BCCCP STUDY GUIDE QUESTIONS WITH COMPLETE SOLUTIONS

FDA-reportable ADE correct answer: For reporting an ADE to the FDA, the FDA defines ADEs as serious adverse events related to drugs or devices in which "the patient outcome is death, life threatening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent, or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage. Reportable serious ADEs to the FDA may include: a. Phenytoin-induced toxic epidermal necrolysis b. Linezolid-induced thrombocytopenia with genitourinary hemorrhage c. Clopidogrel-induced thrombotic thrombocytic purpura with seizures and hepatic failure and the use of plasmapheresis d. Rivaroxaban-induced intracranial hemorrhage e. Olanzapine-induced torsades de pointes f. Gentamicin-induced irreversible auditory ototoxicity g. Acetaminophen-induced hepatotoxicity Mild ADE (definition) correct answer: Results in heightened need of patient monitoring with or without a change in vital signs, but no ultimate patient harm, or any adverse event that results in the need for increased laboratory monitoring Moderate ADE (definition) correct answer: Results in the need for aggressive intervention with antidotes and/or increased length of hospital stay (e.g., severe hypotension (e.g., BP < 90/50 mm Hg), bleeding necessitating transfusions) Severe ADE (definition) correct answer: Results in harm to the patient, prolonged hospitalization, transfer to a higher level of care, permanent organ damage (e.g., irreversible hepatotoxicity or renal failure), or death with probable ADE causality nomogram score ADE definition correct answer: An ADE is an injury resulting from the use of a drug, which includes harm caused by the drug (ADRs and overdoses) and harm from the use of the drug, including dose reductions and discontinuations of drug therapy. ADR definition correct answer: any response to a drug that is noxious and unintended, and that occurs at doses used in humans for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose Documentation formats correct answer: 1. SOAP (subjective, objective, assessment, plan) 2. TITRS (title, introduction, text, recommendation, signature) 3. FARM (findings, assessment, resolution, and monitoring) The Naranjo Nomogram for Causality correct answer: ADE nomograms such as the Naranjo nomogram are designed to evaluate ADEs, not drug-drug interactions; therefore, they should not be used to evaluate drug-drug interaction cases. Drug Interaction Probability Scale (DIPS) correct answer: A series of 10 questions related to the drug interaction are assessed with yes, no, unknown, or not available answers and then scored and tabulated. The total score determines the probability of the drug-drug interaction occurring in the patient and is scaled Critical care pharmacist Fundamental services correct answer: i. Distributive ii. Order entry/verification duties iii. Policy change - Tech-check-tech Critical care pharmacist Desirable services correct answer: i. Clinical (a) Provide formal nutrition consultation. (b) Respond to resuscitation events. Practice Administration and Development: Protocol Development and Quality Assurance ACCP Updates in Therapeutics® 2015: Critical Care Pharmacy Preparatory Review Course 2-201 ii. Educational (a) Provide didactic lectures to health care professionals, students, residents, and fellows in critical care pharmacology and therapeutics. (b) Train pharmacy residents, students, and fellows through experiential critical care rotations. iii. Administrative (a) Develop and implement ICU policies and protocols. (b) Evaluate the economic impact on services provided in the ICU. iv. Scholarly (a) Perform research - Collect data, establish study design, perform data Critical care pharmacist Optimal services correct answer: Integrated, specialized, and dedicated model of direct patient care functions aimed to optimize outcomes i. Clinical: Assist physicians or providers with pharmacy and therapeutics to aid in decisionmaking regarding treatment options. ii. Educational (a) Coordinate or direct residency or fellowship programs. (b) Teach advanced cardiac life support. (c) Implement training programs for personnel working in the ICU. iii. Administrative: Design new pharmacy programs for the ICU. iv. Scholarly (a) Perform clinical research. (b) Disseminate the results of clinical research, outcomes data (c) Perform laboratory analysis. The Belmont report correct answer: Outlines the fundamental ethical principles for the conduct of clinical research 1. Respect for individuals dictates that each research participant be treated with respect for his or her dignity and autonomy. As such, informed consent shall be obtained from research participants or their surrogates. 2. The principle of justice requires that investigators recruit research subjects in a manner that allows equal access to participation for all populations that may potentially benefit from the research endeavor. 3. Beneficence requires research investigators to ensure that risks are minimized and benefits maximized for research participants. Equipoise correct answer: Must be present for the conduct of a clinical trial. Equipoise is defined as the state of uncertainty between treatments A and B for a given population