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Form to request permission to destroy damaged, outdated, or unwanted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

FDA Clinical Trials Phase 2

Small number of patients with condition (100-300)

Establishes testing protocol

Establishes if drug is effective

Further evaluates safety

FDA Clinical Trials Phase 3

1000-3000 patients in a clinical setting

Usually double-blinded

Confirms effectiveness

Monitors side effects

Compares to commonly used treatments

FDA Clinical Trials Phase 4

Post-marketing surveillance

Dietary supplement (also know as food or nutritional supplement)

a preparation intended to supplement the diet and provide nutrients (such as

vitamins, minerals, fiber, fatty acids, or amino acids) that may be missing or

may not be consumed in sufficient quantities in a person's diet

Must contain disclaimer that FDA has not evaluated and is not intended to

"diagnose, treat, cure, or prevent any disease"

Tamper Resistant Prescription Pads

Required for Medicaid outpatient scripts as of 2008

Enacted as a fraud reducing measure

Must contain features to prevent copying, erasure or modifcation, and the use

of counterfeit forms

OTC Advertising

Regulated by FTC

Rx Advertising

Regulated by FDA

Adulteration

the quality or purity of the product is compromised; does not have the

strength, quality or purity represented or expected; potentially contaminated or

prepared under conditions not comforming to GMP

Misbranding

the act of labeling the product falsely or in a misleading way

Refilling a prescription without authorization is misbranding

Behind the Counter Drugs (BTC)

class of drugs sold only by a pharmacist or available only in a pharmacy

Medication Therapy Management Services

Plans must have MTM program that may be provided by a pharmacist;

pharmacists to be reimbursed for time spent counseling targeted patients

Retrospective Drug Use review

performed by DUR board of physicians and pharmacist to review medication

use trends and data over a specified period of time and attempt to evaluate and

improve medication use

Prospective Drug Use Review

actice resolution of drug therapy problems through a comprehensive review of

a patient's prescription at the point of dispensing; includes screening

prescriptions, counseling patients, and documentation

Orange Book

approved drug products with therapeutic equivalence evaluations

Orange Book: Pharmaceutical Equivalents

same active ingredient, identical strength, dosage form

Orange Book: Therapeutic Equivalents

bioequivalence, same clinical effect of safety profile when administered

Orange Book: Code A

therapeutically equivalent to the reference drug product

Orange Book: Code B

not considered therapeutically equivalent

Orange Book: Code AA

drugs in conventional dosage forms, NO bioequivalence problem

Orange Book: Code AB

established scientific bioequivalence, any potential problems have been

identified and resolved

Drug recall class presenting reasonable probability of serious adverse health

consequences or death

1

Drug recall class presenting risk of !!!!!!

temporary or medically reversible adverse effects or remote possibility of

serious adverse effects

Drug Recall: Class 3

not likely to cause advers health effects

National Drug Code (NDC)

used for FDA identification purposes, does not indicate approval status

required on all drugs (RX and OTC)

1st 5 numbers: manufacturer/distributor

2nd 4 numbers: drug name and dosage form

3rd 2 numbers: package size

Kansas: Use of title "pharmacy" or "drugstore"

unlawful for any person not a state licensed pharmacist or any business that

does not have a state licensed pharmacist in continuous employ to use or

exhibit the words "pharmacy", "drugstore", or "apothecary"

Kansas: Vending machine items that cannot be sold

Poisons

Prescription meds

Drugs containing ephedrine

Drugs intended for human use by hypodermic injection

Kansas: Vending machine labeling requirements

Identification of the owner

Toll free telephone number of the owner

Statement advising purchaser to check expiration date prior to using

Telephone number for the state board

Kansas: Conditions for the sale of a poison

Poisons should be colored in such a way to make them readily distinguishable

from food products

Kansas: Labeling and Information requirements for selling non-prescription

DMSO (dimethyl sulfoxide)

must be labeled by the manufacturer and seller

Label muse contain description of all the contents of the solution, statement of

purity, percent concentration of DMSO in solution, manufacturer name and

address

Seller must give additional printed material to the purchaser that provides

adequate warning against use that may be dangerous to the health of the user

Kansas: Vaccine Admisitration Guidelines

A pharmacist or a pharmacy student or intern working under the direct

supervision and control of a pharmacist may administer pursuant to a

vaccination protocol if they have successfully completed an accredited course of

study and training and have current CPR certificate (must be able to furnish

proof of completion to the board upon request)

Kansas: Age restriction for flu vaccine

Can administer to age 6 and older

Kansas: Age restriction of vaccines (not flu)

Can administer to age 18 and older

Kansas: Vaccine documentation

All vaccinees will be given a written immunization recod for their personal files

Administration shall be promptly reported to the PCP by fax, mail, or other

electronic means.

If patient does not have a PCP, report to the physician who has entered the

protocol

Report to appropriate county or state immunization registries

Kansas: Brand Exchange

Dispensing of a different drug product of the same dosage form, strength, and

generic name than the brand name drug product prescribed

Pharmacist may exercise brand exchange with a view toward achieving a lower

cost for the patient unless marked DAW or FDA had determined not to be

bioequivalent

Kansas: Direct Supervision

process by which the responsible pharmacist shall observe and direct the

activities of a pharmacy student or technician to a sufficient degree to assure

that all activities are performed accurately, safely, and without risk or harm to

patients

**And to complete the final check before dispensing**

Kansas: Pharmacist in charge

Person responsible to the board for a registered establishment's compliance

with the laws and regulations of the state

Must pass the law exam by 85% or higher

Kansas: Pharmacy student

an individual registered with the board and enrolled in an accredited school of

pharmacy

Kansas: Pharmacy Technician

an individual, who under the direct supervision and control of a pharmacist may

perform packaging, manipulative, repetitive, or other non-discretionary tasks

related to the processing of a prescription; may not perform duties restricted to

a pharmacist

Kansas: Preceptor

Licensed pharmacist with at least 2 years of experience as a pharmacist who

supervises students obtaining pharmaceutical experience required by law

Kansas: Retail Dealer

A person selling at retail non-prescription drugs that are fully pre-packaged by

the manufacturer or distributor and are labeled for consumer use in accordance

with state and federal regulations

Kansas: Vaccine Protocol

a written protocol, agreed to by a pharmacist and a person licensed to practive

medicine and surgery by the state board of healing arts, which establishes

procedures and recordkeeping and reporting requirements for administering a

vaccine by the pharmacist for a period of time specified within, not to exceed

two years

Kansas: Vaccine Protocol time limit

may not exceed two years

Kansas: Pharmacy Intern

an individual who is a prospective candidate foe examination as a licensed

pharmacist and who is qualified to receive and is obtaining pharmaceutical

experience set forth in the pharmacy practice act

Can be an intern without being a student

Kansas: Pharmacy Intern requirements

Must register with the board and pay fee

All submissions are the responsibility of the intern not the preceptor

Requires 1500 hours (hours do not count before admission to pharmacy school

or registration as an intern)

Kansas: Pharmacy Intern hour requirements

1500 hours

Kansas: Pharmacist qualifications for licensure

18 years old

Graduate of an approved school

Minimum of one year pharmaceutical experience under an approved preceptor

Pass examination

Kansas: Display of license

License must be displayed in an area usually occupied or visible to the public

License may not be displayed if not a business were pharmacist is actively

involved in profession

Kansas: Licensure by reciprocity

May be licensed after taking law exam if already licensed in another state

Shall file proof of training and educatuion to board

Requirements based on requirements at the time of original licensure

Kansas: Requirements of foreign grads

shall provide proog of ability to communicate verbally and in written form in

English

must pass English as a foreign language exam (TOEFL)

