Jurisprudence Exam 2 Flashcards
1
Q
What was The Harrison Narcotic Act?
A
The first federal law involving the regulation and control of certain drugs
2
Q
What 3 things did the Harrison Narcotics Acts require?
A
Required importers, manufacturers, and distributors of cocaine and opiates (narcotics) to:
-Register with the U.S. treasury (the first enforcement agency for controlled substances)
-Pay a special tax on these drugs
-Keep records of each transaction
Note that practitioners were only allowed to prescribe opiates and cocaine in the course of their professional practice only
3
Q
What was the Marihuana Tax Act?
A
Essentially banned the movement of marijuana
-Federal government required a high-cost transfer tax stamp for every marijuana sale
-These stamps were very rarely issued by the federal government
-Following this act, all states made the possession of marijuana illegal for a while
4
Q
What control class is marijuana in?
A
Class I controlled substance
5
Q
What two agencies merged to form the Bureau of Narcotics and Dangerous Drugs (BNDD)?
A
Federal Bureau of Narcotics (FBN)
Bureau of Drug Abuse Control
(now is under the department of Justice, later merged with Customs and changed to the Drug Enforcement Agency (DEA))
6
Q
What was established by the Comprehensive Drug Abuse Prevention and Control Act, Title II (Controlled Substances Act)?
A
Established five separate schedules of controlled substances
Regulated manufacture, distribution, and dispensation of controlled substances
7
Q
What piece of legislation is responsible for 98% of legislation that impacts pharmacy practice related to controlled substances?
A
Controlled Substances Act (CSA)
aka Title II
8
Q
What agency is currently charged with regulating controlled substances?
A
The Drug Enforcement Agency (DEA)
9
Q
What is a Controlled Substance?
A
A drug with dependence liability and/or abuse potential
10
Q
What are the 8 factors used to determine the schedule of a controlled substance?
A
- Actual/relative potential for abuse
- Scientific evidence of its pharmacologic effect, if known
- State of current knowledge regarding the drug or other substance
- Its history and current pattern of abuse
- Scope, duration, and significance of abuse
- What, if any, risk there is to the public health
- Its psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter
11
Q
The eight factors for determining controlled substance scheduling are used to do what 4 things?
A
- Schedule a drug that was previously not scheduled
- Change a drug from one schedule to another
- Remove a drug from the schedules entirely
- Keep a drug in its current position (controlled/uncontrolled)
we do not always anticipate how drugs will be used/abused, these factors allow for scheduling fluidity
12
Q
note
A
Memorize the chart on Lecture 9 Slide 16
13
Q
What are the 4 characteristics of a Schedule I (CI) drug?
A
Abuse Potential: High
Medical Use: No*
Dependency:
Psychological: Not defined
Physical: Not defined
14
Q
What are the 4 characteristics of a Schedule II (CII) drug?
A
Abuse Potential: High
Medical Use: Yes
Dependency:
Psychological: Severe
Physical: Severe
15
Q
What are the 4 characteristics of a Schedule III (CIII) drug?
A
Abuse Potential: Lower than I or II
Medical Use: Yes
Dependency:
Psychological: High
Physical: Moderate to Low
16
Q
What are the 4 characteristics of a Schedule IV (CIV) drug?
A
Abuse Potential: Lower than III
Medical Use: Yes
Dependency:
Psychological: Limited compared to III
Physical: Limited compared to III
17
Q
What are the 4 characteristics of a Schedule V (CV) drug?
A
Abuse Potential: Lower than IV
Medical Use: Yes
Dependency:
Psychological: Limited compared to IV
Physical: Limited compared to IV
18
Q
Which controlled substance schedule has the highest abuse potential?
A
Schedule I
*they are labeled in decreasing order of abuse potential or dependence
19
Q
What is the only schedule with no accepted medical use?
A
Schedule I
20
Q
True or False: Schedule II has the same abuse potential as Schedule I
A
True
21
Q
What are 2 examples of drugs where the schedule is not intuitive?
A
Methamphetamine
Cocaine
22
Q
What is an example of a drug where different dosage forms have different schedules?
A
Dronabinol
23
Q
What is an example of a drug where when it is combined with other ingredients it may have different schedules?
A
Codeine
24
Q
What are the schedules of codeine if it is by itself, with another ingredient, or as a liquid?
A
By itself: Schedule II
With another ingredient: Schedule III
Liquid: Schedule V
25
True or False: If a controlled substance is classified as a nonprescription drug it may be sold without a prescription
True
26
What is the most notable nonprescription controlled substance?
