Questions 1, 2, and 3 pertain to the following case.
1- Your institution wants to evaluate the addition of coagulation factor Xa (recombinant), inactivated - zhzo to your formulary for reversal of direct oral anticoagulants.
Which would best describe the type of cost this medication would have?
- A. Fixed medical.
- B. Variable medical
- C. Indirect
- D. Incremental
Answer: B
- The cost of a medication would be considered a variable medical cost (Answer B is correct).
- The cost of the lights in the clean room would be considered a fixed medical cost (Answer A is incorrect).
- Time resulting in loss of work for a patient requiring this medication would be considered an indirect cost (Answer C is incorrect).
- The additional use of blood products after administration of this medication would be considered an incremental cost (Answer D is incorrect)."
2- Your institution wants to use Pharmacoeconomic data to evaluate the impact of this medication on neurologic disability and cost compared with prothrombin complex concentrate.
Which analysis would be best to find in the literature?
- A. Cost-benefit.
- B. Cost-effectiveness.
- C. Cost-minimization.
- D. Cost-utility.
2. Answer: B
- Given the need to consider efficacy and cost, a cost effectiveness analysis would be the best type of analysis (Answer B is correct).
- A cost-benefit analysis would be used if we were purely interested in a monetary outcome (Answer A is incorrect).
- A cost-minimization analysis would only evaluate the difference in costs between these medications (Answer C is incorrect).
- A cost-utility analysis includes the patient perspective, which was not a focus of this evaluation (Answer D is incorrect)
3- Which would best describe the type of cost of the additional use of blood products after administration of this medication?
- A. Fixed medical.
- B. Variable medical.
- C. Indirect.
- D. Incremental
Answer: D. Incremental
J.R. is a 30-year-old woman admitted to the surgical ICU after a motor vehicle accident.
Which would best exemplify an indirect cost from her perspective?
- A. Loss of wages from her occupation as an engineer.
- B. Effects of posttraumatic stress disorder from her accident.
- C. Fentanyl administered to manage her pain.
- D. Cost of the ambulance that transported her to the hospital.
Answer: A
Indirect costs occur from loss of employment or productivity as the result of illness (Answer A is correct). Effects from stress would be considered an intangible cost (Answer B is incorrect). Costs from fentanyl and transportation would be considered direct costs (Answers C and D are incorrect).
Q1 - Gold standard testing affects
- A- Internal Validity
- B- External Validity
- C- Construct Validity
- D- Statistical Validity
Answer: C- Construct Validity
Validity is assessed by accuracy
Reliability is assessed by precision
What is the definition of construct validity?
Construct validity is about how well a test measures the concept it was designed to evaluate. It’s one of four types of measurement validity, which includes construct validity, face validity, and criterion validity
A wealthy donor left your medium-sized institution $10 million to establish a clinic for one of three disorders (depression, obesity, and smoking).
You want to conduct a pharmacoeconomic study to inform the decision.
Which type of analysis would be best to use for this analysis?
- A. Cost-benefit.
- B. Cost-effectiveness.
- C. Cost-of-illness.
- D. Cost-utility.
Answer: A
- Because different outcomes are being evaluated, cost-effectiveness cannot be used (Answer B is incorrect).
- Cost-of-illness does not provide information on effective or efficient use of resources; therefore, it would be inappropriate (Answer C is incorrect).
- Although quality of life is a consideration for all three disorders, cost-utility studies are complicated and expensive, and an alternative analysis should be used, if possible (Answer D is incorrect).
- Because cost-benefit can be used to compare different types of outcomes and is relatively less expensive than cost-utility, Answer A is the best answer.
The local health system, consisting of the hospital and three physician practices, is conducting a cost-benefit analysis from the provider perspective on opening a dialysis center in a town where the nearest center is currently 75 miles away.
Which best depicts an opportunity cost to the health system?
- A. Opening of a new cancer center.
- B. Equipment for the dialysis center.
- C. Decreased transportation costs.
- D. Work hours gained.
Answer: A
- Opportunity costs are the ability to use resources for the next best use. Equipment for the dialysis center is part of the actual cost, whereas decreasing transportation costs is a reduction in direct nonmedical costs, and work hours gained is an economic outcome (Answers B–D are incorrect).
- The new cancer center is a foregone outcome (Answer A is correct). Opportunity costs = next best use = a foregone outcome
Satisfaction with health is a humanistic outcome. You have designed a new survey instrument designed to directly measure this construct. You are starting a new study using this instrument in a general population of older adults to identify norms within your state.
Which category of assessment would best categorize your research?
- A. Economic modeling.
- B. Outcomes research.
- C. Patient-reported outcomes.
- D. Pharmacoeconomic analysis.
Answer: C
- Satisfaction surveys are completed by the patient, so this project is categorized as patient-reported outcomes research (Answer C is correct).
