• Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

Card Range To Study

through

image

Play button

image

Play button

image

Progress

1/142

Click to flip

Use LEFT and RIGHT arrow keys to navigate between flashcards;

Use UP and DOWN arrow keys to flip the card;

H to show hint;

A reads text to speech;

142 Cards in this Set

  • Front
  • Back
For a refill, what must be entered on the back of a C-III, IV, or V prescription?
1) Dispensing Rx's initials
2) Date the prescription was filled
3) Amount of drug dispensed on the refill
All records of controlled substances must be maintained for how long?
2 years (federal)

5 years (state)
To obtain a DEA registration, which form must be submitted?
DEA Form-224
What form must a pharmacy complete to report a theft or loss of controlled substances?
DEA Form-106
Controlled substance inventories should be maintained and readily retrievable for at least how long?
1) 2 years (federal)
2) 5 years (utah)
What form must a pharmacy complete in order to destroy controlled substances?
DEA Form-41
1)What is the daily sales limit of ephedrine, pseudoephedrine, or phenylpropanolamine for each purchaser?
2) No more than __ grams of these products can be purchased by a single person during a 30 day period
1) 3.6 grams
2) 9 grams
Records involving the transfer or destruction of controlled substances must be kept readily available for how long?
2 years 9federal)

5 years (state)
How many times may a C-III or IV prescription be refilled?
Up to 5 times within six months after the date of issue
For an inventory of C-III, IV, and V substances, when is an actual physical count necessary?
When a container contains more than 1,000 dosage units AND it has been opened
What concentration of a codeine preparation would be considered a C-V substance?
No more than 200 mg/100 ml or 100gm
"CAUTION: Federal law prohibits the transfer of this drug to any person..." must be printed the labels of which controlled substances?
C-II, III, & IV
To obtain a DEA Chemical Distributer registration, which form should be submitted?
DEA Form-510
When may a faxed C-II prescription be considered a "written prescription"?
1) Patient is undergoing home infusion/IV pain therapy
2) Patient is in a long term care facility
3) Patient is in hospice care
"The total number of dosage units of controlled substances distributed by a pharmacy may not exceed __% of all controlled substances dispensed by the pharmacy during a calendar year."
5%
What are the 4 basic elements of negligence?
1) Duty - a legal obligation to conform to a specific standard of conduct for protection of another individual against an unreasonable risk of injury

2) Breach - a violation of that legal obligation by the defendant

3) Causation - the breach is the actual and promiate cause of the plantifs injury

4) Damage
What law required safety testing for medications
Food Drug and Cosmetic Act

Prompted by elixir of sulfanilamade

required "warning, may be habit forming" on narcotics and hypnotics
What law legalized oral prescriptions and refills
Durham-Humphrey Amendment to the FDCA
What law required drugs to be tested for efficacy?
Kefauver-Harris Amendment

Manufactures now required to provide safety and efficacy.

Also allowed for inspection of manufacturing facilities (GMP).

Established advertising procedures (prescription FDA), OTC (FTC))

DESI group
What law created the Drug Enforcement Agency
Controlled Substance Act (1970)

Scheduling of drugs and other substances
What law required that all prescriptions be subject to special packaging requirements?
Poison Prevention Packaging Act (1970)
Can a physician make a blanket request to not place a patients prescription in a child-resistant container?
No
Can a patient make a blanket request to not place their medication in a child-resistant container?
Yes
Whats a class I medical device?
Relatively low potential for causing harm - premarket testing is not necessary

e.g., scissors, forceps, hemostats, needles
What is a class II medical device?
Safety and efficacy must be evaluated by specific standards.

e.g., hearing aids, sunlamps, tampons, thermometers
What is a class III medical device?
Devices that are usually life-supporting systems.

e.g., indwelling catheters, neuromuscular stimulators, pacemakers
What law essentially deregulated the herbal remedies industry
Drug Supplement and Health Education Act (DSHEA) - 1984

Cannot claim they diagnose, cure, mitigate, treat or prevent diseases
What does the Food and Drug Administration Modernization Act do?
Looks for big centers compounding drugs that are commercially available
What is considered biequivalence?
within 80-125% of the reference drugs Cmax and AUC.

