Exam 1 Flashcards
(276 cards)
1
Q
pharmacy errors may be responsible for ____ deaths per year
A
7,000
2
Q
_____% of all prescription errors are discovered during patient counseling
A
83%
3
Q
82% of errors are ___
A
mechanical (dispensing)
4
Q
Thomas v. Winchester
A
pharmacist responsible for the consequences of mistake
5
Q
CT definition of error:
A
act or omission of clinical significance relating to dispensing of a drug that results in or may reasonably be expected to result in injury to or death of a patient
6
Q
CT Error Reporting Regulations: (3)
A
- implement QA program to detect and prevent errors
- Notify patient and practitioner if error discovered, communicate method for minimizing consequences of error
- Post sign - “if you have a concern that an error may have occurred…” - this also appears on receipt or bag
7
Q
QA review for each prescription error within ___ days of discovery
A
2
8
Q
QA review of errors maintained for ____
A
3 years
9
Q
List four elements that must be present for civil lawsuit:
A
duty, breach of duty, causation, damages
10
Q
_________: a dereliction of professional duty or a failure to exercise an accepted degree of professional skill or learning by one rendering professional services which results in injury, loss, or damage
A
malpractice
11
Q
______: a legally enforceable obligation to conform to a particular standard of conduct
A
duty
12
Q
negligence per se:
A
violation of statutes or regulations
13
Q
does causation need to be direct?
A
no
14
Q
Speer v. US
A
superseding cause: patient stockpiled drugs and committed suicide - not foreseeable, so pharmacist not liable
15
Q
Emerging duty
A
“institutional controls” - requires pharmacy owner or chain to institute a system of risk management to reduce number of errors in its pharmacies
16
Q
vicarious liability
A
pharmacy liable for damages caused by its employees if they are acting within the course and scope of their duties for the pharmacy
17
Q
Harco v Holloway
A
vicarious liability of pharmacy for damages caused by employees
18
Q
Duensing v Huscher
A
child gets phenobarb suppositories instead of aspirin suppositories, 22K for damages, 15K for punitive. Rx filled by non pharmacist, no pharmacist present
19
Q
Orzell v Scott Drug
A
plaintiff who is harmed due to own illegal conduct may have responsibility, may be barred from recovery or damages may be reduced
20
Q
statute of limitations: in CT, _____
A
2 years from discovery, 3 years from act
21
Q
are retail sellers liable for faulty products?
A
yes, under some circumstances
22
Q
_________: Rx manufacturer owes duty to patient to warn physician but not the patient directly
A
learned intermediary
23
Q
exception to learned intermediary protection for pharmacists:
A
compounding
24
Q
Fleet and Semple v Hollenkemp
A
it is the duty of druggists to know the properties of the medicine which they vend, and to employ people who can discriminate and compound according to prescription and they are responsible for any consequences if they depart from the prescription, even if they are in general very careful
25
what does malpractice insurance generally cover?
cost of defense and payment of claims
26
what does malpractice insurance generally not cover?
damages due to willful violations or violations of store/chain policy
27
Kampe case
upheld traditional view that the pharmacist has a duty only to give the right medication
28
Horner v Spalitto
pharmacist should have applied knowledge but they need more info on case to say... ?
29
Hooks SuperX v McLaughlin:
CT: Pharmacists possessing superior knowledge needed by patients have a duty to warn of known risks
30
Springhill Memorial Hospital v Larrimore
learned intermediary shields the pharmacist
31
DiGiovanni v Albertson's
learned intermediary shields the pharmacist
32
Plante v Lomibiao, Deed v Walgreen, Robles v AstraZeneca show that
CT apparently adheres to traditional LI principle
33
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Enacted in 1994, applies to dietary supplements and ingredients. Manufactures wishing to use new dietary ingredients must notify FDA 75 days before marketing the product and provide FDA with evidence showing that ingredient will reasonably be expected to be safe. FDA does not need to approve application.
34
Label of Dietary Supplement:
name, including the word supplement, quantity of contents, name and place of manufacturer, directions for use, serving size, dietary ingredients, amount per serving size, %DV, scientific name of any botanical, other ingredients, "this statement not evaluated by FDA. Not intended to..."
