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.

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.

Current Therapeutic Trends in the Treatment of Chemotherapy-Induced Anemia
Faculty: Leon E. Cosler, RPh, PhD | John Glaspy, MD, MPH | Gary H. Lyman, MD, MPH, FRCP (Edin) | Christopher R. Friese, RN, PhD, AOCN^®
CME / CE credit hours: 1.5
Anemia is common in cancer patients, but the impact is often poorly appreciated. It is a major cause of tumor hypoxia, a condition that can further tumor survival and malignant progression and also reduces the effectiveness of several anticancer therapies, including radiotherapy and oxygen-dependent cytotoxic agents. Strategies for incorporating clinical guidelines into practice and the safety and pharmacoeconomic issues surrounding treatment of anemia with ESPs will be discussed in this activity.

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.

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.

Applying Evidence to Practice: Recent Advances in the Management of Chemotherapy-Induced Neutropenia
Faculty: Christopher R. Friese, RN, PhD, AOCN^® | Joan M. Giblin, MSN, APRN-BC, AOCN^® | Rebecca B. Donohue, MSN, RNCS, FNP, AOCN^®, APNG | Anne Doyle, RN, MSN
CE credit hour: 1.0
Neutropenia is the major dose-limiting toxicity associated with cancer chemotherapy and febrile neutropenia is associated with considerable morbidity, mortality, and cost. Colony Stimulating Factors, or CSFs, are used to reduce the severity and duration of chemotherapy-induced neutropenia and diminish the risk of febrile neutropenia and infection for patients receiving chemotherapy. The risk of neutropenia varies depending on the agent used and dose delivered. Predictive factors of febrile neutropenia have been identified for several types of malignancies. Identification of these risk factors when chemotherapy is planned can support the appropriate use of CSFs to reduce the risk of febrile neutropenia for patients.

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.

Chemotherapy-Induced Neutropenia: Impact, Risks & Prevention (Accreditation Expired)
Faculty: David C. Dale, MD | Michael Rader, MD | Robert E. Smith, MD | Christopher R. Friese, RN, PhD
CME Credit hour: 1.0
Three of the nation's leading specialists will discuss the efficacy and appropriate use of myeloid growth factors for the prevention of chemotherapy-induced neutropenia and febrile neutropenia.