Chapter 15: Patient Safety and Pharmacovigilance (Exam #2)

Question 1

When did medication safety issues “go public”?

Answer 1

When IOM released its seminal report “To Err is Human” in 1999

Question 2

How have organizations responded to the IOM report?

Answer 2

-by creating databases that allow for reporting and trending of both medication errors and ADRs

Question 3

T/F?
MEDICATOIN ERRORS are instances of patient harm resulting from
medications being used in the recommended manner, they are generally considered
nonpreventable.2

Answer 3

• false

- ADRs (adverse drug reactions)

Question 4

T/F?
ADEs are instances of medication errors resulting in
patient harm.

Answer 4

true

Question 5

_____________ is a discipline that identifies and describes the nature,
incidence, and severity of adverse drug events

Answer 5

Pharmacovigilance

Question 6

How long does Pharmacovigilance last?

Answer 6

throughout the drug’s use, beginning at drug development

Question 7

T/F?
Historically, punitive action was the method used to address errors, and it
was directed at the PHARMACIST deemed to be at fault.

Answer 7

• false

- PRACTITIONER

Question 8

T/F?

In most recent years medication errors have been attributed to SYSTEMS failures in opposed to individual practitioner.

Answer 8

true

Question 9

What involves identifying how an underlying process contributed to the error.

Answer 9

The focus on the “systems” failures

Question 10

What 2 things has happened as a result of focusing on the “systems” failure?

Answer 10

• individual blame has been minimized

- process improvement has become the primary focus for error prevention

Question 11

________ 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

Answer 11

-just culture

Question 12

Individuals must be held accountable for _______ errors

Answer 12

egregious

Question 13

FDA responsibilities include ?

Answer 13

ensuring that drugs, vaccines, and

other biological products and medical devices intended for human use are safe and effective

Question 14

The Center for Drug Evaluation and research are responsible for the oversight for food, cosmetics, dietary supplements, radiation safety and tobacco regulation

Answer 14

• false

- FDA

Question 15

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?

Answer 15

-The Center for Drug Evaluation and Research

Question 16

As
a requirement for drug approval, ____ ______ procedures have been
incorporated to ensure proper assessment of risk versus benefit of marketed
products.

Answer 16

risk management

Question 17

What 2 things are vital to risk management?

Answer 17

Premarket assessment and ongoing post-market review

Question 18

What act requires drug sponsors to provide

adequate testing to evaluate the safety of the drug for the labeled condition.

Answer 18

The Food, Drug and Cosmetic Act

Question 19

All new drug applicants are
recommended by the FDA to conduct the following assessments for serious
adverse effects: (5)

Answer 19

• QTc prolongation
• liver
• kidney and/or bone marrow toxicity
• drug–drug interactions
• polymorphic metabolism

Question 20

What limitations does drug development have? (5)

Answer 20

• 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

Question 21

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

Answer 21

true

Question 22

___________refers to a population diverse in age, comorbid conditions,
and concomitant medications.

Answer 22

Diversity in a ADR databases

Question 23

_______________is the single most

common safety-related reason for market withdrawal in the last 50 years

Answer 23

Hepatotoxicity

i.e. troglitazone

Question 24

___________ is mandated by the

FDA and requires manufacturers to submit all adverse event data they receive.

Answer 24

AERS- The Adverse Event Reporting System

Question 25

How long does a manufacturer have to submit a serious, unexpected adverse event?

Answer 25

15 days post-receipt

Question 26

T/F?
Manufacturers are required to submit quarterly periodic reports for the
first 2 years following drug approval

Answer 26

• false

- 3 years

Question 27

Who are adverse events pertaining to vaccines reported to?

Answer 27

Vaccine Adverse Event
Reporting System (VAERS)

Question 28

VAERS and AERS are apart of what FDA regulated website?

Answer 28

MedWatch