Info Systems Review
(a little birdie sent me this...is not meant to be comprehensive, just something to get youstarted!)
You should be able to copy it and paste it into word!!!
Hope it helps!!!
Plagiarism
When an author presents as his or her ideas, language, data, graphs, or even scientific protocols created by someone else without giving proper credit.
There are 2 basic reasons to cite:
documentation (to support an idea)
acknowledgement (avoid plagiarism)
Rule of practice: place citation number closest to actual material you are referencing.
Personal communication is listed in running of text, not as works cited page. Use date of communication, oral or written, affiliation of person to est. relevance.
Place registered trademark with first use of word, then omit.
Sample citations:
Journal article
Smith J, Canton EM. Weight-based administration of dalteparin in obese patients. Am J Health-Syst Pharm. 2003;60:683-687.
Books with 2 or more authors
Aronoff GR, Berns JS, Brier ME, et al. Drug Prescribing in Renal Failure. 4th ed. Philadelphia, PA: American College of Physicians;1999:39.
Chapter in a book
Wallace RJ Jr., Griffith DE. Antimycobacterial agents. In: Kasper DL, Fauci AS, Longo DL, Braunwald E, Hauser SL, Jameson JL, eds. Harrison’s Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005:951-952.
(authors of chapter, title of chapter only capitalize first word. In: author(s) of book OR EDITITORS, title of book italic or underlined. X ed. Place, State: Publisher; year: page number.
Package Insert
Lamasil [package insert]. East Hanover, NJ: Sandoz Pharmaceuticals Corp; 1993.
eBook
Rennie D, Guyatt G, eds. Users’ Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice [book online]. Chicago, IL:AMA Press; 2002. http: ……Accessed December 5, 2006.
Lexi programs
Lexi-Comp, name of book or data base (Lexi-Drugs, Comp + Specialties) [computer program]. Compiler of data base Skyscape; date and/or version/date of program
Tertiary Literature
Literature Hierarchy
3’ textbooks, review articles
2’indexing/abstracting sources
1’ original research
I. Tertiary Literature:
established knowledge
consists of package inserts; textbooks; review articles; full-text databases, PDA programs, and practice guidelines.
Provides an “overview” of topics gathered from primary lit, condensed in organized format.
II. Advantages of 3’ Lit
convenient
concise
easy to use format
updated (some)
efficient
organized
III. Disadvantages of 3’ Lit
incomplete information
biased info
lag time
varied interpretations
MONOGRAPHS
Provides extensive overview of a medication
Examples of monograph references:
-package insert
-drug facts n comparisons
-AHFS
-USPDI vol 1
- Lexi-Drugs
-Clinical Pharmacology
-PDR (physicians desk reference)
PACKAGE INSERTS
-contain info from manufacturer
-info provided is FDA approved
-found in 1. Online and http://www.drugname.com/ 2. medication bottles 3. PDR
SECTIONS OF MONOGRAPH
Drug name- brand/generic
Description- chemical name, structure, dosage form info, inactive ingredients
Clinical Pharmacology- explains how rx works in body, differences in action based on gender, age, or ethnicity, and contains drug-drug interactions.
Indications/usage- lists uses that are FDA approved, conditions that have adequate date from clinical trials are included
Pregnancy/Lactation Category- rankings and lists if product is compatible in breast milk
Contraindications- lists situations rx should not be used, warns prescribers not to use rx in conditions in which more prone to adverse effect
Warnings/Precautions- discusses serious side effects that may occur in people, BLACK BOX WARNINGS- severe or life-threatening
Precautions- advises how to use rx safely and effectively, alerts prescribers to patients that need close observation, lab test info, pregnancy, geriatric and ped info in this section. Also lists DRUG INTERACTIONS
Adverse Reactions- lists all side effects that were reported in people who took rx wile it was tested. May be grouped by body systems. May include frequency of occurrence.
Overdosage- effects and treatment
Dosage/ administration- recommended doses, time and route,
How supplied- available forms of Rx, formulation description (color, shape, markings) Storage instructions, and number of units/package.