Codeine/ Guaifenesin liquid
27
What are the 3 limitations regarding nonprescription controlled substance sales?
1. A pharmacist must decide to sell the medication, and only to someone 18 years or older
2. Sale amounts are limited
3. Pharmacist must verify the patient and record information about the sale in a bound book
28
What is the limited amount of controlled substance containing opium that can be sold OTC?
240 mL (8 fl.oz.) or 48 dosage units (tabs, caps) in a 48-hr period
29
What is the limited amount of controlled substance NOT containing opium that can be sold OTC?
120 mL (4 fl.oz.) or 24 dosage units within a 48-hr period
30
When conducting an OTC sale of controlled substances, the pharmacist must verify and record what details about the customer?
1. Review a valid form of ID (not required if the pharmacist knows the pt) and record information
2. Name of purchaser
3. Name and quantity of controlled substance purchased
4. Date of each purchase
5. Name or initials of pharmacist
*this information bust be recorded in a bound book* (not electronic or on loose paper)
31
What are the 3 products that are not controlled substances, but are considered "listed chemicals" due to their ability to produce methamphetamine?
Pseudoephedrine
Ephedrine
Phenylpropanolamine
32
What are the 2 restrictions placed on "listed chemical" drugs?
Federal law requires these drugs to be placed where patients do not have access to them, usually behind the counter
Federal law limits sales to 3.6 grams/day, and 9 grams in 30 days
33
Sale of "listed chemical" drugs are limited to how much per day?
3.6 grams/day
34
Sale of "listed chemical" drugs are limited to how much per 30 days?
9 grams per 30 days
35
What are the 2 requirements for OTC sale of "listed chemical" drugs?
Sellers must maintain a written or electronic sales record which must contain:
-Name, address, and signature of purchaser
-Date and time of sale
-Name and amount of product purchased
Purchaser must present a valid form of ID which contains a photograph, is not expired, and is issued by a state or federal government
36
What are the items that must be maintained in a written or electronic sales record by the seller during OTC sale of "listed chemical" drugs?
Name, address, and signature of purchaser
Date and time of sale
Name and amount of product purchased
37
What 3 criteria must a valid form of ID meet for OTC sale of "Listed chemical" drugs?
Contains a photograph
Is nonexpired
Is issued by a state or federal government
38
Controlled substances are required to have a large symbol that denotes their schedule (CI, CII, CIII, CIV, CV) where on their labeling?
Prominently displayed on the label of the commercial container
*note that if this is missing it is MISBRANDED
39
Which DEA registration type do pharmacies get?
Dispensing or Instructing
(this is the registration primarily used by practitioners, pharmacies, hospitals, and teaching institutions)
40
Who needs their own DEA registration?
Each place of business and practice location where controlled substances are held
41
What is the DEA Form 224?
Application for dispensing or instructing registration
42
What is the DEA form 225?
Application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
43
Most DEA registrations are renewed how often?
Annually
44
What is the one DEA registration that is not reviewed annually?
Dispensing or Instructing
45
How often is a Dispensing or Instructing DEA registration renewed?
Every 3 years
(it is valid for 3 years)
46
What is a narcotic?
Anything that is an opiate or cocaine
47
DEA registration is listed according to what?
What kind of drugs a person can handle
48
What are the drug categories used in DEA registration?
1 (Schedule 1)
2 (Schedule II Narcotic)
2N (Schedule 2 Non-Narcotic)*
3 (Schedule III Narcotic)
3N (Schedule III Non-Narcotic)*
4 (Schedule IV)
5 (Schedule V)
49
What are the 2 schedules that have non-narcotic categories?
Schedule II (2N)
Schedule III (3N)
50
A typical pharmacy would be registered for what drug schedules?
2
2N
3
3N
4
5
(all except 1)
51
True or False: The dispensing or instructing DEA registration is limited to schedules II-V
True
-cannot register for I since it has no medical purpose
52
What are coincident activities?
Each of the 10 DEA registration types corresponds to specific activities
A person cannot perform activities outside of what they are registered for unless coincident activities are allowed
Coincident activities are activities that a DEA registrant may engage in without obtaining a different registration
-often required to allow the registrant to complete their registered function
-limitations exist on the activities that may be done without obtaining a new registration
53
Which registration types do not permit coincident activities?
Reverse Distributing
Narcotic Treatment Programs (includes compounders)
Exporting
54
What are the coincident activities that Dispensing or Instructing DEA registration may perform?
