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DRUG INFORMATICS
Introduction to the concept of drug
Information
5/9/2024
1
Introduction
5/9/2024
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Introduction
 The provision of medication information is
among the most fundamental responsibilities of
pharmacists.
 The information may be
 patient specific, as an integral part of
pharmaceutical care
 relative to a group of patients, such as:
 development of a therapeutic guideline
 publishing an electronic newsletter
 updating a website
5/9/2024
3
Intro…
 The term drug information may have different
meanings to different people depending on the
context in which it is used.
 If asked to define this term,
 one could describe it as printed information in a
reference or verbalized by an individual that pertains to
medications.
 In many cases, individuals use this term in different
contexts by associating it with other words:
1. Specialist/practitioner/pharmacist/provider
2. Center/service/practice
3. Functions/skills 5/9/2024
4
Intro…
 The first group of words implies a specific
individual
 The second group implies a place
 The third implies activities and abilities of
individuals.
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5
Intro…
 The term drug information will be used in these
different contexts to describe the beginnings and
evolution of this area of practice.
 Relative to current practice, the term medication
information is used in place of drug information to
convey the management and use of information on
medication therapy
 These terms may refer to
 provision of information for a specific patient
 Provision of information in the context of addressing
medication use issues for a group of patients
 (e.g., development of policies and procedures on medication
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6
Intro…
 Drug informatics is another term used to
describe the evolving roles of the medication
information specialist.
 Drug informatics
 emphasizes the use of technology as an
integral tool in effectively organizing,
analyzing, and managing information on
medication use in patients.
5/9/2024
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Intro…
 The term drug information developed in the early
1960s
 when used in conjunction with the words center
and specialist.
 In 1962, the first drug information center was
opened at the University of Kentucky Medical
Center in USA.
 An area separated from the pharmacy was
dedicated to provide drug information.
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Introduction
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Intro…
 The center was to be "a source of selected,
comprehensive drug information for
 Physicians
 Dentists
 Nurses
 The center was expected to take an active role in the
education of health professional students including
 Pharmacy
 Medicine
 Dentistry
 Nursing
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Intro…
 Several other drug information centers were
established shortly thereafter.
 Different approaches to providing drug information
services included
 decentralizing pharmacists in the hospital
 offering a clinical consultation service, and providing
services for a geographic area through a regional
center.
 The first formal survey, conducted in 1973,
identified 54 pharmacist operated centers in the
5/9/2024
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Intro….
 The individual responsible for operation of the
center was called the drug information
specialist.
 The expectation was that drug information would
be stored in the center and retrieved, selected,
evaluated, and disseminated by the specialist.
 Information would be disseminated to respond to
specific questions, to assist in the evaluation of
drugs for use in the hospital, or to inform others
through newsletters of current developments
related to drugs.
 These and other functions, as listed in , have
evolved over a period of years and reflect the
services provided in most drug information centers.
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 Medication Information Services
1. Support for clinical services
2. Answering questions
3. Developing criteria/guidelines for medication use
4. Pharmacy and therapeutics committee activity
5. Development of medication use policies
6. Formulary management
7. Publications—newsletter, journal columns, websites
8. Education—in-services for health professionals, students,
consumers
9. Medication usage evaluation/medication use evaluation
10. Investigational medication control
11. Institutional Review Board activities
12. Information for practitioners
13. Coordination of reporting programs, e.g., adverse medication
reactions
14. Poison information
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 Medication Information Skills
1. Assess available information and gather situational
data needed to characterize question or issue
2. Formulate appropriate question(s)
3. Use a systematic approach to find needed
information
4. Evaluate information critically for validity and
applicability
5. Develop, organize, and summarize response for
question or issue
6. Communicate clearly when speaking or writing,
considering the audience level
7. Anticipate other information needs
5/9/2024
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Factors Influencing the Evolution of the
Pharmacist's Role as a Medication Information
Provider
 In addition to the changing philosophy of practice,
several other factors are influential in the evolution of
the pharmacist's role as a medication information
provider.
 These include:
 the prevention of adverse drug events (ADEs)
 growth of information technology
 changes in the health care environment with a focus on
evidence-based medicine and the evaluation of outcomes
 the sophistication of medication therapy
 a more knowledgeable patient 5/9/2024
15
Drug Information Resources
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Objectives
After completing this chapter, the students will be able to
 Differentiate between primary, secondary, and tertiary
sources of information.
 Select resources relevant to different pharmacy practice
areas.
 Identify the most appropriate resource for a specific drug
information request.
 Describe the role of Internet and personal digital
assistant (PDA) resources in the provision of drug
information.
 Critique tertiary resources to determine appropriateness of
information.
Drug information resource
 The quantity of medical information and medical
literature available is growing at an astounding
rate.

 The technology by which this information can be
accessed is also improving exponentially.
 The introduction of PDAs(personal digital assistance)
and Internet resources has to some extent changed
the methods by which information is accessed, but
not the process of providing drug information.
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Resource…..
 Pharmacists are being asked daily to provide
responses to numerous drug information
requests for a variety of people.
 It is tempting just to select the easiest, most
familiar resources to find information.
 Generally, the best method to find information
includes a stepwise approach moving first
through:
 tertiary (e.g., textbooks, full-text databases, and
review articles),
 then secondary (e.g., indexing or abstracting service),
 finally primary (e.g., clinical studies) literature.
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TERTIARY
RESOURCES
“Literatures” evaluation
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Definition
 Tertiary literature is core knowledge
established via primary literature or
accepted as standard of practice within the
medical community.
 Introduction
 tertiary resources include:-
 textbooks, monographs, compendia, handbooks,
and published symposia.
 They represent the condensation of basic facts
originally published in the primary literature.
5/9/2024
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Evaluation of tertiary resources
 Several points should be considered in evaluating
tertiary resources as follows:
1-Does the author has sufficient experience and
expertise to write on the topic?
2-What credentials do the authors/contributors have?
3-Assess the text for timeliness (i.e. when was the last
edition published?)
4-Is this the most recent edition of the tertiary reference?
5-Are statements of fact appropriately supported by
references?
6-How many references does each section have and
how up-to-date are they?
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Cont.
 7-To assess consistency, compare information
presented in one text to the same information
presented in another text.
 8-Is the reference likely to contain information
relevant to the subject being researched?
 9-Is the reference clear, concise and easy to
use?
5/9/2024
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Availability of Tertiary Resources
 Tertiary resources are available in many
formats, including hard copy, microfiche, and
computerized versions.
 Computerized resources may be available on
floppy disks, or CD-ROMs for use in a single
personal computer or computer network, a
main frame system or via internet.
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Classification of Tertiary
Resources
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A. General References
 General features
1-They are referral books.
2-Their formats are either monographs or
monographs plus chapters.
3-Used through their indexes NOT through
their contents lists.
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Cont.
Textbooks
 Different from the general references in:
1-Their formats are chapters.
2-One can read them from cover to cover.
3-One can use their contents list Not necessary to
go to index.
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 The most helpful of them to answer a drug
related questions are:
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Martindale’s The complete drug
reference
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Cont.
 Martindale’s The complete drug reference
European and investigational drugs
-Published by the Royal Pharmaceutical Society of
Great Britain every 4 years
-Has a manufacturer directory and index by clinical
use (typical European style of indexing)
-Lists other pharmacopeias the drug is found in.
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Drug Facts and Comparisons
(F&C)
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Cont.
 Drug Facts and Comparisons (F&C)
* Updated monthly (loose-leaf version)
* Lag time 3 months
* Arranged by therapeutic class
* Prescription and OTC listings
* Helpful summary/comparison tables
* Contains information about investigational,
orphan, and discontinued products and off label
uses
* Not referenced, cumbersome
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American Hospital Formulary
Service (AHFS) Drug Information
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Cont.
 American Hospital Formulary Service (AHFS)
Drug Information
* Arranged by AHFS classification number
* Monographs listed alphabetically
* Information in monograph:
-Chemistry, pharmacology, mechanism
-Dose, administration, pharmacokinetics
-Drug interactions, preparations, toxicity
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Cont.
 (AHFS) Drug Information
* FDA-approved and off-label uses
* Published annually with quarterly updates
* More clinically oriented
* References are not available in the hard copy but
may be available online or with software CD-
ROMS
* Not comprehensive, significant lag time
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USP Dispensing Information (USP
DI)
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Cont.
* Three volumes
i-DRUG Information for the Healthcare
Professional
ii-Drug Information for the Patient (in lay
language)
iii-Legal Requirements
* Monographs in alphabetical order in Volume
I
* Published annually
* Also contains some Canadian drug names
* Most thorough information on:5/9/2024
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Cont.
* Useful Appendices: (typical American style
of indexing)
-Selected List of Drug-Induced Effects
-Therapeutic Guidelines
-Poison Control Center Listing
-Veterinary Medication Classification
-Excluded Monograph Listing
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Cont.
* Off-label uses indexed by drug and by
indication
* Not referenced, lag time, only FDA-approved
uses, inconvenient to compare agents in the
same therapeutic class
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Drug Information Handbook (Lexi-
Comp)
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Cont.
 Drug Information Handbook (Lexi-Comp)
 * Pocket-sized; PDA & online versions are also
available
 * Published annually
 * Drugs listed alphabetically by generic name
 * Useful charts and tables.
 * Specialty versions are available:
 -Pediatric, psychiatric, geriatric
 * Not referenced
 * Lists all reported adverse events but does not always
provide the incidence
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MICROMEDEX®
* CD-ROM
* Access information by brand or generic name of
drugs
* Referenced, quick and easy to use
* Expensive, uses other tertiary references
* Databases available:
-DRUGDEX®-main drug information database
-DISEASEDEX®-disease states
-IDENTIDEX®-drug identification by imprint code
-POISINDEX®-poisoning and toxicology
-Martindale’s –foreign drugs 5/9/2024
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Physicians’ Desk
Reference(PDR)
5/9/2024
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Cont.
 Physicians’ Desk Reference (PDR)
* Updated annually
* Color pictures and markings for drug identification
* Has FDA-approved product information only
* Manufacturers pay to have product information
Included
* Contains section on diagnostics
* May not contain the complete package insert
* Not referenced
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B. Specialized
References
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Pharmacotherapy: A
Pathophysiologic Approach (Dipiro)
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Cont.
* Well-written and referenced with helpful tables.
* Pocket version is available.
* Focuses on drug therapy, good background
information.
* Also covers non-drug treatment options.
* Updated edition about every 4 years.
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Applied Therapeutics: The Clinical
Use of Drugs (Koda-Kimble)
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cont
* Well-written with focus on drug therapy.
* Updated every 4 years.
* Useful summary tables.
* Case presentation format, may be more difficult
to use as a quick reference.
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cont
 The Washington Manual of Medical
Therapeutics
 Quick reference with many charts and tables.
 Updated about every 2 to 3 years.
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Internal Medicine
 Harrison’s Principles of Internal Medicine
* Gold standard for internal medicine
* Published every 5 years, referenced
* Pathophysiology, clinical presentation, diagnosis and
treatment guidelines
 * Little drug information & dosing
recommendations
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cont
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cont
 The Merck Manual
 Used by many healthcare professionals
 Also includes pediatrics, gynecology, psychiatry,
ophthalmology, otolaryngology, dental disorders
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Cont.
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Clinical Medicine (Kumar
&Clark )
5/9/2024
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Cont.
 Clinical Medicine (Kumar &Clark )
* comprehensive and authoritative single-volume
textbook of internal medicine.
* Explains the management of disease, based on an
understanding of scientific principles and including the
latest developments in treatment.
* Colour-coded chapters are attractive and make the
book easy to navigate.
* Comprehensive index, clearly displayed, pinpoints
information rapidly.
5/9/2024
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cont
 Clinical Medicine (Kumar &Clark )
* Boxes and tables pull out and display important
information.
* Drawings and photographs.
* Carefully structured headings provide a useful
outline for study and quick reference.
* Gastrointestinal, Rheumatology, Renal,
Cardiovascular, Respiratory ,Intensive care
medicine, Drug Therapy and poisoning……
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Cardiology
 Textbook of Cardiovascular Medicine
* Published every 5 years.
* Good illustrations.
* Addresses modern-day issues such as medical
economics and assessing quality of care.
* Well-referenced.
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cont
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Cont
 Hurst’s The Heart
* Organized by condition
* Comprehensive information on drug therapies and
regimens
* Rapid Interpretation of ECG’s
* Best guide to learning ECG’s
* User-friendly format.
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Pediatrics
 Harriet Lane Handbook
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cont
Harriet Lane Handbook
* Useful pocket guide published every 3 years
* Has dosing information
* Electronic version updated annually
* Four sections: emergency management,
diagnostic, formulary, and therapeutic data
* Some information on pregnancy and lactation
* Not referenced, not frequently updated,
confusing organization, not complete
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Cont.
Pediatric InjectableDrugs (“TeddybearBook”)
* Alphabetical order by generic name
* Formerly known as Guidelines for Administration
of Intravenous Medications to Pediatric Patients
* Dose, concentration, rate, cautions
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Cont.
Pediatric Dosage Handbook (Lexi-Comp)
* Pediatric version of the Drug Information
Handbook
* Dose, administration, how supplied,
contraindications, adverse effects, drug
interactions, antidotes
* Also contains adult doses
* May sometimes have information on
extemporaneous formulations
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Pregnancy
Drugs in Pregnancy and Lactation (Briggs)
* Excellent reference, gold standard
* Updated every 4 years
* Alphabetical by generic name
* Generic name, class, & pregnancy risk factor
* Summaries of risk to fetus and risk during
breastfeeding
* Editors assign categories for drugs not classified
by the manufacturer
* Referenced
5/9/2024
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Infectious Diseases
Mandell’s Principles and Practice of
* Gold standard reference
* Infection, diagnosis, treatment and useful
background information Infectious Disease
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cont
Sanford Guide to Antimicrobial Therapy
* Published annually
* Pocket-sized and easy to use
* Includes: dosing in renal impairment, brand &
generic names, empiric therapy guidelines,
antimicrobial spectra of the agents
* Not well-referenced
5/9/2024
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Oncology
Cancer: Principles and Practice of Oncology
(devita)
* Gold standard, published every 3 to 4 years
* Pathology, treatment options, & adverse effects
* Referenced
5/9/2024
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cont
Cancer Chemotherapy Handbook
* Useful index, introduction on malignancies
* Pharmacology and use of chemotherapeutic
agents
* Lists investigational drugs and combinations
* Well-referenced
5/9/2024
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Pharmacology
Goodman & Gilman’s Pharmacological Basis of
Therapeutics
* Gold standard pharmacology text
* Grouped by therapeutic class
* Mechanism, absorption, distribution, and
metabolism
* Contains review of pharmacokinetics,
therapeutics, and toxicology
* Well-referenced
* Updated every 5 years (infrequent)
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Drug interaction
Drug Interaction Facts
* Published by F&C
* Alphabetical by drug name
* Referenced
* Provides information regarding:
-Significance and severity
-Onset of interaction
-Documentation
* Not complete, subjective rating scale
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cont
Stockley'sDrug Interactions
* A typical monograph contains a summary,
clinical evidence for the interactions under
discussion, the probable mechanism, clinical
importance and management
* Covers interactions between therapeutic drugs,
proprietary medicines, herbal medicines,
foods, drinks, pesticides and some drugs of
abuse
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Cont
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cont
Stockley'sDrug Interactions
* Based on published sources and fully
referenced
* Covers over 14,000 drug interactions
* Contains over 2,800 monographs
* Includes 17,600 references
* Book & CD-ROM
5/9/2024
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Adverse Drug Reactions
 Meyler’s Side Effects of Drugs
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cont
Meyler’sSide Effects of Drugs
* Indexed by drug and by adverse event
* Most comprehensive
* Published every 4 years with annual updates
* Contains tables and lists
* References for some side effects not included
* Information provided:
-Effects on organs and systems, lab/diagnostic
interference, withdrawal and overdose
* May not be complete, references for widely known
effects are not included
5/9/2024
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Compatibility and Stability
 Handbook on Injectable Drugs (Trissel’s)
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cont
Handbook on InjectableDrugs (Trissel’s)
* Gold standard reference
* Updated every 2 years with annual supplements
* Drugs organized alphabetically by generic name
* Information on compatibility and stability with
diluents and drugs
* Solution, Y-site, syringe, and additive compatibility
* Table format, very useful
* Not complete, lag time
5/9/2024
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cont
 King Guide to Parenteral Admixtures
 * Chart format, loose-leaf
 * Alphabetical listing by generic name
 * Pages are not numbered
5/9/2024
79
Compounding and
Pharmaceutics
Remington’s The Science and Practice of
Pharmacy
* Helpful for extemporaneous compounding
* Pharmaceutical calculations, chemistry,
radioisotopes
* New edition every 5 years
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cont
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cont
Merck Index
* Chemical name, formula, & structure
* Physical data, therapeutic category
* Published every 6 to 10 years
5/9/2024
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cont
United States Pharmacopeia –National Formulary
(USP-NF)
* Official monographs for preparation and assay of
pharmaceutical products
* Published every 5 years with periodic supplements
* Information on storage, packaging, labeling, reference
standards, & assays
* USP: drug substances & dosage forms
* NF: pharmaceutical ingredients
* Not a very useful reference since most
pharmaceuticals are mass-produced
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Pharmacokinetics
Basic Clinical Pharmacokinetics (Winters)
* Case-study format
* Includes principles of monitoring therapy, basic
pharmacokinetics, & clinical applications
* Appendix of commonly used equations
* Mostly theory, little patient integration
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cont
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Toxicology
 Toxicologic Emergencies (Goldfrank’s)
 Poison management guidelines
 Useful tables and case studies
 Practice multiple-choice questions
5/9/2024
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cont
Casarett & Doull's Toxicology: The Basic
Science of Poisons
* gold standard in toxicology field
* basic concepts and fundamental principles
needed to grasp current issues in modern
toxicology
* The text is organized and presented in a logical
progression of general principles to specific
topics such as organ system toxicology,
specific agent toxicology, and environmental
toxicology
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cont
 POISINDEX®
 Toxicology component of MICROMEDEX®
 Search by brand or generic name
 Describes what substance looks like, any imprint
codes, management of toxicity
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Drug Identification
1.American Drug Index
* Cross-referenced by brand, generic, and chemical
names
2.The Pill Book
3.IDENTIDEX®
* Component of MICROMEDEX®
* Identify drug by imprint code
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cont
 4.British National Formulary
* BMJ Publishing, London, United Kingdom.
