General Pharmacy Laws and Rules Pt 1 Flashcards
Pages 28-67 (104 cards)
1
Q
How many attempts do you get to pass the NAPLEX and MPJE?
A
5 attempts
2
Q
How many interns can be working with each pharmacist on duty at the same time?
A
2 interns per pharmacist EXCEPT for immunizations
For immunizations, you can have 6 interns per pharmacist
3
Q
How many years of practice experience must a pharmacist have to be a preceptor?
A
1 year
4
Q
How many interns can be assigned to 1 preceptor?
A
Unlimited
5
Q
If an intern is no longer enrolled in a school of pharmacy, they must notify the board within _________, and return their intern certificate to the board within _________.
A
72 hours; 10 days
6
Q
A Statement of Preceptor form must be submitted to the board for each intern within how many days of beginning work as an intern?
A
30 days
7
Q
T/F: A statement of preceptor form is required for academic rotations related to a school of pharmacy?
A
False, they are not required
8
Q
What can an intern do (under the supervision of a pharmacist)?
Hint - 13 things
A
1) Sell CV substances
2) Receive oral prescriptions
3) Transfer and receive non-controlled prescriptions
4) Counsel patients
5) Immunizations (w/o Rx: ages 13+, w/ Rx: ages 7-13, flu shots: ages 7+)
6) Document informed consent to administer vaccines
7) Dispense naloxone
8) Non-sterile and sterile compounding
9) Sending and receiving e-scripts between pharmacies accessing the same Rx records in a centralized database or pharmacy computers linked in any other manner
10) Contacting a prescriber for clarification
11) Perform diagnostic lab testing
12) Requesting refill authorizations
13) Stock an automated dispensing unit and floor stock
9
Q
What day is intern/pharmacist license renewal day?
A
September 15th
10
Q
How many days notice must be provided for a change of name, address, or employment?
A
30 days
11
Q
How many days notice must be given for a change in responsible pharmacist?
A
10 days
12
Q
How many days notice must be given to discontinue a business?
A
30 days in advance
13
Q
What day is terminal distributor’s license renewal day?
A
April 1st
14
Q
What day is wholesalers license renewal day?
A
July 1st
15
Q
A non-opioid Rx must be filled within __________ of the date it was written.
A
6 months
16
Q
Refills for non-controlled substances are good for _________ from the date it was written.
A
1 year
17
Q
Refills for CIV and CIII substances are good for ________ from the date written.
A
6 months or a maximum of 5 refills
18
Q
How many refills can a CII substance have?
A
Zero
19
Q
Prescriptions for controlled substances must have the quantity written out in both:
A
Numbers and words
20
Q
How long must prescription records be kept under Ohio law?
A
3 years
21
Q
How long must prescription records be kept under federal law?
A
2 years
22
Q
How many controlled substance prescriptions can be written on one form/prescription?
A
One
23
Q
T/F: Controlled and non-controlled substances can be written on the same form/prescription.
A
False, they cannot be on the same form.
24
Q
A pharmacist can dispense a drug quantity that is different from the prescription for this reason:
A
Medication synchronization: the quantity must be less than a 30 day supply
25
All hard copy prescriptions for non-controlled substances may be electronically filed and then destroyed after ________ from the date of creation or receipt.
180 days
26
T/F: Controlled substance hard copy prescriptions can be scanned and stored electronically.
True
27
T/F: The pharmacy is permitted to destroy controlled substance hard copies if they have been stored electronically.
False, they must be kept even if the prescription is stored electronically
28
What is the maximum number of non-controlled substances that can be written on each Rx form/prescription?
Three
29
What is the rule surrounding Legitimate Medical Purpose and responsibility?
The responsibility to ensure a Rx is for a legitimate medical purpose and within the usual course of a prescriber's practice is equal for the pharmacist and the physician (50% pharmacist, 50% physician responsibility)
30
What must be included on a prescription?
Hint: 9 items + 3 for controlled substances
For all prescriptions:
1) Date issued
2) Prescriber's name, title, and address
3) Phone number of the prescriber's office
4) Full name and residential address of the patient
5) Drug name and strength
6) Quantity
7) Appropriate and explicit directions
8) # of refills or period of time
9) Brand or generic name
If controlled:
10) DEA number
11) ICD-10 code (at least first 4 digits) or CDT code (if dentist)
12) Day supply (including gabapentin)
31
What 4 changes can a pharmacist make to a prescription without contacting the prescriber?
