HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast
Educational podcast presented by the Rosalind Franklin University College of Pharmacy. This podcast is produced by our pharmacy faculty to supplement study material and provide relevant drug and professional topics. We're hoping that our real-life clinical pearls and discussions will help you stay up-to-date and improve your pharmacy knowledge.
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191 - The Ultimate Guide to ARBs: An In-depth Drug Class Review
06/23/2025
191 - The Ultimate Guide to ARBs: An In-depth Drug Class Review
In this episode, we review the pharmacology, indications, adverse effects, monitoring, and unique drug characteristics of angiotensin receptor blockers (ARBs). Key Concepts ARBs are equally efficacious as ACE inhibitors when used for hypertension, heart failure with reduced ejection fraction (HFrEF), chronic kidney disease (CKD) with proteinuria, and post-MI care. Some limited evidence suggests that they might be better in reducing albuminuria in patients with diabetes. ARBs are generally better tolerated than ACEi due to a lower risk of angioedema and dry cough. While most ARBs are comparable to each other, small differences exists regarding hepatic metabolism (CYP metabolism for losartan, telmisartan, and azilsartan), degree of blood pressure lowering (generally better with azilsartan, olmesartan, valsartan, and candesartan), and additional pharmacological effects (telmisartan with PPAR-Y agonism, losartan with uricosuric effect). ARBs are contraindicated in pregnancy, those with bilateral renal artery stenosis, and those with previous angioedema to ARBs. The most common adverse effects include hypotension and hyperkalemia, but in rare cases acute renal impairment can also occur. Baseline serum creatinine and potassium should be monitored in patients taking ARBs. After initiation or dose adjustment, blood pressure, serum creatinine, and potassium should be repeated in 1-2 weeks. Signs and symptoms of hypotension as well as angioedema should be monitored throughout the treatment period.
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190 - Can’t Stop, Won’t Drop … The BP That Just Won’t Quit: Diagnosis and Treatment of Resistant Hypertension
05/29/2025
190 - Can’t Stop, Won’t Drop … The BP That Just Won’t Quit: Diagnosis and Treatment of Resistant Hypertension
In this episode, we discuss the diagnosis and treatment of resistant hypertension, including a newer endothelin receptor antagonist (ERA) called aprocitentan (Tryvio®). Key Concepts The diagnosis of true resistant hypertension is based on requiring more than 3 antihypertensives (ACE inhibitor or ARB + calcium channel blocker + diuretic) to achieve goal BP, ruling out inaccurate BP readings, and ensuring patient adherence to their antihypertensive therapy. Non-pharmacologic therapy (especially dietary sodium restriction), medication adherence, and lifestyle changes are critical to the treatment of resistant hypertension. The preferred 4th line option for most patients with resistant hypertension is spironolactone. After adding spironolactone, additional therapies are based on expert opinion and patient-specific factors. These additional therapies may include beta blockers, alpha-2 agonists, alpha-1 blockers, hydralazine, minoxidil, and aprocitentan. References Carey RM, Calhoun DA, Bakris GL, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018;72(5):e53-e90. doi:10.1161/HYP.0000000000000084 Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023;41(12):1874-2071. doi:10.1097/HJH.0000000000003480
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189 - Mice, Macrophages, and Metabolism: Browning Keeps Obesity at Bay
04/07/2025
189 - Mice, Macrophages, and Metabolism: Browning Keeps Obesity at Bay
In this episode, we discuss the very early stages of drug targets and drug development with Dr. Mohd Shahid, PhD. Dr. Shahid’s research involves the IER3 gene, which is an important modulator of the body’s inflammatory response via its action in major immune cells, including macrophages and T-cells, and plays a role in metabolic disorders such as obesity, diabetes, and atherosclerosis, revealing a previously unknown function of this protein. Key Concepts Drug development is a multi-decade journey – human clinical trials occur very late in the process. Drug development often starts before a drug molecule is even conceived by identifying potential drug targets. Chronic inflammation is important for a variety of diseases, including obesity and atherosclerosis. Dr. Shahid’s work focuses on a specific gene, Immediate Early Response 3 Gene (IER3 or IEX-1), and its role in modulating the inflammatory response in these disease states. The research process frequently leads to unexpected discoveries and new lines of inquiry. With Dr. Shahid, his work in obesity and inflammation actually led to a new understanding of the IER3’s role in the interplay between macrophages, inflammation, and energy expenditure. References Shahid M, Javed AA, Chandra D, et al. IER3 deficiency induces browning of white adipose tissue and resists diet-induced obesity. Sci Rep. 2016;6:24135. Published 2016 Apr 11. doi:10.1038/srep24135 Shahid M, Hermes EL, Chandra D, et al. J Am Heart Assoc. 2018;7:e009261. DOI: 10.1161/JAHA.118.009261. Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-2207. doi:10.1056/NEJMoa0807646 Tardif JC, Kouz S, Waters DD, et al. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019;381(26):2497-2505. doi:10.1056/NEJMoa1912388
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188 - The Clot Thickens: Key Updates from the 2025 Acute Coronary Syndromes Guidelines
03/14/2025
188 - The Clot Thickens: Key Updates from the 2025 Acute Coronary Syndromes Guidelines
In this episode, we review the new 2025 ACC/AHA Acute Coronary Syndrome (ACS) guidelines, with a particular focus on guideline recommendations for analgesics, P2Y12 inhibitors, parenteral anticoagulation, and lipid management. Key Concepts Nitrates and opioids are recommended for symptomatic relief of chest pain. Some patients may not be appropriate for nitrates (e.g. recent PDE-5 inhibitor use, hypotension, or right ventricular infarction). Opioids are used for nitrate-refractory angina but have a theoretical risk of delaying the effect of oral antiplatelet medications. Prasugrel and ticagrelor are preferred P2Y12 inhibitors over clopidogrel in most patients. Patient-specific factors, including the use of PCI, play a role in P2Y12 inhibitor selection. Anticoagulation with heparin is recommended in nearly all acute coronary syndrome (ACS) scenarios. Alternative anticoagulants may be used depending on whether PCI/CABG is planned and whether the anticoagulant is used prior to PCI/CABG (“upstream”) or during the PCI procedure itself. LDL goals after ACS have changed again. All ACS patients should have an LDL goal < 70 with a consideration of an LDL goal of 55-69. A variety of non-statin therapies may be added to a high intensity statin regimen if LDL is not at goal. References Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Published online February 27, 2025. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001309
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187 - Infectious Ambitions: A Pharmacist's Career Pivot from Clinical to Industry
01/23/2025
187 - Infectious Ambitions: A Pharmacist's Career Pivot from Clinical to Industry