* The standard reference for prescribing and
dispensing drugs in Britain.
* Included are notes on the different drug groups to
help in the choice of appropriate treatment.
* The BNF is updated in March and September of
each year
* Available on disk and CD-ROM as the Electronic
British National Formulary and An electronic web-
based format is also available.
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Non-Prescription Products
PDR for Nonprescription Drugs and Dietary
Supplements
* Format similar to PDR, updated every year
* Indexed by product name, category, manufacturer,
& active ingredient
* Includes color pictures of products
* Information: indications, cautions, dose,
administration, patient instructions, precautions,
how supplied
5/9/2024
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cont
Handbook of Nonprescription Drugs
* Useful tables and comparisons
* Includes:
-Patient assessment and counseling guidelines
-Pathophysiology and treatment options
-Dosing, adverse events, & interactions
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Electronic tertiary resource
Multipurpose resource
Access Medicine
(http://www.accessmedicine.com/)
* Collection of textbooks, clinical practice guidelines,
news
* Includes: Goodman & Gilman, Harrison’s, Current
Medical Diagnosis & Treatment, and the Lange
series.
* Drug monographs (include images, chemical
structures, patient education materials) provided by
Gold Standard™ 5/9/2024
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cont
ClinicalResource@Ovid
(http://clinicalresource.ovid.com/autologin.html)
*Collection of books, clinical practice guidelines,
patient education materials and links to databases
*Includes: Clin-eguide, Facts and Comparisons and
5-Minute Consult series
5/9/2024
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cont
MD Consult
http://home.mdconsult.com/groups/uwash8783.ht
ml)
*Collection of textbooks, journals, drug information,
guidelines, patient education handouts, news and
updates
*Drug information and updates from Mosby’s drug
Consult, package insert information, FDA
information
*Customizable patient handouts –diseases and
drugs
5/9/2024
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cont
MedlinePlus
(http://medlineplus.gov)
* NLM’s database aimed at consumers for health
and wellness information
* English and Spanish versions as well as “large
print” and audio
* Includes health topics, drug information,
dictionaries, interactive tutorials, directories
and links to other resources
5/9/2024
96
cont
MedlinePlus
* Especially good for quick overview, including
statistics, of topics and illustrations
*Drug information includes MedMaster from ASHP,
USP DI Advice for Patients, Natural Standard
Online (for natural products) and links to FDA and
ClinicalTrials.gov
5/9/2024
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cont
Micromedex Healthcare series
(http://www.thomsonhc.com/hcs/librarian/)
* Collection of databases that can be searched
individually or all together contents of
collection depends on your subscription
* Includes DrugDex and Drug Consults, IV
Compatibility, PoisIndex, AltMedDex,
Martindale, Reproprisk, TOMES and
CareNotes
5/9/2024
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cont
Micromedex Healthcare series
* Use for detailed information about medications
(US and foreign) and natural products as well
as exposures to chemicals, toxins and
poisonous animals and plants
* Lengthy bibliographie
* Instructions for citing under Warranties &
Disclaimers link
5/9/2024
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Drug and Natural Products
Information Resources
Facts & Comparisons
(http://online.factsandcomparisons.com/)
* Collection of resources that can be searched
individually or all together –drugs and natural
products
* Includes Drug Facts & Comparisons,
Nonprescription Drug therapy, Drug Interaction
Facts, Review of Natural Products, MedFacts
Patient information
5/9/2024
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cont
Facts & Comparisons
* Print version has been gold standard for drug
information for years
* Includes comparison tables for drugs by class or
pharmacological action
* In general, references are included in the Drug
Interactions section and in drug class monographs
but not in individual drug monographs
5/9/2024
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cont
Natural Medicines Comprehensive Database
(http://www.therapeuticresearch.net/nd/Search.a
spx?s=ND)
* Comprehensive, evidence-based information
about herbal and dietary supplements used in
the US and Canada
* Produced by publishers of Prescribers' Letter
and Physicians' Letter
* Many products have patient handouts
5/9/2024
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cont
Natural Medicines Comprehensive Database
* Updated daily
* Several entry points, e.g. product or common
name, scientific name, people use
* this for, interactions with foods, herbs, dietary
supplements, lab tests, diseases or conditions
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Resource cont.
Secondary literature
 provides a summary, index, or abstract of a piece
of primary literature, usually written by the authors
of a primary literature paper.
 The vast majority of secondary resources are
utilized primarily in an electronic format, although
some may still have a print form.
5/9/2024
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Resource cont.
 Secondary literature refers to:-
 references that either index or abstract the primary
literature
 The goal is:
 to direct the user to the primary literature.
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Resource cont.
 The two terms, indexing and abstracting, differ
slightly.
 Indexing
 consists of providing bibliographic citation
information (e.g., title, author, and citation of the
article),
 abstracting
 includes a brief description (or abstract) of the
information provided by the article or resource
cited.
 Various systems will index or abstract literature from
different journals, meetings, or publications, therefore,
in order to perform a comprehensive search different
databases must be used.
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Resource cont.
Examples:
• Medline (PubMed is the web
portal)
• IPA
• EMBASE
• current contents
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Resource cont.
 main benefit
 location of primary literature
 main problem
 not enough information to determine quality of
research work
5/9/2024
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Resource cont.
 challenges in searching secondary database systems.
 Systems do not index all terms in the same manner
therefore it is necessary to determine what terms a
database is using to conduct a successful search.
 For example, databases through the National Library of
Medicine index terms by their Medical Subject Heading
(MeSH term)
 while the Iowa Drug Information Service (IDIS) uses the
United States Adopted Name and the International
Classification of Diseases
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Resource cont.
 Most computerized databases also include a free-
text search option, which is very useful when the
defined index terms are not identifying relevant
data.
 This option may also be helpful when only limited data
have been published or are available, perhaps before
an official index term is defined.
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Resource cont.
 Searches generally use Boolean operators, often
AND, OR, and NOT (see ).
 The operator AND will combine two terms, returning
only citations containing both of those concepts or
terms.
 The operator OR will have an equal or greater number
of returns since it will include any citation where either
term is used.
 Use of the term NOT will always decrease the number
of responses, since it eliminates any references having
the term that follows that operator
 therefore it should be used with caution, since it may
eliminate articles that may be appropriate, simply
because the term being eliminated happens to appear
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Resource cont.
 Primary literature
 contains new/original
material.
Examples:
• study published in health
sciences journal (including
symposium and conference
proceedings and abstracts)
• package insert and other
manufacturer technical
pamphlets
• patents and trademarks
• government bulletins
 main benefit
 you can determine the
quality of the research
and usability of
information
 main problem
 not enough time to read
it all
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Internet Resources
5/9/2024
113
 Another method to identify relevant resources
might be a general Internet search for
information.
 This can be especially helpful to serve as a
starting point for questions about unusual
diseases or about marketed over-the-counter
products and combination dietary supplements
Major News Sources Online
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Consumer Health Information
5/9/2024
115
 As consumers become more active and educated
in their health care and disease management, the
need for health information sources geared at
consumers has increased.
 Currently there are a variety of sources where
consumers obtain their health information
Online Consumer Information
Sources
5/9/2024
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Systematic approach to
receiving and answering
questions on drugs
5/9/2024
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Receiving and Classifying Drug
Information Requests
 An essential component within pharmacy
practice is the ability to effectively answer
questions posed by health care professionals
and the lay public.
 In 1975, Watanabe et al. presented a systematic
approach for responding to drug information
requests.

 The systematic approach comprised of five steps
5/9/2024
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Cont…
 Systematic Approach (1975)
 Step I. Classification of the request
 Step II. Obtaining background information
 Step III. Systematic search
 Step IV. Response
 Step V. Reclassification
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Receiving and Classifying Drug
Information Requests
• Answering Drug Information Questions
– These are the steps you should go through when you
are asked a question:
• Step 1: Identify the requester.
– This will help you get an idea of the depth and
detail of information the requester is probably
expecting.
• Step 2: Determine and categorize the “real”
question.
– It is remarkably common for the question you are
asked to not be the requester’s “real” question.
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Drug Information Requests
cont.
 Ask for background information.
 Examples:
 “I want to make sure I answer (or understand)
your question adequately, so tell me a little more
about what led you to ask me this question.”
 “There are several different answers to that
question.
 To make sure I give you the right answer, I’d like you
to describe in more detail what it is you wish to better
understand.”
 “Tell me how you want to use this information.”
5/9/2024
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Drug Information Requests
cont.
• In some cases, it is appropriate to use an
algorithm similar to the one you will learn for
patient interviewing, considering each area but
including only questions about those variables that
might affect your answer.
– history of current question (is this a general question
or specific to a person or situation?)
– other disease states that might affect the answer to the
question, including potential disease states, i.e., signs
or symptoms that have not been diagnosed
(pharmacokinetic, pharmacodynamic, adverse
reaction masquerade)
5/9/2024
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Drug Information Requests
cont.
 other medications (Rx, OTC, herbal, illicit) that
might affect the answer to the question (drug
interactions
 pertinent social or family history (financial,
medical, or belief issues)
 desired detail of response
5/9/2024
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Drug Information Requests
cont.
• Questions you receive will usually be in one of the
following categories:
– proper use of drugs: efficacy for specified disease
state, dosing, compatibility, use in pregnancy or
lactation, monitoring parameters, drug identification,
pharmacokinetics, pharmacodynamics, storage
conditions, stability
– adverse reactions: side effects, drug interactions,
allergic reactions, toxicity, poisoning, contraindications,
warnings
5/9/2024
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Summery Questions you receive
5/9/2024
125
Drug Information Requests
cont.
 Once you think you know the real question,
repeat it to the requester to confirm you have
identified the appropriate question.
 Step 3: Choose an appropriate resource (or
resources) to consult.
5/9/2024
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Drug Information Requests
cont.
• Tertiary literature
– provides an interpretation and summary of the
primary literature by someone other than the
original authors of the primary literature
publication.
Examples:
• review in health sciences journal
• textbooks and other reference material
• computer databases (e.g., Micromedex)
• web sites
• advertisements 5/9/2024
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Drug Information Requests
cont.
 main benefit
 can get a lot of information in a short amount of
time relative to reading all the studies of a subject
yourself
 main problem
 subject to interpretation bias: “spin”
5/9/2024
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Drug Information Requests
cont.
 Secondary literature
 provides a summary, index, or abstract of a piece
of primary literature
Examples:
• Medline (PubMed is the web portal)
• IPA
• EMBASE
• current contents
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Drug Information Requests cont.
• Primary literature
– contains new/original material.
Examples:
• study published in health sciences journal
(including symposium and conference
proceedings and abstracts)
• package insert and other manufacturer
technical pamphlets
• patents and trademarks
• government bulletins
• case studies
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Drug Information Requests cont.
 In general, it is most efficient to start with
tertiary literature (especially for questions from
nonhealth care professionals).
 Sometimes you will use secondary literature to
locate primary literature and then will need
primary literature to answer the question (not
uncommon with questions from health care
professionals: they will expect you to be able to
interpret and explain a study).
5/9/2024
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Drug Information Requests
cont.
• Step 4: Analyze quality and appropriateness of
material in resource(s).
– Summarize the best evidence in your own words.
• Step 5: Synthesize (formulate) a response.
• Step 6: document and follow up on
recommendations, so that others will know what
you advised and why, and so that you can see if your
advice was sound. 5/9/2024
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Using Tertiary Resources
 Introduction
 Tertiary resources are summaries of available
information in an understandable format.
 Examples include textbooks, reference texts,
databases, review articles, lecture notes, and web
sites.
 Tertiary resources are the best starting point
for finding the answer to drug information
queries. 5/9/2024
133
Using Tertiary Resources
• Strengths of tertiary resources:
– Most answers to questions you are asked will be
found in a tertiary resource.
– Because the information is organized, they are
time-efficient to use compared to examining
primary literature yourself.
– Because they summarize information from many
sources, they may contain information important
to the question which you might miss if you
consulted only one piece of the primary literature.
5/9/2024
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Tertiary Resources cont.
• Tertiary resources often provide background
information.
– For example, you may be asked about the treatment
of choice for a sinus infection.
– Many reviews of sinus infections will also include a
short summary of the epidemiology and microbiology
of sinus infections, which can help you better
understand and remember the treatment alternatives.
• Tertiary resources are generally more accessible
to the average pharmacist than secondary or
primary resources.
5/9/2024
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Tertiary Resources cont.
Limitations of Tertiary resources:
– A literature summary is only as good as its
author(s).
• All authors will have interpretation bias.
• Author(s) may not have the expertise to correctly
interpret the literature or may not have consulted the
literature (opinion versus fact).
• Author may not write well.
• You may have no information about the author.
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Tertiary Resources cont.
– Information may not be complete.
• Literature search may not be extensive.
• Space limitations of publisher may limit amount of
information that can be included.
– Information may be out of date.
– Tertiary resources which draw on information from
other tertiary resources can perpetuate incorrect
information.
– Some sources can be difficult to use.
5/9/2024
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Tertiary Resources cont.
Tertiary resources you will use (print and online)
• General medication information.
– You will use these resources for questions involving
indications, pharmacology, pharmacokinetics,
precautions and adverse effects, administration and
dosing, drug interactions, and available commercial
products.
– Example questions for which you should use these
resources: “What is propranolol used for?” “Is there a
liquid form of morphine available?” “Could citalopram
cause an increase in sweating?”
5/9/2024
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Tertiary Resources cont.
• Drugdex (Micromedex) on-line, via Healthlinks
• Facts and Comparisons (eFacts) on-line, via
Healthlinks
• Drug Information Handbook (Lexi-Comp) book, PDA
version
• AHFS (Stat!Ref) on-line, via Healthlinks
• USPDI-I (Stat!Ref) on-line, via Healthlinks
• [Physician’s Desk Reference (PDR)] available on-line,
but not via Healthlinks; medical, bu not pharmacy
5/9/2024
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Tertiary Resources cont.
• Natural Product Resources
– Natural Medicines Comprehensive Database on-line, via
Healthlinks
– Review of Natural Products (eFacts) on-line, via Healthlinks
– AltMedDex (Micromedex) on-line, via Healthlinks
– HerbMed and American Herbal Products Association on-
line at www.ahpa.org.
• These are quasi-tertiary resources, because links to other
tertiary resources are available.
• They are also secondary resources (indexing) as they connect
you to PubMed for info about specific studies.
• HerbMed is assembled by the Alternative Medicine Foundation
and AHPA by a consortium of herbal product manufacturers.
You will find the information on each to be similar.
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Tertiary Resources cont.
• Disease state information.
– You will use these resources to better understand
medical conditions.
– Examples of questions you would use these
resources to answer: “What is the most common
cause of diarrhea in children?” “What are the most
common complications of uncontrolled diabetes?”
• UpToDate on-line, via Healthlinks
• The Merck Manual (www.merck.com) on-line, via
Healthlinks
• Harrison’s Online on-line, via Healthlinks
• medical specialty textbooks (MD Consult) on-line, via
Healthlinks
5/9/2024
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Tertiary Resources cont.
• Pharmacotherapy references.
– Use these for general information about treatment
alternatives for specific disease states.
– Examples of questions you would use these
resources to answer: “What is the recommended
agent and dose for a 45-year old male with newly
diagnosed hypertension?” “What are reasonable
monitoring parameters for patients taking
medication for chronic obstructive lung disease?”
• Pharmacotherapy: a Pathophysiologic Approach book
only
• Applied Therapeutics: The Clinical Use of Drugs book
only
5/9/2024
142
Tertiary Resources cont.
 Over-the-counter Drugs
 Example of questions you would use this
resource to answer: “What is available over-the-
counter that I could use for my cough?” “What
can I use for this rash?”
