Controlled Substances Flashcards

Question

Central Record keeping

Answer 1

-permitted by the DEA provided that they are notified 14 days in advance, in triplicate, by registered or certified mail, return receipt requested --> must tell DEA what records will be kept centrally, their exact location, name, addy, DEA # and type of registration, & whether manual or computerized, access codes etc --> upon request, registrant must provide records to the registered location within *2 business days* --> failure to comply may result in canceling the central record keeping authorization **central record keeping MAY NOT include: rxs, inventory records, and executed 222 order forms *** MAY include unexecuted 222 order forms

Answer 2

-forms may be requisitioned by using DEA form 222a -when completing a single sheet DEA 222 order form, the pharmacy must make a copy of the original DEA 222 form for its records, copy may be kept in electronic or paper form --> supplier retained the original copy and submits a copy to the DEA

Answer 3

-no alterations or white outs are permitted --> if a mistake is made: mark the DEA form "VOID" and store with other executed order forms *do NOT throw away* -DEA 222 may be signed by the registrant or by someone who has been given the power of attorney to execute the form -if an order cannot be filled completely, the supplier has *60 days* from the date of the execution of the order form to supply the balance -the supplier can also "endorse" the reverse side of the DEA 222 form to another supplier if they dont have the item ordered -order froms for Carfentanil, Etorphine Hydrochloride and Diprenorphine shall contain only these substances

Answer 4

-very important for the purchaser to record the number of containers received and the date received on part 5 of the DEA 222 form -a purchaser may cancel part or all of an order by notifying the supplier in writing. The supplier must indicate the cancellation by drawing a line through and marking the item "cancelled" -A supplier may void part or all of an order on a DEA 222 by notifying the pharmacy in writing. the supplier must indicate the voiding on the original DEA form by drawing a line through the cancelled item(s) and printing "void" in the space provided for the number of items shipped. the supplier would then send the original 222 order form back to the pharmacy along with an explanation - pharmacy would retain the voided 222 form and the explanation in its records

Answer 5

-sept 30, 2019- DEA changed from triple 222 to single 222 (2 yrs transition period) -new sheet is 8 1/2 x 11 inch sheet and expands the number of items that may be ordered from 10 to 20

Answer 6

-any registrant permitted to order schedule II controlled substances may do so electronically via the CSOS and maintain the records for 2 yrs (electronically) -CSOSO uses public key Infrastructure (PKI) technology, *which requires CSOS users to obtain a CSOS digital certificate for electronic ordering* - electronic orders must be signed using a digital signature issued be a certification authority* run by the DEA. -a *registrant must appoint a CSOS coordinator* who will serve as that registrant's recognized agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates issued under that registrant's DEA registration

Answer 7

-the required data fields have not been completed -the order is not signed a digital signature issues by DEA -the digital certificate used has expired or been revoked prior to signature -the purchaser's public key will not validate the digital certificate -the validation of the order shows that the order. is invalid for any reason

Answer 8

-supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding -if the entire order is voided, the supplier must make an electronic copy of the order and indicate "void" on the copy and return it to the purchaser -supplier is not required to retain a record of orders that are not filled -purchaser must retain an electronic copy of the voided order -should a supplier partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided

Answer 9

-purchaser must provide, to the supplier, a signed statement: including the unique tracking number and date of the lost order & state that the goods covered by the first order were not received through loss of that order -if the purchaser executes a new order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the 1st order and retain them both

Answer 10

-for each electronic order filled, a supplier must forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within 2 business days.

Answer 11

-the rule provides practitioners with the option of writing prescriptions for controlled substances electronically and for pharmacies to receive, dispense, and archive these electronic prescriptions

Answer 12

-pharmacy cannot process electronic rxs for CSs until its pharmacy application provider obtains a *3rd party audit or certification review that determines that the application complies with DEA's requirements* and the application provides the audit/certification report to the pharmacy.

