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NAPLEX Review > Drug References > Flashcards

Drug References Flashcards

1
Q

What is the package insert?

A

The PI is the FDA-approved drug information that is part of the drug’s official labeling

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2
Q

What are common categories included in a PI?

A

Boxed warning, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, drug abuse and dependence, overdosage/toxicology, pharmacology/mechanism of action etc.

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3
Q

Where can package inserts be located?

A

DailyMed, Drugs@FDA, The Drug Manufacturer’s Website, Attached to the physical product

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4
Q

What does the FDA do when drug safety information change?

A

When drug safety information changes, the FDA publishes a safety communication or alert on their website, and an updated PI will reflect the drug’s safety-related labeling changes

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5
Q

What are boxed warnings?

A

Boxed warnings are the strictest warnings. The black box around the warning alerts prescribers to the risk of death or permanent disability

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6
Q

What are contraindications?

A

When a patient has a contraindication to a drug, the drug cannot be used in that patient. The risk will outweigh any possible benefit

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7
Q

What do warnings and precautions include?

A

Serious reactions that can result in death, hospitalization, medical intervention, disability or teratogenicity

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8
Q

What do adverse reactions in a PI refer to?

A

Refers to undesirable, uncomfortable or dangerous effects from a drug. Risk-benefit assessment is patient-specific

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9
Q

What do general drug information resources rely on the PI for?

A

General drug information resources rely on the PI for much of their drug monograph content

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10
Q

What are some examples of drug monograph sites?

A

Clinical Pharmacology, Facts and Comparisons, Lexicomp and Micromedex

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11
Q

What kind of information do the drug monograph sites have?

A

Trissel’s IV drug compatibility and stability data, drug class comparisons, natural products, drug (tablet/capsule) identification and international drug names

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12
Q

What does the American Hospital Formulary Service and clinical Drug Information provide?

A

Provides comprehensive monographs that link to supporting evidence and references, which makes it a very useful resource for researching a topic in detail

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13
Q

What is something that pharmacists should be cautious of when drug information is updated?

A

There can be a lag time until the PI and the drug’s monograph include the update. Pharmacists may need to check multiple sources to confirm they are retrieving the most current content

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14
Q

Describe the American Hospital Formulary Service

A
  • Collection of drug monographs for medications available in the US
  • Select drug monographs from AHFS Drug Information re-formatted for point of care decision making; expands on therapeutic evidence and includes additional information
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15
Q

Describe the Clinical Pharmacology

A

Monographs for Rx and OTC drugs, natural products and investigational drugs

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16
Q

Describe the Drug Information Portal

A

Free from the National Library of Medicine. Drug searches link directly to other NLM databases for related information

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17
Q

Describe Epocrates

A
  • Free with registration; drug information plus guideline summaries
  • Epocrates + expands into evidence-based disease management and includes sections on natural products, lab and diagnostic information and ICD-10 coding
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18
Q

Describe Facts & Comparisons eAnswers

A

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

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19
Q

Describe Lexicomp

A

Drug monographs organized alphabetically; includes useful appendices

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20
Q

Describe Micromedex

A

Multiple clinical databases beyond DRUGDEX

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21
Q

Describe Prescriber’s Digital Reference

A

Free with registration; includes information for drugs, vaccines and biologics

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22
Q

What popular features does AHFS and AHFS include?

A

Off-label uses, IV drug compatibility, international drug names

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23
Q

What popular features does Clinical Pharmacology include?

A

Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names

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24
Q

What popular features does drugs.com include?

A

Off-label uses, drug/pill identification, natural products, drug class comparisons, pricing, international drug names

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25
Q

What popular features does Epocrates include?

A

Off-label uses, drug/pill identification, natural products, drug class comparisons, pricing

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26
Q

What popular features does Facts& Comparisons include?

A

Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, international drug names

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27
Q

What popular features does Lexicomp include?

A

Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names

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28
Q

What popular features does Micromedex include?

A

Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names

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29
Q

What popular features does mobile PDR include?