Same pharmaceutical agent, and the same dosage form
Adulterated vs. Misbranded

Which one is primarily concerned with the physical condition of the drug or device and the enviornment of their manufacture
Adulterated

Prohibited in interstate commerce
Adulterated vs. Misbranded

Which one is primarily concerned with the representations made by the manufacturer concerning the drug or device
Misbranded
Aldulterated vs. Misbranded

A drug does not bear generic generic name in type not less than 1/2 the size of the trade or brand name
Misbranded
Adulterated vs. Misbranded

Which one does label and labeling discrepencies fall under
Branded
Aldulterated vs. Misbranded

Which one does a drug that does not conform to an official compendium fall under?
Adulterated
Adulterated vs. Misbranded

Insulin or antibiotic drug which is not batch certified
Misbranded
Who has the authority to schedule a drug?
Attorney General
What massive law included an indirect approach by the federal government to regulate the pharmacy profession and health cae industry?

What are the 3 main components?
Omnibus Budget Reconciliation Act (1990) - OBRA 90

1) Rebate programs
2) Demonstration projects
3) DUR programs

Intent was to promote cost savings and better fiscal management in government sponsored health care
Which law protected health information?

Who is in charge of enforcing this law?
Health Insurance Portability Accountabilit Act (HIPPA)

Department of Justice - Office of Civil Rights
What law prohibits knowingly making false statements of a material fact in any application for a benefit or payment?
Medicare/Medicaid Fraud and Abuse Act
Who is in charge of enforcing the Medicare and Medicaid Fraud and Abuse Statute preventing kickbacks and refund checks on medicaid patients?
Attorney General's office and Medicaid Fraud Control Units (MFCUs)

May punish pharmacy and/or pharmacist
True or False

Manufacturers of controlled substances must label commercial containers of their products with a symbol identifying the classification?
True

Typically C-I, C-II, C-III, C-IV, or C-V
What are the three components to a C-I?
1) Drugs that are not available for prescription, dispensing, or administration
2) Requires a seperate DEA registration as a researcher
3) High abuse potential and NO accepted medical use in U.S
What are the two components of a C-II
1) High abuse potential with severe psychological or physical dependence
2) Accepted medical use
What are the two components of a C-III
1) Potential for abuse less than that of substances in Schedules I or II
2) Abuse of drug may lead to moderate or low physical dependence or HIGH psychological dependence
Narcotic schedule III agents may not contain more than:
1) 1.8 grams of codeine or dihydrocodeine per 100 ml or not more than 90 mg per dosage unit
2) 300 mg of dihydrocodeine or ethylmorphine per 100 ml or 15 mg per dosage unit
3) 500 mg of opium per 100 ml or not more than 25 mg per dosage unit
4) 50 mg of morphine per 100 ml
Three components of a Schedule IV medication?
1) Low potential for abuse relative to schedule III drugs
2) Abuse may lead to minimal physical dependence or psychological dependence
3) Primarily benzos and lower dependent barbiturates
Three components of a Schedule V medication?
1) Low potential for abuse relative to substances in Schedule IV
2) Abuse may lead to limited physical or psychological dependence
3) Primarily used to classify antitussive agents and antidiarrheal products
Do pharmacists need a registration to manufacture or distribute any controlled substance or list 1 chemical?
No, we dispense, not manufacture or distribute.
Do pharmacists need to register with the DEA via a 224 form in order to dispense controlled substances?
No - the pharmacy must be registered and we are exempted from this because we are an employee acting in the usual course of our employment
How often must pharmacy registrations be renewed with the DEA?

When should the pharmacy expect to receive a renewal application?
Every 3 years

45 days prior to the registration expiring
Does each place of business have to be registered with the DEA?
Yes
What must a pharmacy do to change an address?
A new DEA certificate reflecting the new address must be obtained. A request for modification of the registration should be sent to the DEA before the effective date of the move.
What form is required for a renewal of a DEA registration?
224a
Corporations that own or operate a chain of pharmacies may submit a single _________ Form that does what?
a DEA Form-224b

This is an affadavit for renewal of retail/chain pharmacy registration.
Who has the right to suspend or revoke a DEA registration?
The Attorney General
What 4 things must be done if terminating a registration?
1) Any registrant who discontinues his/her business or transfers it to another person must notify the nearest DEA registration field office IN WRITING before terminating the pharmacy's registration
2) Send the DEA the certificate of registration and any unused 222 forms
3) Write or stamp VOID across the face of each order form. The DEA should also be notified of where and how the C.S. were transferred and where the records will be stored
4) Records involving C.S. must be kept available for 2 years (federal)
What 2 things must be done if transferring a business
1) Notify the DEA field office at least 14 days before the date of the proposed transfer
2) On the day of the C.S. transfer, a complete controlled substance inventory must be taken and a copy of the inventory must be included in the records of BOTH the person transferring the business and the person acquiring the business
What are the 2 ways to dispose of controlled substances?
1) Transfer controlled substances to another pharmacy via a DEA Form-222 (C-I and C-II only). Document the transfer of C-III through V in writing.

