Exam 1 Flashcards
(187 cards)
1
Q
Laws are enacted by who?
A
Congress on a federal level
State legislature on a state level (Ohio General Assembly)
2
Q
Are statutes broad or general?
A
General in scope
3
Q
What do statutes achieve?
A
They establish a framework within which the intent of the law is to be achieved
4
Q
What type of authority can statutes grant?
A
They may grant administrative authority to implement/administer a body of law.
5
Q
ORC=
A
State level statute
6
Q
Statutes start as
A
Bills
7
Q
Regulations/rules are laws promulgated by what?
A
Administrative agencies
8
Q
Examples of administrative agencies
A
Ohio Board of Pharmacy, FDA, DEA, EPA
9
Q
Regulations/rules are based on a
A
statute that gives the agency authority.
Example- pharmacy practice act
10
Q
Regulations/rules interpret and define
A
Statutes
11
Q
Rules and regulations must bear what?
A
A responsibility to public health, safety, and welfare
12
Q
Rules/regulations have the legal force of
A
statutes
13
Q
Rules/regulations examples
A
Code of federal regulations (CFR)
Ohio administrative code rules (OAC)
14
Q
What is the administrative agency responsible for administering and enforcing the ohio revised code (ORC)?
A
Ohio Board of Pharmacy
15
Q
Is the ohio board of pharmacy a law enforcing agency?
A
Yes
16
Q
How many state agencies are required for administering and enforcing all of the laws regulating the legal distribution of drugs in the state?
A
Just one- the Ohio Board of Pharmacy
17
Q
The Ohio Board of Pharmacy promulgates
A
Rules (regulations) for the purpose of administering and enforcing the above laws in the ORC. These are in the Ohio Administrative Code.
18
Q
BOP mission statement
A
The Ohio BOP shall act efficiently, consistently, and impartially in the public interest to pursue optimal standards of practice through communication, education, legislation, licensing, and enforcement
19
Q
Who many members are in the BOP?
A
9 members
20
Q
Who are the BOP members appointed by?
A
Governor
21
Q
How long are terms at the Ohio BOP?
A
4 years. Each member can be reappointed 1 time at the governors discretion.
22
Q
How many BOP members are licensed pharmacists?
A
- One is a member of the public
23
Q
Is the executive direct a board of pharmacy member?
A
No
24
Q
Can the executive director of BOP vote?
A
No
25
How many voting members of the state board of pharmacy constitute a quorum?
5
26
How often does the BOP have to meet?
At least once
27
What is a major function of the BOP?
Licensure
28
The Ohio BOP licenses:
Pharmacists, Pharmacy interns, Terminal and Wholesale Distributors of Dangerous Drugs (both in and out of state)
Manufacturers and Wholesalers of Controlled Substances, Home medical equipment service providers, medical marijuana dispensaries
29
Does the Ohio BOP license pharmacy techs?
No, they are registered?
30
Requirements for licensure as a pharmacist?
>18 years old
Be of good moral character and habits
Graduate of a pharmacy program recognized and approved by the board
>75% on both the MPJE and NAPLEX
Complete the minimum requirements for pharmacy internship
Submit a request for a criminal records background check
31
Pharmacists can also become licensed in Ohio via
reciprosity
32
Reciprosity qualifications
Must have an active licensure in goof standing
Has successfully completed an examination for licensure in another state
Has completed >1500 hours of internship
Personally appears before the Ohio BOP within 6 months of application.
33
Requirements of pharmacy intern licenses
Renewal every odd numbered year (every 2 years)
| Once graduated from PharmD program, may only be renew intern license for 1 year
34
What is required for license renewal?
Pharmacists- documentation of CE
| Intern- must still be actively working toward the requirements for licensure as a pharmacist.
35
When must you notify the BOP if you change jobs?
W/in 72 hours
36
If an intern is no longer a student, when do they notify BOP?
10 days
37
If a pharmacist lets their license expire >3 years what do they do?
Retake NAPLEX and MPJE
38
1 CEU=
10CE
39
CE requirements
40 hours every 2 years
2 hours must be in pharmacy jurisprudence
2 hours must be patient/medication safety
May satisfy up to 1/3 of requirements by providing healthcare services by volunteer at approved locations.
40
How is CE tracked?
CPE monitor
Keeps track of all ACPE-accredited CEs
Must keep certificates from all non-ACPE accredited providers for 1 year
41
The FDA enforces
the Federal Food, Drug, and Cosmetic Act
42
The FDA is a component of the
Department of Health and Human Services (DHHS)
43
The FDA regulates
```
Human and veterinary drugs, biological products
Medical devices
Nations food supply
Cosmetics
Products that emit radiation
```
44
What is Body Fortress Whey Protein Powder?
| Claim- Supports lean muscle mass
Dietary supplements
45
What is Vitamin B12 injection?
