Final Exam - All Lecture Sets Flashcards
1
Q
Which event most directly led to the passing of the 1938 Federal Food, Drug and Cosmetic Act?
A
The Elixir Sulfanilamide Tragedy
2
Q
Which events caused widespread public outcry and legislative pressure but did not immediately result in legislation?
A
The publication of ‘the jungle’
The American chamber of horrors exhibit
Patent medication scandals
3
Q
What the 1906 Pure Food and Drug Act did?
A
-first federal law regulating meds
-recognized USP and NF as standard drug references
-defined ‘misbranding’ and ‘adulteration’ and assigned their penalties
-established the party responsible for the above penalties as the bureau of Chemistry in the US department of agriculture. Was renamed to the FDA in 1930
4
Q
3 official compendia
A
-USP
-NF
-HPUS (homeopathic)
5
Q
Adulteration and Misbranding -
is the product in the bottle what it is intended to be? If the answer is no, it is ____
A
adulterated
6
Q
class I devices
A
NOT used for supporting human life and/or preventing impairment of human health, do NOT present a potential unreasonable risk of illness of injury
7
Q
class II devices
A
moderate risk to use, require special controls to assure safety and effectiveness of devices
8
Q
class III devices
A
high risk to use, DO support or sustain human life or preventing impairment of human health, and DO present a potential unreasonable risk of illness or injury
9
Q
Adulteration and Misbranding -
is the packaging containing the product (or which must accompany the product) what it is intended to be? If the answer is no, then it is _______
A
misbranded
10
Q
misbranded if:
A
- label is false or misleading
- label does not contain manufacturer, packer, or distributor
- accurate quantity of contents
- required info is NOT PROMINENTLY displayed or clearly stated
- established name (generic name) not included (at least half as large as proprietary (brand) name)
- directions for use
- warnings
11
Q
proprietary name = ?
A
brand name
12
Q
established name = ?
A
generic name
13
Q
examples of how a drug can be both ADULTERATED and misbranded
A
- A PRODUCT IS STORED OUTSIDE ITS RECOMMENDED TEMPERATURE, leading its label to fall off due to adhesive failure.
- AN EXPIRED DRUG IS COUNTED AND PUT INTO A PRESCRIPTION BOTTLE and then dispensed to a patient.
14
Q
importance of US v Johnson
A
claim was that PF&DA only prevented false statements of a drugs identity and not false or misleading efficacy claims
15
Q
1912 Shirley Amendment did what?
A
-amended the PF&DA because of US v Johnson
-prohibited manufacturers from INTENTIONALLY misleading claims about drug effectiveness
-did not address drugs already on market, especially those with known risk and false claims
16
Q
1938 Food, Drug and Cosmetic Act
A
-required new drugs be proven SAFE before marketing
-REPEALED Shirley amendment
-authorized factory inspections
-required selected dangerous drugs to be administered under direct supervision of a qualified expert
17
Q
definition of a drug as defined by the Federal Food, Drug and Cosmetic Act
A
- articles recognized in official compendia
- articles intended for the diagnosis, cure, mitigation, treatment, or prevention of disease (in humans or animals)
- articles (other than food) intended to affect the structure or any function of the body
- articles intended for use as a component of any articles specified in 123
18
Q
1950 Alberty Food Products Co. v US
A
in order for the drug to bear ‘adequate directions for use’ it must, among other things, state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligibly and safely attempt self medication
19
Q
1951 Durham-Humphrey Amendment
A
-OTC meds could be labeled with ‘adequate directions for use’
-legend drugs had to be dispendsed under supervision of a health practitioner as a prescription drug and carry the statement “caution: federal law prohibits dispensing without a prescription.”
-also allowed verbal transmission of prescriptions and refills for prescriptions
20
Q
1962 Kefauver-Harris Amendment
A
- Required drugs be SAFE and EFFECTIVE (applied to all drugs marketed between 1938-1962)
- transferred jurisdiction of Rx drug advertising from FTC to FDA
- established cGMP
- research: informed consent of subjects and reporting of ADR
21
Q
If you don’t comply with cGMP, a drug is considered adulterated, misbranded or both?
A
adulterated
22
Q
If you don’t register with the FDA, a drug is considered adulterated, misbranded or both?
A
both
23
Q
how often must drug manufacturers undergo inspections?
A
at least once every 2 years
24
Q
pharmacy or traditional compounding (503a) includes:
A
- pursuant to a prescription only
- for an individual patient
- done by pharmacist, physician, or another individual under their direct supervision
- ingredients comply with USP-NF
- cannot be a copy of a commercially available product
- can be done in advance but on a limited basis
25
outsourcing facilities (503b) include:
1. compound without receiving a prescription for a patient
2. must register, pay annual fees, and be inspected by FDA
3. compounding cannot be a copy of a commercially available product
26
503b facilities product labels must include:
1. 'this is a compounded drug'
2. name, address, and phone number of outsourcing facility
3. lot number or batch number
4. established name of the drug
5. strength
6. quantity
7. BUD
8. storage and handling instructions
9. NDC
10. 'not for resale'
11. a list of active and inactive ingredients
27
Drugs that were 'grandfathered in' to be considered safe and effective under the Kefauver-Harris Amendment
drugs that came out before 1938 (and are still on the market) are considered to be safe and effective.
