References & Drug Information in Pharmacy

The good, the bad, and the ugly…..

References, so why do we need them?

• There is too much information for one person to know.

• References provide a way for healthcare professionals to gather and verify information to better serve the healthcare community.

• Information is changed or updated frequently.• References provide a resource to pharmacy staff

to keep up-to-date on current medical information without constantly having to relearn and memorize data.

Objectives

• To become familiar with the references commonly used by various healthcare providers.

• Demonstrate where to find specific pharmacy information in the available resources.

• To identify a reliable source when presented with multiple sources.

• Become familiar with various methods of citing information found in various source.

More Objectives…..

• Be familiar with the kind of information available.• List the different kinds of information found in

different sources.• Identify situation in which you would use each of

the resources covered in this chapter.• Describe the role of the internet in performing

medical research.• Describe the role of journals and professional

newsletters in research.

And …..• Be able to describe the information found in:– American Hospital Formulary Service Drug

Information– Drug Topic’s Red Book– FDA Orange Book– Drug Facts & Comparisons– Goodman & Gilman’s: The Pharmacological Basis of

Therapeutics.– Handbook of Injectable Drugs– Ident-a-Drug– Physician Drug Reference (PDR)

Oh Wait! Don’t forget…….

– Monograph– USP DI (United State Pharmacopeia Drug Information)– Smaller Summary PDR’s (Such as the one from

Mosby’s)– Remington’s Pharmaceutical Sciences: The science

and Practice of Pharmacy– Martindale's– Micromedex– LexiComp– Various Brand & Generic Reference’s

Terminology• Primary Source• Secondary Source• Tertiary/Secondary Source• Chemical Name• Nonproprietary Name• Generic Name• Brand Name• Monograph• FDA• USP• AWP

And more terminology….• Indications• Contraindications• Side Effects• ADE or ADR• NDC• NCPDP• SRP• UPC• Formularies

Using References & Reference Material

The ins & outs. The “how to” and “how not”

WarningNO REFERNCE IS A COMPREHENSIVE RESOURCE.

SOME SOURCES ARE BETTER THAN OTHERS, BUT NO SINGLE RESOURCE IS PERFECT.

Types of Information Available

• Scientific Research• Clinical Trials• Monograph• Summarized Studies (aka Meta-Analysis)• Summaries• Extracted Data (Tables, Lists, Charts)• Definitions (Dictionaries)

Scientific Research

• Research typically done in labs & controlled studies.

• Kinetic Data• Pharmacologic Information• Typically found in peer reviewed journals. • Used most often in clinical pharmacy or in a

research or educational setting.

Clinical Trials

• Any situation where a patient is used as a test/study participant.

• Many Different Types• Typically NOT done in:– Oncology (Chemotherapy)– Pregnancy– Pediatrics– Or with any highly toxic medication.

Types of Clinical Trials

• Randomized: Participants are assigned treatment or placebo randomly.

• Blinded: The patient is does not know if they are receiving the active treatment or placebo.

• Double-Blinded: Neither the patient nor the healthcare team knows who in the study is receiving the active treatment or placebo.

• Meta-Analysis: A study of Studies.• Retrospective: Looking back at past Data.

Clinical Trials Hierarchy

• Randomized, Double-Blind• Randomized, Blinded• Randomized• Case-Control• Cohort• Case Study• Allegorical

Met

a-An

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Stages of Clinical Trials• Preclinical: Lab work, establishes preliminary data; not

done in humans.• Stage I: 20-80 healthy participants, determines safe

range and side effects.• Stage II: 100-300 participants, includes healthy and

target population, determines early efficacy and also validates safety data.

• Stage III: 1,000-3,000 participants, confirms efficacy, safety, ADRs, comparison to other available treatments.

• Stage IV: Post-marketing, gathers additional information, typically finds effects only seen in a small population or that rarely occur.

