https://quizlet.com/16876154/kansas-mpje-flash-cards/ Form for hospital pharmacies needing to ...

67 Pages·2015·0.25 MB·English

by  Eric Frankel

https://quizlet.com/16876154/kansas-mpje-flash-cards/

Form for hospital pharmacies needing to purchase large quantities of tax-free
grain alcohol
ATF-1447

Form to request permission to destroy damaged, outdated, or unwanted
controlled substances
Form 41

Form to report substantial theft or loss of controlled stubstances
Form 106

Form used to order C-II controlled substances
Form 222

Form used to send C-II controlled substances to a reverse distributor for
disposal
Form 222

Form used to order the forms used to order C-II controlled substances
Form 222a

Form used to apply for a new DEA dispenser registration
Form 224

Form used to renew a DEA dispenser registration
Form 224a

Form used to renew a DEA dispenser registration for a retail chain
Form 224b

Form used to apply for a new DEA narcotic treatment program registration
Form 363

Form used to renew a DEA narcotic treatment program registration
Form 363a
Form used to apply for a new DEA chemical distributor registration
Form 510

Application form for approval of use of narcotic drugs in a treatment program.
Form 2632

DEA for for physicians authorized to administer and dispense narcotic drugs for
treament of detoxification
Form 2633

Form entitled Hospital Request for Methadone Detoxification Treatment
Form 2636

Controlled substance schedule of a preparation containing not more than 50
mg of morphine/100 mL or per 100g combined with non-narcotic active
ingredients
C-III

Controlled substance schedule of buprenorphine SL
C-III

Controlled substance schedule of oral diphenoxylate with atropine
C-V

Controlled substance schedule of oral diphenoxylate/atropine
C-V

Number of times a C2 script can be transferred
0

Number of refills allowed for phentermine prescribed for obesity in Kansas
0

Number of consumer members on the Kansas Board of Pharmacy
1
Number of business days within which a pharmacy must notify the local DEA
Diversion Field Office after discovery of theft or significant loss of a CS
1

Number of times a C3-C5 (with refills) can be transferred in Kansas if
pharmacies do not share a real time computer system
1

Number of pharmacy students or interns a Kansas pharmacist preceptor may
supervise
2

Number of years a vaccination protocol that establishes what vaccines a
pharmacist may administer, procedures for record keeping, and emergency
response is considered valid
2

Number of days a physician may administer a single day supply of methadone
to a patient waiting for admission into narcotic treatment program
3

Number of years a DEA dispenser registration is valid
3

Number of grams maximum of pseudoephedrine base that may be sold to a
single patient in a day
3.6

Number of times a pharmacist may refill a C3-C4 prescription if authorized
5

Number of days within which a PIC must notify the board of ceasing to serve as
PIC
5

Number of years a pharmacist must practice in Kansas to serve on the Board of
Pharmacy
5

Number of years which incident reports must be kept in Kansas
5

Number of years a pharmacy must keep controlled substance records after last
entry (i.e., last refill)
5

Number of pharmacists on the Kansas Board of Pharmacy
6

Number of years HIPPA documentation, including signed acknowledgements of
Notice of Privacy Practices, must be retained
6

Number of months a pharmacist may refill a C3-C4 if authorized
6

Number of months a C2 prescription is valid from issuance
6

Number of days pharmacist has to obtain the original prescription from a
physician for an emergency C2 script
7

Number of months minimum between controlled substance inventories
8

Number of grams maximum of pseudoephedrine base that may be sold to a
single patient in 30 days
9

Number of different OTC drugs maximum that may be offered for sale through
a vending machine
12
Number of months maximum between controlled substance inventories
12

Number of months allowed to refill authorized C5 refills from the date of
issuance
12

Number of days prior to a proposed transfer a registrant must notify the DEA
prior to transferring to another registrant
14

Number of years minimum age of individuals allowed to purchase C5s OTC
18

Number of doses of codeine containing cough syrup that can be sold in 48
hours
24

Number of days within which a Kansas-licensed pharmacist must notify the
Board of Pharmacy of any change of address
30

Number of days a drug wholesaler, acting as a supplier, has to complete a DEA
Form 222 before it becomes void
60

Number of days to complete a partial fill on a C2 prescription for a patient
diagnosed as terminally ill
60

Number of days allowed to complete a partial fill for a C2 prescription for a
patient residing in a LTCF
60

Number of hours allowable to complete a partial fill for C2 for an ambulatory
patient
72
Number of hours a pharmacist has to verify accuracy of the computer record for
filling/refilling C3-C4 prescriptions
72

Number of days maximum supply that may be prescribed and dispensed on
multiple C2 prescriptions with the same day of issuance
90

Number of mg maximum codeine per dosage unit combined with non-narcotic
active ingredients to be scheduled as C3
90

Number of mL maximum of codeine-containing cough syrup that can be sold to
a single patient in 48 hours
120

Number of mg maximum codeine per 100 ml or 100 g combined with non-
narcotic active ingredients to be scheduled as a C5
200

Number of doses, maximum, of medication a hospital emergency room may
provide to an outpatient when local retail pharmacies are closed and there is no
pharmacist on the premises
QS

Number of doses, maximum, of C2 drug that may be prescribed and dispensed
off of an emergency C2 script
QS