 • Handbook of Non-Prescription Drugs book only
5/9/2024
143
Tertiary Resources cont.
Drug Interaction references
• Example of question you would use these
resources to answer:
– “Can I drink grapefruit juice if I’m taking
atorvastatin?”
• Hansten and Horn’s Drug Interactions book only; in
PCLC
• Drug Interaction Facts (eFacts) on-line, via Healthlinks
• Micromedex also has a decent drug interaction section
on-line, via Healthlinks
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144
Tertiary Resources cont.
 Terminology
 Examples of questions you would use these
resources to answer: “Where is the ‘lateral’ chest
located?” “What does DNR mean?”
• medical dictionary; Stedman’s is on-line, via
Healthlinks
• medical abbreviations (eFacts) on-line, via
Healthlinks
5/9/2024
145
Tertiary Resources cont.
• Laboratory Tests
– Example of question you would use these
resources to answer: “What is the normal serum
concentration range for potassium?”
– Only the first reference will answer the following type
of question, however: “What might be the cause and
consequences of a serum potassium concentration
above the normal range?
• Basic Skills in Interpreting Laboratory Data book only;
in PCLC
• Laboratory test information (online)
• Normal laboratory values (eFacts) on-line, via
Healthlinks 5/9/2024
146
Tertiary Resources cont.
• Drug Identification
– Example of question you would use these
resources to answer: “I found a white tablet with M
23 stamped on it. What drug is this?”
– Martindale would help you answer the following
question: “When I was in England, a doctor gave
me an inhaler called salbutamol. What does this
drug do? Is it similar to any inhaler I normally use
for my asthma?”
• Identidex (Micromedex) on-line, via Healthlinks
• Drug/Imprint Index (eFacts) on-line, via Healthlinks
• Martindale (Micromedex) for non-US drugs on-line,
via Healthlinks 5/9/2024
147
Tertiary Resources cont.
 Bioequivalence
 Example of question you would use this resource
to answer: “Is there a generic form of Levoxyl that
is bioequivalent?”
• Orange book; on-line: www.fda.gov
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Tertiary Resources cont.
• Drug Prices
– Example of question you would use this resource
to answer: What is the AWP for a 30-day supply of
diltiazem 120mg XL capsules?” (Note that here
you might first have to look up the AWP in the
medical abbreviations book!)
• Redbook book only; in PCLC
• Mosby’s Drug Consult (MD Consult). This is also
general medication information on this site. on-
line, via Healthlinks
5/9/2024
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Tertiary Resources cont.
 Drug IV Compatibility
 Example of question you would use this resource
to answer: “Can Lasix be given in the same line in
which dopamine is running?”
• Handbook on Injectable Drugs book only; in PCLC
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150
Tertiary Resources cont.
• Drug dosing in special populations
– Examples of questions you might use some of
these resources to answer:
• “Is it safe to use ibuprofen while I’m pregnant? While
I’m breastfeeding?”
• “How much acetaminophen should I give my 30-lb child
who is running a temperature of 103°F?”
• “What is a good starting dose for lisinopril in an 80
year-old patient?”
• “Does aztreonam cover Pseudomonas aeruginosa?”
• Drugs in Pregnancy and Lactation book only; in
PCLC 5/9/2024
151
Tertiary Resources cont.
• Pediatric Dosage Handbook book, PDA
versions available
• Drug Prescribing in Renal Failure book only; in
PCLC
• pharmacokinetic equation reference book only;
several different books available
• Geriatric Dosage Handbook book, PDA
versions available
• The Sanford Guide to Antimicrobial Therapy
book in PCLC; PDA version available
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Tertiary Resources cont.
 Extemporaneous compounding
 Example of question you would use these
resources to answer:
 “What is the E-value of gentamicin sulfate?”
 • Remington: the Science and Practice of
Pharmacy book only; in PCLC
 • A Practical Guide to Contemporary Pharmacy
Practice book only; in PCLC
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153
Tertiary Resources cont.
• Patient Counseling
– You would use these to augment your verbal
medication information.
– Some pharmacy systems automatically print these,
but look them over carefully for information accuracy
before handing them out.
• Medline Plus (medications, medical conditions, trials)
on-line at medlineplus.gov
• Med Facts: Patient Counseling (eFacts): in English and
Spanish on-line, via Healthlinks
• CareNotes (Micromedex) on-line, via Healthlinks
5/9/2024
154
Tertiary Resources cont.
 Toxicology
 Example of question you would use this resource
to answer:
 “My child just swallowed some of my iron tablets.
Could anything bad happen?”
• Poisindex (Micromedex) on-line, via Healthlinks
5/9/2024
155
Tertiary Resources cont.
• Clinical Guidelines
– Example of question you would use these resources to
answer:
– “What initial medications for treatment of a heart attack
do current American Heart Association guidelines
recommend?”
• National Guideline Clearinghouse on-line at
www.guideline.gov
• Cochrane Library on-line, via Healthlinks This resource is
unique and designed to support practitioners of
“evidence-based medicine” (EBM), which is when
evidence from studies is combined with practitioner
expertise and patient preference to provide the best care
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156
Formulating effective responses
 Pharmacists are asked to provide responses to
a variety of drug information questions every
day.
 While the type of requestor, query, and setting can
vary, the process of formulating responses
remains constant.
5/9/2024
157
Accepting Responsibility and
Eliminating Barriers
 Pharmacists should recognize that their responsibility extends
beyond simply providing an answer to a question.
 Rather, it is to assist in resolving therapeutic dilemmas or managing
patients' medication regimens.
 Knowledge of pharmacotherapy alone does not ensure success.
 Moreover, isolated data or information do not provide answers to
questions or ensure proper patient management.
 In fact, it is uncommon to find comprehensive answers in the literature
that completely and effectively address specific situations or
circumstances that clinicians face in their daily practices.
 Responses and recommendations must often be thoughtfully
synthesized using information and knowledge gathered from a number
of diverse sources.
 To effectively manage the care of patients and resolve complex
situations, pharmacists also need added skills and competence in
problem solving and direct patient care.
5/9/2024
158
Identifying the Genuine Need
 Most queries that pharmacists receive are not
purely academic or general in nature.
 They often involve specific patients and unique
circumstances.
 For example, a physician who asks about the
association of lovastatin and liver toxicity is probably
not asking this question whimsically or out of curiosity.
 He or she most likely has a patient who has
developed hepatic impairment that may be associated
with the use of this medication.
 Of course, other reasonable scenarios, albeit less
likely, also could have prompted such a question.
5/9/2024
159
Cont…
 Even questions that are not related to patient care
must be viewed in their proper context.
 Requestors of information are typically vague in
verbalizing their needs and provide specific
information only when asked.
 Although these requestors may seem confident about
their perceived needs, they may be less certain after
further probing by the pharmacist.
 Requestors, regardless of background, are often
uncertain about what the pharmacist needs to know to
assist them optimally.
 Therefore, critical information that defines the problem
and elucidates the context of the question is not
readily volunteered, but must be expertly elicited
5/9/2024
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Questions to Consider before
Formulating a Response
 Do I know the requestor's name, profession, and
affiliation?
 Does the question pertain to a specific patient?
 Do I have a clear understanding of the question or
problem?
 Do I know if the correct question is being asked?
 Do I know why the question is being asked?
 Do I understand the requestor's expectations?
 Do I know pertinent patient history and background
information?
5/9/2024
161
Cont…
 Do I know about the unique circumstances that
generated the question?
 Do I know what information is really needed?
 Do I know when the information is needed and
in what format?
 Do I have insight about how the information I
provide will actually be used?
 Do I know how the problem or situation has
been managed to date?
 Do I know about alternative explanations or
management options that have been
considered or should be further explored?
5/9/2024
162
Important Questions Not Posed by
the Requestor
 Initial query posed by requestor: Can ranitidine cause
thrombocytopenia?
 What is the incidence of ranitidine-induced
thrombocytopenia?
 Are there any known predisposing factors?
 Is the pathogenesis of this adverse effect understood?
 How does the thrombocytopenia typically present?
 Are there any characteristic subjective or objective
findings?
 Does thrombocytopenia due to ranitidine differ from that
caused by other histamine-2 (H2) receptor antagonists,
other medications, or other etiologies?
 Is the thrombocytopenia dose related?
5/9/2024
163
Cont…
 How severe can it become?
 How soon after discontinuing the drug does it
reverse?
 How is it usually managed?
 What is the likelihood of cross-reactivity with other
histamine-2 receptor antagonists? How risky is
rechallenge with ranitidine?
 Are there treatments available that can be used in
place of ranitidine?
 Are there alternative explanations for the
thrombocytopenia in this patient (including other
medications, medication combinations, or
underlying medical conditions)?
 What complications, if any, can be expected?
5/9/2024
164
Formulating the Response
 Building a Database and Assessing Critical
Factors
 Formulating a response involves a series of steps
that must be performed completely, objectively,
and in a logical sequence.
 This mandates the use of a structured, organized
approach whereby critical factors are
systematically considered and thoroughly
evaluated.
 The steps in this process include assembling and
organizing a patient database, gathering
information about relevant disease states,
collecting medication information, obtaining
pertinent background information, and identifying
other relevant factors and special circumstances.
5/9/2024
165
Factors to Be Considered When
Formulating a Response
Patient Factors
 Demographics (e.g., name, age, height, weight,
gender, race/ethnic group, and setting)
 Primary diagnosis and medical problem
 list Allergies/intolerances
 End-organ function, immune function, nutritional
status
 Chief complaint
 History of present illness
 Past medical history (including surgeries, radiation
exposure, immunizations, psychiatric illnesses,
and so forth)
5/9/2024
166
Cont…
 Family history and genetic makeup Social history
(e.g., alcohol intake, smoking, substance abuse,
exposure to environmental or occupational toxins,
employment, income, education, religion, travel,
diet, physical activity, stress, risky behavior, and
compliance with treatment regimen)
 Review of body systems
 Medications (prescribed, over-the-counter, and
complementary/alternative)
 Physical examination Laboratory tests Diagnostic
studies or procedures
5/9/2024
167
Disease Factors
 Definition
 Epidemiology (including incidence and prevalence)
 Etiology
 Pathophysiology (for infectious diseases, consider site
of infection, organism susceptibility, resistance
patterns, and so forth)
 Clinical findings (signs and symptoms, laboratory
tests, diagnostic studies)
 Diagnosis
 Treatment (medical, surgical, radiation, biologic and
gene therapies, other)
 Prevention and control
 Risk factors Complications Prognosis
5/9/2024
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Medication Factors
 Name of medication or substance (proprietary,
nonproprietary, other)
 Status and availability (investigational, over-the-counter,
prescription, orphan, foreign, complementary/alternative)
 Physicochemical properties
 Pharmacology
 pharmacodynamics
 Pharmacokinetics (liberation, absorption, distribution,
metabolism, and elimination)
 Pharmacogenetics
 Uses (Food and Drug Administration [FDA] approved and
unlabeled)
 Adverse effects
 Allergy
 Cross-allergenicity or cross-reactivity
5/9/2024
169
Medication Factors
 Contraindications and precautions
 Effects of age, organ system function, disease,
pregnancy, extracorporeal circulation, or other
conditions or environments
 Mutagenicity and carcinogenicity
 Effect on fertility, pregnancy, and lactation
 Acute or chronic toxicity
 Drug interactions (drug-drug or drug-food)
 Laboratory test interference (analytical or
physiologic effects)
5/9/2024
170
Cont…
 Administration (routes, methods)
 Dosage and schedule
 Dosage forms, formulations, preservatives,
excipients, product appearance, delivery systems
 Monitoring parameters (therapeutic or toxic)
 Product preparation (procedures, methods)
 Compatibility and stability
5/9/2024
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Pertinent Background Information, Special
Circumstances, and Other Factors
 Setting
 Context
 Sequence and timeframe of events
 Rationale for the question
 Event(s) prompting the question
 Unusual or special circumstances (including medical
errors)
 Acuity and time constraints
 Scope of question
 Desired detail or depth of response
 Limitations of available information or resources
 Completeness, sufficiency, and quality of the
information 5/9/2024
172
Analysis and Synthesis
 Analysis and synthesis of information are the most
critical steps in formulating responses and
recommendations.
 Together they assist in forming opinions, arriving at
judgments, and ultimately drawing conclusions.
 Analysis is the critical assessment of the nature, merit,
and significance of individual elements, ideas, or
factors.
 Functionally, it involves separating the information into
its isolated parts so that each can be critically
assessed.
 Analysis requires thoughtful review and evaluation of
the weight of available evidence.
 While this process requires consideration of all
relevant positive findings, pertinent negative finidings
5/9/2024
173
Cont…
 Once the information has been carefully
analyzed, synthesis can begin.
 Synthesis is the careful, systematic, and orderly
process of combining or blending varied and
diverse elements, ideas, or factors into a coherent
response through the use of logic and deductive
reasoning.
 This process relies not only on the type and
quality of the data gathered, but also on how they
are organized, viewed, and evaluated
5/9/2024
174
Responses and Recommendations
 An effective response obviously must answer the
question.
 Other characteristics of effective responses and
recommendations are outlined bellow.
 The response to a question must include a
restatement of the request and clear identification of
the problems, issues, and circumstances.
 The response should begin with an introduction to the
topic and systematically present the specific findings.
 Pertinent background information and patient data
should be succinctly addressed.
 Conclusions and recommendations are also included
in the response along with pertinent reference citations
from the literature.
5/9/2024
175
Desired Characteristics of a
Response
 Timely
 Current
 Accurate
 Complete
 Concise
 Well referenced
 Clear and logical
 Objective and balanced
 Free of bias or flaws
 Applicable and appropriate for specific
circumstances
 Answers important related questions
 Addresses specific management of patients or
situations
5/9/2024
176
Electronic information
management
 In 1981 drug information was revolutionized
when it suddenly became possible for
nonlibrarians to access MEDLINE® directly.
 Those who first had access were required to
participate in a week-long training class and then
could only access the information via dumb
terminals using a 300 bits per second (bps)
modem.
 Little did practitioners realize that they were
starting down a technologic road that would
quickly accelerate.
 A few years later some of the first pharmacy uses
of what was to become the Internet were seen.
5/9/2024
177
Electronic info…
Information Via the Internet
 Information can be communicated over the
Internet in many ways.
 It is nearly impossible to live in the United States
these days without having heard of the world wide
web (www).
 It is a very popular source of information, including
health information.
 It has been proposed that there should be universal
access to the Internet for health-related information,
to help improve the information reaching underserved
populations.
5/9/2024
178
Electronic info…
 Internet WWW browsing is likely to be farther down the list after books
or other resources—perhaps even after MEDLINE® searching, except
in certain circumstances, such as the following:
 When a reference to the Internet is found (e.g., advertisement and
citation).
 Situations where company-specific information is necessary (e.g.,
product package inserts).
 Items currently in the news
 When U.S. government information is required (e.g., Food and
Drug Administration [FDA]- or CDC-specific subjects—including
clinical information and new drug approvals).
 The U.S. government has been very active in putting a great deal of
information on the web.
 When the information is not likely to be contained in other available
sources of information (e.g., alternative medicine and tropical
diseases).
5/9/2024
179
Electronic info…
 Once the decision to search the web is made, the
pharmacist needs to log onto a computer attached to
Internet and run the web browser.
 To obtain information, the user simply needs to put the
address (referred to as a URL [uniform resource
locator]) of that information in the browser, which will then
find it automatically.
 An example of an address is
 http://druginfo.creighton.edu, which was the address of
the author's main website.
 The first term in an address, which will be followed by a //,
indicates the type of information provided at that site.
 In this case, http stands for hypertext transfer protocol,
which is the technical term for the information generally
5/9/2024
180
Electronic info…
 Common types of information are as follows :
 http: hypertext transfer protocol—normal web
information
 https: a secure form of http, used for confidential
information (e.g., credit card numbers)
 telnet: a site that requires your computer to act like a
dumb terminal
 ftp: file transfer protocol—allows you to transfer
software or a file of information in various formats
 news: USENET News group
 mailto: Internet e-mail address
5/9/2024
181
Electronic info…
 The second term in the address (druginfo) is
often the name of the web server that you are
accessing.
 The next item in this address is the organization's
general address name.
 These servers are at Creighton University.
 Finally, you will notice a three-letter extension at
the end of the URL.
 In this case, it is .edu, which indicates that the
address is that of an educational institution
5/9/2024
182
Electronic info…
 Common three-letter extensions seen in the United
States include:
 .biz: business
 .com: commercial (e.g., http://www.microsoft.com or
http://www.netscape.com)
 .edu: education
 .gov: government (e.g., http://www.cdc.gov for the CDC)
 .info: information
 .mil: military
 .org: organization (e.g., http://www.ashp.org for
American Society of Health-System Pharmacists)
 .net: network (network provider)
5/9/2024
183
Electronic info…
 Links to Internet Sites
 In many cases, the URL of a company or an
organization's website may be known; after all, such
addresses seem to be printed on everything now.
 If the URL is unknown, often a correct guess may be
made.