The Drug Monograph

• Information approved by the FDA• Includes:– Brand Name (Assigned by manufacture)– Generic Name (Assigned by FDA)– Pharmacology– Pharmokinetics– Black Box Warnings– ADR/Side Effects

• Found in PDR or with Stock Prescription Bottle• Does not include off label uses.

Summarized Studies

• Summaries of clinical trials and research.• Uses statistical models to extrapolate data.• Typically used in research, clinical, and

educational settings.

Summaries

• Readily Available• Summaries of published data.• Used frequently in pharmacy practice.• Type of practice setting will determine type of

summary resource used.• Updated frequently• Examples:– Facts & Comparisons– Handbook of Injectable Drugs

Extracted Data

• Tables, Charts, Lists• Benefits: Small, Portable, Easy to handle and

Reference.• Negatives: Small amount of information, not a

comprehensive resource.• Updated often.• Example:– Brand-Generic References– LASA Drug Lists– Protect from light lists.

How Information is Organized!

“A rose by any other name……”

Medications come by many different names. Different references will list the

medications by different names.• Chemical Name• Nonproprietary Name• Brand Name• Abbreviations• Colloquial names

How Information is Organized

• Alphabetically by name.• Therapeutic Class• Diagnostic Class• Mechanism of Action (MOA)• Manufacture

Before you start…….

• What are you looking for?• How much detail do you need?• For whom are you preparing the information?

(or who is your audience?)• What sources do you have available?• How much time do you want to spend

looking?

The Resources

Facts & Comparisons

5 Sections1. Index2. Keeping Up3. Drug Monographs4. Drug Identification5. Appendix

Facts & Comparisons

• Widely used in retail, home health, mail order, and long-term care.

• Contains: both monograph and off label information.• Contains: product, general, pharmacologic, trial data• Tables available for rapid comparison of available

products.• Information arranged by physiologic/therapeutic classes.• Versions available:

– Online (Updated constantly)– PDA (Updated constantly)– Unbound Printed (Updated Monthly)– Bound Printed (Updated Annually)

PDR (Physicians’ Desk Reference)

• Collection of Drug Monographs• Arranged by Classification• Use index to locate desired entry.• Most commonly used in Medical Provider's office.• ONLY contains FDA approved information.• Contains: Pharmacology, Product information,

clinical chemistry, general prescribing data.• Updated annually.• Available: Printed, Online, CD

PDR

6 Sections1. Manufacturer Index2. Generic & Trade

Names3. Product Category4. Product Identification5. Product Information6. Diagnostic

Information• Misc Information

Drug Topic’s “Red Book”• Common reference in Retail & Outpatient Pharmacy.• Generally a reference for obtaining AWP for prescription drugs.• Contains tables for quick referencing:

– Do Not Crush Meds– Sugar Free Products– Alcohol Free Products– Sulfite Containing Products– Photosensitizing Medications– Lactose & Galactose Free Products– Vitamin Comparison Table– Common Drug Interactions– Pregnancy Ratings– Drugs Found in Breast Milk– Common Pharmacy Conversions– Normal Lab Values

The Red Book10 Sections

1. Emergency Information2. Clinical Reference Guide

(TABLES!)3. Herbal Medicine Guide4. Practice Management5. Organizations6. Drug Reimbursement7. Manufacture/Wholesaler

Information8. Product Identification9. Rx Products10. OTC/NonDrug Products

American Hospital Formulary Service Drug Information

• Formulary: A list of approved drugs (either for an institution. A practice setting, or an insurance provider)

• AHFS compiles drug formularies for hospitals.• P&T Committee has final approval of all

formularies.

Quick Challenge!

• Out of the reference we ha cover so far, where would you look to find:

• A sugar-free cough syrup?• The approved uses of gabapentin?• Other proprietary names for Micro-Nor?

