Ch 4: Pharmacy Practice Flashcards by Sarah Coconis

FED for compounded prescriptions, where does the legal responsibility lie if prepared by a technician?

The pharmacist, when the RPh signs off on it they are saying it was prepared correctly…. but tech can still face consequences for careless work, or legal action if illegal shit (theft) has taken place

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FED A collaborative practice agreement can also be called what

collaborative drug therapy management (CDTM)

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FED In some states, the PIC may also be referred to ask these two terms

Responsible pharmacist, pharmacist manager

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FED If a pharmacist is supervising an intern who is training to do a specialized task, such as immunization, under what circumstances does the RPh also need to be licensed?

RPh needs to be licensed to do whatever they are supervising the intern for. So, if immunizing, the RPh needs to be cert to immunize also

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FED Under which circumstances if a pharmacy clerk authorized to fill prescriptions

None, they cannot fill prescriptions

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FED Give 3 examples of when a pharmacy clerk may have their license suspended or revoked

None, because they do not HAVE a license that would be suspended or revoked

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FED What legal change established the criteria for determining if a drug should be Rx only?

Durham-Humphrey amendment of 1951

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FED Federal law mandates that outpatient Medicaid prescriptions must be written on tamper-resistant forms containing how many security features

At least 3

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FED What are the 3 tamper resistant security features that must be present on a written outpatient Medicaid prescription in other to be eligible for reimbursement

1) Prevents duplication (“void” shows when photocopied or faxed)
2) Prevents erasure or modification of information (checkboxes to refills, chemically reactive paper)
3) Prevents use of counterfeit forms (uses pre-printed serial numbers, watermarks, microprint signature lines)

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FED T/F Physicians (MD, DO) and dentists (DMD only) have unlimited, independent prescribing authority in all states

False. Only physicians MD/DO have that. The other prescribers all have to work within their scope of practice and/or under a physician-directed protocol

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FED T/F Although the American Medical Association advises against physicians treating themselves or immediate family members, the DEA does not address this, though individual state boards may

True

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FED T/F Federal law specifies that a prescription remains valid after the prescriber has retired or died up to a max of 180 days after the date written

False. Fed law does NOT specify if it remains valid or not. Some states do not specify, some do

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FED Select all. A prescriber may legally prescribe a drug for off-label use under what 2 conditions

1) It has already been FDA-approved for at least 1 indication
2) They feel it is safe and effective

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FED Under what circumstances can a drug rep or manufacturer discuss off label use

Only if the practitioner has REQUESTED the information. They may not INITIATE a conversation unless it has been REQUESTED

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FED T/F Pharmacists are legally permitted to fill prescriptions for off-label indications so as long as it appears to be efficacious and safe for the patient

True

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FED Most states mandate that Rx records must be maintained for at least how many years

2 years. Think there are 2 letters in Rx

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FED T/F Federal law prohibits the refills of Schedule II substances

True… I’m an idiot

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FED T/F The transfer of non-controlled prescriptions has a federal limitation of a maximum of 10 transfers

False, there are no fed limits on tx of non-controlled prescriptions

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FED Select all. Which of the following are fed law requirements for Rx labels?

1) Patient’s name and secondary descriptor (phone number, address)
2) Prescription number
3) Name and address of dispenser
4) Drug name and strength
5) Date of filling

REQUIRED:

Patients name
Directions for use
Prescribers name
Name/address of dispenser
Serial or Rx number
Date of fill
Cautionary statement (law prohibits tx etcetc)

Required by some states:

Date initial fill
Name RPh
Expiration date
DRUG NAME AND STRENGTH
Refill remaining
More on pg 61

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FED USP Chapter 17 covers

Standards of prescription container labeling, and “is the official standard for prescription label format”

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FED T/F USP labeling standards apply to prescription and inpatient medications

False, USP labeling standards do not apply to inpatient medications

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FED USP Chapter 17 prescription label formatting standards indicates there are 3 critical items on a prescription that should be in a large font size

1) Patient name
2) Drug name and strength
3) Clear and simple directions for use

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FED USP standards state that BUD for a multiple dose-container should be no later than the expiration date on the manufacturers container, or….

One year or date the drug is dispensed–whichever is earlier

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FED Select all. Unit-dose containers:

1) are non-reusable (but may be re-stocked and re-dispensed in certain scenarios)
2) Are intended for retail pharmacy use
3) Are intended for direct oral administration as a single dose
4) Are often used in hospitals and skilled nursing facilities

1, 3, 4

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FED According to FDA and USP standards, the BUD for unit-dose containers should be the manufacturers expiration date, or

SIX months from the date the drugs been repackaged, whichever is earlier

FED The PPPA (poison) requires the use of C-R containers for what broad things?

