Pharmacy Law Review: True or False
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1
*Certification* means a certification awarded by a(n) ___ ___ ___ to signify that a pharmacist has met predetermined qualifications and to signify to the public that the pharmacist is competent to practice in the designated specialty.
nongovernmental specialty organization
2
T/F: A patient's consent is required before a physician can initiate a collaborative drug therapy management with a pharmacist.
true
3
T/F: A pharmacist in a collaborative practice can order or perform laboratory/clinical tests based on standing orders of the physician.
true
4
T/F: A pharmacist in a collaborative practice cannot modify the dose of a medication.
false; can
5
*Modifying* means changing ... (3)
1. drug
2. dose
3. delivery (route)
2. dose
3. delivery (route)
6
*Therapeutic interchange* means the substitution and dispensing of a drug chemically ___ from the prescription drug originally prescribed.
dissimilar
7
Describe the composition of the NJBOP members.
*11 members* (1 P, 1 VP, 1 executive director)
- 2 public members
- 1 state executive dept member
- 8 pharmacists
- 2 public members
- 1 state executive dept member
- 8 pharmacists
8
Describe the requirements of a pharmacist serving on the NJBOP.
1. registered in NJ ≥ 5 years
2. actively engaged in pharmacy
3. must continue in pharmacy
2. actively engaged in pharmacy
3. must continue in pharmacy
9
NJBOP members are appointed by who?
the governor
10
NJBOP members are paid ___ per day.
\$150
11
Additional NJBOP meetings may be called in what 2 ways?
1. president
2. 2/3 members
2. 2/3 members
12
What happens when a NJBOP agent removes a hard copy prescription from your pharmacy?
they leave a certified copy until the hard copy is returned
13
The NJBOP establishes a(n) ___ for patients concerning the health care services a patient may expect in regard to pharmaceutical care.
bill of rights
14
What happens when a representative of the board thinks you have outdated, adulterated, or misbranded drugs in your pharmacy?
detains or embargoes the suspected drugs by putting a tag on them
15
Which of the following is considered a *biological product*? (SATA)
A. metformin
B. arsphenamine
C. trivalent organic arsenic compound
D. Fluarix (influenza vaccine)
E. virus F. albumin
A. metformin
B. arsphenamine
C. trivalent organic arsenic compound
D. Fluarix (influenza vaccine)
E. virus F. albumin
B, C, D, E, F
16
*Dispense/Dispensing* means ... (3)
1. interpretation of Rx
2. proper selection, measuring, labeling, and packing in proper container
3. consultation by the pharmacist
2. proper selection, measuring, labeling, and packing in proper container
3. consultation by the pharmacist
17
Interchangeability data for biological products can be found in the ...
Purple Book
18
T/F: Certified nurse midwives have the authority to prescribe under a supervising physician.
false; in accordance with standing orders and protocols developed in agreement with a *collaborating physician*
19
T/F: Certified nurse midwives are registered with the NJ Board of Nursing.
false; Board of Medical Examiners
20
What is the professional identification for a physician's assistant?
PA-C
21
In what 2 scenarios can a PA-C initiate a Rx for a CDS?
1. after consulting the supervising physician
2. for terminal illness
2. for terminal illness
22
What are the special statements that physician's assistants have to put on their Rx's?
prt - pursuant to protocol
spd - specific physician direction
spd - specific physician direction
23
T/F: Ophthalmologists can only prescribe CIII-CV controlled dangerous substances, with the exception of hydrocodone.
false; optometrists
24
What is the only CII an optometrist can prescribe?
hydrocodone
25
Optometrists must be certified to prescribe ocular pharmaceuticals by taking an exam given by the ...
Board of Optometry
26
Optometrists must receive a ___ certification number in order to prescribe ocular pharmaceuticals.
TPA
27
What are the 2 different prefixes for a TPA certification number?
27TO = topical only
27OM = topical & oral
27OM = topical & oral
28
The joint protocols developed by the collaborating physician and the APN are ___, ___ and ___ at least every ___ by both parties.
reviewed
updated
signed
year
updated
signed
year
29
An APN must complete ___ of continuing professional education in pharmacology related to controlled substances.
6 contact hours
30
T/F: A CDS Rx written by an APN must include the collaborating physician's full name, title, address, telephone number, and DEA number.
false; DEA number not required
31
Therapeutic equivalence data can be found in the ...
Orange Book
32
List the NJBOP fees for each of the following:
- registration application
- initial licensure (1st yr of biennial)
- initial licensure (2nd yr of biennial)
- biennial license renewal
- registration application
- initial licensure (1st yr of biennial)
- initial licensure (2nd yr of biennial)
- biennial license renewal
125
140
70
140
125
140
70
140
125
33
An individual must pay penalties within ___ of receipt of a(n) ___ or ___.
15 *business days*
penalty letter
final order
penalty letter
final order
34
For initial licensure as a pharmacist, an individual must have graduated with a ___ in pharmacy with a minimum ___ year course, or with a ___ from an ___ or equivalent school.
BS
5
Pharm D
ACPE-approved
5
Pharm D
ACPE-approved
35
For initial licensure as a pharmacist, an individual is applying *>2 years* post-graduation shall complete ___ of practical experience as a registered intern.
1440 hours
36
For initial licensure as a pharmacist, an individual who graduated from a non-ACPE equivalent school shall have a valid certification from the ___ of ___.
Foreign Pharmacy Graduate Examination Committee (FPGEC)
NABP
NABP
37
For initial licensure as a pharmacist, an individual who graduated from a non-ACPE equivalent school shall complete ___ of practical experience as a registered intern.
1440 hours
38
If an individual fails the NAPLEX or MPJE 3 times, the applicant will not be eligible to retake the exam until ___ from the date of the last exam.
1 year
39
The results of the NAPLEX or MPJE are only valid for ___ from the date the applicant receives a passing score.
5 years
40
What does "not presently engaged in drug or alcohol use" mean?
at this time or any time within the previous 365 days
41
What are the examples of *crimes involving moral turpitude*? (6)
1. murder
2. rape
3. child abuse
4. robbery
5. theft
6. fraud
2. rape
3. child abuse
4. robbery
5. theft
6. fraud
42
What are the 4 reasons to be a pharmacy intern?
