Exam 2 Flashcards
What was the purpose of the Comprehensive Drug Abuse Control and Prevention Act (Controlled Substances Act (CSA))?
- control and enforcement of controlled substances
- importation and exportation of vontrolled substances
- established a “closed” system for manufacturing, distributing, and dispensing of controlled substances
What federal agency is respondsible for enforcing controlled substance laws and regulations?
Drug Enforcement Administration (DEA)
Define: Narcotic
opium, opium derivative, opioid
Schedule II substances abuse may lead to ______ psychological and ________ physical dependance.
severe, severe
Schedule III substances abuse may lead to ______ psychological and ________ physical dependance.
high, moderate-low
If a manufacture does not include the controlled substance label, the packaging is ________.
misbranded
What drugs must be behind the counter or in locked cabinets?
scheduled listed chemical products (SLCPS)
What drugs are schedule listed chemical products (SLCPS)?
- phenylephrine
- ephrine
- phenylproponolamine
Who must register with the DEA?
any entity that handles controlled substances
What is the DEA form filed by pharmacies that dispense controlled substances?
DEA Form 224
How often do DEA registrations for pharmacies that dispense controlled substances renew their registration?
3 years
What are the types of DEA registration?
- manufacturing
- distributing
- reverse distributing
- dispensing or instructing
- research (I)
- research (II-V)
- narcotic treatment program
- importing
- exporting
- chemical analysis
Who needs a dispensing registration through the DEA?
- practitioners
- hospitals/clinic
- retail pharmacies
- central fill pharmacies
- teaching institutions
What is the DEA renewal form for pharmacies?
224a or 224b (chain pharmacies with 50 or more registrations)
Who is exempt from DEA registration?
- agents or employees of a person registered (pharmacists)
- common or contact carrier, warehouse workers, or employees
- users (patients)
- some armed service members, Public Health Service, Bureua of Prisons, other law enforcement officers
What is included in a valid DEA number?
- starts with A, B, F, or M if mid-level practioner
- 2 letter is first letter of last name
- add number 1, 3, 5
- add 2, 4, 6 and multiply by 2
- add together
- tenth place of math matches final digit od DEA number
What form is filed to order schedule II substances?
DEA form 222
paper forms (books of 7 or 14) or electronic system
What is the use of DEA form 222?
all pharmacy non-prescription transfers nof C-II medications
How long must DEA form 22 be kept on file?
2 years
How often should inventory for controlled substances be taken in pharmacies?
initially, then every 2 years (biennial), and with newly controlled substances
What information on controlled substances must be recorded?
- name of drug
- dosage form
- strength
- number of loose units (record as numbers)
- number of full containers
Which schedule drugs require exact counts?
- C-II
- C-III - C-V if the original container contained more than 1000 units
What records are required to be kept in reguards to controlled substances?
- controlled substances dispensed
- reports of theft or significant loss (DEA form 106)
- controlled substances destroyed (DEA form 41)
- DEA registration certification
- logbook for pseudoephedrine products
- executed DEA 222 forms
- reciepts or invoices for CIII-V
- power of attorney authorization to sign forms
- inventory records
- control substances distributed
Explain how control substance records must be kept:
C-II must be kept separately and C-III-C-V must be kept in such a way that information if readily retrievable (2-file or 3-file) red C if paper or electronic
What records cannot be kept in central recordkeeping?
- executed DEA form 222
- inventories
- prescriptions
To begin central recordkeeping the company must notify the ______ by ______.
DEA, mail
What is the DEA form to report theft or loss?
DEA form 106
After theft or loss, the pharmacy has ____________ to report it to the DEA.
1 business day
When must the DEA form 106 be submitted after theft or loss?
45 days
Distributions cannot exceed ______ of total dosage units of all controlled substances distributed and dispensed in same calender year.
5%
How may agents interact with regards to controlled substances?
- prepare written prescriptions for the signature of the practitioner
- call in C-III - C-V
- fax prescriptions
What is required for a valid controlled substance prescription?
- patients full name
- patients address
- practitioners full name
- practitioners address
- DEA
- drug name
- drug strength
- dosage form
- quality prescribe
- directions for use
- number of refills
- date issued
- signature
C-II - C-V prescriptions must be ________ for medicare D and Indiana by law.
electronically prescribed
When may a verbal C-II prescription be accepted?
emergencies
pharmacist must verify
Pharmacists must recieve a written prescription within ______ of emergency prescription and must ______________ if they do not recieve it.
7 days, notify the DEA
What 3 scenerios may a faxed C-II prescription serve as the original?
- narcotic compounded for direct administration via parenteral, injectable agent, intravenous, IM, subcutaneous or intraspinal infusion
- residents of long term care facility
- patient enrolled in hospice
What can the pharmacist change on a C-II prescription after contacting the provider?
do not forget to document! :)
- dosage form
- strength
- quantity
- directions for use
- issue date
What is the max refills in 6 months for C-III and C-IV?
5 refills
no limit on C-V
What are the labeling requirements for controlled substances?
- pharmacy name and address
- prescription number
- name of prescribing practitoner
- cautionary statements
- date of filling
- name of patient
- directions for use
- “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
What is the labeling requirements for controlled substanced filled at a central fill facility?
- date of filling
- pharmacy name and address
- prescription number
- name of patient
- name of prescribing practitoner
- directions for use
- cautionary statements
- retail pharmacy name and address
- unique identifier (central pharmacy DEA, but doesnt have to be)
When a pharmacist partial fills a prescription the remainder must be filled in ________.
72 hours
When a patient requests a partial fills a prescription the remainder must be filled in ________.
30 days since the prescriptions was written
What are the Scheduled Listed Chemical Products (SLQP) quantity limits?
3.6 grams in 24h, 9 grams in 30 days
What must be recorded when selling SLCP?
- name of purchaser
- address of purchaser
- date and time of sale
- name and amount of product sold
What must the purchaser do when buying SLCP?
- photo ID
- signature
What must be done with theft/loss of SLCPs?
- report to local DEA field office
- written report must be filed in 15 days
What is the age requirement to purchase OTC C-V?
18 years old
What is the limit on codeine-containing OTC cough syrups?
No more than 120mL or 4 oz per 48 hours
What must online pharmacies have on their site?
- name and address of pharmacy
- pharmacy telephone number and email
- pharmacist in charge
- list of states where licensed to dispense
- certification that pharmacy is registered to deliever, distribute, and dispense controlled substances
- information of any practitoner that has a contractual relationship
What is a AWI?
administrative inspection warrant, cannot refuse entry of DEA if presented with one
How can red flags be resolved?
- DOCUMENT!
- review notes and comments on pt profile
- consult with patient
- consult Prescription Drug Monitoring Program