Answer 13

-when a pharmacist receives a paper or oral rx that indicates that it was originally transmitted electronically to the pharmacy, the rph must check the pharmacy's records to ensure that the electronic version was not received and the rx dispensed --> if both prescriptions were received, the pharmacist must mark one as void

Answer 14

act amends the CSA to prevent the illegal distribution of CS on the internet -effective 4/13/09- pharmacies must get a modification of existing DEA registration to allow operation of an online pharmacy

Answer 15

-pharmacies registered with the DEA whose dispensing of controlled substances via the internet consist soley of refilling tx for CS in schedule II, IV, V -or filling a new rx in schedules III, IV, V where the pharmacy has previously filled a non-internet rx for the same pt

Answer 16

-statement that the pharmacy complies with the act -name, addy, e-mail and phone # of the pharmacy -name, professional degrees, and states of licensure for the pharmacist in charge & a # they can be called at -list of states in which the pharmacy is licensed -certification that pharmacy is registered with DEA as on online pharmacy -name and contact of any practitioner who has contractual relationships with the pharmacy

Answer 17

-obtained a verified Internet pharmacy practice site (VIPPS) accreditation from NABP -obtain a pharmacy domain for their website (www.deeznuts.pharmacy) -must register with DEA 30 days prior to engaging in internet pharmacy involving CSs -monthly reports must be made to the DEA of the quantity of each CS dispensed

Answer 18

-supplier is responsible for reporting the in-transit loss of controlled substances to the DEA -if discovered that an in-transit loss or theft has occurred; the purchaser must then submit a *DEA Form 106*

Answer 19

-pharmacy executes another order form and attaches a statement with: --the order form number --the date of the lost form --a statement starting that the goods covered by the first order were not received through loss of that order form -a copy of the second form and a copy of the statement must be retained with a copy of the original order at the pharmacy -if the original form is received by supplier - mark it "not accepted" and return to pharmacy

Answer 20

-immediately report to the special agent in charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost

Answer 21

-pharmacies are required to register with the Attorney General every 3 yrs (pharmacists are not required to register individually) -separate registrations for each pharmacy owned or operated by the same firm are required under DEA regulations -manufacturers & distributors must register annually **pharmacy may "distribute" CS to another pharmacy or physician without having to register as a distributor, provided that such sales amount to less than 5% of all CS dispensed & distributed in a year

Answer 22

-practitioner working in a hospital -physicians who are officials of the Armed Services, Public Health Services, and Bureau of Prisons (who are also allowed to dispense, administer, and prescribe in the usual course of their official duties -other duly authorized law enforcement personnel are exempt from registration for possession of CS as part of their official duties

Answer 23

-pharmacy initially completes application - DEA 224 -can renew online no more than 60 days prior to the current expiration date by completing a DEA 224a application --> if pharmacy does not renew online within 50 days of expiration, one will be sent to addy -if form is not received within 30 days before expiration - pharmacy should contact the local DEA registration specialist or DEA headquarters

Answer 24

e.g. change of address, addition of schedules etc - must notify the DEA in writing -if approved, DEA will issue a new certificate, which must be maintained with the old certificate

Answer 25

-if an individual registrant dies, or an individual registrant ceases legal existence, or d/c business, the DEA must be notified

Answer 26

no registration may be transferred or assigned w/o the approval of the DEA after submitting a written request

Answer 27

the attorney general

Answer 28

Attorney General may do so if applicant has: -materially falsified the application -has been convicted of a felony relative to CS -has had a state license or registration suspended, revoked, or denied --> before this, DEA must issue an order to show cause upon the registrant, who then must deliver the Certificate of Registration and all 222 forms to the DEA (gives the person an opportunity to defend themselves)

Answer 29

-manufacturing -distributing -reverse distributing -dispensing/Instructing -research -importing -exporting -narcotic treatment program -chemical analyses

