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Review of Basic Reference (1) Section- 1 台北醫學大學– 台北醫學大學 雙和醫院 呂宛靜 藥師 101.3.12 Outline Know which tertiary references to look into when you answer A general question about a medication A question about the drug interaction A question about side effect or adverse drug reaction Evaluation for Tertiary Sources Scope: what does it intend to do? Chapters classification Index Content: what is included? Edition Publisher Publication frequency Arrangement: how do you access? Format: drug monograph Strength & Weakness General Drug Information Resources - Drug monograph Monograph Title and Synonyms Pharmacologic-Therapeutic Class Chemistry and Stability Pharmacology Pharmacokinetics Uses Adverse Effects Precaution General Drug Information Resources - Drug monograph Contraindications Mutagenicity and Carcinogenicity Pregnancy, Fertility and Lactation Chronic Toxicity Acute Toxicity Interactions Dosing and Administration Preparations Patients Education Tertiary Information Sources— Good Pharmacopoeia Unbiased Well-indexed Generic Brand Well-referenced Well-categorized Commonly Used Pharmacopoeia American Hospital Formulary Service (AHFS) Drug Information Physician Desk Reference (PDR) Drug Facts and Comparisons Martindale: The Complete Drug Reference USP Dispensing Information (USPDI) 查詢一般藥物諮詢的好幫手 Others 1. 2. 3. 4. MicroMedex Drug Information Handbook MIMS (台灣) … 北醫電子資源 新版介面 北醫電子資源 新版介面 新版MicroMedex2.0 位置 新版 新版MicroMedex2.0 新版 Drug Information Handbook Publisher: Apha (American Pharmaceutical Association) Commonly used by pharmacists Alpharbetically list of monographs No referenced Drug Information Handbook Publisher: Apha (American Pharmaceutical Association) Commonly used by pharmacists Alpharbetically list of monographs Special features: Medication Safety Issues: Sound-alike/look-alike issues Labeled and unlabeled/ investigational indications includes stability, administration, and extemporanious preparations Dictionary-like headings at the top of each pageIncludes U.S. and Canadian trade names Drug Information Handbook Unbiased Well-indexed Generic Brand Well-referenced Well-categorized Physicians’ Desk Reference (PDR) Physician Desk Reference (PDR) Scope: Official package inserts published by pharmaceutical companies美國仿單之集合(結構式,藥動圖表) Company pay a fee Including most of commonly used medications marketed in USA Including only FDA labeled uses Updated annually CD-ROM, hand-held computer format, part of MICROMEDEX CCIS Includes both active and inactive ingredients Publisher: Thomson Healthcare Web site: www.pdr.net Physician Desk Reference (PDR) Arrangement: Color-coded indexes lead to information arranged alphabetically by manufacturer Useful when look for current status of medication Contain about 1000 photographs of drug products (藥物圖片), useful for identification Physician Desk Reference (PDR) Content Index Manufacture’s Brand and Generic name Product Category Product identification guide Product information Diagnostic product information Physician Desk Reference (PDR) Drug Monograph Description Clinic pharmacology Indications and Usage Contraindications Warnings Precautions Adverse Reactions -on body system Overdose –treatment Dosage and Administration general, adult dose, pediatric dose How supplied –store Patients instructions for use Precautions General Information for patients Laboratory tests Drug interactions Drug/Laboratory Test Interactions Carcinogenesis Pregnancy Nursing mothers Physician Desk Reference (PDR) Other information Drug information center FDA use-in-pregnancy ratings list Drugs excreted in breast milk FDA MedWatch form Poison Control Centers Adverse Event Reporting Forms DEA(Drug Enforcement Administration)office telephone directory State AIDS drug assistance programs Patient assistance programs Drugs that should not be crushed Dosing instructions in Spanish Weakness Tylenol ® (Acetaminophen, indications McNeil Cons) Advil® (Ibuprofen, Wyeth Cons) No off-label