Conduct research and instructional activities with substances for which registration was granted
Pharmacist may manufacture a product CONTAINING A NARCOTIC controlled substance in schedule II-V in a proportion not exceeding 20% of the complete solution, compound, or mixture
Retail pharmacy may perform central fill activities
55
As part of their coincident activity, a pharmacist may manufacture a product containing a narcotic not exceeding what % of the complete solution, compound, or mixture?
20%
56
What is the structure of a DEA registration number?
9 total characters with:
2 Letters
7 Numbers
57
What does the first letter of a DEA registration number represent?
The type of registrant
58
Dispensing or Instructing DEA registration types can have DEA numbers that start with what letters?
A, B, F, G
59
Mid-Level practitioners have DEA numbers that start with what letter?
M
60
If a prescriber has a DEA number that starts with A, B, F, or G what does this tell you?
They are one of the "big four"
61
What does the second letter in a DEA number represent?
The registrant's last name
OR
The name of the business that originally registered
62
What equation can we use to determine the validity of the numbers in a DEA number?
Add: 1st, 3rd, 5th digit together
Add: 2nd, 4th, 6th digit together, multiply by 2
Add results from step 1 and step 2
Determine if the right-most digit matches the DEA number's final digit
63
What 3 people are exempt from having to get a DEA number?
An agent or employee of a person who is registered to engage in a particular activity (pharmacists, nurses, etc)
Common contract carriers and warehousemen who possess a controlled substance in the usual course of business
(FedEx, USPS, etc)
The ultimate user who possesses a controlled substance lawfully
(patient)
64
Who can use an institutional DEA number?
Individual practitioners who are agents or employees of a hospital/health system and do not have their own DEA number
65
What 6 requirements must a practitioner meet to use an Institutional DEA number?
1. Activity is done in the usual course of the professional's practice
2. The jurisdiction in which the individual is practicing allows the action
3. The institution has verified the individual may perform the action in the jurisdiction in which they are practicing
4. The practitioner acts only within the scope of their employment
5. The institution applies a specific internal code to the DEA number for each practitioner authorized to practice
6. The institution keeps a current list of internal codes for verification purposes
66
What is required by the Controlled Substances Security Act?
Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances
(this is determined by the registrant and approved or denied by the DEA)
67
When assessing whether procedures put in place to prevent theft and diversion of controlled substances are effective, what 4 things does the DEA consider?
Activities conducted
Type and form of controlled substances handled
Quantity of controlled substances handled
Storage system of controlled substances
68
For C-II through C-V drugs, how can they be stored?
Either in a securely locked, substantially constructed cabinet
OR
Dispersed throughout the stock of non-controlled substances to obstruct theft or diversion
69
How do C-I drugs need to be stored?
MUST be stored in a securely locked, substantially constructed cabinet
70
A practitioner storing controlled substances in their office or clinic must store them how?
In a locked cabinet
71
What drugs are required to be stored in a safe or steel cabinet equivalent to a U.S Government Class V security container?
Thifentanil
Carentanil
Etorphine hydrochloride
Diprenorphine
72
What limitations are put in place when hiring for positions which involve controlled substances?
The registrant shall not employ:
-Any person CONVICTED of a FELONY offence relating to controlled substances
-Any person who at any time had an application for registration with the DEA denied, had a DEA registration revoked, or has surrendered a DEA registration for cause
73
What questions are required to be asked when hiring someone for a position involving controlled substances?
In the past 5 years have you been convicted of a felony, or in the past 2 years of any misdemeanor, or are you presently formally charged with committing a criminal offense?
In the past three year, have you ever knowingly used any narcotics, amphetamines, or barbiturates other than those prescribed to you by a physician?
*note that answers do not disqualify applicants but should be considered to assess potential for diversion*
74
What is an employment waiver?
If a registrant wants to employ an individual who does not qualify for employment, they can apply for a waiver
*DEA will not consider a waiver unless diversion is unlikely to occur
75
All records and reports involving controlled substances are required to be kept for how long?
At least 2 years from their origin date
76
What is the fine for each unintentional violation regarding controlled substance record keeping?
$10,000
*more severe penalties or jail time are in place for intentional violations*
77
Registrants must maintain a record of what, regarding controlled substances?
A complete and accurate record of each substance Manufactured, Imported, Received, Sold, Delivered, Exported, or otherwise Disposed by them
78
How must controlled substance records be kept?