A

Drug/pill identification, drug class comparisons

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30
Q

What does the Pharmacist’s Letter provide?

A

Subscribers receive a monthly newsletter with short summaries on new or updated drug information and have online access to helpful practice tools. including new drug approvals, charts, patient education summaries, continuing education, training materials

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31
Q

What is required for the language on OTC drugs?

A

The language needs to be written in a manner that a lay person can understand, in order to be able to use the drug safely and for its intended purpose

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32
Q

What must be included on the label of OTC drugs?

A

The active ingredients, the uses, specific warnings, side effects, dosage instructions, the inactive ingredients

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33
Q

What are the two methods that a manufacturer can use to market an OTC product?

A

The New Drug Application (NDA) process and the OTC Monograph process

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34
Q

Describe the NDA approval process

A

The NDA approval process for prescription drugs is managed through the FDA’s Center for Drug Evaluation and Research CDER. OTC drugs can go through the same drug approval process, or the manufacturer can opt to stick to the standards in the OTC monograph for that therapeutic class

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35
Q

What happens to OTC drugs that have gone through the NDA approval process?

A

They become FDA-approved drugs

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36
Q

What conditions do the Guidelines from the ACCP CHEST guidelines cover?

A

Stroke Prevention in Atrial Fibrillation, Venous Thromboembolism

37
Q

What conditions do the Guidelines from ACC/AHA cover?

A

Acute coronary syndromes, atrial fibrillation, heart failure, high cholesterol, hypertension

38
Q

What organizations have guidelines about diabetes>

A

American Association of Clinical Endocrinologists and American Diabetes Association

39
Q

What organizations have guidelines about infectious diseases?

A

Infectious Diseases Society of America, US Dept. of Health and Human Services, CDC

40
Q

What organizations have guidelines about oncology?

A

American Society of Clinical Oncology, National Comprehensive Cancer Network

41
Q

What organization has guidelines about pediatrics?

A

The American Academy of Pediatrics

42
Q

What organization has guidelines about pregnancy/women’s health?

A

The American College of Obstetricians and Gynecologists (ACOG)

43
Q

What organization has guidelines about psychiatric conditions?

A

America Psychiatric Association (APA)

44
Q

What organization has guidelines about pulmonary conditions?

A

GINA, NHLBI, GOLD

45
Q

What organization has guidelines about renal disease?

A

Kidney Disease Improving Global Outcomes (KDIGO)

46
Q

What organization has guidelines about vaccines?

47
Q

What specialty references can be used to look or report adverse reactions?

A
  • ASHP’s Drug-Induced Disease: Prevention, Detection and Management
  • FDAble: FDA searchable database of adverse reactions caused by medicines, vaccines, devices, tobacco products, dietary supplements
  • MedWatch: FDA’s Adverse Event Reporting System (FAERS)
  • Vaccine Adverse Event Reporting System (VAERS)
  • Manufacturer and User Facility Device Experience (MAUDE)
  • Safety Reporting Portal
48
Q

What specialty references have information about compounding and pharmaceutics?

A
  • Allen’s The Art, Science, and Technology of Pharmaceutical Compounding
  • ASHP Guidelines on Compounding Sterile Preparations
  • Handbook of Pharmaceutical Excipients
  • Safety Data Sheets (SDS)
  • Merck Index: An Encyclopedia of Chemicals, Drugs and Biologics
  • Remington: The Science and Practice of Pharmacy
  • Trissel’s Stability of Compounded Formulations
  • ASHP’s Extemporaneous Formulations for Pediatric, Geriatric and Special Needs Patients
  • Pediatric Drug Formulations
  • International Journal of Pharmaceutical Compounding
49
Q

Describe the different USP chapters of the USP Compounding Compendium

A
  • USP 795: non-sterile preparation
  • USP 797: sterile preparations
  • USP 800: hazardous drugs
  • USP-NF: monographs for drug substances, dosage forms, compounded preparations and excipients
50
Q

What specialty references have information about drug interactions?