In this episode, we interview Morgan Anderson, PharmD, BCIDP, a graduate of the RFUMS College of Pharmacy, about her career path from a pharmacy resident, emergency medicine specialist, infectious diseases specialist, and now a medical sciences liaison. The views, thoughts, and opinions expressed in this podcast are solely Dr. Anderson’s own and do not necessarily reflect the views, positions, or policies of her employer. This podcast is conducted in a personal capacity, and any reference to her professional background is for context only. Key Concepts Having a wide breadth of skills and making yourself marketable is important when transitioning between jobs or career paths. Skills like communication and teamwork can be improved and are applicable to a wide variety of careers within pharmacy. Medical Science Liaisons (MSLs) are a common role for pharmacists in the pharmaceutical industry. MSLs are field-based roles within the medical affairs department of the company. MSLs are medical and scientific experts who build collaborative relationships with key thought leaders, facilitate exchange of scientific information and insights, and serve as a conduit between these thought leaders and other areas of the company. Two common career paths to pharmacists becoming an MSL are via a fellowship program or after years in clinical practice. A fellowship program provides a more structured approach, including mentoring and networking, with access to a variety of areas of the company outside of medical affairs. A pathway after clinical practice is more self-directed with less structure, but provides pharmacists with a strong clinical background that can be helpful in an MSL role. Being a scientific communicator, possessing strong emotional intelligence, and being adaptable are critical soft skills that are essential for success in an MSL role. These soft skills can be improved with practice! References
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186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss
12/12/2024
186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss
In this episode, we discuss the efficacy and safety of semaglutide and tirzepatide for weight loss with a particular focus on the legal, regulatory, and safety aspects of these “compounded” GLP-1 receptor agonist medications. Key Concepts Semaglutide and tirzepatide have growing evidence that their clinical benefits extend beyond the treatment of diabetes. Evidence now shows benefit in a variety of obesity-related disease states regardless of a patient’s diabetes status. Insurance coverage and drug cost is a major barrier to these medications, with cash prices exceeding $1000 per month in the US. There are many companies that are combining telemedicine visits with “compounded” GLP-1s to provide these medications at a reduced cost. The Food, Drug, and Cosmetic (FD&C) Act regulates compounded drugs. These regulations provide the legal context for pharmacies to compound GLP-1 medications. These regulations describe who can compound, what drugs can be compounded, and other unique circumstances (e.g. compounding in the context of a drug shortage). The FDA has released warnings regarding safety risks of compounded GLP-1s. The main safety concern is dosing errors; however, the warnings also include concerns of patients accessing drug products that are outside of the legal scope of the FD&C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns. References Karagiannis T, Malandris K, Avgerinos I, et al. Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Diabetologia. 2024;67(7):1206-1222. doi:10.1007/s00125-024-06144-1 Müllertz ALO, Sandsdal RM, Jensen SBK, Torekov SS. Potent incretin-based therapy for obesity: A systematic review and meta-analysis of the efficacy of semaglutide and tirzepatide on body weight and waist circumference, and safety. Obes Rev. 2024;25(5):e13717. doi:10.1111/obr.13717 Jastreboff AM, Le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal of Medicine. 2024. Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (CMS-4208-P). Human Drug Compounding. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care. 2024 Dec 2:dci240091. doi: 10.2337/dci24-0091.
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185 - They Are Late, but Don’t Stress: The New 2024 Stress Ulcer Prophylaxis Guidelines
10/04/2024
185 - They Are Late, but Don’t Stress: The New 2024 Stress Ulcer Prophylaxis Guidelines
In this episode, we review the recommendations from the 2024 SCCM/ASHP stress ulcer prophylaxis guidelines and highlight three of the more recent landmark critical care trials investigating the role of stress ulcer prophylaxis. Key Concepts After 25 years, the stress ulcer prophylaxis guidelines have been updated by SCCM and ASHP. These guidelines make 13 recommendations in a PICO format. Three large, landmark randomized controlled trials (SUP-ICU, PEPTIC, and REVISE) have significantly contributed to the body of literature regarding stress ulcer prophylaxis. The SCCM/ASHP guidelines recommend stress ulcer prophylaxis in patients with coagulopathy, shock, chronic liver disease, and possibly in neurocritical care patients. They do not specifically recommend prophylaxis in mechanically ventilated patients; this is a controversial recommendation. The SCCM/ASHP guidelines equally prefer proton pump inhibitor (PPI) and histamine-2 receptor antagonists (H2RA) drug therapies given either intravenously or orally. The prophylaxis regimen should be continued until the indication for prophylaxis has resolved or the patient leaves the ICU. References MacLaren R, Dionne JC, Granholm A, et al. Society of Critical Care Medicine and American Society of Health-System Pharmacists Guideline for the Prevention of Stress-Related Gastrointestinal Bleeding in Critically Ill Adults. Crit Care Med. 2024;52(8):e421-e430. doi:10.1097/CCM.0000000000006330 SUP-ICU study. Krag M, Marker S, Perner A, et al. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018;379(23):2199-2208. doi:10.1056/NEJMoa1714919 PEPTIC study. PEPTIC Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group, Alberta Health Services Critical Care Strategic Clinical Network, and the Irish Critical Care Trials Group, Young PJ, Bagshaw SM, et al. Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial. JAMA. 2020;323(7):616-626. doi:10.1001/jama.2019.22190 REVISE study. Cook D, Deane A, Lauzier F, et al. Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation. N Engl J Med. 2024;391(1):9-20. doi:10.1056/NEJMoa2404245
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184 - Drop it Like it’s Hot! Deprescribing Pharmacotherapy When Appropriate
08/09/2024
184 - Drop it Like it’s Hot! Deprescribing Pharmacotherapy When Appropriate
In this episode, we discuss the approach to deprescribing for several drugs such as benzodiazepine receptor agonists, cholinesterase inhibitors, memantine, antipsychotics, and antihyperglycemics. Key Concepts Medication appropriateness including indication and risk vs. benefit should be evaluated for all stages of life; however, more importantly in older individuals to address polypharmacy. There is an emerging trend of deprescribing networks that conduct research and provide evidence-based recommendations for how to deprescribe certain medications used for specific indications. Evidence-based deprescribing guidelines for PPIs, benzodiazepines, benzodiazepine receptor agonists, opioids, antipsychotics, cholinesterase inhibitors, memantine, and antihyperglycemics are available for patient-provider shared decision making. A general deprescribing approach is gradual tapering of the drug leading to discontinuation over several weeks while monitoring patients for withdrawal symptoms or benefits of discontinuation. References http://deprescribing.org https://www.australiandeprescribingnetwork.com.au
