MI MPJE Flashcards
1
Q
Pharmacist may be a PIC for no more than ___ pharmacies, including remotes
A
3
2
Q
PIC shall work an average of how many hours per week at each pharmacy
A
8
3
Q
Display at remote pharmacy must have a notice visible to public that includes:
A
-Pharmacy services are being provided at a remote pharmacy
-Patient counseling may be provided by a pharmacist using audio and video communication
-Address of the parent pharmacy
4
Q
Pharmacist is responsible for in-person inspection of remote pharmacy and controlled substance inventory reconciliation that must occur how often?
A
Monthly
5
Q
Remote pharmacy may not dispense more than an average of ___ prescriptions per day during a 90 day period
A
150
6
Q
Pharmacy intern must notify BOP within how many days if no longer actively enrolled in pharmacy program
A
30 days
7
Q
T/F: Interns may NOT sell exempt schedule V drugs
A
False; they can
8
Q
T/F: Interns may NOT take verbal schedule 3-5 prescriptions
A
Fale; they can take verbal rx but not transfer without a pharmacist
9
Q
T/F: Interns may NOT transfer schedule 3-5 prescriptions without the involvement of a pharmacist
A
true
10
Q
How many hours of pharmacy work experience must a qualified pharmacy technician complete after being licensed
A
1000 hours
11
Q
Change of PIC must be reported within how many days
A
30
12
Q
Controlled substance inventory must be completed how often?
A
annually
13
Q
Controlled substance inventory requirements
A
- Weather taken at open or close
- Qty
- # commercial containers (e.g., three 500 tablet bottles)
- C2 exact count
- C3-5 may be estimate unless contains more than 1000 units/container, then must be accurate count
- Damaged or expired drugs separate on the inventory
- Licensee to sign and date
- Pharmacy printed name, address and DEA #
- No requirement to send to DEA or board
14
Q
CS inventory must be completed between which months/dates
A
April 1-June 30
15
Q
T/F: CS inventory copy must be sent to the DEA or Board
A
False
16
Q
CS theft or significant loss - must notify DEA & board in writing within what time period
A
One business day (MI is within 15 business days of completion of the investigation to report to BOP)
17
Q
Which DEA form should be used to report CS loss/theft?
A
DEA 106
18
Q
T/F: a non-significant loss of CS does NOT need to be reported
A
False - complete DEA 106 and file with BOP. MI requires reporting of ANY loss
19
Q
T/F: A pharmacy tech opens a tote from their wholesaler for which they have signed and notices a 100-count bottle of alprazolam is missing. Who must report the loss?
A
The registrant (aka the pharmacy) must report to the DEA and BOP because they have signed for the dlivery
20
Q
A filled rx for 30 tabs of alprazolam 1 mg shipped from the central pharmacy to the retail pharmacy was lost in shipment. Who must report the in-transit loss to the DEA?
A
The central fill pharmacy
21
Q
A pharmacy that takes part in disposal of Controlled Substances using a receptacle and mail back programs must have what type of DEA registration
A
Modify DEA registration
22
Q
Collection receptacles must have what features in order to accept controlled substances
A
-Securely fastened to permanent structure
- Locked
- Inner liner must be waterproof, tamper-evident, tear resistant, size marked on outside and have a unique ID number
23
Q
Mail back packages must have what features in order to accept controlled substances
A
-water and spill proof
- tamper evident
- tear resistant
- sealable
- unique ID number
24
Q
How long may a sealed filled drug disposal inner liner be stored at a LTC pharmacy?