 For example, the American Society of Health-System
Pharmacists is commonly known as ASHP and it is an
organization.
 Therefore, http://www.ashp.org would be a logical
guess of its web address, which happens to be correct.
5/9/2024
184
Electronic info…
 A second easy way to find sites is to find cross
references from similar sites or sites that would
have an interest in the site.
 For example, a logical guess of the web address for
the American Pharmaceutical Association would be
http://www.apha.org, but this produces the website
for the American Public Health Association.
 However, by going to the ASHP website, it is possible
to easily find a link to the APhA website at
http://www.aphanet.org.
5/9/2024
185
Electronic info…
 Using Search Engines
 In many cases, the URL of a likely source of
information is not known and a method of searching for
the information is necessary.
 Fortunately, a variety of search engines have been
developed for this purpose; some are general and
some are specific to medically related topics, even
medical specialties.
 Once the decision is made to use one of these search
engines, it is then up to the user to decide which is
most appropriate for his or her needs.
 Unfortunately, there does not seem to be a truly
excellent search engine specific to pharmacy.
5/9/2024
186
Electronic info…
 Google Scholar (http://scholar.google.com) is a
good way to access professional information
including:
 medicine and pharmacy
 whereas, if the need is for information that might not be
supported by the medical literature (e.g., finding what is
being claimed by alternate medicine marketers and
finding "street information" about illegal medications), it
might be better to go to one of the general search
engines.
5/9/2024
187
Electronic info…
 Even though the general search engines index a great
number of websites, they are not all inclusive.
 Therefore, searching for more than one search engine is
important.
 The frequency of adding new pages and deleting
"dead links" should be at least once a month, with
some engines being rather dated.
 Other web technology, such as dynamically prepared
pages and frames (screens on a web browser may
consist of several frames), may not be appropriately
indexed by search engines.
 This material and other things are even referred to as
the hidden Internet, which is estimated to be 500 times
bigger than the normally searchable web.
5/9/2024
188
Electronic info…
 Search engines, such as:
 OAIster at the University of Michigan
(http://oaister.umdl.umich.edu/o/oaister/)
 Find Articles (http://www.findarticles.com/)
 Library Spot (http://www.libraryspot.com/)
 FirstGov.gov (http://firstgov.gov/)
 infoplease (http://www.infoplease.com/)
 Director of Open Access Journals
(http://www.doaj.org/)
 Scirus for Scientific Information Only
(http://www.scirus.com/srsapp/)
 Combined Health Information Database
(http://chid.nih.gov/)
 can be useful for the pharmacist trying to access
material on this hidden Internet.
5/9/2024
189
Electronic info…
 Techniques to narrow a search should be used ease of
searching.
 These techniques may include the use of logical operators (i.e.,
AND, OR, and NOT) or other methods (e.g., putting a phrase in
quotations).
 Unfortunately, the various search engines implement these
search methods differently.
 For example, in some you might put in the word "and," in
others it will need to be "AND" ("and" is just treated as a text
word), and in some you might have to use "+" or "&.“
 Also, features such as truncation, phrase searching, field
searching (e.g., date, URL, and language), case sensitivity
(e.g., finding AIDS instead of aids), and additional logical
operators (e.g., "NEAR," "WITH," and "BEFORE") may be
available.
 On some search engines it is possible to search for non textual
5/9/2024
190
Electronic info…
 Google Search Commands ,
 ....DesktopDI Google Search
Commands.docx
5/9/2024
191
Professional writing
 A common thought when considering the topic of
professional writing is "That doesn't apply to me, I'm
not writing for a journal."
 But professional writing is certainly not limited to journal
articles or books.
 It includes:
 writing evaluations of medications for consideration on a
hospital formulary
 preparing written policies and procedures for the preparation
of an intravenous admixture
 reporting the results of the latest sale to the home office
 preparing a written evaluation of a technician or clerk
 writing in a chart
 writing a term paper for a class
 preparing slides or posters for presentation, and many other
things. 5/9/2024
192
Professional writing…
 Essentially any time a professional takes pen, pencil,
chalk, typewriter, word processor, or any other writing
implement in hand to fulfill professional duties, it is
considered professional writing.
 Although the format changes, the general principles
remain the same.
 So whether the object is to write the ultimate book on
the practice of pharmacy or to type a label, a
pharmacist must know how to write professionally.
5/9/2024
193
Professional writing…
 Steps in Writing
Preparing to Write
 The first step in writing is to know the purpose—why
something needs to be written in the first place.
 It is necessary at this time to have a good idea of the
expected endpoint, which is a good idea, no matter
what is being done.
 For example, someone learning to plow a field with a
tractor may be concentrating on the ground near the
tractor and end up wandering all over the field,
thinking he or she was going straight.
 However, by concentrating on going to a specific point
on the far end of the field, rather than looking just in
front of the tractor, the row will probably be plowed
fairly straight
5/9/2024
194
Professional writing…
 General Rules of Writing
 Once the preparation is completed, it is time to start
writing.
 Unfortunately, there is no easy way to learn how to write
professionally; it just requires a lot of practice.
 However, a number of rules can be followed.
 The first step is to organize the information before starting to
write.
 At the risk of sounding like a high school English teacher, it is
still true that this step should include preparing an outline
5/9/2024
195
Professional writing…
 Checklist in Preparation of Written Materials
 Do research first.
 Put yourself in the reader's position.
 Use proper grammar and spelling.
 Make the document look "professional."
 Keep things simple and direct.
 Keep the document short.
 Avoid abbreviations and acronyms.
 Avoid the first person (e.g., I, we, and us).
 Use active sentences.
 Avoid slash construction (e.g., he or she and him or her).
 Avoid contractions.
 Cite other references wherever appropriate (and get permission to do so
where appropriate).
 Cover things in whatever order is easiest.
 Get everything down on paper before revising.
 Edit, Edit, Edit!
5/9/2024
196
Professional writing…
 Specific Document Sections
A typical document consists of three main
parts—
1. the introduction
2. body
3. conclusion
5/9/2024
197
Professional writing…
1. Introduction
 With the probable exception of policy and procedure
documents, the two most important paragraphs in any
document are the first and last.
 It is vital to start out strong, to encourage the reader to continue
reading.
 Otherwise, the work will end up in that stack of articles
everyone has that they "intend to read someday."
 That first paragraph should also inform the reader of what they
can expect in the rest of the document; it should be similar to a
road map that shows what is to be accomplished in the
document.
 The introduction should have a clear objective for the existence
of the document.
5/9/2024
198
Professional writing…
2. Body
 The body of the document contains all of the details.
 In a research article, the body may be divided into the
methods, results, and, possibly, discussion sections,
although the latter section may be incorporated into the
conclusion.
 Details of what should be included are covered in .
 In other documents, the body will probably be divided
into whatever sections are appropriate or logical.
 A number of rules can be followed in preparing the body
of a document. 5/9/2024
199
Professional writing…
 The first rule is that while it is important to be
concise, all necessary information must be
presented.
 Again, keep an eye on the desired endpoint, and
do not stray from the subject unless it is
absolutely necessary.
 Including unnecessary information, even if it is
interesting, will tend to confuse or obscure the
important points.
 Also, be sure to provide a balanced coverage of
the material and avoid unsupported bias.
5/9/2024
200
Professional writing…
 It is important to cover the information in a
logical order, so that it flows easily from one
point to another.
 A common mistake, when learning to write
professionally, is to skip back and forth
between subjects.
 For example, someone might insert a point
about dosing in the middle of indications, when
dosing is discussed at another point in the
document.
5/9/2024
201
Professional writing…
3. Conclusion
 A conclusion should be placed at the end of the
body of the document, except for certain
documents (e.g., policy and procedures).
 This conclusion should follow logically from the
information presented and should serve to
summarize that information.
 Remember, the conclusion should also
correspond with the objective stated in the
introduction.
5/9/2024
202
Professional writing…
 It is also worth noting that in clinical consultations,
a common mistake is to write the conclusion in a
general manner, rather than addressing the
specific patient in question, which is what the
reader wants to hear about.
 The author must remember to address the
specific patient's situation.
5/9/2024
203
Legal aspect of drug informatics
 An understanding of the legal aspects of DI
can help the practitioner in day-to-day practice,
as well as provide some possible ways to
protect himself or herself in the legal system.
5/9/2024
204
Legal aspect…
 Tort Law
 DI practice is a specialized discipline of
pharmacy.
 Despite the clear prevalence of pharmacist-
staffed DICs, the legal obligations of the DI
specialist remain unclear.
 Specialists are held to the highest degree of care
by the law.
 Because of the DI pharmacists' greater expertise
in the area of DI, it is likely that the courts would
expand their legal and professional liability
beyond that of other pharmacists.
5/9/2024
205
Legal aspect…
 The liability of the DI specialist versus
generalist differs for a number of reasons, the
most obvious of which are the nature of the
information provided and the recipients of the
information.
 In the provision of pharmaceutical care,
pharmacists are providing information to
patients, whereas the DI specialist is often
providing DI to other health professionals.
5/9/2024
206
Legal aspect…
 Functions such as online searching, monitoring
or recommending drug therapy, patient
counseling, participation in clinical studies and
pharmacy and therapeutics (P&T) committees,
drug use evaluation, and identifying adverse
drug experiences entail legal obligations of
proper performance.
 Willing has stated:
 If you voluntarily offer and create a higher
standard of careful practice, the public has a legal
right to assume that pharmacists can and will
consistently perform according to that standard.
5/9/2024
207
Legal aspect…
 Minimal standards of performance and a
consistent level of competence must be
assured by pharmacists promoting or offering
this service regardless of the practice site.
 Although there are no standards to accredit
DICs, professional standards of performance
may be used by courts as an objective
measuring tool for the standard of care.
5/9/2024
208
Legal aspect…
 In addition to the DI specialist, the pharmacy
profession is assuming an increased legal
responsibility to provide DI in the daily practice
of pharmaceutical care.
 Although the physician has been considered the
learned intermediary, responsible for
communicating the manufacturer's warnings to
the patient, the Omnibus Budget Reconciliation
Act of 1990 (OBRA '90) may be shifting this
responsibility to the pharmacist.
5/9/2024
209
Legal aspect…
 Failure to counsel or warn cases are showing an
increasing trend in pharmacist liability.
 Recent cases demonstrate the pharmacist's duty
to warn of foreseeable complications of drug
therapy is becoming a recognized part of the
expanded legal responsibility of pharmacists.
5/9/2024
210
Legal aspect…
 Where the patient is at higher risk than the
general population, the courts have uniformly
found liability.
 There are many such cases against physicians for
failure to disclose material risks of medical
procedures or treatments to their patients.
 Today, there is some question as to when a
pharmacist provides DI, whether they be
generalists or DI specialists, are held to the same
standards as physicians when determining
standard of care.
5/9/2024
211
Legal aspect…
 Traditionally, physicians remain responsible for
their patients and must exert "due care"; that
is, a physician who knows or should have
known that information provided was improper
may be held liable for negligence.
 Currently, most litigation concerning pharmacists
involves negligence.
5/9/2024
212
Legal aspect…
 Therefore, it is safe to assume that a legal
cause of action pertaining to the provision of DI
will be founded on the theory of negligence as
the direct or proximate cause of personal injury
or death.
 Malpractice liability based on negligence refers to
failure to exercise the degree of care that a
prudent (reasonable) person would exercise under
the same circumstances.
 Elements of negligence include the four Ds:
 (1) duty breached, (2) damages, (3) direct
causation, and (4) defenses absent.
5/9/2024
213
Legal aspect…
 Incomplete Information
 Is the pharmacist liable when the DI provided is
incomplete?
 Should the pharmacist provide all the medication
information via a DI sheet or patient package
insert (PPI)?
 There have been several cases against
pharmacists for failure to dispense mandatory
PPIs for certain drugs that later caused harm.
5/9/2024
214
Legal aspect…
• In Parkas v. Saary, the court addressed the issue of
whether the pharmacist's failure to dispense the
Food and Drug Administration (FDA)-mandated PPI
for progesterone was the proximate cause of the
congenital eye defect that occurred.
 Because congenital defects, but not eye
deformities, were specified in the PPI, failure to
provide the PPI could not be proven to be the
proximate cause.
 Therefore, judgment was in favor of the
pharmacy.
5/9/2024
215
Legal aspect…
 In Frye v. Medicare-Glaser Corporation, the
pharmacist counseled the patient regarding
drowsiness with Fiorinal®, but failed to provide
a warning not to consume alcohol.
 The patient died, presumably as a result of
combining the drug with beer.
 Here, the DI provided was incomplete.
 The trial court did not find the pharmacist had a
duty to warn in this instance.
 However, it is important to realize that this case
was decided before OBRA '90 was in effect.
5/9/2024
216
Legal aspect…
 More recent cases are finding pharmacists
have a responsibility for patient counseling
and drug therapy monitoring. In Sanderson v.
Eckerd Corporation, the pharmacist was liable
for "voluntary undertaking" to act in the
absence of a duty, where the pharmacy's
computer was inappropriately used by the
pharmacist in detection of an adverse reaction
and the pharmacist failed to warn the patient of
the potential for an adverse reaction
5/9/2024
217
Legal aspect…
 In Horner v. Spalitto, the court imposed a duty on
a pharmacist to alert the prescriber when the dose
prescribed is outside the therapeutic range.
 In Happel v. Wal-Mart Stores, the pharmacy's
computer system was overridden, and the pharmacist
failed to warn a patient allergic to aspirin and ibuprofen
of the potential for cross-allergenicity with ketorolac.
 The court found the pharmacist has a duty to warn
when a contraindicated drug is prescribed.
 In Morgan v. Wal-Mart Stores, the court held that
pharmacists have a duty beyond accurately filling a
prescription "based on known contraindications, that
would alert a reasonably prudent pharmacist to a
potential problem.
 " However, the court did not find for the plaintiff(ከሳሽ)
opining that pharmacists do not have knowledge that
desipramine may cause hypereosinophilic syndrome.
5/9/2024
218
Legal aspect…
 Clearly, these cases demonstrate an
expansion of pharmacists' duties from the
nondiscretionary standard of technical
accuracy to a discretionary standard which
requires pharmacists to perform professional
functions, that is, from a technical model to a
pharmaceutical care model.
 Knowledge of or access to DI is becoming an
important factor that courts consider in
determination of the pharmacist's duty to warn.
5/9/2024
219
Legal aspect…
 Inappropriate Quality Information
 It has long been recognized by law that false
information provided to another could result in
harm to the recipient if the recipient acted relying
on the false information.
 Although negligent misrepresentation has not
been applied to DI, there is no guarantee that it
will not be in the future.
5/9/2024
220
Legal aspect…
• The relevant law is the Restatement (Second) of
Torts, Negligent Misrepresentation Involving Risk of
Physical Harm, which states:
 One who negligently gives false information to
another is subject to liability for physical harm
caused by action taken by the other in reasonable
reliance upon such information . . .. Such
negligence may consist of failure to exercise
reasonable care in ascertaining accuracy of the
information, or in the manner in which it is
communicated.
5/9/2024
221
Ethical aspect of DI
 The Ethics Course Content Committee of the
American Association of Colleges of Pharmacy
(AACP) described ethics as "the philosophical
inquiry of the moral dimensions of human
conduct".
 They mentioned that Aristotle taught ethics as "an
eminently practical discipline". . .dealing. . . "with
concrete judgments in situations in which action
must be taken despite uncertainty.
5/9/2024
222
Ethical aspect…
 " These authors indicated that the term ethical
is often used synonymously with the term
moral to describe an action or decision as
"good" or "right.
 " They further stated that ethics is not values
clarification, it is not the study of moral
development, and it is not the law.
5/9/2024
223
Ethical aspect…
 Veatch stated that "an ethical, or moral, issue
involves judgments between right and wrong
human conduct or praiseworthy and blameworthy
human character.
 " This author indicated that an ethical deliberation may
be differentiated from other endeavors by three
characteristics:
1) it is ultimate or fundamental, there is no higher standard
against which to measure the rightness of the decision
or action
2) the issue is universal, the parties in disagreement do not
consider it simply a difference of opinion or taste “each
party believes there is a right or wrong answer” even if
they're not sure what the answer is
3) the deliberation takes into account the welfare of all
5/9/2024
224
Ethical aspect…
 Law might be defined as rules of conduct
imposed by society on its members.
 By contrast, professional ethics has been
defined as "rules of conduct or standards by
which a particular group in society regulates its
actions and sets standards for its members.
5/9/2024
225
Ethical aspect…
 " Law involves written rules set by the whole
society (or its representatives) that address
responsibilities of that society's members.
 Professional ethics focuses on explicit or
implicit rules and standards set by a
professional subgroup of society, and
addresses the responsibilities of only those
who are members of that subgroup.
5/9/2024
226
Ethical aspect…
 All pharmacists will be called on to provide
drug information.
 On occasion they will encounter ethical dilemmas
regarding what information, if any, should be
provided.
 It is important that the pharmacy professional
approach such moments prepared to (often
quickly) identify the pertinent facts, analyze
relevant points of the situation, and rank or
balance the pertinent ethical rules and principles
that are involved.
