Drug Lit - N/A. PDF

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Systematic Approach to Responding to DI Requests: 1) Identify the steps necessary to identify the true intent of a drug information (DI) question. 2) Characterize appropriate elements to an effective response to a DI question. ● Drug information: ○ Defined as the integration of locating, analyzing, applying, and communicating information concerning drugs. ○ It is a complex process that is only as good as the weakest link in the chain. ● Potential Requestors of DI: ○ Patient, physicians, nurses, pharmacists, other healthcare professionals, media, law enforcement, lawyers ● Categories of a DI Question: ○ Adverse drug reaction, cost, dosage, drug interactions, drug identification, pharmacokinetics, pregnancy, fertility and lactation, stability and compatibility, therapeutics and pharmacology, toxicity and poisoning. ● Evidence Based Medicine: ○ Want to be able to find information might be even more important .. Gray area. ○ Published data to become clinical data can take up to 17 years ■ Must be studied, published, then put into clinical practice ○ Want to choose dosing or drug based on evidence that is backed up and pertains to PT. ● Outpatient: ○ Will know how the drug effects them because they will come back to fill more drugs, ● Inpatient: ○ When recommending a therapy it will directly affect the PT. ● Systematic approach to DIE: ○ 1. Obtain demographics of question asked ■ Who is asking, when do they need answer by? ■ Want to communicate the response in most direct method ○ 2. Identify true question ■ What is the question about, is it general of patient specific. ○ 3. Obtain pertinent background information ■ Pt name, age, gender, height, weight, allergies, pertinent medical history, patient medication history, pertinent lab values ○ 4. Categorize DI question ■ Which reference do you use? Which will answer your question ■ Indication and route ○ 5. Identify sources using search strategy ■ How current should the literature be? ○ 6. Analyse and synthesize information ■ Is there limitations to what you found, is it relevant, is it current, is it reputable, was more than one checked? ○ 7. Disseminate answer

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■ Begin with restatement of the ultimate question ■ Relay the information to the requestor ■ Critically appraise the info ■ Objectively weigh evidence ■ Articulate a well reasoned answer ○ 8. Document and follow up: ■ QA for DI activities, colleagues can talk about if you're not there. Tertiary sources: ○ Gives overview of topic ○ Easily accessible ○ Easy to use ○ But may not be up to date. Secondary resources: ○ Gives sources for information published in literature ○ But has a steeper learning curve Primary resources: ○ Most current ○ But may not be readily available ○ Steepest learning curve to appropriately evaluate ○ Not all primary literature is useful for the final recommendation, may not be relevant or current Literature and Limitations: ○ Outcomes that evaluate mortality or morbidity should be emphasized over surrogate outcomes (cholesterol, blood glucose etc) ○ May need more than one literature to choose correct drug therapy Strength of literature ○ Meta analysis (least bias, stronger methodology) ○ Systematic review ○ RCT ○ Cohort study ○ Case control study ○ Case report series ○ Expert opinion(most bias)

Tertiary Information Resources Part #1: 1) Define tertiary DI resource. 2) Explain the advantages and disadvantages of tertiary resources 3) Critically evaluate available tertiary resources. 4) Utilize general drug information tertiary sources to obtain information to answer selected DI questions including: Lexicomp Online, Micromedex, Goodman and Gilman's, AHFS drug information, and PDR: ● Overview or summary about a subject and not the original research. ○ textbooks/handbooks -in print/electronic

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○ Review article ○ Computerized information databases (micromedex, clinical pharm) ○ Package inserts ○ Drug information software for electronic devices (apps, for phones) ○ Summary information from websites Should be used first when answering a DI question. Classified as: ○ Disease state oriented ○ Drug therapy oriented ○ Specialty references: IV therapy, drug interaction, product ID (micromedex has all) Advantages: ○ Easy to access, most pharmacists have an electronic version ○ Easy to use, no training needed Disadvantage: ○ May not be current, if not updated electronically ○ Info may not be complete→ not enough detail about population ○ Handbooks are limited ○ May be biased → presented though perspective of author/editor Complete citations of references are in AMA format: ○ Author, Title,Journal, Year, VOlume, Pages) Tertiary Drug Databases: ○ 1. Micromedex ■ Comprehensive ■ Has drug, disease, toxicology, and herbal information → Martindale and Index Nominum ■ Red book for drug cost information ■ Quick answers → in debt answers ○ 2. Clinical Pharmacology ■ Less comprehensive than micromedex ■ Limited disease info ■ Info on product available, and discontinued products ■ Foreign product names ■ Info on common herbal products ■ Beer List (potentially inappropriate meds for old people) ● What to watch out for for older population ■ Adverse reactions in text form and tell you commonly confused names. ■ Black box warnings ○ 3. Lexicomp Online ■ Does a search across handbooks → AHFS DI and Facts and Comparisons Off Label ● Organized by drug class ● Comprehensive ● Focus on rx drugs