A
3 business days
25
T/F: technicians can transfer legend Rxs
true
26
T/F: technicians can receive verbal legend Rxs
true
27
T/F: technicians can compound drugs
true
28
T/F: technicians can prepare or mix IV drugs for injection into a human patient
true
29
T/F: technicians can contact prescribers for Rx clarification
true (except drug regimen review or clinical or therapeutic interpretation)
30
T/F: techs are not allowed to transfer prescriptions
F - they can transfer non-controls
31
What is the tech to pharmacist ratio
None
32
What is the tech (support staff) to pharmacist ratio
none
33
What is the pharmacy intern to pharmacist ratio
2:1
34
DEA form for C2 ordering
DEA 222
35
How many days does a supplier have to fill the DEA 222 form
60 days
36
How long must executed DEA 222 forms be maintained
2 years (this includes voided ones)
37
How long must C3-5 records be maintained
2 years
38
Prescriptions must be kept for how many years
5 years
39
How long must a schedule V logbook be kept
5 years
40
Report or theft or loss (DEA 106 form) must be kept for how many years
2 years
41
Inventory of drugs surrendered for disposal (DEA form 41) must be kept for how long
2 years
42
Records of transfers of CS between pharmacies must be kept for how many years
2 years
43
Self-Certification certificate and logbook or electronic equivalent (ephedrine and PSE) must be kept for how many years
2 years
44
Signature logs must be kept for how many years
2 years
45
What is the Samples-Prescription Drug Marketing Act (PDMA)
Bans reimportation of federal legend drugs manufactured in the US
Prohibits the sale purchase or trade of legend drugs by hospitals or healthcare entities or supplied to charitable institutions
Requires states to license wholesalers
Bans sale, purchase or trade and counterfeiting of drug coupons and drug samples
Requires practitioner to request samples in writing
Only exception for a pharmacist to possess samples is a pharmacist practicing in a hospital pharmacy
46
What is the Drug Supply Chain Security Act Title II
- Manufacturers and repackagers use barcodes on certain rx packages
- Mfqs, wholesalers, drug distributers, repackagers, and dispensers to provide info about a drug and who handled it each time it is sold in the US market
- establish systems & processes to be able to verify the product identifier on certain rx drug packages
- to quarantine and promptly investigate a drug that has been identified as suspect
- to notify DEA and other stakeholders if an illegitimate drug is found
- wholesalers to report their licensing status and contact info to FDA
47
What must be done if a pharmacy receives an illegitimate or suspect product
notify the FDA and immediate trading partners (wholesaler)
Pharmacies to confirm licensure and/or FDA registration of trading partners
Accept ownership of product along with transaction info, history and statements (3Ts) and keep records for 6 years
48
Non-sterile FDA approved drug without a specified in-use time or unapproved drug product:
- Non-aqueous formulations BUD
- water-containing oral formulations BUD
- water-containing topical/dermal and mucosal liquid and semisolid formulation BUD
6 months
14 days
30 days
49
If a pharmacy ships more than 5% compounded products across state lines, the state located in has to do what
sign a memorandum of understanding (MOU) with the FDA
50
Adverse events with compounded products must be reported to FDA and state within what time period
10 days
51
T/F: an outsourcing facility must be licensed as a pharmacy in Michigan & with the FDA
True - only in the state, not the FDA (but may be required to register as a manufacturer)
52
Outsourcing facilities may not compound essentially a copy of one or more approved drug products unless:
- the drugs are on the shortage list at the time of compounding
- there is a change that produces for an individual patient a clinical difference between the compounded drug and the comparable approved drug (must be noted on the Rx by the provider)
53
Who should an outsourcing facility apply to in order to compound without a prescription?
