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

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

1. Large Language Models (LLMs) referenced in the episode: https://chat.openai.com, https://coral.cohere.com, https://claude.ai, https://gemini.google.com.
2. Prompt Engineering Guide (https://www.promptingguide.ai/techniques)
3. OpenAI - Prompt engineering (https://platform.openai.com/docs/guides/prompt-engineering/six-strategies-for-getting-better-results)
   

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