Generic Substitution and Therapeutic Equivalence of Antiepileptic Drugs: Clinical and Pharmacoeconomic Issues in Epilepsy Management A Priority Report Faculty: John M. Pellock, MD | Andrew J. Pultz, Jr, PharmD, RPh CME / CE credit hour: 1.0 The issue of generic drug substitution is complex and often poorly understood by physicians and pharmacists. Although the FDA requires that two drugs are similar as demonstrated by bioequivalence data, therapeutic equivalence (or therapeutic effectiveness) and bioequivalence are not necessarily the same. In the case of antiepileptic drugs (AEDs), the therapeutic range over which they are effective may be narrow and, although generic substitution of AEDs may be appropriate for some patients with epilepsy, it may represent suboptimal care for others. This program will give an overview of these and other important issues associated with generic substitution of AEDs.
The Practical and Regulatory Perspective of Bioequivalence Faculty: Sandra L. Kane-Gill, PharmD, MSC | Joseph F. Dasta, MS, FCCM, FCCP | Nicholas M. Fleischer, RPh, PhD. | Mary Lea Gora-Harper, PharmD, FASHP CE Credit hour: 1.0
Bioequivalence needs to be determined before an automatic substitution of products or product dosage forms can be made. When automatic substitutions between brand and generic, generic and generic or between dosage forms are made, clinicians need to be aware of the potential clinical and regulatory issues associated with these substitutions. While product interchange between brand and generic medications, generic and generic medications or different forms of the same product is not typically a problem, this activity will highlight some examples of clinical concerns and related regulation considerations. It will also provide some direction on obtaining relevant information of bioequivalence.
Management of Febrile Neutropenia and Anemia in Chemotherapy Patients: Clinical Practice Guidelines Update Faculty: Dwight Kloth, PharmD, FCCP, BCOP CME / CE credit hour: 1.0 Despite data showing the positive impact of treating febrile neutropenia and anemia in chemotherapy patients, a majority of patients still do not receive proper treatment. The European Cancer Anemia Survey (ECAS) reported that over 60% of the cancer-associated anemia patients did not receive any treatment for their anemia. Moreover, approximately 60,000 cancer patients are hospitalized annually with febrile neutropenia in the United States. This program will address strategies for treating chemotherapy induced anemia and febrile neutropenia, including identifying patients at risk and available treatment agents. Additionally, a review of the updated practice guidelines from ASCO, NCCN and EORTC and their practical applications will be discussed.
Generic Substitution and Therapeutic Equivalence of Antiepileptic Drugs: Clinical and Pharmacoeconomic Issues in Epilepsy Management Faculty: John M. Pellock, MD | Andrew J. Pultz, Jr, PharmD, RPh | Michael C. Smith, MD CME / CE credit hour: 1.0 The issue of generic drug substitution is complex and often poorly understood by physicians and pharmacists. Although the FDA requires that two drugs are similar as demonstrated by bioequivalence data, therapeutic equivalence (or therapeutic effectiveness) and bioequivalence are not necessarily the same. In the case of antiepileptic drugs (AEDs), the therapeutic range over which they are effective may be narrow and, although generic substitution of AEDs may be appropriate for some patients with epilepsy, it may represent suboptimal care for others. This program will give an overview of these and other important issues associated with generic substitution of AEDs.
Common Misconceptions With Bioequivalence & Interchangeability Faculty:Andrew J. Pultz, Jr, PharmD, RPh | Joseph F. Dasta, MSc, FCCM, FCCP | Sandra L. Kane-Gill, PharmD, MSc CE credit hour: 1.0 Bioequivalence is a comparison of two or more products with respect to their bioavailabilities. Bioequivalence of trade and generic products or different dosage forms of the same product needs to be determined before the products can be legally interchanged. Numerous factors can affect bioavailability (and bioequivalence) determinations. Thus, there is a great potential for wide variability among the pharmacokinetic profiles among patient populations and bioequivalence determinations. As pharmacists and Nurses, we are in an optimal position to prevent or intervene when a patient is experiencing drug-drug and drug-food interaction resulting in bioavailability alterations with outcomes including sub-therapeutic responses or adverse events. While product interchange between trade and generic medications or between dosage forms of the same product is typically not a problem this activity is going to highlight some examples of when it is a concern.
Addressing Safety Concerns in the Treatment of Atopic Dermatitis Faculty: Jon Hanifin, MD | Mark Boguniewicz, MD | Adelaide Hebert, MD | Jonathan Spergel, MD, PhD CME / CE credit hour: 1.0
In this CME activity, four distinguished members of the medical community review and discuss current clinical trial data focusing on safety issues surrounding the use of topical corticosteroid and TCIs. Panel members review the potential short- and long-term adverse effects of each drug class and then place this information into context by evaluating the risk-benefit ratio associated with each treatment.
Chemotherapy-Induced Neutropenia Prevention: Implications of New Clinical Data and Guidelines Faculty: Jeffrey C. Crawford, MD | David C. Dale, MD | Gary H. Lyman, MD, MPH, FRCP (Edin) | Christopher R. Friese, RN, PhD, AOCN® CME / CE credit hour: 1.0
Chemotherapy-induced neutropenia has very serious and important clinical consequences in terms of medical care, quality of life, and economic factors for cancer treatment. Chemotherapy patients who develop neutropenia are at risk of developing febrile neutropenia, which is a medical emergency that requires immediate medical management. Febrile neutropenia has historically been treated through the use of prophylactic antibiotics, but their usefulness continues to be controversial and the incidence of febrile neutropenia continues to be high. The use of hematopoetic colony stimulating factors (CSFs) has improved the outcomes for patients who experience febrile neutropenia.
The Conundrum of Rash in Management of EGFR Inhibitors(Accreditation Expired) Faculty: Roy S. Herbst, MD, PhD | Mario Lacouture, MD | Roman Perez-Soler, MD | Sandy Kurtin, RN, MS, AOCN®, NP CME / CE credit hour: 1.0 New therapies targeting the epidermal growth factor receptor (EGFR) have been used in the treatment of a variety of cancers. Although generally well tolerated, EGFR inhibitors are associated with the development of dermatologic reactions (e.g., papulopustular rash, xerosis, pruritus, periungual inflammation, and alopecia) in most patients. At present, little is known about the etiology of these reactions, and no evidence-based management guidelines have been set forth in the dermatologic literature.
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Generic Substitution and Therapeutic Equivalence of Antiepileptic Drugs: Clinical and Pharmacoeconomic Issues in Epilepsy Management
The Practical and Regulatory Perspective of Bioequivalence
Challenges in Dosing Low Molecular Weight Heparin