Kansas License renewal date

June 30 biennial

Kansas: License Renewal Fee

$150

$200 if late

Kansas: Change of Residential Address

must notify the board in writing within 30 days

Kansas: Continuing Education Requirements

3 CEU (30 hours)

Kansas: Jurisdiction of the Board for License Revocation

May temporarily suspend or limit the license in accordance with emergency

adjudicative proceedings; may revoke, suspend, or place in probationary status

or deny renewal

Kansas: Hearings/appeals for License Revocation

Revocation is for all time but can apply in one year for reinstatement

Kansas: Nametag Requirement

Pharmacist, student, intern, and pharmacy technician must wear name tags

designated with function

Kansas: Pharmacy Technician Registration

Must register with the board

Must pass exam approved by the board within 30 days of becoming registered

Pharmacy must maintain list of techs employed by the pharmacy

Registration must be displayed

Kansas: Pharmacy Tech renewal

$25 fee

Expires 10-31

Kansas: Pharmacy Tech Job Change

Must notfy the board within 30 days of new employment

Kansas: Pharmacy Tech Training Course

Must complete training course within 180 days of employment

Pharmacy keeps records of name and address of tech, date training course

started, name and address of pharmacy

Kansas: Pharmacy Tech Ratio

1 RPh: 2 techs (if not certified)

1 RPh: 3 techs (if certified)

Kansas: Board of Pharmacy Term

Term is 4 years

Serve a maximum of 2 terms

Kansas: Board of Pharmacy Appointment

Appointed by the Governor

Kansas: Board of Pharmacy Inspection Authority

May inspect in a lawful manner drugs kept or for sale in Kansas pharmacy

References Officially Recognized by FDCA

USP/NF and Homeopathic Pharmacopeia

Whom has the authority to sign a DEA-222

A pharmacist or non-pharmacist as designated in a current and properly

executed power of attorney

A pharmacist or non-pharmacist who signed the most recent DEA application

for a controlled substance registration

Approved DEA filing methods for prescriptions

C2 in one file, C3-5 in one file, non-controlleds in 3rd file

C2 scripts in one file, C3-5 and non-controlleds together

Kansas: Change in PIC notification to board

Must notify the board in writing within 5 days of decision to quit as PIC

Kansas: Required references for community pharmacy (3)

Medical dictionary

Recognized reference in drug interactions

Copy of the Kansas Controlled Substance Act and regulations

Kansas: Requirements for community pharmacy medication profile record

Name and address of patient

Initial date of dispensing and prescription number

Name of the dispensing pharmacist

Drug allergies and sensitivities

Kansas: Prescription Format

may be written, telephonic, or electronic

Blank written orders must have two signature lines

Prescription ordes shall be recorded in writing by the pharmacist and the record

so made constitutes an original prescription

A prescription is an order received for OUTpatients

A medication order is for INpatients

Kansas: Prescription Copies

Cannot fill a prescription copy

A copy issued for reference must bear "This prescription copy is issued for

reference only"

Kansas: Pharmacist Function in filling Rx: Legitimate Medical Purpose

rescription for the drug was issued with a valid pre-existing patient-prescriber

relationship rather than an internet or telephone consultation

Kansas: Pharmacist Function in filling Rx: Judgmental Functions

Judgmental functions that constitute filling or refillin can only be performed by

a pharmacist or pharmacy student under the direct supervision of a pharmacist.

Only non-judgmental duties associated with preparation can be designated to a

tech; in process and final checks must be done by a pharmacist

Kansas: Electronic Prescription Transmission

Must be issued within the course of professional practice for legitimate medical

purpose

Must identify the transmitter's phone for verbal confirmation; date and time of

transmission; identity of pharmacy to receive

Must be transmitted by prescriber or designated agent

May be saved as a hard copy or as an electronic document

Kansas: Electronic Prescription Transmission C3-5

May be transmitted electronically

Kansas: Electronic Prescription Transmission C2 (3 cases where acceptable)

Escript counts as hard copy for

C2 order to be compounded for direct administration to patient by injection

C2 order for resident of nursing facility, nursing facility for mental health, or

assisted living facility

C2 order for patient released by registered institution to a home hospice setting

that continues to provide care

Kansas: Emergency Script for C2

Quantity prescribed and dispensed limited to amount adequate to treat patient

during emergency

Must be reduced immediately to hard copy

Prescriber must issue a written prescription within 7 days and write on the face

"authorization for emergency dispensing" and date of the transmitted Rx order

Upon receipt of written order, attach to hard copy, notify DEA if no written Rx

received

Kansas: Emergency Script for C2: time to receive written order

prescriber must issue within 7 days

Kansas: Refill limitations

Limited to one year from date of origin

Controlled Substances limited to 6 months or 5 refills

Refill at will: no limitation to the number of times it may be refilled except may

not be refilled after the expiration of the time specified or one year (whichever

is first)

Kansas: Refill without authorization

May refill without authorization (not controlled substance) when all reasonable

efforts to contact the prescriber have failed and in the pharmacist's professional

judgment continuation is necessary for patient health and welfare. May only

refill amount sufficient to maintain patient until provider can be contacted; no

more than 7 days or one package. May not fill if prescriber states on Rx "no

emergency filling"

Kansas: Refill without authorization limits

7 days or one package

May not fill if prescriber states on Rx "no emergency filling"

Kansas: Drug Scheduling

The Kansas Board of Pharmacy shall submit to the Speaker of the House of

Representatives and the President of the Senate a report on substances

proposed by the Board for scheduling, rescheduling , or deletion by the

legislature.

Kansas: Controlled Substance Samples

Cannot distribute C2-C5 samples (differs from Federal Law)

Kansas: Controlled Substance Records

Must be maintained on file for no less than 5 years from the date of last entry

in the record.

Kansas: Controlled Substance for provider use

A prescription may not be issued in order for a practitioner to obtain CS for

supplying himself or any other practitioner for the purpose of general

dispensing to patients

Kansas: Controlled Substance Preprinted Blanks

CS C2-C5 may not be issued on a prescription blank which is preprinted with

the name of a proprietary preparation or strength or quantity or directions

Kansas: Telephone/Fax C3-C5 scripts

Controlled substance prescriptions C3-C5 may be transmitted by telephone by

a prescriber or designated agent to the pharmacy. The transmission may be

oral or by fax. If telephoned or faxed by other than the prescriber, the

prescription shall bear the name of the person so transmitting the prescription.

Kansas: Cancelling C2 scripts by pharmacist

All written or emergency scripts for a C2 medication must be cancelled on the

face of the prescription with the name of the pharmacist filling it

Kansas: Cancelling C2 Scripts by intern

All written or emergency scripts for a C2 medication must be cancelled with the

name of the pharmacy intern and the preceptor authorizing filling the

prescription

Kansas: C2 Script Length of Validity

A C2 script is valid for 6 months from its date of issuance (no limit in federal

law)

Kansas: Emergency refill of narcs

C2 and narcotic drugs listed in any schedule are exceptions to the 7-day

emergency refilling allowance

Kansas: CS Inventory with PIC change

Resigning PIC must inventory prior to leaving position, new PIC must inventory

all CS within 72 hours or beginning to function as PIC

Kansas: CS Inventory Exact Count

C2 substances and products containing Hydrocodone must be counted exactly

Kansas: Hypodermic needle designation

Defined as "drug paraphenalia"

KS: Treatment of Obesity with Amphetamines

Amphetamines will not be dispensed or prescribed to treat obesity

Kansas: Treatment of Obesity

Physician shall personally take complete history and document it

Physician shall prescribe nutritional counseling, including behavior modification

and exercise for weight loss, and record those on the patient record

The physician shall not dispense more that a 30 day supply of CS at one time

The physician must monitor the patient and record the findings in the patient

chart with each visit

The physician shall not dispense or prescribe additional CS to treat obesity for a

patient who was not achieved a weight loss of at least 5% during initial 90 days

Law does not cover methylphenidate or pemoline

Kansas: Obesity Treatment Supply

Physician may not prescribe nor dispense more than a 30 day supply

Kansas: Long-term Obesity Treatment

A physician shall not dispense or prescribe additional CS to treat obesity for a

patient who has not achieved a weight loss of at least 5% during the initial 90

days

NDC

used by FDA for identification purposes, does not indicate approval status

USP/NF

combination of two official compendi: the United States Pharmacopeia (USP) and

the National Formulary

USP: Mongraphs for drug substances, dosage forms, compounded preparations;

dietary supplements appear in separate section

NF: Excipient monographs

Drug product in US must conform to USP/NF standards to avoid possible

charges of adulteration or misbranding

Kansas: Condition of places the sell drugs

Every place occupied or used for the preparation for sale, manufacture,

packing, storage, sale or distribution of any food or drug shall be properly

lightd, drained, plumbed, ventilated and screened

Conducted with strict regart to the influence of such condition upon the puruty

and wholesomeness of foods or drugs therein produced

Enforced by the Secretary of Health and Environment

Kansas: Use of the title "pharmacy" or "drugstore"

unlawful for any person not a state licensed phamracist or any business that

does not have a state licensed pharmacist in continuous employ to use or

exhibit the words "pharmacy", "drugstore", or "apothecary"

