Exam 2 Flashcards
controlled substance
a drug with dependence liability and/or abuse potential
What are factors that determine the scheduling of controlled substances?
-actual or relative potential for abuse
-scientific evidence of pharmacologic effect
-state of current knowledge regarding drug
-history and current pattern of abuse
-scope duration and significance of abuse
-public health risk
-psychic or physiological dependence liability
-whether substance is immediate precursor of already controlled substance
What is the abuse potential of CIs?
high
Is there a medical use for CIs?
no
What is the psychological dependency for CIs?
not defined
What is the physical dependency for CIs?
not defined
What is the abuse potential of CIIs?
high
Is there a medical use for CIIs?
yes
What is the psychological dependency of CIIs?
severe
What is the physical dependency of CIIs?
severe
What is the abuse potential of CIIIs?
lower than CI/CII
Is there a medical use for CIIIs?
yes
What is the psychological dependence of CIIIs?
high
What is the physical dependence of CIIIs?
moderate to low
What is the abuse potential of CIVs?
lower than CIII
Is there a medical use for CIVs?
yes
What is the psychological dependency of CIVs?
limited compared to CIIIs
What is the physical dependency of CIVs?
limited compared to CIIIs
What is the abuse potential of CVs?
lower than CIVs
Is there a medical use for CVs?
yes
What is the psychological dependency of CVs?
limited compared to CIVs
What is the physical dependency of CVs?
limited compared to CIVs
If federal and state scheduling differ, which law should be followed?
stricter schedule
What is the age at which pharmacists can sell OTC controlled substances to?
≥ 18 years
What are the limits of selling OTC controlled substances?
-240 mL or 48 dosage units of opioid-containing controlled substances
-120 mL or 24 dosage units of other controlled substances
-within 48-hour period
What information must be verified and recorded about the sale of an OTC controlled substance?
-valid form of ID
-name of purchaser
-name and quantity of controlled substance purchased
-date of purchase
-name or initials of pharmacist
Where should information about sales of OTC controlled substances be recorded?
bound book
What are the limits of selling pseudoephedrine, ephedrine, and phenylpropanolamine?
-3.6 g/day
-9 g in 30 days
What information must be verified and recorded about the sale of pseudoephedrine, ephedrine, and phenylpropanolamine?
-name, address, and signature of purchaser
-date and time of sale
-name and amount of product purchased
-valid form of ID
What is the primary DEA registration used by practitioners, pharmacies, hospitals, and teaching institutions?
dispensing or instructing
When is a separate DEA registration required?
for each place of business/practice location where controlled substances are held
DEA Form 224
application for dispensing or instructing registration
DEA Form 225
application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
When are most DEA registrations renewed?
annually
How long is the dispensing or instructing registration valid for?
3 years
What DEA registration types do not permit coincident activities?
-reverse distributing
-exporting
What coincident activities can dispensing or instructing registration perform?
-conduct research and instructional activities with substances for which registration was granted
-manufacture product containing narcotic controlled substance in schedule II-V in proportion < 20% of complete solution, compound, or mixture
-central fill pharmacy activities (retail pharmacy only)
-distribute controlled substance to another practitioner for purpose of general dispensing if distribution < 5% of total dosage units distributed and dispensed within same year
How many characters do DEA registration numbers have?
nine
How many letters do DEA registration numbers have?
two
How many numbers do DEA registration numbers have?
seven
What letters do DEA registration numbers start with for dispensing or instructing registration types?
A, B, F, or G
What letter do DEA registration numbers start with for mid-level practitioners?
M
What does the second letter of the DEA registration number represent?
last name or name of business that initially registered
How do you check if a DEA registration number is valid?
-add 1st, 3rd, and 5th digits
-add 2nd, 4th, and 6th digits, then multiply by 2
-add steps 1 and 2
-determine if sum matches 7th digit
What groups of people are exempt from the DEA registration requirement?
-agent or employee of person who is registered to engage in particular activity
-common or contract carriers and warehousemen who possess controlled substances in usual course of business
-ultimate user who possesses controlled substance
What are the requirements for using an institutional DEA registration number?
-activity is done in usual course of individual’s professional practice
-jurisdiction in which individual is practicing allows the action
-institution has verified individual may perform action in jurisdiction in which they are practicing
-practitioner acts only within scope of employment
-institution applies specific internal code to DEA number for each authorized practitioner
-institution keeps current list of internal codes for verification purposes
Where must CIs be stored?
securely locked, substantially constructed cabinet
Where must controlled substances in a practitioner’s office or clinic be stored?
locked cabinet
What drugs must be stored in a safe or steel cabinet equivalent to a U.S. government class V security container?