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183 - The Ultimate Guide to Loop Diuretics: An In-Depth Drug Class Review
06/28/2024
183 - The Ultimate Guide to Loop Diuretics: An In-Depth Drug Class Review
In this episode, we review the pharmacology, pharmacokinetics, adverse effects, monitoring, medicinal chemistry, and more of loop diuretics. Key Concepts Loop diuretics (furosemide, torsemide, bumetanide, ethacrynic acid) are the most potent type of diuretic and are used to relieve edema. Loop diuretics cause an increased loss of sodium, chloride, potassium, hydrogen, magnesium, and calcium ions into the urine. Excessive loss of these ions manifests as hypokalemia, hypomagnesemia, and metabolic alkalosis. Loop diuretics have an S-shaped dose response curve – a minimum dose is required for diuresis and a “ceiling” effect occurs at higher doses (leading to more ADRs). Doses should be individualized based on the clinical response of the patient. Ethacrynic acid is incorrectly used in patients with a “sulfa” allergy. The other loop diuretics contain a sulfa moiety but are safe for use in patients with “sulfa” allergy (e.g. allergy to sulfamethoxazole-trimethoprim). The TRANSFORM-HF trial strongly suggests that there is no clinical difference between furosemide and torsemide. References Rachoin JS, Cerceo EA. Four nephrology myths debunked. J Hosp Med. 2011;6(5):E1-E5. doi:10.1002/jhm.703 Strom BL, Schinnar R, Apter AJ, et al. Absence of cross-reactivity between sulfonamide antibiotics and sulfonamide nonantibiotics. N Engl J Med. 2003;349(17):1628-1635. doi:10.1056/NEJMoa022963 Buggey J, Mentz RJ, Pitt B, et al. A reappraisal of loop diuretic choice in heart failure patients. Am Heart J. 2015;169(3):323-333. doi:10.1016/j.ahj.2014.12.009 Mentz RJ, Anstrom KJ, Eisenstein EL, et al. Effect of Torsemide vs Furosemide After Discharge on All-Cause Mortality in Patients Hospitalized With Heart Failure: The TRANSFORM-HF Randomized Clinical Trial. JAMA. 2023;329(3):214-223. doi:10.1001/jama.2022.23924
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182 - 2023 Beers Criteria Update: Navigating Medications Safely in Older Patients
05/08/2024
182 - 2023 Beers Criteria Update: Navigating Medications Safely in Older Patients
In this episode, we discuss principles for medication use in the geriatric patient population and summarize the updated 2023 American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Key Concepts The Beer’s Criteria was originally developed by Dr. Mark Beers in 1991 to identify medications in which the risks may outweigh the benefits in nursing home patients. This list is now maintained by the American Geriatrics Society and includes a variety of drug safety information related to elderly patients including medications that are considered potentially inappropriate (Table 2 and 3), medications used with caution (Table 4), drug-drug interactions (Table 5), drugs with renal dose adjustments (Table 6), and drugs with anticholinergic properties (Table 7). The newest update prefers apixaban over other DOACs for VTE and atrial fibrillation in elderly patients. This is a very controversial recommendation given that other guidelines (e.g. from the ACC/AHA) have not published a similar preference of one DOAC over another. Many of the medications that are potentially inappropriate involve drugs that have anticholinergic properties and drugs that increase the risk of incoordination and falls. Other resources exist to guide drug therapy decisions in elderly patients. As an example, the STOPP/START criteria (published in the European Geriatric Medicine journal) outlines drugs to avoid but also drugs to consider in elderly patients. References By the 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 Updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J AM Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372. O'Mahony D, Cherubini A, Guiteras AR, Denkinger M, Beuscart JB, Onder G, Gudmundsson A, Cruz-Jentoft AJ, Knol W, Bahat G, van der Velde N, Petrovic M, Curtin D. STOPP/START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023 Aug;14(4):625-632. doi: 10.1007/s41999-023-00777-y.
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181 - From Meds to Machine Learning: How AI is (and will) Revolutionizing Pharmacy Practice
04/16/2024
181 - From Meds to Machine Learning: How AI is (and will) Revolutionizing Pharmacy Practice
In this episode, we discuss artificial intelligence large language models (LLMs) and how these will impact the future of the practice of pharmacy. Key Concepts Generative AI with large language models (LLMs) have already changed how healthcare is delivered to patients. In the future, these changes will be more substantial and require pharmacists and other healthcare professionals to understand the benefits and downsides of this technology. Commercial LLMs, such as ChatGPT, are not HIPAA compliant and should not be used with protected health information. Companies currently offer software products that are HIPAA compliant and can integrate directly into electronic health records in a HIPAA-compliant manner. Currently, most commercial use cases of LLMs for healthcare providers focus on expediting or simplifying the documentation process (e.g. generating a first draft of a progress note or summarizing a patient encounter from an audio recording). In the future, LLMs will be used to perform a variety of clinical tasks, including drug interaction checking, renal dose adjustments, duplication of therapy, and even the appropriateness of a patient’s drug regimen for a given medical condition. These clinical tasks will almost certainly be done as a “first pass” to highlight or flag specific aspects of a patient’s chart and will then be reviewed by a licensed (human) healthcare provider as a final check prior to clinical decisions being made. References Large Language Models (LLMs) referenced in the episode: , , , . Prompt Engineering Guide () OpenAI - Prompt engineering ()
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180 - The Ultimate Guide to Statins: An In-Depth Drug Class Review
03/26/2024
180 - The Ultimate Guide to Statins: An In-Depth Drug Class Review
In this episode, we review the pharmacology, indications, adverse effects, monitoring, and unique drug characteristics of HMG CoA reductase inhibitors (“statins”). Key Concepts Statins reduce LDL cholesterol by 20-60% (depending on the dose and statin potency). They have modest favorable effects on HDL and triglycerides. Clinically, statins reduce the risk of major adverse cardiac events by about 30% depending on the statin potency. There are four main groups of patients who are indicated for a statin: LDL >= 190 mg/dL, diabetes with age 40-75 years with LDL 70-189 mg/dL, those with an elevated 10-year ASCVD risk of > 7.5% (or possibly > 5%), and those who have had an ASCVD event (“secondary prevention”). Atorvastatin, lovastatin, and simvastatin heavily rely on CYP 3A4 metabolism and tend to be most susceptible to drug interactions compared to the other statins. When a statin is started, baseline lipid panel and liver function tests should be obtained. After 4-12 weeks, a lipid panel should be repeated. Liver function and creatine kinase testing should only be done if a patient has a symptom (e.g. jaundice, right upper quadrant pain, muscle pain or weakness, dark urine, etc.) References Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143.