FDA-approved products only USP DI Manufacturers pay to have products Martindale included : bias PDR F&C AHFS 新版 新版 Drug Facts & Comparisons Loose-leaf edition Hardbound edition Drug Facts and Comparisons Scope: US prescription and OTC products (Mostly extensive information for pharmaceutical products marketed in USA) Updated from FDA package information Publisher: Drug Facts and Comparisons Co. Loose-leaf edition updated monthly, hardbound edition updated annually Available on CD-ROM as CliniSphere www.drugfacts.com Drug Facts and Comparisons Arrangement: Content Therapeutic/ pharmacological category in chapters (eg., CH.2 Hematological Agents →Anticoagulants →Warfarin Sodium) Drugs with similar use/content are listed together Keeping up (KU) Orphan drugs (eg., octreotide for acromegaly) Investigational drugs Index Trade, generic, and official name Therapeutic class Canadian drug index Drug Facts and Comparisons Strength Including all of therapeutic uses FDA labeled and unlabeled uses Having good class comparison tables Color Locator (CD-format): organized by the colors of products Indicate sugar and alcohol free Patient information Weakness Not referenced No laboratory values & patient monitoring parameters Drug Facts and Comparisons Drug Monograph Content Actions Indications/Contraindic ations Warnings/precautions Drug interactions Adverse reaction Administration/ dosage Overdosage info Patient information Tables compare Adverse Reactions (specific drug/ drug class) Incidence rate % PK Onset, peak, duration of actions Administration routes Dosage equivalents (oral vs. IVF) Dosage ranges Drug interactions Drug Facts and Comparisons Product Listing include: Products/distributor Dosage form Dosage strength Package sizes Colors for tablets and capsules Distribution status (Rx, OTC, etc) Product ID codes Drug Facts and Comparisons Appendix FDA new drug classification Controlled substances FDA pregnancy categories Treatment guidelines General management of acute overdosage Management of acute hypersensitivity reactions International system of units Normal laboratory values Calculations Standard medical abbreviations Manufacturer/distributor abbreviations Manufacturers/distributors index 新版 舊版 USP Dispensing Information (USP DI) USP Dispensing Information (USP DI) Three-set volume: Volume I – Health Care Professional Volume II – Advice for the patients Volume III – Approved Drug Products and Legal Requirements Index: Indication / Generic, brand, common name US and Canada Published annually. Monthly Updates Online http://uspdi.micromedex.com/ Publisher: MicroMedex Thomson Healthcare, US. USP DI Volume I For the Health Care Provider Information on drug products in monograph format, including both FDA-approved and off-label indications. Includes information on veterinary drugs, OTC, and diagnostic agents Fast reference Content: Drug monograph: indications, pharmacology, precautions, SE, patient consultation, dosage information Others: Therapeutic guidelines, Orphan drugs, Biological designations list— fast reference (STAT reference), reviewed by more than 800 healthcare experts USPDI Volume II Advice for the Patient Drug information for the patient in lay language grouped by drug class Content: Simplified drug monographs: proper drug use, precautions, S.E., age considerations, allergies, pregnancy and breast feeding considerations Others: glossary of medical terms, poison control centers USPDI Volume III Approved Drug Products and Legal Requirements Federal guideline information affecting drug prescribing and dispensing Includes the complete FDA “Orange Book” Therapeutic equivalence information Helps select an appropriate generic substitute Quickly identifies drug chemical properties Determines if a drug has been discontinued provides a list of discontinued drug products USP Dispensing Information (USP DI) Strength Thorough information on: Adverse effect: By severity and incident rate, followed by “Treatment of Adverse Reactions” Patient