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Alternative Information Sources

Alternative Information Sources. Amy Lodolce, PharmD, BCPS Maria Tanzi, PharmD. Learning Objectives. Explain the hierarchy of references used in drug information

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Alternative Information Sources

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  1. Alternative Information Sources Amy Lodolce, PharmD, BCPS Maria Tanzi, PharmD

  2. Learning Objectives • Explain the hierarchy of references used in drug information • Compare and contrast available secondary references such as The Medical Letter, The Pharmacist’s Letter, Prescrire, and Worstpill • Critically evaluate skeptical and non-skeptical secondary references and how they can be used to aid in formulary decisions

  3. Hierarchy of References • Tertiary • Textbooks • Micromedex? • Secondary • Newsletters • Medline • IPA • Primary

  4. What is the prevalence and importance of the condition the drug is intended to treat? • Key organizational websites • General statistics on various disease states • www.cdc.gov • www.nih.gov • Cardiac conditions • www.americanheart.org • www.acc.org • Infectious diseases • www.idsociety.org • Diabetes • www.diabetes.org

  5. Are the claims (both on and off-label) being made for this drug supported by the data presented? • MICROMEDEX • Explore “therapeutic uses” section of the monograph • MEDLINE • Search generic drug name AND off-label condition • Manufacturer: “Data on file” • Request standardized response letters on off-label uses

  6. What is the quality and strength of the evidence supporting the efficacy? • Examine study design • RCT vs. cohort vs. case-control • Include an evidence raking for each trial • Type I: Obtained from at least one properly designed RCT • Type II-1: Obtained from well-designed controlled trials without randomization • Type II-2: Obtained from well-designed cohort or case-control analytic studies, preferably from more than 1 center • Type II-3: Obtained from multiple time series with or without intervention; dramatic results in uncontrolled experiments could also be regarded as this type of evidence • Type III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

  7. Is there a potential for look-alike, sound-alike name errors raised by or reported for this drug? • ISMP • www.ismp.org • MedWatch • http://www.fda.gov/medwatch/ • USP • http://www.usp.org/hqi/patientSafety/newsletters/practitionerReportingNews/

  8. Are there warning signals of potential safety concerns? • Drug interactions, hepatotoxicity • Theoretical concerns • CYP450 effects • Concurrent therapy • Medline • FDA website

  9. Are there demonstrated shortcomings of existing therapy? • Assess comparative safety, efficacy, acceptability, convenience • Premise for non-inferiority trials • Medical Letter • Pharmacist’s Letter • Prescrire

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