Three shocking recommendations from CHEST 2016 that will blow your mind (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-50--three-shocking-recommendations-from-chest-2016-that-will-blow-your-mind/)
2. #29, 30, and 31 - Therapeutic Drug Monitoring (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-29--therapeutic-drug-monitoring-i/, https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-30--therapeutic-drug-monitoring-ii/, https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-31--therapeutic-drug-monitoring-iii/)
3. #111 - The Basics of Immune Checkpoint Inhibitors for Non-Oncology Healthcare Providers (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-111-the-basics-of-immune-checkpoint-inhibitors-for-non-oncology-healthcare-providers/)
4. #51 - Pharmacists to the rescue! (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-51--pharmacists-to-the-rescue/)
5. #124 - The ABCs of EUAs: Understanding FDA Emergency Use Authorizations (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-124-the-abcs-of-euas-understanding-fda-emergency-use-authorizations/)
6. #123 - Dr. Rosalind Franklin: Beyond Photo 51 (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-123-dr-rosalind-franklin-beyond-photo-51/)
7. #137 - It’s Time for PBM Reform: How PBMs Have Hurt Pharmacies and Increased Drug Costs (https://www.rosalindfranklin.edu/academics/college-of-pharmacy/helixtalk/helixtalk-episode-137-it-s-time-for-pbm-reform-how-pbms-have-hurt-pharmacies-and-increased-drug-costs/)

In this episode, we will cover a complete overview of definition, diagnosis, treatment and monitoring of iron deficiency anemia (IDA).

Key Concepts

1. Iron-deficiency anemia (IDA) is the most common type of nutritional anemia. The most common risk factors are insufficient dietary intake, malabsorption, and increased requirement states like pregnancy or blood loss.
2. Serum ferritin serves as the most confirmatory lab test for diagnosis of IDA. A low serum ferritin level usually indicates the presence of IDA. Other iron studies and CBC can be helpful in diagnosing IDA as well. 
3. Generally oral iron therapy is a well-accessible, inexpensive, safe, and effective approach for IDA treatment. Almost all PO options are equally effective and safe. Gastrointestinal adverse effects are common and can sometimes limit further dosing. 
4. Intravenous iron therapy is generally reserved for patients who are refractory or intolerant to PO treatment, have malabsorption of PO iron therapy, or have other health conditions such as chronic kidney disease, cancer, upcoming surgery, etc. Available IV options are equally effective and selection of an agent depends on insurance coverage, formulary inclusion, patient preference for test dose, frequency of dosing, etc. 

In this episode, we interview Hetal Patel, PharmD and RFUMS COP Alumni, regarding her career path that eventually led her to open Lebanon Family Pharmacy in TN in 2021. We discuss the challenges and opportunities of starting a new independent pharmacy and what the future of independent pharmacy looks like.

Key Concepts

1. Starting a new, independent pharmacy requires substantial planning 8 to 12 months before the pharmacy’s doors even open. New pharmacy owners need to consider a variety of factors such as location, type of building, a business plan with financial analysis, a variety of building and pharmacy inspections, paperwork and government approvals, and so much more.
2. PSAOs (pharmacy services administrative organizations) can be helpful, especially for new pharmacy owners, to serve as a liaison between the pharmacy and PBMs (pharmacy benefit managers) to negotiate reimbursement contracts. As owners gain more experience, there may be financial advantages to not using PSAOs and negotiating with PBMs directly.
3. Companies like “Health Mart” have a franchise-like model to provide products, services, documentation, policies and procedures, and more to independent pharmacies. These companies reduce the workload associated with running a pharmacy so that the pharmacy owners can focus their time and attention on the business itself and providing exceptional customer service.
4. There are a number of challenges to independent pharmacies – some of these challenges involve PBMs (DIR fees and MAC pricing) as well as unrestricted dispensaries in primary care clinics.

References

• Lebanon Family Pharmacy. https://lebanonfamilypharmacy.com/

In this episode, we review new updates and key concepts from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. This guideline is newly published (April 2022) and is a full update of the 2013 guidelines and the 2017 focused update for heart failure.

Key Concepts

1. Heart failure is classified as HFrEF (heart failure with reduced ejection fraction <= 40%), HFimpEF (with improved ejection fraction – was <=40% but is now > 40%), HFmrEF (ejection fraction 41% to 49% with increased LV filling pressures), and HFpEF (preserved ejection fraction >= 50% with increased LV filling pressures). Most drug therapy recommendations are similar for HFrEF, HFimpEF, and HFmrEF whereas HFpEF therapies are different.
2. The 2022 AHA/ACC/HFSA heart failure guidelines now recommend SGLT2 inhibitors, such as dapagliflozin and empagliflozin, in patients with HFrEF, HFmrEF, and HFpEF.
3. The 2022 AHA/ACC/HFSA heart failure guidelines continue to prefer ARNi, such as sacubitril/valsartan (Entresto), over ACE inhibitors and ARBs in patients with HFrEF. Based on the PARAGON-HF trial, ARNi is also recommended in those with HFpEF albeit with a weak recommendation.
4. Avoiding excessive dietary sodium is reasonable to reduce congestive symptoms in patients with heart failure; however, guidelines do not recommend a specific maximum intake nor does data support clinical outcome benefit with dietary sodium restriction.

