Pharm Law, Registration, Ordering Controls, Rx Requirements

Front 1

pharmacies and other dispensers register with DEA form ______ and ___ for renewal?

Back 1

DEA form 224 for inital registration and DEA 224a for renewal

Front 2

pharmacy registers DEA as _______

• repackaging for purposes of sale
• purchases of controlled substances within pharmacy or other registrants
• compounds for office use

Back 2

manufacturer

Front 3

pharmacy regsiters DEA as ______

• participates in joint buying activities and is the location where drugz are stored and shipped
• distribution of controlled substances to toher pharmacies or practitioners >5% of total # dosage units

Back 3

distributor

Front 4

how long are DEA 222 forms active for if the ordered drug is not rec'd?

Back 4

-form is active for 60 days

-if not rec'd after 60 days the item is voided and new order must be placed in order to rec'd da drugz

Front 5

DEA 222 form1

Back 5

• brown,
• goes to supplier
• closest to the ground and is brown like dirt

Front 6

DEA 222 form2

Back 6

• green like the grass
• goes to supplier to be forwarded to DEA

Front 7

DEA 222 form3

Back 7

• blue like the sky
• maintained by pharmacy or other recipient

Front 8

IL law authorizes who to Rx control substances?

Back 8

physicians, residents, podiatrists, veterinarians

-within a hospital: interns, residents, foreign-trained MDs using hospital DEA number within dey scope

Front 9

how long is Rx valid for and what is the supply amt for a C2?

Back 9

-90 days from date written

-30 day supply

Front 10

what is the amount of time a prescriber must provide a written Rx for emergency situations that might result in 'loss of life' or 'intense suffering'?`

Back 10

• 7 days after issuing emergency Rx
• if mailed by prescriber must be postmarked w/in 7 days

Front 11

IL requirements for emergency kits

Back 11

• CS must be obtained from a DEA registered hospital, pharmacy or practitioner
• for LTCF
• <=10 different CS/kit, <=3 single inj doses of each cs SUBSTANCES
• Administered only by an RN, LPN, or practitioner
• Proof of use sheet in each kit kept on file for 2 years
• notified consultant pharmD w/in 24 hrs of opening

Front 12

limited compounds for office use requirements:

Back 12

• aqueous, oleginous, or solid dosage form
• only contains 20% CS; and (but can write an Rx for stronger strength doe)
• must be distributed only to a practitioner who is also registered to dispense

If any of these is missing, a manufacturer's registration is required

Front 13

Rph dispenses a drug w/out valid Rx or an authorized refill, the product is ______

Back 13

misbranded

Front 14

______ is a package that has 'an indicator or barrier to entry which if breach or missing can reasoanably be expected to proivde visible evidence to consumers that tampering has ocurred'

Back 14

tamper-resistant packaging

Front 15

• blister packs,
• film wrappers around products
• aerosol containers,
• tape seals
• break-away caps
• foil paper or plastric pouches that 'must be torn or broken to obtain product'

Are examples of what?

Back 15

anti-tampering measures

Front 16

All of the following is included in a ______ means and includes evaluation of Rx drug orders and patient records for:

• known allergies
• potential therapy contraindications
• reasonable dose, duration, route, with age, gender and contraindications
• reasonable directions for use
• DDI
• D-food-I
• druge-disease-I
• therapeutic duplication
• patient lab values when authorized and available
• proper utilization and optimum therpaeutic outcomes
• abuse and misuse

Back 16

Drug regimen review /

Drug utilization review

Front 17

Duties of a PIC when a pharmacy ceases operations:

Back 17

• notify DPR and forward DPR copy of closing inventory of all controlled drugs and a statment of intended disposition of all legend drugs and Rx files within 30 days
• --DPR then has 30 days to notify PIC of approval or disapproval of statement
• if disposition or alt plan not completed w/in 30 days, DPR may confiscate all legend drugs with `as final administrative decision

Front 18

the PIC must work an average of at least ______ hours per week at each location where he or she is the PIC

Back 18

8 hrs

Front 19

who can check-in control orders arrived at a pharmacy? who would be the best person to do it also?