- No mention of pharmaceuticals was made in the question, so the project is not pharmacoeconomic analysis (Answer D is incorrect).
- Because the project involves a survey that must be completed by individuals, modeling is not being done (Answer A is incorrect).
- Outcome research involves a comparison where measures of changes in patient outcomes are the end point and your project is not measuring change in satisfaction, just the level (Answer B is incorrect).
Patient-reported Outcomes
FDA Definition: "Any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else."
Methods: Collected via standardized tools: Questionnaires, Instruments, Surveys, Measures, Tests
A national group is conducting a study on the change in the cost of illness for a major disease after the first biological specialty drug had been on the market for 1 year.
Given the usual cost-of-illness study, which type of outcome study would be most applicable to the data?
- A. General outcomes research study.
- B. Cost-benefit analysis.
- C. Cost-utility analysis.
- D. Cost-effectiveness with patient-reported outcomes.
Answer: B
- Cost-of-illness analyses normally include direct medical costs and indirect costs.
- Health-related quality of life and utilities cannot be determined from these data points (Answers C and D are incorrect).
- Because the study is looking at a comparison of treatment with and without the new drug, a pharmacoeconomic analysis rather than a general outcomes study is the best approach (Answer A is incorrect).
- Because the data are most easily collected as dollars of cost and outcome, a cost-benefit analysis can be done (Answer B is correct)
Device pump error (it works automatically), thus the result is a dose error
A – FDA (MedWatch)
B - ISMP
Overview of Medical Device Reporting
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
Medication error (Error in dose)
A – Joint Commission
B - ISMP
A pharmacotherapist is asked to conduct research about the causality of certain drugs & defined adverse events. He depends on the FDA
A- FDA isn’t reliable; not all reports reach the FDA. He should depend on other extra resources
B – FDA is a reliable resource to depend on
Answer: B-FDA is a reliable resource to depend on FDA is one of the main drug information resources about adverse events of the drugs
Assessment of adverse event causality
A – Naranjo scale
B - FEMA
After a sentinel event
A – Root cause analysis
B – Open Discussion
FDA MedWatch data
A – Reliable and can be used directly
B – Unreliable as there are many limitations concerning it (the healthcare team aren’t required to prove causality before reporting)
What does the Health Insurance Portability and Accountability Act (HIPAA) protect against?
- The disclosure of health information without patient permission (13%)
- Health information that is held or electronically transmitted (1%)
- Both A and B (8.4%)
- None of the above (2%)
There are two parts of HIPAA:
- Standards for Privacy of Individually Identifiable Health Information (The Privacy Rule)
- National standards that regulate the use of disclosures of health information without patient permission
- Security Standards for the Protection of Electronic Protected Health Information (The Security Rule)
- Sets national regulations that protect health information that is held or electronically transmitted
A patient with nonvalvular atrial fibrillation is prescribed rivaroxaban for stroke prevention. The patient is later initiated on rifampin, which increases rivaroxaban hepatic metabolism through cytochrome P450 3A4 and induction of P-glycoprotein, causing a subtherapeutic serum concentration of rivaroxaban, which in turn causes the patient to develop a stroke. Which best describes this interaction?
A. Side effect
B. Adverse drug reaction (ADR)
C. Preventable adverse drug event (ADE)
D. ADE
A preventable ADE, by definition, is a medication error that occurs and reaches the patient to cause harm because of a breach of standard professional behavior or practice. The drug interaction between rivaroxaban and rifampin is a known interaction that is described in the prescribing information. This is a medication error, and the stroke is the harm (Answer C is correct). Although this case of rifampin/rivaroxaban drug interaction-induced stroke is an ADE, a preventable ADE best describes this case (Answer D is incorrect). In general, ADRs and side effects are synonymous, and a stroke resulting from a rifampin/rivaroxaban drug interaction is an ADR; however, a preventable ADE best describes this case (Answers A and B are incorrect).
In process indicator for anticoagulation clinic?
A- Time in Therapeutic Range (TTR)
B – Providing Evidence-based resources for appropriate warfarin dosage
C – Staff to patients ratio
Structure indicator for anticoagulation clinic?
A- Time in Therapeutic Range (TTR)
B – Providing Evidence-based resources for appropriate warfarin dosage
C – Staff to patients ratio
Outcome indicator for anticoagulation clinic?
A- Time in Therapeutic Range (TTR)
B – Providing Evidence-based resources for appropriate warfarin dosage
C – Staff to patients ratio
Study the appropriate time for next visit in anticoagulation clinic to check INR is
A - Structure indicator
B - In process indicator
C - Outcome indicator
The latest information about vaccine
A. CDC
B. WHO
C. FDA
D. NACQA
To know newly approved vaccines
A - FDA
B - CDC
C – WHO
D - AHRQ
Pharmaco-therapist calls the patient to tell him that his medications arrived but he didn’t answer. What will you do according to HIPAA?