1) Add/change pt's address (must verify with pt or caregiver)
2) Changing to a generic or biosimilar agent
3) Dispense a quantity different than the written quantity (within Ohio law)
4) For a non-controlled med for a human pt, can change dosage form, strength, quantity, and directions if the new drug has the same active chemical ingredients of equivalent strength, frequency, and duration of therapy
32
What 3 changes can a pharmacist make to a prescription with agreement from the prescriber or prescriber's agent?
1) Can add or change dosage form, drug strength, quantity, directions, or issue date (for controls and non-controls)
2) Can add or change days supply, ICD-10 code, or CDT code
3) Can add DAW or similar phrase
33
What medications/prescriptions are eligible for multiple simultaneous refills?
Non-controlled substances that are one of the following:
1) maintenance med taken regularly for a chronic condition
2) drug to be taken regularly for the prevention of a disease
3) contraceptive agent
34
What is the maximum days supply that can be dispensed with multiple simultaneous refills?
90 day supply
35
T/F: A physician can prohibit the dispensing of multiple simultaneous refills.
True
36
Who is allowed to complete the required patient counseling prior to dispensing multiple simultaneous refills?
It must be the pharmacist. Interns and techs are not allowed to complete this counseling.
37
What is included under a category I terminal distributor's license?
Single dose injections of IV fluids
38
What is included under a category II terminal distributor's license?
Any dangerous drug
39
What is included under a category III terminal distributor's license?
Controlled substances
40
T/F: Terminal distributor's licenses are cumulative.
True. With a category III license, you can dispense drugs in categories I, II, and III
41
If there are any changes in a terminal distributor's license (address, category, etc.), when must a new application and fee be sent to the board?
Within 30 days
42
What type(s) of compounding can registered techs perform?
Non-sterile only
43
What type(s) of compounding can certified techs perform?
Sterile and non-sterile
44
How many CE hours must be completed every 2 years?
40 hours
45
How many hours of jurisprudence CE must be completed every 2 years?
2 hours (all programs ending in 03)
46
How many hours of patient safety/medication errors CE must be completed every 2 years?
2 hours (all programs ending in 05)
47
How long must evidence of CE participation be kept for?
1 year following the year in which the evidence and reporting of CE was required
48
When is the CE reporting cycle?
September 16th to September 15th
49
What is required for licensure if there has been a lapse in licensure <3 years?
Pay fee and prove CE is up to date
49
What is required for licensure if there has been a lapse in licensure >3 years?
Must retake the NAPLEX and MPJE exams and must redo criminal background check
50
Who may have the keys to the prescription department of a pharmacy?
Only a pharmacist
51
What is the definition of a generic drug?
1) identical active ingredients
2) meets the identical compendial or other applicable standard of identity, strength, quality, purity, potency, uniformity, disintegration times, and dissolution rates
3) has not been listed by the FDA as having proven bioequivalence problems (BD or BX)
52
T/F: When a generic substitution is made, a "generic substitution made" label must be placed on the bottle
True
53
A pharmacist must notify a physician within ___________ when an interchangeable biological product is substituted, including the name and manufacturer.
5 business days
54
How many times can a controlled substance prescription be transferred?
Once UNLESS it is being transferred through a shared database (ex. between 2 CVS's) which it could then be transferred an unlimited number of times
55
How many times can a non-controlled substance prescription be transferred?
Unlimited number of times
56
Who is allowed to transfer a controlled substance?
Only pharmacists
57
What information must a transfer/copy include?
Hint - 9 things
1) Original Rx number
2) Name and address of the pharmacy transferring the Rx
3) If its controlled, DEA of the pharmacy
4) Date Rx was written
5) Date of original dispense/first fill
6) Original # of refills
7) Date of last refill
8) Number of refills remaining
9) Full name of transferring pharmacist
Person receiving the transfer must write "transfer" on the front and record the date of the transfer on the Rx
58
If a controlled substance is transferred, what 4 things must be written on the original prescription?
