Chapter 5- Drug References Flashcards

1
Q

Package Inserts

A

Include the FDA approved drug information that is part of the drugs official labeling.
Prescribing information, boxed warning, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings/precautions, AE, drug interactions, use in specific populations, drug abuse/dependence, overdosage/toxicology, pharmacology/MOA

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2
Q

Package inserts locations

A

DailyMed- online
Drugs@FDA- online and app
The drug manufacturers website
Attached to physical product

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3
Q

What happens when drug safety information changes?

A

The FDA publishes a safety communication or alert on their website and an updated PI will reflect the changes

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4
Q

Boxed Warnings

A

Strictest warnings.
Alerts the prescribers to the risk of death or permanent disability

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5
Q

Contraindications

A

When a patient has a contraindication, the drug cannot be used.
The risk will outweigh the benefit.

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6
Q

Warnings/precautions

A

Includes serious reactions that can lead to death, hospitalization, medical intervention, disability, or teratogenicity.
May or may not change prescribing decision.

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7
Q

The American Hospital Formulary Service (AHFS) Clinical Drug Information

A

Provides comprehensive monographs that link to supporting evidence and references. The off label drug section is well researched with linked references.
Collection of drug monographs for medications available in the US.

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8
Q

Clinical Pharmacology

A

Online and mobile app
Monographs for Rx, OTC, natural products, and investigational products

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9
Q

Drug Information Portal

A

Online
Free from NLM

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10
Q

Epocrates/Epocrates+

A

Online and mobile app
Free with registration
Drug information plus guideline summaries

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11
Q

Facts and Comparisons

A

Online
Collection of databases; includes drug monographs, comparative drug charts, and other unique resources

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12
Q

Lexicomp

A

Book, online, and app
Drug monographs and multiple clinical databases

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13
Q

Micromedex

A

Online and mobile app
Multiple clinical databases

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14
Q

Prescribers digital reference

A

Online and mobile app
Free with registration
Includes information on drugs, vaccines, and biologics
Detail is more than the drugs PI and contains more practical information

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15
Q

Drugs.com

A

Online and mobile app
Free
Drug info is primarily sourced from other products

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16
Q

RxList

A

Online
Free

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17
Q

RxList

A

Online
Free
Drug info is primarily sourced from other products

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18
Q

Which references include off-label uses?

A

All except mobilePDR

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19
Q

Which references include IV Drug Compatibility?

A

AHFS, Clinical Pharmacology, Facts and Comparisons, Lexicomp, Micromedex

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20
Q

Which references include drug/pill identification?

A

All except AHFS

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21
Q

Which references include natural products?

A

All except AHFS and mobilePDR

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22
Q

Which references include drug class comparisons?

A

All except AHFS

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23
Q

Which references include pricing?

A

Clinical pharmacology, Drugs.com, Epocrates, Lexicomp, Micromedex

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24
Q

Which references include international drug names?

A

All except epocrates and mobilePDR

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25
Pharmacists Letter
Does not contain traditional drug monographs, but is a valuable resource that provides evidence-based drug information. Subscribers receive a monthly newsletter with short summaries of new or updated drug information and have online access to helpful practical tools -Charts, patient flyers, CR, training material
26
Labeling requirements for OTC drugs
Written for patients who may not have medical training. Package labeling is typically in the Drug Facts panel -active ingredients, including amount in dosage unit and purpose -Uses -Warnings -AE -Dosage instructions -Inactive ingredients
27
OTC drug approval
2 methods- NDA and OTC monograph process
28
Anticoagulation guideline
CHEST guidelines -Stroke Prevention in AFib -VTE
29
CV disease guidelines
ACC/AHA Guidelines: -Acute coronary syndromes -Afib -HF -High cholesterol -HTN
30
Diabetes guidelines
ADA, AACE
31
Infectious disease guidelines
IDSA HIV/AIDS: US dept of Health and Human Services STD: CDC
32
Oncology guidelines
ASCO, NCCN
33
Pediatrics guidelines
AAP
34
Pregnancy/Womens health guidelins
ACOG
35
Psychiatric conditions guidelines
APA DSM5
36
Pulmonary conditions guidelines
Asthma- GINA and NHLBI COPD- GOLD
37
Renal disease guidelines
KDIGO
38
Vaccine guidelines
ACIP, CDC
39
Specialty references for AE
ASHPs Drug Induced diseases FDAble: FDA searchable database MedWatch (FAERS) VAERS Manufacturer and user facility device experience (MAUDE) Safety reporting portal Meylers side effects of drugs
40
Compounding and pharmaceutics specialty references
Allen's ASHP Guidelines SDS Merck Index Remington Trissels USP Compounding compendia
41
USP 795
Non sterile drugs
42
USP 797
Sterile preparations
43
USP 800
Hazardous drugs
44
USP-NF
Monographs for drug substances, dosage forms, compounded preparations, and excipients
45
Drug interactions specialty resources
Hansten and Horns Drug Interaction Facts: Facts and Comparisons
46
Drug Pricing Resources
Red Book (Micromedex) Med-Span Price Rx
47
Drug Shortages references
ASHP Current drug shortages, FDA drug shortages, CDC vaccine shortages, AHFS CDI
48
Drug substitution references
FDAs Orange Book- approved drug products with therapeutic equivalent evaluations FDAs Purple Book- List of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluation
49
Geriatrics drug references
Beers criteria
50
Immunization references
CDCs Pink Book- epidemiology and prevention of vaccine preventable diseases Immunization action coalition CDC ACIP
51
ID resources
IDSA and Sanford guide
52
HIV Resources
HIV.info.NIH.gov
53
Travel Medicine resources
CDC WHO CDC Yellow book- international travel CDC Travelers Health
54
International drug information
Index Nominum Martindale USP Dictionary of USAN and international drug names Lexicomp European drug index
55
IV Drug compatibility and stability resources
ASHPs handbook on injectible drugs King Guide Trissels
56
Natural Products resources
Natural Medicines Dietary Supplements Label Database USP Dietary Supplements Compendium
57
Overdoses, Poisoning, and toxicology resources
Lexi-Tox Micromedex Toxicology Management TOXLINE in Pubmed
58
Pediatrics resources
NeoFax (micromedex) Lexicomp Red Book- report on infectious diseases The Harriet Lane handbook AAP
59
Pharmacology resources
Goodmans and Gilmans
60
Pregnancy and Lactation Resources
Briggs CDC Hales medication and mothers milk LactMed (NLM) Micromedex MothertoBaby
61
Regulatory and Business development Resources
FDA CDER Pink Sheet
62
Therapeutics and Disease Management Resources
DiPiros Handbook of Nonprescription Drugs Koda-Kimbles The Merck Manual UptoDate CDC
63
Veterinary references
Plumbs
64
Orange Book (FDA)
List of approved drugs that can be interchanged with generics based on therapeutic equivalence
65
Pink Book (CDC)
Information on epidemiology and vaccine preventable diseases
66
Pink Sheet (Pharma Intelligence)
News reports on regulatory, legislative, legal, and business developments
67
Purple Book (FDA)
List of biological drug products, including biosimilars
68
Red Book, Pharmacy
Drug Pricing Information
69
Red Book, Pediatrics (AAO)
Summaries of pediatric infectious diseases, antimicrobial treatment, and vaccinations
70
Yellow Book (CDC)
Information on the health risks of international travel, required vaccines, and prophylaxis medications
71
Green Book (FDA)
Information on approved animal drug products