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Transcript
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
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