-thifentanil
-carentanil
-etorphine hydrochloride
-diprenorphine
How long must records and reports involving controlled substances be kept from their origin date?
2 years
How must controlled substance records be stored?
-CII separately
-CIII-V can be with other records if readily retrievable
What are the requirements for a prescription to be “readily retrievable?”
-red “C” ≥ 1 inch tall stamped in lower right corner of prescription OR
-must identify prescriptions by prescription number in computer system and be able to search by prescriber name, patient name, drug dispensed, and date filled
How far in advance must a registrant notify the DEA if doing central recordkeeping?
14 days
If central recordkeeping is allowed, when must all records be transferred to the central location?
within 2 business days
What items cannot be stored centrally?
-executed order forms (DEA Form 222)
-inventories
-prescriptions
-power of attorney forms
How are CIII-Vs ordered?
-same way as non-controls
-include date of order
-must be easily identifiable from non-controls
What form is required to purchase CIIs?
DEA Form 222
What form needs to be submitted to order DEA Form 222s?
DEA Form 222a
What information must be included in a DEA Form 222a?
-name, address, and registration number of registrant
-number of books desired
-signed by registrant or authorized agent
What information is included in a DEA Form 222?
-supplier information
-purchaser name
-purchaser signature
-date
-number of packages
-package size
-drug name
-last line completed
How many drugs require multiple DEA Form 222 forms?
> 20
Who keeps the original copy of the DEA Form 222?
supplier
Who keeps the copy of the DEA Form 222?
purchaser
What must be written across DEA Form 222s if an error occurs?
VOID
What information does the supplier need to add to a DEA Form 222?
-supplier DEA number
-NDC number for product(s) sent
-number of bottles or containers sent
-date sent
How soon should the supplier forward a copy of the DEA Form 222 to the DEA?
by the end of the month
How long does a supplier have to supply remaining balance of a partial fill?
60 days
How long does a supplier have to send an order to another supplier?
60 days
In what situation can a supplier not endorse an order?
electronic DEA Form 222
How often must official inventories be conducted?
biennially
What schedule of controlled substances must be inventoried as an exact count?
CI and CII
What schedule of controlled substances can be estimated if the bottle holds ≤ 1000 dosage units?
CIII-V
What information do controlled substance records need to contain?
-drug name
-dosage form
-strength
-number of loose units
-number of full containers
What type of prescription can agents not communicate?
CII emergency prescriptions
What happens to a prescription if the pharmacist refuses to fill it?
returned to the patient
What type of signature is required for controlled substance written prescriptions?
wet signature
What type of signature is required for controlled substance fax prescriptions?
wet signature
What type of signature is required for controlled substance electronic prescriptions?
electronic signature
What types of prescriptions are acceptable for CIIs?
-written prescription
-electronic prescription
-fax prescription if manually signed prescription is presented to pharmacist
What types of narcotic CII prescriptions can be accepted through fax?
-injectable
-for hospice patients
What type of CII prescription can be accepted through fax?
for long-term care facility patients
What information is required for controlled substance prescriptions?
-date issued
-full name and address of patient
-drug name, strength, and dosage form
-quantity prescribed
-directions for use
-name, address, and DEA number of prescriber
-signature of prescriber
What information cannot be changed for controlled substance prescriptions?
-patient’s name
-drug name
-prescriber’s name
What prescriptions can never be refilled?
CIIs
How long are CII prescriptions valid after its written date?
1 year
Is there a limit on quantity of CII prescriptions?
no
What must be written on a prescription if multiple are written at once for CIIs?
-date issued
-earliest fill date
How long are CIII-V prescriptions valid after its written date?
6 months
How many refills can CIII-V prescriptions have?
≤ 5
What information must written CIII-IV refill documentation include?
-drug name and dosage form
-date filled or refilled
-quantity dispensed
-initials of dispensing pharmacist per refill
-total number of refills for prescription
What information must electronic CIII-IV refill documentation include?
-original prescription number
-date of issue
-name and address of patient
-name, address, and DEA of prescriber
-name, strength, dosage form, and quantity prescribed of drug
-refills authorized
-refill history
If an electronic record system is used to document CIII-V refills, what methods must the pharmacy employ for recordkeeping?