35
what claims are permitted on dietary supplements?
"structure-function" claims, general well-being, describe benefit related to nutrient deficiency disease as long as statement tells how widespread the disease is in US
36
Structure-Function claims:
describe the role of a nutrient or dietary ingredient: calcium builds strong bones
37
Proposed new dietary supplement guidelines:
Safety of supplements would be evaluated according to:
- documented history of use
- formulation and proposed daily dose
- recommended duration of use
38
would proposed new dietary supplement guidelines require any human studies?
no
39
Under DSHEA, FDA may remove a dietary supplement from the market if:
it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use
40
lazy cakes =
adulterated food
41
Poison Prevention Packaging Act:
1970 - protect children under 5 from poisoning from ingestion of hazardous substances from open containers
42
Child-Resistant Container:
80% of children under 5 cannot open and at least 90% of adults can open
43
child resistant container exemptions:
elderly or handicapped - label says not child resistant. Also unflavored powder or effervescent tablets of aspirin or acetaminophen
44
Collaborative Drug Therapy Management (CDTM)
prescribers authorize pharmacists to engage in specific activities such as initiating, adjusting, or evaluating drug therapy. Generally requires a written guideline or protocol
45
T/F: Authorization for collaborative practice agreements usually requires amending the definition of the practice of pharmacy at the state level to authorize agreements
T
46
In most states, collaborative practice agreements must be filed with and approved by ______
The Pharmacy Commission
47
Washington Program (Collaborative Practice Agreement):
Pilot program to provide emergency contraceptives through pharmacies
48
CT Collaborative Practice. Are there restrictions on practice settings? On drugs? On conditions?
No no no
49
NY Collaborative Practice:
teaching hospitals only
50
ME Collaborative Practice:
Nope
51
NH Collaborative Practice:
hospital, ambulatory clinic, LTC, hospice
52
When deciding whether to make medication OTC, FDA usually seeks recommendation of a joint advisory committee made up of members of the agency's ____. Are they bound by the advisory's counsel?
Nonprescription Drugs Advisory Committee. No
53
the FDA has approved the switch of a number of drugs from prescription to OTC status under ____
NDAs
54
Durham-Humphrey Law
two system dichotomy - OTC or Rx
55
HIPAA is enforced by _____________
the Office of Civil Rights of HHS
56
PHI =
protected health information
57
HIPAA says pharmacy must develop and distribute a notice of privacy and must make a good faith effort to
obtain a written acknowledgement that the patient received it. They also have to post the privacy notice in a prominent area of the pharmacy
58
How long is privacy acknowledgement retained for?
6 years
59
can information be disclosed without consent if it concerns a victim of abuse, neglect, or domestic violence?
yes
60
Incidental disclosure:
A disclosure that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another use or disclosure that is permitted by the rule
61
What privacy rules govern suits?
State privacy rules, not HIPAA
62
New Self Reporting regulations
must notify patients when breach of PHI is discovered. Give plain language notice by mail or email within 60 days
63
written accountings for information not subject to the exemptions must include for each disclosure:
- date of disclosure
- name of the entity who received PHI, and address
- description of PHI disclosed
- statement of purpose of disclosure
64
covered entities have _____ to meet requests for accounts of PHI disclosures
60 days, additional 30 day extension is allowed
65
individuals are entitled to accounts that list PHI disclosures for the past _____. Frequency of accounting without charge is ____.
6 years/ 12 months
66
pharmacy must designate a ______ responsible for development and implementation of privacy policies and procedures as well as a ______ to the public to receive complaints.
