1
Q
T/F: if the FDA feels that a drug has serious safety concerns that would not be sufficiently addressed with BW and med guides, they can mandate the use of a REMS
A
True
2
Q
What is the risk associated with Thalidomide?
A
Severe birth defects
Thalidomide is known for causing severe birth defects if taken during pregnancy.
3
Q
What is the risk associated with Isotretinoin?
A
Severe birth defects
Isotretinoin is a medication used to treat severe acne but poses a high risk of birth defects.
4
Q
What is the risk associated with Clozapine?
A
Neutropenia
Clozapine can cause a dangerous drop in white blood cells, leading to neutropenia.
5
Q
What is the risk associated with Phentermine/Topiramate (Qsymia)?
A
High abuse potential, life-threatening respiratory depression
Qsymia is a combination medication for weight loss that has significant risks.
6
Q
What is the risk associated with Opioid analgesics?
A
High abuse potential, life-threatening respiratory depression
Opioids are effective for pain relief but carry a high risk of addiction and overdose.
7
Q
What is the risk associated with Flibanserin (Addyi)?
A
Risk of hypotension and syncope due to an interaction with alcohol
Addyi is used for treating low sexual desire in women and has specific alcohol-related risks.
8
Q
What is the REMS program for Thalomid?
A
Thalomid REMS Program: Negative pregnancy test required prior to dispensing each prescription
This program is designed to prevent fetal exposure to Thalomid.
9
Q
What is the REMS requirement for Isotretinoin?
A
iPledge Program: Two negative pregnancy tests required before first fill & one negative test prior to dispensing each subsequent prescription for patients who can get pregnant
The iPledge Program ensures that patients are not pregnant when receiving Isotretinoin.
10
Q
What is the REMS program for Clozapine?
A
Clozapine REMS program: Monitor the absolute neutrophil count (ANC)
This program is essential to prevent severe neutropenia in patients taking Clozapine.
11
Q
What is the REMS program for Qsymia?
A
Qsymia REMS Program: MedGuide required, healthcare training program, dispensed only through certified pharmacies
This program ensures safe prescribing and dispensing of Qsymia.
12
Q
What must be documented for each prescription dispensed by a pharmacist?
A
The name or initials of the dispensing pharmacist
This documentation is crucial for accountability and tracking in pharmacy practice.
13
Q
What information must be kept on a patient medication profile?
A
- Patient’s full name and address
- Telephone number
- Date of birth (or age)
- Gender
- Drug name
- Strength
- Dosage form
- Route of administration
- Quantity
- Directions
This information is essential for ensuring safe and effective medication management.
14
Q
True or false: A pharmacy must keep medication profiles on all patients who have prescriptions filled at the pharmacy.
A
TRUE
This requirement ensures that pharmacists have access to important patient medication history.
15
Q
What information must be included in a prescription profile?
A
- Prescriber’s name
- License number
- DEA registration number (if needed)
- Date each drug was dispensed or refilled
- Prescription number for each prescription
- Allergies, idiosyncrasies, current medications, relevant prior medications, OTC medications, devices, social history, or medical conditions (if provided)
- Any other information deemed appropriate by the pharmacist
The profile must be kept for at least one year from the date when the last prescription was filled.
16
Q
Name the three types of drug utilization reviews (DURs).
A
- Prospective DUR
- Retrospective DUR
- Concurrent DUR
Each type serves a different purpose in evaluating medication therapy.
17
Q
What is the purpose of Prospective DUR?
A
Evaluation of a patient’s medication profile prior to dispensing
Conducted by the dispensing pharmacist each time a prescription is filled.
18
Q
What does Retrospective DUR involve?
A
Review of drug therapy after the drug is dispensed
Often conducted for many patients at once by the state or medical institutions.
19
Q
What is the focus of Concurrent DUR?
A
Ongoing monitoring during the course of treatment
Regulations require hospital pharmacists to obtain a medication profile for each high-risk patient.
20
Q
In what situations must pharmacists provide patient counseling?