-print out controlled substance refills with information of pharmacist who refilled prescription; must be reviewed and signed by pharmacist
-maintain bound logbook that each pharmacist dispensing signs each day
What are the circumstances for partially filling a CII prescription?
-at request of patient, patient representative, or prescribing practitioner
-pharmacy cannot provide full amount
-for patient in long-term care facility or terminally ill
What are the requirements for partially filling a CII prescription?
-not prohibited by state law
-patient, patient representative, or prescribing practitioner requested
-total quantity of partial fillings does not exceed total quantity prescribed
-remaining portions filled ≤ 30 days from written date
What are the regulations for partially filling a CII prescription due to the drug being out of stock?
-remainder must be ready for pickup within 72 hours of partial fill
-if not filled, then must notify prescriber and rest of prescription is void
If a CII partial fill is due to the patient being in a long-term care facility or terminally ill, when must it be filled before being void?
≤ 60 days from date issued
What must be documented for long-term care facility or terminal illness CII partial fills?
-date of partial fill
-quantity dispensed
-remaining quantity to be dispensed
-dispensing pharmacist
What are the conditions for a CII emergency prescription?
-immediate administration is needed
-no appropriate alternatives
-not possible for prescriber to provide written prescription
What must be sent to the pharmacy after a CII emergency prescription?
covering prescription within 7 days of emergency prescription
What information must be recorded by the community pharmacy if sending a controlled prescription to a central fill pharmacy?
-CENTRAL FILL on original prescription
-name, address, and DEA number of central fill pharmacy
-name of pharmacist transmitting prescription
-date transmitted
What information must be recorded by the central fill pharmacy for controlled prescriptions?
-copy of faxed prescription or electronic record with name, address, and DEA number of community pharmacy
-date prescription was received, pharmacist filling prescription, and date prescription was filled
-date delivered to community pharmacy and delivery method
What information must all controlled substance prescription labels have?
-date of filling
-dispensing pharmacy name and address
-prescription number
-name of patient
-name of prescriber
-directions for use
-cautionary statements (if included)
What statement is required on CII-IV prescription labels?
Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
What must a prescription label for a controlled substance filled at a central fill pharmacy include?
unique identifier
Under what circumstance do prescription labeling requirements not apply to CII prescriptions?
≤ 7-day supply for administration in an institution
Under what circumstances do prescription labeling requirements not apply to CIII-V prescriptions?
≤ 34-day supply or ≤ 100 dosage units for administration in an institution
What are the conditions for transferring CIII-V prescriptions?
-must have been filled at least once
-cannot be transferred more than once unless the pharmacies share a real-time online database
What must the transferring pharmacist record for CIII-V prescription transfers?
-VOID on prescription
-name, address, and DEA number of receiving pharmacy
-date of transfer and name of transferring pharmacist
What must the receiving pharmacist record for CIII-V prescription transfers?
-date of issue of original prescription
-original number of refills authorized
-date of original dispensing
-number of refills remaining, and date and location of previous refills
-transferring pharmacy name, address, DEA number, and prescription number
-name of transferring pharmacist
-original pharmacy name, address, DEA number, and prescription number
What is the duration of therapy for short-term detoxification?
≤ 30 days
What is the duration of therapy for long-term detoxification?
30 to 180 days
When may controlled substances be dispensed for substance use disorder (SUD)?
-practitioner registered with DEA as narcotic or opioid treatment program
-practitioner dispensing from office supply
-hospitalized patient
-prescription for direct administration
What is the day supply for office dispensing of controlled substances for SUD?
3 days
What dosage forms are allowed for direct administration of controlled substances for SUD?
-injection
-implantation
What is the timeframe for administering controlled substances for SUD if it is a direct administration?
within 14 days of receiving product from pharmacy
What forms must be filled out for reverse distributing?
-DEA Form 222
-DEA Form 41
What are the four methods of disposal of controlled substances?
-on-site destruction
-delivery to a reverse distributor
-sending product back to distributor, warehouse, or manufacturer
-request assistance directly from local DEA field office
How soon after a theft or robbery must a DEA Form 106 be filed?
within 45 days of discovery
What information is included in a DEA Form 106?
-date of issue occurrence or discovery
-theft or significant loss
-name, dosage form, strength, and quantity of controlled substances lost or stolen