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179 - Annual Dose of Sweetness: 2024 Updates from the American Diabetes Association Guidelines
03/05/2024
179 - Annual Dose of Sweetness: 2024 Updates from the American Diabetes Association Guidelines
In this recurring episode, we discuss the important updates from the 2024 American Diabetes Association Guidelines! Key Concepts Tirzepatide is now recommended as one of the weight loss pharmacotherapy options along with semaglutide in patients with diabetes. The language for its use in comparison to insulin therapy has been updated similar to GLP-1RAs. The new hypoglycemia section in chapter 6 now houses all recommendations regarding screening, education, prevention, and treatment of hypoglycemia. The recommendation for prescribing glucagon has been clarified - regardless of type of diabetes, it is recommended that glucagon be prescribed to all patients using insulin or those who are at high risk with proper education of family members or caregivers. Teplizumab, a monoclonal antibody against CD30, is available for preventing progression of stage 2 type 1 diabetes to stage 3 type 1 diabetes. Guidelines have updated screening criteria for staging type 1 diabetes and recommends use of teplizumab in these patients. Other updates revolve around emphasis of using diabetes technology such as CGMs and AID for appropriate patients, clarified or strengthened screening recommendations for type 1 staging, peripheral arterial disease, bone mass density, etc., and emphasis on weight management alongside meeting glycemic goals. References American Diabetes Association. Standards of Care in Diabetes - 2024. Diabetes Care. 2024;47(1):S1-S322. Available at: .
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178 - Law & Order: Pharmacy Edition. A Concise Review of High-Yield Pharmacy Law Topics for the MPJE
02/13/2024
178 - Law & Order: Pharmacy Edition. A Concise Review of High-Yield Pharmacy Law Topics for the MPJE
In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen especially for graduates preparing for their MPJE exam after graduation! Key Concepts The FDA (via the Food, Drug, and Cosmetic Act) primarily regulates manufacturers. Most regulation for pharmacies and pharmacists is via the federal Controlled Substances Act and state-based regulations (acts and administrative codes). An IND (investigational drug application) is required to begin human clinical trials (phase I-III). An NDA (new drug application) is used for the FDA to consider whether a drug should be approved for use in the US. The Federal Controlled Substances Act outlines which drugs are scheduled I-V. State law can be more restrictive. C-II drugs have special regulations related to prescribing, ordering/distribution, refills, partial fills, etc. In Illinois, pharmacists, student pharmacists, and pharmacy technicians are permitted to vaccinate patients aged 7 years and older (or temporarily 3 years and older per the PREP act for COVID-19 and influenza vaccines). Pharmacists can order and administer COVID-19 and influenza vaccines; other vaccines require a standing order or a prescription in order prior to administration in a pharmacy. References Illinois Pharmacy Practice Act (225 ILCS 85) Illinois Pharmacy Practice Act Administrative Code (Part 1330): Illinois Controlled Substances Act (720 ILCS 570) Illinois Controlled Substances Act Administrative Code (Part 3100) Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. Drug Enforcement Administration.
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177 - The Antidote Arsenal: Exploring the Emergency Toolbox for Anticoagulant Reversals
01/23/2024
177 - The Antidote Arsenal: Exploring the Emergency Toolbox for Anticoagulant Reversals
In this episode, we review evidence-based guidelines for the emergency reversal of warfarin, dabigatran, and the oral Xa inhibitors (apixaban, edoxaban, and rivaroxaban). Key Concepts Reversal of anticoagulation is indicated in patients with major hemorrhage or when emergency surgery is necessary. Reversal of warfarin (Coumadin®) involves a fast-acting, short-term solution (usually prothrombin complex concentrates [PCC]) and a slower-acting, long-term solution (intravenous vitamin K). Idarucizumab (Praxbind®) is the preferred reversal strategy for dabigatran (Pradaxa®). Idarucizumab is a monoclonal antibody fragment specific that binds and inactivates dabigatran. If idarucizumab is unavailable, PCCs are recommended. Andexanet alfa (Andexxa®) is the preferred reversal strategy for oral Xa inhibitors and has FDA approval specific to apixaban and rivaroxaban. Andexanet alfa is a decoy factor Xa protein with higher binding affinity than human clotting factor Xa. There are several barriers to use with andexanet alfa that has led to low utilization in hospitals. If andexanet alfa is unavailable, PCCs are recommended. References Baugh CW, et al. Anticoagulant Reversal Strategies in the Emergency Department Setting: Recommendations of a Multidisciplinary Expert Panel. Ann Emerg Med. 2020;76(4):470-485. Cuker A, Burnett A, Triller D, et al. Reversal of direct oral anticoagulants: Guidance from the Anticoagulation Forum. Am J Hematol. 2019;94(6):697-709. doi:10.1002/ajh.25475 Tomaselli GF, et al. 2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020;76(5):594-622.
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176 - Hormonal Harmony: A Pharmacist’s Guide to Hormonal Contraceptives (Part 2)
01/02/2024
176 - Hormonal Harmony: A Pharmacist’s Guide to Hormonal Contraceptives (Part 2)
In this two part episode, we review some of the most important clinical pearls in the pharmacotherapy and practice aspects of hormonal contraceptives with a brief focus on the very first FDA approved OTC hormonal contraceptive product (Opill). Key Concepts (Part 2) Missed dose instructions are particularly important with progestin only pills (POPs). Patients should take POPs at the same time (within 3 hours) each day - missing a dose beyond this 3 hour window is considered a missed dose and requires barrier contraception. There are a wide variety of hormonal contraception options for patients - each with its own unique advantages and disadvantages. Shared decision making between a healthcare provider and a patient is critical to selecting the most appropriate form of contraception! The CDC's Medical Eligibility Criteria (MEC) is an important resource to guide prescribers with regards to selecting hormonal contraception and also in identifying the clinical significance of a variety of drug interactions with hormonal contraception. One of the most important aspects of hormonal conctraception is adequate patient follow-up. Especially given the wide variety of hormonal contraception options, patients may need to switch their contraceptive multiple times until they find one that works best for them. Close follow-up and patient counseling are pivotal for helping a patient identify their optimal regimen. References CDC Selected Practice Recommendations for Contraceptive Use. 2016. CDC Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. 2016.
