Helixtalk - Rosalind Franklin University's College Of Pharmacy Podcast

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. compound

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. Th

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 discontinuatio

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 t

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 publi

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

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. Liv

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 pati

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 fi

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 a

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 h

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

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 c

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 a

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 ex

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 fa

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 rela

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 y

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 servi

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