5/9/2024
227
Ethical aspect…
 The individual pharmacist must recognize his
or her rights and responsibilities relative to the
client, to other involved individuals, to society
as a whole and to any higher power to whom
the pharmacist feels accountable.
 Organizations can assist the employee
pharmacist by formal recognition of certain
implicit and explicit policies
5/9/2024
228
Ethical aspect…
 Furthermore, opportunities for deliberate study
and rehearsal of important analytic steps are
important to help pharmacists be prepared to
address ethical dilemmas that arise when
providing drug information.
5/9/2024
229

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  • 1. DRUG INFORMATICS Introduction to the concept of drug Information 5/9/2024 1
  • 3. Introduction  The provision of medication information is among the most fundamental responsibilities of pharmacists.  The information may be  patient specific, as an integral part of pharmaceutical care  relative to a group of patients, such as:  development of a therapeutic guideline  publishing an electronic newsletter  updating a website 5/9/2024 3
  • 4. Intro…  The term drug information may have different meanings to different people depending on the context in which it is used.  If asked to define this term,  one could describe it as printed information in a reference or verbalized by an individual that pertains to medications.  In many cases, individuals use this term in different contexts by associating it with other words: 1. Specialist/practitioner/pharmacist/provider 2. Center/service/practice 3. Functions/skills 5/9/2024 4
  • 5. Intro…  The first group of words implies a specific individual  The second group implies a place  The third implies activities and abilities of individuals. 5/9/2024 5
  • 6. Intro…  The term drug information will be used in these different contexts to describe the beginnings and evolution of this area of practice.  Relative to current practice, the term medication information is used in place of drug information to convey the management and use of information on medication therapy  These terms may refer to  provision of information for a specific patient  Provision of information in the context of addressing medication use issues for a group of patients  (e.g., development of policies and procedures on medication 5/9/2024 6
  • 7. Intro…  Drug informatics is another term used to describe the evolving roles of the medication information specialist.  Drug informatics  emphasizes the use of technology as an integral tool in effectively organizing, analyzing, and managing information on medication use in patients. 5/9/2024 7
  • 8. Intro…  The term drug information developed in the early 1960s  when used in conjunction with the words center and specialist.  In 1962, the first drug information center was opened at the University of Kentucky Medical Center in USA.  An area separated from the pharmacy was dedicated to provide drug information. 5/9/2024 8
  • 10. Intro…  The center was to be "a source of selected, comprehensive drug information for  Physicians  Dentists  Nurses  The center was expected to take an active role in the education of health professional students including  Pharmacy  Medicine  Dentistry  Nursing 5/9/2024 10
  • 11. Intro…  Several other drug information centers were established shortly thereafter.  Different approaches to providing drug information services included  decentralizing pharmacists in the hospital  offering a clinical consultation service, and providing services for a geographic area through a regional center.  The first formal survey, conducted in 1973, identified 54 pharmacist operated centers in the 5/9/2024 11
  • 12. Intro….  The individual responsible for operation of the center was called the drug information specialist.  The expectation was that drug information would be stored in the center and retrieved, selected, evaluated, and disseminated by the specialist.  Information would be disseminated to respond to specific questions, to assist in the evaluation of drugs for use in the hospital, or to inform others through newsletters of current developments related to drugs.  These and other functions, as listed in , have evolved over a period of years and reflect the services provided in most drug information centers. 5/9/2024 12
  • 13.  Medication Information Services 1. Support for clinical services 2. Answering questions 3. Developing criteria/guidelines for medication use 4. Pharmacy and therapeutics committee activity 5. Development of medication use policies 6. Formulary management 7. Publications—newsletter, journal columns, websites 8. Education—in-services for health professionals, students, consumers 9. Medication usage evaluation/medication use evaluation 10. Investigational medication control 11. Institutional Review Board activities 12. Information for practitioners 13. Coordination of reporting programs, e.g., adverse medication reactions 14. Poison information 5/9/2024 13
  • 14.  Medication Information Skills 1. Assess available information and gather situational data needed to characterize question or issue 2. Formulate appropriate question(s) 3. Use a systematic approach to find needed information 4. Evaluate information critically for validity and applicability 5. Develop, organize, and summarize response for question or issue 6. Communicate clearly when speaking or writing, considering the audience level 7. Anticipate other information needs 5/9/2024 14
  • 15. Factors Influencing the Evolution of the Pharmacist's Role as a Medication Information Provider  In addition to the changing philosophy of practice, several other factors are influential in the evolution of the pharmacist's role as a medication information provider.  These include:  the prevention of adverse drug events (ADEs)  growth of information technology  changes in the health care environment with a focus on evidence-based medicine and the evaluation of outcomes  the sophistication of medication therapy  a more knowledgeable patient 5/9/2024 15
  • 16. Drug Information Resources 5/9/2024 16 Objectives After completing this chapter, the students will be able to  Differentiate between primary, secondary, and tertiary sources of information.  Select resources relevant to different pharmacy practice areas.  Identify the most appropriate resource for a specific drug information request.  Describe the role of Internet and personal digital assistant (PDA) resources in the provision of drug information.  Critique tertiary resources to determine appropriateness of information.
  • 17. Drug information resource  The quantity of medical information and medical literature available is growing at an astounding rate.   The technology by which this information can be accessed is also improving exponentially.  The introduction of PDAs(personal digital assistance) and Internet resources has to some extent changed the methods by which information is accessed, but not the process of providing drug information. 5/9/2024 17
  • 18. Resource…..  Pharmacists are being asked daily to provide responses to numerous drug information requests for a variety of people.  It is tempting just to select the easiest, most familiar resources to find information.  Generally, the best method to find information includes a stepwise approach moving first through:  tertiary (e.g., textbooks, full-text databases, and review articles),  then secondary (e.g., indexing or abstracting service),  finally primary (e.g., clinical studies) literature. 5/9/2024 18
  • 20. Definition  Tertiary literature is core knowledge established via primary literature or accepted as standard of practice within the medical community.  Introduction  tertiary resources include:-  textbooks, monographs, compendia, handbooks, and published symposia.  They represent the condensation of basic facts originally published in the primary literature. 5/9/2024 20
  • 21. Evaluation of tertiary resources  Several points should be considered in evaluating tertiary resources as follows: 1-Does the author has sufficient experience and expertise to write on the topic? 2-What credentials do the authors/contributors have? 3-Assess the text for timeliness (i.e. when was the last edition published?) 4-Is this the most recent edition of the tertiary reference? 5-Are statements of fact appropriately supported by references? 6-How many references does each section have and how up-to-date are they? 5/9/2024 21
  • 22. Cont.  7-To assess consistency, compare information presented in one text to the same information presented in another text.  8-Is the reference likely to contain information relevant to the subject being researched?  9-Is the reference clear, concise and easy to use? 5/9/2024 22
  • 23. Availability of Tertiary Resources  Tertiary resources are available in many formats, including hard copy, microfiche, and computerized versions.  Computerized resources may be available on floppy disks, or CD-ROMs for use in a single personal computer or computer network, a main frame system or via internet. 5/9/2024 23
  • 25. A. General References  General features 1-They are referral books. 2-Their formats are either monographs or monographs plus chapters. 3-Used through their indexes NOT through their contents lists. 5/9/2024 25
  • 26. Cont. Textbooks  Different from the general references in: 1-Their formats are chapters. 2-One can read them from cover to cover. 3-One can use their contents list Not necessary to go to index. 5/9/2024 26
  • 27.  The most helpful of them to answer a drug related questions are: 5/9/2024 27
  • 28. Martindale’s The complete drug reference 5/9/2024 28
  • 29. Cont.  Martindale’s The complete drug reference European and investigational drugs -Published by the Royal Pharmaceutical Society of Great Britain every 4 years -Has a manufacturer directory and index by clinical use (typical European style of indexing) -Lists other pharmacopeias the drug is found in. 5/9/2024 29
  • 30. Drug Facts and Comparisons (F&C) 5/9/2024 30
  • 31. Cont.  Drug Facts and Comparisons (F&C) * Updated monthly (loose-leaf version) * Lag time 3 months * Arranged by therapeutic class * Prescription and OTC listings * Helpful summary/comparison tables * Contains information about investigational, orphan, and discontinued products and off label uses * Not referenced, cumbersome 5/9/2024 31
  • 32. American Hospital Formulary Service (AHFS) Drug Information 5/9/2024 32
  • 33. Cont.  American Hospital Formulary Service (AHFS) Drug Information * Arranged by AHFS classification number * Monographs listed alphabetically * Information in monograph: -Chemistry, pharmacology, mechanism -Dose, administration, pharmacokinetics -Drug interactions, preparations, toxicity 5/9/2024 33
  • 34. Cont.  (AHFS) Drug Information * FDA-approved and off-label uses * Published annually with quarterly updates * More clinically oriented * References are not available in the hard copy but may be available online or with software CD- ROMS * Not comprehensive, significant lag time 5/9/2024 34
  • 35. USP Dispensing Information (USP DI) 5/9/2024 35
  • 36. Cont. * Three volumes i-DRUG Information for the Healthcare Professional ii-Drug Information for the Patient (in lay language) iii-Legal Requirements * Monographs in alphabetical order in Volume I * Published annually * Also contains some Canadian drug names * Most thorough information on:5/9/2024 36
  • 37. Cont. * Useful Appendices: (typical American style of indexing) -Selected List of Drug-Induced Effects -Therapeutic Guidelines -Poison Control Center Listing -Veterinary Medication Classification -Excluded Monograph Listing 5/9/2024 37
  • 38. Cont. * Off-label uses indexed by drug and by indication * Not referenced, lag time, only FDA-approved uses, inconvenient to compare agents in the same therapeutic class 5/9/2024 38
  • 39. Drug Information Handbook (Lexi- Comp) 5/9/2024 39
  • 40. Cont.  Drug Information Handbook (Lexi-Comp)  * Pocket-sized; PDA & online versions are also available  * Published annually  * Drugs listed alphabetically by generic name  * Useful charts and tables.  * Specialty versions are available:  -Pediatric, psychiatric, geriatric  * Not referenced  * Lists all reported adverse events but does not always provide the incidence 5/9/2024 40
  • 41. MICROMEDEX® * CD-ROM * Access information by brand or generic name of drugs * Referenced, quick and easy to use * Expensive, uses other tertiary references * Databases available: -DRUGDEX®-main drug information database -DISEASEDEX®-disease states -IDENTIDEX®-drug identification by imprint code -POISINDEX®-poisoning and toxicology -Martindale’s –foreign drugs 5/9/2024 41
  • 43. Cont.  Physicians’ Desk Reference (PDR) * Updated annually * Color pictures and markings for drug identification * Has FDA-approved product information only * Manufacturers pay to have product information Included * Contains section on diagnostics * May not contain the complete package insert * Not referenced 5/9/2024 43
  • 46. Cont. * Well-written and referenced with helpful tables. * Pocket version is available. * Focuses on drug therapy, good background information. * Also covers non-drug treatment options. * Updated edition about every 4 years. 5/9/2024 46
  • 47. Applied Therapeutics: The Clinical Use of Drugs (Koda-Kimble) 5/9/2024 47
  • 48. cont * Well-written with focus on drug therapy. * Updated every 4 years. * Useful summary tables. * Case presentation format, may be more difficult to use as a quick reference. 5/9/2024 48
  • 49. cont  The Washington Manual of Medical Therapeutics  Quick reference with many charts and tables.  Updated about every 2 to 3 years. 5/9/2024 49
  • 51. Internal Medicine  Harrison’s Principles of Internal Medicine * Gold standard for internal medicine * Published every 5 years, referenced * Pathophysiology, clinical presentation, diagnosis and treatment guidelines  * Little drug information & dosing recommendations 5/9/2024 51
  • 53. cont  The Merck Manual  Used by many healthcare professionals  Also includes pediatrics, gynecology, psychiatry, ophthalmology, otolaryngology, dental disorders 5/9/2024 53
  • 56. Cont.  Clinical Medicine (Kumar &Clark ) * comprehensive and authoritative single-volume textbook of internal medicine. * Explains the management of disease, based on an understanding of scientific principles and including the latest developments in treatment. * Colour-coded chapters are attractive and make the book easy to navigate. * Comprehensive index, clearly displayed, pinpoints information rapidly. 5/9/2024 56
  • 57. cont  Clinical Medicine (Kumar &Clark ) * Boxes and tables pull out and display important information. * Drawings and photographs. * Carefully structured headings provide a useful outline for study and quick reference. * Gastrointestinal, Rheumatology, Renal, Cardiovascular, Respiratory ,Intensive care medicine, Drug Therapy and poisoning…… 5/9/2024 57
  • 58. Cardiology  Textbook of Cardiovascular Medicine * Published every 5 years. * Good illustrations. * Addresses modern-day issues such as medical economics and assessing quality of care. * Well-referenced. 5/9/2024 58
  • 60. Cont  Hurst’s The Heart * Organized by condition * Comprehensive information on drug therapies and regimens * Rapid Interpretation of ECG’s * Best guide to learning ECG’s * User-friendly format. 5/9/2024 60
  • 61. Pediatrics  Harriet Lane Handbook 5/9/2024 61
  • 62. cont Harriet Lane Handbook * Useful pocket guide published every 3 years * Has dosing information * Electronic version updated annually * Four sections: emergency management, diagnostic, formulary, and therapeutic data * Some information on pregnancy and lactation * Not referenced, not frequently updated, confusing organization, not complete 5/9/2024 62
  • 63. Cont. Pediatric InjectableDrugs (“TeddybearBook”) * Alphabetical order by generic name * Formerly known as Guidelines for Administration of Intravenous Medications to Pediatric Patients * Dose, concentration, rate, cautions 5/9/2024 63
  • 64. Cont. Pediatric Dosage Handbook (Lexi-Comp) * Pediatric version of the Drug Information Handbook * Dose, administration, how supplied, contraindications, adverse effects, drug interactions, antidotes * Also contains adult doses * May sometimes have information on extemporaneous formulations 5/9/2024 64
  • 65. Pregnancy Drugs in Pregnancy and Lactation (Briggs) * Excellent reference, gold standard * Updated every 4 years * Alphabetical by generic name * Generic name, class, & pregnancy risk factor * Summaries of risk to fetus and risk during breastfeeding * Editors assign categories for drugs not classified by the manufacturer * Referenced 5/9/2024 65
  • 66. Infectious Diseases Mandell’s Principles and Practice of * Gold standard reference * Infection, diagnosis, treatment and useful background information Infectious Disease 5/9/2024 66
  • 67. cont Sanford Guide to Antimicrobial Therapy * Published annually * Pocket-sized and easy to use * Includes: dosing in renal impairment, brand & generic names, empiric therapy guidelines, antimicrobial spectra of the agents * Not well-referenced 5/9/2024 67
  • 68. Oncology Cancer: Principles and Practice of Oncology (devita) * Gold standard, published every 3 to 4 years * Pathology, treatment options, & adverse effects * Referenced 5/9/2024 68
  • 69. cont Cancer Chemotherapy Handbook * Useful index, introduction on malignancies * Pharmacology and use of chemotherapeutic agents * Lists investigational drugs and combinations * Well-referenced 5/9/2024 69
  • 70. Pharmacology Goodman & Gilman’s Pharmacological Basis of Therapeutics * Gold standard pharmacology text * Grouped by therapeutic class * Mechanism, absorption, distribution, and metabolism * Contains review of pharmacokinetics, therapeutics, and toxicology * Well-referenced * Updated every 5 years (infrequent) 5/9/2024 70
  • 71. Drug interaction Drug Interaction Facts * Published by F&C * Alphabetical by drug name * Referenced * Provides information regarding: -Significance and severity -Onset of interaction -Documentation * Not complete, subjective rating scale 5/9/2024 71
  • 72. cont Stockley'sDrug Interactions * A typical monograph contains a summary, clinical evidence for the interactions under discussion, the probable mechanism, clinical importance and management * Covers interactions between therapeutic drugs, proprietary medicines, herbal medicines, foods, drinks, pesticides and some drugs of abuse 5/9/2024 72
  • 74. cont Stockley'sDrug Interactions * Based on published sources and fully referenced * Covers over 14,000 drug interactions * Contains over 2,800 monographs * Includes 17,600 references * Book & CD-ROM 5/9/2024 74
  • 75. Adverse Drug Reactions  Meyler’s Side Effects of Drugs 5/9/2024 75
  • 76. cont Meyler’sSide Effects of Drugs * Indexed by drug and by adverse event * Most comprehensive * Published every 4 years with annual updates * Contains tables and lists * References for some side effects not included * Information provided: -Effects on organs and systems, lab/diagnostic interference, withdrawal and overdose * May not be complete, references for widely known effects are not included 5/9/2024 76
  • 77. Compatibility and Stability  Handbook on Injectable Drugs (Trissel’s) 5/9/2024 77
  • 78. cont Handbook on InjectableDrugs (Trissel’s) * Gold standard reference * Updated every 2 years with annual supplements * Drugs organized alphabetically by generic name * Information on compatibility and stability with diluents and drugs * Solution, Y-site, syringe, and additive compatibility * Table format, very useful * Not complete, lag time 5/9/2024 78
  • 79. cont  King Guide to Parenteral Admixtures  * Chart format, loose-leaf  * Alphabetical listing by generic name  * Pages are not numbered 5/9/2024 79
  • 80. Compounding and Pharmaceutics Remington’s The Science and Practice of Pharmacy * Helpful for extemporaneous compounding * Pharmaceutical calculations, chemistry, radioisotopes * New edition every 5 years 5/9/2024 80
  • 82. cont Merck Index * Chemical name, formula, & structure * Physical data, therapeutic category * Published every 6 to 10 years 5/9/2024 82
  • 83. cont United States Pharmacopeia –National Formulary (USP-NF) * Official monographs for preparation and assay of pharmaceutical products * Published every 5 years with periodic supplements * Information on storage, packaging, labeling, reference standards, & assays * USP: drug substances & dosage forms * NF: pharmaceutical ingredients * Not a very useful reference since most pharmaceuticals are mass-produced 5/9/2024 83