1. graduated from ACPE approved or equivalent
2. graduated from foreign country from a non-ACPE approved school
3. reciprocal licensure and practicing <1500 hours within the 2-yr period preceding the date of application
4. graduate student participating in ASHP-accredited post-graduate pharmacy residency program
2. graduated from foreign country from a non-ACPE approved school
3. reciprocal licensure and practicing <1500 hours within the 2-yr period preceding the date of application
4. graduate student participating in ASHP-accredited post-graduate pharmacy residency program
43
Describe how quickly or slowly a pharmacy intern can complete his/her 1440 hours of practical experience.
34 - 104 weeks
15 - 45 hours per week
15 - 45 hours per week
44
In order to be an intern preceptor, the pharmacist must have worked for at least ___ immediately preceding the date of application and is currently engaged in the practice of pharmacy in NJ.
2 years
45
An intern preceptor can only supervise the training of how many interns at a time?
1
46
The Board shall send a notice of renewal to each licensee, at least ___ prior to the expiration of the license.
60 days
47
No penalties or fines shall apply to the license holder for failure to renew provided that the license is renewed within ___ from the date the notice is ___ or within ___ following the date of license expiration, whichever is ___.
60 days
sent
30 days
later
sent
30 days
later
48
A licensee who fails to submit a renewal application within ___ of license expiration shall have his/her license suspended *without a hearing*.
30 days
49
Once an individual passes his exams, the applicant will receive a signed authorization to practice pharmacy from the ___ that is valid until his initial license is issued.
Board Secretary
50
When must a pharmacist notify the Board of a personal name change?
within 30 days of such change
51
Which of the following can be submitted to the Board as proof of a name change? (SATA)
A. original court order
B. certified copy of court order
C. original marriage certificate D. certified copy of marriage certificate
A. original court order
B. certified copy of court order
C. original marriage certificate D. certified copy of marriage certificate
A, B, C, D
52
When must a pharmacist notify the Board of a personal address change?
within 30 days of such change
53
Pharmacist license renewal takes place on ___ years.
A. even B. odd
A. even B. odd
B. odd
54
Describe the CE requirements.
30 CE credits for each biennial renewal
- 10 = didactic
- 3 = law
- 1 = CDS
- 2 = immunization
- 10 = per collaborative practice dz state
- 10 = didactic
- 3 = law
- 1 = CDS
- 2 = immunization
- 10 = per collaborative practice dz state
55
What are the 3 times the Board will not grant CE credits?
1. participation in routine business
2. presentation to sell a product or promote a business
3. programs < 1 contact hour
2. presentation to sell a product or promote a business
3. programs < 1 contact hour
56
Describe the rules for carrying over CE credits.
*10 credits* may be carried over if the credits were earned during the *last 6 months* of the preceding biennial period and were *not previously reported*
57
What are the 7 ways a licensee can obtain CE credits?
1. ACPE approved program
2. Board approved program
3. graduate course work
4. teaching/research
5. extern preceptor
6. intern preceptor
7. publication of an article in a peer-reviewed professional journal
2. Board approved program
3. graduate course work
4. teaching/research
5. extern preceptor
6. intern preceptor
7. publication of an article in a peer-reviewed professional journal
58
No credit shall be granted for programs or courses which are less than 1 contact hour, defined as ___ of actual attendance in a program or course of study.
50 min
59
How many CE credits are awarded for every 30 minutes beyond 1 initial contact hour?
0.5 CE credits
60
How many CE credits are awarded for completion of graduate coursework?
3 credits per course credit
61
How many CE credits are awarded for teaching/research?
3 credits per new course taught or research topic
*Max = 6 credits*
*Max = 6 credits*
62
How many CE credits are awarded for being an intern preceptor?
3 credits per 160 hours of work performed by the intern(s)
*Max = 6 credits*
*Max = 6 credits*
63
How many CE credits are awarded for being an extern preceptor?
3 credits per student
*Max = 6 credits*
*Max = 6 credits*
64
How many CE credits are awarded for publishing an article?
3 credits per article
*Max = 6 credits*
*Max = 6 credits*
65
A licensee shall maintain all documentation concerning the completion of CE requirements for a period of ___ from the completion of the credit hours.
5 years
66
What are the requirements to be a CE course instructor?
1. pharmacist with ≥ 5 years experience
2. pharmacist certified by a nationally recognized board or association
3. pharmacist with expertise in subject area
4. licensed HCP with expertise in subject area
2. pharmacist certified by a nationally recognized board or association
3. pharmacist with expertise in subject area
4. licensed HCP with expertise in subject area
67
Applications for pre-approval of CE programs or courses shall be submitted by the Board at least ___ prior to the date the program or course is to be offered.
45 days
68
Which of the following should be on a Board approved CE program's verification of attendance? (SATA)
A. attendee's name
B. sponsor's name
C. sponsor's phone #
D. presenter's name E. location of the program
A. attendee's name
B. sponsor's name
C. sponsor's phone #
D. presenter's name E. location of the program
B, C, D, E
69
The CE sponsor shall maintain a list of all attendees who completed each approved program or course for a period of ___ from the date the program or course was offered.
5 years
70
Pharmacy practice sites must renew their permits how often?
every year
71
A report with the ___, ___ and ___ of all principal corporate officers of the out-of-state pharmacy shall be made every ___ and within ___ after any change of office or corporate officer.
location
names
titles
year
30 days
names
titles
year
30 days
72
Describe the requirements of the toll-free telephone service of out-of-state pharmacies.
open ≥ 6 days/week
open ≥ 40 hours/week
open ≥ 40 hours/week
73
What are pharmacy practice sites required to report to the Board?
1. closing of the pharmacy
2. change of ownership, interior design, location, permit classification or PIC
3. theft/loss of drugs or devices
4. theft/loss of records
5. malpractice cases >\$10,000
2. change of ownership, interior design, location, permit classification or PIC
3. theft/loss of drugs or devices
4. theft/loss of records
5. malpractice cases >\$10,000
74
T/F: I work in a pharmacy.
false; pharmacy department
75
T/F: A restroom contiguous to the pharmacy department must be indicated in the new pharmacy application.
true
76
Which of the following must be completed in a new pharmacy application? (SATA)
A. name of PIC
B. address of PIC
C. location of proposed pharmacy
D. name of owners and operators
E. address of owners and operators F. Board inspection and approval
A. name of PIC
B. address of PIC
C. location of proposed pharmacy
D. name of owners and operators
E. address of owners and operators F. Board inspection and approval
A, C, D, E, F
77
After approval of a new pharmacy application, the Board shall issue a ___ that will allow the applicant to place legend drugs in stock.
permit #
78
After approval of a new pharmacy application, the pharmacy has ___ to open for business.