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175 - Hormonal Harmony: A Pharmacist’s Guide to Hormonal Contraceptives (Part 1)
12/13/2023
175 - Hormonal Harmony: A Pharmacist’s Guide to Hormonal Contraceptives (Part 1)
In this two part episode, we review some of the most important clinical pearls in the pharmacotherapy and practice aspects of hormonal contraceptives with a brief focus on the very first FDA approved OTC hormonal contraceptive product (Opill). Key Concepts (Part 1) The effectiveness of contraceptives varies based on “ideal use” (e.g. in a clinical trial with optimal compliance) versus “typical use” (e.g. real-world effectiveness in patients who may sometimes be less adherent than in clinical trials). Oral, patch, and ring-based hormonal contraceptives (combination estrogen-progestin or progestin-only formulations) with “typical” use are about ~90% effective, meaning in one year there are ~10 unplanned pregnancies with these contraceptive options. When using an estrogen-based oral contraceptive, the estrogen dose should be initiated at a low dose (25 mcg or less per day of ethinyl estradiol). The dose of estrogen may need to be increased if breakthrough bleeding occurs in the early/mid cycle despite being on therapy for at least 6 months. Breakthrough bleeding later in the cycle is typically due to an inadequate progestin dose. In general, manufacturers do not provide multiple different formulations with different progestin doses; therefore, if late breakthrough does occur, an alternative formulation with a different progestin should be considered. If a patient misses one dose of a combination oral contraceptive, they should take the missed dose as soon as possible (even taking two doses at once if they remember when the next dose is due). If two or more doses are missed, the package insert should be consulted for instructions – management depends on the timing of the cycle, recency of unprotected sex, and other factors. References CDC Selected Practice Recommendations for Contraceptive Use. 2016. CDC Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. 2016.
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174 - Finding Your Mount Rushmore: The Journey of an Industry Pharmacist
12/04/2023
174 - Finding Your Mount Rushmore: The Journey of an Industry Pharmacist
In this episode, we interview Scott Glosner, PharmD, MPH, BCPS about his extensive experience working at Pfizer in medical outcomes and as a field medical director. Dr. Glosner will share his career journey from a clinical pharmacist transitioning into the pharmaceutical industry in the late 1990s and what current pharmacists and students should know about a job in a pharmaceutical company. Key Concepts Pharmacists are playing an increasingly important role within the pharmaceutical industry. Prior clinical experience is a significant advantage to applicants for these positions. Key characteristics of a competitive pharmacist applicant for an industry position include strong communication skills, being perseverant (“tough skin”), being extremely persistent, and having real-world clinical experience. Different companies and job positions within industry often require differing amounts of prior experience. Applicants with more than several years of experience (or equivalent fellowship experience) may be more competitive for positions. Standing out in any way, whether board certification, doing research, networking, etc. is important for any applicant. In the future, pharmacists in industry may be playing a greater role in the oncology space, social determinants of health, emerging topics (such as gene therapy), and being capable of analyzing and interpreting “real world” clinical trial data. Questions for Dr. Scott Glosner? He can be reached at [email protected] or on LinkedIn ().
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173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)
10/31/2023
173 - Balancing Access and Safety: The FDA's Prescription Drug Risk Mitigation Strategy (REMS)
In this episode, we will discuss the definition of REMS (Risk Evaluation and Mitigation Strategies), why they exist, the role of FDA in administering REMS, types and examples of REMS, and how they impact pharmacy practice. Key Concepts The REMS (Risk Evaluation and Mitigation Strategies) program was developed in 2007 as part of the FDA’s drug risk management strategies designed to balance risk and benefits of certain drugs. Elements of REMS vary depending on the drug, but commonly include medication guides, communication plans, and other elements to assure safe use. REMS can require patients, providers, and pharmacies to take certain actions including training, registration, enrollment, safety monitoring, documentation of safety concerns, and follow prescribing and dispensing regulations. The FDA captures and assesses data on a regular basis to make changes in the REMS program. It also has authority to enforce compliance and take punitive actions against non-compliant parties. References Risk Evaluation and Mitigation Strategies. Food and Drug Administration. May 16, 2023. Accessed October 17, 2023.
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172 - Battle of the Clot Busters: Alteplase vs. Tenecteplase for Acute Ischemic Stroke
10/10/2023
172 - Battle of the Clot Busters: Alteplase vs. Tenecteplase for Acute Ischemic Stroke
In this episode, we review the role and indications of thrombolytics in acute ischemic stroke. The efficacy, safety, administration considerations, and cost between alteplase and tenecteplase are compared and contrasted. Key Concepts Alteplase (Activase) is a recombinant DNA version of human TPA (tissue plasminogen activator). Tenecteplase (TNKase) is similar to human TPA except it has three amino acid changes that result in a longer half-life and higher fibrin specificity. In patients with stroke, alteplase is given as a bolus followed by a 60-minute infusion. Tenecteplase is given as an IV bolus without the need for an infusion due to its longer half-life. Tenecteplase is at least as safe and effective as alteplase in acute ischemic stroke (with some studies showing greater benefit with tenecteplase). In patients with acute ischemic stroke who are candidates for mechanical thrombectomy, thrombolytics (with alteplase or tenecteplase) will still be given in patients who meet inclusion criteria and have no exclusion criteria. References Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association [published correction appears in Stroke. 2019 Dec;50(12):e440-e441]. Stroke. 2019;50(12):e344-e418. doi:10.1161/STR.0000000000000211 Campbell BCV, Mitchell PJ, Churilov L, et al. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018;378(17):1573-1582. doi:10.1056/NEJMoa1716405 Kobeissi H, Ghozy S, Turfe B, et al. Tenecteplase vs. alteplase for treatment of acute ischemic stroke: A systematic review and meta-analysis of randomized trials. Front Neurol. 2023;14:1102463. Published 2023 Jan 23. doi:10.3389/fneur.2023.1102463
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171 - Two Vax’s and a MAB: What’s New in RSV Prevention
09/19/2023
171 - Two Vax’s and a MAB: What’s New in RSV Prevention
In this episode, we briefly review RSV (respiratory syncytial virus) infections and focus on new data supporting the use of two different RSV vaccines (Abrysvo and Arvexy) in preventing RSV infections in older adults and in pregnant women. Key Concepts RSV is a contagious respiratory virus that is usually mild and self-limiting in most patients but can cause severe disease especially in young children or older adults with certain risk factors. The FDA recently approved two vaccines for RSV (Abrysvo from Pfizer and Arexvy from GSK). The initial FDA approval was for adults 60 years of age and older; however, the FDA recently granted an additional indication for Abrysvo for pregnant women (to prevent the infant from severe RSV infection once born). When studied in older adults, both vaccines did meet efficacy criteria but the incidence of RSV infection was relatively low and thus the number needed to treat (NNT) is high. Both studies were done at times with lower RSV prevalence - the NNT would likely be more favorable during RSV outbreaks. Unlike Abrysvo, Arvexy (GSK) contains an adjuvant to improve the immune response. Although direct comparisons of efficacy and safety are not appropriate, Arvexy does appear to elicit more systemic adverse effects such as fever, myalgias, headache, and fatigue. References Respiratory Syncytial Virus Infection (RSV). Centers for Disease Control and Prevention. Abrysvo (respiratory syncytial virus vaccine). US Food & Drug Administration. Arexvy (respiratory syncytial virus vaccine, adjuvanted). US Food & Drug Administration. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. Morbidity and Mortality Weekly Report (MMWR). July 21, 2023 / 72(29);793-801. CDC. ACIP Recommendations. Last reviewed August 4, 2023. . Accessed August 23, 2023. RENOIR - Walsh EE, Pérez Marc G, Zareba AM, et al. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836 AReSVi-006 - Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604 MATISSE - Kampmann B, Madhi SA, Munjal I, et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023;388(16):1451-1464. doi:10.1056/NEJMoa2216480 RSV-NET Interactive Dashboard. Centers for Disease Control and Prevention. ACIP Meeting Information - Meeting Materials.