Kansas: Conditions for sale of poison

must be colored in such a way to make them readily distinguishable from food

products

Kansas: Labeling requirements for selling non-prescription DMSO (dimethyl

sulfoxide)

Label shall contain a description of all contents of the solution, staement of

purity, the percent of DMSO in the solution, the manufactures name and

address

Seller or supplier muse provide addtional prointent material to the person

receiving that provides adequate warning against use that may be dangerous to

the health of the user

Kansas: administer

Direct application of a drug, whether by injection, inhalation, ingection or other

means by a practioner pursant to the lawful direction of a practioner. Nothing

contained in the pharmacy act shall prohibit a duly licensed practioner from

purchasing and keeping drugs, from compounding precriptions, or from

adminsitering, supplying or dispensing to such practioner's patients such drugs

as may be fit, proper, and necessary

Kansas: Vaccine Administration Requirements

A pharmacist or pharmacy student or intern working under the direct

supervision and control of a pharmacist may administer influenza vaccine to a

person 6 or older and may administer other vaccines to a person 18 or older

pursuant to a vaccine protocol if the individual has successfully completed an

accredited course of study and training and has current CPR certification

Kansas: Flu shot requirements

Pharmacist, pharmacy student, or intern

Age 6 and up

Kansas: Vaccine requirements (not flu)

Pharmacist, pharmacy student, or intern

Age 18 and up

Kansas: Vaccine Record

All vaccinees will be given a written immunization record for their personal files

Administration shall be promptly reported to PCP by mail, fax, or other

electronic means. If patient does not have PCP it shall be eported to physician

whom has entered the protocol.

Immunization will also be reported to appropriate county or state immunization

registries.

Kansas: Brand Exchange

Dispensing of a different drug product of the same dosage form, strenth, and

generic name than the brand name drug prescribed

Pharmacist may exercise brand exchange with a view toward achieving a lower

cost for patient unless marked DAW or FDA has determined not to be

bioequivalent

Kansas: Direct Supervision

process bu which the responsible pharmacist shall

Codeine C-III

Not more than :

- 1.8 grams of codeine per 100 milliliters

- 90 milligrams per dosage unit

-with one or more active, nonnarcotic ingredients in recognized therapeutic

amounts

Codeine C-V

Not more than 200 milligrams of codeine or any of its salts per 100 milliliters

or per 100 grams.

Equiv table for Sudafed Tabs totaling 3.6g

30 mg Sudafed HCl : 146 tabs

60 mg Sudafed HCl : 73 tabs

120 mg Sudafed HCl : 36 tabs

Which FDCA amendment exempted certain drugs from the "adequate directions

for use" labeling requirement if they bear "Rx only" on their labels?

a. Durham Humphrey

b. Kefauver-Harris

c. Prescription Drug Marketing

d. Waxman-Hatch

a. Durham Humphrey

The FDCA defines a "new drug" as a previously approved drug entity with a new:

a. route of administration.

b. indication for use.

c. combination of ingredients.

d. a and b

e. a, b and c.

e. route of administration, indication for use, combination of ingredients.

Which of the following circumstances would be considered "adulteration" under

the FDCA?

a. A drug is prepared and packaged under unsanitary conditions.

b. The drug's manufacturing procedures do not conform to GMP standards.

c. The drug is subject to the Poison Prevention Packaging Act and is not

packaged accordingly.

d. a and b

e. a, b and c

d. A drug is prepared and packaged under unsanitary conditions, The drug's

manufacturing procedures do not conform to GMP standards.

Which of the following circumstances would be considered "misbranding" under

the FDCA?

a. A drug's label or labeling is false or misleading.

b. A prescription for a legend drug is refilled without the prescriber's

authorization.

c. A drug is subject to the Poison Prevention Packaging Act is not packaged

accordingly.

d. a and b

e. a, b and c

e. A drug's label or labeling is false or misleading, A prescription for a legend

drug is refilled without the prescriber's authorization, A drug is subject to the

Poison Prevention Packaging Act is not packaged accordingly.

The purpose of DESI was to prove efficacy of prescription and OTC drugs that

were marketed:

a. between 1938 and 1962.

b. before 1938.

c. after 1962.

d. none of the above.

a. between 1938 and 1962.

6. The label on the container of an OTC drug intended for sale directly to a

patient must include:

a. adequate directions for safe and effective use.

b. cautions and warnings needed for the protection of the user.

c. net contents of the package

d. name and address of the manufacturer, packer, or distributor

e. all of the above

f. only a, b and c

e. adequate directions for safe and effective use; cautions and warnings needed

for the protection of the user; net contents of the package; name and address

of the manufacturer, packer, or distributor

Which of the below is(are) officially recognized by the FDCA?

a. USP/DI

b. USP/NF

c. Homeopathic Pharmacopeia

d. a and b

e. b and c

e. USP/NF, Homeopathic Pharmacopeia

According to the Prescription Drug marketing Act of 1987, no person may sell,

purchase, or trade:

a. prescription drug samples.

b. OTC drug samples.

c. starter packages of prescription drugs.

d. a and b

e. a, b, and c

a. prescription drug samples.

When a pharmacy repackages a drug product in unit-dose packages, a record

should be maintained which includes among other things the:

a. pharmacy's identification number if different from the manufacturer's lot

number.

b. product's manufacturer or supplier.

c. expiration date of the original container.

d. a and b

e. a, b, and c

e. pharmacy's identification number if different from the manufacturer's lot

number, product's manufacturer or supplier, expiration date of the original

container.

Which of the following situations may require a pharmacy to register with the

FDA, be subject to FDA inspections, and comply with CGMP?

a. Community pharmacist compounds large bulk quantities of inhaler solution

and ships the product to

numerous out-of-state pharmacies for dispensing.

b. Hospital pharmacy repackages and relabels a drug product in unit-dose

packaging for routine use for inpatients.

c. Community pharmacist compounds drugs in anticipation of prescription drug

orders based on routine prescribing patterns.

d. a and b

e. a, b, and c

a. Community pharmacist compounds large bulk quantities of inhaler solution

and ships the product to numerous out-of-state pharmacies for dispensing.

According to the Poison Prevention Packaging Act of 1970, a pharmacist may

reuse:

a. a glass container on a prescription refill, provided a new child-resistant

closure is used.

b. plastic non-child-resistant containers and lids on prescriptions for which the

patient has requested waiver.

c. plastic child-resistant containers and lids on prescription refills.

d. a and b

e. a, b and c

d. a glass container on a prescription refill, provided a new child-resistant

closure is used, plastic non-child-resistant containers and lids on prescriptions

for which the patient has requested waiver.

Child Resistant &/or Patient Package Insert?

nitroglycerin 0.4mg, S.L. tablets

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert?

isosorbide dinitrate 40mg sustained release tablets, #100

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert?

isosorbide dinitrate 5mg sublingual tablets, #100

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert?

Ovral-28, 1 month

Requires patient-package insert and NO child-resistant packaging

Child Resistant &/or Patient Package Insert?

methylprednisolone dosepak

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert?

potassium chloride liquid 10%, 16 oz

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert?

Haloperidol liquid concentrate, 15ml, dispensed in dropped bottle

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert?

Prempro™ dial pack

Requires patient-package insert and NO child-resistant packaging

Child Resistant &/or Patient Package Insert?

Anhydrous cholestyramine powder

Requires NEITHER child-resistant packaging nor a patient-package insert

It is not necessary to dispense an oral prescription drug for human use in a

child-resistant container if the:

I. patient requests standard packaging.

II. prescriber requests standard packaging on the prescription for a specific

patient.

III. prescriber requests a blanket waiver for child-resistant packaging for all of

the prescriptions of one

patient.

IV. pharmacist, in his/her professional judgment, deems it is not necessary.

a. I

b. I and II

c. II and III

d. II, III and IV

b.

I. patient requests standard packaging.

II. prescriber requests standard packaging on the prescription for a specific

patient.