OTC products, oral prescriptions, and dangerous household chemicals

FED C-R containers under the PPPA act should stop ___% of children from opening without a demonstration, ___% of children following a demonstration, and ___% of adults

85% of children w/o demo 80% of children w/demo 90% of adults

FED C-R containers are designed on the basis of a child under __ being unable to open them

Under age 5

FED Select all. Under the PPPA, the following should be done: A) A new lid should be given when reusing a plastic container B) A new lid should be given when using a glass container C) Reversible containers are recommended so patients may choose their preference D) C-R packaging is not required to be used on SL NTG

Only need a new lid if its GLASS. If its PLASTIC, need to give entire new container. Reversible not recommmended. C-R not for NTG.

FED T/F A prescriber can waive the use of a C-R container

True, but only for a single prescription

FED T/F A patient can provide a blanket waiver for all prescriptions to be dispensed in non-CR containers

True, it must be signed by the patient I believe....

FED Select all. All of the following must be met for a manufacturer package to OTC drugs in a non-C0R container 1) Must be labeled with "not child-resistant" 2) As long as the same product is also available in a C-R 3) The patient purchasing the medication is over 18 years of age 4) The manufacturer only packages one size of the drug 5) The drug is in an effervescent form

1, 2, 4 Effervescent only applies to APAP or ASA, not everything

FED USP Chapter 681 provides guidance on ___

Customized patient medication packages (med paks)

FED T/F Per USP, the med pak label should contain all of the same information required for a prescription label for each drug

False. It should contain all of that PLUS: - Serial/Rx number of med pack - Name, strength, physical description, total quantity of each drug - Required storage - Date of prep, BUD - If you can separate the containers each container needs a label identifying the drug inside

FED T/F (Not sure if law or?) recordkeeping of med packs should identify any pertinent information that will allow subsequent preparation of an identical med pack

True, page 66

FED Which org requires each state to have a DUR program in order to be reimbursed for Medicaid services?

OBRA requires this

FED OBRA requires which two types of DURs in order to be reimbursed for Medicaid services

1) prospective DUR | 2) retrospective DUR

FED Who performs a prospective DUR and retrospective DUR if being done for reimbursement for Medicaid services

``` Prospective = dispensing RPh (think Pro-Pharm, both have P) Retrospective = performed by the state ```

FED Select the correct statements: 1) RPh must perform prospective DUR prior to dispensing any Medicaid refills 2) OBRA requires a retrospective DUR to be done by the RPh in order for Medicaid reimbursement 3) Pharmacy software cannot be overriden if a DUR error presents during evaluation of a Medicaid script 4) OBRA requires pharmacists to perform a retrospective DUR prior to dispensing any refills or new scripts through Medicaid

1) True, for both refills and new scripts 2) False. Retrospective DUR is done by the STATE 3) False. Pharmacy software may be overriden 4) False. Retrospective DUR is done by the STATE

FED T/F OBRA requires the PIC of each pharmacy to perform a retrospective DUR to analyze physician prescribing habits at least anually

False. OBRA requires STATES to perform a system-wide retrospective DUR to analyze physician prescribing habits and assess the appropriate use of certain drugs. No time period is specified, pg 67

``` FED Select all. Which of the following components are considered to be part of the drug's labeling? A) The label on the drug container B) Consumer Medication Information (CMI) C) Patient Package Inserts (PPI) D) Instructions for Use (IFU) E) MedGuides F) REMS Paperwork ```