A
- Prescription drug has not been previously dispensed
- Refill is dispensed in a different dosage form or strength
- Patient requests counseling
- Pharmacist feels counseling is necessary
Counseling is an essential part of patient care in pharmacy practice.
21
Q
What must patient counseling include?
A
- Directions for use and storage
- Importance of compliance with directions
- Precautions and relevant warnings, including common or severe side effects and interactions
These items are essential for ensuring patient safety and effective medication use.
22
Q
When is it appropriate for patient counseling to include additional information?
A
- Name and description of the drug
- Dose and/or dosage form
- Route of administration
- Duration of therapy
- Special directions for use and storage
- Instructions on how to prepare the drug for administration
- Techniques for self-monitoring
- Refill information
- Additional adverse drug reactions or interactions
- What to do if a dose is missed
This additional information can enhance patient understanding and adherence.
23
Q
Who can make the offer to counsel patients?
A
Only the pharmacist or intern pharmacist
The offer to counsel must be made, but patients can refuse counseling.
24
Q
Where must patient counseling be conducted?
A
In an area suitable for confidential patient consultation
This is to protect the patient’s privacy.
25
What must be included in a written notice if a **prescription is mailed or delivered**?
* Availability of a pharmacist for consultation
* Telephone number for patient inquiries
* Hours of availability
## Footnote
This ensures patients know how to reach a pharmacist for questions.
26
How many days a week must a **pharmacist** be available for consultation?
At least six days of the week
## Footnote
Pharmacists must also be available for at least 40 hours per week.
27
What is required in California for pharmacies interacting with patients with a **limited grasp of the English language**?
* Provide interpretive services in the patient's language during all hours the pharmacy is open
* Use of pharmacy staff who can communicate in the patient's language or a third-party interpretive service
## Footnote
This requirement ensures safe medication use for all patients.
28
Are pharmacists required by state law to counsel **inpatients**?
No
## Footnote
However, discharge counseling must be provided by a registered nurse, pharmacist, or prescriber.
29
What is the purpose of the **Notice to Consumers**?
To ensure consumers understand their rights, including counseling from a pharmacist with each new prescription
## Footnote
The notice advises patients about the information provided, their right to ask questions, and availability of interpreter services and drug prices.
30
What must be posted in public view according to the **Notice to Consumers**?
The full-size poster of the Notice to Consumers
## Footnote
Smaller versions can be printed out, and the poster can be provided in languages applicable to the pharmacy's customer population.
31
What does **HIPAA** stand for?
Health Insurance Portability and Accountability Act
## Footnote
HIPAA was enacted in 1996 to create national standards for protecting patient privacy.
32
What is **protected health information (PHI)**?
Individually identifiable health information related to:
* Past, current, or future physical or mental health
* Healthcare provided to the patient
* Payment for healthcare
## Footnote
PHI includes identifying information like name, address, and social security number when associated with health information.
33
True or false: **HIPAA** allows patient information to be accessible to anyone.
FALSE
## Footnote
HIPAA requires that patient information is secure and not available to unauthorized viewers.
34
Who are considered **covered entities** under HIPAA?
* Healthcare professionals (e.g., pharmacists, doctors)
* Facilities providing healthcare (e.g., pharmacies, nursing homes)
* Health insurance companies
## Footnote
Covered entities must ensure the security of patient information.
35
What must healthcare professionals have documented training in regarding **HIPAA**?
How to protect patient PHI
## Footnote
Violation of HIPAA can result in fines and imprisonment.
36
What is an acceptable option for providing required information in settings where the patient does not see the pharmacist?
Written receipts containing the required information
## Footnote
This is applicable for mail-order or closed-door pharmacies.
37
What can a pharmacy opt to display to communicate the **Notice to Consumers**?
A PowerPoint presentation of the notice on a video screen
## Footnote
This is an alternative method of communication for consumers.
38
Fill in the blank: **PHI** includes health information associated with a patient's _______.
name, address, birthdate, social security number
## Footnote
If identifying information is not related to health information, it is not considered PHI.
39
What does **PHI** stand for?
Protected Health Information
## Footnote
PHI includes any individually identifiable health information related to a patient's health.
40
What types of information are included in **PHI**?