2) Destruction of controlled substances (4 possible means of destruction)
Who may a pharmacy transfer controlled substances to?
1) To another pharmacy
2) To another supplier or manufacturer
3) To a reverse distributor (DEA Form-222 needed from distributor)
How may a pharmacy destroy controlled substances?
First contact the nearest DEA Field Office
1) Once-a-year DEA Authorization for Destruction - DEA Form-41
2) Obtain an authorized member of a state law enforcement authority or regulatory agency to witness the destruction (Send in a DEA Form-41 after)
3) Reverse Distributor
4) "Blanket Authorization" for destruction - hospitals
What must be done in order for a reverse distributor to destroy controlled substances from your pharmacy?
They must issue a DEA Form-222 to the pharmacy for C-IIs, then they will fill out a DEA Form-41 after the drugs have been destroyed.
What must be done for the Once-a-year DEA authorization for destruction of controlled substances?
1)A DEA Form-41 must be filled out listing all drugs that will be destroyed.
2) Pharmacy must prepare a letter outlining the drugs, date, and method of destruction, along with the names of at least 2 MLP who will witness the destruction.
3) After destruction, the pharmacy needs to send in the signed DEA Form-41 into the DEA
What are the 2 options for keeping controlled substances in a pharmacy?
1) in a locked cabinet
2) Dispersed throughout the pharmacy along with the non-controlled substances

State law requires an alarm system - not federal.
Can an employee with a felony relating to a controlled substance be hired as a pharmacist?
Yes - the pharmacy must request the DEA for an employment waiver.
What must be done if controlled substances are found to be missing or stolen?
1) Contact the nearest DEA Field Office
2) Notify the local police
3) Complete a DEA Form-106 listing the name, address, DEA number, date of theft, name and # of local police, type of theft, listing of C.S. missing)
When may the federal government investigate thefts or robberies.
1) above $500
2) someone is killed or suffers significant bodily damage
3) interstate or foreign commerce is involved
What are the 3 options for precription record keeping?
1) A file for C-II, C-III-V, non controlled
2) A file for C-II, and a file for all others with C-III through V having a red C stamp.
3) A file for C-II through V (schedule III - V must have a red C stamp), then a non-control file.
How often must a pharmacy take a controlled substance inventory (federal)?
Biennial inventory (every 2 years)

no need to submit to DEA

An actual physical count of all C-IIs has to be done. C-III through V can be estimated unless the container holds > 1000 pills and is open.
What form is used to order more 222 forms?
222a form
How many order forms does each 222 form contain?
Each book contains seven sets of forms. Each pharmacy may have up to 6 books. Max of 42 forms in the pharmacy
What must a pharmacist do to complete a 222 order form?
fill in the # of packages, the size of the package, and the name of the item. When the items are recieved, the RPh must document on the purchaser's copy (copy 3) the actual # of packages received and the date received.
Outline the Power of Attorney to Sign an Official Order Form
Any registered pharmacy may authorize one or more individuals (do not have to be Rphs) to obtain and execute the forms.

The POA must be signed by the same person who signed the most recent application for registration.
What must be done upon discovering the loss or theft of unused order forms?
You must immediately report the loss to the nearest DEA diversion field office and report the serial numbers.
According to federal law, how long does a patient have to fill a C-II?
Indefinitely (some interpret as 1 year). The RPh must determine that the prescription is still needed by the patient.
Emergency C-II prescriptions
1) May only fill for 72 hours
2) Immediately reduced to writing by the pharmacist
3) Pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner.
3) Within 7 days the M.D. must furnish the pharmacist a written, signed prescription. The prescription must have written on its face "Authorization for Emergency Dispensing". The pharmacist must notify the nearest DEA office if this does not happen, if the RPh fails to do this he/she will not longer be able to dispense without a written Rx.
Can a pharmacy provide a partial fill for a C-II prescription?
Yes - if the pharmacy is unable to fill the entire quantity. The RPh must write the quantity supplies on the front of the prescription.

The remaining quantity may be dispensed within 72 hours of the first partial dispensing.
What are the 4 elements necessary for a doctor/patient relationship?
1) A patient has a medical compaint
2) A medical history has been taken
3) A physical exam has been performed
4) Some logical connection exists between the medical compaint, medical history, physical exam, and the drug prescribed
Narcotic treatment program registered with DEA can only handle the narcotic substances applied for on what form?
DEA Form-363
Can you mail a controlled substance?
Yes - has to meet U.S. Postal Service Mailing Requirements for Controlled Substances.

