References & Drug Information in Pharmacy

1. References & Drug Information in Pharmacy The good, the bad, and the ugly…..

2. 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.

3. 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.

4. 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.

5. 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)

6. 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

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

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

9. Using References & Reference Material The ins & outs. The “how to” and “how not”

10. Warning NO REFERNCE IS A COMPREHENSIVE RESOURCE. SOME SOURCES ARE BETTER THAN OTHERS, BUT NO SINGLE RESOURCE IS PERFECT.

11. Types of Information Available • Scientific Research • Clinical Trials • Monograph • Summarized Studies (aka Meta-Analysis) • Summaries • Extracted Data (Tables, Lists, Charts) • Definitions (Dictionaries)

12. 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.

13. 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.

14. 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.

15. Clinical Trials Hierarchy • Randomized, Double-Blind • Randomized, Blinded • Randomized • Case-Control • Cohort • Case Study • Allegorical Meta-Analysis

16. 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.

17. 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.

18. Summarized Studies • Summaries of clinical trials and research. • Uses statistical models to extrapolate data. • Typically used in research, clinical, and educational settings.

19. 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

20. 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.

21. How Information is Organized!

22. “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

23. How Information is Organized • Alphabetically by name. • Therapeutic Class • Diagnostic Class • Mechanism of Action (MOA) • Manufacture

24. 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?

25. The Resources

26. Facts & Comparisons 5 Sections • Index • Keeping Up • Drug Monographs • Drug Identification • Appendix

27. 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)

28. 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

29. PDR 6 Sections • Manufacturer Index • Generic & Trade Names • Product Category • Product Identification • Product Information • Diagnostic Information • Misc Information

30. 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

31. 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

32. 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.

33. 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?

34. 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

35. 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

36. 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.

37. 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?

38. 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

39. Handbook of Injectable Drugs • Mostly used in an inpatient setting • Provides information on the compatibility of various agents given parenterally.

40. 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.

41. Goodman & Gilman’s • Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. • Provides: • Pharmacology • Kinetics • Common Drug Interactions • Dosing & Monitoring

42. Remington’s • Remington’s Pharmaceutical Sciences • Most commonly used in compounding pharmacy. • Contains compounding formulae, techniques, and stability information.

43. Handbook of Nonprescription Drugs • Published by APhA • Covers OTC Medications, Diagnosis, and Treatment.

44. 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.

45. 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.

46. 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

47. Brand-Generic Guide(s) • Pocket Guides • Many different versions often available. • Usually has most common drugs, or newer medications. • NOT A COMPREHENSIVE GUIDE.

48. Specialty Specific

49. Other References Professional Journals Internet Professionals

50. Professional Journals & Newsletters • Published Frequently • Reviewed by professionals. • Only sent to subscribers or members of the organization.