* Patient's past, current or future physical or mental health
* Healthcare provided to the patient
* Payment for providing healthcare to the patient
## Footnote
Examples include medical records, laboratory tests, and hospital bills.
41
True or false: **PHI** includes identifying information not related to health information.
FALSE
## Footnote
Identifying information not associated with health data, like names in a public directory, is not considered PHI.
42
List examples of **identifying information** that can make health information PHI.
* Name
* Address
* Birthdate
* Social Security number
## Footnote
This information must be associated with health information to be classified as PHI.
43
Fill in the blank: **PHI** includes the patient's past, current, or future physical or mental health, the healthcare provided, and the _______ for providing healthcare.
payment
## Footnote
This includes aspects like hospital bills and other related financial information.
44
PHI can be shared with
Patient
Other healthcare providers caring for the patient
Payment or operational purposes e.g care coord, quality improvement
Limited data set for research, public health or institutional operations
Law enforcement
DEA,FDA, MEDICALand pharmacy board inspectors
Organization related to donation and transplantation of organs and tissue
45
Who is it permissible to share **PHI** with?
* The patient
* Other healthcare providers caring for the patient
* Entities requiring the information for payment or operational purposes
* A limited data set for research, public health or institutional operations
* Law enforcement
* Pursuant to a court order, warrant, subpoena or administrative request
* To identify or locate a suspect, fugitive or missing person
* In response to an information request about a victim of a crime
* In response to criminal activity or death related to criminal activity
* The DEA, FDA, medical board inspectors and pharmacy board inspectors
* Organizations related to donation and transplantation of organs and tissues
## Footnote
These are the circumstances under which PHI can be shared without patient authorization.
46
What must a **healthcare provider** receive if PHI is released for purposes not listed?
The patient's written authorization
## Footnote
The authorization must be in plain language and include details such as the purpose and expiration date.
47
What should be in place for **disclosures** of PHI?
Policies, procedures or protocols
## Footnote
These ensure that only the 'minimum necessary' information is shared or used.
48
True or false: **Incidental disclosures** of PHI are avoidable and unacceptable under HIPAA.
FALSE
## Footnote
Incidental disclosures are unavoidable and acceptable, but should be minimized.
49
Give an example of an **incidental disclosure**.
* Oral coordination of patient care at a nursing station
* A healthcare provider discussing a patient's condition over the phone
* A discussion between providers while on rounds
* A pharmacist discussing a prescription in person or over the phone
## Footnote
These examples illustrate situations where incidental disclosures may occur.
50
What is the purpose of sharing only the **minimum necessary** information?
To encourage evaluation of who should be accessing PHI
## Footnote
This principle helps protect patient privacy while allowing necessary information flow.
51
Can **prescriptions** be picked up by family or friends?
Yes, unless the pharmacist has reason to believe it would be against the patient's wishes
## Footnote
This allows flexibility in medication retrieval while respecting patient preferences.
52
What is required if a patient is requesting the release of their **PHI**?
A written authorization is not necessary according to HIPAA
## Footnote
However, some facilities may still require it.
53
What should healthcare providers **avoid discussing** to minimize disclosures?
* Patient care in common areas (e.g., elevators, cafeteria)
* Posting information about patients on social media
## Footnote
These practices help protect patient confidentiality and comply with privacy regulations.
54
What is the appropriate method of **PHI destruction**?
* Shredding documents
## Footnote
Redaction is not considered an appropriate method for destroying protected health information (PHI).
55
What should be covered on **prescription bottles and bags** before dispensing?
* Patient identifiers
## Footnote
This is essential to maintain patient confidentiality during the dispensing process.
56
What must healthcare providers do with **electronic medical records** when not in use?
* Close computer screens
* Log out of the system
## Footnote
This practice helps prevent unauthorized access to patient information.
57
According to **HIPAA**, what must be included in a site-specific notice?
* Policies to protect PHI
* Information on who can access the information
* Patient rights regarding their information
## Footnote
The notice should be in simple language and clearly state the patient's rights.
58
When must the **HIPAA privacy notice** be given to patients?