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Recognized by CMS as good source for off label use of drugs and biologicals in anticancer regimens ● Available through State Ref and Lexicomp. ■ Less detail than micromedex ■ Limited disease info ■ Link to AHFS DI gives most detail ■ Links to Drugs in Pregnancy and Lactation ■ Drug pronunciation ■ Info on compounding extemporaneous ○ 4. Facts and Comparisons (eAnswers) ■ Organized by drug class ■ Easy to compare agents within a given class ■ OTC and RX drugs ■ Available through eAnswers ■ Hardcopy stopped being made in 2017 What do they have in common? ○ General drug monographs ○ Including off label use ○ Info on natural products ○ Iv compatibility checkers ○ Product ID lookup ○ Patient education leaflets ○ Lexi and Micro have multiple languages ○ Calculators and other tools Electronic Textbooks: ○ Updated quick, and easy to use ○ Just cost a lot Remember*** more than one resource should be used to verify information if possible. Common General drug Therapy Texts: ○ 1. AHFS DI ■ Not referenced ○ 2. Goodman and Gilman's The pharmacological basis of therapeutics (available through access pharmacy) ○ 3. Physicians Desk Reference: ■ Organized by manufacturer (not all drugs in it) ■ Official product labeling info → package inserts ■ No off label use. ○ 4. Drug Information Handbook: ■ Organized by generic name in order of A-Z ■ Limited info (made for quick and easy retrieval) ■ Available through lexicomp online (lexi Drugs) ○ General drug therapy textbooks provide pcol, indications (including off label use, except PDR) side effects, drug interactions, dosing, federal control schedule etx.

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Difference is in level of detail , handbooks just don't have much.

Tertiary Information Sources Part #2: 1) Identify pharmacotherapy and disease state references that can be used to answer THE question. 2) Discuss information that is obtained from drug product labeling/prescribing information/package inserts. ●

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Databases/eBooks of Interest: ○ 1. Access Medicine ■ Variety of e books (>75) ■ Includes drug database ■ Mobile app, case of week, Qanda of week ○ 2. Access Pharmacy ■ Variety of e books from McGraw Hill Medical ■ Selection by core curriculum organ system ■ Mobile app ■ Drug of week ■ Naplex review ■ Topics in evidence based pharmacy practice ■ Quick answers ■ Patient handouts ○ 3. DynaMed Plus ■ Overview of different conditions using evidence based medicine ● Similar to Uptodate ■ Helpful for risk factors, diagnosis, guidelines ■ Mobile app, calculators, decision trees (help in finding therapeutic regimen) ○ 4. Stat!Ref ■ Variety of e books that can be searched at once ■ Available from MAHSLIN ○ 5. Pharmacy Library: ■ American pharmacists association textbooks ■ Naplex review ■ Active learning stuff Product labeling: ○ Defined by FDA as labels and other written printed, or graphic matters ○ Patient labeling ○ Prescribing information ○ This includes Package Inserts Package Inserts ○ Structured format for a drug has ■ Prescribing infor

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■ Black box warning ■ Recent changes ■ Indications and usage ■ Dosage and administration Available through National Library of Medicine → give drug label information Package insert information: ■ Information for package insert derived from clinical trials conducted prior to marketing ■ May have limited information on adverse drug reactions and use ni special populations ■ Revisions ● Look at last revision date Package insert can be found in DailyMed → national library of Medicine site ■ Highlights are not enough should look at rest of full prescribing information Off Label Drug Use: ■ Off label prescribing is not uncommon ● Seen in psychiatric ■ Rate of adverse drug effects are higher in off label use than on label use ■ FDA can not restrict how a drug is used but can limit marketing to lny what is FDA approves ■ Resources for Off Label: ● Dynamed Plus → dosing and indication → non FDA labeled indication ● Lexicomp → uses → off label ● Micromedex → dosing/administration → non fda uses

Tertiary Information resources Part #3: 1) Utilize specialty tertiary resources to obtain information to answer THE question for problems including Washington Manual, Merck Manuals 2) Utilize specialized tertiary information sources and databases to obtain information to answer selected DI question on drug bioequivalence, drug dosing in special populations IV compatibility, drug prices, extemporaneous compounding, lab values, OTC medication, natural products, patient counseling, toxicology. 3) Describe some websites useful for accessing DI. ●

Specialty Tertiary resources: ○ Information on specific patient populations ○ Specific practice area