Drug
46
What is under arm deodorant?
Cosmetic
47
what is Under arm deodorant/antiperspirant?
Combo
| Cosmetic and drug
48
What is Foltx tablets (Vitamin B12/folic aid/B6)
| claim- for the dietary manafement of hyperhomocyteinemia
Medical food because of claim
49
What is No-Salt Salt substitute?
Special dietary food
| Can buy it at the grocery store
50
What is OraQuick at home HIV test?
Device
51
What is Feverfew Herbal Supplement?
| Claim- for the prevention of migraines
Drug bc of claim
52
What is duct tape
Other-just duct tape not regulated by the FDA
53
What is E-cigarette containing nicotine?
Tobacco product
54
What is drug-eluting stent?
Combo- device and drug
55
For a dietary supplement, is this an acceptable claim?
| Valerian root is an herb commonly used to help people sleep
Yes
56
For a dietary supplement, is this an acceptable claim?
| Saw Palmetto is an herb that has been used in men with BPH symptoms
Prohibited
57
Is this an acceptable claim for a cosmetic?
| Makes hair look and feel thick
Yes
58
Is premarket approval required by the FDA for a cosmetic?
No
59
Is premarket approval required by the FDA for a drug?
Yes
60
Is premarket approval required by the FDA for a dietary supplement?
No
61
Is premarket approval required by the FDA for a medical food?
No
62
Is premarket approval required by the FDA for a device?
Yes
63
Is prescription/physician supervision required for a cosmetic?
No
64
Is prescription/physician supervision required for a drug>
Yes
65
Is prescription/physician supervision required for a dietary supplement
No
66
Is prescription/physician supervision required for a medical food
Yes
67
Is prescription/physician supervision required for a device
Yes (Class I does not require supervision)
68
Do cosmetics have to list all ingredients on their labels?
Have to list all ingredients, but not amounts. Ingredients listed from most to least used.
69
Do dietary supplements have to list ingredients?
Yes, list active ingredients and their amount or list ingredients in a proprietary blend
70
What is a drug?
Definition according to the Food, Drug, and Cosmetic Act (FDCA)
Article recognized in the Official COmpendia
Article intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease
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 above
71
How can drugs be classified?
Supplier making a therapeutic or health claim, or a structure/function claim
Suppliers intended use of the product
72
What is a cosmetic?
Definition according to FDCA
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied ot the human body for promoting attractiveness
Does not include soap
73
Do cosmetics have consent to perform cGMP?/
No
74
What is a device?
Definition according to the FDCA
Any instrument, apparatus, implement, machine, implant, in vitro reagent or article which is recognized in teh USP/NF, intended for use in disease, intended to affect structure or function
75
Do devices achieve their intended purpose via chemical action or metabolism?
No
76
Federal laws primarily relate to
Drug products
77
State laws primarily relate to
Pharmacy practice
78
How does congress have the authority to regulate drug products?
Through the commerce clause of the US. Constitution
79
Adulteration
Refers to the composition of the product
| Mainly pertains to a drugs strength, purity, and quality.
80
A drug or device is considered adulterated by the FDCa if
It contains in whole or part any filthy, putrid, decomposed substance.
Has been prepared in unsanitary conditions
Has been manufactured under conditions that do not meet GMP standards.
Quality lower than official standards
Drug not recognized in official compendia
Contains any ingredient as a substitute of an active drug
Container is expired or altered
81
Official compendia
United States Pharmacopeia (USP)
Homeopathic Pharmacopeia of the United States
National Formulary (NF)
82
Can you return dispensed doses to a manufacturers bottle?
NO
83
Misbranding
Mainly pertains to representations made on the label or labeling.
84
Label vs labeling
Written, printed, or graphic matter upon the immediate container
Labeling- includes the label as well as other written, printed, or graphic matter upon the article or any of its containers or wrappers, or accompanying item
85
A drug or device is considered misbranded according to FDCA if the labeling:
Is false or misleading
Does not contain a word, statement, or other info required
Does not include the established name of the active drug
Does not have the active ingredient identified
Is missing quantity of ingredients
Has inadequate directions
If it is dangerous to health when used as recommended on the labeling
Offers the sale of a drug under the name of another (imitation)
86
Import drug act of 1848
First federal statute to protect US citizens from harmful drugs.