Number of doses, maximum, of C2 drug that may be prescribed and dispensed
off of a single written C2 script
No Limit

In Kansas, combination products containing this drug must be counted exactly
during annual CS inventory, regardless of CS schedule
Hydrocodone
Pure Food and Drug Act of 1906
Focused on Purity and Quality
Prohibited the interstate transfer of adulterated or misbranded drugs
Recognized USP/NF Standards

Food, Drug, and Cosmetic Act of 1938
Focused on Safety
New drug cannot be marketed until proven safe (drugs prior to 1938 were
exempt)
Power given to Congress via authority over interstate commerce

Durham-Humphrey Amendment of 1951
Established 2 classes of drugs: Rx and OTC
Established provisions for dispensing prescription drugs
Established labeling requirements for OTC and prescription drugs
Established use of NDC numbers

Kefauver-Harris Amendments of 1962
Focused on safety AND efficacy
Impacts all drugs after 1962 and new drugs with an NDA approved since 1938
Established effectiveness as a standard
Established Good Manufacturing Practices (GMP)
Transfered jurisdiction of Rx advertising from FTC to FDA

Poison Prevention Packaging Act of 1970
All new and refilled scripts must be dispensed in child-proof container unless:
Prescriber specifies for single prescription
Patient indicates they do not want
Container is being used in institution and maintained by health professionals
SL Nitroglycerin or Isosorbide
Potassium in UD form
Aerosol containers for inhalation
Oral Contraceptives or estrogens in dispenser pak
Enforced by Consumer Product Safety Commission
Failure to comply is MISBRANDING
Medical Device Amendment of 1976
Classification of all devices into 3 classes based on the degree of control
necessary to assue safety and effectiveness; most regulated are class 3

Federal Anti-Tampering Act of 1982
Federal offense to tamper with consumer products

Requires tamper resistant packaging for OTC

Waxman-Hatch Act of 1984
AKA Drug Price Competition and Patent Term Restoration Act
Granted pharmaceutical manufacturers incentives by granting some market
exclusivity
Increased availability of generics
Required FDA to publish an up-to-date list of all Rx and OTC drugs approved
for safety and efficacy (The Orange Book)

Drug Price Competition and Patent Term Restoration Act of 1984
AKA Waxman-Hatch Act
Granted pharmaceutical manufacturers incentives by granting some market
exclusivity
Increased availability of generics
Required FDA to publish an up-to-date list of all Rx and OTC drugs approved
for safety and efficacy (The Orange Book)

Prescription Drug Marketing Act of 1987
Prohibits sale, purchase, or trade or RX samples
Restricts distribution to prescribers or hospital pharmacy (no retail pharmacy)
Prescriber must write a written request for samples
Guidelines for advertising
Requires licensing of prescription drug wholesalers

Omnibus Reconciliation Act of 1990 (OBRA 90)
First fedeal law to directly address pharmacy practice standards
Establised a federal policy requiring DUR (prospective instead of retrospective)
Established standards of practice for pharmacists as a condition of participating
in Medicaid program
Rebates from "best price" go back to state Medicaid program

Dietary Supplement Health and Education Act of 1994 (DSHEA)
Defined dietary supplements as foods rather than drugs and limited FDA's role
in regulatioin
Burden is on FDA to probe lack of safety prior to removal from market
Defined specific claims manufacturers can make

Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Notice of privacy practices must be provided to patients
When PHI used for a purpose not associated with treatment, payment, or
operations (TPO) consent must be obtained
Established training requirements and requirements for Privacy Officer

FDA Modernization Act of 1997
Federal Compliance Guide regarding Pharmacy Compounding

Changed the wording of required legend to "Rx Only"

Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Added Part D (prescription drug benefit) to Medicare
Provision for MTM
Required development and implementation of standard for e-prescribing
Permits importation of Rx drugs from Canada if HHS Secretary certifies safety

Food and Drug Administration Amendments Act of 2007 (FDAAA)
Post marketing safety initiatives: Medguides, PPI, DTC advertising

PPI must be dispensed each time Rx dispensed; in institutional setting given
prior to first dose and every 30 days

Provided FDA with the authority to impose risk evaluation and mitigation
strategies (REMS) including Medguides and other restricted distribution
programs
Labeling requirements for OTC Drugs
"Adequate directions for use"

Labeling requirements for Rx Drugs
"Adequate information for use"

Drug Efficacy Study Implementation (DESI)
established ANDA process (abbreviated new drug application for generics)
Deals with the efficacy of drugs marketed between 1938-1962

Class 3 Medical Device
one that supports or sustains human life or is of substantial importance in
preventing impairment of human health or presents a potential, unreasonable
risk of illness or injury

New Drug Application (NDA)
Used if new drug is a newly discovered chemical or for an established drug
offered in a new dosage form, with ne therapeutic claims, in new dosage levels,
or for a different patient population

Abbreviated New Drug Application (ANDA)
approval to market a generic

IND
investigational new drug

Supplemental New Drug Application (sNDA)
application to allow a company to make changes to a product that already has
an approved NDA. CDER must approve all changes to ensure that conditions
originally set for the product are still met

FDA Clinical Trials Phase 1
Small number of patients (20-80)
Evaluates safety
Determines safe dosage range
Identifies side effects