privacy officer/ contact person
67
PHI disclosure penalty system: __/ incident, __/ year for innocent breach
100/ 25,000
68
PHI disclosure penalty system: __/ incident, __/ year for non-innocent breach
1,000/ 100,000
69
PHI disclosure penalty system: __/ incident, __/ year for willful breach
50,000/ 1.5 million
70
criminal: _____ v___
govt/ private party
71
civil: _____ v_____
private party/ private party (or govt)
72
administrative: __ v__
agency/ private party
73
___: statute, act, ordinance
law
74
laws are enacted by
a legislative body
75
regulation: _____
derives from and interprets law
76
regulations are enacted by
administrative agencies such as the FDA or the Pharmacy Commission
77
___ fills in "gaps"
regulation
78
common law: ______
court decisions
79
common law is enacted by
judicial body
80
_______ acts as quasi-judicial role (e.g. hearing to suspend license)
administrative agency
81
Pharmacy law derives from _______
police power
82
_______: power of a state to enact laws promoting public health, safety, morality and welfare. Must be reasonably related to protecting the public
police power
83
In CT, Pharmacy is regulated by ______
Department of Consumer Protection
84
______ is a board that advises and assists DCP in adopting regulations and enforcing laws and rules
Commission of Pharmacy
85
Practice Act defines
- pharmacy
- how it is practiced
- by whom
- where it is practiced
- conditions of practice
86
Describe the composition of CT Pharmacy Commission:
6 members appointed by the Governor, 4 pharmacists (at least 2 community, 1 hospital), 2 public members
87
How often must pharmacy license be renewed?
every 2 years
88
how often does the CT Pharmacy Commission meet?
at least 6 times per year
89
T/F: A copy of meeting records from pharmacy commission meeting can be admitted as evidence in a civil or criminal case.
T
90
Are pharmacy commission meeting records available to the public on request?
yes
91
Which of the following are not licensed by the CT commission? Long term care, infusion therapy, nuclear pharmacy, hospital pharmacy, community, specialty pharmacy
hospital pharmacy
92
CT Pharmacy Commission can compel attendance at ______
hearings
93
CT Pharmacy Commission can produce documents by _____
subpoena
94
CT Pharmacy Commission can administer _______
oaths
95
CT Pharmacy Commission can grant temporary and permanent ______
injunctions
96
CT Pharmacy Commission can grant temporary ________ pending a hearing
restraining orders
97
how often does the commissioner inspect retail pharmacies?
every four years
98
are pharmacist recognized as health care providers by the state of Connecticut?
yes
99
what do pharmacists do?
dispense
100
does dispensing include delivering a drug to a patient?
no
101
does dispensing include administering a drug to the patient?
no
102
what is the required intern experience for a pharmacist's license in CT?
1500 hours, NMT 40 hours/ week
103
is a written application required for a CT pharmacy license?
yes
104
how often are pharmacy licensing exams given?
twice a year
105
The pharmacy license form is furnished by
the department of consumer protection
106
how far in advance must the application be submitted prior to the pharmacy licensing exam?
45 days
107
list the three parts of the pharmacy licensing exam:
NAPLEX, Contemporary Pharmacy Practice, Jurisprudence (MPJE and State specific)
108
what are the competency areas tested on the NAPLEX (3)
- manage drug therapy to optimize patient outcomes
- assure safe and accurate preparation and dispensing of medications
- provide drug information and promote public heath
109
What covers licensing of pharmacists and pharmacies?
CT Pharmacy Practice Act
110
What is the MPJE?
Multistate Pharmacy Jurisprudence Examination
111
What are the 3 competency areas of the MPJE?
- pharmacy practice
- licensure, registration, certification & operational requirements
- regulatory structure and terms
112
is the MPJE in the kind of testing format you like?
no
113
what are the additional requirements for foreign graduates?
- pass TOEFL
| - pass FPGEE
114
How many CE hours must you have per year?
15
115
how many CEU/year?
1.5
116
how many CE hours must be live each year?
5
117
how many CE hours must be in pharmacy law?
1
118
can CE credits be carried forward?
yes
119
for how long are records of CE credits retained?
3 years
120
are CE credits required for first time license renewal?
no
121
a retired pharmacist holding an inactive license may obtain a CE waiver. To reinstate, need _____ hours ( __ live)
30/ 10
122
What covers registering pharmacy interns and technicians?