A. Leave voice message through answer machine and freely mention private information
B. Leave voice message through answer machine but limit private information
C. HIPAA does not allow any voice message through answer machine
Outcome indicator for the use of warfarin in atrial fibrillation
A- Adherence to guidelines
B- Percent of specialists in healthcare facility
C- Percent of INR TTR (Time in Therapeutic Range)
Medical student wants to get access to patient file
A. HIPAA privacy rule prohibits medical students' access to patient files
B. HIPAA permits medical students to get access to patient files
Which act allows patients to use investigational drugs?
A- Obama Act
B- Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina (Right to Try Act)
In expanded access drug use, patient:
A- Must sign consent
B- No need for consent
Infusion pump error leads to death. To whom to report the death?
- A. FDA
- B. TJC
Off label use of a drug can be applied if:
- A. Not FDA approved but allowed for treatment according to IND.
- B. The drug can be submitted directly to the patient if his physician ordered it. (= direct shipping if the physician submitted it)
- C. Patients or his representative writes consent to take the drug.
- D. Ask the physician & see if the benefit outweighs the risk.
Non-punitive environment in reporting errors
- A- Just a culture
- B- Justice
- C- Beneficence
- C- Autonomy
What To Do If You Can't Find Your Records
It is safe to repeat vaccines.
Your parents bought you stock in a drug company when you were accepted into pharmacy school. The stock value has decreased over the last year, but it still exceeds $20,000. This company has just marketed a new drug, and as clinical manager it is your responsibility to present the drug to the pharmacy and therapeutics (P&T) committee for possible addition to the formulary. Do you have any ethical or legal responsibility to disclose your stock holding to the committee?
- A. Yes, because there is a Centers for Medicare & Medicaid Services requirement to disclose any material holdings exceeding $10,000.
- B. No, because the stock purchase was made by someone else without your knowledge.
- C. No, because you are not a voting member of the P & T committee
- D. Yes, because the stock holding could be perceived as a conflict of interest
Answer is D:
- The stock holding should be disclosed to the P&T committee because its value is substantial, and even the perception of conflict of interest could be a problem because of the possibility of bias in presenting information about the drug. However, there is no CMS requirement for disclosure. It is an ethical issue.
- The stock holding should be disclosed to the P&T committee because its value is substantial, and even the perception of conflict of interest could be a problem because of the possibility of bias in presenting information about the drug. The fact that the stock purchase was not made by you is not relevant because you now own it.
- The stock holding should be disclosed to the P&T committee because its value is substantial, and even the perception of conflict of interest could be a problem because of the possibility of bias in presenting information about the drug. The fact that you are not a voting member of the P&T committee is not relevant.
- The stock holding should be disclosed to the P&T committee because its value is substantial, and even the perception of conflict of interest could be a problem because of the possibility of bias in presenting information about the drug.
You have 15 vials of certain drug and your monthly rate is 30 vials per month. there are 250 vials only in the whole distributer store
- A. Ask the distributer to send you the all 250 vials
- B. Implement a protocol to use the 15 vials
- C. Wait until you dispense the total amount and ask any nearby pharmacy to give you
A 60-year-old man is regularly managed by a pharmacist directed lipid clinic. The patient has a time-consuming job and must travel frequently. He would like to receive his laboratory results by email.
- A. Email communication of protected health information is not acceptable in this situation.
- B. If the patient signs a consent form acknowledging the risk of potential breaches of privacy and confidentiality, email communication is acceptable.
- C. The patient can email the pharmacist, but HIPAA does not allow the pharmacist to email the patient because protected health information would be disclosed in that email.
- D. HIPAA requires that the provider set up a secure website for the patient to access any protected health information.
When give chemotherapy as curative and didn't give as palliative this is
- A. Beneficence
- B. Justice
- C. Maleficence
- D. Anonymous
When withdraw chemotherapy as palliative this is
- A. Beneficence
- B. Justice
- C. Non-Maleficence
- D. Anonymous
In research on niacin, we can't recruit patients with hyperuricemia or liver disease due to
- A. Beneficence
- B. Justice
- C. Autonomy
- D. Non-maleficence
To whom to report fatal medical device adverse events?
- MedWatch
- ISMP
You want to convince hospital by a new procedure of managing infections>>>answer
A. Decrease use of antibiotic (Stewardship)[Deescalation]
Interpretation of results is written in
- A-Discussion
- B-Results
- C-Methodology
- D-Introduction
Interpretation of the most important main result
- A. Methodology
- B. Conclusion
- C. Background
- D. Results
According to HIPAA, patient files should be kept in
Nurse stations (Cabinets)
Data from MedWatch isn't reliable?