Back 19

anyone can check in controls, but best would be a pharmd

Front 20

who retains DEA forms for a return to distributor/manufacturer transfer between registrants?

Back 20

• if returning for credit, supplier prepares form and provides copies 1 (brown), 2(green) to pharmacy
• pharmacy forwards green copy 2 to DEA, retains brown copy1
• manufacturer/distributor keeps blue copy 3

Front 21

agents may prepare a CS Rx for a practitioner's sign but a _____ or ____ cannot act as an agent of a practitioner

Back 21

-pharmacist or technician

Front 22

what is required on label for all CS Rxs

Back 22

1. Patient name
2. Rx number
3. pharmacy name and address
4. prescriber name
5. dispensing Rph name
6. drug name, dosage,quantity (IL only)
7. directions for use and any precaution label s
8. date drug was filled or dispensed

• fed requires transfer warning statement: 'caution federal prohibits dispensing w/out Rx'
• CS require transfer warning: 'federal law prohibits x-fer of drug to any other than the patient for who it was Rx'd'

Front 23

what are the inventory requirements?

Back 23

must be taken bienially, on any date w/in 2 years of previous biennial inventory

• state whether was taken at open or close of bidness
• signed by person taking inventory
• record should be filed within pharmacy for 2 years. no copy needs to be sent to DEA
• must be in any written format
• new schelued substances must be inventoried on the date of official schedling and filed with most recent inventory
• for new pharmacies; don't need to inventory new stock. invoices and 222 forms are fine
• actual count of C2s. estimation of C3-5s in containers <1000 units. physical count if containers >1000units

Front 24

what are the required contents of inventory record?

Back 24

• name of drug
• dosage and strength
• number of units or volume in container
• number of containers

Front 25

what is counted in inventory?

Back 25

• drugs in inventory
• wasted drugs awaiting disposal
• will drugs NOT in inventory no mo

Front 26

______ files a copy of the DEA 106 to report _____ _____

Back 26

PIC files DEA 106 to report theft or loss of CS to DPR and DEA. if drug is not scheduled under federal law and only under IL (ex: PSE) not requried to report to the DEA

Front 27

______ amendement reuired Rx drugs to contain a warnign that the drugs could be dispensed legally only with an authorization of a helath professional?

Back 27

durham-humprhey amendment of 1951

Front 28

______amendment requires

• manufactureres show effectiveness of products with safety
• report adverse events
• jurisdiction of advertising
• require a regulatory submission or NDA before drug marketing
• GMP practices

Back 28

kefauver-harris amendment of 1962

Front 29

_____ amdenement required

• states to license wholesale distributors of Rx drugs
• ban reimportation of Rx drugs, except for emergency
• drug sample definition
• mandate storage, handling, and recordkeeping requirements
• ban trafficking in or counterfeting of drug coupons
• require drug pedigrees

Back 29

prescripition drug marketing act and prescripition drug amdents of 87, 92

Front 30

if a rph misfills a Rx, the product that is dispensed is not supported by a valid rx or authorized refill it is ______

Back 30

misbranded

Front 31

-_____- requires the existance of a valid, doctor-patient-pharmd relationship. a doctor must presribe or order the compounded product for a patient in order for the pharmacist to ______

Back 31

compounding...to compound

Front 32

compoudning a product for otc sales in considered

Back 32

manufacturing

Front 33

conditions when it is OK to compound

Back 33

• a licensed Rph extemporaneously compounds drugs pusuant to a valid Rx for an individual pt
• Rph compounds small amounts of drug before reciving Rx, based on previously filled valid Rx within an established practitioner-pt-Rph relationship and Rx is kept on file
• Rph compounds small amt of drug that differes slightly from commercially available product b/c of individual pt's medical need that the pharmD has documented after consulting with the pt's physician

Front 34

IL permission for compounding for office use rules/ office use compounding

Back 34

• compoudning a product for a MD to adminster to a patient in the office
• but CANNOT sell compounded proudct to doctor who resells product to his pt for use outside the office (manufacturing)

Front 35

an OTC product except (a dermatological, dentifrice, insulin, lozenge) not packaged in a tamper-resistant package is_____

Back 35

adulterated

Front 36

_____articles recognized in official USP/NF main use is the dx, cure, mitigation, tx or prevention of disease in man or animals by the FDA and affecting any structure or any function

Back 36

Drugs

Front 37

when can a rph administer drugs and what route?