Prohibited the importation of adulterated drugs.
87
Federal Pure Food and Drug Act of 1906
Prohibited the adulteration and misbranding of food and drugs in interstate commerce.
88
Category I TDDD
Limited to single dose injections of IV fluids
89
Category II TDDD
Any dangerous drug (except controlled substances)
90
Category III TDDD
Includes controlled substances (must also be registered with the DEA)
91
License renewal for TDDD
every 2 years
92
A TDDD license is
cumulative
93
MTM TDDD
MTM services have a category II limited TDDD. They are not permitted to stock dangerous drugs.
Only pharmacists and pharmacy interns can perform MTM at a 2:1 ratio
94
When are out of state terminal distributors of dangerous drugs required to obtain a license from the Ohio board of pharmacy?
If they are delivering medications to Ohio
95
Does a prescriber need a TDDD license to legally prescribe?
no
96
May anyone other than a pharmacist legally dispense medications in Ohio?
No, but prescribers could personally furnish to patients.
97
What requirements need to be met for a pharmacist to make an "occasional sale"?
The total value of all dangerous drugs distribured by the TDDD shall not exceed 5% of the cost of the dangerous drugs purchased by the terminal distributor of dangerous drugs during the same calendar year.
98
Responsible person
The pharmacist in full and actual charge at all time
99
The responsible person must
Sign the pharmacies TDDD license
Be physicially present in the pharmacy for a sufficient amount of time.
Responsible for the practice of pharmacy.
Provide supervision and control of the dangerous drugs
Maintain all drug records required by state and federal law.
100
The BOP must be notified about a change in the responsible person within how many days?
10
101
What must the responsible person do on the effective date of the change?
A complete inventory of the controlled substances
102
May pharmacies utilize an ATM like machine to dispense prescriptions to patients?
Yes, if it is board approved and the pharmacist is physically present.
103
May anyone not a pharmacist, intern, or technician work in the pharmacy department?
Yes, pharmacy support personnel. They cant do anything related to pharmacy.
104
May support personnel enter new prescriptions into the pharmacies computer system?
No
105
How does someone become a pharmacy technician trainee?
18 years of age or older
High school diploma
Submit a criminal records background check
Trainee registration valid for 1 year and cannot be renewed.
106
How does someone become a registered pharmacy technician?
All for trainee, plus
Complete an approved program
- accredited by ASHP, conducted by a branch of armed forces, public highschool, employer sponsored
107
How may someone become a certified pharmacy technician?
Maintain certification from either ExCPT or PTCP
108
Does Ohio have a pharmacist to tech max ratio?
No
109
Controlled substances act (CSA)
Also known as the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
Enforced by the DEA (US department of Justice)
Establishes a closed system for controlled substances
110
Only persons registered with the DEA may legally engage in the following activities with controlled substances
Manufacturing, distributing, dispensing, conducting research with controlled substances, conducting a narcotic treatment program, importing controlled substances, exporting controlled substances, conducting chemical analysis with controlled substances.
111
How many schedules of controlled substances does the CSA provide for?
5
112
Who does the CSA grant authority to schedule substances?
Attorney general of the United States
113
Can states schedule substances differently than the DEA?
Yes as long as the states scheduling is more strict.
114
Factors considered when scheduling a controlled substance
Actual or relative potential for abuse
Scientific evidence of pharmacologic effect
State of current scientific kowledge regarding the substance.
History and pattern of abuse
What, if any, risk to public health
Psychic or physiological dependence liability.
If it is an immediate precursor to a substance already scheduled.
115
Schedule I controlled substances
High potential for abuse
No currently accepted medical use in tx in the US
Lack accepted information on the safety of use even under direct medical supervision.
116
Examples of scheduled I substances
Heroin, marijuana, LSD
117
Schedule II controlled substances
High potential for abuse
Currently accepted medical use in treatment in the US
Abuse may lead to severe physical or psychological dependence
118
Examples of scheduled II substances
Morphine, fentanyl, oxycodone, hydrocodone, methamphetamine, cocaine, amphetamine, methylphenidate, pentobarbital
119
Schedule III controlled substances
Potential for abuse but less than schedule I and II drugs.
Currently accepted medical use in treatment in the US.
When abused may lead to moderate or low physical dependence or high psychological dependence.
120
Examples of scheduled III substances
Paregoric, dronabinol, Tylenol #3, #4
121
Scheduled IV controlled substances
Low potential for abuse relative to the substances in schedyle III
Currently accepted medical use
When abused, may lead to limited physical dependence or psychological dependence.