28
1968: Drug Efficacy Study Implementation (DESI) did what?
1. reviewed all medications approved between 1938-1962 for efficacy and made recommendations to the FDA
2. FDA then makes decisions on these drugs but in the mean time the product is to stay on the market until that decision is made
29
drug development process steps
1. discovery and development of novel chemical for drug consideration
2. Step 1: preclinical research (in vivo animal studies)
3. Step 2: submission of IND
4. Step 3: Clinical research
-phase I, II, III
5. Step 4: NDA
6. post-market safety monitoring
-Phase IV
30
What Step 1: preclinical research (in vivo animal studies) looks at
in vivo animal testing for toxicity and pharmacology of the product
31
What Step 2: IND looks at
1. drug must be shown safe and effective to submit IND
2. IND must contain:
-animal pharmacology and toxicology studies
-manufacturing info
-clinical protocols and investigator info
32
What Step 3: clinical research phase I looks at
1. 20-100 healthy volunteers receive the drug to evaluate the safety and dosage of the compound
2. baseline human PK and pharmacologic properties are also reviewed and reported
3. happens across several months
33
What Step 3: clinical research phase II looks at
1. several hundred volunteers who have condition or disease being studied
2. goal is to expand info on safety and AE and to determine effectiveness of therapy
3. continues up to 2 years
34
What Step 3: clinical research phase III looks at
1. drug given to hundreds or thousands of pts in several geographic locations who have the conditions or disease being treated
2. drug compared to placebo (usually double blind)
3. goal is to demonstrate efficacy at a higher power and expand info on AE
4. continues up to 1-4 years
35
What Step 4: NDA looks at
A. NDA is submitted by sponsor to the FDA with all info studied
B. must include:
1. proposed labeling
2. safety updates
3. drug abuse info
4. patent info
5. any data from studies that have been conducted outside US
6. institutional review board compliance info
7. directions for use
36
1983 orphan drug act did what?
provided a lower statistical burden for proof of safety and efficacy when appropriate and also allowed:
1. tax incentives for orphan drug production
2. enhanced patent protection and marketing
3. clinical research subsidies
4. government incentive to engage in drug research
37
1984 Hatch-Waxman Act did what?
-AKA: the drug price competition and patent term restoration act
to reduce the requirements of approval of generic prescription drugs
38
before hatch-waxman
-FDA approval for generic cannot be started until after brand patent expires
-generic companies had to perform own safety and efficacy studies
after hatch-waxman
-generic companies can prepare for approval without impinging on patent
-generic companies only had to prove bioequivalence and proof of acceptable manufacturing practices and controls
39
what is an abbreviated NDA
pathway for generic drug approval
1. does not need animal or human clinical trial data to establish safety and effectiveness
2. must be bioequivalent, meaning delivers the same amount of drug in the same amount of time
40
1970 poison prevention packaging act (PPPA) describes special packaging as:
1. targeted as kids under 5 yo
2. not difficult for normal adults to access
3. most kids under age 5 should struggle to open, and those that can open it will be prevented from obtaining a toxic amount in a reasonable time
41
what does child resistant mean?
child resistant means 20% of children or less can open packaging in 10 minutes
AND
at least 90% of adults can open after 10 minutes
42
drugs for ORAL admin require special packaging, including
OTC, Rx, controls, and samples or oral products
43
Drugs intended to be dispensed in the manufacturers packaging must be in ____
CRCs
*if not dispensed this way, may be considered misbranded
44
Bulk products and unit dose containers are/are not required to be manufactured in CRCs
are not
*if not dispensed this way, may be considered misbranded
45
special packaging exemptions
1. non-oral dosage forms
2. waivers
-given by pts or providers for a single prescription
-blanket waivers, given by pt only, waives CRC requirement for all of that pts prescriptions
3. Consumer Product Safety Commission (CPSC) exemptions
46
Consumer Product Safety Commission (CPSC) notable exemptions
1. SL nitroglycerin
2. oral contraceptives in mnemonic dispenser packages
3. steroid dose packs
4. some oral formulations
5. unit-dose potassium
47
exception to reusing packaging
-in general, don't reuse packaging
-one exception is for glass that has a new cap used (safe to reuse)
48
1982 Chicago Tylenol Murders significance
-exposed OTC drug safety faults
-required tamper-evident packaging for OTC human products
-federal anti-tampering act makes tampering a federal crime in 1983
49
Recall Class I
Drug product may cause serious adverse health consequences including death (pharmacies notify pts who received recalled drugs)
50
Recall Class II
drug may cause temporary or reversible effects, but the probability of serious health consequences is remote
51
Recall Class III
drug product is unlikely to cause serious adverse health consequences
52
a drug ______ is voluntary, while a ______ is not
recall, seizure
53
Label vs. Labeling
-Label definition
any printed, written or graphic material on the product container
-label is part of labeling
54
Label vs. Labeling
-Labeling definition
all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product
55
If a drug on a shelf at the pharmacy does not have a package insert, it is _______
misbranded
56
List the 3 sections related to reproduction in PIs
1. pregnancy
2. lactation
3. females and males of reproductive potential
-used to be pregnancy cat. A, B, X, etc.