Back 37

in the context of patient eduction a rph can adminster oral, topical, injectable, and inhalation products

Front 38

what groups can rph vaccinate?

Back 38

• peds patients ages 10 to 13 can administer inactived and live-intransal vaccine AND Tdap, gardasil, MMR
• vaccinate anyone 14 yo and older

Front 39

____ means the interpretation, evaluation, implementaiton of a Rx drug order, including the prepartion and delivery of a drug or device to a pt or pt's agent in a suitable container with approriate labels for use by a patient

Back 39

dispensing

Front 40

the organization responsible for overseeing the selection of a nonproprietary name for a new drug is the

Back 40

USAN - United States Adopted Name of the American Medical Association

Front 41

what is the USP-NF?

Back 41

Contains pharmacopeial standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. It is a combination of the United States Pharmacopeia (USP) with monographs for drug substances & preparations and the National Formulary (NF) with monographs for excipients. Dietary supplements and ingredients appear in a separate section of the USP.

Front 42

the consumer product safety commision is responsible for what particular act?

Back 42

poison prevention packaging act

Front 43

A female patient that appears to be a minor comes to the pharmacy to purchase Plan B One Step® without a prescription. The pharmacist requests proof of age, and the patient states that she left her identification at home. The pharmacist should:

a.Go ahead and sell the Plan B as requested.

b. Refuse to sell the Plan B.

c. Call the patient’s parents to obtain permission to sell Plan B, and if authorized, go ahead and sell it.

d. Ask the patient how old she is, and if she replies “17”, go ahead and sell it.

Back 43

a. go head and sell plan b as requested

Front 44

permission to not use a child-reistant closure on all prescripition may be made by the: rph, prescriber, patient?

Back 44

patient only

Front 45

small group of healthy subjects rec drug; eval of tox, PK, and pharmacologic properites; assessment of safety of drugs in humans

Back 45

phase 1

Front 46

drug is given to a larger gorup (100 or more) of patients iwth the disease or stms of the condition claimed to be treated by the drug; determine effectiveness and obtain info about dosing relative safety and adverse effects

Back 46

phase 2

Front 47

drug given to large group of patients (sometimes thousands) in several geographical lcoations as part of controlled clinical trials; obtain data concerning drugs effectiveness compared to placebo; most studies are double blinded

Back 47

phase 3

Front 48

post-marketing surveillance - monitor use of drug for additional info regarding safety and effectiveness. manufaturer collets data and submits yearly report to FDA. Note: reporting of s/e by health care practitoitioners to FDA or manufacturer is voluntary; reporting by manufactorer of information rec'd is mandatory

Back 48

phase 4 studies

Front 49

when does a C3-5 Rx expire?

Back 49

• 6 months from the date it is written on the Rx
• or up to the maximum number of refills on the Rx

Front 50

how can an MD obtain cocaine HCl powder for office use?

Back 50

must order all C2 controls like cocaine directly from a supplier using DEA form 222

Front 51

used or unused DEA form 222 that are lost or stolen by any purchaser or supplier ______

Back 51

the purchaser or supplier must immediately upon discovery of the theft or less, report it to the Special Agent in Charge of the DEA in the in area of the registrant stating the serial number of each lost form

Front 52

the operations of the pharmacy and the establishment and maintenance of security provisions are the dual responsibility of the ________ & ______

Back 52

PIC and owner of the pharmacy

Front 53

what are the activities that a registered pharm tech cannot do?