CT Pharmacy Practice Act
123
Reciprocity: has practiced for ____ year in the last ___ or has been licensed by exam within the last ___
1/ 5/ 12 months
124
reciprocity: must pass _____ exam and sit for ___
CT pharmacy law/ interview
125
Temporary permit to practice pharmacy - expires when licensed in CT or not later than ____ from date of issuance, whichever comes first
3 months
126
pharmacy interns must have completed at least ___ years of college and be enrolled in accredited SOP
2
127
supervising pharmacist may supervise training of how many interns?
one
128
ratio of technicians to pharmacist: retail:
3:1 - one must be certified technician or else 2:1
129
ratio of technicians to pharmacist: IV, unit dose, compounding:
3:1
130
pharmacist may refuse to supervise 3 in _____ setting only
retail
131
can techs accept new phoned prescriptions?
no
132
can techs consult with patients or practitioners?
no
133
Penalties for Violation of Practice Act:
suspension or revocation of license, up to 5K fine for each offense, up to 5 years in jail
134
what must be on a prescription?
name and address of prescriber and patient, date, name, dosage form, strength, and amount of drug, directions, refills, any cautionary statements, serial number, date filled, refills recorded on back
135
how long must prescriptions be kept on file?
3 years
136
what must be on a label?
name and address of pharmacy, name of patient, name of prescriber, serial number of prescription, directions, name of drug, drug quantity and expiration date
137
What covers investigation of pharmacy complaints?
CT Pharmacy Practice Act
138
a pharmacy receiving a transferred Rx must note:
names of transferring pharmacy and pharmacist, date of issuance, serial number of original Rx, date original was first dispensed, number of refills authorized, complete refill record, number of valid refills remaining
139
for non-controlled substances, a fax
may be saved as original if non-fading and durable, otherwise, reduce to writing, photocopy or convert into hard copy printout
140
in an emergency situation, a prescription may be refilled ___ for a quantity of drug not to exceed a ______ supply
once, 72 hour
141
you need an Rx for >___ hypodermic needles
10
142
how long is a prescription for hypodermic needles good for?
1 year, but seller must confirm continuing need with prescriber every 6 months
143
how long do you keep an Rx for hypodermic needles?
3 years
144
how many pharmacies can one pharmacist manage at the same time?
one
145
how many hours per week must a pharmacy be open?
35
146
pharmacies may be closed on an unscheduled basis for ____ consecutive day(s), NMT __ in 30 days and NMT ______ times in a year
1/ twice/ 18
147
pharmacy manager must report unscheduled closing to commission within ____ hours
72
148
What covers disciplinary action (revocations and sanctions)
CT Pharmacy Practice Act
149
T/F: if a pharmacy is located out of state and ships or mails Rx drugs to CT, it must register with the CT Pharmacy Commission
T
150
Name 6 entities regulated by the Federal Food and Drug Law
- manufacturer
- wholesaler
- packer
- shipper
- practitioner
- drug retailer
151
drugs are articles recognized in the _____, _______ or ______
US Pharmacopoeia, National Formulary, Homeopathic Pharmacopoeia
152
A drug is considered new when:
- new substance (active or excipient)
- new combination of approved drugs
- proportion of ingredients in combination has changed
- new intended use for the drug
- dosage, method, or duration of administration is changed
153
a drug is considered adulterated if manufactured under non ______ conditions
GMP
154
does the FDA have to prove that a drug is actually adulterated?
no
155
_______ standards are officially recognized by FDCA and enforceable by FDA
USP
156
if USP monograph exists for product, it must
conform to standards or say "Not USP" on it
157
Prior to ____ there were no standards, no assurance of safety, no required labeling
1906
158
the _________ enacted in 1906 prohibited the movement in interstate commerce of "adulterated" and "misbranded" food, drugs, cosmetics and devices
Pure Food and Drug Act
159
the Pure Food and Drug Act required that labeling on drugs be ______
truthful
160
the _________ in the Department of Agriculture was empowered to administer the Pure Food and Drug Act
Bureau of Chemistry
161
Did the Pure Food and Drug Act require that ingredients be put on the label?
with some exceptions, no
162
US v Johnson (1911)
Supreme Court: misbranding did not apply to false therapeutic claims of drugs
163
Food Drug and Cosmetic Act required
1938 - filing of NDA and premarket evidence of safety for all drugs (approval by FDA). Drugs on the market prior to 1938 were grandfathered
164
The FDCA eliminated the Sherley Amendment requirement to
prove intent to defraud in drug misbranding cases
165
What covers maintenance of prescription records?