Answer 30

-destroy using an on-site method (for pharmacies that have modified DEA registrations that allow them to be collectors) -deliver the CS to a reverse distributor's registered location by common or contract carrier pick-up -for return/recall: deliver to the registrants registered location (the manufacturer) -request assistance from the special agent in charge of the administration --> request can be made by submitting 1 copy of DEA form 41

Answer 31

-DEA 41 lists the CS or substances which the registrant desires to dispose -Special agent then disposes drugs by: -- transfer to a registrant authorized to transport or destroy the substance -- delivery to an agent of the administration or to the nearest offie of the Administration -- by destruction in the presence of an agent of the Administration or other authorized person

Answer 32

-(reverse distributor can return controlled substances to manufacturer or dispose of them on their behalf) -RD fills out a 222 form for any schedule II substances being destroyed -pharmacy records the drug name, dosage form, strength, quantity and date of transfer from any CIII - CIV -RD (NOT the pharmacy) is responsible for completing the DEA form 41 once the drugs are destroyed

Answer 33

-became effective October 9, 2014 -sets requirements for DEA registrants that *voluntarily* decide to establish disposal programs to collect unwanted CS from ultimate users --> allows numerous DEA registrants to become authorized to establish disposal programs (manufacturers, distributors, reverse distributors, narcotic tx programs, hospital, pharmacies) --> allows a number of disposal program including mail-back programs, collection receptacles and collection events (authorized only by law enforcement) -requires destruction of CS, no particular way

Answer 34

-notify the DEA *in writing* within ONE business day (fax) via a DEA form 106 --> if no theft, then no 106 but still write the DEA & tell them why no DEA form 106 was filed -the registrant must also file a complete and accurate DEA form 106 with the Administration through DEA's Diversion Control Substance secure network application *within 45 days* after discovery of the theft or loss

Answer 35

-rx may not be issued for Methadone for detoxification or maintenance tx. however, methadone can be dispensed in a retail pharmacy for analgesic purposes

Answer 36

-may be written on prescription blanks or may be oral -dates, signed, pts full name, address -drug name, strength, dosage form, quantity prescribed, directions -name, addy and DEA # of prescriber -manual sig of physician -DEA number cannot be reprinted on the rx

Answer 37

A Pharmacist may: -add the pts addy or change the pts addy upon verification -change or add the dosage form, drug strength, drug quantity or directions for use, only AFTER consultation w/ and agreement of the prescribing practitioner --> pharmacist is NEVER permitted to make changes to the pts name, CS prescribed (except for generic sub) or the prescribers signature

Answer 38

-"VOID" on the face of the rx -name, addy and DEA od the transferee pharmacy -name of the transferee pharmacist -date the prescription was transferred -pharmacist that transferred the prescription

Answer 39

-permissible as a one-time basis only! -pharmacies electronically sharing a real time, on-line, database may transfer up to the max refills allowed by state

Answer 40

-"transfer" on the face of the rx -date of issue of the original rx -original number of authorized refills -original date of dispensing -number of valid refills remaining and the dates and location of the previous fills -pharmacy name, addy, DEA number, and the rx number from which the rx information was transferred -name of the pharmacist who transferred the rx -pharmacy name, addy, DEA #, and rx number from which the rx information was originally filled

Answer 41

-DEA implemented (Aug 2023) a law that allows the transfer of unfilled electronic prescriptions for CS for initial filling, upon request from the pt - applies to CIIs as well -when CIII-IC CS rx is issued with authorized refills, they are transferred with the original prescription **PA Pharmacy Act has provision that states that CIIs may NOT be transferred**

Answer 42

-pharmacist must initial and date the back of the rx for each refill -refills are allowed on substances III-V w/ a *max of 5 times or over a period of 6 months, whichever comes first* , to the extent allowed by the physician

Answer 43

-on-line retrieval of original prescription order information -on-line retrieval of the current refill hx -documentation that any refill information entered in the computer is correct (rph must generate a printout of each days CS refill data, verify, date and sign it) -capability of printing out refill information -auxiliary procedure to document refills in the event of system downtime

