Pharmacy Law and Regulations Flashcards
(125 cards)
1
Q
What federal act established the DEA?
A
Controlled Substances Act of 1970
2
Q
How many DEA schedules are there?
A
Five (I II III IV V)
3
Q
What information must be on a DEA number?
A
2 letters followed by 7 numbers
4
Q
What does the first letter of a DEA number indicate?
A
Type of registrant (A B = practitioner
5
Q
How often must DEA registration be renewed?
A
Every 3 years
6
Q
What is the maximum days supply for Schedule II drugs?
A
90 days (in most states)
7
Q
Can Schedule II prescriptions be refilled?
A
No no refills allowed
8
Q
How many refills are allowed for Schedule III-IV drugs?
A
Maximum 5 refills within 6 months
9
Q
What is the maximum quantity for Schedule V drugs?
A
Varies by state
10
Q
Who can prescribe controlled substances?
A
DEA-registered practitioners within their scope of practice
11
Q
What form is used to order Schedule II drugs?
A
DEA Form 222 or electronic equivalent
12
Q
How long must controlled substance records be kept?
A
Minimum 2 years
13
Q
What is a DEA Form 41?
A
Form for reporting destroyed controlled substances
14
Q
When must controlled substance inventories be taken?
A
When opening biennially and when closing
15
Q
What is required for Schedule II drug storage?
A
Locked cabinet or safe
16
Q
What act established the FDA?
A
Food Drug and Cosmetic Act of 1938
17
Q
What does the FDA regulate?
A
Drug safety efficacy manufacturing and labeling
18
Q
What is an NDA?
A
New Drug Application (required for new drug approval)
19
Q
What is an ANDA?
A
Abbreviated New Drug Application (for generic drugs)
20
Q
What is bioequivalence?
A
Generic drug performs similarly to brand drug
21
Q
What does AB rating mean?
A
Therapeutically equivalent (generic substitution allowed)
22
Q
What does BX rating mean?
A
Not therapeutically equivalent (substitution not recommended)
23
Q
What is the Orange Book?
A
FDA publication listing approved drug products and equivalence
24
Q
What is a black box warning?
A
FDA’s strongest warning for serious adverse effects
25
What is a drug recall?
Removal of defective or dangerous drugs from market
26
What is a Class I recall?
Dangerous products that could cause serious harm or death
27
What is a Class II recall?
Products that might cause temporary health problems
28
What is a Class III recall?
Products unlikely to cause health problems
29
What is REMS?
Risk Evaluation and Mitigation Strategy
30
What drugs commonly require REMS?
High-risk medications (e.g. isotretinoin clozapine)
31
What act requires child-resistant packaging?
Poison Prevention Packaging Act of 1970
32
What medications are exempt from child-resistant caps?
Sublingual nitroglycerin some contraceptives certain others
33
When can non-child-resistant caps be used?
When specifically requested by patient or prescriber
34
What is the Combat Methamphetamine Epidemic Act?
Restricts sales of pseudoephedrine-containing products
35
What is the daily limit for pseudoephedrine sales?
3.6 grams per day
36
What is the monthly limit for pseudoephedrine sales?
9 grams per month
37
What documentation is required for pseudoephedrine sales?
Photo ID and signature in logbook
38
What is HIPAA?
Health Insurance Portability and Accountability Act
39
What does HIPAA protect?
Patient health information privacy
40
Who can receive patient information without authorization?
Patient healthcare providers involved in care insurance companies
41
What is a HIPAA violation?
Unauthorized disclosure of protected health information
42
What penalties exist for HIPAA violations?
Fines and potential criminal charges
43
What is required for prescription validity?
Patient name prescriber signature drug name strength quantity directions
44
How long are prescriptions valid?
Varies by state (typically 6 months to 1 year)
45
Can verbal orders be taken for controlled substances?
Only Schedule III-V in emergencies
46
What information must be on prescription labels?
Patient name prescriber drug info directions date pharmacy info
47
What is required for prescription transfers?
Original pharmacy voids prescription
48
Can controlled substances be transferred?
Schedule III-V once only
49
What is partial filling?
Dispensing less than the full quantity prescribed
50
When is partial filling allowed for Schedule II?
For hospitalized or long-term care patients
51
What is the time limit for Schedule II partial fills?
60 days from original prescription date
52
What is automatic substitution?
Dispensing generic equivalent when brand prescribed
53
When is generic substitution prohibited?
When prescriber writes DAW or Brand Medically Necessary
54
What does DAW mean?
Dispense As Written
55
What are DAW codes?
Numeric codes indicating reason for brand dispensing
56
What is DAW 0?
No product selection indicated (generic substitution allowed)
57
What is DAW 1?
Substitution not allowed by prescriber
58
What is DAW 2?
Patient requested brand
59
What is compounding?