Monitoring: Pharmacokinetics, Laboratory Value Alternation, Patient Monitoring parameters Drug interaction more detail Dosage classified by form & age Weakness Drug monograms in alphabetic order, instead of therapeutic class, inconvenient to compare among agents of similar use Not referenced Eg., Patient Consultation of Octreotide in USPDI Martindale: The Complete Drug Reference Martindale: The Complete Drug Reference Formerly Martindale: The Extra Pharmacopoeia Publisher: London Pharmaceutical Press Updated every 4 to 5 years Available on CD-ROM and a part of MICROMEDEX CCIS http://www.pharmpress.com Martindale: The Complete Drug Reference Scope Mostly extensive information for pharmaceutical products marketed in Europe (歐系用藥 歐系用藥) 歐系用藥 Excellent resource for herbal and homeopathic medications Arrangement Pharmacology-therapeutic classification References Synopsis of disease treatments Content: 3 parts Part 1: Monograph on drugs arranged by uses or actions Part 2: Supplementary drugs and other substances Herbals, toxic substances, acids, essential oils Part 3: Preparations form many countries + General index: generic, brand, and chemical name, therapeutic class, clinical use Directory of manufacturers Martindale: The Complete Drug Reference Drug monograph Pharmacopoeia description (Ph.Eur ,USP) Adverse effect(on body system) Treatment of Adverse Effects Precaution Interaction(以藥理分類列出) Pharmacokinetics Uses and Administrations Preparations BP, USP Proprietary Preparations Multi-ingredient 隨每個段落的結束會附上相關的reference Weakness Scarce information on patient education & monitoring Adverse effect details are brief, lack incident rate Inconvenient to locate approved indications for individual drug? 新版 舊版 American Hospital Formulary Service (AHFS) Drug Information AHFS Drug Information Scope Mostly extensive pharmacopoeia in USA Including all of medications marketed in USA Including all of therapeutic uses FDA labeled and unlabeled uses Publisher: official pharmacopoeia published by ASHP (American Society of Health-System Pharmacists) Updated annually with quarterly supplements Full-text format (e.g., with references) on CD-ROM and on-line systems Web site : www.ahfsdruginformation.com AHFS Drug Information Arrangements Pharmacologic-therapeutic classification Drugs with similar use/content are listed together Index: (alphabetically) Under a variety of names: proprietary (trade) name, generic name, synonym, abbreviation AHFS Drug Information – Eg., How to locate Warfarin Table of Content 20:00 → Blood Formation and Coagulation 20:12 → Coagulants and Anticoagulants 20:12.04 → Anticoagulants 20:12.04.08 → Coumarin and Indandione Derivatives Index Generic name Warfarin → p.1410 AHFS Drug InformationPhenytoin Content: Drug monograph Classification: 28:12 . 12 CNS agent anticonvulsants hydantoin Uses : FDA and off-label use Seizure disorders, Cardiac arrhythmias. Dosage and Administration Reconstitution and Administration Dosage: specify by indication/ renal and hepatic impairment AHFS Drug Information Cautions Adverse Effects Precautions and Contraindications Pregnancy Drug Interaction Laboratory Test Interferences Pharmacology Pharmacokinetics -ADME Chemistry and Stability Preparations Brand availability AHFS Drug Information Strength >500 Reviewers Over 70,000 sited references on the electronic version More clinical-oriented Weakness Diagnostic agents omitted from print version 新版 五本藥典比較表 AHFS Frequency of updating pharmacological Content alphabetical General/drug Manufactures Index Product category Disease electronic PDR DFC 1 years 1years 1years USPDI Martindale 1years 3 years 五本藥典比較表 AHFS Frequency of updating pharmacological Content Index DFC 1 years 1years 1years ˇ alphabetical General/drug PDR ˇ Manufactures ˇ Product category ˇ 3 years ˇ ˇ ˇ Disease electronic 1years ˇ ˇ ˇ USPDI Martindale ˇ ˇ ˇ ˇ ˇ ˇ ˇ ˇ 五本藥典比較表 AHFS PDR DFC USPDI Martindale Indication/uses ˇ ˇ ˇ ˇ ˇ Dosage and Administration ˇ ˇ ˇ ˇ ˇ Pharmacology/Pharmacokin