A
  • Hansten and Horn’s Drug Interactions Analysis and Management
  • Drug Interaction Facts: Facts & Comparisons
51
Q

What specialty references have information about drug pricing?

A

Red Bood (Micromedex), Medi-Span Price Rx

52
Q

What specialty references have information about drug shortages?

A
  • ASHP Current Drug Shortages
  • FDA Drug Shortages
  • CDC Current Vaccine Shortages and Delays
  • American Hospital Formulary Service Clinical Drug Information (AHFS CDI)
53
Q

What specialty references have information about drug substitution?

A
  • FDA’s Orange Book: approved drug products with therapeutic equivalence evaluations
  • FDA’s Purple Book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
54
Q

What specialty references have information about geriatrics?

A
  • American Geriatrics Society (AGS) Beers Criteria for Potentially Inappropriate Medication Use in Older Adults
  • ASHP’s Fundamentals of Geriatric Pharmacotherapy
  • Geriatric Dosage Handbook (Lexicomp)
55
Q

What specialty references have information about immunizations?

A
  • CDC Advisory Committee on Immunization Practices
  • Updates published in the Morbidity and Mortality Weekly Report (MMWR)
  • CDC Pink Book: Epidemiology and Prevention of Vaccine-Preventable Disease
  • Immunization Action Coalition
  • APhA Immunization Center
  • Vaccines, Blood & Biologics (FDA)
56
Q

What specialty references have information about infectious diseases?

A
  • IDSA Practice Guidelines

- Sanford Guide to Antimicrobial Therapy

57
Q

What specialty references have information about human immunodeficiency virus (HIV)?

A
  • HIVInfo.NIH.gov from the US Dept. of Health and Human Services
  • Sanford Guide to HIV/AIDS Therapy
  • Johns Hopkins ABX and HIV Guides
58
Q

What specialty references have information about travel medicine?

A
  • World Health Organization (WHO)
  • Yellow Book: Health Information for International Travel
  • Traveler’s Health: resources for travelers and healthcare professionals
  • International Society of Travel Medicine (ISTM)
  • International Association For Medical Assistance to Travelers (IAMAT)
59
Q

What specialty references have information about international drug information?

A
  • Index Nominum: International Drug Directory
  • Martindale: The Complete Drug Reference
  • USP Dictionary of United states Adopted Names (USAN) and International Drug Names
  • Drug Information Handbook with International Trade Names Index
  • European Drug Index
60
Q

What specialty references have information about investigational drugs?

A

Clinicaltrials.gov (NIH)

61
Q

What specialty references have information about IV Drug Compatibility and Stability?

A
  • ASHP’s Handbook on Injectable Drugs
  • King Guide to Parenteral Admixtures
  • Trissel’s 2 Clinical Pharmaceutics
62
Q

What specialty references have information about medication safety?

A
  • FDA MedWatch
  • Institute for Safe Medication Practices (ISMP)
  • NIOSH List of Antineoplastic (Chemotherapy) and Other Hazardous Drugs in Healthcare Settings
  • Crediblemeds.org (QT drugs lists)
  • FDA: Drug and Biological Recalls, Drug Safety Label Changes database, Medication Guides, Drug Communications and Safety Alerts
63
Q

What specialty references have information about natural products/alternative medicine?

A
  • Natural Medicines Database (Therapeutic Research Center)
  • Dietary Supplements Label Database (NIH)
  • USP Dietary Supplements Compendium
64
Q

What specialty references have information about overdoses, poisoning and toxicology?

A
  • Lexi-Tox
  • Micromedex Toxicology Management
  • TOXLINE in PubMed
  • Goldfrank’s Toxicologic Emergencies
  • State Poison Control Center
  • The American Association of Poison Control Centers
65
Q

What specialty references have information about pediatrics?