C-II records must be kept separately from other records
C-III, C-IV, and C-V records may be kept separately or with other records (but they must be readily retrievable!!!)(put a red C on them)
79
Controlled prescriptions may be stored using what two systems?
Three-File System (most common)
Two File System
80
What is a Three-File System?
File for C-II prescriptions
File for C-III, C-IV, and C-V prescriptions
File for non-controlled prescriptions
81
What is a Two File System?
File for C-II prescriptions
File for C-III, C-IV, C-V, and non-controlled substance prescriptions
(C-III, C-IV, and C-V prescriptions must be readily available)
82
What criteria must a prescription meet to be considered "readily retrievable"?
1. Have a red "C" no less than 1 inch high, stamped in the lower right corner of the prescription's face
2. Must identify prescriptions by prescription number in a computer system, and be able to search by:
-Prescriber name
-Patient name
-Drug Dispensed
-Date filled
83
For a drug to be considered "readily retrievable" it must be able to be searched in a computer system by what 4 things?
Prescriber name
Patient name
Drug dispensed
Date filled
84
Records are expected to be held where as a default?
At the registered location
85
The DEA allows central recordkeeping if the registrant meets what criteria?
They notify the DEA of its intent in writing 14 days in advance
86
If a registrant notifies the DEA that they want to conduct central recordkeeping, their note must include what information?
The records to be kept centrally
The exact location of the records
The name, address, DEA registration number, and type of DEA registration of the registrant storing records centrally
Whether central records will be maintained manually or by computer
87
If a registrant is allowed to conduct central recordkeeping, all records must be transferred to the central location by when?
within 2 business days
88
What 3 things cannot be stored centrally?
EXECUTED order forms (DEA Form 222)
Inventories
Prescriptions
89
How are C-III, C-IV, and C-V medications ordered?
The same way as non-controlled medications
90
After ordering C-III, C-IV, and C-V drugs, what can be used as a record of receipt?
Standard invoice
as long as it contains:
-Date
-Able to easily identify controlled substances from non-controlled medications
(either labelled or as a separate section)
91
What is a DEA Form 222 used for?
Distribution of C-IIs
(includes purchases, transfers, and sales)
(only other way to deliver C-IIs is via prescription)
92
How are C-IIs ordered?
All distributions must be completed using a DEA Form 222
Originally a triplicate ordering form but is now a single-sheet order form
93
Who is allowed to fill out DEA C-II ordering forms (Form 222)?
Only the signatory of the DEA registrant
*But agency may be provided to others through a Power of Attorney (POA)
94
What are important facts to remember about Power of Attorney?
A separate POA must be filled out for each person individually
POAs may be revoked at any time and must be available for inspections alongside other records (kept at the registered location)
POA agents should sign "Roberta Registrant by Agnes Agent, Attorney in Fact"
95
What is a DEA Form 222a?
Used to order DEA Form 222s
96
When ordering more DEA Form 222s, what information must be included?
Name, Address, and Registration Number of the registrant
Number of books desired
Must be signed by the registrant or authorized agent
97
What parts of a DEA Form 222 are automatically added and cannot be chanced?
Order form numbers
Name, Address, Registration Number, Authorized Activities, and Schedules the registrant can handle
98
What information must be added to a DEA form 222?
Supplier Information
Purchaser name
Purchaser Signature (supplier)
Date (supplier)
of packages (purchaser)
Package Size
Drug name
**Indicate what the last line completed was so additional lines cannot be added**
99
What can be used to complete a DEA 222 Form?
Typewriter
Computer Printer
Pen
Indelible Pencil
100
Why should NDC's preferably not be filled in by purchasers on a DEA 222 form?
This prevents substitutions from being made and may delay the order if the NDC is not available
-can be filled in by purchaser but it is better not to
101
What is the maximum number of products that can be put on one DEA 222 Form?
20
102
When a DEA Form 222 is completed, what is the first thing that needs to be done?
Make a copy because the original will be sent to the supplier
103
If an error occurs when filling out a DEA 222 form, what must be done?
Must be voided
-write "VOID" across the front and file with all other executed forms
104
When a supplier receives a DEA Form 222 order form, what information will they add?
Supplier DEA number
NDC for products sent
Number of bottles or containers sent
Date sent
105
What records must a supplier keep regarding a Form 222 order?
Keep the original DEA 222 for 2 years
Foward a copy of the form to the DEA by the end of the month or reports information on the Automation of Reports and Consolidated Orders System (ARCOS)
106
Suppliers are required to report DEA Form 222's to who?