etics ˇ ˇ ˇ ˇ ˇ Contraindications/warnings/ precautions ˇ ˇ ˇ ˇ ˇ Drug interactions ˇ ˇ ˇ ˇ ˇ Adverse Reactions ˇ ˇ ˇ ˇ ˇ Overdosage ˇ ˇ ˇ ˇ ˇ Patient information ˇ ˇ ˇ ˇ ˇ Preparations ˇ ˇ ˇ ˇ ˇ 五本藥典比較 最詳細的藥物資料 條列式、簡易快速得到藥物資料 藥物辨識圖片 提供較多病人藥品資訊 參考文獻附在文章旁,便於查尋 歐系藥品 五本藥典比較 最詳細的藥物資料 條列式、簡易快速得到藥物資料 USPDI 參考文獻附在文章旁,便於查尋 PDR, USPDI, Drug Facts and Comparisons(CD版) 提供較多病人藥品資訊 Drug Facts and Comparisons, USPDI 藥物辨識圖片 AHFS Martindale 歐系藥品 Martindale Review of Basic Reference (1) Section- 2 Outline Know which tertiary references to look into when you answer A general question about a medication A question about the drug interaction A question about side effect or adverse drug reaction Tertiary drug interaction references <1.> Drug Interaction Facts (Tatro) <2.> Drug Interactions Analysis and Management (Hasten & Horn) Drug Interaction Facts Drug Interaction Facts One of the clearest and easiest to use DI publications. Well-referenced, providing details. Well-indexed: significance rating next to each entry Well-evaluated Publisher: Drug Facts and Comparisons Co. Updated quarterly Loose-leaf format, computer program (as part of the CliniSphere) Features of Drug Interaction Monograph Drug Class Drug Class Drugs Significance 1~5 Effects Mechanism Management Discussion Reference Onset □ Rapid □ Delayed Severity □ Major □ Moderate □ Minor Drugs Documentation □ Established □ Probable □ Suspected □ Possible □ Unlikely Drug Interaction Facts Significance Rating Onset Rapid ~ within 24 hr (Immediate action is necessary) Delayed ~ days to weeks Severity Major ~ life threatening or permanent damage Moderate ~ deterioration of pt’s status Minor ~ bothersome or little effect Drug Interaction Facts Significance Rating Documentation Established 確立的 proven to occur in well controlled studies Probable 很可能發生的 very likely, but not proven clinically Suspected 懷疑的 may occur , but needs more study Possible 可能的 could occur, but data are very limited Unlikely 不大可能的 doubtful, no good evidence of a clinical effect Drug Interaction Facts Significance Rating Significance Rating 1 5 Severity Documentation 1 Major Suspected or > Suspected or > Suspected or > 2 Moderate 3 Minor 4 Major / Moderate Possible 5 Minor Possible Any Unlikely is a severe and well-documented interaction is an interaction of no more than unlikely or possible documentation Drug Interaction Facts Effects- pharmacologic effects and clinical manifestations Mechanism- how the interaction occurs, PD (eg, decreased receptor sensitivity) or PK (eg, decreased metabolism) Management- recommendations for appropriate action to prevent or respond Discussion- brief review of published data and selected primary references Drug Interaction Monograph- example Anticoagulants Warfain (eg, Counadin) Significance 1 Effects Mechanism Management Discussion Reference Onset □ Rapid ■ Delayed Azole antifungal agnets Fluconazole (Diflucan) Severity ■ Major □ Moderate □ Minor Voriconazole (Vfend) Documentation ■ Established □ Probable □ Suspected □ Possible □ Unlikely The anticoagulant effect of Warfarin maybe increased. Inhibition of Warfarin metabolism Monitor PT and INR values frequently (eg, every2 days) when adding or dc an Azole antifungal agents. Adjust the Warfarin doses as needed. 新版 Micromediex 2.0 1. 輸入藥名 2. 點選 3. 帶入 4. 舊版 輸入藥名 選擇劑型 Drug Interactions Analysis and Management (Hasten & Horn) Drug Interactions Analysis and Management (Hasten & Horn) Emphasize the management options available for a patient receiving an interacting pair of drugs. Well-referenced guide to drug-drug, and some drug-food, interactions. Published annually with quarterly updated Drug Interactions Analysis and Management (Hasten & Horn) Significance numbers: 1= Avoid Combination. Risk always outweighs benefit 2= Usually Avoid Combination. Use combination only under special circumstances. 3=Minimize Risk. Take action as necessary to reduce risk. 4=No Action Needed. Risk of adverse outcomes appears small. 