  • 84. Pharmacokinetics Basic Clinical Pharmacokinetics (Winters) * Case-study format * Includes principles of monitoring therapy, basic pharmacokinetics, & clinical applications * Appendix of commonly used equations * Mostly theory, little patient integration 5/9/2024 84
  • 86. Toxicology  Toxicologic Emergencies (Goldfrank’s)  Poison management guidelines  Useful tables and case studies  Practice multiple-choice questions 5/9/2024 86
  • 87. cont Casarett & Doull's Toxicology: The Basic Science of Poisons * gold standard in toxicology field * basic concepts and fundamental principles needed to grasp current issues in modern toxicology * The text is organized and presented in a logical progression of general principles to specific topics such as organ system toxicology, specific agent toxicology, and environmental toxicology 5/9/2024 87
  • 88. cont  POISINDEX®  Toxicology component of MICROMEDEX®  Search by brand or generic name  Describes what substance looks like, any imprint codes, management of toxicity 5/9/2024 88
  • 89. Drug Identification 1.American Drug Index * Cross-referenced by brand, generic, and chemical names 2.The Pill Book 3.IDENTIDEX® * Component of MICROMEDEX® * Identify drug by imprint code 5/9/2024 89
  • 90. cont  4.British National Formulary * BMJ Publishing, London, United Kingdom. * The standard reference for prescribing and dispensing drugs in Britain. * Included are notes on the different drug groups to help in the choice of appropriate treatment. * The BNF is updated in March and September of each year * Available on disk and CD-ROM as the Electronic British National Formulary and An electronic web- based format is also available. 5/9/2024 90
  • 91. Non-Prescription Products PDR for Nonprescription Drugs and Dietary Supplements * Format similar to PDR, updated every year * Indexed by product name, category, manufacturer, & active ingredient * Includes color pictures of products * Information: indications, cautions, dose, administration, patient instructions, precautions, how supplied 5/9/2024 91
  • 92. cont Handbook of Nonprescription Drugs * Useful tables and comparisons * Includes: -Patient assessment and counseling guidelines -Pathophysiology and treatment options -Dosing, adverse events, & interactions 5/9/2024 92
  • 93. Electronic tertiary resource Multipurpose resource Access Medicine (http://www.accessmedicine.com/) * Collection of textbooks, clinical practice guidelines, news * Includes: Goodman & Gilman, Harrison’s, Current Medical Diagnosis & Treatment, and the Lange series. * Drug monographs (include images, chemical structures, patient education materials) provided by Gold Standard™ 5/9/2024 93
  • 94. cont ClinicalResource@Ovid (http://clinicalresource.ovid.com/autologin.html) *Collection of books, clinical practice guidelines, patient education materials and links to databases *Includes: Clin-eguide, Facts and Comparisons and 5-Minute Consult series 5/9/2024 94
  • 95. cont MD Consult http://home.mdconsult.com/groups/uwash8783.ht ml) *Collection of textbooks, journals, drug information, guidelines, patient education handouts, news and updates *Drug information and updates from Mosby’s drug Consult, package insert information, FDA information *Customizable patient handouts –diseases and drugs 5/9/2024 95
  • 96. cont MedlinePlus (http://medlineplus.gov) * NLM’s database aimed at consumers for health and wellness information * English and Spanish versions as well as “large print” and audio * Includes health topics, drug information, dictionaries, interactive tutorials, directories and links to other resources 5/9/2024 96
  • 97. cont MedlinePlus * Especially good for quick overview, including statistics, of topics and illustrations *Drug information includes MedMaster from ASHP, USP DI Advice for Patients, Natural Standard Online (for natural products) and links to FDA and ClinicalTrials.gov 5/9/2024 97
  • 98. cont Micromedex Healthcare series (http://www.thomsonhc.com/hcs/librarian/) * Collection of databases that can be searched individually or all together contents of collection depends on your subscription * Includes DrugDex and Drug Consults, IV Compatibility, PoisIndex, AltMedDex, Martindale, Reproprisk, TOMES and CareNotes 5/9/2024 98
  • 99. cont Micromedex Healthcare series * Use for detailed information about medications (US and foreign) and natural products as well as exposures to chemicals, toxins and poisonous animals and plants * Lengthy bibliographie * Instructions for citing under Warranties & Disclaimers link 5/9/2024 99
  • 100. Drug and Natural Products Information Resources Facts & Comparisons (http://online.factsandcomparisons.com/) * Collection of resources that can be searched individually or all together –drugs and natural products * Includes Drug Facts & Comparisons, Nonprescription Drug therapy, Drug Interaction Facts, Review of Natural Products, MedFacts Patient information 5/9/2024 100
  • 101. cont Facts & Comparisons * Print version has been gold standard for drug information for years * Includes comparison tables for drugs by class or pharmacological action * In general, references are included in the Drug Interactions section and in drug class monographs but not in individual drug monographs 5/9/2024 101
  • 102. cont Natural Medicines Comprehensive Database (http://www.therapeuticresearch.net/nd/Search.a spx?s=ND) * Comprehensive, evidence-based information about herbal and dietary supplements used in the US and Canada * Produced by publishers of Prescribers' Letter and Physicians' Letter * Many products have patient handouts 5/9/2024 102
  • 103. cont Natural Medicines Comprehensive Database * Updated daily * Several entry points, e.g. product or common name, scientific name, people use * this for, interactions with foods, herbs, dietary supplements, lab tests, diseases or conditions 5/9/2024 103
  • 104. Resource cont. Secondary literature  provides a summary, index, or abstract of a piece of primary literature, usually written by the authors of a primary literature paper.  The vast majority of secondary resources are utilized primarily in an electronic format, although some may still have a print form. 5/9/2024 104
  • 105. Resource cont.  Secondary literature refers to:-  references that either index or abstract the primary literature  The goal is:  to direct the user to the primary literature. 5/9/2024 105
  • 106. Resource cont.  The two terms, indexing and abstracting, differ slightly.  Indexing  consists of providing bibliographic citation information (e.g., title, author, and citation of the article),  abstracting  includes a brief description (or abstract) of the information provided by the article or resource cited.  Various systems will index or abstract literature from different journals, meetings, or publications, therefore, in order to perform a comprehensive search different databases must be used. 5/9/2024 106
  • 107. Resource cont. Examples: • Medline (PubMed is the web portal) • IPA • EMBASE • current contents 5/9/2024 107
  • 108. Resource cont.  main benefit  location of primary literature  main problem  not enough information to determine quality of research work 5/9/2024 108
  • 109. Resource cont.  challenges in searching secondary database systems.  Systems do not index all terms in the same manner therefore it is necessary to determine what terms a database is using to conduct a successful search.  For example, databases through the National Library of Medicine index terms by their Medical Subject Heading (MeSH term)  while the Iowa Drug Information Service (IDIS) uses the United States Adopted Name and the International Classification of Diseases 5/9/2024 109
  • 110. Resource cont.  Most computerized databases also include a free- text search option, which is very useful when the defined index terms are not identifying relevant data.  This option may also be helpful when only limited data have been published or are available, perhaps before an official index term is defined. 5/9/2024 110
  • 111. Resource cont.  Searches generally use Boolean operators, often AND, OR, and NOT (see ).  The operator AND will combine two terms, returning only citations containing both of those concepts or terms.  The operator OR will have an equal or greater number of returns since it will include any citation where either term is used.  Use of the term NOT will always decrease the number of responses, since it eliminates any references having the term that follows that operator  therefore it should be used with caution, since it may eliminate articles that may be appropriate, simply because the term being eliminated happens to appear 5/9/2024 111
  • 112. Resource cont.  Primary literature  contains new/original material. Examples: • study published in health sciences journal (including symposium and conference proceedings and abstracts) • package insert and other manufacturer technical pamphlets • patents and trademarks • government bulletins  main benefit  you can determine the quality of the research and usability of information  main problem  not enough time to read it all 5/9/2024 112
  • 113. Internet Resources 5/9/2024 113  Another method to identify relevant resources might be a general Internet search for information.  This can be especially helpful to serve as a starting point for questions about unusual diseases or about marketed over-the-counter products and combination dietary supplements
  • 114. Major News Sources Online 5/9/2024 114
  • 115. Consumer Health Information 5/9/2024 115  As consumers become more active and educated in their health care and disease management, the need for health information sources geared at consumers has increased.  Currently there are a variety of sources where consumers obtain their health information
  • 117. Systematic approach to receiving and answering questions on drugs 5/9/2024 117
  • 118. Receiving and Classifying Drug Information Requests  An essential component within pharmacy practice is the ability to effectively answer questions posed by health care professionals and the lay public.  In 1975, Watanabe et al. presented a systematic approach for responding to drug information requests.   The systematic approach comprised of five steps 5/9/2024 118
  • 119. Cont…  Systematic Approach (1975)  Step I. Classification of the request  Step II. Obtaining background information  Step III. Systematic search  Step IV. Response  Step V. Reclassification 5/9/2024 119
  • 120. Receiving and Classifying Drug Information Requests • Answering Drug Information Questions – These are the steps you should go through when you are asked a question: • Step 1: Identify the requester. – This will help you get an idea of the depth and detail of information the requester is probably expecting. • Step 2: Determine and categorize the “real” question. – It is remarkably common for the question you are asked to not be the requester’s “real” question. 5/9/2024 120
  • 121. Drug Information Requests cont.  Ask for background information.  Examples:  “I want to make sure I answer (or understand) your question adequately, so tell me a little more about what led you to ask me this question.”  “There are several different answers to that question.  To make sure I give you the right answer, I’d like you to describe in more detail what it is you wish to better understand.”  “Tell me how you want to use this information.” 5/9/2024 121
  • 122. Drug Information Requests cont. • In some cases, it is appropriate to use an algorithm similar to the one you will learn for patient interviewing, considering each area but including only questions about those variables that might affect your answer. – history of current question (is this a general question or specific to a person or situation?) – other disease states that might affect the answer to the question, including potential disease states, i.e., signs or symptoms that have not been diagnosed (pharmacokinetic, pharmacodynamic, adverse reaction masquerade) 5/9/2024 122
  • 123. Drug Information Requests cont.  other medications (Rx, OTC, herbal, illicit) that might affect the answer to the question (drug interactions  pertinent social or family history (financial, medical, or belief issues)  desired detail of response 5/9/2024 123
  • 124. Drug Information Requests cont. • Questions you receive will usually be in one of the following categories: – proper use of drugs: efficacy for specified disease state, dosing, compatibility, use in pregnancy or lactation, monitoring parameters, drug identification, pharmacokinetics, pharmacodynamics, storage conditions, stability – adverse reactions: side effects, drug interactions, allergic reactions, toxicity, poisoning, contraindications, warnings 5/9/2024 124
  • 125. Summery Questions you receive 5/9/2024 125
  • 126. Drug Information Requests cont.  Once you think you know the real question, repeat it to the requester to confirm you have identified the appropriate question.  Step 3: Choose an appropriate resource (or resources) to consult. 5/9/2024 126
  • 127. Drug Information Requests cont. • Tertiary literature – provides an interpretation and summary of the primary literature by someone other than the original authors of the primary literature publication. Examples: • review in health sciences journal • textbooks and other reference material • computer databases (e.g., Micromedex) • web sites • advertisements 5/9/2024 127
  • 128. Drug Information Requests cont.  main benefit  can get a lot of information in a short amount of time relative to reading all the studies of a subject yourself  main problem  subject to interpretation bias: “spin” 5/9/2024 128
  • 129. Drug Information Requests cont.  Secondary literature  provides a summary, index, or abstract of a piece of primary literature Examples: • Medline (PubMed is the web portal) • IPA • EMBASE • current contents 5/9/2024 129
  • 130. Drug Information Requests cont. • Primary literature – contains new/original material. Examples: • study published in health sciences journal (including symposium and conference proceedings and abstracts) • package insert and other manufacturer technical pamphlets • patents and trademarks • government bulletins • case studies 5/9/2024 130
  • 131. Drug Information Requests cont.  In general, it is most efficient to start with tertiary literature (especially for questions from nonhealth care professionals).  Sometimes you will use secondary literature to locate primary literature and then will need primary literature to answer the question (not uncommon with questions from health care professionals: they will expect you to be able to interpret and explain a study). 5/9/2024 131
  • 132. Drug Information Requests cont. • Step 4: Analyze quality and appropriateness of material in resource(s). – Summarize the best evidence in your own words. • Step 5: Synthesize (formulate) a response. • Step 6: document and follow up on recommendations, so that others will know what you advised and why, and so that you can see if your advice was sound. 5/9/2024 132
  • 133. Using Tertiary Resources  Introduction  Tertiary resources are summaries of available information in an understandable format.  Examples include textbooks, reference texts, databases, review articles, lecture notes, and web sites.  Tertiary resources are the best starting point for finding the answer to drug information queries. 5/9/2024 133
  • 134. Using Tertiary Resources • Strengths of tertiary resources: – Most answers to questions you are asked will be found in a tertiary resource. – Because the information is organized, they are time-efficient to use compared to examining primary literature yourself. – Because they summarize information from many sources, they may contain information important to the question which you might miss if you consulted only one piece of the primary literature. 5/9/2024 134
  • 135. Tertiary Resources cont. • Tertiary resources often provide background information. – For example, you may be asked about the treatment of choice for a sinus infection. – Many reviews of sinus infections will also include a short summary of the epidemiology and microbiology of sinus infections, which can help you better understand and remember the treatment alternatives. • Tertiary resources are generally more accessible to the average pharmacist than secondary or primary resources. 5/9/2024 135
  • 136. Tertiary Resources cont. Limitations of Tertiary resources: – A literature summary is only as good as its author(s). • All authors will have interpretation bias. • Author(s) may not have the expertise to correctly interpret the literature or may not have consulted the literature (opinion versus fact). • Author may not write well. • You may have no information about the author. 5/9/2024 136
  • 137. Tertiary Resources cont. – Information may not be complete. • Literature search may not be extensive. • Space limitations of publisher may limit amount of information that can be included. – Information may be out of date. – Tertiary resources which draw on information from other tertiary resources can perpetuate incorrect information. – Some sources can be difficult to use. 5/9/2024 137
  • 138. Tertiary Resources cont. Tertiary resources you will use (print and online) • General medication information. – You will use these resources for questions involving indications, pharmacology, pharmacokinetics, precautions and adverse effects, administration and dosing, drug interactions, and available commercial products. – Example questions for which you should use these resources: “What is propranolol used for?” “Is there a liquid form of morphine available?” “Could citalopram cause an increase in sweating?” 5/9/2024 138
  • 139. Tertiary Resources cont. • Drugdex (Micromedex) on-line, via Healthlinks • Facts and Comparisons (eFacts) on-line, via Healthlinks • Drug Information Handbook (Lexi-Comp) book, PDA version • AHFS (Stat!Ref) on-line, via Healthlinks • USPDI-I (Stat!Ref) on-line, via Healthlinks • [Physician’s Desk Reference (PDR)] available on-line, but not via Healthlinks; medical, bu not pharmacy 5/9/2024 139
  • 140. Tertiary Resources cont. • Natural Product Resources – Natural Medicines Comprehensive Database on-line, via Healthlinks – Review of Natural Products (eFacts) on-line, via Healthlinks – AltMedDex (Micromedex) on-line, via Healthlinks – HerbMed and American Herbal Products Association on- line at www.ahpa.org. • These are quasi-tertiary resources, because links to other tertiary resources are available. • They are also secondary resources (indexing) as they connect you to PubMed for info about specific studies. • HerbMed is assembled by the Alternative Medicine Foundation and AHPA by a consortium of herbal product manufacturers. You will find the information on each to be similar. 5/9/2024 140
  • 141. Tertiary Resources cont. • Disease state information. – You will use these resources to better understand medical conditions. – Examples of questions you would use these resources to answer: “What is the most common cause of diarrhea in children?” “What are the most common complications of uncontrolled diabetes?” • UpToDate on-line, via Healthlinks • The Merck Manual (www.merck.com) on-line, via Healthlinks • Harrison’s Online on-line, via Healthlinks • medical specialty textbooks (MD Consult) on-line, via Healthlinks 5/9/2024 141
  • 142. Tertiary Resources cont. • Pharmacotherapy references. – Use these for general information about treatment alternatives for specific disease states. – Examples of questions you would use these resources to answer: “What is the recommended agent and dose for a 45-year old male with newly diagnosed hypertension?” “What are reasonable monitoring parameters for patients taking medication for chronic obstructive lung disease?” • Pharmacotherapy: a Pathophysiologic Approach book only • Applied Therapeutics: The Clinical Use of Drugs book only 5/9/2024 142
  • 143. Tertiary Resources cont.  Over-the-counter Drugs  Example of questions you would use this resource to answer: “What is available over-the- counter that I could use for my cough?” “What can I use for this rash?”  • Handbook of Non-Prescription Drugs book only 5/9/2024 143