90 days
79
After approval of a new pharmacy application, if the pharmacy cannot open for business in the specified time, the pharmacy should notify the Board no less than ___ prior to the expiration of the ___ period for a time extension.
30 days
90 day
90 day
80
What happens when the pharmacy opens for business but has not notified the Board of opening or for an extension?
rescind permit
81
What is the time period to renew a pharmacy practice site permit?
within 30 days after permit expiration
82
The Board shall send a notice of renewal to each pharmacy permit holder, at least ___ prior to the expiration of the permit.
60 days
83
Which of the following must be conspicuously displayed?
A. license
B. permit
C. both A and B D. neither A nor B
A. license
B. permit
C. both A and B D. neither A nor B
C. both A and B
84
When a *complete change in ownership* occurs and none of the current owners retains any ownership interest, the new owner(s) shall, within ___ after the change, submit to the Board ... (3)
30 days
1. new permit application
2. new permit application fee
3. inventory of CDS
1. new permit application
2. new permit application fee
3. inventory of CDS
85
If there is a change of *registered agents or officers*, the business entity shall, within ___ after the change, submit to the Board an affidavit indicating the changes that have taken place.
30 days
86
If there is a *change of stock ownership* involving ___ or more, the corporation shall, within ___ after the change, submit to the Board an affidavit indicating the changes that have taken place.
10%
30 days
30 days
87
If a *reallocation of ownership* interests occurs among existing owners, the owners shall, within ___ after the change, submit to the Board an affidavit explaining the asset reallocation.
30 days
88
Upon a change in ownership, the new ownership of such entity shall take custodial ownership of the previous ___ of ___ and ___ records.
5 years
prescription
profile
prescription
profile
89
What is the time period to notify the Board of a pharmacy location change?
at least 30 days prior to such change
90
What is the time period to notify the Board of a change in pharmacy address but not location?
within 10 *business days* of such change
91
What is the time period to notify the Board of a pharmacy remodeling?
at least 30 days prior
92
What is the time period for the Board to inspect the completed remodeling of a pharmacy?
within 60 days after completion
93
What is the time period to notify the Board of a pharmacy name change?
at least 30 days prior to such change
94
When a pharmacy is to be discontinued and closed for any reason, the permit holder must immediately send written notice of the anticipated closing to the ___, ___, and ___ at least ___ to the anticipated closing date.
NJBOP
Office of Drug Control
DEA
15 days prior
Office of Drug Control
DEA
15 days prior
95
What is the time period to notify the Board of an unanticipated pharmacy closure, such as the result of the death of the permit holder?
ASAP
96
Within ___ of discontinuation and closing of a pharmacy, the permit holder or representative shall remove all ___ and notify the Board in writing of the location of the previous ___ of prescription and patient profile records.
30 days
drug signs
5 years
drug signs
5 years
97
What is the time period to *return a permit* to the Board after discontinuing and closing a pharmacy?
within 30 days of closing
98
When a pharmacy ceases operations, patrons should be notified of their right to retrieve currently valid prescriptions and the location of the prescriptions and profile records for a(n) ___ year period.
1
99
When a pharmacy ceases operations, patrons should be notified of their rights by what 4 methods?
1. Board in writing
2. publication of rights once a week for 2 consecutive weeks in local paper
3. sign in pharmacy of rights
4. social media (if applicable)
2. publication of rights once a week for 2 consecutive weeks in local paper
3. sign in pharmacy of rights
4. social media (if applicable)
100
Upon a change in ownership, both the new and former pharmacy permit holders shall ensure that there is access to patient prescription and profile records with ___ of the transfer of business assets, and that all telephone calls to the former pharmacy shall be ___ to the new pharmacy.
24 hours
forwarded
forwarded
101
A NJ pharmacy shall be kept open for the transaction of business at least ...
5 days/week
*AND*
40 hours/week
*AND*
40 hours/week
102
If any *permanent changes* are made in the opening or closing hours of a pharmacy, the Board shall be notified in writing of these changes within ___.
30 days
103
Any temporary closing of a pharmacy for more than ___ shall be reported to and approved by the Board.
48 hours
104
Any temporary pharmacy closing of more than ___ without prior Board approval shall result in the pharmacy being deemed a(n) ___ pharmacy.
48 hours
discontinued
discontinued
105
In the case of a pharmacy or pharmacy dept that has been issued a(n) ___ permit, pharmacy technicians may remain within the permitted premises when the pharmacy or pharmacy dept is closed and secured.
institutional
106
What agencies/organizations must be notified of a theft or loss of CDS? (3)
1. Board
2. DEA
3. Office of Drug Control
2. DEA
3. Office of Drug Control
107
What are the 4 components of handling a prescription?
1. intake
2. processing
3. fulfillment
4. dispensing
2. processing
3. fulfillment
4. dispensing
108
What are the 4 types of pharmacies in centralized prescription handling?
1. intake (originating) pharmacy
2. central processing pharmacy
3. central fill pharmacy
4. dispensing pharmacy
2. central processing pharmacy
3. central fill pharmacy
4. dispensing pharmacy
109
Which of the following may be a function of a central processing pharmacy? (SATA)
A. data entry
B. pro-DUR
C. claims submission
D. patient counseling E. refill authorizations
A. data entry
B. pro-DUR
C. claims submission
D. patient counseling E. refill authorizations
A, B, C, D, E
110
Describe the audit trail requirements for central prescription handling.
audit trail maintained for 5 years
- oldest 4 years = retrievable and readable within 2 weeks
- most recent 1 year = retrievable and readable within 1 business day
- oldest 4 years = retrievable and readable within 2 weeks
- most recent 1 year = retrievable and readable within 1 business day
111
What is the definition of the "use by" date in NJ?
earlier of:
- one year from the date of dispensing
*OR*
- manufacturer's exp date
- one year from the date of dispensing
*OR*
- manufacturer's exp date
112
What information is required on the prescription label for each pharmacy involved in central prescription handling?
name, address, telephone #
113
What information on a prescription label must stand out from the rest? (4)
1. patient name
2. drug name
3. directions for use
4. pharmacy contact info (hours and telephone #)
2. drug name
3. directions for use
4. pharmacy contact info (hours and telephone #)
114
Practitioners can only get their NJ prescription blanks from a vendor approved by the ___ in the ___.