57
Patient package inserts differ from PIs how?
-written in pt friendly language
-MUST be dispensed with the drug they correspond to whenever that product is being dispensed. failure to do this is MISBRANDING
-rqrmnts apply to ANY person that dispenses these, including institutions and practitioners
58
List the drugs requiring PPIs
1. estrogens
2. oral contraceptives
59
what are medication guides?
FDA-approved labeling written in pt-friendly language that explains issues related to a drug or drug class
1. must be provided with new and refill prescriptions for pts in an outpt setting (not rqrd under direct healthcare professional supervision)
60
when are medguides required?
when one or more of the following exists:
1. labeling could help prevent serious adverse effects
2. serious risks of use exist which pts should be made aware of
3. pt adherence to directions is crucial to drug effectiveness
61
failing to dispense a Medguide with a drug that requires one is considered ______
misbranding
62
What are REMS for
Risk Evaluation and Mitigation Strategy
-used to address serious risks associated with using a medication or class of medications
-can be rqrd by FDA for drug labeling
63
name the 4 REMS types
1. pt-friendly labeling
2. communication plans
3. elements to assure safe use (ETASU)
4. implementation system
64
1. pt-friendly labeling
med guides and PPIs
65
2. communication plans
info sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for pts
66
3. elements to assure safe use (ETASU)
required activities that must be done before prescribing, dispensing, or receiving a product. Can be rqrd for pharmacies, pts, practitioners
67
4. implementation system
a quality assurance process to ensure that risks are being mitigated successfully
68
ALL OTC products are required to have a drug facts section which includes
1. active ingredients
2. purpose
3. uses
4. warnings
5. directions
6. inactive ingredients
7. other info
69
In addition to the drug facts label, OTC products must have
1. the expiration date, when applicable (if not on label, drug should be considered expired 3 years after purchase)
2. lot or batch code
3. name and address of manufacturer, packer or distributor
4. net quantity of contents
5. description of tamper-evident packaging utilized
70
Medwatch has 2 forms to report AE's for any FDA covered product, what are the 2?
FDA form 3500: for health professionals
FDA form 3500B: for pts
71
pharmacies must provide pts with what to report AE?
a toll free number
72
Name the big 4 prescribers
Dentist
Podiatrist
Veterinarian
Physicians
73
full prescribers prescriptions are honored when?
in any part of the US so long as they are licensed in at least one jurisdiction of the US
74
mid-level prescribers include:
1. APRN
2. PA
3. Optometrist
4. pharmacists
5. naturopaths
6. chiropractors
7. psychologists
75
scope of practice for each of the big 4 - physician
whole body authority for humans
76
scope of practice for each of the big 4 - dentist
mouth and maxillofacial (jaw and face) area for humans
77
scope of practice for each of the big 4 - vet
whole body authority for animals
78
scope of practice for each of the big 4 - podiatrist
feet, ankles, and in some cases, hands for humans
79
MD or DO means what?
they are a physician and therefore can prescribe for whole body authority
80
Federal law technically does not cover what two major things that state laws cover?
1. uniform standards for non-controlled prescriptions in the US
2. prescription expiration or refills
*they do address prescription labels
81
Federal prescription label requirements to be exempted from misbranding:
1. the name and address of the dispenser
2. the serial number of the prescription (Rx number)
3. the date of the prescription or its filling
4. the name of the prescriber
5. IF stated on the prescription, the name of the patient
6. IF contained on the prescription, any directions for use
7. If contained on the prescription, any cautionary statements
82
MOST STRICT between Indiana and Federal law when it comes to REFILLS
refer to chart in notes
83
1990 Omnibus budget Reconciliation Act (OBRA '90) targeted who/what:
targeted spending on mediations by Medicaid beneficiaries
84
4 primary requirements of OBRA '90 related to pharmacy practice:
1. prospective Drug Utilization Review (DUR)
2. retrospective DUR
3. offer to conduct patient counseling
4. maintaining records
*many states applied these laws to all patients, not just Medicaid*
85
Which Act required pharmacy workers to ask, "would you like to speak to a licensed pharmacist today?"
OBRA '90
86
OBRA '90 prospective DUR requirement
pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness
87
OBRA '90 retrospective DUR requirement
states must review medication use of drugs and compare how they are being used against accepted standards
88
OBRA '90 patient counseling requirement
-law requires an offer be made to have a pharmacist counsel the patient
-pharmacist should counsel on matters, which in the pharmacists professional judgement, are significant
89
OBRA '90 patient records requirement
-a reasonable effort must be made by the pharmacist to obtain, record and maintain at least the following information:
1. name, address, phone #, DOB (or age), and gender
2. disease states, allergies and reactions, medication list
*only required for Medicaid patients, but many states have adopted this for all pts
90
1994 Dietary Supplement Health and Education Act (DSHEA)
-passed to clarify the place in the law for dietary supplements
-defined dietary supplement as a product (other than tobacco) intended to supplement the diet that contains one or more of the following:
1. a vitamin
2. a mineral
3. an herb or other botanical
4. an amino acid
91
T/F: dietary supplements have labeling requirements
True
92
dietary supplements labeling requirements
1. the name of the product and the phrase 'dietary supplement'
2. the quantity of the contents
3. the manufacturer's, packer's or distributor's name and address
4. directions for use
5. supplement facts panel containing serving size, ingredients, amount per serving, and %DV
93
Dietary supplements that have any of the 3 claims on their label must include a statement that says what on the label
"this statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease."