FDA Orange Book• Compares bioequivalence (BE) data in order to determine

generic interchangeability.– AA, AN, AO, AP, AT: No Suspected BE Problem, Generically

Interchangeable– AB: BE Problems have been resolved with studies; Generically

Interchangeable– BC, BD, BE, BN, BP, BR, BS, BT, BX: NOT GENERICALLY INTERCHANGABLE

• Generic Equivalence ≠ Therapeutic Equivalence• Contains:

– Bioequivalence data– Orphan Drugs– Discontinued Drugs– Recently Approved Medications

• Available online

United State Pharmacopeia (USP)

United State Pharmacopeia Drug Information (USP DI)

• USP: Governmental organization that established standards and definitions for medications and manufacturing. – Ex: USP 797

United State Pharmacopeia (USP)• USP DI: Available in 3 Volumes– Volume I: General drug

information, including on & off label uses.

– Volume II: Information relevant to patient counseling.

– Volume III: Information pertaining to state and federal laws and standards.

Quick Challenge!

• In which volume of the USP DI would CPhT look to find the current guidelines for sterile compounding?

• To which volume of the USP DI would pharmacist turn to locate patient counseling information?

Ident-A-Drug

• Lists both tablets and capsule identifications• Is the most extensive reference book available

with more than 7000 listings• The drugs are not listed by pictures but by

identifiable codes, shapes, and whether the tablet is scored.

• Update Annually• Or you could simply use the pill

identifier on Drugs.com

Handbook of Injectable Drugs

• Mostly used in an inpatient setting

• Provides information on the compatibility of various agents given parenterally.

Martindale’s

• A resource guide that provides information on pharmaceutical products from other nations.

• Particularly helpful when patients travel or if the have allergies.

• Ex: A single ingredient (say corn starch) may have many different names, even in the US.

Goodman & Gilman’s

• Goodman & Gilman’s: The Pharmacological Basis of Therapeutics.

• Provides:– Pharmacology– Kinetics– Common Drug Interactions– Dosing & Monitoring

Remington’s

• Remington’s Pharmaceutical Sciences

• Most commonly used in compounding pharmacy.

• Contains compounding formulae, techniques, and stability information.

Handbook of Nonprescription Drugs

• Published by APhA• Covers OTC

Medications, Diagnosis, and Treatment.

Quick Challenge!

• In the references we have covered, where would you locate:

• Extemporaneous compounding recipes.• Parentaral Stability Information.• Information on OTC treatments of vaginal

yeast infections.

Other Reference Books.

• Targeted for specialty practice.• Often handheld• Easy to carry and reference.• Updated often.• Be cautious of over simplified and over

summarized information.• These books are often summaries of

summaries.

Pocket Guides

• Technicians need to have his or her own reference books

• Pocket versions contain trade/generic names, drug classifications, indications, side effects

• Downside: softbound, need to be updated yearly

• Upside: drugs remain same year after year

Brand-Generic Guide(s)

• Pocket Guides• Many different versions

often available.• Usually has most

common drugs, or newer medications.

• NOT A COMPREHENSIVE GUIDE.

Specialty Specific

Other References

Professional JournalsInternet

Professionals

Professional Journals & Newsletters

• Published Frequently• Reviewed by

professionals.• Only sent to

subscribers or members of the organization.

Websites & the Internet

• The internet is great source of information.• BUT, not all of that information is accurate or

correct.• The researcher (you) must be judicious when

deciding which sites to trust.

Internet Basics

Good• Professionally maintained

databases.• .edu sites• .gov sites• Drugs.com (Professional

Database)• WebMD.com (Professional

database if available)• Online Databases

– Micromedex– eFacts– Up-to-Date

Bad• WIKIPEDIA• Blogs• .com sites• Popular media or News sites

intended for the general public.

• Advertisements

Professionals

“To err is human……”

Professional or Expert Opinion

A FEW SIMPLE REMINDERS

1. No one is perfect. (No matter how much we would like to think so.)

2. No one can know everything about pharmacy.

3. Everyone makes mistakes. (Yes, Everyone.)

Questions?