must apply to the Department/Board
54
Outsourcing facilities must report adverse events regarding compounded products to who and within what time period
FDA and state within 10 days
55
Types of USP compounding:
Non-sterile to non-sterile
Sterile to sterile
Non-sterile to sterile
Non-sterile to non-sterile: USP<795>
Sterile to sterile: USP<797>
Non-sterile to sterile: USP<797>
56
T/F: compounded drugs need to have FDA finding of safety, efficacy, and manufacturing quality
false
57
T/F: APRNs can prescribe controlled substances
True but must be delegated from MD or DO (only up to 30 days supply)
58
T/F: Optometrists (OD) may prescribe oral corticosteroids
FALSE
59
T/F: Optometrists (OD) may prescribe any CII drugs
FALSE - only hydrocodone containing products
60
T/F: APRNs must have a controlled substance license
False
61
Which out of state prescribers can prescribe controlled and non-controlled drugs
MD/DO, veterinarian and dentist
62
T/F: Canadian MD or DO may prescribe controlled and non-controlled substances
False - only non-controlled
63
Examples of healthcare professionals who are NOT prescribers within their scope of practice
Chiropractor
Physical therapist
Psychologist
Dental hygienist
Doctor of neuropathic medicine
Doctor of Audiology
Occupational therapist
Respiratory therapist
64
T/F: pharmacists cannot dispense a prescription if the physician is retired
Depends if they are still licensed
65
T/F: MI does not allow prescriber's self-prescribing or prescribing for immediate family members
MI is silent on this -- requires bona fide prescriber-patient relationship
66
T/F: methadone can be dispensed by the pharmacy for substance use disorder or opioid use disorder
False - only for pain (but no requirement for pain to be indicated on the rx)
67
Pharmacies must notify the DEA and State BOP ___ days before offering to fill CS prescriptions by means of the internet
30 days
68
How many medical evaluations must be carried out in person for a patient to fill a CS through an internet pharmacy
1
69
Which DEA registration is needed for online pharmacies
Modify DEA
70
Required record-keeping for vaccines
Date of administration
Vaccine manufacturer
Vaccine lot number
Name and title of person who administered vaccine and address of the facility where the permanent record will reside
VIS (date printed and date VIS was given to patient)
71
Vaccine storage temperatures:
Refrigerators
Freezers
Refrigerators: 36F-46F (2C-8C)
Freezers: -58F - +5F (-50C - 15C)
72
How long must you keep storage temperature data
3 years
73
Written Rxs for non-controlled meds can have up to how many drug orders
4
74
Electronic Rxs for non-controlled meds can have up to how many drug orders
6
75
What can a pharmacist NOT change on a CS prescription
Patient name, CS prescribed, prescriber's signature
76
What are 3 situations where physician-patient relationship not required for prescription
- Auto-injectable epinephrine (pharmacist can dispense to authorized entity)
- Opioid antagonist
- Expedited Partner Therapy (EPT) for chlamydia and gonorrhea diagnosis - dispense in name of partner if known or "expedited partner therapy" if unknown. Information sheet must be given to patients on dispensing
77
Expedited Partner Therapy (EPT) for chlamydia and gonorrhea - which drugs can be prescribed
Chlamydia: azithromycin 1 gram PO single dose
Gonorrhea: cefixime 400 mg PO single dose + azithromycin 1 gram PO single dose
78
T/F: technicians can accept verbal orders for CS
False
79
If prescriber does not check MAPS, what is the qty limit on CS prescriptions
3 days
80
What is the limit for opioid prescriptions for acute pain
7 days
81
T/F: doctors must note on prescription that MAPS was checked or the prescription is for acute pain
False
82
T/F: prescribers may issue more than one C2 on a single prescription form
True
83
C2 prescriptions are valid for ___ days from written date
90
84
Patients in LTCF or patients with terminal illness medical diagnosis RX shall be valid for ___ days from issue date
60 & must have notation on rx "terminally ill" or "LTCF patient"
85
For emergency dispensing of a C2, the prescriber must furnish a written, signed, rx for the C2 prescribed within how many days
7
86
For emergency dispensing of a C2, how can the rx be delivered?
In person or mail
87
T/F: A NP with delegation can phone in an emergency morphine rx
True - any prescriber or provider with delegation can (PA, NP)
88
What are the 3 exceptions to faxing schedule 2 prescriptions where the fax serves as the original rx
1. compounding for direct administration to a patient by parenteral, IV, IM, SQ or intraspinal infusion
2. LTCF resident
3. Hospice patient certified and/or paid for by Medicare or licensed by the state
89
T/F: a PA can phone in an emergency rx for oral morphine in a skilled nursing facility for a 60 day qty
True
90
Who must the pharmacist notify if the written C2 rx is not received for the verbal emergency order?
The DEA and Board/Department
91
What is the time limit on a schedule V rx that is being partially filled?
6 months
92
What is the max qty a prescriber can call in for an emergency C2 rx?