1) "Void" on both sides of the prescription
2) Date of the transfer
3) Pharmacist's signature
4) Name, address, and DEA # of pharmacy it was transferred to
59
How do you check a DEA number?
Add digits 1, 3, and 5
Add digits 2, 4, and 6, then multiply by 2
Add the two numbers together
Last digit of the sum must match the last digit of the DEA #
60
What 9 outpatient activities require positive identification to complete?
1) Prescription info entered into the record keeping system
2) Prospective DUR
3) Dispensing
4) Pt counseling
5) Administering adult immunizations
6) Rx info reduced to writing from phone, facsimile, or recording device
7) Compounding
8) Administering injectables
9) Any changes made to an Rx order
61
What counts as a form of positive identification?
Hint - 6ish things
1) Manual signature on a hard copy record
2) Magnetic card reader
3) Biometric method
4) Bar code reader
5) Proximity badge reader
6) Board approved system of random questions
7) Anything else approved by the board
62
What must be included on an outpatient prescription label?
Hint - 10 points
1) Name and address of dispenser
2) Directions
3) Full name of patient (if animal, owners last name, pet name, and species)
4) Full name of prescriber
5) Date of dispensing
6) Cautions (all) and/or federal caution statements (if controlled)
7) Rx number
8) Drug name and strength
9) Quantity
10) If compounded, "compounded drug product" statement
63
What must be included on an inpatient (unit dose) prescription label?
Hint - 5 points
1) Name, strength, dosage form
2) NDC or UPC
3) Manufacturer or repacker
4) Lot number and exp date
5) Special storage conditions
64
What must be included on an inpatient IV prescription label?
Hint - 7 points
1) Pts full name
2) Name and amount of parental solution
3) Name and amount of drugs added
4) Exp date or beyond use date
5) Name and address of institution pharmacy
6) Cautionary statements
7) If supplemental labels needed, must have positive ID check
65
What must be included on an outpatient IV prescription label?
Hint - 11 points
1) Name, address, and phone number of pharmacy
2) Full pt name
3) Full prescriber name
4) Directions and route of administration
5) Date of dispense
6) Cautions
7) Name and volume of solution
8) Name and amount of drugs added
9) Quantity of drug dispensed (if appropriate)
10) Exp date
11) Storage conditions
66
What must be included on inpatient customized patient medication packages (multiple drugs in same packages)?
Hint - 7 points
1) ID of dispensing pharmacy
2) Pts full name
3) Date
4) Name of drug
5) NDC, bar code, or similar
6) Strength
7) Exp date
67
Who is able to dispense, order, or personally furnish a sample?
Only pharmacists working at licensed charitable pharmacies
68
For compounded products made in advance/batched, what must be included on the label?
Hint - 5 points
1) Name, strength, and quantity of each drug used in the compound
2) ID of repackager by name or last 6 digits of its terminal distributor license number
3) Pharmacy control number
4) Pharmacy's exp date or beyond use date
5) "Compounded drug product" label/statement
69
What is the definition of a customized patient medication package?
A package for a specific patient that is a series of "containers" that contain 2 or more oral drugs
AKA convenience or compliance packaging
70
What is the day supply limit for a customized patient medication package?
31 days
71
What is the max expiration date for a customized patient medication package?
6 months OR earliest expiration date of one of the contents (whichever comes first)
72
Who is considered a practitioner?
MD, DO, podiatrists, veterinarians, DDS, NP, PA, optometrists, interns/residents, out-of-state practitioners
73
A prescription written by a prescriber that has underwent a change of status can be dispensed if:
Hint - 4 things
1) The drug is essential to sustain life
2) Continues therapy for a chronic condition
3) Failure to dispense the drug could result in harm to the pt
4) The Rx was issued prior to the prescriber's change in status
74
What is the max day supply that can be dispensed for a non-controlled substance Rx written by a prescriber that has had a change of status?
30 day supply or standard unit of dispensing
75
What is the max day supply that can be dispensed for a controlled substance Rx written by a prescriber that has had a change of status?
72 hour supply
76
How long should patient profiles be maintained for?
At least 1 year from the date of last entry
77
T/F: If filling an Rx for an animal, you do not have to include a DOB in the patient profile.
False, a DOB is required.
78
T/F: The pharmacist must make an offer to provide the service of counseling on every new and refilled prescription.