While employed as a hospital pharmacy intern, you routinely repackage

commercially available prescription drugs into USP-quality unit-dose

containers. On January 1, 2011, you repackage Killacillin 200mg that carries an

expiration date on the container of January 2, 2013. According to FDA

recommendations, which expiration date should you place on the unit-dose

packages?

a. February 1, 2011

b. April 1, 2011

c. January 1, 2012

d. July 1, 2011

e. January 2, 2013

c. January 1, 2012

Which of the following statements is accurate concerning NDC numbers?

a. The FDA requires all commercial products to carry NDC numbers.

b. NDC number identifies the drug, strength, and size of package and is

frequently used for third-party

claims submission.

c. An NDC indicates that the drug has received NDA approval.

d. a and b

e. a, b, and c

d. The FDA requires all commercial products to carry NDC numbers; NDC

number identifies the drug, strength, and size of package and is frequently

used for third-party

claims submission

According to the FDA Compliance Policy Guide, which of the following

pharmacy activities does the FDA consider to be traditional pharmacy activity

that is NOT subject to FDA enforcement?

a. Extemporaneously compounding medication on receipt of a valid prescription

from a licensed practitioner for an individual patient.

b. Compounding a medication from components that have not been determined

to meet official compendial requirements.

c. Compounding drugs for third parties who resell the drugs to individual

patients.

d. Compounding drugs that have been withdrawn from the market due to safety

concerns

a. Extemporaneously compounding medication on receipt of a valid prescription

from a licensed practitioner for an individual patient.

The FDA has notified Slipshod Pharmaceutical Manufacturer that several lots of

their OTC analgesics have been found to be contaminated with digitoxin and

present serious threat to patients' safety. The FDA is likely to request that

Slipshod announce which class of drug recall?

a. Class I

b. Class II

c. Class III

d. Class IV

a. Class I

Ipecac syrup, dispensed in a 4 ounce bottle to patient, is considered to be a(n):

a. prescription drug and dispensed only upon prescriptive authorization.

b. OTC drug and labeled accordingly.

c. OTC drug and labeled with specific FDA labeling requirements.

a. prescription drug and dispensed only upon prescriptive authorization.

Ipecac syrup, dispensed in 15-30ml unit-dose containers and labeled according

to FDA requirements, may be considered:

a. prescription only.

b. OTC.

b. OTC.

It is within an opthalmologist's scope of practice to prescribe:

I. Acetazolamide (Diamox)

II. Sodium Sulfacetamide solution 10%

III. Oxycodone 2.5mg/APAP 325mg

a. I only

b. III only

c. I and II only

d. II and III only

e. I, II and III

e.

I. Acetazolamide (Diamox)

II. Sodium Sulfacetamide solution 10%

III. Oxycodone 2.5mg/APAP 325mg

The expiration date on the manufacturer's label of a prescription drug is July

2011. The pharmacist should consider the expiration of this drug to be:

a. July 1, 2011

b. July 15, 2011

c. July 31, 2011

d August 1, 2011

c. July 31, 2011

Which of the following has/have the authority to sign a triplicate DEA Form-222

in order to obtain C-II drugs from another registrant?

a. a pharmacist or non-pharmacist, as designated in a current and properly

executed power of attorney.

b. the pharmacist or non-pharmacist, who signed the most recent DEA

application for a controlled substance registration.

c. a pharmacist who has received verbal authorization from the owner or

manager of a pharmacy registrant.

d. a and b

e. a, b and c

d. a pharmacist or non-pharmacist, as designated in a current and properly

executed power of attorney; the pharmacist or non-pharmacist, who signed the

most recent DEA application for a controlled substance registration.

A properly executed power of attorney:

a. automatically expires in three years with the registration.

b. authorizes an individual to sign any legal document on behalf of the person

granting power of attorney.

c. must be notarized.

d. must be photocopied and the photocopy sent to the regional DEA office.

e. none of the above.

e. none of the above.

Annually, a pharmacy dispenses by prescription 100,000 dosage units of

controlled substances. Without obtaining registration as a distributor, the

pharmacy can distribute to other registrants a maximum of how many dosage

units?

a. 2500

b. 5000

c. 7500

d. 10,000

b. 5000

Controlled substance records that must be kept at the registration site include:

I. Invoices for controlled substance purchases.

II. Controlled substance prescriptions.

III. Controlled substance inventory records

IV. Executed DEA Form-222s

a. I and II

b. I, II, and III

c. II, III, and IV

d. I, II, III and IV

c.

II. Controlled substance prescriptions.

III. Controlled substance inventory records

IV. Executed DEA Form-222s

A pharmacist can fill a prescription for methadone for what medical reason?

a. maintenance of a patient's addiction.

b. detoxification of an addicted patient.

c. analgesic purposes.

d. a and c

c. analgesic purposes.

C-III and C-IV controlled substance prescriptions may be partially filled,

provided:

a. no dispensing occurs after 6 months from the date the prescription was

issued.

b. the total quantity dispensed in all partial fillings does not exceed the total

quantity prescribed.

c. each partial filling is recorded in the same manner as a refilling.

d. a and b

e. a, b, and c

e. no dispensing occurs after 6 months from the date the prescription was

issue; the total quantity dispensed in all partial fillings does not exceed the

total quantity prescribed; each partial filling is recorded in the same manner as

a refilling.

In general, C-II controlled substance prescriptions may be partially filled

provided:

a. no dispensing occurs after 72 hours from the date it was partially filled.

b. the pharmacist is unable to supply the full quantity.

c. the quantity dispensed in the partial fill is recorded on the face of the

prescription or in the computer

record

d. a and b

e. a, b, and c

e. no dispensing occurs after 72 hours from the date it was partially filled; the

pharmacist is unable to supply the full quantity; the quantity dispensed in the

partial fill is recorded on the face of the prescription or in the computer

record

Which of the following are DEA-authorized methods that a pharmacist may use

to file hardcopy controlled and noncontrolled substance prescriptions?

I. All prescriptions are filed together with C-II prescriptions stamped with a red

"C".

II. C-II prescriptions in one file; C-III, C-IV, and C-V prescriptions in another

file; Non-controlled prescriptions in a third file.

III. C-II prescriptions in one file; C-III, C-IV and C-V and non-controlled

prescriptions together.

a. I only

b. III only

c. I & II

d. II and III

e. I, II, & III

d.

II. C-II prescriptions in one file; C-III, C-IV, and C-V prescriptions in another

file; Non-controlled prescriptions in a third file.

III. C-II prescriptions in one file; C-III, CI-V and C-V and non-controlled

prescriptions together.

After a pharmacy purchaser completes a DEA Form-222, which copy does the

pharmacy retain?

a. Copy 1

b. Copy 2

c. Copy 3

d. Copies 1 and 2

c. Copy 3

Under which of the following circumstances does the pharmacist need to notify

the DEA?

a. The pharmacy was robbed and C-IIs and 222 forms were taken.

b. The pharmacy is planning to move to a new location.

c. The owner (sole proprietor) of a community pharmacy dies.

d. All of the above.

d. The pharmacy was robbed and C-IIs and 222 forms were taken; The

pharmacy is planning to move to a new location; The owner (sole proprietor) of

a community pharmacy dies.

Which of the following statements is(are) accurate concerning the dispensing of

OTC C-V cough preparations?

a. The customer must be at least 18 years old.

b. The pharmacy technician may complete the entire transaction, including the

dispensing, under the

supervision of a pharmacist.

c. The purchaser must present suitable identification to the pharmacist if he or

she is unknown to the

pharmacist.

d. a and c

d. The customer must be at least 18 years old ; The purchaser must present

suitable identification to the pharmacist if he or she is unknown to the

pharmacist.