94
which of the 3 dietary supplement claims need prior approval by the FDA
health claims and nutrient claims
*structure-function relationship claims do not*
95
1987 Prescription Drug Marketing Act (PDMA)
focused on 4 main aspects:
1. reimportation
2. preferential pricing
3. samples and coupons
4. wholesale licensure
96
PDMA reimportation
1. a drug cannot be reimported into the US unless reimported by the drug manufacturer or for emergency use after FDA review
2. bans importation of American made drugs from foreign countries, not importation of drugs from a foreign country
97
PDMA preferential pricing
1. bans the sale, purchase, or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity
98
PDMA samples and coupons
1. bans the sale, purchase or trade of a drug sample or drug coupon and bans counterfeiting of drug coupons
2. practitioners must ask for drug samples in writing
3. community pharmacies cannot have drug samples at anytime
4. established record keeping, storage, and handling requirements for drug samples
99
PDMA wholesale licensure and more
1. states were required to license wholesalers
2. records related to PDMA must be maintained for at least 3 years
3. whistleblower awards up to $125,000 enacted for reporting someone violating PDMA
100
2013 Drug Supply Chain Security Act (DSCSA)
-included 10 year lead in period and 1 year stabilization period, so law didn't fully go into effect until Nov. 27th, 2024
required:
1. manufacturers and repackagers to add barcodes or QR codes to prescription drug packages
2. manufacturers and wholesalers to verify the legitimacy of products in question within 24 hours of inquiry from a pharmacy
3. any illegitimate products must be brought to the FDA within 24hours of discovery by the manufacturer, repackager, distributor, or dispenser
4. pharmacies must track lot numbers throughout filling process
5. product tracking must be documented for all parts of the supply chain and maintained for 6 years
101
NDC
11 numbers
55555: first 5 identify the manufacturer
-assigned by the FDA
4444: second 4 identify the drug, strength, dosage form and formulation of the product
-assigned by manufacturer
22: last 2 identify the package size
-assigned by manufacturer
102
who represents prescription drug advertising?
FDA
103
who regulates non-prescription drug advertising?
FTC
104
advertising to health care professionals must include:
1. established (generic) name of drug
2. formula of drug
3. AE info
4. CI
5. effectiveness
105
How can advertising lead to misbranding?
if advertising info is false or misleading, or biased in its discussion of AE as compared to effectiveness
106
DTC advertising standards when it relates to a major statement highlighting "SE, warnings, precautions and CI" include:
1. presented in consumer-friendly language
2. presented with appropriate audio (understandable and good pacing)
3. in TV ads, presented in audio and text
4. in TV ads, text must be easily readable
5. free of audio or visual elements that might interfere with the comprehension of the major statement
107
off-label advertising must:
1. have complete, peer-reviewed journal articles published outside of company influence
108
to disseminate the journal articles relating to off-label advertising, a company must:
1. have applied for approval for that indication
2. submit a copy of the info and any clinical trial data the company has at least 60 days before disseminating
3. include the statements:
a. a disclosure noting that the information has not been approved
b. a copy of the official labeling for the product
c. any other products that have been approved for off-label use
d. the funding source for the studies relating to the use
e. a bibliography of publications relating to the use
109
1996 Health Insurance Portability and Accountability Act (HIPAA)
1. applies to 3 groups: health care providers, health plans (insurance), and health care clearinghouses (PBMs, EHR)
110
HIPAA rules
1. privacy
2. security
3. breach notification
4. enforcement
111
HIPAA privacy rule: PHI
information that relates to:
1. a persons past, present or future physical or mental health or condition
2. the provision of healthcare to the person
3. the past, present or future payment for the provision of health care to the person
112
is de-identified health information still PHI?
no
113
HIPAA privacy rule: permitted uses and disclosures
a covered entity MUST disclose PHI:
1. to individuals requesting access to their own PHI AND
2. to HHS when it is undertaking an investigation, review or enforcement action
a covered entity MAY disclose PHI:
1. to the individual
2. for treatment, payment and health care operations
3. for an opportunity to agree or object
4. for incidental use and disclosure
5. for public interest and benefit activities
6. for a limited data set
114
HIPAA breach notification rule
1. if an uncovered entity discovers a breach of unsecured PHI, it is obligated to report that breach
-if breach affects <500 people: report to HHS within 60 days of the end of the calendar year in which the breach was discovered
-if breach affects >500 people: report to HHS within 60 days from the discovery of the breach, report the breach to prominent media outlets serving the state or jurisdiction
115
Drug monographs in the USP have the force of law which means not following that info leaves a drug adulterated, misbranded or both?
both
116
USP 795 focuses on?
non-sterile compounding
-quality and safety
-requires BUDs
117
USP 797 focuses on?
sterile compounding
-includes personnel, training, facilities, environmental monitoring, storage and testing of finished products
118
USP 800 focuses on?
hazardous substances
-discusses handling of hazardous drugs in healthcare setting
119
hazardous means:
1. carcinogenic
2. teratogenic or developmental toxicity
3. reproductive toxicity
4. organ tox. at low doses
5. genotox.