Division of Consumer Affairs
Dept of Law and Public Safety
Dept of Law and Public Safety
115
T/F: A NJ prescription blank must contain a practitioner's NPI number.
true
116
The practitioner shall notify the ___ in the ___ as soon as possible but no later than ___ of being made aware that any NJ prescription blank in the practitioner's possession has been stolen.
Office of Drug Control
Division of Consumer Affairs
72 hours
Division of Consumer Affairs
72 hours
117
A pharmacist shall not fill a prescription unless the prescription bears the practitioner's ___ or the unique ___ assigned to a health care facility.
license #
provider #
provider #
118
What are the permissible methods of receiving a C2 prescription?
1. written
2. e-script
2. e-script
119
The ___ in the ___ shall establish the format for NJPBs.
Division of Consumer Affairs
Department of Law and Public Safety
Department of Law and Public Safety
120
Forgery of NJ prescription blanks is considered a(n) ___ act.
volatile
121
Which of the following is considered an *administration* of medication by the Board of Medical Examiners? (SATA)
A. IV
B. IM
C. PO
D. topical E. neublization
A. IV
B. IM
C. PO
D. topical E. neublization
A, B, E
122
Which of the following is considered a *drug* by the Board of Medical Examiners? (SATA)
A. amoxicillin capsules
B. vitamin D capsules
C. compounded nitroglycerin ointment
D. transdermal scopolamine E. ginkgo biloba
A. amoxicillin capsules
B. vitamin D capsules
C. compounded nitroglycerin ointment
D. transdermal scopolamine E. ginkgo biloba
A, B, C, D, E
123
What are the exceptions for issuing a prescription without examining a patient first? (6)
1. established patient
2. newly hospitalized patient
3. new patient prior to 1st appt
4. patient of another physician for whom the practitioner is taking calls
5. collaborative practice patient already examined by a HCP
6. emergency medical condition
2. newly hospitalized patient
3. new patient prior to 1st appt
4. patient of another physician for whom the practitioner is taking calls
5. collaborative practice patient already examined by a HCP
6. emergency medical condition
124
Words, in addition to numbers, to indicate the drug quantity is required for which schedule CDS prescriptions? (SATA)
A. C2
B. C3
C. C4 D. C5
A. C2
B. C3
C. C4 D. C5
A
125
How may a prescribing practitioner notify each patient of their right to request the generic of a prescribed brand name medication?
sign or pamphlet in the waiting room
126
*Obesity* is defined as a BMI >___.
27
127
Before prescribing medications for treatment of obesity, what must the prescriber get from the patient?
written or verbal informed consent
128
What is the definition of *chronic pain*?
refractory pain persisting ≥3 consecutive months
129
What is the definition of *initial prescription*?
1. has never previously been issued
2. current Rx issued >1 year since drug was last used
2. current Rx issued >1 year since drug was last used
130
T/F: Palliative care can also refer to the treatment of a curable, progressive illness.
false; only applies to incurable
131
What is the dispensing limit for a single C2 prescription?
30 day supply
132
What are the 2 exceptions for dispensing >30 day supply for C2 prescriptions?
1. 90 day supply; implantable infusion pump for cancer, intractable pain, or terminal illness
2. 90 day supply; multiple Rx with earliest fillable dates noted
2. 90 day supply; multiple Rx with earliest fillable dates noted
133
A prescriber must have an opioid discussion with patients under ___ of age prior to issuing a C2 prescription.
18 years
134
A prescriber must repeat the opioid discussion with the patient prior to issuing the ___ C2 prescription.
3rd
135
At the time of, or prior to, the issuance of the ___ prescription for a C2 medication, the practitioner shall enter into a(n) ___ with the patient.
3rd
pain management agreement
pain management agreement
136
In a pain management agreement, what are the ways the practitioner can monitor a patient's compliance? (2)
1. random specimen screens
2. pill counts
2. pill counts
137
The practitioner shall review, at a minimum of every ___, the course of chronic pain treatment with CDS.
3 months
138
T/F: When treating chronic pain with CDS, the practitioner should periodically make reasonable efforts to either stop the use of the CDS or try other drugs.
true
139
A practitioner treating chronic pain with CDS should conduct *random urine screens* at least every ___.
12 months
140
What is the quantity limit for an initial opioid prescription for the treatment of acute pain?
5 day supply
141
No less than ___ after issuing the initial opioid prescription, upon request of the patient, a practitioner may issue a subsequent prescription.
4 days
142
T/F: In order to issue a subsequent opioid prescription for the continued treatment of acute pain, the practitioner must consult with the patient.
true
143
What is the quantity limit for a subsequent opioid prescription?
30 day supply
144
What must a practitioner indicate on an initial opioid prescription for the treatment of acute pain?
"initial Rx for acute pain"
145
What are the 2 scenarios that a practitioner may dispense or administer narcotic or depressant drugs intended for "detoxification" or "maintenance treatment"?
1. acute withdrawal symptoms
2. adjunct to other treatment for conditions other than addiction in a licensed health care facility
2. adjunct to other treatment for conditions other than addiction in a licensed health care facility
146
Describe the dispensing/administering rules for narcotic or depressant drugs intended for "detoxification" or "maintenance treatment". (3)
1. treatment shall not exceed 72 hours
2. patient shall receive no more than 1 day's supply at a time
3. patient is referred to an addiction specialist or drug treatment program
2. patient shall receive no more than 1 day's supply at a time
3. patient is referred to an addiction specialist or drug treatment program
147
Practitioners shall not prescribe any C2 amphetamine or sympathomimetic amine for ___ purposes or for the treatment of ___.