DRUG FACTS AND COMPARISONS
-updated monthly
-black box warnings
Investigational drugs
Manufacturer index
Orphan drugs
Normal lab values
Drug ID database
Rx, otc, and herbal info
Extensive product listings
Patient leaflets
AHFS
American Society of Health-System Pharmacists
Official source for unlabeled drug uses
Incorporates evidence based medicine principles from nationally recognized organizations
Most used by hospital pharmacists
USPDI VOL 1
Official source of unlabeled drug uses
Contains auxiliary information
Does not have all drugs
Monthly updates online
MICROMEDEX
Online database
Contains info related to ID of drug products
Info of foreign drugs, drug interactions, and IV compatibility
May contain info about FAQ related to drug therapy
OFFICIAL COMPENDIUM for unlabeled drug uses
PDR (PHYSICIANS DESK REFERENCE)
Contains selected package inserts for paid manufactures
Medications organized by manufacture
Contains photo of RX
Updated annually
Most used by Drs.
MOSBY’S DRUG CONSULT
Contains Package inserts of all drugs
Updated annually
Contains photo of RX
CLINICAL PHARMACOLOGY
Online database
Contains info related to id, availability, choice for condition, interactions, alternative medicine
Contains patient info in espanol
LEXI-COMP
Online, print and PDA
Contains drug interaction checker and drug ID
Patient info in several languages
Special population databases
Retail prices
Photos of RX
International brand names available
Compounding formulas
Free monograph references include
-RxList.com
-drugs.com
DRUG THERAPY REFERENCES
Pharmacotherapy
Applied therapeutics
UNLABELED USES
AHFS
USPDI vol 1 official compendia
Micromedex
Lexi-comp
Facts n comparisons
GENERAL VS SPECIFIC
General offers overview
Specific have more comprehensive, focused info. Includes in-depth discussions of the topic and practice-related experiences to a greater extent than general
OTC/HERBAL
Handbook of Nonprescription Drugs
Natural Medicines Comprehensive Database
ADRs
Meyler’s Side effects of Drugs
Monograph references
COMPOUNDING
Allen’s Compounding
Pediatric Drug Formulations
DRUG INTERACTIONS
Drug Interaction Analysis and Management (Hansten and Horn)
Drug Interaction Facts
Lexi- Interact
IV STABILITY/COMPATABILITY
Handbook on Injectible Drugs
King’s Guide to Parenteral Admixtures
PATIENT COUNSELING
USPDI Vol 2
MedFacts Patient Information (online or print)
Lexi- Pals
COST
Drug Topics Red Book
Lexi-Comp (retail only)
Clinical Pharmacology (retail only)
Mosby’s Drug Consult (AWP)
PREGNANCY CATEGORY/ LACTATION
Drugs in Pregnancy and Lactation (Briggs)
Monographs (non-specialty)
DRUG INFORMATION CENTERS (Biomedical Lit Section of Notebook)
Began in 1962, University of Kentucky
“Source of selected, comprehensive drug information for staff physicians and dentists to evaluate and compare drugs”
Questions generated by health care professionals
Specialists usually trained in drug info practice
Majority of questions concern therapeutic recommendations, ADRS, drug ID, and dosage
Most (70%) DICS are in hospitals or medical centers; other areas include: colleges, libraries, and poison control centers
DIC DUTIES
Answer questions
Provide pharmacy and therapeutic support
Develop policies and procedures
Develop medication use programs
Conduct research
Train students/residents
POISON CONTROL CENTERS
Accurate and timely info to enhance quality of care of patients calling
Questions mostly generated by consumers
More urgent responses required
Specialists trained in clinical toxicology
Some nationally certified
Free service
ANSWERING DRUG INFORMATION QUESTIONS
Modified Approach (1986)
Step I: Secure demographics of requestor
requestor occupation
determine method of delivery
contact info
Step II: Obtain background information
essential for effectively using approach
used to help clarify question
determine if question is patient specific vs general
if patient specific acquire info concerning age, weight, allergies, organ function, ect.
