HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

In this episode, we review the pharmacology, indications, adverse effects, monitoring, and unique drug characteristics of HMG CoA reductase inhibitors ("statins").

Key Concepts

1. 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.
2. 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").
3. Atorvastatin, lovastatin, and simvastatin heavily rely on CYP 3A4 metabolism and tend to be most susceptible to drug interactions compared to the other statins.
4. 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. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000625

In this recurring episode, we discuss the important updates from the 2024 American Diabetes Association Guidelines!

Key Concepts

1. 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.
2. 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.
3. 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.
4. 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: https://diabetesjournals.org/care/issue/47/Supplement_1.

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

1. 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).
2. 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.
3. 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.
4. 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

1. Illinois Pharmacy Practice Act (225 ILCS 85) https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24
2. Illinois Pharmacy Practice Act Administrative Code (Part 1330): https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html
3. Illinois Controlled Substances Act (720 ILCS 570) https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID=53
4. Illinois Controlled Substances Act Administrative Code (Part 3100) https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html
5. Pharmacist's Manual: An Informational Outline of the Controlled Substances Act. Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist%27s_Manual_DEA.pdf

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

1. Reversal of anticoagulation is indicated in patients with major hemorrhage or when emergency surgery is necessary.
2. 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).
3. 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.
4. 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.

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)

1. 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.
2. 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!
3. 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.
4. 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. https://www.cdc.gov/mmwr/volumes/65/rr/rr6504a1.htm?s_cid=rr6504a1_w#B-1-1_down
• CDC Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. 2016. https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html

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)

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.
2. 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.
3. 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.
4. 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. https://www.cdc.gov/mmwr/volumes/65/rr/rr6504a1.htm?s_cid=rr6504a1_w#B-1-1_down
• CDC Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. 2016. https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html

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

1. Pharmacists are playing an increasingly important role within the pharmaceutical industry. Prior clinical experience is a significant advantage to applicants for these positions.
2. 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.
3. 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.
4. 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 (https://www.linkedin.com/in/scott-glosner-b743234).

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

1. 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.
2. Elements of REMS vary depending on the drug, but commonly include medication guides, communication plans, and other elements to assure safe use.
3. 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.
4. 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. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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

1. 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.
2. 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.
3. Tenecteplase is at least as safe and effective as alteplase in acute ischemic stroke (with some studies showing greater benefit with tenecteplase).
4. 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

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

1. 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.
2. 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).
3. 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.
4. 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. https://www.cdc.gov/rsv/index.html
• Abrysvo (respiratory syncytial virus vaccine). US Food & Drug Administration. https://www.fda.gov/vaccines-blood-biologics/abrysvo
• Arexvy (respiratory syncytial virus vaccine, adjuvanted). US Food & Drug Administration. https://www.fda.gov/vaccines-blood-biologics/arexvy
• 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. https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm
• CDC. ACIP Recommendations. Last reviewed August 4, 2023. www.cdc.gov/vaccines/acip/recommendations.html. 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. https://www.cdc.gov/rsv/research/rsv-net/dashboard.html
• ACIP Meeting Information - Meeting Materials. https://www.cdc.gov/vaccines/acip/meetings/index.html