6. new drugs that mimic existing hazardous drugs
120
BUDs shall not be later than the expiration date or:
1 year from the date the drug is dispensed, whichever is earlier
121
In terms of repackaging, when you take the drug out of the stock bottle and put it into the prescription bottle, does this constitute as repackaging?
no
122
FDA knows pharmacies engage in repackaging and do not meet all requirements of the FDCA. They do NOT take action against these pharmacies where these exemptions are in place:
1. a prescription drug product on the drug shortage list
2. a drug product repackaged under direct supervision of a licensed pharmacist
3. if repackaged by a pharmacy, only distributed upon receipt of a valid prescription for an individual pt
4. repackaged product is assigned a BUD as described in the repackaging guidance
123
determining BUDs 1
1. FDA-approved product with specific in use time: BUD established with in-use time or the expiration date on the repackaged product, whichever is sooner
124
determining BUDs 2
2. FDA-approved product without an in-use time, or an unapproved product (a compound):
a. non-aqueous formulation: no more than 6 months or the expiration date, whichever is sooner
b. water-containing oral formulations: no more than 14 days or the expiration date, whichever is sooner
c. water containing topical, mucosal, and semisolid formulations: no more than 30 days or the product expiration date, whichever is sooner
125
determining BUDs 3
3. FDA-approved sterile product with specified in-use time: BUD established with in-use time or the expiration date on the product repackaged, whichever is sooner
126
determining BUDs 4
4. FDA-approved sterile product without a specified in-use time or unapproved product: BUD established by USP 797 or the expiration date of the product repackaged, whichever is sooner
127
2 types of inspections
1. routine (random) inspections
2. inspection triggered by knowledge or suspicion of wrongdoing that may be a danger to public safety
128
who can conduct inspections?
FDA, DEA and state board of pharmacy
129
notice of inspection for by FDA inspectors is what number?
FDA form 482
130
when requesting inspection, a DEA inspector must:
1. state the purpose of their inspection
2. show their credentials
3. provide written notice of inspection to the pharmacy owner or pharmacist in charge
131
What a DEA inspector can do without a warrant:
1. examine records and reports related to controlled substances
2. inspect the premises where controlled substances are kept
3. inventory controlled substances without a warrant
132
what form number is DEA notice of inspection (NOI)?
DEA form 82
133
A DEA form 82 (NOI) lists out these rights:
1. you have the right to require the DEA to get an administrative inspection warrant (AIW)
2. You have the right to refuse an inspection (at which point they will get an AIW)
3. anything incriminating can be seized and used against you in prosecution
4. you will get a copy of the NOI
5. you may withdraw your consent to inspection at any time
134
difference between AIW and search warrants for DEA inspections
AIW: low bar to clear
search warrants: higher bar to clear ("convince a judge that a reasonable person would believe that a crime has been or will be committed on the premises to be searched or that evidence relevant to a crime exists at the premises")
135
when can AIWs and search warrants be served?
AIWs: only during regular business hours
search warrants: any time
136
Do BoP inspectors need a warrant?
no (you cannot say no to these inspections)
137
what the orange book contains
equivalency ratings for products
138
what the purple book contains
interchangeable biological product info
139
To be therapeutically equivalent, a drug must be:
pharmaceutically equivalent AND bioequivalent
140
pharmaceutically equivalent
active ingredient
dosage form
strength
route
labeling
141
bioequivalent
in vivo results (humans
in vitro results (lab)
142
therapeutic equivalence code (TE code)
-1st letter indicates: relevant therapeutic equivalence code
-2nd letter indicates dosage form
143
first letter therapeutic equivalence code of A means what?
product is therapeutically equivalent
144
first letter therapeutic equivalence code of B means what?
product is NOT therapeutically equivalent
145
second letter of TE code means what?
relates to dosage from (has nothing to
146
1914 the Harrison Narcotics Act
1. required importers, manufacturers and distributors of cocaine and opiates (narcotics) to:
a. register with the US treasury
b. pay a special tax on these drugs
3. keep records of each transactions
147
Title II of the 1970 Comprehensive Drug Abuse, Prevention and Control Act (more commonly called the Controlled Substance Act (CSA)) addressed what?
basis for 98% of all federal regulation regarding controlled substances
-don't need to memorize but be familiar with:
1. schedules
2. DEA registration
3. inventory
4. record keeping
5. ordering
6. prescription rqrments
7. dispensing rqrments
8. security rqrments
9. transfer or disposal of CS
148
most notable of the controlled substances that are classified as non-prescription drugs and may be sold without a prescription
codeine/guaifenesin liquid
149
rules for selling controlled substances OTC
1. pharmacist must decide to sell the medication and only to someone who is 18+
2. sale is limited to 240mL (8oz) or 48 dosage units (tabs/caps) of any controlled substance containing opium or 120mL (4oz) or 24 dosage units of any other controlled substance in a 48 hour period
3. must collect pt info
150
what the pharmacist must record related to pt info for the sale of OTC controls
1. valid ID (not rqrd if pharmacist knows pt)
2. name of purchaser
3. name and quantity of controlled substance purchased
4. date of each purchase
5. name or initials of pharmacist
*must be recorded in a bound book, not electronic or on loose paper*
151
OTC sales of what drugs are limited and for what reasons?