Answer 44

Practitioner may authorize refills of schedule III-V provided that: -total quantity authorized, including original does not exceed 5 refills nor extend beyond 6 months from the date of issue -the rph initials and records the date, quantity authorized, & the # of additional refills authorized on the reverse of the original rx -the quantity of each additional refill is equal to or less than the quantity authorized for the initial filling -a new rx is required for any refills beyond the 6- month, 5 refill limit

Answer 45

Before an inspection, the inspector is required to: -state the purpose of the inspection -present credentials -provide a written Notice of Inspection (rph has the right to refuse unless a search warrant or an Administrative Inspection Warrant is issued) --> an AIW is issued by a judge given a probable cause of serving "a valid public interest"

Answer 46

-must be placed in a plain outer mailing container or securely over-wrapped in plain paper -the inner container must also be labeled to show the prescription # and the name and address of pharmacy, practitioner, or other person dispensing the rx -the outer mailing wrapper or container is free of markings that indicate the nature of the content

Answer 47

Faxing of CII rx is allowed, but before dispensing, the rph must generally receive the original signed RX for review, except for a fax for: -a CII to be compounded for direct admin to pt by parenteral, IV, IM, SQ or intra-spinal infusion -a CII narcotic for a hospice pt -any CII for a pt in a long term care facility *CSA permits faxed rx for C III-V (and non controlled substances) to serve as original rxs

Answer 48

-analgesic purposes only --> for addicts, tx with methadone is only allowed in a methadone clinic

Answer 49

-dispensing by a physician over a 3 day period while in the process of enrolling a pt in a clinic -administering to a pt while hospitalized for a condition unrelated to the addiction -for intractable pain (terminal cancer pt)

Answer 50

AKA methadone clinics: allow physicians to provide medication - assisted tx (MAT) - combines use of meds w/ behavioral health services -> must obtain approval and certification from the substance abuse and mental health services admin (SAMHSA) & from the state methadone authority --> must also register with the DEA as a Narcotic tx program via a DEA form 363

Answer 51

-methadone -levo-alpha-methadol (LAAM) (Buprenorphine and Buprenorphine - Naloxone are allowed but are C III)

Answer 52

-the dispensing of an opioid tx med in decreasing doses to an individual to alleviate adverse physiological or effects incident to withdrawal --> short term: period not in excess of 30 days --> long term: period more than 30 days but not in excess of 180 days

Answer 53

-the dispensing of an opioid agonist tx med at stable doses for a period in excess of 21 days

Answer 54

-expanded the tx of opioate addicts beyond the clinic - allows for the use of Buprenorphine (Subutex- initial tx) and Buprenorphine & Naloxone (Suboxone- maintenance) *C-IIIs* to be dispensed in a retail pharmacy for tx of opiate addiction

Answer 55

Prescribers are no longer required to obtain a DATA waiver (Xnumber) to tx pts with buprenorphine for opioid use disorder --> all rx require a DEA registration # -no longer a cap/limit on the number of pts a prescriber may treat for opioid use disorder w/ buprenorphine -one-time training requirement for all controlled substance prescribers (not dentists and vets) - 8hrs CE

Answer 56

*may place in non-DEA registered Long term care facility* must delineate: -source of CS -security safeguards 9who may access, limitation of the type & quantity of CS permitted in the kit) -responsibility for proper control and accountability -emergency medical condition's under which the CSs may be administered - prohibited activities (that if violated could result in state revocation, denial or suspension of the privilege)

Answer 57

-symbol designating which schedule the CS is listed -

Answer 58

-2 alpha characters followed by 7 digits (2nd letter = first letter of practitioner last name) -physician DEA #s will begin with A, B, F, G) -mid level prac begin with M -wholesaler DEA begin with P or R 1) Add the second, fourth, and sixth digits TIMES 2. 2) To this subtotal, add the first, third, and fifth digits. --> The last digit of the total should correspond with the last digit of the DEA number