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170 - Hope and Healing: Overcoming Opioid Use Disorder Through Evidence-Based Therapies
08/29/2023
170 - Hope and Healing: Overcoming Opioid Use Disorder Through Evidence-Based Therapies
In this episode, together with our faculty colleague, Dr. Roberta Dume, PharmD, BCPP, we discuss the pharmacologic options and evidence for the treatment of opioid use disorder (OUD) and how pharmacists play a vital role in assisting patients suffering from opioid use disorder. Key Concepts The treatment for OUD should be provided by either the treating clinician or a certified Opioid Treatment Provider (OTP) using one of three FDA-approved therapies which include buprenorphine, methadone, and naltrexone. Selection of the OUD treatment depends on availability of treatment provider; pharmacologic agent specific factors such as efficacy, dose titration, safety, and need for detoxification; and patient factors such as ability to safe-keep medications, adherence to required clinic visits, or presence of comorbidities. Pharmacists can play an important role for patients needing OUD by providing treatment education, treatment induction, monitoring treatment outcomes, harm reduction by providing naloxone and related education, and utilizing preventative strategies such as monitoring opioid use, offering non-opioid pain management options, and promoting safe storage and disposal of opioids. References SAMHSA. Tip 63. SAMHSA. Medications for substance use disorders. NIDA. Medications to treat opioid use disorder research report. How effective are medications to treat opioid use disorder?
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169 - Introducing HelixTalk’s 2023 Drug Superlative Awards!
08/08/2023
169 - Introducing HelixTalk’s 2023 Drug Superlative Awards!
In this episode, we announce the second iteration of the HelixTalk Drug Superlative Awards -- awards given to medications on the market that are outstanding or notorious. In announcing these completely fictitious awards, we review key clinical pearls and pitfalls that every clinician should be aware of with these notable medications. Key Concepts The award for the most unique phase III patient population for a widely used medication goes to … Pneumovax-23 (PPSV-23) for its predecessor versions that were studied in South African novice gold miners. The award for the most misunderstood boxed warning goes to … all of the DOACs (but specifically apixaban and rivaroxaban). In particular, due to BOTH an increased risk of thrombosis and bleeding when switching from a DOAC to warfarin therapy in patients with atrial fibrillation. The award for the biggest difference between pharmacokinetic properties and pharmacodynamic effects goes to … aspirin due to its short-half life and short duration of analgesic effect and yet very prolonged antiplatelet effect. The award for the drug that should be dispensed with extra toilet paper … TIE between irinotecan and clindamycin. The most common dose-limiting adverse effect of irinotecan is diarrhea – loperamide is extensively used in these patients. Clindamycin earns the award because it is the antibiotic most associated with Clostridium difficile-associated diarrhea (CDAD). References Smit P, Oberholzer D, Hayden-Smith S, Koornhof HJ, Hilleman MR. Protective efficacy of pneumococcal polysaccharide vaccines. JAMA. 1977;238(24):2613-2616. Farrar JL, Childs L, Ouattara M, et al. Systematic Review and Meta-Analysis of the Efficacy and Effectiveness of Pneumococcal Vaccines in Adults. Pathogens. 2023;12(5):732. Published 2023 May 19. doi:10.3390/pathogens12050732 Pavia M, Bianco A, Nobile CG, Marinelli P, Angelillo IF. Efficacy of pneumococcal vaccination in children younger than 24 months: a meta-analysis. Pediatrics. 2009;123(6):e1103-e1110. doi:10.1542/peds.2008-3422 Deshpande A, Pasupuleti V, Thota P, Pant C, Rolston DD, Sferra TJ, Hernandez AV, Donskey CJ. Community-associated Clostridium difficile infection and antibiotics: a meta-analysis. J Antimicrob Chemother. 2013 Sep;68(9):1951-61. doi: 10.1093/jac/dkt129.
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168 - Beyond the Controversy: Exploring Efficacy and Safety of Medication Abortion
07/18/2023
168 - Beyond the Controversy: Exploring Efficacy and Safety of Medication Abortion
There has been a lot of news about abortion (abortifacient) medications recently. Since the overturn of Roe v. Wade in 2022, individual states passed their own laws restricting access to abortion, this includes access to abortion medications. This clearly impacts the way pharmacists practice. In this episode, we summarize the science behind the two main abortive drugs, mifepristone and misoprostol, and provide a picture of how the access to these medications stand in the United States. Key Concepts Among other modalities to terminate pregnancies, medication abortion is a safe and alternative option that is picking up popularity given recent changes post-Dobbs vs. Jackson WHO decision. The FDA-approved use of combination mifepristone and misoprostol regimen to terminate pregnancy up to 70 days (10 weeks of gestation) is based on strong evidence for its efficacy and safety. Since the overturning of Roe vs. Wade in 2022, states have taken their own action to further restrict or increase access to abortion services including access to medication abortion. These legal changes further impact dispensing of mifepristone and misoprostol by pharmacists across the country adding to more confusion. Legal councils, state boards of pharmacies, or state pharmacy associations may serve as suitable resources to consult regarding these fast-changing laws. References American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Gynecology, Society of Family Planning. Medication Abortion Up to 70 Days of Gestation: ACOG Practice Bulletin, Number 225. Obstet Gynecol. 2020 Oct;136(4):e31-e47. doi: 10.1097/AOG.0000000000004082. PMID: 32804884. Kaiser Family Foundation. Guttmacher Institute.