anorectic
fatigue
fatigue
148
Amphetamines or sympathomimetic amines can only be prescribed to treat what conditions? (7)
1. narcolepsy
2. idiopathic CNS hypersomnia
3. ADD
4. drug-induced brain dysfunction
5. epilepsy
6. refractory depression
7. senile apathetic behavior
2. idiopathic CNS hypersomnia
3. ADD
4. drug-induced brain dysfunction
5. epilepsy
6. refractory depression
7. senile apathetic behavior
149
What are valid indications for HGH? (5)
1. short stature (hormone deficiency)
2. short stature (Turner's syndrome)
3. growth failure (lack of GH)
4. adult deficiency (pituitary tumors or muscle wasting associated with HIV/AIDS)
5. dx of adult short bowel syndrome
2. short stature (Turner's syndrome)
3. growth failure (lack of GH)
4. adult deficiency (pituitary tumors or muscle wasting associated with HIV/AIDS)
5. dx of adult short bowel syndrome
150
Which of the following is a valid indication for anabolic steroids? (SATA)
A. Turner's syndrome
B. severe burn injury
C. endometriosis
D. HIV/AIDS muscle wasting syndrome
E. pituitary tumor
F. dx of short bowel syndrome G. anemia with renal failure
A. Turner's syndrome
B. severe burn injury
C. endometriosis
D. HIV/AIDS muscle wasting syndrome
E. pituitary tumor
F. dx of short bowel syndrome G. anemia with renal failure
B, C, D, G
151
What is the quantity limit for emergency dispensing of chronic maintenance medications?
72 hours
152
Describe the timeliness of complying with a patient's request for a copy of a prescription and/or patient profile.
Rx < 1 yr old = within 24 hours
Rx > 1 yr old = within 72 hours
Rx > 1 yr old = within 72 hours
153
What must be written on a copy of a patient's prescription and/or profile?
COPY - FOR INFORMATION ONLY
*make sure this statement is UNDERLINED*
*make sure this statement is UNDERLINED*
154
Describe the timeliness of complying with a patient's request to transfer a Rx.
within 4 hours
155
How many times can each of the following be transferred?
- C2 - C3-5
- C2 - C3-5
C2 = 0
C3-5 = 1
C3-5 = 1
156
What must the sending pharmacy document for a Rx transfer? (5)
*on back of Rx*:
1. Rx has been transferred
2. date of transfer
3. name and address of receiving pharmacy
4. name of receiving pharmacist
5. initials of sending pharmacist
1. Rx has been transferred
2. date of transfer
3. name and address of receiving pharmacy
4. name of receiving pharmacist
5. initials of sending pharmacist
157
What must the receiving pharmacy document for a Rx transfer? (3)
1. name and address of sending pharmacy
2. original Rx #
3. name of sending pharmacist
2. original Rx #
3. name of sending pharmacist
158
T/F: The sending pharmacy team member must inform the patient that the original Rx was cancelled at their pharmacy.
false; receiving must inform patient
159
A red "C" is required on C3-5 Rxs when they are filed ... (SATA)
A. alone
B. with C2 Rxs C. with non-CDS Rxs
A. alone
B. with C2 Rxs C. with non-CDS Rxs
B, C
160
When it comes to facsimile Rxs, who in particular cannot be considered an authorized agent?
nurse employed by assisted living facility
161
The facsimile transmission of the prescription shall contain ... (4)
1. ID # of transmitting facsimile machine
2. date & time of transmission
3. name, address, telephone # and facsimile # of the pharmacy
4. full name and title of authorized agent (if applicable)
2. date & time of transmission
3. name, address, telephone # and facsimile # of the pharmacy
4. full name and title of authorized agent (if applicable)
162
How long must a pharmacy keep a facsimile Rx?
5 years
163
What are the 3 exceptions to filling a C2 CDS by facsimile?
pain management
- patients of LTCF
- patients of hospice *certified by Medicare* or *licensed by NJ*
- compounding for direct parenteral administration
- patients of LTCF
- patients of hospice *certified by Medicare* or *licensed by NJ*
- compounding for direct parenteral administration
164
T/F: An electronic prescription sent by an authorized agent must include on the prescription his/her full name, title, and must sign the prescription.
false; shall not sign
165
How long must an electronic Rx be kept?
5 years
166
Which of the following are required on the container label of a dispensed medication? (SATA)
A. pharmacy address
B. patient address
C. prescriber phone #
D. "use by" date
E. date Rx was issued
F. dispensed quantity G. dispensing RPh's initials
A. pharmacy address
B. patient address
C. prescriber phone #
D. "use by" date
E. date Rx was issued
F. dispensed quantity G. dispensing RPh's initials
A, D, F
167
If an animal's DOB is unknown, what date should be used?
January 1 *PLUS* estimated year of birth
168
How should an animal's name be formatted on a prescription medication label?
name of animal, species, owner's last name
ex: Tabatha (feline) Smith
ex: Tabatha (feline) Smith
169
The pharmacist shall have the right to refuse to fill a prescription if in his/her professional judgement ... (3)
1. outside the scope of practice of practitioner
2. sufficient reason to question validity of Rx
3. protect the health and welfare of patient
2. sufficient reason to question validity of Rx
3. protect the health and welfare of patient
170
Price quotes for prescription drugs in ads shall stipulate ___ and ___ required to be purchased for an offered price.
strength
quantity
quantity
171
In the advertisement of a drug sold by a particular pharmacy, there shall be no references in ads to drug's ___ or ___.
quality
beneficial use
beneficial use
172
A price quote must include ___ of that price.
effective date
173
What is the quantity limit for C5 OTC controlled substances?
*in a 48 hour period...*
≤ 240 mL of opium or 48 dosage units
≤120 mL of any other CS or 24 dosage units
≤ 240 mL of opium or 48 dosage units
≤120 mL of any other CS or 24 dosage units
174
What should be done with the *1st request* for a C5 OTC?
1. full name of purchaser
2. address of purchaser
3. name of CS sold
4. quantity of CS sold
5. date of sale
6. name or initials of RPh making the sale
2. address of purchaser
3. name of CS sold
4. quantity of CS sold
5. date of sale
6. name or initials of RPh making the sale
175
What is the definition of *short period of time* when it comes to C5 OTC controlled substance sales?
2-4 days
176
What should be done with the *2nd request* for a C5 OTC?
1. used correctly?
2. how many people?
3. condition improving?
2. how many people?
3. condition improving?
177
What should be done with the *3rd request* for a C5 OTC?
1. abuse potential
2. consult a physician if condition does not improve
2. consult a physician if condition does not improve
178
What should be done with the *4th request* for a C5 OTC?
1. how many people?
2. continued use therapeutic?
3. condition require physician consultation?
4. signs of drug abuse?
5. similar requests of other local pharmacies?
2. continued use therapeutic?
3. condition require physician consultation?
4. signs of drug abuse?
5. similar requests of other local pharmacies?