References

• Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published online ahead of print, 2022 Apr 1]. Circulation. 2022;101161CIR0000000000001063. doi:10.1161/CIR.0000000000001063. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001063
• Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022;399(10333):1391-1400. doi:10.1016/S0140-6736(22)00369-5

In this episode, we discuss six newer antibiotics that target multidrug resistant gram negative bacteria with Dr. Christie Bertram, PharmD, BCIDP. We review common resistance mechanisms, particularly to carbapenems, and highlight the current role in therapy for the following antibiotics: ceftolozane/tazobactam (Zerbaxa®), ceftazidime/avibactam (Avycaz®), meropenem/vaborbactam (Vabomere®), imipenem/cilastatin/relebactam (Recarbrio®), cefiderocol (Fetroja®), and eravacycline (Xerava®).

Key Concepts

1. Ceftolozane/tazobactam (Zerbaxa®) is primarily used for multidrug resistant Pseudomonas; it does not cover carbapenemase-producing organisms and (despite the tazobactam) needs metronidazole for intra-abdominal anaerobic coverage.
2. Ceftazidime/avibactam (Avycaz®) is primarily used to cover CRE (Carbapenem-resistant Enterobacterales) but also has activity for many other gram negatives except Acinetobacter.
3. Meropenem/vaborbactam (Vabomere®) has similar coverage to Avycaz® but may provide coverage for certain KPCs (Klebsiella pneumoniae carbapenemase). Vaborbactam does not restore activity for meropenem-resistant Pseudomonas.
4. Imipenem/cilastatin/relebactam (Recarbrio®) has similar coverage to Avycaz® and Vabomere®; true niche in therapy is not yet well defined.
5. Cefiderocol (Fetroja®) uses a unique mechanism to enter gram negative bacteria and has a broad spectrum of activity against carbapenemase-producing bacteria and many other multidrug resistant gram negatives. It has no gram positive activity.
6. Eravacycline (Xerava®) is a tigecycline-like tetracycline with a broad spectrum of activity against carbapenemase-producing gram negative, gram positive, an anaerobic bacteria EXCEPT it lacks coverage for Pseudomonas.

References

• Yusuf E, Bax HI, Verkaik NJ, van Westreenen M. An Update on Eight "New" Antibiotics against Multidrug-Resistant Gram-Negative Bacteria. J Clin Med. 2021;10(5):1068. Published 2021 Mar 4. doi:10.3390/jcm10051068
• CDC Antibiotic Resistance Threats in the United States, 2019 report. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

In this episode, we bring in two guests to discuss the impact of professional advocacy and resulting professional advancements in the state of Illinois. These guests were the front-line agents of advocacy which resulted in pharmacists' ability to prescribe hormonal contraceptives for patients in Illinois (HB 135). We take a deep dive into their efforts to make this change possible, how it will impact patient care, and its implications on possibilities for further advancement of the pharmacy profession all the while highlighting the importance of professional advocacy.

In this episode, we interview Dr. Danyelle Martin, a Medical Science Liaison (MSL) at Moderna, in order to learn more about the what, how, and future of mRNA-based therapeutics, and what impact it can have on healthcare and healthcare professionals in general.

Key Concepts

1. Moderna has a “Research Engine” proprietary service that takes an mRNA idea from a web-based digital designer, to a digital ordering system, and finally to a production facility where mRNA constructs are synthesized and quality tested.
2. Pharmaceutics play a big role in the formulation of mRNA particles. Lipid nanoparticles (LNPs) play an important role for stability and delivery of mRNA cargo. After LNPs and mRNA are co-formulated, the product is purified, filtered, frozen, and subjected to a series of good manufacturing practice (GMP) tests to ensure product quality.
3. COVID-19 vaccines are a small glimpse into the potential future of mRNA-based therapeutics. Moderna’s pipeline includes mRNA vaccines for other viruses (including RSV, influenza, Zika and CMV) as well as therapeutics for non-viral diseases (including a personalized cancer vaccine and a VEGF-A mRNA molecule for myocardial ischemia).

In this episode, we review the diagnostic criteria and treatment strategy of hypothyroidism including the controversy surrounding brand versus generic levothyroxine and non-levothyroxine thyroid drugs.

Key Concepts

1. The most common cause of hypothyroidism is autoimmune thyroiditis - the body attacks the thyroid gland cells. Typically in hypothyroidism, TSH levels will be high and thyroid hormone levels (T3 and T4) will be normal or low.
2. Levothyroxine is the drug of choice to treat hypothyroidism. Doses should start low (to avoid cardiovascular side effects) and then be titrated up based on TSH levels.
3. All other thyroid hormone formulations (including Thyroid USP, Armour Thyroid, liothyronine, etc.) are NOT recommended for use in hypothyroidism. These are not FDA approved medications and there is no data showing these products are more effective than levothyroxine.
4. Generic formulations of levothyroxine are as effective and safe as brand-name Synthroid®. Although several levothyroxine formulations are AB compatible and can be interchanged by a pharmacist, patients should be maintained on the same formulation whenever possible.

References

• Dong BJ, Hauck WW, Gambertoglio JG, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA. 1997;277(15):1205-1213.
• Rennie D. Thyroid storm. JAMA. 1997;277(15):1238-1243.
• American Thyroid Association. https://www.thyroid.org/

In this episode, we will build up on our previous Weight loss Pharmacotherapy Episode, episode #13 to discuss updates in guidelines, prevention of obesity from comorbidity standpoint, and new treatment agents for weight-loss with a particular focus on Contrave (naltrexone/bupropion), Saxenda (liraglutide), and Wegovy (semaglutide).