All, pg 67

``` FED Select all. Which of the following types of drug labels are FDA approved? A) REMS Paperwork B) Consumer Medication Information (CMI) C) Patient Package Inserts (PPI) D) Instructions for Use (IFU) E) MedGuides ```

The only non-FDA approved written material that is part of the drug's labeling is the Consumer Medication Information (CMI)

FED A patient picking up a new prescription for lisinopril rips off the leaflet that was stapled to the outside of her prescription bag, and asks you what this paper is for. What do you tell her? A) This is a drug information handout that the FDA mandates be included with each new prescription B) This information has been approved by the FDA and you should read it before using the medication C) The DEA mandates that all new prescriptions include an FDA-approved medication guide

This is a CMI handout, which is usually stapled or put inside the bag--they are NOT FDA approved/reviewed, they are simplified for patients to REFLECT the FDA-approved package inserts. The FDA mandates that info be provided with each new script.

FED Select the correct statements regarding patient package insert (PPI) use and oral contraceptive drugs A) PPI must be given during the initial fill in an outpatient or retail setting B) PPI must be given with both the initial fill and refills in the retail setting C) PPI must be given prior to administering the first dose and subsequent refills in inpatient settings D) If the PPI is not provided under circumstances required by law, it is considered misbranding

Outpatient/retail = PPI with initial fill and with refills Institutional/hospital/LTC = PPI prior to administration of first dose, and every 30 days thereafter Misbranding if not given when required, pg 68

FED Select the correct statements regarding MedGuides A) MedGuides are not FDA-approved B) MedGuides are supplied by the FDA to the dispenser so the pharmacy/etc may print and distribute them C) Antipsychotics in an intranasal or sublingual form are not required to be dispensed alongside a MedGuide D) MedGuides must be given both for initial fills and refills in the outpatient setting if the patient is to self-administer the medication E) MedGuides for products that are considered to be OTC (such as ibuprofen) do not need to be dispensed, so as long as the dose is an OTC dose

A) False, MedGuides are FDA-approved B) False, MedGuides are supplied by the manufacturer C) False, antipsychotics in any form need MedGuide D) True E) False, MedGuides need to be dispensed with NSAIDs with first fill and refills in outpatient settings where patient will self-administer

FED T/F A MedGuide must be given the first time a drug is dispensed to a HCP for admin to patient in an outpatient setting, but not for subsequent refills

True

FED Communication plans, elements to assure safe use, implementation systems, and MedGuides are the 4 parts to

A REMS

FED For meds with complicated administration, the FDA requires a document that contains

Containing instructions for use

FED T/F For meds with complicated administration such as injections and inhalations, the FDA requires a document containing instructions for use to be written by the manufacturer and approved by the FDA

True

FED What risk associated with clozapine makes it part of the REMS program

Severe neutropenia

FED T/F All opioid analgesics require a MedGuide, but not all are part of the REMS program

False. The correct statement is: all opioids are part of the REMS program, but not opioids require a MedGuide

What are the name brands of isotretinoin?

CAMAZ = Clavaris, Amnesteem, Myorisan, Absorica, Zenatane... Maybe think of a better mnemonic

FED What are the pregnancy test requirements, enrollment, and days supply requirements for REMS drugs isotretinoin and thalidomide?

Isotretinoin = 2 neg tests before first fill, 1 neg test before other fills.... no more than 30 ds.... pts/prescriber/pharmacy must enroll in iPLEDGE REMS Thalidomide = neg test before "dispensing each prescription", no more than 28 ds, page 70.... pt/prescriber/pharmacy must enroll in Thalomid REMS

FED T/F Federal law does not require patients to provide identification prior to receiving prescription in a retail pharmacy

True

``` FED When administering meds or performing procedures in an institutional setting certified by the The Joint Commission, HCPs must verify how many patient-specific identifiers? A) Not required by federal law B) 1 C) 2 D) 2, one of which must be a barcode ```

Must identify 2

FED Pursuant to OBRA, retail RPhs must offer ____ before dispensing any new Rxs to Medicaid patients A) Written instructions written in patient-friendly language that include images if the product is to be used by any route that is not by mouth B) oral consultation C) Patient Package Inserts (PPIs)

B, oral consultation. PPIs are only for oral contraceptives

FED What does HIPAA stand for

Health Insurance Portability and Accountability Act

FED Select all the circumstances that are considered to be in violation of HIPAA A) Law enforcement pursuant to an administrative request B) To locate a missing person C) Giving a patient a medication that has a sticker from another patient attached to it inadvertently D) Organizations related to donation of organs/tissues

FED Select all the requirements for a release of PHI A) Must have patients written authorization B) Must be authorized by the healthcare administration of the cosigned hospital/place of care C) Patients signature D) Expiration date

All except B

FED What does redaction mean in the context of HIPAA

Editing to censor/obscure content such as crossing off PHI before throwing something away. Redaction is NOT an appropriate method of PHI destruction

FED T/F Redaction is an appropriate method of PHI destruction in an institutional setting

False. Shred all documents before disposal, redaction is NOT an appropriate method of PHI destruction

FED Where should the HIPAA privacy notice be posted within a pharmacy

a prominent location within the pharmacy and on its website

FED T/F A pharmacy cannot provide services if the patient refuses to sign the HIPAA privacy notice

False

FED T/F The written acknowledgement of the HIPAA privacy policy can be a shared signature (such as a signature required to deny counseling services) so as long as both records are maintained accordingly

False, the written acknowledgement must be separate from other signatures

FED the signed HIPAA privacy disclosure forms should be kept for how many years

FED In relation to generic drug substitution, what is the difference between a permissive drug product selection law and a mandatory drug product selection law?