pseudoephedrine
ephedrine
phenylpropanolamine
-ability to use these to make methamphetamine illegally
152
federal daily and 30 day limits for: pseudoephedrine
ephedrine
phenylpropanolamine
3.6g/day
9g/30 days
153
sales of OTC pseudoephedrine, ephedrine, phenylpropanolamine requires:
1. seller must maintain written or electronic (dif. than OTC controls) sales record which must contain:
a. name, address, and signature of purchaser
b. date and time of sale
c. name and amount purchased
2. purchaser must present a valid ID containing photograph, non-expired and issued by federal or state gov.
154
list the 10 DEA registration types
1. manufacturing
2. distributing
3. reverse distributing
4. dispensing or instructing
5. research CI
6. research CII-CV
7. narcotic treatment program
8. importing
9. exporting
10. chemical analysis
155
can all CVS locations use the same DEA registration?
no, each location where narcotics are stored/dispensed must have a new registration
156
application for dispensing or instructing registration
DEA form 224 (pharmacies)
157
application for manufacturer, distributor, reverse distributor, researcher, analytical lab, importer or exporter registration
DEA form 225
158
which registrations are renewed annually and which are renewed every 3 years?
dispensing or instructing (pharmacies) are renewed every 3 years, all others yearly
159
3 registration types allowed no coincident activity
reverse distributing
exporting
narcotic tx program *
*as of 2024, NTP can have one or more mobile NTPs and this is considered a coincident activity
160
coincident activities for dispensing or instructing registrations
1. may conduct research
2. a pharmacist can manufacture a product containing a narcotic CII-CV in a proportion that does not exceed 20% of the complete solution
3. a retail pharmacy may perform central fill pharmacy activities
161
DEA registration numbers consist of:
9 total characters
-2 letters
-7 numbers
ex.: AB1234563
162
what DEA registration numbers represent:
1st letter is type of registrant:
-dispensing or instructing registration types start with A, B, F or G
-mid-level practitioners starts with M
-big 4 prescribers start with A, B, G or F
2nd letter represents the registrants last name or the name of the business that initially registered
-will not always match the prescriber or company name
163
what DEA registration letters represent:
how to verify legitimacy:
1. add 1,3,5
2. add 2,4,6 and multiply that by 2
3. add result from step 1 and 2
4. determine if the right most digit from step 3 matches the DEA number's final digit
164
DEA registration exemptions
1. agent or employee of a person who is registered is exempt from getting their own DEA when engaging in some activities (pharmacist, nurse)
2. contract carriers and warehousemen who possess a controlled substance in their usual course of business are exempt (FedEx, USPS)
3. the ultimate user who possesses a controlled substance is lawfully exempt (pt, caregiver)
165
which drugs must be in a securely locked cabinet at all times while in a pharmacy?
non-controlled drugs
CIII-CV
CII
none of these have to be, as long as the controls are dispersed among the non-controls in a manner to prevent the theft or diversion of the controls
166
which drugs must be in a securely locked cabinet at all times while in a practitioners office or clinic?
all controlled substances
167
which drugs must be stored in a securely locked, substantially constructed cabinet?
C-I
168
the CSA requires all records and reports involving controlled substances to be kept for at least ___ years from their date of origin
2
169
what is the penalty for an unintentional violation of recordkeeping
fine of $10,000
170
what is the penalty for an intentional violation of recordkeeping
more severe penalties or jail time
171
T/F: all controlled substance records should be stored together, separate from non-controls
False
-CII must be stored separately from all other records
-CIII-V can be stored with non-controls but must be 'readily retrievable'
172
describe the 3 file system (most common) for prescription storage
1 file for CII prescriptions
1 file for CIII-V prescriptions
1 file for non-controls
173
describe the 2 file system for prescription storage
file for CII
file for CIII-V and non-controls
*CIII-V must be 'readily retrievable', meaning:
1. they have a red C no less than one inch high, stamped in the lower right corner of the prescriptions face
2. they are identifiable by a prescription number in a computer system and able to be searched by prescriber name, pt name, drug dispensed and date filled
174
When does the DEA allow central record keeping?
1. when a registrant lacks the storage space to appropriately store these records
2. if the registrant notifies the DEA of its intent in writing 14 days in advance.
3. if allowed, must be transferred to central location within 2 business days
175
what 3 things cannot be stored centrally?
1. executed order forms (DEA form 222)
2. inventories
3. prescriptions
176
what form is used for ordering CIII-V?
no special form, ordered same as non-control drugs
177
form for ordering CIIs
DEA form 222
178
form for ordering DEA 222 forms
DEA form 222a
179
important points about DEA 22 forms
1. forms must be completed using typewriter, computer printer, pen or indelible pencil
2. executed = filled out, unexecuted = not filled out
3. most you can order on one form is 20
4. Send original to supplier and keep a copy for yourself, send a copy to DEA
180
unique situations regarding DEA 222 forms
1. suppliers can partially fill an order, after which they have 60 days to complete the order
2. suppliers can endorse and order to be filled by another supplier within 60 days (2nd supplier fills full order or nothing at all)
181
if your business is closing and you have DEA 222 forms left over, what should you do with them?
send back to FDA
182
If you suspect your DEA 22 form has got lost or stolen, how long do you have to report it to the DEA?
must report it immediately
183
controlled substance inventory dates:
1. initial, must be done the day the registrant first engages in activities with controlled substances
2. official, must be conducted at least once every 2 years (biennially). Some states have stricter rqrments
3. rescheduling, must be conducted when a previously non-controlled drug becomes controlled. Only have to inventory the new drug.