5=No interaction. Evidence suggests no interaction. Monograph Significance number Generic drug (eg., Brand name) Summary: Risk factors: Clinical Evaluation Related Drugs: Management Options Dosage regimen Concurrent Diseases Mechanism Avoid unless benefit outweighs risk Consider Alternative Circumvent /Minimize Monitor Reference Tertiary adverse reaction references <1.> Meyler’s side effects of drug <2.> Davies’s Textbook of adverse drug reaction <3.> Drug-Induced Diseases Prevention, Detection, and Management Meyler’s side effects of drug Side effects of Drugs Annual Meyler’s side effects of drug Side effects of Drugs Annual The most comprehensive resource for information on adverse reactions associated with drug therapy. Side effects of Drugs Annual published yearly. 1st edition, 1977~ 32th edition, 2010. A world-wide yearly survey of new data and trends in ADR Meyler’s side effects of drug, Encyclopaedic edition published every 4 years. 9th edition, 1980 ~ 15th edition, 2006. Comprehensive references to the primary literature. Combined the followed database: Side Effects of Drugs Annuals , SEDBASE (the Side Effects of Drugs Database)- CD-ROM format, Drug-Induced Disorders edited by Dukes N.M.G., Unwanted Effects of Cosmetics and Drugs Used in Dermatology, Immunotoxicology of Drugs and Chemicals, Drugs and Human Lactation, Responsibility for Drug-Induced Injury, Drug Safety in Pregnancy, The International Journal of RISK AND SAFETY IN MEDICINE. Meyler’s side effects of drug Monographs, American spelling. Content: Pharmacologic class-based chapter Index of drugs Preferred by pharmacist. Acebutolol,580,583 Acetaminophen see paracetamol … Index of side effects Abdominal cramp Anthraquinone derivative,1235 Bisacodyl,1235,1240 …….. A series of derivative volums based on Meyler’s Side Effect of Drugs, 15th Edition. 1. 2. 3. 4. 5. 6. 7. 8. Meyler's Side Effects of Drugs Used in Anesthesia, 2008 Meyler's Side Effects of Psychiatric Drugs, 2008 Meyler's Side Effects of Herbal Medicines, 2008 Meyler's Side Effects of Endocrine and Metabolic Drugs, 2009 Meyler's Side Effects of Cardiovascular Drugs, 2009 Meyler's Side Effects of Antimicrobial Drugs, 2010 Meyler's Side Effects of Analgesics and Anti-inflammatory Drugs, 2010 Meyler's Side Effects of Drugs in Cancer and Immunology, 2010 A series of 8 derivative works, grouped by specialty , drawn from the 15th of internationally renowned encyclopedia, Meyler's Side Effect of Drugs, and the latest volumes in the companionseries, Side effects of Drugs Annuals. Includes clinical case studies and expert analysis, and also drug-drug interactions. Cross references: Side effects of Drugs Annuals are cited as SEDA-1, SEDA-2, etc. Davies’s Textbook of adverse drug reaction Davies’s Textbook of adverse drug reaction Content: Organ based chapter Well-indexed and cross indexed: Preferred by clinician. Presented in a format of organ based adverse reactions, making the clinical presentation the entry point. Alphabetically, by drug name- adverse effect (Paracetamol aspirin sensitivity, 210) Well-referenced Well-evaluated, unbiased data Publisher: Oxford Medical Publication (Mandatory ADR reporting system in European) Drug-Induced Diseases Prevention, Detection, and Management Drug-Induced Diseases Prevention, Detection, and Management (2nd, 2010) Content: Organ based chapter (over 50 disease states) Index: Alphabetically, primary by adverse effect Goal: provides a detailed analysis of how to identify, prevent, and manage drug-induced diseases. Useful Tables: eg., Epidemiology (incidence rate) of drug-induce disease Risk factors Mechanisms Sign and symptoms Prevention, Monitoring Parameters for the Prevention of Drug-Induced seizures Management A new chapter: “The Legal, Regulatory, and Practice Environment”, “Evaluating Patients for Drug-Induced Disease”. . Levels of Evidence classification for identifying the “strength of evidence” that links a listed drug to a specific drug-induced disease. Well-referenced More textbook like