Cannot be superficially identified. Inner contents are labeled to show the name and address of pharmacy.
When does the logbook for the combat methamephetamine epidemic act not apply?
The logbook does not apply to any purchase by an individual of a single sales package that contains less than 60 mg of PSE.

The logbook requires photo ID
How many members are on the board of pharmacy?
Seven

5 pharmacists, one technician, and one lay person.

R.Phs and tech need to have practiced continuously for at least three years in the state, and at least 5 years overall.
How long does a license last before it expires?
2 years

September 30 on odd years
How long must you maintain your CE information?
4 years after your licensed has been renewed.
What is the shortest duration for which a license may be suspended?
A minimum period of 90 days
Diversion committees consist of how many professionals within the same or similar occupation?
At least 3
How many times may a licensee be eligible for the diversion program?
Only once for the same or similar offense.
Whats the maximum term of a diversion agreement?
Maximum of 5 years
Does a diversion offense remain on a pharmacist's record if he/she successfully completes the diversion program as stipulated by the board?
No - its as if it had never happened
Can DOPL inspect a pharmacy whenever they want?
Nope - it has to be within regular business hours and they must present ID, describe the nature of the visit, provide upon request the authority of the division to conduct the search, and then they may view the license(s)
What is a class A pharmacy?

Does it require a pharmacist-in-charge?
A retail pharmacy

Yes - must have a PIC
How many hours must a pharmacist who is applying for licensure by endorsement have?
A minimum of 2000 hours in 4 years immediately preceeding application in Utah.
How many hours of supervised practice must a pharmacist applicant have to be eligible for licensure?
1500 total hours
How many hours can an applicant receive from the college of pharmacy?

Need at least 120 in what settings
Maximum of 900

120 in community pharmacy
120 in institutional pharmacy and
120 in any clinical setting
What is required to be a preceptor?
An active license
2 years of experience
Provide supervision to only 1 intenr during a working shift
How many hours of CE are required?
30 total hours (RPh) and 20 (tech)
How many hours of live CE are required?
12
How many hours of CE are required for Drug therapy and patient management?
15
How many hours of CE are required to be on law or ethics?
1
Within what time frame must you contact DOPL when changing your address?
10 days

Considered unprofessional conduct
How many techs and interns can a pharmacist supervise at any given time?
3 technicians and 1 intern
What 8 items must a label contain?
1) pharmacy info (name, etc)
2) Rx #
3) fill date or last dispensing date
4) patient name
5) presciber
6) directions for use
7) medication info (name, strength, etc)
8) beyond use date
Whats the minimum notice a pharmacy can give to DOPL before it closes?
14 days

PIC must write a letter to DOPL within 10 days of closing
State law dictates a CS inventory be taken how often?
Annually
Unprofessional vs. Unlawful conduct

Not offering counseling
Unprofessional
May a pharmacist refill a controlled susbtance prescription if the patient is out of refills?

If so, what must be done?
Yes - other than C-II substanceas

A pharmacist may exercise his/her professional judgment to refill a prescription, provided:
1) Failure to refill might result in an interruption of a regimen or create patient suffering
2) RPh made a reasonable effort to contact the practitioner, this effort must be documented
3) Quantity does not exceed a 72 hour supply
4) inform the patient that this refill is being provided without authorization
5) Pharmacist informs the M.D.
6) Maintains a record of the emergency fill.
What references must a pharmacy have readily available and retrievable to personnel?
1) DOPL Act
2) General rules of DOPL
3) Pharmacy practice act
4) Utah Pharmacy Practice Act Rules
5) Utah Controlled Substance Act
6) Utah Controlled Substance Act Rules
7) USP DI Drug Reference Guides
8) Orange Book
9) any other reference needed to perform practice dictated by the usual course of business
Can a physician write a controlled substance with a sig of UD?
Nope - must be something like QID UD
How many times may a CIII or C-IV be filled?
May be filled only within 6 months of issuance, and may not be refilled more than 5 times.
How long is a C-V good for?
12 months
When does a C-II expire?
after 30 days?
True or False

Each Rx for a controlled substance may have other controlled substances on it, but not non-controlled substances?
False

Each Rx for a CS may contain only 1 controlled substance and may not contain any other legend drugs.
When an M.D. writes for three C-II prescriptions that are for the same medication, what must be included on the 2nd and 3rd Rx?
The date of issuance and the date for dispensing.