Send the DEA a copy of the form by the end of the month
OR
Report information to the Automation of Reports and Consolidated Orders System (ARCOS)
107
If a supplier must partial fill an order on a Form 222, how long do they have to supply the balance?
60 days
108
What does it mean if a supplier endorses an order from a Form 222?
The supplier may send an order to another supplier within 60 days
-Second supplier then fills the order
(this is all or nothing, no partial fill)
109
If a supplier is going to endorse an order, how long do they have if they are going to send it to another supplier?
60 days
110
Is a supplier finds an issue with a DEA 222 form, what do they do? (defective order)
Send the form back to the purchaser with a statement explaining the refusal to fill
111
If a supplier refuses to accept an order what do they do? (order refusal)
They must send the form back to the purchaser with a note that the order was not accepted
112
Why would a supplier void an order, and if an order is voided, what must the supplier do?
If a supplier cannot fill a full order, they may draw a line through the voided items and print "cancelled" on the number of items shipped
113
When a purchaser received their order, what must they record?
Date the order is received
Number of containers of each item received
114
If an executed DEA 222 is lost, what must be done?
The purchaser must execute a new DEA form 222 identical to the first
-Accompanying this should be a note stating the original form number, date of lost form, and a note that the substances were not received
115
If an unexecuted DEA Form 222 is lost or stolen, what must be done?
Must report immediately to the DEA with form numbers if known, or dates of order if unknown
If found, report to DEA immediately
116
If a business is terminated and has unused DEA 222 forms, what should be done?
Return order forms to the DEA
117
What is required in order to fill out DEA Form 222s electronically?
Registrants must apply for a digital certificate from the DEA authorizing a digital certificate as proof of identity
-Digital certificate gives access to the Controlled Substance Order System (CSOS)
-CSOS orders may include drugs from any schedule and non-controlled drugs
118
What is one limitation to using electronic 222 order forms?
They cannot be endorsed from one supplier to another
119
What are the required parts of a controlled substance inventory?
Every registrant must have "a complete and accurate record of all controlled substances on hand on the date the inventory is taken"
Including:
-Drugs stored in other areas of an institution
-Drugs returned by patient
-In the waiting bins ready to be picked up by a patient
*if the drug is in the registrant's possession, it must be inventoried*
120
What are the 4 points at which an inventory must occur?
Initial inventory
Official inventory
Rescheduling inventory
Final inventory
121
What is an initial inventory?
Must be conducted on the day the registrant first engages in activities with controlled substances
122
How often must an official inventory take place?
Must be conducted at least once every two years (biennially)
123
What is a rescheduling inventory?
Must be conducted when a previously non-controlled medication becomes a controlled substance
-only includes the newly controlled drug and must be conducted day-of
124
What is a final inventory?
Conducted when a registrant goes out of business
125
Inventories can be taken in what two ways?
At the opening of business on the inventory date
At the close of business on the inventory date
126
C-I and C-II substances must be inventoried as what?
an exact count
127
C-III, C-IV, and C-V substances may be estimated in inventories except for in what scenarios?
The bottle holds more than 1000 product units
*if more than 1000 product units, an exact count must be conducted
128
True or False: You can use a perpetual inventory for your official inventory
False
-you must handle the product (count or when estimating, look at and feel the weight of the product)
129
Each controlled substance record in an inventory should include what information?
Drug name
Dosage form
Strength
Number of loose units
Number of full containers
130
What is a prescription?
An order for medication which is dispensed to or for an ultimate user BUT DOES NOT INCLUDE an order for medication which is dispensed for immediate administration to the ultimate user
131
Who can issue a controlled substance prescription?
Can only be done by practitioners authorized to prescribe
-must have a DEA number or be exempt from registration
132
Who can communicate emergency C-II prescriptions?
*Agents cannot communicate these*
-A prescriber cannot give agency to anyone for these types of prescriptions, must be communicated by the prescriber themself
133
Prescribers must ensure what about a prescription being issued?
It is issued for a legitimate medical purpose by a practitioner acting in the usual course of practice
134
What is a "legitimate medical purpose"?
The patient has a medical need for the medication
135
What is "usual course of practice"?
Prescriber has a valid patient-provider relationship
136
What is considered a "valid patient-provider relationship"?
Used to require at least one in-person patient evaluation
-Since COVID this has included telemedicine visits
137
The responsibility for the proper prescribing and dispensing of controlled substances falls upon who?
