HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Latest Episodes:

139 - They Did What?! FDA Approval of Aducanumab for Alzheimer's Disease Nov 16, 2021

Show notes

In this episode, we discuss the recent accelerated approval of the new monoclonal antibody-based treatment agent, aducanumab (Aduhelm), by the FDA. We dive into the drug approval process, the efficacy and safety data, and the behind-the-scenes story of the FDA approval. Furthermore, we will present the controversy behind the approval and what it means for stakeholders.

Key Concepts

Aducanumab (Aduhelm) is a monoclonal antibody proven to reduce beta amyloid plaques in patients with Alzheimer's disease.
Despite reducing plaques, aducanumab did NOT result in meaningful cognitive improvements in patients receiving the drugs versus placebo; additionally, the drug was associated with a potentially concerning adverse effect called ARIA-E (amyloid related imaging abnormalities-edema).
Despite an advisory panel unanimously recommending AGAINST approval and a lack of clinical outcome improvement, the FDA did go on to approve the drug in patients with Alzheimer's disease using an accelerated approval process.
In the episode, we discuss the substantial ramifications of the FDA's approval primarily in hurting its credibility in validating the safety and efficacy of other medications on the US market.

138 - Hidden Pharmaceutics: The Fascinating Science Behind Dosage Formulations Oct 26, 2021

Show notes

In this episode, we discuss the fascinating science of pharmaceutics with Dr. Kristen Ahlschwede and Dr. Rahul Deshmukh. We explore how dosage forms and excipients play an important role in how a drug product behaves in the human body with a particular focus on fentanyl patches, osmotic tablets (with laser-drilled holes), Depakote Sprinkles, and IV amiodarone.

Key Concepts

Fentanyl patches were reformulated from a drug-in-a-reservoir system to an adhesive matrix system to prevent abuse and misuse. The new formulation prevents fentanyl from "leaking" out when cut.
Osmotic tablet systems, such as Procardia XL, Glucotrol XL, and Concerta, use an "active" layer (containing drug) adjacent to a "push" layer that is osmotically active. When the push layer is exposed to water in the GI tract, it swells and pushes the active layer through a small laser-drilled precision hole.
"Sprinkle" dosage forms typically involve small pellets inside a capsule, such as Depakote Sprinkles. The capsule itself does not delay or extend release; instead, the pellets themselves are involved in prolonging the absorption profile of the drug.
Amiodarone IV is commercially available in two formulations -- the conventional formulation (Cordarone) contains benzyl alcohol and tween 80 to solubilize the drug but these excipients are associated with hypotension. A newer formulation (Nexterone) uses cyclodextrin as a solubilizing agent and is not associated with hypotension (although has a risk of nephrotoxicity, especially at higher cumulative doses).

137 - It's Time for PBM Reform: How PBMs Have Hurt Pharmacies and Increased Drug Costs Oct 05, 2021

Show notes

In this episode, we reveal what goes on behind the scenes for drug pricing and pharmacy reimbursement with Dr. Benjamin Jolley. Our discussion covers important concepts like PBMs, DIR fees, MAC pricing, and even possible upcoming changes at the federal government.

Key Concepts

Prescription drug reimbursement is a major factor in the decline of independent pharmacies nationwide. Complex reimbursement models, fees, and drug pricing structures are frequently not well understood by both patients and many healthcare providers.
A pharmacy benefits manager (PBM) is a company hired by an insurance company to handle prescription drug coverage and reimbursement. Three PBMs control more than three-quarters of the entire US market and can often dictate the terms of a drug reimbursement contract with pharmacies.
PBMs determine how much they will pay for the cost of a medication using either a benchmark (such as the average wholesale price minus some percentage) or a list of the maximum allowable cost (MAC) maintained by the PBM. Pharmacies are required to accept the PBM's reimbursement amount regardless of the cost the pharmacy paid to acquire the drug from a wholesaler.
DIR fees, clawbacks, and PBM rebate or discount agreements with manufacturers have resulted in lower reimbursements to pharmacies, higher drug prices for patients, and increased profits for PBMs.

136 - Major Recommendations from the 2021 CHEST Anticoagulation for VTE Disease Guideline Updates Sep 14, 2021

Show notes

In this episode, we discuss the recently published major updates in the 9th edition of the anticoagulation guidelines from CHEST. These new recommendations range from initiation of therapy, secondary prevention, and management of post-thrombotic syndrome.

Key Concepts

Among patients with cancer-associated VTE, DOACs are preferred over low molecular weight heparins (LMWH) EXCEPT in patients with GI cancers. The preferred anticoagulant in those with GI cancers is either LMWH or apixaban.
Among patients with antiphospholipid antibody syndrome, warfarin (INR goal 2-3) is preferred over DOAC therapy.
In the extended phase of treatment (secondary prevention after 3 months of treatment), lower anticoagulant doses should be used (such as apixaban 2.5 mg BID or rivaroxaban 10 mg daily).
In patients with a DVT, IVC filters should only be used when anticoagulation therapy is contraindicated. IVC filters reduce the risk of PE but do not alter the risk of DVT extension or future DVTs.
Compression stockings are not recommended for prevention of post-thrombotic syndrome nor for recurrent DVT prevention.

135 - Top Four Medications Myths: BUSTED! Aug 24, 2021

Show notes

In this episode, we debunk four medication myths that have persisted for decades: metronidazole and alcohol; statins and hepatotoxicity; cidal vs. static antibiotics; and "sulfa" allergies.