- A. Because report is voluntary
- B. Because they are only medication errors
- C. Because report is mandatory
- D. Because report is only from patients
Pharmacotherapist wants to apply use of sterile compounding to respond to JC exigency. Which reference will help him?
- A. FDA
- B. USP 797
- C. Martindale
- D. Micromedex
Student takes a routine round with you, and sees a box of patients' files on the door outside the exam room. He asks you, is that not connected with HIPAA?
- A. yes, if de-identified
- B. no, should be kept inside exam room
- C. no, should be kept in nursing station, and patient room
- D. yes
Newly approved vaccines
A- Pink Book
B- Purple Book
C- FDA
D- Yellow Book
38- What is a sentinel event?
Surgery removes right breast instead of left breast.
IRB composed of:
a- Male nurse, female laboratory, male physician, female physician, male pharmacy technician.
b- Male priest, female physician, male pharmacist, female nurse.
c- Male nurse, male 3 physicians, male pharmacist.
d- Female lawyer, male physician, female nurse, male lab, female pharmacist, female state board representative.
To which of the following should a serious adverse drug event from a suspected counterfeit medication be reported?
A. National Medication Error Reporting Program
B. The Joint Commission
C. MedWatch
D. National Association of Boards of Pharmacy
- The Institute for Safe Medication Practices (ISMP) operates the National Medication Error Reporting Program. This confidential voluntary program provides expert analysis of system-based causes of medication errors. Examples include but are not limited to errors in the prescribing, transcribing, dispensing, administering, and monitoring of medications and vaccines; wrong drug, wrong strength, or wrong dose errors; wrong patient errors; confusion over lookalike sound-alike drugs or similar packaging; wrong route of administration errors; dose calculation or preparation errors; and misuse of medical equipment. ISMP does not have the authority to act on suspected counterfeit medications.
- Organizations accredited by The Joint Commission are required to report Sentinel Events, although not all serious adverse drug events are Sentinel Events. The Joint Commission does not have the authority to act on suspected counterfeit medications.
- MedWatch is the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. MedWatch solicits voluntary reports from healthcare professionals and consumers about serious adverse events, product quality problems, product use errors, and therapeutic inequivalence/failures associated with the use of FDA-approved drugs, biologics, medical devices, dietary supplements, or cosmetics. Serious adverse drug events from suspected counterfeit medical products should be reported to the FDA through MedWatch.
- The National Association of Boards of Pharmacy (NABP) accredits online pharmacies through their Verified Internet Pharmacy Practice Sites (VIPPS) program. However, NABP does not have the authority to act on suspected counterfeit medications.
Reporting side effects occurred to a patient should be:
A) Include patient name & telephone number so that FDA can contact these people for follow-up.
B) Patient names should not be included because it is protected information.
Which of the following is considered a sentinel event?
A. Giving the patient a wrong drug.
B. Hip replacement surgery on the right side instead of the left.
C. Patient fall that led to a bruised elbow.
D. Switching a mother's baby that was discovered at the last minute.
A diabetic patient who is non-adherent to his treatment visited your pharmacy today. In your trial to educate the patient, he said that he forgot his glasses. What is the appropriate action to do for him in his next visit?
1- Let him go for hospital’s advice.
2- Let him go to his primary care provider.
3- Give the patient more papers to read at home.
4- Let the patient read & interpret the instructions to evaluate literacy.
There were some prescription errors done by some best way the clinical pharmacist can use to inform them ?
- A- Open meeting/ seminar with all physicians
- B- Meeting / seminar with those who make this error
- C- Just keep notes of the mistakes
- D- Counsel the physicians to make eligible writing
A mother gave to her child double the prescribed dose:
- A- This should be considered a medication error anyway
- B- Not a medication error at all
- C-Medication Error if prescribed false
What is true regarding adverse event reporting of U.S.FDA-approved products to the MedWatch program?
- A. Reporting is voluntary.
- B. Minor adverse events should be reported.
- C. Serious adverse events caused by vaccine administration should be reported.
- D. No report should be filed if it is uncertain whether a medication directly caused an adverse event.
A Physician decided to open a pharmacy unit for diabetes for a 6 months pilot trial. Which data do you need to collect as outcome indicator
- A- A1C at 3 and 6 months
- B- Patient knowledge of diabetes and adherence to medication
- C- Diabetes mortality rate
According to the health insurance portability & accountability act 'HIPAA) which of the following items is considered protected health information (PHI)?
- A-De identified information
- B-Medical record number
- C-Age if under than 90 days
- D-State of residence
Which of the following is an example of a process indicator for a medication use evaluation?
- A- Detecting an adverse reaction to antibiotics.
- B- Ensuring proper timing and dosage of the antibiotics.
- C- Detecting a defervescence in a neutropenic patient receiving antibiotics.
- D- Determining the availability of adequately trained laboratory personnel to perform the culture and sensitivity.