-The prescribing practitioner
-A corresponding responsibility rests with the pharmacist who fills the prescription to make sure controlled substances are prescribed and dispensed appropriately
138
To violate the law regarding responsibility in controlled substance prescribing and dispensing, a pharmacist must have done what?
Knowingly filled a fraudulent prescription
139
What does "knowingly" mean in the context of filling a fraudulent prescription?
The pharmacist recognized the possibility of wrongdoing but refused to conduct a proper investigation
*note that the DEA believes that pharmacists should refuse all prescriptions that have concerns that cannot be resolved*
140
True or False: Concerns that appear on prescriptions are guaranteed indications of fraud
False, they could be indicative of fraud but it is not guaranteed
141
True or False: All concerns found on a prescription should be resolved and all resolutions must be documented
False
-all concerns should be resolved is true
-resolutions do not have to be documented but this is RECOMMENDED to avoid legal issues and prove that you have met corresponding responsibility
142
When documenting issues with a prescription, what should NOT be done?
Do not deface the prescription since this is the property of the patient
143
If you decide not to fill a controlled substance prescription, what should you do with it?
Return the prescription to the patient
*Unless the prescriber asks you to destroy it*
note that with electronic prescriptions you may need to call the provider and tell them to send it to another pharmacy
144
If you decide not to fill a controlled substance prescription, what needs to be documented?
Your rationale for filling or refusing to fill the prescription
145
For written controlled substance prescriptions, what kind of signature is required?
Wet signature
146
For faxed controlled substance prescriptions, what kind of signature is required?
Wet signature
147
For electronic controlled substance prescriptions, what kind of signature is required?
Electronic signature
(uses a two-factor authentication to verify identity)
148
What are the requirements for controlled substance telephone prescriptions?
-Transcribed by a pharmacist or intern when received at the pharmacy
-Can be called in by the prescriber or an agent
149
C-II prescriptions may be dispensed as what prescription types?
Written, paper prescription signed by the provider
Electronic prescription transmitted by the prescriber
Fax prescription (*only if patient presents the manually signed prescription to the pharmacist prior to dispensing)
*note that telephone prescriptions are not allowed*
150
What are the exceptions that can use a C-II faxed prescription as the original prescription (patient does not need to bring a physical signed prescription)?
C-II NARCOTIC substance to be COMPOUNDED for the direct administration to a patient by parenteral, IV, IM, SQ, or intraspinal infusion
(All compounded narcotic C-II injectable prescriptions)
All C-II prescriptions for a resident of a Long Term Care Facility
Narcotic C-II prescriptions of any route for a Hospice patient
151
C-II, C-IV, and C-V prescriptions may be dispensed as what prescription types?
Written, paper prescription signed by the prescriber
Electronic prescription transmitted by the prescriber
Fax prescription transmitted by the prescriber or an agent
Telephone prescription promptly reduced to writing by the pharmacist
152
True or False: C-II through C-V may be dispensed or administered without a prescription by an individual prescriber
True
-this is a prescribing quirk
-note that this involves all controlled substances except C-I (obviously)
153
When may institutions administer or dispense (not prescribe) C-II through C-V drugs?
Based on a prescription or order from an individual practitioner *if it is dispensed for immediate administration to the ultimate user*
154
What information is required to be on a controlled substance prescription?
Date the prescription was issued
Full Name + Address of patient
Drug Name, Strength, and Dosage Form
Quantity prescribed
Directions for use
Name, Address, and DEA number of prescriber
Signature of prescriber
155
For *C-II* prescriptions, pharmacists are allowed to make updates to the prescription EXCEPT for 3 things. What 3 things can the pharmacist NOT update?
Name of patient
Name of drug (except generic substitution)
Name of prescriber, including signature
*new prescriptions must be issued for any mistakes that cannot be updated*
156
What difference do C-III, C-IV, and C-V prescriptions have regarding corrections that the pharmacist can make compared to C-II prescriptions?
*These prescriptions have all of the same rules related to corrections that C-II's do
However:
Since we can accept verbal orders for these prescriptions, we can convert erroneous written prescriptions into telephone prescriptions
-MUST GET AUTHORIZATION FROM PRESCRIBER TO DO THIS
-note that state prescribing requirements may limit this
157
Who is allowed to fill prescriptions for controlled substances?
