Chapter 15: Patient Safety and Pharmacovigilance (Exam #2) Flashcards
When did medication safety issues “go public”?
When IOM released its seminal report “To Err is Human” in 1999
How have organizations responded to the IOM report?
-by creating databases that allow for reporting and trending of both medication errors and ADRs
T/F?
MEDICATOIN ERRORS are instances of patient harm resulting from
medications being used in the recommended manner, they are generally considered
nonpreventable.2
- false
- ADRs (adverse drug reactions)
T/F?
ADEs are instances of medication errors resulting in
patient harm.
true
_____________ is a discipline that identifies and describes the nature,
incidence, and severity of adverse drug events
Pharmacovigilance
How long does Pharmacovigilance last?
throughout the drug’s use, beginning at drug development
T/F?
Historically, punitive action was the method used to address errors, and it
was directed at the PHARMACIST deemed to be at fault.
- false
- PRACTITIONER
T/F?
In most recent years medication errors have been attributed to SYSTEMS failures in opposed to individual practitioner.
true
What involves identifying how an underlying process contributed to the error.
The focus on the “systems” failures
What 2 things has happened as a result of focusing on the “systems” failure?
- individual blame has been minimized
- process improvement has become the primary focus for error prevention
________ has been defined as a strategy to determine the issues surrounding an adverse
drug event and determining whether it was a system error or reckless
behavior on the part of an individual
-just culture
Individuals must be held accountable for _______ errors
egregious
FDA responsibilities include ?
ensuring that drugs, vaccines, and
other biological products and medical devices intended for human use are safe and effective
The Center for Drug Evaluation and research are responsible for the oversight for food, cosmetics, dietary supplements, radiation safety and tobacco regulation
- false
- FDA
What is the regulating center for drug development, that
houses the Office of Surveillance and Epidemiology, which conducts
risk management and pharmacovigilance activities within the agency?
-The Center for Drug Evaluation and Research
As
a requirement for drug approval, ____ ______ procedures have been
incorporated to ensure proper assessment of risk versus benefit of marketed
products.
risk management
What 2 things are vital to risk management?
Premarket assessment and ongoing post-market review
What act requires drug sponsors to provide
adequate testing to evaluate the safety of the drug for the labeled condition.
The Food, Drug and Cosmetic Act
All new drug applicants are
recommended by the FDA to conduct the following assessments for serious
adverse effects: (5)
- QTc prolongation
- liver
- kidney and/or bone marrow toxicity
- drug–drug interactions
- polymorphic metabolism
What limitations does drug development have? (5)
- min. vol. of exposed patients
- lack of long-term experience
- co-morbid condition assessment
- diversity of patients exposed
- use of a wide variety of concomitant medications
T/F?
The FDA
recommends an exposure rate of 1,500 subjects, with 300 to 600 exposed
for at least 6 months and 100 patients exposed for at least 1 year
true
___________refers to a population diverse in age, comorbid conditions,
and concomitant medications.
Diversity in a ADR databases
_______________is the single most
common safety-related reason for market withdrawal in the last 50 years
Hepatotoxicity
i.e. troglitazone
___________ is mandated by the
FDA and requires manufacturers to submit all adverse event data they receive.
AERS- The Adverse Event Reporting System
How long does a manufacturer have to submit a serious, unexpected adverse event?
15 days post-receipt
T/F?
Manufacturers are required to submit quarterly periodic reports for the
first 2 years following drug approval
- false
- 3 years
Who are adverse events pertaining to vaccines reported to?
Vaccine Adverse Event Reporting System (VAERS)
VAERS and AERS are apart of what FDA regulated website?
MedWatch