CT Pharmacy Practice Act
166
the FDCA authorized ______ inspections
factory
167
the FDCA added the remedy of _______ to the previous penalties of seizures and prosecutions
court injunctions
168
the ______ to the FDCA formally distinguished between Rx and OTC drugs
Durham-Humphrey Amendment
169
________ authorized oral Rx and refill
Durham-Humphrey Amendment
170
Prescription drugs are exempt from the requirement of adequate directions for use by a lay person as long as the drug's labeling bears a ______
statement (known as legend)
171
the _________ required manufacturers to prove effectiveness of new drugs. It was precipitated by the thalidomide tragedy.
Kefauver-Harris Amendment
172
____: First application a sponsor provides to FDA
IND
173
IND includes all ___________ studies relating to safety and efficacy of drug
preclinical
174
IND gives complete description of ____________ for testing on humans
clinical protocols
175
IND describes ______ and quality control methods
manufacturing
176
FDA has __________ to decide on an IND
30 days
177
Phase _________ trial: small number of patients with indicated diseases. Tests effectiveness, dosing, safety, side effects.
2
178
the _______ required manufacturers to report adverse events to FDA
Kefauver-Harris Amendment
179
Phase ________ trial: small number of healthy volunteers, assess safety in humans, pharmacokinetic and pharmacologic properties. Usually males.
1
180
Phase _____ trial: larger number of patients in several locations. Test effectiveness. Usually double-blind against placebo.
3
181
Informed consent via writing for which phases of trials?
I, II
182
Oral informed consent permissible for which phase(s) of trials?
III
183
The _______ authorized the FDA to regulate Rx drug advertising and to require that advertising to physicians disclose risks as well as benefits
Kefauver-Harris Amendment
184
_____: sponsor submits data from clinical trials along with documentation on toxicity, stability, production methods, packaging and proposed labeling
NDA
185
_______: 1962 amendment that required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that the FDA had approved as safe between 1938 and 1962
DESI
186
__________: provides for review and approval of generic equivalents.
ANDA
187
ANDA (Abbreviated New Drug Application) was established by the _______________, or _______
Drug Price Competition and Patent Term Restoration Act of 1984/ Waxman-Hatch Act
188
ANDA requires proof of _____________ equivalence (3)
pharmacokinetic, bioavailibility, clinical
189
bioequivalence: based on _________ data
pharmacokinetic
190
bioequivalence: complex formula generally between ___ and ____ of reference compound
80%, 125%
191
the ____ was mandated by the Waxman-Hatch Act. Actual title: Approved Drug Products with Therapeutic Equivalence Evaluations
Orange Book
192
_______: abbreviated licensure pathway for biological products that are demonstrated to be interchangable with an FDA-licensed biological product. Includes vaccines, proteins, blood products, gene therapy
biosimilars
193
_________ is an abbreviated application used for new synthesis, new production procedure, new manufacturing location, new packaging, labeling, or new use
supplemental NDA
194
________ instituted NDA
Kefauver-Harris Amendment
195
______________ allows administration of investigational new drug to patients not enrolled in the clinical trial
Treatment IND
196
For Treatment IND, drug must be in _________ with preliminary evidence of efficacy
phase 2 or 3
197
_______: drugs will have finished phase 1 and pharmacokinetic testing. There will be some data available on their interactions with drugs in common use. They will have shown sufficient efficacy to warrant wider release
Parallel Track
198
Special Distribution Programs: ____ Isotretinoin (Accutane). Patient signs document about risks, agrees to monthly doctor visits, two forms of contraception, registered in national database, pharmacist checks database for identification code
iPLEDGE
199
______ may only be prescribed and dispensed by physician and pharmacist registered with _________ National Registry. Must supply current blood results before dispensing
clozapine
200
________ program for thalidomide: 28 day supply, no refill, use monitored by mandatory patient survey, pregnancy testing and birth control
STEPS
201
_______ program for TYSABRI for MS (increased risk of progressive multifocal leukoencephalopathy PML)
TOUCH
202
_____ (GHB, sodium oxybate) requires patient enrollment and review of educational materials on safe and appropriate use
Xyrem
203
_______ clarified FDA authority on devices
Medical Device Act - 1976
204
Medical Device Act Class _: requires pre-market approval: heart valves, pacemakers, soft contact lenses
Class III
205
_________ instituted GMPs
Kefauver-Harris Amendment
206
What needs to be on an OTC label?
