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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.
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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”
Warning NO 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 Meta-Analysis
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.
“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?
Facts & Comparisons 5 Sections • Index • Keeping Up • Drug Monographs • Drug Identification • 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 Sections • Manufacturer Index • Generic & Trade Names • Product Category • Product Identification • Product Information • 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 Book 10 Sections • Emergency Information • Clinical Reference Guide (TABLES!) • Herbal Medicine Guide • Practice Management • Organizations • Drug Reimbursement • Manufacture/Wholesaler Information • Product Identification • Rx Products • 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.
Other References Professional Journals Internet Professionals
Professional Journals & Newsletters • Published Frequently • Reviewed by professionals. • Only sent to subscribers or members of the organization.