4. final, conducted when a registrant goes out of business
184
inventories can be taken 1 of 2 ways:
1. at the opening of business on the inventory date
2. at the close of business on the inventory date (easier)
*if done at open, controlled substances dispensed that day must be taken into account*
185
which controls can be estimated counts and which must be exact?
CI and CII must be exact
CIII-V can be estimates, unless the bottle holds more than 1000 units
186
each controlled substance record should record:
1. drug name
2. dosage form
3. strength
4. number of loose units
5. and full containers
187
Refusal to fill a controlled substance prescription
1. you cannot deface the prescription
2. you must return it to the patient unless you communicate with the prescriber and they tell you to destroy it
3. Document, Document, Document - everything about why you refused
188
ways you may receive a CII prescription
1. written, paper, signed by prescriber
2. electronic transmitted by prescriber
3. faxed, if the pt presents the manually signed prescription to the pharmacist prior to dispensing
189
all Narcotic CII injectable prescriptions are acceptable when/where
any location
190
all CII prescriptions are acceptable when/where
LTCF
191
all Narcotic CII prescriptions are acceptable when/where
hospice
192
CIII-V prescriptions may be dispensed pursuant to each of the following:
1. written, PAPER prescription signed by the prescriber
2. ELECTRONIC prescription transmitted by the prescriber
3. FAX prescription transmitted by the prescriber or their agent
4. TELEPHONE prescription promptly reduced to writing by the pharmacist
193
rqrd info for controlled substance prescriptions
1. date the prescription was issued
2. full name and address of pt
3. drug name, strength, and dosage form
4. quantity prescribed
5. directions for use
6. name, address and DEA number of prescriber
7. signature of prescriber
194
What pharmacists can change on CII prescriptions
1. adding or correcting pt address
Adding or changing (after confirming with prescriber):
2. dosage form
3. strength
4. quantity
5. directions
195
What pharmacists can NOT change on CII prescriptions
1. name of pt
2. name of drug (except generic sub)
3. name of prescriber, including signature
196
What circumstances can you have refills on CIIs
never
197
CII prescriptions are good for ___ ____ from the date written
1 year
198
after filled once, how long are CIII-V prescriptions good for?
6 months
199
prescribing multiple CIIs simultaneously
1. prescriber must date each prescription with the date it was issued and indicate the earliest fill date for each 1 month apart
2. must meet all other requirements for CII prescriptions
200
CIII and CIV refills require documentation when refilled, this includes:
1. name and dosage form of controlled substance
2. date filled or refilled
3. quantity dispensed
4. initials of dispensing pharmacist for each refill
5. total number of refills for that prescription
201
List the 3 circumstances in which you may partial fill a CII
1. at the request of the patient, patient rep., or prescribing practitioner
2. if the pharmacy cannot provide the full amt of the prescription
3. for pt in LTCF or who has a medical diagnosis documenting terminal illness
202
when partial filling CIIs related to pt request, must do:
1. total quantity of all partial fillings does not exceed total quantity prescribed
2. the remaining portions are filled no later than 30 days from the dat the prescription was written
203
considerations of CII partial fill related to pharmacy out of stock
1. if done, remainder needs to be filled within 72 hours of the partial fill
2. if it cannot be provided in 72h, pharmacist must notify the prescriber of partial fill, including quantity and reason for partial fill. Remainder of prescription is voided
204
considerations of CII partial fills related to LTCF/terminal illness
-may be partially filled for up to 60 days from the date issued
-must document:
1. date
2. quantity
3. remaining quantity to be dispensed
4. ID of dispensing pharmacist
205
partial filling CIII-V
unlike refills, you can partially fill a prescription more than 5 times
206
only time a CII can be taken over the phone?
emergency situation
207
situations constituted as emergency when filling CII prescriptions
1. immediate admin of controlled substance is needed
2. there is no appropriate alternative, including non-controls
3. it's not possible for the prescriber to provide a written prescription before dispensing the medication
*document everything*
208
CII emergency prescriptions must have a covering prescription sent within ___ days of authorizing the emergency prescription
7
209
when sending a controlled substance prescription for central fill pharmacy, the pharmacist must:
1. write the words "CENTRAL FILL" on the original prescription
2. record the name, address, and DEA number of the central fill pharmacy
3. record their name and the date of the transmittal to the central fill pharmacy
4. must be kept for 2 years
210
controlled substance prescription label requirements
1. date
2. dispensing pharmacy name and address
3. Rx #
4. pt name
5. prescriber name
6. directions
7. "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
211
is "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" required on all prescriptions?