122
Examples of scheduled IV controlled substances
Carisoprodol, alprazolam, diazepam, phenobarbital, phentermine, diethylpropion, zolpidem, tramadol
123
Scheduled V controlled substances
Low potential for abuse relative to the substances in controlled IV
Currently accepted medical use
When abused, may lead to limited physical dependence or psychological dependence.
Some may be sold OTC with restrictions ("Exempt narcotics"- guafenesin w/ codeine)
124
Examples of schedule V substances
Pregabalin, promethazine/codeine, Lomotil
125
Pharmacy controlled substance registration form
Form 224
renewal- Form 224a
Renew every 3 years
126
If a pharmacy sells a bottle of Vicodin® to another pharmacy or a practitioner
(for office use), must it also be registered as a wholesaler?
No, as long as:
• The total number of dosage units distributed does not exceed
5% of the total units of controlled substances distributed and
dispensed during a calendar year. (21 CFR § 1307.11)
• The pharmacy or practitioner is registered with DEA.
• Proper records are kept (will discuss at a later date).
• (This is considered an “occasional sale”)
127
DEA registration for institutions
A single registration covers both hospital inpatient and outpatient dispensing activities. No need for separate registrations for decentralized pharmacy services as long as they are part of the same physical structure.
128
The following persons may possess controlled substances without registration
A common or contract carrier or warehouseman, whose possession of the controlled substance is the usual course of business.
An ultimate user who possess such substance for a lawful purpose
Agent/employee of manufacturer or distributor if acting in the usual course of business.
129
Purchasing/transferring schedule I or II controlled substances
Must be ordered/transferred via FDA form 222 (remember closed system of distribution)
Controlled substance ordering system (CSOS)
130
Purchasing/transferring schedule III-V controlled substances
Can be ordered/transferred with an invoice. One copy kept by distributor and one copy kept by recipient.
131
DEA form 222
Order form used for the legal distribution of schedule I and II controlled substances among persons registered with the DEA. Only schedule I or II drugs may be ordered on these forms.
Registrants may request forms in writing from the nearest DEA field offices (DEA form 222a)
132
DEA form 222 purchaser must prepare using
typewriter, pen, indelible pencil
133
What to include in DEA 222 form
Name of substance (NDC optional)
Finished form (tab, suspension)
Number of units or volume in each container
Number of commercial containers ordered
134
How many items can you put on form 222 form?
10 items
135
Controlled substance ordering system (CSOS)
Electronic form equivalent to DEA form 222
136
Form 222, what if the supplier cannot fill an order in its entirety?
The supplier may fill the order in part and supply the balance within 60 days. After 60
days from the date of execution by the purchaser, the order form becomes invalid.
137
What if you are a pharmacy and wish to return CII controlled substances to your wholesaler?
Utilize DEA 222 form, list your pharmacy as supplier
138
What if you are a pharmacy and you wish to purchase a CII controlled substance from another pharmacy?
Utilize a DEA 222 form. List the item(s) that you would like to purchase and list the
other pharmacy as the supplier.
139
May a physician write a prescription as a means of obtaining any controlled substances for office use?
No, must use DEA form 222 for CII drugs or an invoice/order form for III-IV
140
Dangerous drug
Prescription drug, any drug that is injection, exempt narcotics
141
Controlled substance
A substance that has the potential for addiction and abuse
142
Narcotic
Any of the following, no matter how they are derived or synthesized
-Opium, opiate
-Coca leaves
Cocaine
Ecgonine (an alkaloid found naturally in coca leaves)
143
Which DEA form is used to register with the DEA?
224
144
Must pharmacists register with the DEA?
No
145
Your “closed door” pharmacy runs out of lorazepam and a physician’s office needs it today. May you sell it to them from one of your other pharmacies even though they aren’t registered as distributors?
Yes, as long as it is an occasional use
| The total number of dosing units (tablets, etc,) may not exceed 5% of all controlled substances.
146
Do prescribers need to register with DEA?