  • 144. Tertiary Resources cont. Drug Interaction references • Example of question you would use these resources to answer: – “Can I drink grapefruit juice if I’m taking atorvastatin?” • Hansten and Horn’s Drug Interactions book only; in PCLC • Drug Interaction Facts (eFacts) on-line, via Healthlinks • Micromedex also has a decent drug interaction section on-line, via Healthlinks 5/9/2024 144
  • 145. Tertiary Resources cont.  Terminology  Examples of questions you would use these resources to answer: “Where is the ‘lateral’ chest located?” “What does DNR mean?” • medical dictionary; Stedman’s is on-line, via Healthlinks • medical abbreviations (eFacts) on-line, via Healthlinks 5/9/2024 145
  • 146. Tertiary Resources cont. • Laboratory Tests – Example of question you would use these resources to answer: “What is the normal serum concentration range for potassium?” – Only the first reference will answer the following type of question, however: “What might be the cause and consequences of a serum potassium concentration above the normal range? • Basic Skills in Interpreting Laboratory Data book only; in PCLC • Laboratory test information (online) • Normal laboratory values (eFacts) on-line, via Healthlinks 5/9/2024 146
  • 147. Tertiary Resources cont. • Drug Identification – Example of question you would use these resources to answer: “I found a white tablet with M 23 stamped on it. What drug is this?” – Martindale would help you answer the following question: “When I was in England, a doctor gave me an inhaler called salbutamol. What does this drug do? Is it similar to any inhaler I normally use for my asthma?” • Identidex (Micromedex) on-line, via Healthlinks • Drug/Imprint Index (eFacts) on-line, via Healthlinks • Martindale (Micromedex) for non-US drugs on-line, via Healthlinks 5/9/2024 147
  • 148. Tertiary Resources cont.  Bioequivalence  Example of question you would use this resource to answer: “Is there a generic form of Levoxyl that is bioequivalent?” • Orange book; on-line: www.fda.gov 5/9/2024 148
  • 149. Tertiary Resources cont. • Drug Prices – Example of question you would use this resource to answer: What is the AWP for a 30-day supply of diltiazem 120mg XL capsules?” (Note that here you might first have to look up the AWP in the medical abbreviations book!) • Redbook book only; in PCLC • Mosby’s Drug Consult (MD Consult). This is also general medication information on this site. on- line, via Healthlinks 5/9/2024 149
  • 150. Tertiary Resources cont.  Drug IV Compatibility  Example of question you would use this resource to answer: “Can Lasix be given in the same line in which dopamine is running?” • Handbook on Injectable Drugs book only; in PCLC 5/9/2024 150
  • 151. Tertiary Resources cont. • Drug dosing in special populations – Examples of questions you might use some of these resources to answer: • “Is it safe to use ibuprofen while I’m pregnant? While I’m breastfeeding?” • “How much acetaminophen should I give my 30-lb child who is running a temperature of 103°F?” • “What is a good starting dose for lisinopril in an 80 year-old patient?” • “Does aztreonam cover Pseudomonas aeruginosa?” • Drugs in Pregnancy and Lactation book only; in PCLC 5/9/2024 151
  • 152. Tertiary Resources cont. • Pediatric Dosage Handbook book, PDA versions available • Drug Prescribing in Renal Failure book only; in PCLC • pharmacokinetic equation reference book only; several different books available • Geriatric Dosage Handbook book, PDA versions available • The Sanford Guide to Antimicrobial Therapy book in PCLC; PDA version available 5/9/2024 152
  • 153. Tertiary Resources cont.  Extemporaneous compounding  Example of question you would use these resources to answer:  “What is the E-value of gentamicin sulfate?”  • Remington: the Science and Practice of Pharmacy book only; in PCLC  • A Practical Guide to Contemporary Pharmacy Practice book only; in PCLC 5/9/2024 153
  • 154. Tertiary Resources cont. • Patient Counseling – You would use these to augment your verbal medication information. – Some pharmacy systems automatically print these, but look them over carefully for information accuracy before handing them out. • Medline Plus (medications, medical conditions, trials) on-line at medlineplus.gov • Med Facts: Patient Counseling (eFacts): in English and Spanish on-line, via Healthlinks • CareNotes (Micromedex) on-line, via Healthlinks 5/9/2024 154
  • 155. Tertiary Resources cont.  Toxicology  Example of question you would use this resource to answer:  “My child just swallowed some of my iron tablets. Could anything bad happen?” • Poisindex (Micromedex) on-line, via Healthlinks 5/9/2024 155
  • 156. Tertiary Resources cont. • Clinical Guidelines – Example of question you would use these resources to answer: – “What initial medications for treatment of a heart attack do current American Heart Association guidelines recommend?” • National Guideline Clearinghouse on-line at www.guideline.gov • Cochrane Library on-line, via Healthlinks This resource is unique and designed to support practitioners of “evidence-based medicine” (EBM), which is when evidence from studies is combined with practitioner expertise and patient preference to provide the best care 5/9/2024 156
  • 157. Formulating effective responses  Pharmacists are asked to provide responses to a variety of drug information questions every day.  While the type of requestor, query, and setting can vary, the process of formulating responses remains constant. 5/9/2024 157
  • 158. Accepting Responsibility and Eliminating Barriers  Pharmacists should recognize that their responsibility extends beyond simply providing an answer to a question.  Rather, it is to assist in resolving therapeutic dilemmas or managing patients' medication regimens.  Knowledge of pharmacotherapy alone does not ensure success.  Moreover, isolated data or information do not provide answers to questions or ensure proper patient management.  In fact, it is uncommon to find comprehensive answers in the literature that completely and effectively address specific situations or circumstances that clinicians face in their daily practices.  Responses and recommendations must often be thoughtfully synthesized using information and knowledge gathered from a number of diverse sources.  To effectively manage the care of patients and resolve complex situations, pharmacists also need added skills and competence in problem solving and direct patient care. 5/9/2024 158
  • 159. Identifying the Genuine Need  Most queries that pharmacists receive are not purely academic or general in nature.  They often involve specific patients and unique circumstances.  For example, a physician who asks about the association of lovastatin and liver toxicity is probably not asking this question whimsically or out of curiosity.  He or she most likely has a patient who has developed hepatic impairment that may be associated with the use of this medication.  Of course, other reasonable scenarios, albeit less likely, also could have prompted such a question. 5/9/2024 159
  • 160. Cont…  Even questions that are not related to patient care must be viewed in their proper context.  Requestors of information are typically vague in verbalizing their needs and provide specific information only when asked.  Although these requestors may seem confident about their perceived needs, they may be less certain after further probing by the pharmacist.  Requestors, regardless of background, are often uncertain about what the pharmacist needs to know to assist them optimally.  Therefore, critical information that defines the problem and elucidates the context of the question is not readily volunteered, but must be expertly elicited 5/9/2024 160
  • 161. Questions to Consider before Formulating a Response  Do I know the requestor's name, profession, and affiliation?  Does the question pertain to a specific patient?  Do I have a clear understanding of the question or problem?  Do I know if the correct question is being asked?  Do I know why the question is being asked?  Do I understand the requestor's expectations?  Do I know pertinent patient history and background information? 5/9/2024 161
  • 162. Cont…  Do I know about the unique circumstances that generated the question?  Do I know what information is really needed?  Do I know when the information is needed and in what format?  Do I have insight about how the information I provide will actually be used?  Do I know how the problem or situation has been managed to date?  Do I know about alternative explanations or management options that have been considered or should be further explored? 5/9/2024 162
  • 163. Important Questions Not Posed by the Requestor  Initial query posed by requestor: Can ranitidine cause thrombocytopenia?  What is the incidence of ranitidine-induced thrombocytopenia?  Are there any known predisposing factors?  Is the pathogenesis of this adverse effect understood?  How does the thrombocytopenia typically present?  Are there any characteristic subjective or objective findings?  Does thrombocytopenia due to ranitidine differ from that caused by other histamine-2 (H2) receptor antagonists, other medications, or other etiologies?  Is the thrombocytopenia dose related? 5/9/2024 163
  • 164. Cont…  How severe can it become?  How soon after discontinuing the drug does it reverse?  How is it usually managed?  What is the likelihood of cross-reactivity with other histamine-2 receptor antagonists? How risky is rechallenge with ranitidine?  Are there treatments available that can be used in place of ranitidine?  Are there alternative explanations for the thrombocytopenia in this patient (including other medications, medication combinations, or underlying medical conditions)?  What complications, if any, can be expected? 5/9/2024 164
  • 165. Formulating the Response  Building a Database and Assessing Critical Factors  Formulating a response involves a series of steps that must be performed completely, objectively, and in a logical sequence.  This mandates the use of a structured, organized approach whereby critical factors are systematically considered and thoroughly evaluated.  The steps in this process include assembling and organizing a patient database, gathering information about relevant disease states, collecting medication information, obtaining pertinent background information, and identifying other relevant factors and special circumstances. 5/9/2024 165
  • 166. Factors to Be Considered When Formulating a Response Patient Factors  Demographics (e.g., name, age, height, weight, gender, race/ethnic group, and setting)  Primary diagnosis and medical problem  list Allergies/intolerances  End-organ function, immune function, nutritional status  Chief complaint  History of present illness  Past medical history (including surgeries, radiation exposure, immunizations, psychiatric illnesses, and so forth) 5/9/2024 166
  • 167. Cont…  Family history and genetic makeup Social history (e.g., alcohol intake, smoking, substance abuse, exposure to environmental or occupational toxins, employment, income, education, religion, travel, diet, physical activity, stress, risky behavior, and compliance with treatment regimen)  Review of body systems  Medications (prescribed, over-the-counter, and complementary/alternative)  Physical examination Laboratory tests Diagnostic studies or procedures 5/9/2024 167
  • 168. Disease Factors  Definition  Epidemiology (including incidence and prevalence)  Etiology  Pathophysiology (for infectious diseases, consider site of infection, organism susceptibility, resistance patterns, and so forth)  Clinical findings (signs and symptoms, laboratory tests, diagnostic studies)  Diagnosis  Treatment (medical, surgical, radiation, biologic and gene therapies, other)  Prevention and control  Risk factors Complications Prognosis 5/9/2024 168
  • 169. Medication Factors  Name of medication or substance (proprietary, nonproprietary, other)  Status and availability (investigational, over-the-counter, prescription, orphan, foreign, complementary/alternative)  Physicochemical properties  Pharmacology  pharmacodynamics  Pharmacokinetics (liberation, absorption, distribution, metabolism, and elimination)  Pharmacogenetics  Uses (Food and Drug Administration [FDA] approved and unlabeled)  Adverse effects  Allergy  Cross-allergenicity or cross-reactivity 5/9/2024 169
  • 170. Medication Factors  Contraindications and precautions  Effects of age, organ system function, disease, pregnancy, extracorporeal circulation, or other conditions or environments  Mutagenicity and carcinogenicity  Effect on fertility, pregnancy, and lactation  Acute or chronic toxicity  Drug interactions (drug-drug or drug-food)  Laboratory test interference (analytical or physiologic effects) 5/9/2024 170
  • 171. Cont…  Administration (routes, methods)  Dosage and schedule  Dosage forms, formulations, preservatives, excipients, product appearance, delivery systems  Monitoring parameters (therapeutic or toxic)  Product preparation (procedures, methods)  Compatibility and stability 5/9/2024 171
  • 172. Pertinent Background Information, Special Circumstances, and Other Factors  Setting  Context  Sequence and timeframe of events  Rationale for the question  Event(s) prompting the question  Unusual or special circumstances (including medical errors)  Acuity and time constraints  Scope of question  Desired detail or depth of response  Limitations of available information or resources  Completeness, sufficiency, and quality of the information 5/9/2024 172
  • 173. Analysis and Synthesis  Analysis and synthesis of information are the most critical steps in formulating responses and recommendations.  Together they assist in forming opinions, arriving at judgments, and ultimately drawing conclusions.  Analysis is the critical assessment of the nature, merit, and significance of individual elements, ideas, or factors.  Functionally, it involves separating the information into its isolated parts so that each can be critically assessed.  Analysis requires thoughtful review and evaluation of the weight of available evidence.  While this process requires consideration of all relevant positive findings, pertinent negative finidings 5/9/2024 173
  • 174. Cont…  Once the information has been carefully analyzed, synthesis can begin.  Synthesis is the careful, systematic, and orderly process of combining or blending varied and diverse elements, ideas, or factors into a coherent response through the use of logic and deductive reasoning.  This process relies not only on the type and quality of the data gathered, but also on how they are organized, viewed, and evaluated 5/9/2024 174
  • 175. Responses and Recommendations  An effective response obviously must answer the question.  Other characteristics of effective responses and recommendations are outlined bellow.  The response to a question must include a restatement of the request and clear identification of the problems, issues, and circumstances.  The response should begin with an introduction to the topic and systematically present the specific findings.  Pertinent background information and patient data should be succinctly addressed.  Conclusions and recommendations are also included in the response along with pertinent reference citations from the literature. 5/9/2024 175
  • 176. Desired Characteristics of a Response  Timely  Current  Accurate  Complete  Concise  Well referenced  Clear and logical  Objective and balanced  Free of bias or flaws  Applicable and appropriate for specific circumstances  Answers important related questions  Addresses specific management of patients or situations 5/9/2024 176
  • 177. Electronic information management  In 1981 drug information was revolutionized when it suddenly became possible for nonlibrarians to access MEDLINE® directly.  Those who first had access were required to participate in a week-long training class and then could only access the information via dumb terminals using a 300 bits per second (bps) modem.  Little did practitioners realize that they were starting down a technologic road that would quickly accelerate.  A few years later some of the first pharmacy uses of what was to become the Internet were seen. 5/9/2024 177
  • 178. Electronic info… Information Via the Internet  Information can be communicated over the Internet in many ways.  It is nearly impossible to live in the United States these days without having heard of the world wide web (www).  It is a very popular source of information, including health information.  It has been proposed that there should be universal access to the Internet for health-related information, to help improve the information reaching underserved populations. 5/9/2024 178
  • 179. Electronic info…  Internet WWW browsing is likely to be farther down the list after books or other resources—perhaps even after MEDLINE® searching, except in certain circumstances, such as the following:  When a reference to the Internet is found (e.g., advertisement and citation).  Situations where company-specific information is necessary (e.g., product package inserts).  Items currently in the news  When U.S. government information is required (e.g., Food and Drug Administration [FDA]- or CDC-specific subjects—including clinical information and new drug approvals).  The U.S. government has been very active in putting a great deal of information on the web.  When the information is not likely to be contained in other available sources of information (e.g., alternative medicine and tropical diseases). 5/9/2024 179
  • 180. Electronic info…  Once the decision to search the web is made, the pharmacist needs to log onto a computer attached to Internet and run the web browser.  To obtain information, the user simply needs to put the address (referred to as a URL [uniform resource locator]) of that information in the browser, which will then find it automatically.  An example of an address is  http://druginfo.creighton.edu, which was the address of the author's main website.  The first term in an address, which will be followed by a //, indicates the type of information provided at that site.  In this case, http stands for hypertext transfer protocol, which is the technical term for the information generally 5/9/2024 180
  • 181. Electronic info…  Common types of information are as follows :  http: hypertext transfer protocol—normal web information  https: a secure form of http, used for confidential information (e.g., credit card numbers)  telnet: a site that requires your computer to act like a dumb terminal  ftp: file transfer protocol—allows you to transfer software or a file of information in various formats  news: USENET News group  mailto: Internet e-mail address 5/9/2024 181
  • 182. Electronic info…  The second term in the address (druginfo) is often the name of the web server that you are accessing.  The next item in this address is the organization's general address name.  These servers are at Creighton University.  Finally, you will notice a three-letter extension at the end of the URL.  In this case, it is .edu, which indicates that the address is that of an educational institution 5/9/2024 182
  • 183. Electronic info…  Common three-letter extensions seen in the United States include:  .biz: business  .com: commercial (e.g., http://www.microsoft.com or http://www.netscape.com)  .edu: education  .gov: government (e.g., http://www.cdc.gov for the CDC)  .info: information  .mil: military  .org: organization (e.g., http://www.ashp.org for American Society of Health-System Pharmacists)  .net: network (network provider) 5/9/2024 183
  • 184. Electronic info…  Links to Internet Sites  In many cases, the URL of a company or an organization's website may be known; after all, such addresses seem to be printed on everything now.  If the URL is unknown, often a correct guess may be made.  For example, the American Society of Health-System Pharmacists is commonly known as ASHP and it is an organization.  Therefore, http://www.ashp.org would be a logical guess of its web address, which happens to be correct. 5/9/2024 184
  • 185. Electronic info…  A second easy way to find sites is to find cross references from similar sites or sites that would have an interest in the site.  For example, a logical guess of the web address for the American Pharmaceutical Association would be http://www.apha.org, but this produces the website for the American Public Health Association.  However, by going to the ASHP website, it is possible to easily find a link to the APhA website at http://www.aphanet.org. 5/9/2024 185