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○ Specific aspect of drug therapy ○ Herbs and natural products AAP Red Book: ○ Published by american academy of pediatrics ○ Focus is on treatment of infectious disease in children ○ Immunization guidelines, infection control practices ○ Not the same thing as pharmacy red book → used for pricing information on drugs and is in micromedex Orange Book: ○ Approved drugs with therapeutic equivalence evaluations ○ On FDA website ○ Gives AB ratings ○ AA,AND, AO,AP,AT → no bioequivalence problems, interchangeable ○ Ab→ bioequivalence problems have been resolved, interchangeable ○ B → FDA considers not to be therapeutically equivalent to interchangable ○ Orange book codes listed in redbook(micromedex), clinical pharm, facts and comparisons FDA Purple Book: ○ Released in 2015 ○ Similar to orange book but is for biological products ○ Lists biologic products, including biosimilar and interchangeable products ○ B designates designates product is biosimilar to original product but not interchangeable The Pink Book: ○ Published by CDC ○ Gives update on Vaccine Preventable Diseases ○ Chapters have info on disease, epidemiology, trends in us, clinical features, diagnosis, management, vaccine schedule, vaccine AND, vaccine storage and handling ○ On cdc.gov. The Yellow Book: ○ Published every 2 years by CDC ○ Information on international travel for health professionals ○ Includes how to plan for trips, risk with travel to certain countries, info on specific diseases, and counseling/advice ○ On cdc.gov ADRs (Adverse Drug Reaction references) ○ Give information on the nature and scope of certain ADRs, but are limited to usefulness for new drugs or new reported ADR ○ Information on general ADR cns be found in general drug therapy tertiary sources previously discussed (AHFS, Facts and Comparisons and Micromedex) ○ Need electronic resources or primary literature of most current and reliable info on ADR for new drug

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ADR References: ○ 1. Meyler's Side Effects of Drugs: ■ Has detail on lost of meds ■ 7 volume set Drug Interaction references: ○ General resources have DDI info ○ Buy specialized DDI give mechanism of action, clinical significance, and management of drug-drug interactions ○ Limited info on drug food and drug laboratory interactions ○ Gives references ■ 1. Hansten and Horn's: Drug Interactions Analysis and Management ● Print only ■ 2. Stockley's Drug Interactions: ● International reference, more detail than ^ ● Includes importance and management ● Print only Pregnancy and Lactation References: ○ Limited info on subject ○ Ethical issue prevent systematic evaluation ○ Based on animal data ○ Lexicomp has section dedicated to pregnancy and lactation ○ 1. Drugs in pregnancy and Lactation text (Briggs): ■ Gold standard reference to topic ■ Summarizes human and animal literature and made recommendations for fetal risk and breastfeeding ■ Well referenced with supplements available through lexicomp. ○ 2. LactMed: ■ Part of national library of medicine (toxnet)system ■ Info on levels of substance in breast milk and infant blood ■ Possible adverse effects in nursing infant ■ Therapeutic alternatives ■ Toxnet.gov Parenteral Compatibility references: ○ 1. Handbook on Injectable drugs ■ “Trissels” ○ Published by ASHP ○ Very comprehensive ○ Compatibility information divided into 4 sections→ solution compatibility, additive, syring, and y site. ■ C→ compatible ■ I→ incompatible ○ Available in Stat Ref ○ Is a source used by micromedex and lexicomp ○ 2. King Guide to Parenteral Admixtures:

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■ Less comprehensive than trissels ■ Updated quarterly References For Compounding: ○ 1. Merck Index ■ Chemical properties of drug ○ 2. Remington: The science and practice of pharmacy ■ Pharmaceutics, medicinal chemistry, compounding technique and ingredients ○ 3. The United States Pharmacopeia and the national formulary ■ Pharmacopeial standards ■ Monographs for drugs, dosage and compounded preparations ■ Excipient monograph Foreign product references: ○ 1. Martindale: the complete Drug reference: ■ Info on use, dosing drug, interactions, herbal therapies, covers 43 countries ■ In micromedex ○ 2. Index Nominum: ■ Domestic and foreign products ■ Each generic entry includes international trade names, manufacturer and therapeutic use ■ No pcol, dose or adr ■ Not as detailed as martindale ■ Part of micromedex Natural Products: ○ 1. Handbook of nonprescription drugs: ■ OTC stuff ■ Organized by disease state ■ Natural products, dietary supplements, anc CAM ○ 2. Natural Medicines: ■ Checks for interactions, effectiveness and use in pregnancy and lactation ■ Well referenced ■ Has patient handouts Drugs.Com ○ Info on drugs, AHFS, pill identifier, drug interactions checker, natural productsπ info, news updates, drug approvals, drug shortages, medwatch, medical dictionary...