Enough needed for the emergency period
93
Prescriber must be notified within ___ days after dispensing an interchangeable biological drug product
5 days (must give the name and manufacturer of product)
94
T/F: a prescriber can request a blanket waiver for a patient's prescriptions to be dispensed with easy-open caps
False - can only request for single rx
95
What medications MUST be dispensed in child-resistant containers
- Oral investigational drugs for outpatient clinical trials
- Oral prescription drug samples
- All controlled substances intended for oral human use
96
What are special situations where medications can be dispensed in child-resistant containers
-Sublingual nitroglycerin
- Chewable and sublingual isosorbide dinitrate 10 mg strength or less
- Methylprednisolone tablets not more than 84 mg per package
- Prednisone tablets in packages containing not more than 105 mg
- Preparations in aerosol containers intended for inhalation therapy
- Medroxyprogesterone acetate tablets
- Oral contraceptives
- Drugs dispensed to hospital or traditional nursing home patients if administered by institutional staff
- Most topical applied drugs (except lidocaine more than 5 mg in single package)
97
What is required for CPMP (customized patient medication packages) label
- Serial number for CPMP and separate serial number for each drug
- Date of preparation
- Expiration date at max 60 days
- Telephone number of pharmacy
- Any other info, warnings, statements required for any of the drug products
- Name and address of patient
- Name, strength, physical description, total qty of each drug product, directions for use
_ Prescriber name
- Name or initials of RPh who prepared
98
What would make a drug be considered adulterated?
1. If a drug is manufactured under conditions that do not conform to CGMP
2. Contains any filthy, putrid, or decomposed substance
3. Prepared, packed or held under unsanitary conditions where it may have been contaminated
4. Contains unsafe coloring
5. Strength, quality or purity differs from tat in the official compendium
6. If the drug has been substituted in whole or part
7. Dropping a tablet on the floor
8. Contaminated drug
9. Dispensing a liquid that has been diluted
10. Compounding sterile products in unsterile conditions and representing as sterile
11. A product with an unapproved color additive
12. Dispensing a drug mixed with another drug
99
What would make a drug be considered misbranded?
1. Labeling is false or misleading
2. Does not identify name and place of manufacturer, packer or distributer
3. Lacks quality of contents
4. Lacks name of drug
5. Lacks "adequate directions for use"
6. Drug liable for deterioration, unless packaged as required
7. Labeling is false or misleading
8. If it is imitation of another drug
9. If it is offered for sale under the name of another drug
10. If drug packaging is in violation of PPP Act
11. Labeling of drug fails to have "Rx Only" prior to dispensing when required
12. Nitroglycerin SL in non-original package
13. Dispensing without rx
14. Dispensing without authorized refill
15. Imitation of another drug
16. Dispensing without mandated med guide or Patient Package Insert
17. Failure to comply with packaging requirements
18. Dispensing a generic and labeling as the brand name only
19. Dispensing Prempro without PPI
20. Dispensing Cytotec not in unit of use package
21. Side effect statement not given when required
100
BUD for single-dose amplules
Immediately used
101
BUD for single-dose container (syringes, vials, bottles, bags) opened in LESS than ISO Class 5 and opened in ISO Class 5 or cleaner
- Less than ISO Class 5: within 1 hour
- ISO Class 5 or cleaner: within 6 hours
102
BUD for multi-dose vials
28 days
103
Hospice emergency drug boxes must have a label that contains all of the following information that shall be attached so that it is visible from the outside of the box:
(a) The name and address of the pharmacy.
(b) The name and address of the hospice.
(c) The name of the pharmacist who last inspected and restocked the drug box.
(d) The date the drug box was last restocked.
(e) The date on which the drug box must be returned to the pharmacy for the replacement of expired drugs.
(f) The number of the drug box.
104
Pharmacy Drug Box Exchange Log for hospice must include:
(a) The number of the box.
(b) The name of the hospice to which the box is released.
(c) The date the box is released to the hospice.
(d) The name and signature of the pharmacist who releases the box to the hospice.
(e) The expiration date assigned.
(f) The date the box is returned to the pharmacy for restocking.
(g) The name and signature of the pharmacist who received the box for restocking.
105
Any LTCF location that utilizes emergency kits must be audited by a pharmacist how often?