Answer 59

-name and addy of the pharmacy -phone # and DEA # of pharmacy -Serial # & date of initial dispensing -name of pt and prescribing practitioner -directions for use and cautionary statements including Caution: federal law prohibits transfer of those drug to any person other than the pt for whom it is prescribes" -the trade or brand name of the drug, strength, dosage from and quantity dispensed (if generic- manufacture's name will also be shown) * reqs waived for institutional pts if: - CII dispensed in no more than 7 ds -C III- V drug is dispensed in a 34 day supply or 100 unit doses (whichever is less)

Answer 60

-retail pharmacy name and addy -a unique identifier (central fill pharmacy DEA #)

Answer 61

-transmitted electronically from the retail (transmitting) - must write "central fill" pharmacy on the face of the rx and record the name, addy, and DEA # of the central fill pharmacy, name of transmitting pharmacist and date of transmission

Answer 62

-must keep a copy of the rx if fax or an electronic record of the info sent: name, addy, and DEA number of the transmitting pharmacy -keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling, record of the date delivered to the retail pharmacy and the method of delivery.

Answer 63

-may prescribe, administer, or dispense a CS --> in good faith in the course of his/her practice & --> not for the use by a human (*alert where physician is attempting to write a rx for an animal or a vet tryna write one for a human - both not allowed) -rx for CS for an animal would not list the animals name- the species of the animal and the name & addy of the owner

Answer 64

-mandates that a federal investigation result if: 1- replacement cost of CS taken is $500 + 2- registrants or other person is killed or suffers injury - burglary or robbery: max $25k fine and/or 20 yrs jail -dangerous weapon used: max $35k fine and/ore 25 yrs jail - death results = max $50k fine and/or life in jail 3- interstate or foreign commerce is involved in planning or execution of the crime

Answer 65

-return the certificate of registration, any unused 222 forms tot he DE at the Washington DC office -must also complete a DEA 41 form & wait for a response on how to dispose the CSs

Answer 66

-when transferring to another person: must submit the proposal to the DEA 14 days in advance & include: --> name, addy and DEA # of the registrant d/cing the business as well as the same info for the registrant acquiring the business --> whether the business activities will continue at the current location or not -unless the DEA says no, the transfer can occur, and on the day of the transfer a complete CS inventory must be taken (transfer of CIIs must be done via 222 form) -CS records are also transferred

Answer 67

-records required must be kept by the registrant for 2 yrs -no DEA registrant can employ an individual who has access to CS if they have a previous felony offense related to CSs, had an application for CS registration denied, revoked or suspended (can ask DEA for waiver if they are in this situation) -under federal law- no specific quantity limit for a CS rx -under federal law- no specific time limit during which a C II must be filled: *PA placed a 6 month limit from the date of rx issue*

Answer 68

-daily sale limit on Retailers: may not exceed 3.6 gram (base) per day per purchaser -30 day purchase limit on consumers: cannot purchase more than 9 g (base) -Mail order limits: may not sell more than 7.5 gram (base) within a 30 day period

Answer 69

-Ephedrine HCL 25 mg has 20.57 mg base -Pseudoephedrine HCl 30 mg tab has 24.65 mg base --> can purchase 146 tabs per day of Sudafed 30 mg -Pseudoephedrine S)4 30 mg tab has 23.22 mg base

Answer 70

-all SLCP products must be kept behind the counter or in locked display on the floor -written or electronic logbook of transactions --> must include: Warning section 1001 of title 18: if someone makes false doc: $250,000 fine for individual, $500,000 fine for organization and/or 5 yrs jail -each entry must be maintained for 2 yrs following the date of entry -need to have photo ID * any loss or disappearance must be reported to the DEA orally ASAP, followed by a written report within 15 days