With regard to treatment trials, the primary purpose of the informed consent process is to provide:
- A-Information regarding trial participation the treatment and the financial costs associated with
- B-Liability coverage for the institution and the participating investigators.
- C- A contract between the investigator and a person participating in the trial.
- D- Sufficient information for a potential subject to make a decision about participating in a trial.
An inspector for the FDA requests records from an IRB that contain confidential patient-specific information. The proper course of action by the IRB is to do which of the following?
- A- Grant the request, because the FDA inspector is a health professional and bound by the same ethical and legal considerations as the IRB
- B- Refuse the request, because the patients in a study of FDA-regulated products have a guaranteed right of confidentiality
- C- Refuse the request, because FDA regulations allow for the release of confidential patient-specific data only under extraordinary circumstances
- D- Grant the request, because the patient's legal right to privacy does not apply to FDA review of research records.
New policy for in patient service what is the most approach?
- A- Economic analysis from provider perspective
- B- Review JCI and policies
- C- Obtain approval budget from the Head office
- D- Approach key individuals nurse and doctor
Which would be the best quality measure for evaluating a transition of care service from the inpatient to the outpatient setting?
- A. The number of patients adherent to their medications 1 year after discharge.
- B. The number of patients who arrive at their outpatient follow-up visit after discharge.
- C. The number of patients who are knowledgeable about their medications 6 months after discharge.
- D. The number of patients who have a medication error during hospitalization out of the total number of patients admitted.
You are a pharmacotherapy specialist at your hospital and found many medications errors concerning heparin use from physician, what to do?
- A - Make weight based protocol
- B - Make Educational newsletters for low performance physicians
- C - Make Educational newsletters for all physicians
If a pharmacist evaluate a patient's's planned drug therapy before dispensing the medication this is considered a:
- A. Concomitant medication use evaluation
- B. Prospective medication use evaluation
- C. Retrospective medication use evaluation
- D. Prevention medication use evaluation
A researcher who took a table from an already published research and wrote it in handouts and refrenced it then he distributed it in a big conference. This describes?
- A. Publication Bias
- B. Plagiarism
- C. Copy right violation
- D. Academic Dishonesty
Patient with Penicillin allergy and ordered for penicillin while in ICU for his infection, he developed anaphylaxis, and patient expired, after informing all medical team about it , what is the first step to interpret what happened?
- A. RCA
- B. Tell JCI
- C. Tell FDA
- D. Tell ISMP
Accuracy of test results refers to
- A. Reliability
- B. Validity
- C. Responsiveness
What is true regarding expanded access protocol
A hospital information technology team is designing software for a new computerized physician order entry (CPOE) program at its institution. The team, which is receiving input from a variety of providers, wants an effective way to enforce the formulary within the program. Which strategy would be most useful for formulary management in the CPOE system for providers?
Secondary research (research based on previous research ) previously collected blood samples
- A – Expedited review
- B – Exempt Review
According to national patient safety goals (NPSG)
- A - Label the drug with name + birth date “2 Patient identifier”
- B – Keep drugs out of reach of nurses
Answer: A - Label the drug with name + birth date “2 Patient identifier”. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Which one is Medication error and should be reported to ISMP?
- A - Pharmacist forgets insulin vial out of refrigerator
- B – Nephrotoxicity after gentamicin
Medication error that should be reported to ISMP
- A - Pharmacist dispense 30 pills for patient, but prescription is ( 2 tablets daily for 30 days)
- B- Rash after carbamazepine
HIPAA is enforced by
- A – DHHS office of civil rights
- B – Joint Commission
- C – NAQA
- D - AHRQ
Employee satisfaction survey
If survey is published or shared with other organizations so , IRB is needed, If survey is research ...... Informed consent is required, If survey is Quality improvement ...... No need for informed consent
When there is conflict of interest related to certain IRB participant So, exclude from voting R&T committee conducts formulary update every
- A – 3 months
- B – 6 Months
- C - 1 year
Formulary update is every 1 year. Also, maybe every 6 months, 1 year, but if 1 year isn’t an option, select 6 months
Which of the following organizations considers HIPAA in its standards?