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167 - Beyond One-Size-Fits-All: Unraveling the Genetic Tapestry of CYP2D6 Drug Metabolism
06/27/2023
167 - Beyond One-Size-Fits-All: Unraveling the Genetic Tapestry of CYP2D6 Drug Metabolism
In this episode, we review the science behind genetic differences in humans in the CYP2D6 hepatic enzyme responsible for drug metabolism and how these genetic variants can lead to certain drugs being metabolized far too much or far too little, which can cause drug toxicities or a lack of effectiveness. Key Concepts About 20-25% of drugs on the market are metabolized by CYP2D6. Humans have a huge degree of variability in CYP2D6 metabolism ranging from “ultra” metabolizers to “poor” metabolizers. Drugs that heavily rely on CYP2D6 metabolism are prone to large variability in responses due to these genetic differences. Some drugs rely on metabolic inactivation of CYP2D6 whereas other drugs use the enzyme to become converted to a more active compound. Codeine and tramadol both heavily rely on CYP2D6 activation to a more potent opioid compound. Patients with excessive CYP2D6 activity will have toxicities (from too much of an active metabolite) whereas patients with low CYP2D6 activity will have little therapeutic effect. Numerous antidepressants (paroxetine, nearly all tricyclic antidepressants, and venlafaxine) rely on CYP2D6 metabolism. Differences in CYP2D6 metabolism have been shown to either cause toxicity or a lack of effectiveness with these medications. References Chartrand R, Forte AM, Hoger JD, Kane SP, Kisor DF. Pharmacogenomics and Commonly Prescribed Medications. AdvanCE. October 10, 2022. . Caudle KE, Sangkuhl K, Whirl-Carrillo M, et al. Standardizing CYP2D6 Genotype to Phenotype Translation: Consensus Recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci. 2020;13(1):116-124. doi:10.1111/cts.12692 Bousman CA, Stevenson JM, Ramsey LB, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A Genotypes and Serotonin Reuptake Inhibitor Antidepressants [published online ahead of print, 2023 Apr 9]. Clin Pharmacol Ther. 2023;10.1002/cpt.2903. doi:10.1002/cpt.2903 Crews KR, Monte AA, Huddart R, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6, OPRM1, and COMT Genotypes and Select Opioid Therapy. Clin Pharmacol Ther. 2021;110(4):888-896. doi:10.1002/cpt.2149
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166 - Thiazide Throwdown: Hydrochlorothiazide vs. Chlorthalidone - The Ultimate Showdown for Hypertension Management
06/06/2023
166 - Thiazide Throwdown: Hydrochlorothiazide vs. Chlorthalidone - The Ultimate Showdown for Hypertension Management
In this episode, we compare hydrochlorothiazide and chlorthalidone, but specifically from a cardiovascular outcomes perspective when used in patients with hypertension. Key Concepts Chlorthalidone, hydrochlorothiazide, and indapamide are available thiazide diuretics for treatment of hypertension; however, hydrochlorothiazide is the most commonly used agent. Chlorthalidone is more potent in reducing blood pressure but also is associated with a higher risk of electrolyte abnormalities compared to HCTZ. Recent studies for cardiovascular outcomes show that chlorthalidone is not better than HCTZ in preventing CV outcomes, but increases risk for hypokalemia, need for monitoring and even potassium supplementation. References Ishani A, Cushman WC, Leatherman SM, et al. Chlorthalidone vs. Hydrochlorothiazide for Hypertension–Cardiovascular Events. N Engl J Med 2022; 387:2401-2410. DOI: 10.1056/NEJMoa2212270. Akbari P, Khorasani-Zadeh A. Thiazide Diuretics. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Available from:
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165 - QT and the Beast: Managing Medications That Prolong the QT Interval
05/16/2023
165 - QT and the Beast: Managing Medications That Prolong the QT Interval
In this episode, we discuss the concerns of QTc prolongation, which can cause a fatal arrhythmia called torsades de pointes (TdP). We cover the difference between QT and QTc, how to interpret a QTc (and when it is inaccurate), common medications that prolong QTc, and how pharmacists can evaluate the risk of QTc/TdP in patients who are receiving QTc-prolonging therapies. Key Concepts The QTc interval is the QT interval that has been “corrected” for heart rate. In nearly all cases, when describing a QT interval, it should be expressed as the QTc. Although a prolonged QTc is usually defined as a QTc exceeding 450-480 msec, the risk of torsades de pointes (TdP) begins to become concerning when the QTc is more than 500 msec, 15-20% longer than baseline, or if the QTc has increased by more than 60 msec. Vaughan-Williams Class III antiarrhythmics are most implicated in QTc prolongation and TdP risk. These therapies include sotalol, dofetilide, and dronedarone. Although amiodarone is a class III antiarrhythmic, its risk of TdP is quite low despite the fact that it often substantially prolongs the QTc. When pharmacists are assessing the risk of QTc prolongation and TdP, multiple factors (not just the QTc itself) should be considered. Risk scores, like the Tisdale Risk Score, as well as considering the risks/benefits of switching drug therapy, should be evaluated. References CredibleMeds.com. Arizona Center for Education and Research on Therapeutics. . Noel ZR, See VY, Flannery AH. Walk the Line-The Importance of Well-Informed Interpretation of QT Prolongation. Ann Pharmacother. 2021;55(1):123-126. doi:10.1177/1060028020934718 E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Food and Drug Administration (FDA).
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164 - Breaking Down the Updates: Key Changes and Implications of the 2023 American Diabetes Association Guidelines
04/25/2023
164 - Breaking Down the Updates: Key Changes and Implications of the 2023 American Diabetes Association Guidelines
In this episode, we will discuss the most important updates from the American Diabetes Association’s 2023 Standards of Care in Diabetes. Key Concepts The first-line therapy for type II diabetes is based on whether the primary goal of therapy is cardiorenal benefit (reduced risk of ASCVD, heart failure, or CKD) or glycemic and weight goals. For cardiorenal benefit, GLP1 receptor agonists and SGLT2 inhibitors are heavily emphasized. For glycemic control and weight gain, GLP1 receptor agonists (or GLP1/GIP in the case of tirzepatide) have a very favorable effect on weight loss and glycemic control. While metformin is still mentioned, it is no longer the sole, first-line therapy for type II diabetes. For patients with diabetes and a high risk of ASCVD (20% or higher), high-intensity statins, ezetimibe, and/or PCSK9 inhibitors are recommended to achieve an LDL less than 70 mg/dL. In patients with a history of ASCVD events, these same therapies are used to achieve a recommended LDL goal of less than 55 mg/dL. Among selected patients with diabetes and CKD with albuminuria, finerenone (a new mineralocorticoid receptor antagonist) is recommended to improve renal and cardiovascular outcomes. A variety of different therapies are now recommended for neuropathic pain, including gabapentinoids, SNRIs, TCAs, and several antiseizure medications (lamotrigine, lacosamide, oxcarbazepine, and valproic acid). A wide variety of other new recommendations are discussed in the episode, including NASH/NAFLD, obesity and weight management, special populations, diabetes technology, and health behavior changes. References American Diabetes Association. Standards of Care in Diabetes-2023. Diabetes Care. 2023; 46(1): S1-S292.