at least federally, no, only required for CII-IV
212
the DEA allows transfer of ELECTRONIC controlled substance prescriptions (CII-V), even if they have never been filled, if:
1. state law allows
2. prescription was electronically prescribed
3. communicated between two licensed pharmacists
4. prescription is maintained in an electronic format
213
for non-electronic transfers, these are limited to schedules ___-___ and come with what three constituents
CIII-CV
-must have been filled at least once before being transferred
-may only be transferred once unless pharmacies share a real time database (like going from one CVS to another)
-transfers must be communicated btwn 2 pharmacists
214
documentation requirements for controlled substance transfers
-transferring pharmacist:
-must write VOID on the face of the invalidated prescription or for an electronic prescription, note that the prescription has been transferred in the prescription record
-record the name, address, and DEA # of the receiving pharmacy
-record the date of transfer and the name of the transferring pharmacist
215
documentation requirements for controlled substance transfers
-receiving pharmacist:
1. date of issue of OG Rx
2. OG # refills
3. date of OG dispensing
4. # refills remain
5. transferring pharmacy name, address, DEA # and Rx #
6. name of transferring pharmacist
216
SUD short term detox.
30 days or less
217
SUD long term detox.
30-180 days
218
SUD maintenance detox.
more than 180 days
219
SUD prescription requirements
-prescriptions cannot be issued for 'detox tx' or 'maintenance tx' UNLESS it is a CIII-V FDA approved drug specifically for use in maint. or detox. tx
220
4 situations related to SUD outside the definitions in previous card allows the prescriber to administer or dispense (not prescribe) a narcotic in any schedule for maint. or detox. tx
1. practitioner registered with DEA as narcotic or opioid tx program
2. practitioner dispensing from their office supply
3. hospitalized pt
4. prescription for direct admin
221
Methadone is/is not approved for detox. or maint. tx by the FDA, cannot fill for this indication
is not (for prescription use, I'm assuming its ok to admin or dispense
222
can a practitioner dispense (not prescribe) from their office supply?
yes
-only a 3 day supply, no extensions
223
DEA form for destruction of any controlled substance
DEA form 41
224
how long do you have to report theft or significant loss to the local DEA field office and BoP?
must be reported within one day of discovery
225
DEA form for theft or significant loss? When must this be submitted?
DEA form 106 (electronic)
submitted within 45 days of discovery
226
how many pills is considered significant loss and must be reported?
no specific number
227
how many pills have to be stolen for you to report it to DEA and BoP?
any number (could be 1 pill, could be 10,000)
228
sale includes what?
manufacturing
processing
transporting
handling
packing
production
preparation
repackaging
exposure
offer
proffer
holding
storing
possession
dispensing
giving
delivering
supplying
applying
administering
using
*so basically everything*
229
APRNs are:
certified nurse midwives
nurse practitioner
clinical nurse specialist
230
APRNs must work under:
one of:
-physician
-podiatrist
-dentist
231
what a PA cannot prescribe
ophthalmic devices
anesthesia or deep sedation
232
what a pharmacist can independently prescribe in indiana
1. supplies for medical devices
2. nebulizer
3. inhalation spacer
4. BG testing supplies
5. pen needles
6. normal saline and sterile water for irrigation
7. syringes for medication use
233
main goal of the board of pharmacy
to protect the public and enforce laws and rules that govern pharmacy
234
list all sanctions
revocation
suspension
probation
letter of reprimand
censure
fine
235
revocation
license taken away permanently
236
suspension
license taken away temp.
237
probation
an practice but with limits
238
letter of reprimand
written expression of disapproval
239
censure
verbal expression of disapproval
240
fine
up tp $1000 each violation
241
summary (emergency) suspension
-clear and immediate danger to the public
-90 days suspended
242
board can require what exam to determine if a practitioner is capable to practice
physical or mental examination
-must come from a disciplinary hearing in which the practitioners physical or mental ability to practice is at issue
243
which two practitioners do not have to submit controlled substance prescriptions electronically
vets
medical residents
244
list the 7 telehealth prescribers
1. physician
2. PA
3. APRN
4. optometrist
5. podiatrist
6. dentist
7. vet
245
Indiana opioid prescription limitations
may not be written for >7 days if:
1. prescription is for an adult being prescribed an opioid for the 1st time by the prescriber
2. the prescription is for someone less than 18
3. the prescription is for an animal for the 1st time by the vet
246
7 day limitation of opioid prescriptions does not apply if prescription is for:
1. cancer
2. palliative care (must document in pt MR)
3. medication assisted tx for SUD
4. condition that is exempted by the medical licensing board
5. prescriber uses professional judgement and determines pt needs more (must document in pt MR)
247
opioid partial fills can be given upon request of:
1. pt
2. representative of pt
3. guardian of pt
*must document this was requested and by who*
248
in IN law, a prescription written without refills indicated is assumed to be how many refills?
0
-unless you speak to the provider and they say otherwise
249
who can use mechanical storage devices like omnicell and pyxis?
1. a pharmacy that holds a permit issued by the IN BoP
2. remote location under the jurisdiction of the BoP
3. a licensed healthcare facility
250
which insulins can be sold OTC in IN as of Jan. 1, 2021
regular insulin
NPH
combo NPH/regular