Who has primary authority on the federal level for the scheduling, rescheduling,

or de-scheduling of controlled substances?

a. DEA

b. FDA

c. Attorney General

d. Attorney General in conjunction with the Secretary of Health and Human

Services

d. Attorney General in conjunction with the Secretary of Health and Human

Services

If a pharmacist uses the 2-drawer manual filing system (not the computer) for

storing controlled substance prescriptions as the primary method, which of the

following schedules of medication should be marked with a red "C"?

a. All C-IIs

b. C-III, C-IV, and C-Vs

c. C-III and C-IV only

d. All non-controlled prescriptions

b. C-III, C-IV, and C-Vs

On a controlled substance inventory, opened containers with which of the

following drugs must be counted exactly?

a. C-IIs

b. C-II, C-III, and C-IVs in any size of container

c. All controlled substances

d. Only C-II, C-III, and C-IVs in opened containers

a. C-IIs

When a DEA inspector conducts an audit of your controlled substances, what

percent error are you allowed?

a. 0%

b. 3%

c. 5%

d. 10%

a. 0%

Dispensing a C-V, OTC cough syrup containing codeine is limited to which of

the following?

a. 120 ml within 48 hours

b. 180 ml within 48 hours

c. 240 ml within 48 hours

d. No limitation if Barb Woods needs it!

a. 120 ml within 48 hours

A patient requests a refill of his prescription for diphenoxylate 2.5mg/Atropine

sulfate 0.025mg. What are the limitations for refilling this prescription (with

appropriate authorization) in Kansas?

a. no refills permitted

b. maximum of 5 refills

c. maximum of 5 refills or 6 months, whichever comes first

d. one year from the date of issuance

d. one year from the date of issuance

Which of the following prescription medications can be mailed by a community

pharmacy through the US Postal Service to a patient?

a. meperidine 50 mg tablets

b. diazepam 10 mg injections

c. methylphenidate 5mg tablets

d. all of the above

d. meperidine 50 mg tablets; diazepam 10 mg injections; methylphenidate 5mg

tablets

A physician develops a product to relieve oral discomfort in cancer patients. He

has a number of colleagues who are interested in using the product and asks

you to compound it so that he may ship it to his colleagues in other states. He

will supply you with a prescription marked "For Office Use" for a very large

quantity of the preparation. The FDA

would likely:

a. view this a marketing a new drug without an approved NDA.

b. view you as a manufacturer.

c. consider your activities as being within the normal course of pharmacy

practice.

d. Both a and b

d. view this a marketing a new drug without an approved NDA; view you as a

manufacturer.

Which statement is correct about dispensing a drug for a use that is

unapproved by the FDA?

a. It is illegal for a pharmacist to dispense a prescription for an unapproved

use.

b. It is illegal only if the pharmacist is aware that it is for an unapproved use.

c. It is illegal if the use varies significantly from the regular usage (in terms of

dose, etc.)

d. It is legal to dispense a medication for an unapproved use.

d. It is legal to dispense a medication for an unapproved use.

The advertising of OTC products is regulated primarily by:

a. FDA

b. HHS

c. FTC

d. DEA

c. FTC

In order to serve on the Kansas State Board of Pharmacy, you must:

a. be a resident of Kansas.

b. have been actively engaged in the practice of pharmacy in Kansas for 5 years

prior to appointment.

c. have had your name submitted to the governor by the Kansas Pharmacist

Association.

d. a and b only

e. a, b, and c

d. be a resident of Kansas; have been actively engaged in the practice of

pharmacy in Kansas for 5 years prior to appointment.

The authority to grant practitioners a license to prescribe drugs resides with:

a. the federal government

b. the state government

c. the local district court

d. none of the above

b. the state government

The statement: "Caution: Federal law prohibits the transfer of this drug to any

person other than the person for whom it was prescribed." Must appear on

prescription medication containers which contain controlled substances in the

following schedules EXCEPT:

a. C-III

b. C-V

c. C-II

d. C-IV

e. It must be on containers of all of the above schedules.

b. C-V

When a manufacturer refuses to recall its violative drug product at the request

of the FDA, which of the following legal remedies is available to the FDA?

a. Publicity

b. Injunction

c. FDA-initiated recall

d. Seizure of the product

d. Seizure of the product

(New Law - FDA can order a recall??)

Pharmacist Van received a methylphenidate prescription that was dated March

1, 2011. On what date is this prescription no longer valid in Kansas?

a. March 8, 2011

b. April 15, 2011

c. June 2, 2011

d. September 2, 2011

d. September 2, 2011

The minimum necessary requirement for disclosing PHI does NOT apply to:

a. Payment for services

b. Marketing activities

c. Treatment activities

d. a and c

c. Treatment activities

Dr. Johns, a DEA-registered internist, calls on Friday evening requesting that

you dispense #15 Levo-Dromoran tablets to Susan Folkes. You are satisfied

that the situation is an emergency. Dr. Johns must supply you with a signed

prescription within how much time?

a. 72 hours

b. 96 hours

c. 5 days

d. 7 days

d. 7 days

Dr. Johns would also like to continue Susan on this medication for two more

weeks. Which of the following is true?

a. He may write on the prescription he sends to you for the emergency period

for a total of 45 doses.

b. He may authorize and you may fill 2 refills on the emergency prescription

you wrote.

c. He must give you two prescriptions: one covering #15 doses for the

emergency time and one for the

additional doses.

d. You may alter the emergency prescription to reflect the additional doses and

have him sign his name on

it.

c. He must give you two prescriptions: one covering #15 doses for the

emergency time and one for the

additional doses.

Which items is(are) included in the definition of "unprofessional conduct" stated

in the Kansas Pharmacy Practice Act?

a. Fraud when applying for registration or a permit.

b. Intentionally falsifying or altering prescriptions.

c. Unlawful diversion of drugs to others.

d. Intentionally adulterating any drug.

e. All of the above.

e. Fraud when applying for registration or a permit; Intentionally falsifying or

altering prescriptions; Unlawful diversion of drugs to others; Intentionally

adulterating any drug.

Which of the following are true concerning pharmacists' continuing education

requirements in Kansas?

I. One CEU is equal to one contact hour.

II. Thirty contact hours are required biennially for re-licensure.

III. Failure to supply the Board of Pharmacy evidence of adequate CE will cause

one's license to become

inactive.

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

d.

II. Thirty contact hours are required biennially for re-licensure.

III. Failure to supply the Board of Pharmacy evidence of adequate CE will cause

one's license to become

inactive.

According to DEA regulations, all of the following information is required for

recording an OTC C-V sale, EXCEPT:

a. name and address of purchaser

b. name and quantity of drug

c. intended use of the drug

d. date of sale of the drug

e. name or initials of dispensing pharmacist

c. intended use of the drug

As the pharmacist-in-charge of a retail pharmacy that is owned by a non-

pharmacist, you are responsible for notifying the Board in writing within what

period of time if you decide to quit as the pharmacist-in-charge?

a. 5 days

b. 10 days

c. 14 days

d. None of the above

a. 5 days

When a pharmacist leaves the premises of a community pharmacy, a pharmacy

intern may:

a. continue to fill prescriptions as long as none are dispensed.

b. take prescription transfers from other pharmacies.

c. hand prescriptions to patients as long as they are refills and were filled by

the pharmacist.

d. a and c

e. do none of the above.

e. do none of the above

Which of the following statements is (are) accurate concerning the transferring

of prescriptions?

I. Non-controlled prescriptions may be transferred as many times as there are

authorized refills on the

prescription.

II. C-II prescriptions may be transferred only one time.

III. Pharmacy technicians may process the prescription transfer in Kansas.

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

I. Non-controlled prescriptions may be transferred as many times as there are

authorized refills on the

prescription.

During a routine DEA inspection, the pharmacist is required to allow the

inspector to examine:

a. personnel files of current employees.

b. controlled substances destruction records.

c. controlled substances pricing data.

d. controlled substances sales revenue data.

e. a and b

b. controlled substances destruction records.

Identify which of the following functions can be performed by a Kansas

pharmacy technician.

I. Read and interpret the prescription

II. Personally offer to counsel each patient with each new prescription

III. Affix the prescription label to the drug container

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

III. Affix the prescription label to the drug container

Pharmacist Erickson is the pharmacist in charge of a community pharmacy that

offers on-premises pharmacist services for 55 hours per week. The local county

hospital has requested that Jones also become the PIC for the county hospital

pharmacy that has on-premises pharmacist services for 20 hours per week.

May pharmacist Erickson

legally be PIC at both registered sites?

a. yes

b. no

a. yes

A physician's assistant may legally perform which of the following activities

under written protocol with a responsible physician?

I. May directly administer a prescription drug.

II. May prescribe a C-II drug by oral or telephonic communication in an

emergency.

III. May prescribe a C-III, C-IV, or C-V drug in writing.

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

e.