Step III: Determine/ Categorize ultimate question
confirm request by restating question to requestor
aids in directing researcher to specific resource or type of resources
establish timeline for response
Classifications from practicum and website (adrs, bioequivalence, compounding, patient education, ect.)
Step IV: Develop search strategy and conduct search
a. choose references that complement question categorization
b. begin with established knowledge (3’ lit)
c. Secondary lit can be used
d. primary lit can be “consulted”
Step V: Perform evaluation, analysis, and synthesis
evaluate info located
answers may not be clearly stated
confirm answers in multiple references (> 2)
Step VI: Formulate and provide response
restate question with background info
include a brief review of search strategy and references used
include assessments of conflicting data
Step VII: Conduct follow-up and documentation
document question and response
conduct follow up
protects against legal liability
justification of professional value
future reference
quality control
new info may become available
SECONDARY LITERATURE
Indexing and abstracting services of the primary and tertiary literature
PUB MED vs IPA
PubMed
Scope is biomedical literature
Contains information related to drugs and diseases
Contains biomedical lit related to clinical practice
Began in 1966 by national library of medicine
Contains > 11 million references
Indexes review articles, clinical trials, practice guidelines, editorials, letters, ect
Updated daily
Shortest lag time
Freely accessible
Contains full-text journal articles in addition to abstracts
Contains links to articles that have fee
Controlled vocabulary is Medical Subject Headings (MeSH)
IPA
Pharmacy practice
Clinical and technical drug info
Pharmaceutical education
Legal aspects of pharmacy
Compounding formulations
Medication protocol
Produced by American society of health systems pharmacy
Began in 1964
Indexes > 750 journals, abstracts of papers presented at pharmacy meetings, US state journals, letters, editorials, and reviews
Updated once monthly
May have long lag time
Contains journal articles in English, foreign languages, hum and non human subjects
Only contains abstracts
Controlled voc is SUGGEST
Boolean operators and, or, not
ADVANTAGES/ DISADVANTAGES OF SECONDARY LITERATURE
Advantages
Indexed by topic
Uses controlled vocab
Efficient method to search literature
Organized format
Different scopes per database
Citations contain abstracts
Full text journal articles may be available (PUBMED)
Special search features (limits)
Can store, email searches
Disadvantages
Lag time for some databases (IPA)
Limited scope
Indexing methods
Full text journals not available in some
Equipment required
Costs
PRIMARY LITERATURE
Original publications published in biomedical journals; new information
Most current resource of information
Provides details of research methods and results
Basis of secondary/tertiary lit
ADVANTAGES:
current
most subjected to peer review
less lag time
reader can critically evaluate to determine usefulness
organized format
provides specific details of study and results
DISADVANTAGES:
flaws in study methods may exist
all investigators do not follow format
may not provide reader with enough info
limited access
results may be biased
conclusions may be inflated
interpretations may be varied
DESCRIPTIVE: CASE REPORT/SERIES
records observations related to a drug or technology applied to a single patient or group of patients
retrospective, observational
does not involve multiple treatment periods
useful in identifying drug toxicities
results may or may not be compared to a control group
hypothesis generating; results should be confirmed with a controlled, clinical trial
ADVANTAGE
id treatments for rare disorders where large subject populations do not exist
early recognition of drug toxicities
hypothesis generating
DIS
difficult to determine cause and effect
interpretation can be difficult
design and methods for conducting case report not well defined
usually only applied when all treatment options have failed
EXAMPLE: 50 year old man presents to ER with a 36 yr history of painless decreased vision in his left eye after a visit to his family MD 3 days prior with complains of dizziness. The MD prescribed fosinopril 20mg/d and HCTZ 25 mg/d. The next morning the patient noted loss of vision in his left eye.