Key concepts

Metronidazole does not interact with alcohol (ethanol) and does not cause a disulfiram-like reaction.
Statins can cause transient increases in liver function tests; however, these increases are not associated with hepatotoxicity. Routine LFT monitoring is not recommended unless clinically indicated signs or symptoms of liver injury exist.
The distinction of bactericidal versus bacteriostatic antibiotics is irrelevant. No evidence exists showing that having a bactericidal drug has superior efficacy to a bacteriostatic drug.
A "sulfa" allergy nearly always means an allergy to Bactrim (sulfamethoxazole-trimethoprim). There are many non-antibiotic sulfonamide-containing medications that do not need to be avoided in patients with a sulfa allergy; however, patients with an allergy to any medication have an increased risk of an allergic reaction to other medication classes.

134 - Hypertensive Emergencies Demystified: A Brief Clinical Review Aug 03, 2021

Show notes

In this episode, we provide a concise review of the diagnostic criteria and general treatment approach to patients with hypertensive emergencies.

Key Concepts

Hypertensive "urgency" is a misnomer - patients do not require immediate therapy and definitely should not receive IV therapy.
In most cases, the goal blood pressure in hypertensive emergencies is to decrease by no more than 25% in the first hour, achieve a BP of 160/100 in hours 2-6, then over the next 24-48 hours lower to a more normal blood pressure goal.
Labetalol is the preferred IV push antihypertensive UNLESS patients have acute heart failure, bradycardia, or possibly in patients with asthma/COPD.
Nicardipine is one of the most commonly used IV infusions for hypertensive emergencies. Most other continuous infusions are reserved for special types of hypertensive emergencies (e.g. nitroglycerin for pulmonary edema or acute MI, esmolol for aortic dissection).

133 - Tell Me More: Exploring Covid 19 Vaccine Hesitancy and Solutions! Jul 13, 2021

Show notes

In this episode, we will explore depths of COVID 19 vaccine hesitancy - what it is, how to identify and address it, and some helpful resources.

Key Concepts

When a patient seems hesitant to consider the COVID-19 vaccine, explore their hesitations further with a simple "why" or "tell more more" question.
Understand the root of hesitancy and provide personalized responses using motivational interviewing. Key concepts of motivational interviewing include asking open-ending questions, asking the patient to share their concerns, reflective listening, acknowledging without judgement, and asking for permission to share information.
The goal of a vaccine hesitancy conversation is not necessarily to have the patient receive the vaccine today; the goal is to move the patient one step closer to validated facts (combating misinformation) and consideration of receiving the vaccine.

132 - The Warp Speed of Covid-19 Vaccine Authorizations: Timeline and Discussion with Dr. Archana Chatterjee Jun 22, 2021

Show notes

In this episode, we will explore the history of COVID vaccine development and have a heart-to-heart conversation with Dr. Archana Chatterjee regarding her role as a dean of the RFUMS Chicago Medical School, her career path, and her position and functions on the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).

131 - Come One, Come All: Know Everything about Beta-blockers! Jun 01, 2021

Show notes

In this episode, we will review the beta-blocker drug class. We discuss their pharmacology, pharmacokinetic/pharmacodynamic parameters, evidence-based use, efficacy, and safety considerations.

Key Concepts

Various beta-blockers are divided into four main subtypes: non-selective, B1-selective, beta-blockers with alpha 1 antagonistic activity, and beta-blockers with intrinsic sympathomimetic activity (ISA). These subtypes govern their place in therapy, efficacy, and adverse effects.
With regards to dosing, "start low and go slow". The antihypertensive effect is dose-specific, but heart failure therapy requires a GDMT dosing approach to initiate and reach a certain target dose. Do not initiate as a new agent in acutely decompensated heart failure and definitely do not abruptly stop the therapy -- a taper over 1-2 weeks is required.
Beta blockers are not first-line antihypertensives; however, they should be used in patients with compelling indications, such as systolic heart failure and post-MI. Other uses include angina, atrial fibrillation, migraine, tremors, and more.
Beta blockers are associated with a number of adverse effects including bradycardia, bronchoconstriction, weight gain, dyslipidemia, hyperkalemia, and masking of hypoglycemia. More severe adverse effects include heart block, exacerbation of heart failure, and morbidity/mortality from acute withdrawal.

130 - From Pharmacy Student to Clinical Scientist in Pharma: An Interview with Dr. Anastasiya Koshkina May 11, 2021

Show notes

In this episode, we discuss pharmaceutical industry career paths with Dr. Anastasiya Koshkina, a graduate of the RFUMS College of Pharmacy and Associate Director and Clinical Scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Concepts

When preparing for the fellowship application process, do your homework on the sector(s) you plan to apply for. It is crucial that you have a cohesive and logical story for why you are applying and what makes you a good fit for the position.
Strong clinical knowledge is important in the pharmaceutical industry even though there are no traditional direct patient care interactions.
Postgraduate pharmaceutical fellowship programs are looking for applicants with strong academics (high GPA), leadership experience in extracurricular, and research experiences.
Pharmacy fellowship programs are specific to a sector of a pharmaceutical company (e.g. medical affairs, regulatory affairs, research and development, etc.).. Unlike with pharmacy residencies, fellowships may or may not have rotations; if rotations exist, they are usually many months in length.
The team (the people you will be working with) are an essential component of a position. It is much better to work with a team that is supportive and committed to your professional development than to have a seemingly perfect job but be part of a team that is not supportive. The people are everything!

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