I. May directly administer a prescription drug.

II. May prescribe a C-II drug by oral or telephonic communication in an

emergency.

III. May prescribe a C-III, C-IV, or C-V drug in writing.

The reference library of a community pharmacy is required to include all of the

following items EXCEPT:

a. Medical dictionary

b. Recognized reference in drug interactions

c. Recognized reference on compounding and manufacturing

d. Copy of the Kansas Controlled Substance Act and regulations

c. Recognized reference on compounding and manufacturing

What is the maximum number of pseudoephedrine HCl 60mg tablets a

pharmacist may legally sell to one purchaser in one day if he/she presents the

required identification?

a. 36

b. 60

c. 73

d. 146

c. 73

Which of the below practitioners may apply for and receive a DEA registration

number in Kansas?

a. Dentists

b. Surgeons

c. Optometrists

d. a and b only

e. a, b and c

e. Dentists; Surgeons; Optometrists

A pharmacist must send a copy of each of the following documents to the

regional DEA office EXCEPT:

I. Power of Attorney

II. Most recent controlled substance inventory

III. State pharmacy registration

a. I only

b. III only

c. I and II only

d. II and III only

e. I, II and III

e.

I. Power of Attorney

II. Most recent controlled substance inventory

III. State pharmacy registration

All of the following practice activities must be performed by a licensed

pharmacist EXCEPT:

a. Performing drug regimen reviews.

b. Interpreting and verifying patient medication records.

c. Prepackaging medications in unit-dose containers.

d. Ensuring the proper selection of prescription drugs, devices or suppliers.

c. Prepackaging medications in unit-dose containers.

In Kansas, a patient's medication profile record in a community pharmacy is

required to contain all of the following information EXCEPT:

a. Name and address of the patient

b. Patient's age

c. Initial date of dispensing and prescription number

d. Name of the dispensing pharmacist

e. Drug allergies and sensitivities

b. Patient's age

Which of the following individuals are required to be identified by nametags if

performing pharmacy-related duties?

a. Pharmacist

b. Pharmacy Technician

c. Pharmacy student and intern

d. All of the above

d. Pharmacist; Pharmacy Technician; Pharmacy student and intern

A "brick and mortar" pharmacy operates an Internet site that provides

advertising for pharmacy services, provides some patient educational material,

and accepts non-controlled prescription and OTC orders. Orders received from

the Internet site are dispensed from inventory located in the physical pharmacy.

Which of the entities must be registered

with the DEA?

a. The "brick and mortar" pharmacy

b. The Internet site

c. a and b

d. Neither a nor b

a. The "brick and mortar" pharmacy

Which of the following activities is (are) the responsibility of a pharmacist-in-

charge of a community pharmacy?

I. Develop or approve written policies and procedures for the pharmacy.

II. Maintain records in the pharmacy describing the training and education

regarding work functions

performed by all pharmacy personnel.

III. Inventory all controlled substances in the pharmacy within 72 hours after

beginning to function as the PIC.

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

e.

I. Develop or approve written policies and procedures for the pharmacy.

II. Maintain records in the pharmacy describing the training and education

regarding work functions

performed by all pharmacy personnel.

III. Inventory all controlled substances in the pharmacy within 72 hours after

beginning to function as the PIC.

Which of the following might represent a breach of privacy based on federal

HIPAA?

I. Allowing a pharmaceutical sales representative to peruse your prescription

files to ascertain of a certain doctor is prescribing a new antidepressant.

II. Providing a husband with a list of drug products and their therapeutic uses

that his wife received last year.

III. Allowing a pharmacy clerk to call out the names of waiting patients to pick

up their prescriptions.

a. I only

b. III only

c. I & II only

d. II & III only

e. I, II, & III

c.

I. Allowing a pharmaceutical sales representative to peruse your prescription

files to ascertain of a certain doctor is prescribing a new antidepressant.

II. Providing a husband with a list of drug products and their therapeutic uses

that his wife received last year.

The term "preceptor" in Kansas is defined as a licensed pharmacist who

possesses at least ___ years of experience as a registered pharmacist and who

supervises students obtaining their required pharmaceutical experience.

2 years

Prescriptions in Kansas must be kept on file for __ years.

5 years

The total number of dosage units of all controlled substances distributed to

DEA registrants by a practitioner during the twelve-month calendar year in

which the practitioner is registered to dispense cannot exceed ___ percent of

the total number of dosage units of all controlled substances distributed and

dispensed during this time period.

5%

A pharmacist in charge in Kansas must successfully pass the PIC exam with a

score of at least ____% within ___ days of the change in the pharmacy

registration at the location.

85% ; 30 days

Incident reports must be kept on file for __ years in Kansas.

5 years

Each registrant shall notify the executive secretary of the Board in writing of any

change in majority ownership of the operation for which the registration was

issued within ___ days after the date the change in ownership becomes

effective.

5 days

A treating physician shall not prescribe dispense or prescribe more than a ___ -

day supply of controlled substances to treat obesity for a patient at one time.

30 day supply

Dolittle Pharmacy needs to order the following medications from their drug

wholesaler.

diazepam 10mg tablets 2 bottles of 100

codeine sulfate 30mg tabs 4 bottles of 100

Fioricet tabs 1 bottle of 100

Fiorinal tabs 2 bottles of 100

Dilaudid 2mg/ml inj. 5 boxes of 25 amps

methadone 5mg tabs 2 bottles of 100

Tylox caps. 1 bottle of 100

Lomotil liquid 2.5mg/5ml 1 bottle of 60ml

Which of the above drugs must be ordered from the wholesaler using a DEA-

222 form?

codeine sulfate tabs

Dilaudid inj.

methadone tabs

Tylox

The ratio of pharmacy technicians to pharmacists must not exceed ___ unless

two of the

technicians hold certification approved by the board, in which case the ratio of

technicians to pharmacists may be ___.

2:1; 3:1

A prescriber may issue multiple prescriptions authorizing a patient to receive a

total of up to a ___-day supply of C-II medication providing the prescriber

writes specific directions on each prescription indicating the earliest date it may

be filled and no pharmacist fills it before that date.

90 day

In Kansas, revocation of one's pharmacist license is for all time, except that any

time after ___(amount of time) the licensee may reapply to the Executive

Secretary of the Board of Pharmacy for reinstatement.

1 year

According to Kansas law, syringes may be sold OTC but are considered to be

____ [(see definition 21-36a01(f)(11) and 21-36a10(b)]

Drug paraphernalia

The Kansas Board of Pharmacy consists of ___ members who are eligible to

serve for a maximum of ___ terms of ___ years each (see 74-1603 & 74-1604).

7; 2 terms; 4 years each

To comply with minimum CQI requirements in Kansas, a community pharmacy

must meet at least ____ (how many times) each quarter of each calendar year to

review all incident reports generated for each reportable event that occurred in

that pharmacy since the last meeting.