Unless there is a valid medical reason, the date for dispensing may not be < 30 days from the dispensing date of the previous prescription.
Can a M.D. prescribe a controlled substance for a minor without notifying the parental unit?
No - unless it is an emergency
Are M.D.'s allowed to write for a C-II or C-III for weight loss?
No
What must be done for a C-II emergency prescription?
1) Cannot exceed 72 hours
2) M.D. has examined the patient w/i 30 days
3) A written prescription is delivered to the pharmacist within 7 days
4) A reasonable effort to ensure that the M.D. is licensed to prescribe a C.S.
As of July 15, 2008, each pharmacy shall submit all data collected during the previous ____________ days?
7 days at least once weekly
How many interns on rotation may a preceptor supervise?
Up to 2 externs - potentially another working intern
Which of the following may a support personnel not help with?

a) Stocking
b) Cashiering
c) Billing
d) Filing hardcopies
e) Counting and filling prescriptions
e) Counting and filling prescriptions
Unlawful vs. Unprofessional
Knowingly preventing or refusing to permit any authorized agent to conduct an inspection
Unlawful
Unlawful vs. Unprofessional

Failing to deliver the license, permit, etc to the division upon demand if it has been revoked, suspended, or refused
Unlawful
Unlawful vs. Unprofessional

Conducting business under the name which contains “drugstore” , “apothecary”, “pharmacy”, etc. unless the place is a licensed pharmacy
Unlawful
Unlawful vs. Unprofessional

Buying, selling any drug which bears the name “sample”, “not for resale”, “for investigational use only
Unlawful
Unlawful vs. Unprofessional

Using to his own advantages or revealing to anyone other than the division or BOP, any information acquired under authority of this chapter or concerning any method of process which is a trade secret
Unlawful
Unlawful vs. Unprofessional

Requiring any employed pharmacist, intern, etc. to engage in conduct in violation of this chapter
Unlawful
Unlawful vs. Unprofessional

Being in possession of a Rx-only drug for any unlawful purpose
Unlawful
Unlawful vs. Unprofessional

Willfully deceiving the division, the board, or agents regarding compliance with this chapter
Unprofessional
Unlawful vs. Unprofessional

Paying rebates to practitioners or other providers
Unprofessional
Unlawful vs. Unprofessional

Misbranding or adulteration of any drug
Unprofessional
Unlawful vs. Unprofessional

Dispensing of any outdated, misbranded, or adultered drug
Unprofessional
Unlawful vs. Unprofessional

Engaging in the sale or purchase of drugs that are samples
BOTH
Unlawful vs. Unprofessional

Accepting back and redistributing of any unused drug after it has left the premises of the pharmacy unless the drug is in a unit pack or the manufacturer’s sealed container
Unprofessional
Unlawful vs. Unprofessional

Violating the Fed and Utah CSA
Unprofessional - probably both?
Unlawful vs. Unprofessional

Disclosing confidential patient information in violation of HIPAA
Unprofessional
Unlawful vs. Unprofessional

Engaging in practice of pharmacy without a licensed pharmacist designated as pharmacist in charge
Unprofessional
Unlawful vs. Unprofessional

Preparing as a pharmacist or intern, a prescription drug for sale to another pharmacist or pharmacy
Unprofessional
Unlawful vs. Unprofessional

Obtaining a passing score on licensing exam or application by fraud, forgery, or deception or omission
Unlawful
Unlawful vs. Unprofessional

Practicing through gross imcompetence, and gross negligence
Unprofessional
Unlawful vs. Unprofessional

Violating any statue, rule or order regulating the pharmacy profession
Unprofessional
1. A pharmacist may accept back and redistribute any unused drug after it has left the pharmacy if:
a. The drug was prescribed to a patient in an nursing care facility, LTCF, state prison, county jail, or state hospital
b. The drug was stored under the supervision of a licensed health care provider according to the manufacturer recommendations
c. The drug is in a unit pack or manufacturer’s sealed container
d. The drug was returned to the original dispensing pharmacy
e. The drug was initially dispensed by a licensed pharmacist or intern
f. Accepting back and redistribution of the drug complies with the FDC Act and CSA
Test
Whats the punishment for unlawful practice?
Class A Misdemeanor
Unlawful vs. Unprofessional

Failing to provide DOPL with a current mailing address within 10 business days following the change of address
Unprofessional
Unlawful vs. Unprofessional

Practicing pharmacy with the inappropriate pharmacist to intern ratio (1:1)

Practicing pharmacy with the inappropriate pharmacist to tech ratio(1:3)
Unprofessional