Shared Flashcard Set

Details

UMB PPML - Safety (Call)
P3 - Exam 1
26
Pharmacology
Professional
10/06/2016

Additional Pharmacology Flashcards

 


 

Cards

Term
What are the JCM (Joint Commission Medication) Management Standards
Definition
Should:
1. Provide framework for an effective and safe medication management system
2. Measure, asses, and improve performance
3. Reasonable,achievable,surveyable
Term
What do REMS ensure?
Definition
drugs benefit can be safely achieved and outweigh the risk of harm
Term
REMS
Definition
Risk Evaluation and Mitigation Strategies
Term
Under what circumstance does the FDA require REMS
Definition
Drugs with serious risks
Term
***4 REMS Elements***
Definition
1. Medication guides
2. Communication plan
3. Elements to Assure Safe Use (ETASU)
4. Implementation System
Term
Do all REMS require a medication guide
Definition
No
Term
When are medication guides required by REMS
Definition
1. When a drug is dispensed in an outpatient setting
2. When requested by patient
3. The first time a drug is dispensed
Term
How is the communication plan element of REMS used?
Definition
Provider letters
Disseminated through professional societies
Term
Describe the Elements to Assure Safe Use element of REMS
Definition
1. Provider training
2. Certifications for pharmacies, providers...
3. Registry enrollments for patients, providers...
4. Restricted dispensing
5. Labs before dispensing
6. Patient monitoring
Term
The iPledge program which was established for isotretinoin is an example of what REM element?
Definition
ETASU (elements to assure safe use)
Term
How often must drug sponsor's evaluate REMS?
Definition
18mo, 3yrs, and 7yrs after the REM was approved
Term
Can REMS be modified or eliminated
Definition
Yes

Example: Rosaglitazone - CVD events --> Restricted use (REMs) ---> further study determined not an issue --> REM modified
Term
USP Chapter 795 covers
Definition
NON-STERILE compounding standards
Term
USP Chapter 797 covers
Definition
STERILE compounding standards
Term
USP Chapter 800 covers
Definition
Hazardous drugs
Term
If a FDA Form 483 is issued the facility is
Definition
Out of compliance with FDA standards
Term
In addition to including many of the requirements of USP 795, Chapter 797 also includes
Definition
PPE
Personnel Qualifications
Facilities ISO class reqs
Term
T/F An Iso class 3 is a more stringent on particle counts than an ISO class 8
Definition
True. An ISO class 3 facility can only have 35.2 particle count/m^3
Term
Drug quality act of 2013
Definition
Federal response to NECC
Title 1: Drug compounding
Title 2: Drug Supply Chain
Term
Describe Maryland's response to NECC
Definition
HB 986
1. Any facility that performs STERILE compounding for MD patients must have a MD compounding permit
2. Entities that STERILE compound for office use or distribution must have MD Wholesalers Permit and FDA 503B registration
Term
797-Can compounding facilities compound without a prescription
Definition
Yes in limited quantities
Term
797-How much extra drugs can compounding facilities distribute out of state?
Definition
No more than 5% of total prescriptions dispensed
Term
797-Are outsourcing facilities required to be a licensed pharmacy?
Definition
No - but licensed pharmacist must supervise
Term
797-T/F Outsourcing facilities must comply with cGMP?
Definition
True
Term
Can products from outsourcing facilities be resold?
Definition
NO
Term
Is USP 800 more concerned with patients or healthcare workers
Definition
healthcare workers exposure to hazardous drugs
Supporting users have an ad free experience!