Drug References Flashcards
What is the package insert?
The PI is the FDA-approved drug information that is part of the drug’s official labeling
What are common categories included in a PI?
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.
Where can package inserts be located?
DailyMed, Drugs@FDA, The Drug Manufacturer’s Website, Attached to the physical product
What does the FDA do when drug safety information change?
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
What are boxed warnings?
Boxed warnings are the strictest warnings. The black box around the warning alerts prescribers to the risk of death or permanent disability
What are contraindications?
When a patient has a contraindication to a drug, the drug cannot be used in that patient. The risk will outweigh any possible benefit
What do warnings and precautions include?
Serious reactions that can result in death, hospitalization, medical intervention, disability or teratogenicity
What do adverse reactions in a PI refer to?
Refers to undesirable, uncomfortable or dangerous effects from a drug. Risk-benefit assessment is patient-specific
What do general drug information resources rely on the PI for?
General drug information resources rely on the PI for much of their drug monograph content
What are some examples of drug monograph sites?
Clinical Pharmacology, Facts and Comparisons, Lexicomp and Micromedex
What kind of information do the drug monograph sites have?
Trissel’s IV drug compatibility and stability data, drug class comparisons, natural products, drug (tablet/capsule) identification and international drug names
What does the American Hospital Formulary Service and clinical Drug Information provide?
Provides comprehensive monographs that link to supporting evidence and references, which makes it a very useful resource for researching a topic in detail
What is something that pharmacists should be cautious of when drug information is updated?
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
Describe the American Hospital Formulary Service
- 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
Describe the Clinical Pharmacology
Monographs for Rx and OTC drugs, natural products and investigational drugs
Describe the Drug Information Portal
Free from the National Library of Medicine. Drug searches link directly to other NLM databases for related information
Describe Epocrates
- 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
Describe Facts & Comparisons eAnswers
Collection of databases; includes drug monographs, comparative drug charts and other unique resources
Describe Lexicomp
Drug monographs organized alphabetically; includes useful appendices
Describe Micromedex
Multiple clinical databases beyond DRUGDEX
Describe Prescriber’s Digital Reference
Free with registration; includes information for drugs, vaccines and biologics
What popular features does AHFS and AHFS include?
Off-label uses, IV drug compatibility, international drug names
What popular features does Clinical Pharmacology include?
Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names
What popular features does drugs.com include?
Off-label uses, drug/pill identification, natural products, drug class comparisons, pricing, international drug names
What popular features does Epocrates include?
Off-label uses, drug/pill identification, natural products, drug class comparisons, pricing
What popular features does Facts& Comparisons include?
Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, international drug names
What popular features does Lexicomp include?
Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names
What popular features does Micromedex include?
Off-label uses, IV drug compatibility, drug/pill identification, natural products, drug class comparisons, pricing, international drug names
What popular features does mobile PDR include?
Drug/pill identification, drug class comparisons
What does the Pharmacist’s Letter provide?
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
What is required for the language on OTC drugs?
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
What must be included on the label of OTC drugs?
The active ingredients, the uses, specific warnings, side effects, dosage instructions, the inactive ingredients
What are the two methods that a manufacturer can use to market an OTC product?
The New Drug Application (NDA) process and the OTC Monograph process
Describe the NDA approval process
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
What happens to OTC drugs that have gone through the NDA approval process?
They become FDA-approved drugs