In this episode, we discuss the new FDA categorizations of biosimilars, the legal implications of biologic/biosimilar prescriptions, and the new "follow-on" approval pathway of Basaglar, a new insulin glargine U-100 product.

056 - Entering the era of biosimilars!

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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. 

182 - 2023 Beers Criteria Update: Navigating Medications Safely in Older Patients

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: https://chat.openai.com, https://coral.cohere.com, https://claude.ai, https://gemini.google.com. Prompt Engineering Guide (https://www.promptingguide.ai/techniques) OpenAI - Prompt engineering (https://platform.openai.com/docs/guides/prompt-engineering/six-strategies-for-getting-better-results)  

181 - From Meds to Machine Learning: How AI is (and will) Revolutionizing Pharmacy Practice

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. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000625 

180 - The Ultimate Guide to Statins: An In-Depth Drug Class Review

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: https://diabetesjournals.org/care/issue/47/Supplement_1. 

179 - Annual Dose of Sweetness: 2024 Updates from the American Diabetes Association Guidelines

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)  https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID;=24 Illinois Pharmacy Practice Act Administrative Code (Part 1330):  https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html Illinois Controlled Substances Act (720 ILCS 570)  https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID;=53 Illinois Controlled Substances Act Administrative Code (Part 3100)  https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html 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 

056 - Entering the era of biosimilars!

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