review of basic reference (1) section- 1

Review of Basic Reference (1)

Section- 1

台北醫學大學台北醫學大學台北醫學大學台北醫學大學– 雙和醫院雙和醫院雙和醫院雙和醫院

呂宛靜呂宛靜呂宛靜呂宛靜藥師藥師藥師藥師

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?� Edition

� Publisher

� Publication frequency

� Arrangement:

how do you access?� Chapters classification

� Index

� Content:

what is included?

� 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查詢一般藥物諮詢的好幫手查詢一般藥物諮詢的好幫手查詢一般藥物諮詢的好幫手

Others

1. MicroMedex

2. Drug Information Handbook

3. MIMS (台灣)

4. …

北醫電子資源北醫電子資源北醫電子資源北醫電子資源新版介面新版介面新版介面新版介面

新版新版新版新版MicroMedex2.0 位置位置位置位置

新版新版新版新版MicroMedex2.0

Drug Information Handbook

� Publisher: Apha (American Pharmaceutical

Association)

� Commonly used by pharmacists

� Alpharbetically list of monographs

� No referenced


� 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


� 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 MICROMEDEXCCIS

� Includes both active and inactive ingredients

� Publisher: Thomson Healthcare

� Web site: www.pdr.net


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


Content

� Index

� Manufacture’s

� Brand and Generic name

� Product Category

� Product identification guide

� Product information

� Diagnostic product information


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


� 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

WeaknessWeakness

� No off-label indications

� FDA-approved products only

� Manufacturers pay to have products

included : bias

Tylenol ®

(Acetaminophen, McNeil Cons)

Advil®

(Ibuprofen, Wyeth Cons)

USP DI ��

Martindale ��

PDR ��

F&C ��

AHFS ��

新版新版新版新版

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


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


StrengthStrength

� 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

WeaknessWeakness

� Not referenced

� No laboratory values & patient monitoring parameters


Drug Monograph Content

� Actions

� Indications/Contraindications

� 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


Product Listing include:

� Products/distributor

� Dosage form

� Dosage strength

� Package sizes

� Colors for tablets and capsules

� Distribution status (Rx, OTC, etc)

� Product ID codes


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

舊版舊版舊版舊版

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 IIAdvice 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 IIIApproved 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)

StrengthStrengthThorough 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

�� WeaknessWeakness� Drug monograms in

alphabetic order, instead of therapeutic class, inconvenient to compareamong agents of similar use

� Not referenced

Eg., Patient Consultation of Octreotidein 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


Scope

� Mostly extensive information for pharmaceutical products marketed in Europe (歐系用藥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


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, USPProprietary PreparationsMulti-ingredient

� 隨每個段落的結束會附上相關的reference ��

WeaknessWeakness

� Scarce information on patient education &

monitoring

� Adverse effect details are brief, lack incident

rate

� Inconvenient to locate approved indications

for individual drug?

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


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 IndandioneDerivatives

� IndexGeneric nameWarfarin → p.1410

AHFS Drug Information-Phenytoin

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


� Cautions� Adverse Effects

� Precautions and Contraindications

� Pregnancy

� Drug Interaction

� Laboratory Test Interferences

� Pharmacology

� Pharmacokinetics -ADME

� Chemistry and Stability

� Preparations� Brand availability


StrengthStrength

� >500 Reviewers � Over 70,000 sited references on the

electronic version � More clinical-orientedWeaknessWeakness

� Diagnostic agents omitted from print version

五本藥典比較表五本藥典比較表五本藥典比較表五本藥典比較表

AHFS PDR DFC USPDI Martindale

Frequency of updating 1 years 1years 1years 1years 3 years

Contentpharmacological

alphabetical

Index

General/drug

Manufactures

Product

category

Disease

electronic



Frequency of updating 1 years 1years 1years 1years 3 years

Contentpharmacological ˇ ˇ ˇ

alphabetical ˇ ˇ

Index

General/drug ˇ ˇ ˇ ˇ ˇ

Manufactures ˇ

Product

categoryˇ

Disease ˇ

electronic ˇ ˇ ˇ ˇ ˇ



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

五本藥典比較五本藥典比較五本藥典比較五本藥典比較

� 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

五本藥典比較五本藥典比較五本藥典比較五本藥典比較

� 最詳細的藥物資料� AHFS

� 條列式、簡易快速得到藥物資料� Drug Facts and Comparisons, USPDI

� 藥物辨識圖片� PDR, USPDI, Drug Facts and Comparisons（CD版）

� 提供較多病人藥品資訊� USPDI

� 參考文獻附在文章旁,便於查尋� 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


� 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 Drugs

Significance Onset Severity Documentation

□ Rapid □ Major □ Established

□ Delayed □ Moderate □ Probable

□ Minor □ Suspected

□ Possible

□ Unlikely

1~5

Effects

Mechanism

Management

Discussion

Reference


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 FactsSignificance 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

Severity Documentation

1 Major Suspected or > Suspected or > Suspected or >

2 Moderate

3 Minor

4 Major / Moderate Possible

5 Minor Possible

Any Unlikely

1 is a severe and well-documented interaction

is an interaction of no more than unlikely or

possible documentation5


� 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 Azole antifungal agnets

Warfain(eg, Counadin)

Significance Onset Severity Documentation

□ Rapid ■ Major ■ Established

■ Delayed □ Moderate □ Probable

□ Minor □ Suspected

□ Possible

□ Unlikely

1

Effects The anticoagulant effect of Warfarin maybe increased.

Mechanism Inhibition of Warfarin metabolism

Management Monitor PT and INR values frequently (eg, every2 days) when adding or dc an Azole antifungal agents. Adjust the Warfarin doses as needed.

Discussion

Reference

Fluconazole Voriconazole(Diflucan) (Vfend)

1. 輸入藥名

2. 點選

3. 帶入

4.

新版新版新版新版 Micromediex 2.0

輸入藥名

選擇劑型

Drug Interactions

Analysis and Management

(Hasten & Horn)

Drug Interactions Analysis and


� 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


� 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:

� Dosage regimen

� Concurrent Diseases

� Mechanism

� Clinical Evaluation

� Related Drugs:

� Management Options

� 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 DiseasesPrevention, Detection, and Management

Meyler’s side effects of drugSide 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� Preferred by pharmacist.

� Index of drugs� 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. Meyler's Side Effects of Drugs Used in Anesthesia, 20082. Meyler's Side Effects of Psychiatric Drugs, 20083. Meyler's Side Effects of Herbal Medicines, 20084. Meyler's Side Effects of Endocrine and Metabolic Drugs,

20095. Meyler's Side Effects of Cardiovascular Drugs, 20096. Meyler's Side Effects of Antimicrobial Drugs, 20107. Meyler's Side Effects of Analgesics and Anti-inflammatory

Drugs, 20108. 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

� Preferred by clinician.

� Presented in a format of organ based adverse reactions, making the clinical presentation the entry point.

� Well-indexed and cross indexed:

� Alphabetically, by drug name- adverse effect (Paracetamolaspirin 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 DiseasesPrevention, 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 managedrug-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

review of basic reference (1) section- 1

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