- active ingredients, including amount in each dosage unit
- purpose of the medication
- indications for the drug
- specific warnings, including when not to use and when to consult health care provider
- directions - when, how, how often to take
- allergy information
207
Rx drug label includes:
- manufacturer's name and address
- name of drug
- ingredient information
- strength
- net quantity
- recommended or usual dose
- legend
- route if not oral
- C if controlled
- lot number
- statement to pharmacist if special container is needed
- expiration date
- optional NDC
208
T/F FDA requires NDC number on label
F: recommended but not required
209
package insert includes
- name and generic name
- description
- clinical pharmacology
- indications and usage
- contraindications
- warnings
- precautions
- adverse reactions
- overdosage
- dosage and administration
- how supplied
210
are pharmacy generated consumer leaflets regulated by the FDA?
no
211
advertising for over the counter drugs is regulated by
the Federal Trade Commission
212
prescription drug advertising is regulated by
FDA thanks to FDCA
213
Medical Device Act Class __: must meet specific performance standard: insulin syringe, tampons, thermometers, heating pads
Class II
214
Medwatch is generally voluntary, but mandatory if ___
IND
215
Class III recall:
unlikely to cause adverse health effects
216
Class II recall:
temporary or reversible effects. Affects pharmacy stock
217
Class I recall:
drug product may cause serious adverse health effects. Recall includes pharmacy stocks and letter to users
218
Does FDA have statutory authority to order recall?
no
219
Medical Device Act Class __: least regulation: needles, toothbrushes
Class I
220
____________ regulates distribution of free samples, use of coupons redeemable for drugs at no cost or low cost, sale of deeply discounted drugs to hospitals and health care entities
Prescription Drug Marketing Act
221
_____________________ mandated inspection of manufacturers every 2 years
Kefauver-Harris Amendment
222
_____ limits outdoor tobacco advertising within 1000 ft of schools and playgrounds, ban sports and entertainment sponsorships, light or mild descriptions of cigarettes, ban candy or fruit flavors, allows FDA to limit amount of nicotine or other ingredients
Family Smoking Prevention and Tobacco Control Act
223
Title I of Comprehensive Drug Abuse Prevention and Control Act of 1970:
rehab programs for drug abusers
224
Title II of Comprehensive Drug Abuse Prevention and Control Act of 1970:
registration and distribution of controlled drugs
225
Title III of Comprehensive Drug Abuse Prevention and Control Act of 1970:
Importation and exportation of controlled substances
226
________: tax and importation act passed in 1914 to control opium trade. Provided for licensing and payment of a fee for manufacturers, importers, pharmacists, physicians.
Harrison Act
227
____ put limits on narcotics in OTC products - larger quantities could be obtained by Rx
Harrison Act
228
Harrison Act stated that treatment of ___ was not legitimate medical purpose
addicts
229
___: Title II of Comprehensive Drug Abuse Prevention and Control Act of 1970
CSA
230
CSA is enforced by ___
DEA of Federal Department of Justice
231
Drug Scheduling: ___ requests from ___ a scientific and medical evaluation and recommendation as to control. ___ solicits info from ___ and ____, compiles this info, and gives it back to ___. If it is recommended not to be controlled, it can't be controlled
DEA/HHS/ HHS/FDA/NIDA/DEA
232
What schedule drug is GHB?
I
233
what schedule drug is secobarbital?
II
234
what schedule drug are long acting barbs such as phenobarb?
IV
235
what schedule drug are benzos?