Answer 71

-submit self-certifications to the Attorney General - kept updated on an annual basis -The Attorney General may prohibit persons who sell products in violation of the sales restrictions or the logbook, training, and certification requirements from selling any SLCPs - Retail stores may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of SLCP products

Answer 72

Pharmacies must submit sales of SLCP's via the National Precursor Log Exchange (NPLEX) - keeps track of OTC pseudoephedrine and ephedrine -provides real time tracking and alerts the pharmacy if an individual attempts to purchase more than legal limits

Answer 73

-individual practitioner may issue multiple rxs authorizing a pt to receive up to a total of 90 ds - must meet conditions: 1- each rx is issued for a medical purpose 2- writes instructions on each rx- indicating earliest fill date 3- practitioner concludes that providing the patient with multiple rxs does not create risk of diversion or abuse 4- permitted by law *even though some have the "do not fill until", they are all still dated as of the same date of issue

Answer 74

-database contains info on dispensed CS II-V -RPH & other authorized HCPs can access the database in order to better recognize signs of diversion and "doctor shopping" -HB 602 Act 53: required that all who sell Pseudoephedrine OTC submit electronic transactions to NPLEX by april 5, 2014. (replaced former submission of CII data on a monthly basis to Attorney Generals office)

Answer 75

within 1 business day of dispensing CS must record: -name of prescriber -prescriber DEA, NPI # -date the rx was written -date it was filled -name, DOB, gender and addy of pt -NDC # of the drug dispensed, quantity and DS -number of refills authorized & refill # -DEA, NPI of pharmacy -payment method pt used

Answer 76

before dispensing an opioid or benzo to a pt if: - pt is new to the pharmacy -pt pays cash when they have insurance -pt requests an early refill -pt is getting opioids or benzos from more than 1 prescriber

Answer 77

-submit a zero-report to notify the PDMP office that it did not dispense any on a given business day --> pharmacies who never dispense a CS or dispense less than 5 CS/month can request a waiver from submitting zero-reports

Answer 78

-a prescriber may authorize a non employee agent to transmit a prescription for a controlled substance to a pharmacist -creates a vehicle (written agent agreement) for individuals acting outside of an employer/employee relationship to be considered agents of the prescriber.

Answer 79

-prepare a CS rx for the signature of the prescriber -orally communicate a prescribers C III, C IV or C V rx to a pharmacist or via practitioner-signed fax -transmit by fax a prescriber's written C II rx to a pharmacist for a pt in hospice or LTFC **Emergency oral communication of C-II prescription may not be delegated to an authorized agent**

Answer 80

Provider must have a consent form signed by a parent or authorized adult, as well as advising on the risks and dangers of opioids, etc. -The prescriber also cannot prescribe more than a 7 days’ supply of an opioid to a minor (72-hour supply if the individual who signs the consent form is an authorized adult and not the parent) - if in the professional medical judgment of the prescriber, more than a seven-day supply of a CS containing an opioid is required to stabilize the minor's acute medical condition, then he/she can prescribe a larger quantity--> doc med condition in the minor’s record and a reason listed why a non-opioid would not be appropriate. -Another exception would be for the management of pain associated with cancer, palliative or hospice care, or management of chronic pain not associated with cancer.

Answer 81

-A health care practitioner may not prescribe an opioid to an individual seeking treatment in a ED or urgent care center, or who is in observation status in a hospital, for more than a 7 days’ supply- No refills -if provider says its needed or is necessary for the treatment of pain associated with a cancer diagnosis or for palliative care -then ok. doc the condition and medical records

Answer 82

-requires pharmacists to obtain 2 hours of the 30 hours of required continuing education in the area of pain management, identification of addiction, or prescribing or dispensing of opioids. -preliminary requirement for those obtaining an initial license to demonstrate compliance within 12 months of obtaining a license by completing 2 hours of education in pain management or ID of addiction AND 2 hours in prescribing or dispensing of opioids.

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