True, but they do not have to offer if the pharmacist believes it would harm the patient
79
Who is allowed to counsel a patient?
Pharmacists and interns (with supervision)
Technicians CANNOT counsel patients
80
Drug utilization review conducted at the time a prescription is dispensed is called what?
Prospective DUR - required by law
81
Drug utilization review conducted weeks or months after a prescription has been dispensed is called what?
Retrospective DUR - not required by law
82
Prior to dispensing any prescriptions, what should the pharmacist review the patient profile for?
Hint - 9 points
1) Over or under-utilization
2) Therapeutic duplication
3) Drug-disease state contraindications
4) Drug-drug interactions
5) Incorrect drug dose
6) Drug-allergy interaction
7) Abuse/misuse
8) Inappropriate duration of treatment
9) Food/nutritional supplements-drug interactions
83
How many pharmacies can a "responsible pharmacist" be in charge of at the same time?
One (can get special permission for >1)
84
When there is a change in responsible pharmacist, the board must be notified within how many days?
10 days
85
If requested, pharmacy records must be retrieved within ________.
72 hours
86
How long must invoices of all purchased drugs be kept for?
3 years
87
How long do pharmacies have to get rid of outdated drugs?
1 year
88
How long do wholesalers have to get rid of outdated drugs?
2 years
89
Define adulterated
Anything that affects the physical condition of the drugs or the environment in which they were manufactured - anything unsanitary, damaged, outdated, melted capsules, drugs that left the pharmacy and where redispensed, etc.
90
Define misbranded
Anything that affects the labeling of a drug - dispensed w/o a prescription, OTC w/o proper labeling, false advertising, wrong drug dispensed, anything incorrect on the Rx label, inability to ID a drug, etc.
91
Which pharmacy name should appear on the label of a prescription dispensed at a central fill pharmacy?
The name of the central pharmacy and the name and address of the originating pharmacy should appear on the label
92
T/F: There can be multiple prescriptions, including CIII-V substances, issued on one prescription blank when using an electronic prescription transmission system.
True
93
T/F: A prescription transmitted by an electronic prescription transmission system doesn't need to have a signature.
True
94
When discontinuing a pharmacy business, what 4 things must be included in the notice sent to the board?
1) Name, address, and terminal distributor's number
2) Name, address, and terminal distributor's number or wholesaler number who the drugs will be sold/transferred to
3) Name and address of a secure location where records will be stored
4) Proposed date of discontinuing business
95
Who must be notified in the event of theft or loss?
Board of Pharmacy, law enforcement authorities, DEA (if controlled substances are missing)
96
In the event of theft/loss, how many days do you have to submit a report to the board online?
30 days
97
Who can participate in drug repository programs?
Any pharmacy, hospital, or non-profit clinic licensed as a terminal distributor of dangerous drugs
98
Who can donate drugs to a drug repository program?
Licensed terminal distributor of dangerous drugs, wholesale distributor of dangerous drugs, or a person who was legally dispensed a dangerous drug pursuant to a patient specific drug order
99
T/F: A person donating an eligible drug to a drug repository program cannot have taken custody of the drug prior to the donation.
True
100
What non-cancer drugs are eligible to be donated to drug repository programs?
Hint - 5 things
All non-controlled substances that are:
1) In their original, sealed unit-dose package
2) Have been in possession of a licensed healthcare professional
3) Stored properly and have an exp date of 6 months or greater
4) Have a lot and exp date
5) Have no physical signs of tampering
101
Who is eligible to receive a drug from a drug repository program?
Ohio residents that have no third party coverage for the drug prescribed or that are a patient of a nonprofit clinic
102
How long must donor and recipient records/forms be kept for drug repository programs?
3 years
103
What cancer drugs are eligible to be donated to drug repository programs?
Hint - 6 things
1) Oral drugs used to treat cancer or cancer-related SE
2) Oral drugs used to treat the SE of a drug used to treat cancer
3) Controlled substances in long-acting or extended release form used for the treatment of opioid dependence or addiction
4) Must be stored appropriately
5) Exp date of 6 months or longer
6) No physical signs of tampering/adultering
These do not have to be in original, sealed packaging! (except controls and anything that requires fridge/freezer storage)