IV
236
_______ allowed any chemical substantially similar to an illegal drug to be treated as illegal if intended for human consumption
Federal Analog Act
237
Are there any federal laws or regulations that limit the quantity of controlled substances that may be prescribed?
no
238
in CT, controlled drug must be filled within ___ of issue date
6 months
239
are refills allowed for Schedule II drugs?
no
240
refills for C III-V?
yes, up to 5 times in 6 month period from date of issue, record refill on back of Rx
241
can CIII-V refills be authorized orally?
yes
242
what needs to be on a controlled rx label?
name of pt, prescriber, name and address of pharmacy, serial number, directions, date, warning not to transfer to other person (except C-V)
243
CIII-V may be transfered ___
once
244
when transferring CIII-V,
- write "void" on face of rx
- record name, address, DEA number of receiving pharmacy and pharmacist on back
- receiving pharmacy writes "transfer" on face
245
can pharmacist dispense C-II on oral rx in emergency?
yes, must have signed rx delivered to pharmacy within 7 days, needs to have "authorization for emergency dispensing" and date of oral order written on front
246
when can fax serve as original C-II Rx?
resident of LTC facility, patient in licensed hospice, compounded for direct administration to patient by the parenteral route
247
Schedule II partial orders:
note quantity supplied on face of Rx, balance must be filled within 72 hours (60 days if for pt in LTC with terminal illness)
248
Schedule III-V partial orders:
partial filling recorded in same manner as a refill
249
how often to take inventory in CT?
q 2 years
250
how long to keep inventory in CT?
3 years
251
fine for inadequate record keeping:
$25,000
252
Which schedule counts can be estimated?
CIII-V, unless container holds more than 1,000 tablets or capsules
253
what form do you use to order schedule I or II drugs?
DEA form 222
254
what part of DEA form 222 does pharmacy keep? supplier? DEA?
3/1/2
255
______: may authorize one or more persons to obtain or execute CII order form
Power of Attorney
256
how to transfer CIII-V between pharmacies:
invoice
257
how to transfer CII between pharmacies:
DEA Form 222
258
if total number of dosage units distributed exceeds ___ of total units distributed and dispensed in one year, pharmacy required to register as a distributor
5%
259
Form for reporting theft or loss to DEA:
DEA Form 106
260
Form for destruction of controls:
DEA Form 41, at least 2 weeks in advance
261
_________ establishes penalties for stealing drugs from people registered with the DEA, fines and jail time for killing pharmacists
Controlled Substance Registrant Protection Act of 1984
262
US v Hughes
pharmacist should attempt to verify validity of questionable Rx
263
VT & 110th Medical Arts Pharmacy v Board of Pharmacy
use common sense and professional judgement
264
Lawson
court convicted pharmacist - he should have known not for legitimate purpose
265
Anabolic Steroids Control Act made steroids schedule __
III
266
Ryan Haight Online Pharmacy Consumer Protection Act
Amends CSA - prohibits dispensing controlled substances via the internet without a valid prescription
267
______ makes it a crime to use the internet to advertise the illegal sale of a controlled substance by means of the internet
Ryan Haight Online Pharmacy Consumer Protection Act
268
controlled substance prescription must have
- name and address of patient and prescriber
- name of drug and amount
- indicate adult or child or age of patient
- directions
- date
- DEA number of prescriber
- be in ink, indelible pencil, or typed, no photocopy or rubber stamp
- C-II only one Rx per blank
- cannot be post dated
- cannot be issued for an inanimate obect or thing
- must be kept for 3 years in CT
269
What info can, after proper consultation, be changed on a C-II prescription?
- patient's address
- drug strength
- drug quantity
- directions for use
- dosage form
270
What info cannot be changed on C-II prescriptions?
- patient's name
- substance prescribed (except for generic substitution if allowed)
- prescriber's signature
- date
271
Schedule V Exemptions: Rx not needed for
4 fl oz stokes expectorant,
4 fl oz brown mixture,
8 fl oz camphorated tincture of opium
272
_________________: monitors the prescribing and dispensing of Schedule II-V controlled substances in CT
Connecticut Prescription Monitoring and Reporting System (CPMRS)
273
_____ allows pharmacists and prescribers to review data online to check for patterns of misuse
CPMRS
274
_________ regulates sale of large amounts of ephedrine, pseudoephedrine, and phenylpropanolamine
Comprehensive Methamphetamine Control Act (Federal)
275
_________ prevent diversion of meth precursors - must be placed behind the counter
Combat Methamphetamine Epidemic Act
276
How many grams of PSE can you buy per day? Per 30 days? Per 30 days by mail order?
3.6/ 8/ 7.5