One time

Pharmacist to Intern Ratio

1:2

Length of time Technician has to notify State Board of switching employers

30 days

Pharmacist to Technician Ratio

>Unlicensed Techs = 1:2

>At least 2 licensed techs = 1:3

Requirements to not have to carry a Retail Permit

Carry 12 or less OTC, and nothing injectable

Pharmacist in Charge Exam

1)Must pass with 85%

2)Pharmacy may not go 30 days without having a Pharmacist in Charge

PIC of more than one location

Can't be PIC or more that one location that has on-premises Rx services of 30

hours or more weekly

Branches or Pickup Stations

Pharmacists can only participate with licensed locations

Cancer Drug Repository

>Unit dosed

>Cancer drugs, or drugs used to treat side effects

>Must have 6 months expiration left prior to donation

>Can't be re-posited twice

>No Controlled substances

>Can charge a handling fee no more than $15

Institutional Drug Room Definition

>Serves Drug needs of Jail, Juvy Hall, College, Places of business, hospice

>Not a Dr. office or registered pharmacy

>Must be supervised by pharmacist or practitioner for inventory and record

keeping

Drug Store : Changing PIC / Ownership

Must notify State Board at least 5 days prior

Changing PIC

>Outgoing PIC needs to do a Controlled Substance inventory before leaving

>Incoming PIC needs to do a CS inventory within 72hrs of taking over

>Both records need to be kept for 5 years

Minimum Requirements for a Pharmacy Library

>Current copy of Kansas Pharmacy Practice Act, Kansas Uniform Controlled

substances Act, and regulations for both acts

>Drug Information Reference

>Reference in Toxicology, Pharmacology, and Drug Interactions

>Reference on drug equivalencies

>Medical Dictionary

Incident Reports

>Duty of PIC to setup and maintain

>Any reportable incident

>Kept for 5 years

>PIC must meet quarterly with Continuous Quality Improvement Program to go

over incidents and steps to correct and prevent

Medical Care Facility Requirements

>Must have a PIC assigned

>Registered nurse or PA can distribute drugs when PIC isn't around

>May have an Emergency Med Kit

Emergency Medication Kit

>Maintained by PIC of a medical care facility

>May have controlled substances, as long as a Drug Committee limits what

goes in

>PIC in charge of inventory/maintenance

Medical Facility Drug Order Review

Must be done within 7 days of the order being written

Health Department and Not for Profit Private Company Drug Restrictions

>Only non-controlled

>Must have a PIC

>Normal drug record keeping

Patient Med Profile Requirements

>Name, etc, allergies

>Dr., Pharmacist dispensing

>Initial date of filling, drug name, etc

>Record Must be kept for 5 years from last entry

Poisons

Must be labeled as such and be specially colored

OTC DMSO

>Properly labeled with strength, etc

>Printed material giving adequate warning of its dangers

Central Fill Pharmacies : Send direct to patients?

No, they can't send to patients or individual practitioners.

Central Fill Retail Site : C-II Rx

>Write on Rx "Central Fill", with name, address, and DEA of Central Fill location,

name of transferring pharmacist and date of transmission

>Keep original on file for 2 years from fill date

Central Fill - Filling Site : C-II Rx

>All the normal stuff, plus date it was delivered to the retail pharmacy and

method of how it was delivered

Shared Order Filling Definition

Same as Federal "Central Fill"

Shared Order Processing Requirements

>Share an electronic record

>Same owner or written contract

>Joint P&P manual

Time a pharmacist has to obtain the original RX from a Dr for an emergency C-

II

7 days

Allowable time to complete a partial fill for C-II for a pt in a LTCF

60 days

Allowable time to complete a partial fill for C-II for an ambulatory pt

72 hrs

Allowable number of times and/or length of time a pharmacist may refill a C-III

or C-IV Rx, if authorized

5 refills or 6 months

Allowable time limitation to refill C-V Rx if authorized

1 year from issuance

Quantity of drug a Pharmacist may dispense to a Pt off an emergency C-II Rx

Enough to handle the emergency

C-II Rx is valid for how many days from it date of issuance in KS

6 months

For central fill pharmacies, the length of time a Pharmacist has to verify

accuracy of the computer record for filling/refilling of C-III-C-V Rx's

72 hours

A registrant transferring a pharmacy to another registrant must notify the

nearest DEA office at least ____ days before the date of the proposed transfer

14 days

Allowable number of refills of phentermine prescribed for treatment of obesity

in KS

0

Maximum number of doses (quantity) that may be prescribed and dispensed on

a single C-II Rx

Unlimited

Max # of days supply that may be prescribed and dispensed on multiple C-II

Rx's that have the same date of issuance

30 days each RX ; 90 days max between them all

DEA form used by pharmacists to report theft or significant loss

Form-106 (Online)

Max amount of pseudoephedrine that can be sold to a purchaser in 30 days

9g or 7.5g over mail order

Length of time a pharmacy must keep controlled substance records

5 years

During CS inventory, an exact count must be taken of all C-II products and

products containing _____

Hydrocodone

FDA is under what regulatory agency?

Dept. of Health and Human Services (DHHS)

Pure Food and Drug Act of 1906

Prohibited the adulteration and misbranding of foods and drugs in interstate

commerce

Food, Drug, and Cosmetic Act of 1938 (FDCA)

> No new drug, cosmetic, or device could be marketed until proven safe

> Labels must contain adequate directions for use and warnings about the

habit-forming properties of certain drugs.

Durham-Humphrey Amendment of 1951

> Aka the Prescription Drug Amendment

> Established 2 classes of drugs, prescription and OTC

> Labels of prescription drugs need not contain "adequate directions for use"

so long as they contained the legend, "Caution: Federal law prohibits

dispensing without a prescription."

> Authorizes oral prescriptions and refills of prescription drugs

Kefauver-Harris Amendment of 1962

> Required that drugs be proved not only safe, but also effective

> Established Good Manufacturing Practices (GMP) requirements

> Required informed consent of research subjects and reporting of adverse

drug reactions

> Retroactive to all drugs marketed b/w 1938 and 1962

Poison Prevention Packaging Act (1970)

>Enforced by the Consumer Product Safety Commission

>Defines tamper resistant vs Child resistant

>Failure to abide by child resistant packaging is misbranding

Medical Device Amendments of 1976 (MDA)

> Provided for more extensive regulation and administrative authority

regarding the safety and efficacy of medical devices by requiring:

- Classification of devices according to their function

- Premarket approval

- Establishment of performance standards

- Conformance with GMP regulations

- Adherence to record and reporting requirements

Orphan Drug Act of 1983

Provide tax and exclusive licensing incentives for manufacturers to develop and

market drugs or biologicals for the treatment of "rare diseases or conditions"

Drug Price Competition and Patent Term Restoration Act of 1984

> Aka Waxman-Hatch Amendment

> ANDA process initiated

> Patent extensions, in certain cases to innovator drugs

> Intent: make generic drugs more readily available to the public and, at the

same time, provide incentives for manufacturers to develop new drugs

Prescription Drug Marketing Act of 1987

> Blocks re-importation of exported US drugs

> Bans the sale, purchase, or trade of drug samples

> Prohibits hospitals and other health care entities from reselling their drug

purchases to other businesses (exceptions)

> Requires the state licensing of drug wholesalers

Exceptions to Hospital Resales

>Sale among hospitals under common control or nonprofit entities

>Emergency Medical Reasons

> Alleviate a temporary shortage

Omnibus Budget Reconciliation Act (1990)

>For Medicaid Patients

>Prospective DUR

>Maintaining adequate medical records

>Counseling

>Lower cost back to state

Safe Medical Devices Act of 1990

Gave the FDA additional authority esp. related to postmarketing requirements

and premarket notification and approval, while expediting the premarket device

approval process

Nutrition Labeling and Education Act of 1990

> Mandates nutrition labeling on food products and authorizes health claims

on product labeling, as long as they are made in compliance with FDA

regulations>

The Generic Drug Enforcement Act of 1992

> Authorized the FDA to ban individuals or firms from participating in the drug

approval process if convicted of related felonies

> Also imposes severe civil penalties for any false statements, bribes, failures

to disclose material facts, and other related offenses

Prescription Drug User Fee Act of 1992 (PDUFA)

> Requires manufacturers to pay fees for applications and supplements when

the FDA must review clinical studies

> The fees provide the FDA with the resources to hire more reviewers to assess

these clinical studies and hopefully speed up the NDA reviews

Dietary Supplement Health and Education Act of 1994 (DSHEA)

> Defined dietary supplements and permit manufacturers to make certain

claims that otherwise would have been illegal under the FDCA

> Forced the FDA to regulate dietary supplements more as foods than as drugs

Food and Drug Administration Modernization Act of 1997 (FDAMA)

> Expedited availability of safe and effective drugs and devices

> Changed "legend" to "Rx only"

> Fast-track approval process for serious or life-threatening diseases

> Expands the rights of manufacturers to disseminate unlabeled use

information

> Expands the FDA's authority of OTC drugs and establishes ingredient-

labeling requirements for inactive ingredients

Food and Drug Administration Amendments Act of 2007 (FDAAA)

>Allows the FDA broader use of the fees generated from PDUFA, while

substantially increasing the fees

>Provides the FDA with significantly enhanced responsibilities and authority to

regulate drug safety, including to:

- Mandate labeling changes related to safety

- Require clinical trial data reporting and registries

- Require post-market (phase 4) clinical studies to assess risks

- Require companies to implement risk evaluation and mitigation strategies

(REMS) when necessary

When does a Approved Drug become a New Drug?