179
What should be done with the *5th or greater request* for a C5 OTC?
1. justification
2. consult with a physician
3. potential hazard of continued use
2. consult with a physician
3. potential hazard of continued use
180
If any Schedule V substance is dispensed to one individual more than ___ times within any ___ period, the pharmacist shall obtain oral or written ___ from the purchaser's physician as to the continued need for the substance and shall document such ___ in the ___.
5
12 month
confirmation
confirmation
OTC Schedule V Record Book
12 month
confirmation
confirmation
OTC Schedule V Record Book
181
T/F: A patient was dispensed lisinopril 10 mg tablets in a manufacturer stock bottle. The patient realizes that s/he still has lisinopril tablets at home and brings the unopened bottle back for return. The pharmacist may place the unopened bottle back in stock for reuse or resale.
false; may not
182
What is the time period for a PPRS to retrieve a patient's medication history?
immediately
183
A patient profile record shall be maintained for a period of not less than ___.
5 years
184
If the pharmacy uses an electronic data processing system, a(n) ___ ___ ___ shall be established when the processing system is inoperative for any reason.
auxiliary recordkeeping system
185
If an electronic data processing system was inoperative and becomes operative again, patient profile information during the inoperative time shall be entered within ___.
72 hours
186
With regard to a patient profile for an animal, what information from the owner should be included?
1. owner's name
2. owner's address
2. owner's address
187
The offer to counsel must be made prior to dispensing a:
A. new medication
B. medication refill
C. both A and B D. neither A nor B
A. new medication
B. medication refill
C. both A and B D. neither A nor B
A. new medication
188
Describe the documentation for acceptance/refusal of patient counseling.
refusal not documented = assumes the pt accepted and received counseling
refusal documented = pt refused and did not receive counseling
refusal documented = pt refused and did not receive counseling
189
T/F: In order to document a refusal to counsel, the pharmacist must obtain a signature from the patient.
true
190
The offer to counsel does not apply in what 2 settings?
1. hospital inpatient w/ 24-hour nursing
2. LTCF w/ 24-hour nursing
2. LTCF w/ 24-hour nursing
191
When may a pharmacist substitute a biological product for a prescribed biological product?
prescriber did not indicate "no substitution"
*AND*
interchangeable (Purple Book)
*AND*
therapeutically equivalent (Orange Book)
*AND*
interchangeable (Purple Book)
*AND*
therapeutically equivalent (Orange Book)
192
If a pharmacist dispenses a biological product, the pharmacist shall, within ___ following the dispensing of the biological product, communicate to the prescriber the specific product provided to the patient, including the ___ of the product and the ___.
5 business days
name
manufacturer
name
manufacturer
193
T/F: If a pharmacist dispenses a biological product that has an interchangeable and therapeutically equivalent product available on the market, communication to the prescriber by telephone is acceptable.
false; electronic or facsimile are the only acceptable methods
194
In a collaborative practice, what is the time period to notify the prescriber if the pharmacist changes the dosage form of a prescribed drug?
within 48 hours after dispensing of Rx
195
Who initiates a collaborative drug therapy management agreement?
prescriber
196
A written protocol for collaborative drug therapy management must be reviewed and renewed at least every ___.
2 years
197
No collaborative drug therapy management shall include, without the prior consent of the patient and the patient's physician, ___ at the time of dispensing.
therapeutic interchange
198
Describe the age requirements for administering an influenza vaccine.
7-11 = Rx & consent
12-17 = consent only
18+ = no reqeuirements
12-17 = consent only
18+ = no reqeuirements
199
Which of the following can be administered by a pharmacist to a 15 year old child pursuant to a prescription and with patient consent? (SATA)
A. influenza vaccine
B. MMR vaccine
C. Gardisil-9
D. Prevnar-13 E. Boostrix
A. influenza vaccine
B. MMR vaccine
C. Gardisil-9
D. Prevnar-13 E. Boostrix
A
200
T/F: A pharmacist can participate in collaborative drug therapy management with more than one physician at any one time.
true
201
In order for a pharmacist to participate in collaborative drug therapy management, s/he must be pre-approved by the Board. The Board will require ... (3)
1. certificate training program (ACPE)
2. post-graduate residency program (ASHP)
3. certification program (Board of Pharmacy Specialties)
2. post-graduate residency program (ASHP)
3. certification program (Board of Pharmacy Specialties)
202
What are the CE requirements for collaborative drug therapy management?
10 credits per collaborative practice disease state
203
What type of date is required on a collaborative practice agreement?
effective date
204
Records relating to a collaborative practice agreement shall be maintained for a period of not less than ___.
7 years
205
For collaborative practice, a physician needs to have a *bona fide relationship* with a patient. What does this mean?
1. physician has ongoing responsibility
2. relationship existed ≥ 1 year
3. physician has seen pt ≥ 4 visits
2. relationship existed ≥ 1 year
3. physician has seen pt ≥ 4 visits
206
In collaborative practice, written notification by either ___ or ___ shall be provided to the physician no later than ___ after any change in prescribed medication is made by the pharmacist.
facsimile
electronic means
8 hours
electronic means
8 hours
207
In order for a pharmacist to perform therapeutic interchange in a collaborative practice, the pharmacist needs informed consent from who?
1. patient
2. physician
2. physician
208
No pharmacy shall operate without a registered PIC for longer than ___.
30 days
209
Whenever the PIC is absent from the pharmacy for more than ___, the ___ and the ___ shall notify the ___ of the name of the registered pharmacist who shall act as the interim PIC.
30 days
PIC
permit holder
Board
PIC
permit holder
Board
210
What must be done when there is a change in PIC?
inventory of CDS
211
What is the time period to notify the Board when a registered pharmacist assumes or terminates the duties as a PIC?
within 30 days
212
A PIC shall be a full-time employee, employed for a minimum of ___.
35 hours per week
213
T/F: Pharmacy technicians can accept prescription renewal authorizations from a prescriber or his/her registered agent.
true
214
What must the PIC do upon completion of the biennial inventory of all CDS?
sign and date
215
What are the minimum requirements on an identification tag?
1. first name
2. first initial of last name
3. job title
2. first initial of last name
3. job title
216
Pharmacists are permitted what amount of time for a meal break?