Back 53

• patient counseling
• drug regimen review
• clinical conflict resolution
• sell C5s
• transfer or recieve transfers to/from another pharmacy

Front 54

what are the physical requirements of a pharmacy?

Back 54

• all dispensing and drug storage areas of the pharmacy must be contiguous
• the pharmacy area and all store rooms shall be well-lighted and properly ventilated
• refrigerartes should be between 36-40 and for exclusive use of Rx drugs

Front 55

what are the labeling requirements for future use parenteral sol'ns to which drugs are diluents are added?

Back 55

• name, concentration, and volume of base parenteral sol'n
• name and strength of drugs added
• BUD or expiration
• reference code to identify source and lot # of drugs added

Front 56

what are the labeling requirements for non-parenterals packaged for future use?

Back 56

• drug name generic and proprietary
• strength if applicable
• BUD / expiration
• reference code to identify source and lot # of drugs added

Front 57

what are the labeling requirements for medictions prepared for immediate use ?

Back 57

• name of resident
• bed and room number
• dispensing date
• name, strength, dosage form of drug, or descripition of medical device order
• quantity dispensed
• directions for use
• prescriber's name and
• BUD if <60 days from date of dispensing

Front 58

what are the labeling requirements for unit dose meds for a specific resident?

Back 58

• name of resident
• room and bed #
• date of order
• name, strength, dosage or device descript
• directions for use
• prescriber name

Front 59

what are the labeling requirements for single or multi-dose drugs (not sterile soln)

• in a facility that are not intended for immediate dispensing to a specific pt

Back 59

• brand and generic name
• strength
• BUD; expiration date
• reference code for source and lot #

Front 60

what are the labeling requirements sterile soln with drugs added

• in a facility that are not intended for immediate dispensing to a specific pt

Back 60

• name, conc, and volume of base sterile soln
• name and strength of drugs added
• BUD and time of admixture, expiration date
• refernce code for source and lot #

Front 61

what are the labeling requirements for immediate dispensing to a specific patient or resident: single or multi dose drugs

• in a facility that are not intended for immediate dispensing to a specific pt

Back 61

• brand and generic name
• strength if applicable

Front 62

what are the labeling requirements for immediate dispensing to a specific patient or resident: sterile sol'n with drug

• in a facility that are not intended for immediate dispensing to a specific pt

Back 62

• name, conc, volume of base sterile soln'
• name and strength of drugs added
• BUD and date and time of admixture

Front 63

what are the tree things required to substitute? is patient consent required?

Back 63

1. prescriber must not prohibit
2. product must be included in the IL formulary
3. product dispensed must have a lower unit cost than the product Rx'd

patient consent no longer required

Front 64

what current resource materials must be in a pharmacy preparing sterile parenteral products?

Back 64

• USP/NF
• Hospital AHFS (American hospital formulary service)
• Copies of IL practice act and rules, the IL CSA, 21 CFR and IL hypodermic syringe and needles act
• one compatibile reference (kings, trissels,)
• a file on extended stability data given to finish products

Front 65

what is the 5% rule in relation to wholesaler distribution

Back 65

wholesale distributors cannot exceed the sale of rx drugs by a pharmacy to practitioners of 5% of the annual dollar purchases of Rx drugs by the pharmacy and providing the pharmacy maintains a log of sales to practitioners that includes

1. date of dale
2. practitioners name and address
3. drug and strength
4. size of package
5. quantity sold

Front 66

what equipment is needed in a licensed pharmacy preparing sterile parenteral products?

Back 66

LESTR

• Laminar airflow hood. certified annually
• EPA approved disposal contianers for biological waste and cytotoxic waste, etc
• Sink with hot and cold running water
• Temperature controlled container for off site deliveries
• Refrigerator and or freezer with thermometer

Front 67

when a medication error occurs ie wrong drug in bottle the product is deemed to be:

Back 67

misbranded & adulterated