OBSERVATIONAL STUDIES
CASE CONTROL:
useful for studying rare conditions
short duration
relatively small numbers of patients needed; inexpensive
aid in generating hypothesis about causes of a new disease
difficult to sort exposure and outcome
only one outcome can be studied
relies on self-report
possible incomplete/inaccurate information on patients
difficult to determine cause and effect
risk factor may not be reason for group differences
COHORT
describes incidence and investigates potential causes of a condition
provides a view of “real life” since they reflect natural unfolding of a disease state or exposure to certain condition
difficult to determine cause and effect
expensive
inefficient way to study rare outcomes
CROSS SECTIONAL
do not have to wait for outcome to occur
inexpensive
short duration
difficult to establish cause and effect
not useful for rare diseases
subject to transient effects that may occur during study
CLINICAL TRIALS
-gold standard
- can determine cause and effect
- can quantify differences between groups
-provides evidence for/against clinical practice use
-costly
-time consuming
- may not be able to apply results into clinical practice
-publication of results may be delayed
EDITORIALS
commentaries about current controversies
commentaries from experts in the field related to a study
may be biased
LETTERS TO EDITORS
brief reports
preliminary observations
may ask authors of a recent study questions
STRUCTURE OF CLINICAL STUDY REPORT
Abstract- article summary
Introduction- rational of study/ background info/ objective or purpose
Methods- study design/ patient inclusion/exclusion info/ explanation of what was measured/description of intervention and control/statistical analysis
Results- patient demographics/ measurements for endpoint(s)/ medication side effects reported
Discussion- interpretation of study results
References/ Bibliograph
Fine Print- acknowledgements/ funding/ peer review dates
BIOMEDICAL EXTRAS- LECTURE BY DR. LAUDERDALE 10/26/06
Peer review process
GOALS
to raise quality of end product (journal)
provide mechanism for fair and objective decision making
ADVANTAGES
incorrect work filtered out
increased accuracy and clarity of end product
DISADVANTAGES
decreased timeliness and increased time to publication
Upon peer-review have options of:
Accept manuscript
Accept manuscript with minor revisions
Accept manuscript with major revisions
Reject manuscript
Journal supplements
Not a regular issue of journal
Usually a theme-disease or drug
Differences exist between supplement and parent journal
May not be peer reviewed
Can be sponsored by pharmaceutical company which is way to push their drug
Pure Food and Drug Act of 1906
prohibit adulteration and misbranding of food and drugs
only prevent false statements for strength, quality, purity, but not false or misleading claims of cure or efficacy
Food, Drug and Cosmetic Act of 1938
sulfanilamide elixir
had to prove drug was safe
required testing with results
directions for use and habit forming properties
exempted all pre-1938 drugs
Durham- Humphrey Amend. 1951
federal law prohibits dispensing without a prescription
started OTC vs prescription drugs
Kefauver-Harris Amend 1962
Thalidomide
Required drug not only to be safe, but effective
Retroactive to 1938
Orphan Drug Act 1983
provided tax incentives exclusitivity and grants to companies developing drugs for diseases that affect small number of people
Drug Price Competition and Patent Term Restoration Act 1984
streamline generic approval (ANDA) but still aid and encourage research with patents
Dietary Supplement Health and Education Act 1994
defined dietary supplement- permitted some claims on drug
no regulation of strength, FDA must prove Unsafe before removal from market
Food and Drug Administration Modernization Act 1997
expedite availability of drugs
fast track designation for key drugs
ensured continuation of pharmacy compounding
FDA APPROVAL PROCESS
Phase I
determine the safety and toxicity of a drug
pharmacokinetics
pharmacology
dose range
last 6 months to 1 year
patient population of 20-80 HEALTHY volunteers
Phase II
determine efficacy of drug in targeted disease state
duration- 2 years
patient base 100-200 with disease state
Phase III
further build on safety and efficacy established
duration 3 years
patients 600-1000
NDA
PHASE IV
post marketing trials
additional information on drug’s risks and benefits
evaluates different doses
safety in extended patient population
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