30 min
217
When a pharmacist is on a meal break, what must be done?
sign stating "Pharmacist on meal break, but is available for emergencies and counseling"
218
Which of the following actions can a pharmacy technician NOT perform? (SATA)
A. data entry
B. provide patient counseling
C. transfer prescriptions between pharmacies
D. label preparation E. verify dosage and directions
A. data entry
B. provide patient counseling
C. transfer prescriptions between pharmacies
D. label preparation E. verify dosage and directions
B, C, E
219
In order to have a greater pharmacist to technician ratio, technicians must take what exam?
National Pharmacy Technician Certification Examination
220
In order to have a greater pharmacist to technician ratio, the pharmacy must require and maintain on site a signed ___ ___ ___ from each technician.
patient confidentiality statement
221
The PIC shall review the policy and procedure manual at least every ___.
2 years
222
On pharmacy permit renewal applications, the pharmacy shall list what information for each pharmacy technician?
name and address
223
A pharmacy technician or pharmacy technician applicant who is receiving in-service training, which shall not exceed ___, shall be excluded from the pharmacist to technician ratio.
210 days
224
Describe the pharmacy technician applicant registration requirements.
*max of 1 time; max of 180 consecutive days*
must file application with Board during the first 10 days of employment
must file application with Board during the first 10 days of employment
225
After Board approval of pharmacy technician registration, the pharmacy technician will receive an authorization signed by the ___ granting the applicant the right to practice until the initial registration is issued.
Executive Director of the Board
226
What is the time period to notify the Board if a pharmacy technician changes his/her name?
within 30 days of such change
227
What is the time period to notify the Board if a pharmacy technician changes his/her address?
within 30 days of such change
228
What are the 3 components of OBRA-90?
1. rebates
2. demonstration project
3. DUR
2. demonstration project
3. DUR
229
With regard to OBRA-90, what are the 3 components of DUR?
1. screening before dispensing
2. counseling
3. documentation
2. counseling
3. documentation
230
What are the exceptions for the distribution of premiums or rebates for the sale of drugs/medications?
1. trading stamps
2. ≥ 60 years of age
2. ≥ 60 years of age
231
Rules and regulations for the advertising of prescription drug prices are promulgated by who?
Director of the Division of Consumer Affairs
232
Authorization for the advertising of prescription drug prices is done by who?
Commissioner of Health and Senior Services
233
A pharmacist license has been suspended or revoked by the Board. The pharmacist has a right to appeal to the ___.
Superior Court Appellate Division
234
A pharmacist may dispense an *opioid antidote* without a prescription pursuant to a standing order from what 3 people?
1. prescriber
2. Commissioner of Health
3. Deputy Commission of Public Health Services
2. Commissioner of Health
3. Deputy Commission of Public Health Services
235
Describe the *sign* requirements for a pharmacy/pharmacy department.
1. *PHARMACY* on exterior of building visible from public roadway
2. business hours & name of PIC at all entrances (including drive-thru window, drop-off boxes, and entrance of pharmacy dept)
2. business hours & name of PIC at all entrances (including drive-thru window, drop-off boxes, and entrance of pharmacy dept)
236
For pharmacies in operation prior to ___, the space devoted to the prescription area and laboratory shall not be less than ___ of the main floor area of the pharmacy, and in no instance shall it be less than ___.
July 1, 1963
10%
50 sq-ft
10%
50 sq-ft
237
For older pharmacies, if the main floor area of the pharmacy exceeds ___, the ___ requirement does not apply and the minimum requirement for the prescription area shall not be less than ___.
1,200 sq-ft
10%
120 sq-ft
10%
120 sq-ft
238
For newer pharmacies, the prescription area must occupy exclusively a minimum of ___.
150 sq-ft
239
What are the required dimensions for the prescription counter?
width = 18 inches
length = 12 feet
length = 12 feet
240
Pharmacy temperature should be maintained in a range of ___.
20-25 degrees Celsius (68-77 degrees Fahrenheit)
241
Which of the following is a minimum equipment/facility requirement for a prescription area in a pharmacy that does not perform compounding? (SATA)
A. OTC Schedule V Record Book, even if the pharmacy does not sell this
B. rubber spatula
C. Grade A balance
D. glass funnel E. up-to-date pharmaceutical reference texts
A. OTC Schedule V Record Book, even if the pharmacy does not sell this
B. rubber spatula
C. Grade A balance
D. glass funnel E. up-to-date pharmaceutical reference texts
B, E
242
A pharmacy is required to have 2 ___ ___ ___ ___ ___.
drug utilization review council placards
243
Which of the following is a minimum equipment/facility requirement for a prescription area in a pharmacy that performs non-sterile compounding? (SATA)
A. OTC Schedule V Record Book, even if the pharmacy does not sell this
B. rubber spatula
C. Grade A balance
D. glass funnel E. up-to-date pharmaceutical reference texts
A. OTC Schedule V Record Book, even if the pharmacy does not sell this
B. rubber spatula
C. Grade A balance
D. glass funnel E. up-to-date pharmaceutical reference texts
B, C, D, E
244
All pharmacies shall have all balances, scales, weights and automatic counting devices ___ and ___ every ___ by the ___.
inspected
sealed
12 months
Dept of Weights and Measures
sealed
12 months
Dept of Weights and Measures
245
How long must pharmacy temperature documentation be maintained?
2 years
246
To ensure the temperature control is maintained during delivery, the shipping processes may include the use of appropriate packaging material or devices according to information provided by the ___, ___, or other learned treatises or expert qualification analysis.
manufacturer
USP <1079>
USP <1079>
247
Describe the required actions for pharmacy temperature excursions.
≥ 24 hours = notify the Board *within 48 hours*
≥ 72 hours = cease dispensing and verify with manufacturer before dispensing
≥ 72 hours = cease dispensing and verify with manufacturer before dispensing
248
A pharmacy shall maintain a prescription drug retail price list of the ___ most frequently prescribed drugs.
150
249
Describe the advisory statement requirements posted in a pharmacy.
1. availability of retail list
2. right to ask for current retail price
3. right to obtain price comparison of brand/generic
4. need to tell pharmacist about all medications pt is taking
2. right to ask for current retail price
3. right to obtain price comparison of brand/generic
4. need to tell pharmacist about all medications pt is taking
250
If a patient requests the pharmacy for the drug retail price list, the list shall be printed in at least ___-point type.
12
251
What is the time period for a pharmacy to update the drug retail price list following a change in a drug price?