- A – NCOA
- B – ISMP
- C - TJC
Drug information resource that covers drugs and related substances reported to be of clinical interest anywhere of the world
- A – USP-NF
- B – Martindale
- C – Micromedex
- D- Up-To-Date
Action plan is a detailed plan outlining actions needed to reach one or more goals
During watching TV patients knows that certain drugs are recalled as they are class I recall
- A- Ask her to not use it as they have remote hazard
- B- Ask her not use them as they have reasonable hazard
- C-Tell her to use them as no hazard at all
Patient comes back to your pharmacy with blood glucose testing strips that FDA has recalled
- A- Return them and tell him they are dangerous as they are Class I Recall
- B- Return them and calm him down as they are Class III Recall and no dangerous from them
- C- Return them these strips are class II recall
Answer: A - Return them these strips are class I recall, “Due to the risk that the test strips may provide inaccurate blood sugar readings and potentially cause diabetes patients to suffer a serious injury or even death”
Class I recall
- A- Remote serious ADE
- B- Reasonable serious ADE
Answer: B- Reasonable serious ADE. "Reasonable possibility" "means there is evidence to suggest a causal relationship between the drug and the adverse event
Randomized clinical trials report should comply with :
- A. The Consolidated Standards of Reporting Trials (CONSORT)
- B. PRISMA
- C. MOOSE
Any submitted meta-analyses should follow
- A. Consort
- B. PRISMA
Physician wants to write case-report what to write
- A- Medication related problems only
- B- Problem only
- C- All lab tests & medication history & drug related problems
Osteoporosis case report what to write in the abstract
- A- The outcome and severity of the adverse effect
- B- History and patient medications + consent
P&T Committee Inform New drug protocol
- A- Email communication
- B- Newsletter email
PGY2 program accreditation
- A- ACPE
- B- ASHP
- C- JCI
- D- AHRQ
The main result of clinical trial is interpreted in
- A-Discussion
- B-Conclusion
- C-Methodology
- D-Results
To get recently published guidelines
- A- FDA
- B- (Guidelines.gov), Trip, NIH, Up-to-date
To assess effectiveness of Proton Pump Inhibitors Medication Use Evaluation
- A - Rate Of PPI Prescription (Increased Or Decreased)
- B – Improvement of healthcare team performance
Copyright is assigned to
- A – Author
- B - Publisher
The Reducing Prescription Drug Shortages Executive Order was signed by President Barack Obama on October 31, 2011
- A- Broaden the reporting of manufacturing discontinuances that may lead to shortages of drugs that are life supporting or life sustaining or that prevent debilitating disease to CMS
- B- Expedite regulatory reviews to avoid or mitigate existing or potential drug shortages. Reviews may include new drug suppliers, manufacturing sites, and manufacturing changes.
Answer is B- Expedite regulatory reviews to avoid or mitigate existing or potential drug shortages. Reviews may include new drug suppliers, manufacturing sites, and manufacturing changes.
A is wrong: A- Broaden the reporting of manufacturing discontinuances that may lead to shortages of drugs that are life supporting or life sustaining or that prevent debilitating disease to FDA not CMS
Outcome indicator for ICU protocol
- A-Increase Nurse satisfaction
- B-Decrease physicians work load
- C-Decrease patient duration on ventilator
Sildenafil DUE
- A- Drug is frequently used by population
- B-Has many ADE
- C- It is most effective in ED
- D- Due to formulary considerations
After medication error report to ISMP
- A – You should contact Med Watch
- B – You should contact manufacturer
- C – ISMP will contact FDA & manufacturer
Why adverse effects of a drug appear after marketing
- A- Company not mention all ADE
- B- Phase III is not enough to detect all adverse drug effects
The term 'underserved population' means the population of an area designated with a shortage of elder justice programs
- (i) areas or groups that are geographically isolated
- (ii) racial and ethnic minority populations
- (iii) because of special needs (such as language barriers, disabilities)
Post Use Date: Medium risk + freezing --- 45 Days
To whom to report Pulmonary embolism occurs to women on combined oral contraceptive
- A- MedWatch (FDA)
- B-JCI
- C-ISMP
Redundant publication
- A- Article published before
- B-Part of it published before in poster
- C-Part of it mentioned before
A pharmacist during his presentation shows table taken from another study with reference. This is considered
- A-Copy right violation
- B-Redundant publication
Informed consent contains
- A- Trial duration
- B- Hospital phone number to contact in case of problems
- C- Study fund
- D- Patient identification
Answer: Essential Elements of Informed Consent: Research description, Risks, Benefits, Alternatives, Confidentiality, Compensation, Contacts, Voluntary participation and withdrawal
For patient smoking cessation ( abstinence)
- A- Meet with single physician privately
- B- Group meeting with physicians
- C- Telephone service
After rhabdomyolysis due to statin and increased CK ... Statin is discontinued then CK decreases to normal level... Why we don’t need to report this event
- A- Because it is minor & common & resolved
- B- This event is previously reported to FDA
Pro-active tool against hazard
- A – Root Cause analysis
- B- Failure mode effect analysis
A patient who can’t remember his medication& wants the caregiver to help him so according to the reconciliation measurements what to do?
- A- Stop reconciliation at this time
- B- Let caregiver help patient
- C- Reconciliation must assess the patient
You are making reconciliation to a woman who usually forgets her medications. She is always telling you to ask her Husband. What should you do in this situation?