A
  • NeoFax and Pediatrics (Micromedex)
  • Pediatric & Neonatal Dosage Handbook
  • Red Book: Report of the Committee on Infectious Diseases
  • The Harriet Lane Handbook
  • American Academy of Pediatrics (AAP)
  • ASHP’s Pediatric Injectable Drugs
  • Nelson Textbook of Pediatrics
  • Pediatric Pharmacy Association Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List
66
Q

What specialty references have information about pharmacology?

A
  • Goodman and Gilman’s The Pharmacological Basis of Therapeutics
  • Katzung’s Basic and Clinical Pharmacology
67
Q

What specialty references have information about pregnancy and lactation?

A
  • Briggs’ Drugs in Pregnancy and Lactation
  • CDC: Medications during pregnancy/breastfeeding
  • Hale’s Medications and Mother’s Milk
  • LactMed (NLM)
  • Reprotox and Reprorisk (Micromedex)
  • MotherToBaby
68
Q

What specialty references have information about regulatory and business development?

A
  • FDA Center for Drug Evaluation and Research (CDER)

- Pink sheet

69
Q

What specialty references have information about therapeutics and disease management?

A
  • DiPiro’s Pharmacotherapy: A Pathophysiology Approach
  • Handbook of Nonprescription Drugs: An Interactive Approach to Self Care
  • Koda-Kimble’s Applied Therapeutics: The Clinical Use of Drugs
  • The Merck Manual
  • UpToDate
  • CDC: Diseases & Conditions
  • Harrison’s Principles of Internal Medicine
  • Medscape
  • Plumb’s Veterinary Drug Handbook
70
Q

What is the FDA Orange Book?

A

List of approved drugs that can be interchanged with generics based on therapeutic equivalence based on an AB rating

71
Q

What is the CDC Pink Book?

A

Information on epidemiology and vaccine preventable diseases

72
Q

What is the Pharma Intelligence Pink Sheet?

A

News reports on regulatory, legislative, legal and business developments

73
Q

What is the FDA Purple Book?

A

List of biological drug products, including biosimilars

74
Q

What is the Pharmacy Red Book?

A

Drug pricing information

75
Q

What is the AAP Red Book?

A

Summaries of pediatric infectious diseases, antimicrobial treatment and vaccinations

76
Q

What is the CDC Yellow Book?

A

Information on the health risks of international travel, required vaccines and prophylaxis medications

77
Q

What is the FDA Green Book?

A

Information on approved animal drug products

78
Q

What are the two of the more common databases to search for published studies, systematic reviews, meta-analyses and review articles?

A

PubMed and Cochrane Library

79
Q

Describe PubMed

A

Accesses MEDLINE and is a free service available from the NLM

80
Q

Describe the Cochrane Library

A

Provides evidence-based information to guide clinical decision making. The database of Cochrane Systematic Reviews contains > 7500 reviews supported by government funds and donations

81
Q

What kind of information does the CDC provide for patients?

A

The CDC has a symptom checker and provides information on infectious diseases, immunizations and travelers’ health

82
Q

What kind of information does drugs.com and RxList provide for patients?

A

Drugs.com and RxList provide drug monographs and other information

83
Q

What kind of information does the Mayo Clinic provide for patients?

A

Mayo Clinic provides comprehensive patient information for diseases, symptoms, tests and procedures and drugs and suppplements

84
Q

What kind of information does MedlinePlus provide for patients?

A

Medline Plus has sections on health topics, drugs and supplements, health-related videos, lab tests and a medical encyclopedia with images

85
Q

What kind of information does WebMD provide for patients?

A

WebMD covers diseases, healthy living, pregnancy, prescription and PTC drug information, plus it has a pill identifier and interaction checker

86
Q

What kind of information does the FDA for consumers website provide for patients?

A

FDA for Consumers website provides comprehensive information on drugs (including recalls), food products and other topics that fall under the FDA’s jursidiction

87
Q

What kind of information does MyHealthfinder provide for patients?

A

MyHealthfinder has a mission to encourage healthy living through various topics

88
Q

What kind of information does SafeMedication provide for patients?

A

SafeMedication includes medication tips and tools and a searchable database for patient-focused drug monographs, pulled from AHFS

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