Only pharmacists
-acting in usual course of practice and who either registered individually or are employed in a registered institution
*Note that "pharmacist" includes anyone authorized to dispense controlled substances under the supervision of a pharmacist
158
True or False: Prescribers can fill prescriptions
False
-they may dispense controls, but this cannot be pursuant to a prescription
159
If a prescription has 3 refills, how many times can it be filled?
4 times
-because the initial fill is not counted in the refill amount
160
If a prescription is written for a quantity of 60mL and has 3 refills, what is the TOTAL quantity of drug that is going to be dispensed to this patient?
Need to include all fills when calculating this:
60mL x 1 (original fill)
+
60mL x 3 (refills)
=240mL total
161
How many refills are allowed on C-II prescriptions?
0
NO REFILLS ARE ALLOWED FOR C-II DRUGS EVER
162
How long are C-II prescriptions good for?
1 year from the date written
163
What is the maximum length of time that a C-II prescription can be filled for?
NO LIMIT (besides 1 year expiration)
-theoretically a prescriber could write a prescription for 365 days
164
Since C-II prescriptions cannot be refilled, prescribers may authorize multiple prescriptions at the same time.
What is the maximum day supply that these prescriptions may count toward?
90-day supply
165
When a prescriber decides to write multiple C-II prescriptions at once, what are the requirements for these prescriptions?
1. Each prescription must be written in accordance with controlled substance prescribing responsibilities
2. ***Prescriber must date each prescription with the DATE IT WAS ISSUED, and provide written instructions on each prescription indicating the EARLIEST DATE OF FILL
*note: earliest date of fill is not needed for the initial prescription but is required for all subsequent*
3. Prescriber must decide that multiple prescriptions to a patient does not create a diversion risk
4. Must adhere to state statutes and regulations
5. Must meet all other C-II prescription requirements
166
In what instance is a C-II prescription not valid?
(this comes from the example given during lecture)
If the "Date:" section is filled with a date that has not occurred yet (or technically one that has expired by being over 1 year old)
*note that the "Date:" section is not the same as "fill on/after," this must be written separately on the prescription
167
C-III and C-IV prescriptions are valid for how long?
6 months
168
C-III and C-IV prescriptions may have how many refills?
up to 5 refills *regardless of day supply
(total of 6 fills)
169
True or False: A prescriber may authorize additional refills on a C-III or C-IV prescription
It depends!:
-Prescribers who authorize fewer than 5 refills initially may authorize additional refills on the original prescription but the total refills cannot exceed 5
-Refills cannot extend beyond 6 months from the original issue date
170
What are the 3 options available to document C-III and C-IV refill information?
Write on the back of the prescription or another appropriate document
Document in an electronic prescription record
Alternative record (computer application)
171
What is required to be included in C-III and C-IV refill documentation?
(note that this does not include alternative record systems)
Name + Dosage Form of controlled substance
Date Filled or Refilled
Quantity Dispensed
Initials of dispensing pharmacist for each refill
Total number of refills for that prescription
172
If an alternative record system (computer application) is used for C-III and C-IV refill documentation, what is required to be included in the documentation?
Original prescription number
Date of issue
Name + address of patient
Name, address, + DEA number of prescriber
Name, strength, dosage form, + quantity prescribed of drug
(and quantity dispensed if different than prescribed)
Refills authorized
Refill history
173
If an alternative record system is utilized, pharmacies must employ one of what 2 recordkeeping methods for C-III and C-IV refills?
Print out all controlled substance refills with the information of the pharmacist who refilled the prescription. (printout must be reviewed and signed by the pharmacist who refilled the prescription and stored for 2 years)
or
Maintain a bound logbook that each pharmacist involved in dispensing shall sign each day, attesting to the fact that the refill information entered has been reviewed and is correct
174
True or False: The government does not care about C-V refills so there are no limits on refills or dates
True
-at least from the federal law, state law may be different but we have not talked about this yet
175
Partial filling of C-II prescriptions is allowed as long as what criteria are met?
1. It is not prohibited by state law
2. The patient, representative, or prescriber requested the partial fill
3. The total quantity of all partial fillings does not exceed the total quantity prescriber
4. The remaining portions are filled no later than *30 days* from the date the prescription is written
5. Does not apply related to stock shortages or insurance limitations
176
If a pharmacy partial fills a C-II prescription, the remainder must be ready for pickup when?
Within 72 hours of the partial fill
(but have 30 days from the date the prescription is written to actually fill)
177
If the remainder of a partial filled C-II prescription cannot be filled within 72 hours, what must be done?