- A- Stop reconciliation
- B- Order her to tell you what she remembers
- C- Listen to her Husband
Old patient (who can’t speak) comes with his son. How to get consent
- A - Caregiver only
- B - Patient
Answer: B - Patient (To be not able to speak --- not prevent patient to give consent). The issue is his consciousness and cognitive ability
Hospital manager wants to know the quality gap from new guidelines to the hospital what piece of information would help him find that?
- A - Number of reduced death
- B - Applied protocols for HTN
- C - 3 years cost of HTN medications
- D - Published in highly trusted journals
IRB study about device for hypertension pharmacists will publish the result.
- A. Exempt review
- B. Expedited review
- C. Full review
Answer is B: Non-invasive diagnostic devices undergo expedited review
A Researcher wants to estimate accuracy and precision for a new blood pressure device. In order to compare the efficacy of the new device with the old device, he will take the blood pressure of group of people measured by the two devices now and 2 weeks later. The results will be announced in a conference? What type of IRB review for this study
- A. Investigational peer review .
- B. Exempt from review
- C. Full IRB review
- D. Expedited review
Which of the following is an example of assent
- A- 14 Y.O. boy wants to participate in a study about weight loss
- B- A mother of 3 Y.O. girl to participates in a study about new vaccine
The management of the integrity of the pharmaceutical supply chain is governed by which of the following?
- a. Food Drug and Cosmetic Act
- b. Hatch/Waxman Act
- c. Drug Quality Security Act
- d. Biologics Price and Competition and Innovation Act
Answer: C
- Choice A is incorrect because the Food, Drug and Cosmetic focuses primarily on drug efficacy/safety under the purview of FDA/public health services.
- Choice B is incorrect because this act established the pathway for an abbreviated new drug application for generic drugs.
- Choice C is correct because the Drug Quality Security Act requires the pharmaceutical supply chain to implement medication tracking/tracing, detection of suspicious products and enforces guidelines for wholesaler licensing/reporting.
- Choice D is incorrect because this legislation focused on creating a regulatory pathway for testing biosimilar products for biologics.
Which of the following could be considered a best practice to manage ongoing oncology drug shortages?
- A. Contracts with every commercial wholesaler
- B. Insource with compounding generic IV cytotoxic oncolytics.
- C. Organize a multidisciplinary team that meets regularly to manage drug shortages as they arise.
- D. Borrow stock from a larger cancer center for drugs on shortage
Answer: C
- Choice A is incorrect because contracting with every commercial wholesaler is impractical and will cause the organization to lose financial incentives for exclusivity purchasing.
- Choice B is incorrect because maintaining the infrastructure for compounding multiple IV cytotoxic chemotherapy drugs is beyond what an institutional compounding center can reasonably expect to manage.
- Choice C is correct because organizing a multidisciplinary team that has standing meetings to manage ongoing shortages and has decision making authority has been identified as a best practice by the ASHP Guidelines for manage drug product shortages.
- Choice D is incorrect because larger cancer center is attempting to manage the drug shortages with the same drugs as smaller institutions and are not likely to allow borrowing of their stock to outside institutions
Which of the following is most correct regarding the difference between the FDA approval process for generic drugs and biosimilars?
- a. The biosimilar pathway involves drugs with a wide range of molecular weights
- b. The endpoint for approval for generic drugs and biosimilars is +/-20% bioavailability
- c. Biosimilars are generated in the lab from reproducible steps of chemical synthesis
- d. Biosimilars must demonstrate similar safety, purity, and potency
Answer: D
- Choice D is correct because the FDA definition of a biosimilar states that a biosimilar product must show no difference in terms of safety, purity, and potency to the reference product.
- Choice A is incorrect because biosimilars are biologically based complex molecules that have a high molecular weight.
- Choice B is incorrect because the +/- 20% bioavailability only applies to generic drugs – biosimilars have additional pre-clinical and clinical data requirements to demonstrate being “highly similar”.
- Choice C is incorrect because biosimilars are generated from cell lines not from chemical synthesis in the lab.
Which of the following time points is recommended for follow-up by a pharmacist for patients starting a new oral oncolytic therapy?
- a. Prior to first refill
- b. At consistent 6-month intervals
- c. With first report of patient toxicity
- d. Within 7 to 14 days following starting the drug
Answer: D
- Choice D is correct because the HOPA best practices for oral oncolytic therapy and the ASCO/NCODA standards for medically integrated dispensing of oral oncolytics recommend 7 to 14 days and within 7 days of therapy initiation, respectively.
- Choice A, B, and C are incorrect because the HOPA best practices for oral oncolytic therapy and the ASCO/NCODA standards for medically integrated dispensing of oral oncolytics recommend 7 to 14 days and within 7 days of therapy initiation, respectively.
Which of the following is not addressed in the ASCO/ONS safety standards with relevance to oncology pharmacy practice?