ASAP, but at least weekly
252
A *Health Care Facility* means a facility licensed by the ___.
Dept of Health and Senior Services
253
What are the required elements on the label of unit dose packaging?
1. name of drug
2. strength
3. lot #
4. use by date
5. manufacturer or re-packager
2. strength
3. lot #
4. use by date
5. manufacturer or re-packager
254
T/F: An institutional pharmacy may receive oral medication orders from the prescriber's authorized agent.
false; must be from prescriber only
255
An institutional pharmacy shall only accept oral C2 orders in what situation?
bona fide emergency situation
256
Oral orders to an institutional pharmacy must be countersigned by who?
prescriber
257
RPh may dispense any remaining medication to the patient upon discharge in a multiple dose container, such as ... (5)
1. inhalers
2. multiple dose injectable like insulin
3. topical preparations
4. drops
5. ointments
2. multiple dose injectable like insulin
3. topical preparations
4. drops
5. ointments
258
What are the requirements to dispense remaining medications to the patient upon discharge? (4)
1. multiple dose container medications only
2. label the medication for out-patient use
3. counsel the patient prior to discharge
4. discharge orders contain attending physician's authorization to release remaining medication
2. label the medication for out-patient use
3. counsel the patient prior to discharge
4. discharge orders contain attending physician's authorization to release remaining medication
259
A drug-dispensing device must be approved by ___ and ___.
PIC
P&T
P&T
260
An approved *drug-dispensing device* can be used when RPh is not on duty provided that the absence is not greater than ___.
24 hours
261
CDS in a drug-dispensing device should be documented every ___.
24 hours
262
For *drug-dispensing devices*, RPh shall check record of ___ against ___ and document it within ___ from time of original order.
withdrawals
prescribers orders
24 hours
prescribers orders
24 hours
263
If there is no licensed pharmacy on the premise of the health care facility, the drug-dispensing device shall be controlled by who?
PIC
264
For disposal of unused medications, if the medications are missing the ___, ___ or ___, send them to the pharmacy for final disposition.
drug source
control number
expiration date
control number
expiration date
265
The record of disposal of unused or non-administered CDS shall be signed and witnessed by who?
licensed nurse, physician or pharmacist
266
The audit trail in an institutional pharmacy shall be maintained for how long?
5 years
267
Inpatient PPRs shall be maintained for how long?
5 years
268
On each patient care unit, the pharmacist must maintain ... (3)
1. copy of current formulary
2. reference drug compendium
3. phone # of local or regional poison control cener
2. reference drug compendium
3. phone # of local or regional poison control cener
269
Who has access to the institutional pharmacy after hours if the RPh is absent?
registered nurse designated by PIC in emergency situations when floor stock is not available
270
A registered nurse designated by PIC can remove what types of drugs from the pharmacy stock? (3)
1. drug in original container
2. drug pre-packaged by pharmacy
3. single dose from original container for specific patient
2. drug pre-packaged by pharmacy
3. single dose from original container for specific patient
271
Documentation of a designated, registered nurse removing medication from the pharmacy must be kept for how long?
5 years
272
Institutional pharmacies must check every ___ for out of date drugs.
2 months
273
If an institutional pharmacy wants to open a decentralized pharmacy in the health care facility, what application must be filed with the Board?
remodeling application
274
What is an ambulatory care facility?
patients depart from facility on same day the services are provided
275
What is the "P&T committee" of an ambulatory care facility called?
patient care policy committee
276
The patient care policy committee shall review the policies and procedures and document the review at least how often?
every year
277
How should needles and syringes be stored in an ambulatory care facility?
locked storage area
278
The intentional wasting of CDS in an ambulatory care facility requires how many signatures?
2
279
In an ambulatory care facility, where should a patient's drug allergies be documented? (2)
1. patient's medical record
2. outside front cover of patient's medical record
2. outside front cover of patient's medical record
280
What 2 things shall be reported immediately to the nurse in charge and to the prescriber of an ambulatory care facility?
1. medication errors
2. adverse drug reactions
2. adverse drug reactions
281
In an ambulatory care facility, all drugs, except ___, shall be kept in locked storage areas.
IV infusion solutions
282
T/F: In an *ambulatory care facility*, drugs for external use must be kept separate from drugs for internal use.
true
283
In an ambulatory care facility, a declining inventory of all CDS shall be made how often?
termination of each shift
284
The ambulatory care facility shall retain a ___ who has no affiliation with the pharmacy that provides services to the facility.
consultant pharmacist
285
What does a consultant pharmacist do? (5)
1. develop and/or review policies and procedures
2. educational programs in pharmacology
3. drug regimen reviews
4. quarterly reviews of medical records
5. quarterly written reports to administrator and medical director
2. educational programs in pharmacology
3. drug regimen reviews
4. quarterly reviews of medical records
5. quarterly written reports to administrator and medical director
286
A consultant pharmacist may offer education programs in what situations? (5)
1. facility administrator
2. director of nursing
3. use of new medication systems
4. pharmacological innovation
5. advances in technology
2. director of nursing
3. use of new medication systems
4. pharmacological innovation
5. advances in technology
287
Prior to the first use of an AMS, what must be done?
1. pharmacy self-inspection of AMS
2. Board inspection of AMS
3. Board approval
2. Board inspection of AMS
3. Board approval
288
How often must a pharmacy do a self-inspection of an AMS?
every year
289
How often must medications in an AMS be inspected for expiration dates, misbranding, and physical integrity?
every 2 months
290
How often must an AMS be inspected for security and accountability?
every 2 months
291
How often must an AMS's policies and procedures be reviewed and/or revised?
every year
292
How often must an AMS be tested for accuracy?
every 6 months
*OR*
whenever any upgrades are made to the system
*OR*
whenever any upgrades are made to the system
293
What is a "recurring error" for an AMS?
any specific type of inaccuracy within the AMS that occurs more than *twice in a 14 day period*
294
Recurring errors for an AMS must be reported to who?
Board
295
Quality assurance documentation for an AMS must be maintained for how long?
2 years
296
What are the ISO air requirements for the ante area?
ISO class 8 or better
297
What are the ISO air requirements for the buffer area?
ISO class 7
298
Where are primary engineering controls usually located?
buffer area
299
___ + ___ = cleanroom
ante area + buffer area
300
Immediate use compounded sterile preparations involve the use of no more than ___ drug products.
3
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