Pharmacist must notify the prescriber of the partial fill
-including quantity and reason for partial
Remainder of the prescription is then voided
178
Partial C-II fills written for a patient in a Long-Term Care Facility or with a Terminal Illness may be partially filled for up to how many days from the date issued?
60 days from the date issued
(note that normally it is 30 days)
179
For C-II partial fills of patients in long term care facilities or terminal illnesses, what must be documented?
Date of partial fill
Quantity dispensed
Remaining quantity to be dispensed
Identification of dispensing pharmacist
180
Partial fills of C-III, C-IV, and C-Vs are allowed as long as they meet what criteria?
Total quantity dispensed does not exceed total quantity prescribed
No amount is dispensed after the prescription expires
181
True or False: Partial fills for C-III's, C-IV's, and C-V's can be dispensed in any amount
True
182
How do we record partial fills for C-III, C-IV, and C-V's?
The same way we record refills
183
How do partial fills differ from refills for C-III, C-IV, and C-V's?
Refills can only be done five times
Partial fills can be done more than five times
184
How are C-II emergency prescriptions taken?
Only over the phone
*note that this is the only time a C-II prescription can be taken over the phone
185
What 3 criteria must be met for a C-II prescription to be considered an emergency?
1. The immediate administration of a controlled substance is needed
+
2. There is no appropriate alternative available, including non-controls
+
3. It is not possible for the prescriber to provide a written prescription before dispensing the medication
186
What amount should emergency C-II prescriptions be written for?
Only the amount needed to cover the emergency period
187
An emergency C-II prescription must be followed up with a covering prescription within how many days?
within 7 days of authorizing the emergency prescription
188
If a pharmacist receives a paper covering prescription for an emergency C-II, what documentation should they do?
Attach the covering prescription to the emergency prescription previously dispensed
189
If a pharmacist receives an electronic covering prescription for an emergency C-II, what documentation should they do?
Annotate the prescription with the oral order's original authorization and date
190
If a covering prescription for an emergency C-II is not received, what needs to be done?
Pharmacist must notify the nearest DEA office
-otherwise it is misbranding and illegal distribution
191
If a covering prescription for an emergency C-II is not received within 7 days, what should be done?
Notify the DEA immediately
192
True or False: Central fill pharmacies cannot fill controlled substances
False
-they can but they require additional documentation
193
If a controlled substance prescription is sent to a central fill pharmacy, the pharmacist sending it must do what 3 things?
1. Write the words "CENTRALL FILL" on the face of 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
194
If a controlled substance prescription is sent to a central fill location, the original prescription must be kept at the local pharmacy for how long?
2 years
195
Besides the original prescription, what else must be kept at the local pharmacy for a controlled substance prescription that was sent to central fill?
A record of receipt of the filled prescription
(need to keep documentation that you received the prescription from central fill)
196
Central fill pharmacies are required to maintain what records relating to filling a controlled substance prescription?
A copy of the faxed prescription or electronic record with the:
-name
-address
-DEA number
(of the community pharmacy)
-The date the prescription was received
-Pharmacist filling the prescription
-Date the prescription was filled
-Date the prescription was delivered to the community pharmacy + delivery method
197
How long must central fill pharmacies maintain record relating to filling controlled substance prescriptions?
2 years
198
For C-III, C-IV, and C-V prescriptions being refilled at central fill locations, what must be done by the community pharmacy?
They must indicate in the information transmitted the number of refills already dispensed and the refills remaining
199
For C-III, C-IV, and C-V prescriptions being refilled at central fill locations, what must be recorded by the central fill pharmacy?
The dates the prescription was filled and refilled
200
All controlled substance prescription labels must contain what information?
1. Date of filling
2. Dispensing pharmacy name and address
3. Prescription number
4. Name of the patient
5. Name of the prescriber
6. Directions for use
Optional: cautionary statements contained in the prescription, if any
201
All C-II, C-III, and C-IV prescription labels must contain what?
A statement with the exact wording:
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
*note that this may be on all prescription labels but is only required for these drugs*
202
If a controlled substance is dispensed by a central fill pharmacy, its label must contain what additional item?
A unique identifier
203
In what circumstance do C-II labeling requirements not apply?
Administration in an institution as long as no more than a *7-day supply* of medication is dispensed at a time
204
In what circumstance do C-III, C-IV, and C-V labeling requirements not apply?
Administration in an institution as long as no more than a *34-day supply* of medication OR no more than *100 dosage units* is dispensed at a time