* On the first day of service
* Whenever requested by the patient
## Footnote
This ensures that patients are informed about their privacy rights from the outset.
59
What must pharmacies make a good faith effort to obtain from patients regarding the **HIPAA privacy notice**?
* Written acknowledgment of receipt
## Footnote
This acknowledgment must be separate from other signatures and retained for six years.
60
How long must pharmacies keep the signed **HIPAA privacy disclosure forms**?
Six years
## Footnote
Patients have the right to request their privacy disclosures for the past six years.
61
In California, how quickly must patients be able to **inspect their medical records** after a written request?
Within five business days
## Footnote
Patients must receive copies within 15 business days, with specific charges for copies outlined.
62
What is the maximum charge for copies of medical records in California?
* $0.25 cents/page
* $0.50 cents/page for microfilm copies
## Footnote
Reasonable clerical costs may also be added to the total charge.
63
Patients can request a copy of their records in what formats?
* Printed copy
* Electronic version (e.g., via email)
## Footnote
This flexibility ensures that patients can access their information in a way that suits them best.
64
What is the **purpose of generic substitution**?
To provide the patient with a lower-cost drug while still providing the same therapeutic benefit
## Footnote
Generic substitution allows pharmacists to offer cost-effective alternatives to branded medications.
65
A pharmacist can substitute **generic, therapeutically-equivalent drugs** for a branded drug using what resource?
FDAS Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
## Footnote
The Orange Book is essential for determining therapeutic equivalence.
66
True or false: A pharmacist can substitute a generic drug for a branded drug if the prescriber or patient has requested otherwise.
FALSE
## Footnote
Substitution can only occur unless the prescriber or patient explicitly requests otherwise.
67
What must a substituted drug have in common with the branded drug for **generic substitution** to occur?
* Same active ingredients
* Same strength
* Same quantity
* Same dosage form
* Same generic drug name (USAN)
## Footnote
These criteria ensure that the generic drug is therapeutically equivalent to the branded drug.
68
When a **generic equivalent** is dispensed, what must the label contain?
* Generic name
* Statement 'generic for [brand name]'
* Manufacturer name
## Footnote
This labeling is important for transparency and patient information.
69
If the **brand** is dispensed, what is required on the label?
Only the brand name
## Footnote
This simplifies the labeling process when a brand-name drug is provided.
70
Where can the **Orange Book** be accessed?
* In print
* Online at the FDA website
* As a mobile application (Orange Book Express)
## Footnote
The Orange Book is a vital resource for pharmacists and healthcare providers.
71
What actions by the prescriber indicate that **substitution cannot be made**?
* Indicates 'Do not substitute'
* Checks off a box with 'Do not substitute'
* Initials a box with 'Do not substitute'
## Footnote
These actions explicitly prevent any changes to the prescribed medication.
72
A pharmacist can select a different formulation with the same **active ingredients** when it will improve what?
Patient compliance
## Footnote
For example, changing from tablets to a pediatric suspension if indicated.
73
Substitution is not permitted between **long-acting** and **short-acting** forms of a medication with the same chemical ingredients. Give an example.
Long-acting clonidine (Kapvay) cannot be interchanged with immediate-release clonidine
## Footnote
This rule ensures that the therapeutic effects and release profiles are maintained.
74
Substitution is also not permitted between **combination drug products** and what?
Multiple single agents
## Footnote
For example, isosorbide dinitrate/hydralazine (BiDil) cannot be dispensed as the two individual drugs.
75
What is a **biosimilar**?
Considered 'highly similar' to an FDA-approved biologic with no clinically meaningful difference
## Footnote
Not all biosimilars are therapeutically equivalent to their reference products.
76
What must occur for an FDA-approved **interchangeable biosimilar** to be substituted without contacting the prescriber?
Prescriber did not indicate 'Do not substitute'
## Footnote
The substitution must be communicated to the patient and the prescriber must be notified within five days.
77
Name two examples of **interchangeable biosimilars** found in the Purple Book.
* Insulin glargine-ygn (Semglee) for insulin glargine (Lantus)
* Adalimumab-adbm (Cyltezo) for adalimumab (Humira)
## Footnote
These biosimilars are therapeutically equivalent to their reference products.