No less than every 30 days
106
What are the exceptions for returning drugs to the pharmacy?
- Prescription error from patient
- Recalled drug from patient
- Prison system (no CS)
- Cancer Drug Reciprocity Program (no CS) from patient
- Prescription Drug Reciprocity & Distribution Program drugs from a facility or manufacturer (no CS)
- Registered with DEA to collect CS from non-registrants
107
What is the priority order of dispensing a cancer drug from the Cancer Drug Repository Program
1. Individuals who are uninsured or do not have insurance coverage for those cancer drugs or supplies
2. Individuals who are enrolled in Medicaid, Medicare, or any other public assistance health care program
3. All other individuals who are residents of this state and diagnosed with cancer
108
What must be reported to MAPS for controlled substance rxs?
- Patient identifier (full name, address, DOB, DL # or state-issued ID number from photo ID)
- Name of CS dispensed
- Metric quantity
- NDC
- Date of issue of Rx
- Date of dispensing
- Estimated days supply
- Rx number
- DEA number of prescriber and pharmacy
- MI pharmacy license number
109
PSE records must be maintained for how long
2 years
110
Which DEA form must you submit if any unusual or excessive loss/disappearance for PSE is discovered and how long do you have to report it orally and in writing?
DEA form 107
Orally at earliest opportunity
In writing within 15 days
111
What is the max amount of PSE that can be sold to a customer per day and in a 30-day period?
3.6 grams per day
9 grams per 30 days
112
T/F: Schedule 3-5 controlled substances must be an exact count when doing inventory
False- can be an estimate unless bottle contains more than 1,000 units/container must be an accurate count
113
How long must prescription records be kept, including Medicare part D requirements
5 years from last refill (Medicare part D requires 10 years)
114
How often must the pharmacy report to the state the total number of doses of opioid antagonist dispensed under the standing order
Quarterly (also prescriptions, not including standing order)
115
For terminally ill patients, how long can a C2 prescription be partial filled for?
60 days (same as the expiration time)
116
What medications can be dispensed to a patient without a patient-physician relationship
- Naloxone
- Cefixime or azithromycin (for EPT)
- Auto-injectable epi-pen
117
Within how many days must a prescriber be notified if dispensing an interchangeable biological product in place of the product prescribed?
5 days
118
T/F: Prescription labels do not require pharmacy's telephone number
True
119
T/F: Federal Caution statement must be included on prescription labels for C2-5
False - only C2-4
120
What is the max expiration date for a Customized Patient Medication Package (CPMP)?
60 days
121
The maximum BUD for water containing oral formulation stored at controlled room temp
14 days
122
The maximum BUD for water containing topical/dermal formulation stored at controlled room temp
30 days
123
The maximum BUD for a multi-unit vial that has antimicrobial preservative and an expiration 2 years from today if puncturing the vial today
28 days
124
Max time allowed before administration must begin for an immediate use compounded sterile prep
1 hour
125
Max time allowed for a single dose ampule opened in ISO class 5
Must be used immediately
126
How long may a sealed filled drug disposal inner liner be stored at a LTCF
3 business days
127
Drugs donated to the cancer drug repository program must have an expiration date of at least
6 months
128
Drugs donated to the program for utilization of unused prescription drugs must have an expiration date of at least
6 months
129
What is required for DEA inventory if the pharmacy is acting as a collector of controlled substances from the ultimate user?
- Date of inventory
- Number of unused liners and size of each
- Number and size of used sealed liners
- Unique ID number of each unused inner liner
130
A copy of the patient receipt for a prescription must be retained by the pharmacy for a minimum of how long
90 days
131
What are the CE requirements for a pharmacy technician?
20 hours (5 live)
- 1 hour pain
- 1 hour patient safety
- 1 hour pharmacy law
- One time identifying victims of human trafficking training
132
How many hours of internship must a new pharmacist complete before being issued a pharmacist license?
1600 hours
133
How many years of practice must a pharmacist have before becoming a preceptor?