>New additive or proportion of additive changes

>New combo of already approved drugs

>For a new indication

>New duration, dose, or method

Ryan Haight Online Pharmacy Consumer Protection Act - 2009

>Prevent illicit CS internet sales

>Pharmacies must obtain a modified DEA registration

>Exemptions : Indian Health and Federal entities

USP-NF

>Private, independent organization

>Combo of the United States Pharmacopeia (USP) and the National Formulary

(NF).

>Standards for medicines, dosage forms, drug substances, excipients,

biologics, compounded preparations, medical devices, dietary supplements,

and other therapeutics.

>Enforceable by the FDA

FDA Post Marketing Surveillance

>Called MedWatch (drugs) & VAERS (vaccines)

>Mandatory for Industry

>Voluntary for Practitioners, Lay Public

VAERS

Vaccine Adverse Event Reporting System

Classes of Drug Recalls

>Class 1 : Serious adverse health/death

>Class 2 : temporary or reversible

>Class 3 : adverse health not likely

Who regulates drug advertising : OTC and RX?

OTC - FTC

RX - FDA

Orange Book Basics

>NOT Official Compendium

>Has approved RX, OTC that have conditional approval, blood products,

products that were never marketed or pulled from market for reasons other

than safety or efficacy

>Does NOT include Pre-1938 drugs or DESI drugs (1938-1962)

>Therapeutic equivalents

Pharmaceutical Equivalent

>Same active ingredient(s)

>Same dosage form/route

>Same strength / concentration

Therapeutic Equivalent

>Pharmaceutically Equivalent

>Bioequivalent

Orange Book Therapeutic Equivalent Codes

No Code = no generic on market

A = Equivalent

B = Not Equivalent

Beyond Use Dating : Compounded Non Sterile

>Non-aqueous - 25% of Manufacturer's Expire date or 6 months.

>USP or NF ingredients - 6 months or manufacturer's expire date

>Aqueous - 14 days if stored between 2-8 Celsius

>Anything else - duration of treatment or 30 days.

OTC Refills

OK to refill except:

>Higher dose than OTC

>Stated refill directions

>C-V must have authorized refills

Drug Sample Restrictions

>Must be requested in writing and have written receipt

>Only licensed prescribers, hospitals, and health care entities can request

>Must follow normal inventory, etc

Alcohol Federal Regulations

>Community Pharmacy - buy with tax 190 proof alcohol from wholesalers for

compounding

>Hospital Pharmacy - buy tax free, compounding for inpatients only, not sold

or distributed off premises

Ipecac Syrup OTC / Child Resistant Caps

>Not Ipecac Fluid Extract

>larger than 30ml is Rx and needs child resistant lid

DEA-222 Form - 3 Copies go to whom?

>Copy 1 - Suppliers (brown)

>Copy 2 - DEA (green)

>Copy 3 - Purchaser (blue)

DEA-222 Form - What if Supplier can't supply Drug?

>Can be endorsed to another supplier, but must send all drugs to that new

supplier

Who determines Controlled Substance Schedules?

Attorney General in conjunction with the Secretary of Health and Human

Services

Meth. Anti-Prolif. Act 2000 : List I and II Chemicals

List I - any precursor to Meth

List II - substances key to making meth but aren't precursors

Combat Meth...Act of 2005 - Listed Chemicals

Ephedrine, pseudoephedrine, and phenylpropanolamine (EPPs)

Combat Meth...Act of 2005 - Sales Limits

>3.6g of base per purchaser per day

>9g per purchaser per 30 days

>7.5g per purchaser per 30 days if over mail order

Combat Meth...Act of 2005 - Logbook

>Signed, dated, product info, date, time

>Kept for 2 years

Schedule 1 Drug examples

heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote,

methaqualone, and 3,4-methylenedioxymethamphetamine ("ecstasy")

Pharmacy DEA Application as a Dispenser

Form 224

Application as a Manufacturer

>Form 225

>Pharmacy may stay a dispenser if they keep sales to other registrants under

5% of their sales

Exemption to DEA Registration

>People working under a registrant (ie hospital)

>Pharmacists

>Law Enforcement, Armed Services, etc who dispense but not procure

Where do you store DEA Registration Certificate?

At place of business readily retrievable

Pharmacy DEA Renewal Form

>Form 224a

>Renewal every 3 years

DEA : Transferring Pharmacy Time Frame

>At least 14 days prior

>Return unused 222 Forms

DEA : Employment Requirements

>No employee convicted of CS felony or who had license revoked for cause

without prior written permission from DEA

Methadone Detox Limitations

>Pharmacy may dispense only for analgesic purposes

>Physician may administer in office 3 days total - 1 day at a time

>Hospital Inpatients can receive if being treated at hospital for something other

than detox

Narcotic Treatment DEA Form

Form 363

Internet Dispensing of CS

>Importers must be DEA registered

>Must have a legitimate doctor/patient relationship

>VIPPS - Verified Pharmacy Practice Sites

VIPPS

>Verified Pharmacy Practice Sites

>Site to verify a valid internet dispenser

Drugs Approved for Opioid Dependence Treatment

Subutex (buprenorphine) (C-III)

Suboxone (buprenorphine/naloxone) (C-III)

CS Records : What is kept and time frame

>Kept for 5 years (KS Law)

>Maintained Separate from Others

>Executed 222, Prescriptions, Inventory records, Power of attorney

Centralized CS Record Keeping

Financial and Shipping records. C-II's must be kept at each site

Name of Electronic C-II ordering system

CSOS - Controlled Substance Ordering System

Procedure for Dr. to get C-II from Pharmacy for office use

Must use a 222 form. Can NOT use a written Rx

When is the Red "C" waived on Controlled substance record keeping?

If registrant is using electronic record keeping

Disposal / Destruction of C-II (2 ways)

1) Complete Form 41 and request permission from DEA

2) Use a reverse distributor's 222 and they submit the Form 41

Controlled Substance Inventory Records

>Yearly

>Done of all on hand, including Rx's not picked up

>"Opening of Business" or "Closing of Business"

CS Inventory Exact vs Estimated Counts

>Exact count of C-II, hydrocodone, and any CS in a container over 1000 doses

>Estimated count of C-III thru C-V in containers less than 1000

Faxed orders for Controlled Substances

>C-II : only for narcotic parentral pain, pt in LTCF, pt in a Medicare certified

hospice care

DEA Inspections : What can and can't they inspect

>Yes : records, reports, required forms, equipment, CS, may take samples with

a receipt

>No : financial, sales, pricing data

DEA Notice of Inspection form

Form-82

Registration with State Board for dispensing CS

Everyone except:

1) employees working under a registrant

2)Pharmacies already registered as a dispenser

3)Any person licensed by State Board of Healing Arts or Veterinary Examiners

Kansas CS Inventory

Kept for 5 years

Codeine Scheduling

>C-III : Not > 1.8g per 100ml or 90mg per dosage unit with at least 1 other

non narcotic drug

>C-V : Not > 200mg or any salts per 100ml or 100g

Diphenoxylate / Atorpine Scheduling

C-V : Not > 2.5mg diphenoxylate and not < 25mcg atorpine per dosage unit

Obesity Treatment

>No amphetamines

>30 day supply max

>Pt must lose 5% of weight in first 90 days to continue with drug

What on a C-II Script may not be changed?

1)Name of the patient

2)Name of the Drug

3)Name of the prescribing Dr.

4)Date of the prescription

USP <797> Sterile Preparation Levels

>Immediate use : intended for immediate use

>Low : Single transfer of sterile dosage forms. Manually measuring and mixing

no more than 3 manufactured products into IV

>Medium : TPN's or more than 3 injections

>High : Non-sterile bulk drug that will be terminally sterilized

Federal Register vs. Code of Federal Regulations (CFR)

>Federal Register - daily updates to laws

>CFR - Final year end copy of Federal Register

Kansas Law on how Drugs get Scheduling

State board sends recommendations to Speaker of the House and President of

Senate

Controlled substance schedules for which office samples are allowed

None

Controlled substance schedules for which pre-printed scripts are permitted

None

Utilization of Unused Medications

>Only from adult care homes, mail order pharmacies, medical care facilities

>No controls, unit dosed, and normal precautions

>Not to be resold

Updated daily, this publication is made up of notifications from federal

agencies, many of which pertain to new regulations

Federal Register