78
Biosimilars book
The purple book lists the reference products, biosimilars and interchangeable products
79
What is a **formulary**?
A preferred drug list chosen for patients or members by a hospital, healthcare plan, or PBM
## Footnote
The formulary includes the safest and most effective drugs according to clinical guidelines while considering cost.
80
What process is used when similar drugs exist in a class for a **formulary**?
Competitive bidding process
## Footnote
For example, a P&T Committee may choose the least expensive option among equally safe and effective drugs.
81
What may lead to a drug being **removed from the formulary**?
* Safety concern
* Availability of a less expensive drug
## Footnote
Safety concerns can include sound-alike or look-alike drugs and abuse potential.
82
Who are the members of the **P&T Committee**?
* Physicians
* Pharmacists
* Nurses
* Administrators
* Quality improvement managers
* Medication safety officer
## Footnote
The P&T Committee is responsible for all aspects of drug use in a healthcare system.
83
What are the primary responsibilities of the **P&T Committee**?
* Create and update the formulary
* Conduct medication use evaluations (MUE/DUE)
* Monitor and report adverse drug events
* Conduct medication error safety initiatives
* Develop clinical care plans and protocols
## Footnote
These responsibilities ensure safe and effective medication use.
84
What is a **copay**?
An out-of-pocket expense that the patient must pay for services
## Footnote
This includes costs for doctor visits and prescription drugs.
85
How many tiers are typically in an **outpatient formulary**?
Three to five tiers
## Footnote
The lower the tier, the lower the copay for the patient.
86
What is the copay for **specialty drugs** in an outpatient formulary?
10% copay, up to $250 maximum per prescription
## Footnote
Specialty drugs, including biologics, are usually placed on a high tier.
87
What is a **therapeutic interchange protocol**?
A protocol to dispense therapeutically similar medications that are different from the prescribed medication
## Footnote
The substituted drug is usually in the same pharmacological/therapeutic class.
88
Why have **therapeutic interchange protocols** become more common?
Availability of multiple drugs in the same therapeutic class
## Footnote
This strategy is cost-effective, allowing substitution of more expensive drugs with less costly alternatives.
89
In California, a pharmacist can refuse to dispense certain medications based on _______.
religious, moral or ethical beliefs
## Footnote
A written protocol must be established to ensure timely access to the prescribed drug despite a pharmacist's refusal.
90
What must a pharmacist do to refuse to dispense a medication based on moral objection?
Notify employer in writing
## Footnote
This notification allows for the establishment of a protocol to ensure patient access to medications.
91
Legitimate mail-order pharmacies must dispense medications pursuant to a prescription from a prescriber who has performed a _______.
good faith medical exam
## Footnote
Internet prescriptions should only be dispensed if the prescriber has conducted an examination.
92
Entities that do not require legitimate prescriptions and sell drugs for non-medical purposes are considered _______.
illegal
## Footnote
These entities contribute to increased controlled substance abuse and drug overdoses.
93
What act was signed into law in 2008 to prevent illegal sales of controlled substances via the internet?
Ryan Haight Online Pharmacy Consumer Protection Act
## Footnote
This act aims to regulate online pharmacies and protect consumers.
94
To legally dispense controlled substances through an online pharmacy, the pharmacy must register with the _______.
DEA
## Footnote
The pharmacy must also report their dispensing activity to the DEA.
95
Remote dispensing sites, or telepharmacies, are permitted to operate in underserved locations that do not have an outpatient pharmacy within _______ miles.
10 miles
## Footnote
Telepharmacies are managed by a supervising pharmacy that is licensed.
96
A remote telepharmacy site is considered to be a _______ location of the licensed, supervising pharmacy.
satellite
## Footnote
The remote site is not licensed and is managed by the supervising pharmacy.
97
The pharmacist supervises all activities in the remote pharmacy using _______ technology.
audio-visual equipment
## Footnote
This technology allows for activities such as DUR, filling, and counseling.
CPJE Mine
flashcards
Decks in class (4)
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