  • 186. Electronic info…  Using Search Engines  In many cases, the URL of a likely source of information is not known and a method of searching for the information is necessary.  Fortunately, a variety of search engines have been developed for this purpose; some are general and some are specific to medically related topics, even medical specialties.  Once the decision is made to use one of these search engines, it is then up to the user to decide which is most appropriate for his or her needs.  Unfortunately, there does not seem to be a truly excellent search engine specific to pharmacy. 5/9/2024 186
  • 187. Electronic info…  Google Scholar (http://scholar.google.com) is a good way to access professional information including:  medicine and pharmacy  whereas, if the need is for information that might not be supported by the medical literature (e.g., finding what is being claimed by alternate medicine marketers and finding "street information" about illegal medications), it might be better to go to one of the general search engines. 5/9/2024 187
  • 188. Electronic info…  Even though the general search engines index a great number of websites, they are not all inclusive.  Therefore, searching for more than one search engine is important.  The frequency of adding new pages and deleting "dead links" should be at least once a month, with some engines being rather dated.  Other web technology, such as dynamically prepared pages and frames (screens on a web browser may consist of several frames), may not be appropriately indexed by search engines.  This material and other things are even referred to as the hidden Internet, which is estimated to be 500 times bigger than the normally searchable web. 5/9/2024 188
  • 189. Electronic info…  Search engines, such as:  OAIster at the University of Michigan (http://oaister.umdl.umich.edu/o/oaister/)  Find Articles (http://www.findarticles.com/)  Library Spot (http://www.libraryspot.com/)  FirstGov.gov (http://firstgov.gov/)  infoplease (http://www.infoplease.com/)  Director of Open Access Journals (http://www.doaj.org/)  Scirus for Scientific Information Only (http://www.scirus.com/srsapp/)  Combined Health Information Database (http://chid.nih.gov/)  can be useful for the pharmacist trying to access material on this hidden Internet. 5/9/2024 189
  • 190. Electronic info…  Techniques to narrow a search should be used ease of searching.  These techniques may include the use of logical operators (i.e., AND, OR, and NOT) or other methods (e.g., putting a phrase in quotations).  Unfortunately, the various search engines implement these search methods differently.  For example, in some you might put in the word "and," in others it will need to be "AND" ("and" is just treated as a text word), and in some you might have to use "+" or "&.“  Also, features such as truncation, phrase searching, field searching (e.g., date, URL, and language), case sensitivity (e.g., finding AIDS instead of aids), and additional logical operators (e.g., "NEAR," "WITH," and "BEFORE") may be available.  On some search engines it is possible to search for non textual 5/9/2024 190
  • 191. Electronic info…  Google Search Commands ,  ....DesktopDI Google Search Commands.docx 5/9/2024 191
  • 192. Professional writing  A common thought when considering the topic of professional writing is "That doesn't apply to me, I'm not writing for a journal."  But professional writing is certainly not limited to journal articles or books.  It includes:  writing evaluations of medications for consideration on a hospital formulary  preparing written policies and procedures for the preparation of an intravenous admixture  reporting the results of the latest sale to the home office  preparing a written evaluation of a technician or clerk  writing in a chart  writing a term paper for a class  preparing slides or posters for presentation, and many other things. 5/9/2024 192
  • 193. Professional writing…  Essentially any time a professional takes pen, pencil, chalk, typewriter, word processor, or any other writing implement in hand to fulfill professional duties, it is considered professional writing.  Although the format changes, the general principles remain the same.  So whether the object is to write the ultimate book on the practice of pharmacy or to type a label, a pharmacist must know how to write professionally. 5/9/2024 193
  • 194. Professional writing…  Steps in Writing Preparing to Write  The first step in writing is to know the purpose—why something needs to be written in the first place.  It is necessary at this time to have a good idea of the expected endpoint, which is a good idea, no matter what is being done.  For example, someone learning to plow a field with a tractor may be concentrating on the ground near the tractor and end up wandering all over the field, thinking he or she was going straight.  However, by concentrating on going to a specific point on the far end of the field, rather than looking just in front of the tractor, the row will probably be plowed fairly straight 5/9/2024 194
  • 195. Professional writing…  General Rules of Writing  Once the preparation is completed, it is time to start writing.  Unfortunately, there is no easy way to learn how to write professionally; it just requires a lot of practice.  However, a number of rules can be followed.  The first step is to organize the information before starting to write.  At the risk of sounding like a high school English teacher, it is still true that this step should include preparing an outline 5/9/2024 195
  • 196. Professional writing…  Checklist in Preparation of Written Materials  Do research first.  Put yourself in the reader's position.  Use proper grammar and spelling.  Make the document look "professional."  Keep things simple and direct.  Keep the document short.  Avoid abbreviations and acronyms.  Avoid the first person (e.g., I, we, and us).  Use active sentences.  Avoid slash construction (e.g., he or she and him or her).  Avoid contractions.  Cite other references wherever appropriate (and get permission to do so where appropriate).  Cover things in whatever order is easiest.  Get everything down on paper before revising.  Edit, Edit, Edit! 5/9/2024 196
  • 197. Professional writing…  Specific Document Sections A typical document consists of three main parts— 1. the introduction 2. body 3. conclusion 5/9/2024 197
  • 198. Professional writing… 1. Introduction  With the probable exception of policy and procedure documents, the two most important paragraphs in any document are the first and last.  It is vital to start out strong, to encourage the reader to continue reading.  Otherwise, the work will end up in that stack of articles everyone has that they "intend to read someday."  That first paragraph should also inform the reader of what they can expect in the rest of the document; it should be similar to a road map that shows what is to be accomplished in the document.  The introduction should have a clear objective for the existence of the document. 5/9/2024 198
  • 199. Professional writing… 2. Body  The body of the document contains all of the details.  In a research article, the body may be divided into the methods, results, and, possibly, discussion sections, although the latter section may be incorporated into the conclusion.  Details of what should be included are covered in .  In other documents, the body will probably be divided into whatever sections are appropriate or logical.  A number of rules can be followed in preparing the body of a document. 5/9/2024 199
  • 200. Professional writing…  The first rule is that while it is important to be concise, all necessary information must be presented.  Again, keep an eye on the desired endpoint, and do not stray from the subject unless it is absolutely necessary.  Including unnecessary information, even if it is interesting, will tend to confuse or obscure the important points.  Also, be sure to provide a balanced coverage of the material and avoid unsupported bias. 5/9/2024 200
  • 201. Professional writing…  It is important to cover the information in a logical order, so that it flows easily from one point to another.  A common mistake, when learning to write professionally, is to skip back and forth between subjects.  For example, someone might insert a point about dosing in the middle of indications, when dosing is discussed at another point in the document. 5/9/2024 201
  • 202. Professional writing… 3. Conclusion  A conclusion should be placed at the end of the body of the document, except for certain documents (e.g., policy and procedures).  This conclusion should follow logically from the information presented and should serve to summarize that information.  Remember, the conclusion should also correspond with the objective stated in the introduction. 5/9/2024 202
  • 203. Professional writing…  It is also worth noting that in clinical consultations, a common mistake is to write the conclusion in a general manner, rather than addressing the specific patient in question, which is what the reader wants to hear about.  The author must remember to address the specific patient's situation. 5/9/2024 203
  • 204. Legal aspect of drug informatics  An understanding of the legal aspects of DI can help the practitioner in day-to-day practice, as well as provide some possible ways to protect himself or herself in the legal system. 5/9/2024 204
  • 205. Legal aspect…  Tort Law  DI practice is a specialized discipline of pharmacy.  Despite the clear prevalence of pharmacist- staffed DICs, the legal obligations of the DI specialist remain unclear.  Specialists are held to the highest degree of care by the law.  Because of the DI pharmacists' greater expertise in the area of DI, it is likely that the courts would expand their legal and professional liability beyond that of other pharmacists. 5/9/2024 205
  • 206. Legal aspect…  The liability of the DI specialist versus generalist differs for a number of reasons, the most obvious of which are the nature of the information provided and the recipients of the information.  In the provision of pharmaceutical care, pharmacists are providing information to patients, whereas the DI specialist is often providing DI to other health professionals. 5/9/2024 206
  • 207. Legal aspect…  Functions such as online searching, monitoring or recommending drug therapy, patient counseling, participation in clinical studies and pharmacy and therapeutics (P&T) committees, drug use evaluation, and identifying adverse drug experiences entail legal obligations of proper performance.  Willing has stated:  If you voluntarily offer and create a higher standard of careful practice, the public has a legal right to assume that pharmacists can and will consistently perform according to that standard. 5/9/2024 207
  • 208. Legal aspect…  Minimal standards of performance and a consistent level of competence must be assured by pharmacists promoting or offering this service regardless of the practice site.  Although there are no standards to accredit DICs, professional standards of performance may be used by courts as an objective measuring tool for the standard of care. 5/9/2024 208
  • 209. Legal aspect…  In addition to the DI specialist, the pharmacy profession is assuming an increased legal responsibility to provide DI in the daily practice of pharmaceutical care.  Although the physician has been considered the learned intermediary, responsible for communicating the manufacturer's warnings to the patient, the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) may be shifting this responsibility to the pharmacist. 5/9/2024 209
  • 210. Legal aspect…  Failure to counsel or warn cases are showing an increasing trend in pharmacist liability.  Recent cases demonstrate the pharmacist's duty to warn of foreseeable complications of drug therapy is becoming a recognized part of the expanded legal responsibility of pharmacists. 5/9/2024 210
  • 211. Legal aspect…  Where the patient is at higher risk than the general population, the courts have uniformly found liability.  There are many such cases against physicians for failure to disclose material risks of medical procedures or treatments to their patients.  Today, there is some question as to when a pharmacist provides DI, whether they be generalists or DI specialists, are held to the same standards as physicians when determining standard of care. 5/9/2024 211
  • 212. Legal aspect…  Traditionally, physicians remain responsible for their patients and must exert "due care"; that is, a physician who knows or should have known that information provided was improper may be held liable for negligence.  Currently, most litigation concerning pharmacists involves negligence. 5/9/2024 212
  • 213. Legal aspect…  Therefore, it is safe to assume that a legal cause of action pertaining to the provision of DI will be founded on the theory of negligence as the direct or proximate cause of personal injury or death.  Malpractice liability based on negligence refers to failure to exercise the degree of care that a prudent (reasonable) person would exercise under the same circumstances.  Elements of negligence include the four Ds:  (1) duty breached, (2) damages, (3) direct causation, and (4) defenses absent. 5/9/2024 213
  • 214. Legal aspect…  Incomplete Information  Is the pharmacist liable when the DI provided is incomplete?  Should the pharmacist provide all the medication information via a DI sheet or patient package insert (PPI)?  There have been several cases against pharmacists for failure to dispense mandatory PPIs for certain drugs that later caused harm. 5/9/2024 214
  • 215. Legal aspect… • In Parkas v. Saary, the court addressed the issue of whether the pharmacist's failure to dispense the Food and Drug Administration (FDA)-mandated PPI for progesterone was the proximate cause of the congenital eye defect that occurred.  Because congenital defects, but not eye deformities, were specified in the PPI, failure to provide the PPI could not be proven to be the proximate cause.  Therefore, judgment was in favor of the pharmacy. 5/9/2024 215
  • 216. Legal aspect…  In Frye v. Medicare-Glaser Corporation, the pharmacist counseled the patient regarding drowsiness with Fiorinal®, but failed to provide a warning not to consume alcohol.  The patient died, presumably as a result of combining the drug with beer.  Here, the DI provided was incomplete.  The trial court did not find the pharmacist had a duty to warn in this instance.  However, it is important to realize that this case was decided before OBRA '90 was in effect. 5/9/2024 216
  • 217. Legal aspect…  More recent cases are finding pharmacists have a responsibility for patient counseling and drug therapy monitoring. In Sanderson v. Eckerd Corporation, the pharmacist was liable for "voluntary undertaking" to act in the absence of a duty, where the pharmacy's computer was inappropriately used by the pharmacist in detection of an adverse reaction and the pharmacist failed to warn the patient of the potential for an adverse reaction 5/9/2024 217
  • 218. Legal aspect…  In Horner v. Spalitto, the court imposed a duty on a pharmacist to alert the prescriber when the dose prescribed is outside the therapeutic range.  In Happel v. Wal-Mart Stores, the pharmacy's computer system was overridden, and the pharmacist failed to warn a patient allergic to aspirin and ibuprofen of the potential for cross-allergenicity with ketorolac.  The court found the pharmacist has a duty to warn when a contraindicated drug is prescribed.  In Morgan v. Wal-Mart Stores, the court held that pharmacists have a duty beyond accurately filling a prescription "based on known contraindications, that would alert a reasonably prudent pharmacist to a potential problem.  " However, the court did not find for the plaintiff(ከሳሽ) opining that pharmacists do not have knowledge that desipramine may cause hypereosinophilic syndrome. 5/9/2024 218
  • 219. Legal aspect…  Clearly, these cases demonstrate an expansion of pharmacists' duties from the nondiscretionary standard of technical accuracy to a discretionary standard which requires pharmacists to perform professional functions, that is, from a technical model to a pharmaceutical care model.  Knowledge of or access to DI is becoming an important factor that courts consider in determination of the pharmacist's duty to warn. 5/9/2024 219
  • 220. Legal aspect…  Inappropriate Quality Information  It has long been recognized by law that false information provided to another could result in harm to the recipient if the recipient acted relying on the false information.  Although negligent misrepresentation has not been applied to DI, there is no guarantee that it will not be in the future. 5/9/2024 220
  • 221. Legal aspect… • The relevant law is the Restatement (Second) of Torts, Negligent Misrepresentation Involving Risk of Physical Harm, which states:  One who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information . . .. Such negligence may consist of failure to exercise reasonable care in ascertaining accuracy of the information, or in the manner in which it is communicated. 5/9/2024 221
  • 222. Ethical aspect of DI  The Ethics Course Content Committee of the American Association of Colleges of Pharmacy (AACP) described ethics as "the philosophical inquiry of the moral dimensions of human conduct".  They mentioned that Aristotle taught ethics as "an eminently practical discipline". . .dealing. . . "with concrete judgments in situations in which action must be taken despite uncertainty. 5/9/2024 222
  • 223. Ethical aspect…  " These authors indicated that the term ethical is often used synonymously with the term moral to describe an action or decision as "good" or "right.  " They further stated that ethics is not values clarification, it is not the study of moral development, and it is not the law. 5/9/2024 223
  • 224. Ethical aspect…  Veatch stated that "an ethical, or moral, issue involves judgments between right and wrong human conduct or praiseworthy and blameworthy human character.  " This author indicated that an ethical deliberation may be differentiated from other endeavors by three characteristics: 1) it is ultimate or fundamental, there is no higher standard against which to measure the rightness of the decision or action 2) the issue is universal, the parties in disagreement do not consider it simply a difference of opinion or taste “each party believes there is a right or wrong answer” even if they're not sure what the answer is 3) the deliberation takes into account the welfare of all 5/9/2024 224
  • 225. Ethical aspect…  Law might be defined as rules of conduct imposed by society on its members.  By contrast, professional ethics has been defined as "rules of conduct or standards by which a particular group in society regulates its actions and sets standards for its members. 5/9/2024 225
  • 226. Ethical aspect…  " Law involves written rules set by the whole society (or its representatives) that address responsibilities of that society's members.  Professional ethics focuses on explicit or implicit rules and standards set by a professional subgroup of society, and addresses the responsibilities of only those who are members of that subgroup. 5/9/2024 226
  • 227. Ethical aspect…  All pharmacists will be called on to provide drug information.  On occasion they will encounter ethical dilemmas regarding what information, if any, should be provided.  It is important that the pharmacy professional approach such moments prepared to (often quickly) identify the pertinent facts, analyze relevant points of the situation, and rank or balance the pertinent ethical rules and principles that are involved. 5/9/2024 227
  • 228. Ethical aspect…  The individual pharmacist must recognize his or her rights and responsibilities relative to the client, to other involved individuals, to society as a whole and to any higher power to whom the pharmacist feels accountable.  Organizations can assist the employee pharmacist by formal recognition of certain implicit and explicit policies 5/9/2024 228
  • 229. Ethical aspect…  Furthermore, opportunities for deliberate study and rehearsal of important analytic steps are important to help pharmacists be prepared to address ethical dilemmas that arise when providing drug information. 5/9/2024 229