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163 - The Two-Drug Tango: A Concise Guide to Tacrolimus and Mycophenolate in Organ Transplantation
04/04/2023
163 - The Two-Drug Tango: A Concise Guide to Tacrolimus and Mycophenolate in Organ Transplantation
In this episode, we review clinical pearls and common pitfalls of immunosuppression regimens for organ transplantation with a particular focus on tacrolimus and mycophenolate. Key Concepts Most recipients of an organ transplantation will be on a two or three drug regimen. The most common regimen is tacrolimus and mycophenolate with/without a corticosteroid. Tacrolimus is hepatically eliminated and susceptible to CYP3A4 and PGP drug interactions. Particularly at higher drug concentrations, it is associated with nephrotoxicity and neurotoxicity (among several other adverse effects). Mycophenolate is unstable in the acidic environment of the stomach. The two formulations on the market are CellCept (which uses a prodrug, mycophenolate mofetil, that is converted in the liver to an active compound) and Myfortic (an enteric-coated formulation of mycophenolic acid, which releases after exiting the stomach). The intensity of an immunosuppression regimen is determined by numerous factors, including the type of organ, how long ago the organ was transplanted, if acute rejection has occurred in the past, patient-specific risk factors, and more. Additional Resources Register to be a donor at Donate Life America () or at the HRSA OrganDonor.gov site () Learn more about stem cell donation and transplant at
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162 - A1C You Later: A Concise Review of Continuous Glucose Monitors for the Practicing Pharmacist
03/14/2023
162 - A1C You Later: A Concise Review of Continuous Glucose Monitors for the Practicing Pharmacist
In this first ever CE episode, we discuss the A-Zs of continuous glucose monitors (CGMs). In specific, our learning objective for the CE are: Describe commonly available types of continuous glucose monitors (CGMs) in the US market and the features and capabilities of these devices. Summarize the evidence and guideline recommendations for use of CGMs in the management of diabetes. Identify the role of the pharmacist in the selection of CGMs and provision of education to patients and providers. Interpret the ambulatory glucose profile (CGM data output) and recommend changes in antihyperglycemic regimen for a patient. ACPE-Accredited Pharmacist CE (1.0 hrs) To obtain CE credit for a $5 fee, visit the following link: . Once payment is successful, you will be redirected to our CE partner (CE Impact) to complete an evaluation and to earn 1.0 hour of CE credit. CE is available for 12 months after episode publication. Key Concepts There are two main types of stand-alone personal CGMs available in the US market – real-time (rtCGM) and intermittently scanning (isCGM). [1] These CGMs vary in their features such as sensor wear time, sensor warm up time, sensor application site, reader availability, approved age for use, fingerstick calibration, non-adjunctive FDA labeling, interconnectability with other technology such as insulin pumps, and drug interactions – these variabilities can be used in decision-making when selecting an appropriate CGM for a patient. [2-7] Based on the evidence for use, both types of CGMs (real-time and intermittently scanning) are recommended in patients with Type 1 and Type 2 diabetes who are on multiple-daily insulin or continuous insulin infusion (pump), patients with Type 2 diabetes on basal insulin therapy, and as adjunct use in patients with diabetes who are pregnant. The strength of recommendations in general is stronger for real-time CGMs than for intermittently scanning CGMs. [1,11] These recommendations are supported by the evidence that CGMs can help improve glucose control, reduce risk of hypoglycemia, diabetes-related hospitalizations, and patient/caregiver satisfaction. Pharmacists play an integral role in education, on-going support, data interpretation, and resulting disease management in patients who qualify for CGM use and providers who care for patients with diabetes. [14] The ambulatory glucose profile is a standardized data output that informs understanding of glucose trends. [15] The recommended goal for most patients is to maintain a glucose range between 70-180 mg/dL with at least 70% of time spent in this range with variability coefficient of no more than 36%. [1,11,15] Supplemental Content Comparison of rtCGM and isCGM devices "Mary's" Example AGP Report (adapted from Battelino et al.) References ElSayed NA, Aleppo G, Aroda VR, et al. American Diabetes Association. Chapter 7. Diabetes technology: Standards of medical care in diabetes - 2023. Diabetes Care. 2023;46(suppl 1):S111-S127. Dexcom G6 User Guide. Dexcom, Inc. 2020. Accessed February 20, 2023. https://s3-us-west-2.amazonaws.com/dexcompdf/G6-CGM-Users-Guide.pdf. Dexcom G7 User Guide. Dexcom, Inc. 2022. Accessed February 20, 2023. https://dexcompdf.s3.us-west-2.amazonaws.com/en-us/G7-CGM-Users-Guide.pdf#page=12 Guardian Connect System User Guide. Medtronic MiniMed. 2020. Accessed February 20, 2023. https://www.medtronicdiabetes.com/sites/default/files/library/download-library/user-guides/Guardian-Connect-System-User-Guide.pdf. Eversense E3 User Guide. Sensionics, Inc. 2022. Accessed February 20, 2023. https://www.eversensediabetes.com/wp-content/uploads/LBL-4002-01-001-Rev-F_Eversense-E3-User-Guide_mgdL_R1_web.pdf FreeStyle Libre 3 User’s Manual. Abbott Diabetes Care Inc. 2022. Accessed February 20, 2023. https://freestyleserver.com/Payloads/IFU/2022/q2/ART44140-002_rev-A.pdf FreeStyle Libre 2 User’s Manual. Abbott Diabetes Care Inc. 2020. Accessed February 20, 2023. https://freestyleserver.com/Payloads/IFU/2020/q2/ART40703-001_rev-D-Web.pdf. Products. American Diabetes Association. Accessed February 20, 2023. https://consumerguide.diabetes.org/ Wood A, O'Neal D, Furler J, Ekinci EI. Continuous glucose monitoring: a review of the evidence, opportunities for future use and ongoing challenges. Intern Med J. 2018 May;48(5):499-508. Edelman SV, Argento NB, Petty SJ, Hirsch IB. Clinical implications of real-time and intermittently scanned continuous glucose monitoring. Diabetes Care. 2018;41:2265-2274. Fonseca VA, Grunberger G, Anhalt H, et al. Continuous glucose monitoring: A consensus conference of the American Association of Clinical Endocrinologists and American College of Endocrinology. Endocr Pract. 2016;22(8):1008-21. Reiterer F, Polterauer P, Schoemaker M, Schmelzeisen-Redecker G, Freckmann G, Heinemann L, Del Re L. Significance and Reliability of MARD for the Accuracy of CGM Systems. J Diabetes Sci Technol. 2017 Jan;11(1):59-67. doi: 10.1177/1932296816662047. Epub 2016 Sep 25. PMID: 27566735; PMCID: PMC5375072. Food and Drug Administration. Premarket Notification 510(k). 2022. Accessed February 25, 2023. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Isaacs, Diana. The pharmacist’s role in continuous glucose monitoring. Pharmacy Today. 2020;26:37-54. Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations from the International Consensus on Time in Range. Diabetes Care. 2019;42(8):1593-1603.
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