1 year of practice in MI
134
Pharmacist CE requirements
30 hours (10 live)
- 1 hour ethics and jurisprudence
- 1 hour pain and symptom management
- 1 hour per year implicit bias (in addition to 30 hours)
- 1 time CS awareness (live)
- 1 time human trafficking awareness
135
If the pharmacy license is not renewed by the expiration date, the license is null and void after how many days
60
136
What is the Prescription Drug Marketing Act
ensures that drug products purchased by consumers are safe and effective, and to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs
137
What must drug companies submit for approval to market a generic product
Abbreviated New Drug Application (ANDA)
138
What do the 3 sections of an NDC identify
Manufacturer/labeler, product, package size
139
What are the 3 ways to violate the FD&C Act
Adulterating, misbranding, placing into interstate commerce an unapproved drug
140
How often must the BOP meet
No less than quarterly
141
How long is a term for the chairperson and vice-chairperson on the BOP
1 year
142
How many members are on each BOP and who does it consist of? How long is the term
11 members (6 pharmacists, 1 tech, 4 public members)
4 year terms, max may serve is 2 terms + 1 partial
143
Disciplinary subcommittee of the board includes:
3 professional and 2 public members
- ONE public member has to vote with the majority or it does not pass
144
How often are intern license renewed?
Annually
145
License reinstatement requirements for a license that has been lapsed up to 3 years
Submit application, pay fee, and prove completion of CE hours in last 2 years
146
License reinstatement requirements for a license that has been lapsed 3-8 years
Submit application, pay fee, prove completion of CE hours in last 2 years, retake MPJE and complete 200 intern hours
147
License reinstatement requirements for a license that has been lapsed more than 8 years
Submit application, pay fee, prove completion of CE hours in last 2 years, retake MPJE and NAPLEX, and complete 400 intern hours
148
How long does a pharmacy have to notify the board in changes to hours/closing a pharmacy?
15 days
149
Changes to ownership, PIC or address must be notified to board within how many days
30
150
Medications/orders removed from medicine cabinets from LTCF must be reviewed by a pharmacist within what amount of time
48 hours
151
Prescription records older than ___ months must be made available to an authorized agent of the board upon request within ___ hours from the time the request was made:
a. 12 months; 24 hours
b. 12 months; 48 hours
c. 16 months; 48 hours
d. 16 months; 72 hours
e. 18 months; 48 hours
f. 18 months; 72 hours
D. 16 months; 72 hours
152
A pharmacist, pharmacy, dispensing prescriber, or vet shall report all C2-5 dispensed to MAPS within what time period
By the end of the next business day
153
Durham-Humphrey Amendment
- Established OTC vs Rx
- Authorized verbal prescription orders and permitted prescription refills.
154
Kefauver Harris Amendment
- mandated efficacy and safety before a drug could be marketed
- Required Informed Consent for Human Research Subjects
-Implemented CGMPs
155
What does each book provide:
1. Red Book
2. Orange Book
3. Yellow Book
4. Green Book
5. Pink Book
6. Purple Book
1. Red Book - Drug Pricing
2. Orange Book - Therapeutic equivalence
3. Yellow Book - International travel vaccines
4. Green Book - Animal drug products
5. Pink Book - Vaccine-preventable diseases
6. Purple Book - Biological products
156
After how many years can a paper rx be copied as an electronic duplicate to become the original order
3 years
157
How often must a pharmacist at a medical institution inspect areas where medications are stored
Not less than every 6 months
158
How often must a pharmacist inspect the drugs located in a hospice drug box?
at least weekly
159
Food, Drug & Cosmetic Act
-Established the New Drug Application/Approval Process (NDA)
-Required medications to have adequate directions for use.
-Required labeling for
Prescriptions
Manufactured Products
Habit-forming drugs
- Recognized USP-NF and Homeopathic Pharmacopoeia of the US as official compendia.
160
Hatch-Waxman Act
-Created Abbreviated New Drug Application/Approval (ANDA)
- Established the FDA Orange Book
161
Prescription Drug Marketing Act
-Requires licensure of wholesalers under state law.
-Bans the sale of drugs samples (complimentary starter doses)
162
Omnibus Budget Reconciliation Act
-Requires “necessary and appropriate” prospective drug utilization review
-Mandates offer to counsel