Yes, to prescribe controlled substances
Except employees of hostpitals who are acting in the normal course of business can use hospital DEA
Officials of the US Armed Forces public health service or Bureau of prisons can use service ID as DEA
147
Does a PA or ARNP need DEA
Yes
148
What do you do if you make a type on form 222
Keep it, write void
149
Max orders on form 222
10
150
Heroin, marijuana, peyote scheduled class
I
151
Amphetamine, Coca leaves, codeine schedule class
II
152
Fentanyl, hydrocodone, hydromorphone, lisdexamphetamine, meperideine schedule class
II
153
Methadone, methamphetamine, methylphenidate, morphine scheduled class
II
154
Nabilone, opiumm oxycodone, pentobarbital scheduled class
II
155
Tapentadol scheduled class
II
156
Anabolic steroids scheduled class
III
157
Buprenorphine, butabital, codeine scheduled class
III
158
Dronabinol, ketamine scheduled class
III
159
Opium combo products (paregoric) scheduled class
III
160
Thiopental, testosterone scheduled class
III
161
Alprazolam, butorphanol, carisoprodol scheduled class
IV
162
Chlordiazepoxide, clonazepam, clorazepate, diazepam scheduled class
IV
163
Diethylpropion, flurazepam, lorazepam, meprobromate scheduled class
IV
164
Midazolam, modafinil, oxazepam, phenobarbitol scheduled class
IV
165
Phentermine, suvorexant, tempazepam, tramadol scheduled class
IV
166
Triazolam, Zaleplon, Zolpidem, Zopiclone scheduled class
IV
167
Cannibadiol drugs (Epidiolex), codeine preparations, pregabalin, diphenoxylate preparations scheduled class
V
168
Storing controlled substances in the pharmacy
Dangerous drugs must be secured by either a physical or electronic barrier to detect entry if a pharmacist is not present.
CII substances must be in a locked case
CIII-CV substances can be either securely locked or dispersed amongst non-controls
169
Who cannot work in a pharmacy?
Anyone who has been convicted of a felony related to controlled substances or anyone who had an application for DEA registration denied, revoked, or surrendered for cause
170
What do pharmacies have to do to employ an individual who has been convicted of a felony relating to controlled substances?
The pharmacies must request a waiver from the DEA and it must be approved prior to hiring the applicant.
171
When can dangerous drugs be mailed via the US postal service?
The outside wrapper or container is free of markings that would indicate the nature of the contents.
The inner container (Rx vial) is properly labeled and includes the name and address of the pharmacy dispensing the prescription.
172
Reporting loss or theft
ANY theft or significant loss of any dangerous drugs or controlled substances (including if lost during transit) must be reported immediately upon discovery to the Ohio BOP via the online portal or telephone.
Have to report initial immediately
Detailed report within 30 days
173
Who must be notified about a theft or significant loss?
Law enforcement agencies
The DEA (if controlled substances)
Ohio BOP
174
How must the DEA be notified about a theft or significant loss?
In writing to the local DEA diversion field office within 1 business day of discovery. Brief written message explaining the circumstances.
AND
Complete DEA form 106 online and send a copy to the BOP within 30 days
175
A controlled substance order from your wholesaler is missing a bottle of Ambien. Who must report the loss/theft?
If the pharmacy has already signed for it, they must report it. If they have not signed for it, the wholesaler must sign it.
176
When is a loss considered significant?
Burden to determine if the loss was significant is on the registrant
177
Factors to consider when determining if a loss was significant
Actual quantity lost in relation to the type of business.
The specific controlled substance
Whether the loss can be associated with access by specific individuals.
A pattern of losses over a specific time period
Whether the specific controlled substance is a likely candidate for diversion.
178
Should miscounts or adjustments to inventory involving errors be reported to the DEA?
No
179
Do you report spilled controlled medications as a loss?
No, you know what happened to it.
Breaking/spillage of controlled substances does not constitute a loss.
Document circumstances in inventory records and report on DEA form 41
180
T/F you also have to report losses of drug documents
True
| ANY theft of these must be reported, not just significant losses
181
How do pharmacies transfer controlled substances to another registrant?
Via DEA form 222
182
How do pharmacies destroy controlled substances?
1.) Incineration
2.) Chemical digestion
Or deliver to a reverse distributor location.
Or request assistance from the DEA Special Agent in charge of administration by submitting form 41
183
How long must you keep records of disposal?
3 years
184
Can a pharmacy take back (touch) dangerous drugs/controlled substances from a patient?
NO
185
Who may voluntarily participate in drug disposal collection receptacles?
Must obtain a modified DEA registration as a collector.
-manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with onsight pharmacy, retail pharmacies
186
Location of collection receptacles
Retail pharmacy- inside registered location in proximity to where CS are stored and employees are present.
Hospitals/clinics- area regularly monitored by employees. NOT near emergency/urgent care areas
Long term care facilities- must be placed and managed by a retail pharmacy or hospital/clinic with an onsite pharmacy.
187
Collection of contents of collection receptacles
2 ppl must be present
2 employees of collector OR 1 employee and 1 supervisor of LTCF.
Sealed upon removal