Permissive = pharmacist can decide whether or not to sub generic Mandatory = mandatory to sub the generic unless noted otherwise

FED For a drug to be therapeutically equivalent to a reference listed drug (RLD), what two equivalencies must it meet

Pharmaceutically equivalent, and bioequivalent (PKPD)

FED A new generic states that it is pharmaceutically equivalent to a reference listed drug, but the active ingredient is absorbed at a much quicker rate. This drug may be considered to be: A) therapeutically equivalent B) bioequivalent C) pharmaceutically equivalent

pharmaceutically equivalent, pg 76

FED T/F If a drug in the Orange Book AB, then it is both bioequivalent and pharmaceutically equivalent

True

FED T/F In the Orange Book, a drug rated AB1 is therapeutically equivalent to a drug rated AB2

False

FED Some states do not permit the substitution of NTI drugs and will define an NTI list which is commonly referred to as a

negative formulary

FED T/F A biosimilar is considered "highly similar" to an FDA-approved biologic (known as a "reference product") and has no clinically meaningful difference

True.... but, biosimilars are NOT considered therapeutically equivalent to the reference product

FED T/F There are currently no FDA-approved interchangeable biosimilars for a reference product, and therefore none that are therapeutically equivalent

True

FED A hospital therapeutic interchange protocol suggests changing rosuvastatin to atorvastatin. This interchange is considered: A) therapeutically equivalent B) therapeutically similar

B, therapeutically SIMILAR

FED T/F The RPh who subs one drug for another due to hospital formulary established by the P&T committee to be therapeutically similar does not require physician approval to change the drug

True, as long as the sub is established in the institutions therapeutic interchange protocol

FED Death with dignity can also be called

aid-in-dying

FED Select all. What are some of the requirements to be eligible for death with dignity? A) Age 18+ B) State resident C) Diagnosed with a terminal illness that will lead to death in 8 months D) Age 26+

A) True B) True C) Should be 6 months D) Should be 18+

FED What class of drug is typically prescribed for aid-in-dying patients

Barbiturates (secobarbital, pentobarbital)

FED Death with dignity generally requires patients to make both oral and written requests as well as having a letter of reference from a friend or family member

False, no letter from friend/fam needed

FED Select all. The Emergency Prescription Assistance Program (EPAP) managed by the DHHS allows pharmacies to process claims from federally-identified disaster areas as declared by the US President. What may be eligible? A) Insured patients B) Uninsured patients C) Durable medical equipment

Only for uninsured patients. And yes, DME may be covered

FED For which immunizations does CMS no longer require a physician order for, if administered in participating hospitals, LTC, or home health care agencies

influenza and pneumococcal

FED When sending excess prescription drugs back to suppliers, how should opened drug containers be treated? A) Marked with an X B) Stored separate from unopened containers C) Stored in a pharmacy yellow bag D) A&B E) All of the above

``` FED Select all. Under the Secure and Responsible Drug Disposal Act, DEA-authorized collectors can collect which of the following substances: A) Controlled substances B) Non-controlled substances C) Illicit drugs D) Sharps E) Fentanyl patches ```

A, B, E... they cannot take illicit drugs or sharps

``` FED The FDA flush list mostly includes: A) OTC drugs B) Opioids C) Chemotherapy drugs D) Hazardous drugs E) REMS drugs ```

B, Opioids

FED A patient comes to your pharmacy, a DEA-authorized collector, wanting to dispose of Fentanyl, pantoprazole, and Ambien. Where should you tell the patient dispose of each? A) Flush the Fentanyl. Mix the others with kitty litter and dispose of in household trash B) Dispose all in household trash C) Flush the Fentanyl immediately. Leave the remainder at your pharmacy to be collected D) Leave all of them to be collected at your pharmacy

D--you always want them to be given to a DEA-authorized collector if there is one readily available

FED A patient calls you from their rural campsite stating they found some old Fentanyl in their dresser from several years ago. There is no DEA-authorized collector readily available. What do you tell the patient to do? A) Flush the meds immediately B) Mix them with kitty litter and save them in a bag in the car until she can reach a DEA-authorized collector C) Mix with kitty litter and dispose of in the household trash

A) Flush immediately. If the drug is on the flush list, always flush it immediately, do not dispose of in the household trash

FED Select all. Under the Prescription Drug Marketing Act (PDMA), the resale of prescription drugs is permitted under what circumstances? A) Nonprofit sales B) Community pharmacy sales C) Emergency reasons D) Pursuant to a prescription E) To other healthcare facilities at a profit

A, C, D