Preparing customized medications for specific patients
60
What is the difference between compounding and manufacturing?
Compounding is for specific patients
61
What standards govern compounding?
USP chapters 795 (non-sterile) and 797 (sterile)
62
What is USP Chapter 795?
Standards for non-sterile compounding
63
What is USP Chapter 797?
Standards for sterile compounding
64
What is a master formula record?
Recipe and instructions for compounded preparation
65
What is a compounding record?
Documentation of actual preparation of compound
66
What is beyond use dating?
Expiration date for compounded preparations
67
How is beyond use dating determined?
Based on stability data USP guidelines or manufacturer information
68
What is unit dose packaging?
Single-dose containers for individual administration
69
What are the advantages of unit dose?
Reduced errors improved accountability waste reduction
70
What is an automated dispensing system?
Computer-controlled storage and dispensing device
71
What is the role of pharmacy technicians with automated systems?
Loading maintenance monitoring override documentation
72
What is medication therapy management (MTM)?
Comprehensive review of patient's medications
73
Who can provide MTM services?
Pharmacists (not technicians)
74
What is a drug utilization review (DUR)?
Review of patient's drug therapy for appropriateness
75
What types of DUR exist?
Prospective concurrent retrospective
76
What is prospective DUR?
Review before medication is dispensed
77
What is retrospective DUR?
Review after medication has been dispensed
78
What is Medicare Part D?
Prescription drug benefit program
79
What is the Medicare donut hole?
Coverage gap in Medicare Part D
80
What is Medicaid?
State and federal health insurance for low-income individuals
81
What is a formulary?
List of covered medications
82
What is prior authorization?
Requirement for insurance approval before dispensing
83
What is step therapy?
Requirement to try less expensive medications first
84
What is quantity limits?
Insurance restriction on amount of medication covered
85
What is AWP?
Average Wholesale Price
86
What is MAC pricing?
Maximum Allowable Cost (for generic drugs)
87
What is copay?
Fixed amount patient pays for prescription
88
What is coinsurance?
Percentage of prescription cost patient pays
89
What is deductible?
Amount patient must pay before insurance coverage begins
90
What documentation is required for insurance claims?
Patient info prescriber info drug info diagnosis codes
91
What is a reject code?
Insurance denial with reason code
92
What are common reject codes?
Prior authorization required refill too soon NDC not covered
93
What is NDC?
National Drug Code (unique identifier for drug products)
94
How many segments are in an NDC number?
Three (labeler-product-package)
95
What is a BIN number?
Bank Identification Number for insurance processing
96
What is a PCN?
Processor Control Number for insurance routing
97
What is group number?
Insurance plan identifier
98
What is person code?
Identifies individual covered under insurance plan
99
What is days supply?
Number of days medication should last
100
How is days supply calculated?
Total quantity ÷ daily dose = days supply
101
What is the role of state boards of pharmacy?
License and regulate pharmacy practice within state
102
What is required for pharmacy technician certification?
Pass PTCB or ExCPT exam maintain continuing education
103
How often must PTCB certification be renewed?
Every 2 years
104
What continuing education is required for PTCB?
20 hours every 2 years (including 1 hour pharmacy law)
105
What can cause loss of PTCB certification?
Criminal conviction failure to renew ethics violations
106
What is the scope of practice for pharmacy technicians?
Defined by state law and pharmacy policy
107
What tasks require pharmacist verification?
Prescription interpretation drug utilization review counseling
108
Can pharmacy technicians counsel patients?
No only pharmacists can provide clinical counseling
109
Can pharmacy technicians take verbal prescriptions?
Varies by state law and pharmacy policy
110
What is professional liability?
Legal responsibility for professional actions
111
What is negligence?
Failure to exercise reasonable care
112
What is malpractice?
Professional negligence resulting in harm
113
What is the standard of care?
Level of care expected from competent practitioner
114
What constitutes prescription fraud?
Altering forging or illegally obtaining prescriptions
115
What are signs of prescription fraud?
Altered prescriptions unusual quantities frequent refills
116
How should suspected fraud be handled?
Document notify pharmacist possibly contact authorities
117
What is drug diversion?
Illegal distribution of prescription drugs
118
What are signs of drug diversion?
Missing inventory altered records unusual patterns
119
What is the role of the state prescription monitoring program?
Track controlled substance prescriptions
120
When must prescribers check the monitoring program?
Varies by state (often before prescribing controlled substances)
121
What is the purpose of medication guides?
Provide important safety information to patients
122
When must medication guides be dispensed?
For certain high-risk medications as required by FDA
123
What is risk communication?
Sharing information about medication risks and benefits
124
What is informed consent?
Patient's agreement to treatment after understanding risks
125
What is the pharmacy's duty to warn?
Obligation to inform patients of significant risks