- a. Guidelines for preparation and handling of hazardous drugs
- b. Adjudication of verbal orders for chemotherapy regimens
- c. Policy requirements for preparation of intrathecal chemotherapy
- d. Tracking of cumulative doses of chemotherapy drugs with significant end-organ toxicity
Answer: A
- Choice A is correct because the 2016 update of the ASCO/ONS safety standards does not address safe handling of hazardous drugs or engineering controls required to compound cytotoxic agents safely.
- Choice B is incorrect because Domain 3 states that no verbal orders for chemotherapy should be accepted except to hold or discontinue the orders.
- Choice C is incorrect because Domain 3 speaks to the requirement for a policy for preparation of intrathecal chemotherapy and assurance that vinca alkaloids will be prepared in an IV piggyback to avoid inadvertent intrathecal instillation.
- Choice D is incorrect because Domain 4 requires that cumulative dose of chemotherapy be tracked such that agents such as anthracyclines can be monitored for the risk of cardiac toxicity.
Which of the following is most correct regarding QOPI certification?
- a. On-site reviewers from ASCO will abstract chart data for compliance.
- b. Reported core measures are the sole criteria for QOPI certification.
- c. Core measures are required for each malignancy that has treatment guidelines written by National Comprehensive Cancer Network (NCCN)
- d. Institutions are required to undergo a site visit by ASCO to be surveyed on compliance with ASCO/ONS safety standards
Answer: D
- Choice D is correct because site visits are a required component for consideration of QOPI certification.
- Choice A is incorrect because institutional staff are required to do the data abstraction for core measures from patient charts, not ASCO staff.
- Choice B is incorrect because performance with core measures is only part of the criteria for QOPI certification. An on-site visit by an ASCO surveyor assessing practice compliance with ASCO/ONS safety standards also is an important determinant of certification.
- Choice C is incorrect because the number of diseases represented in the core measure reporting is limited to lung, prostate, breast, colon, and gynecologic oncology.
Which of the following is a new component of the CMS Enhancing Oncology Model (EOM)?
- a. Appropriateness of prescribing erythroid colony stimulating factors
- b. Percentage of patients that utilize the emergency room during cancer treatment.
- c. Number of patients that a practice enrolls in NCI-sponsored phase III clinical trials.
- d. Intentional reaching out to patients with health disparities
Answer: D
- Choice D is correct because the EOM will require providers to establish a health equity plan and report disparities data to CMS.
- Choice A is incorrect because the OCM is not focused on reviewing drug prescribed within a certain class of medications.
- Choice C is incorrect because OCM is focused more so on continuity of care issues and not whether patients are participating in a clinical trial.
- Choice B is incorrect because the OCM has set the number of visits to the emergency room during a specific treatment episode and the usage of the emergency department during the last 30 days of life as reportable quality metrics.
Which of the following best summarizes the requirements for maintaining a hazardous drug list per USP<800>?
- a. The institution can opt out of maintaining a HD list if they have a low volume of chemotherapy patients.
- b. The institution is required to prepare a HD list and update it annually.
- c. The HD list must mirror the NIOSH list exactly.
- d. Investigational agents are exempt from the institutional HD list
Answer: B
- Choice B is correct because USP<800> specifies the requirement for creating an institutional HD list and ensuring that it is updated at least annually.
- Choice A is incorrect because institutions are required to maintain a HD list regardless of their volume of chemotherapy dispensed.
- Choice C is incorrect because institutions are provided flexibility to deviate from the NIOSH list of hazardous drugs based on their own internal risk assessment of individual drugs as potential HDs.
- Choice D is incorrect because investigational agents should undergo a risk assessment to determine if they should be classified as an HD.
According to USP<800>, which of the following is most correct regarding PPE requirements?
- a. Double gloving is required only for compounding of HDs
- b. Laminate coated gowns are only required for administration of HDs
- c. Eye and face protection is required when working outside of a C-PEC or at eye level with HDs
- d. PPE that has not been subject of a spill event is not required to be disposed of as hazardous waste
Answer: C
- Choice A is incorrect because USP<800> requires use of double gloving for handling activities of HDs beyond compounding such as administration.
- Choice B is incorrect because laminate gowns are required for activities beyond administration such as dispensing.
- Choice C is correct because USP<800> requires eye and face protection only for specialized procedures that may induced splashing or risk of HDs infiltrating the eyes.
- Choice D is incorrect because all PPE must be discarded as hazardous waste following HD handling activities.
Which of the following FDA-approved agents can now be discarded as non-hazardous waste because of the Hazardous Waste Pharmaceuticals amendment to RCRA?
- a. Warfarin
- b. Cyclophosphamide
- c. Nicotine patches
- d. Melphalan
Answer: C
- Choice C is correct because the Hazardous Waste Pharmaceutical amendment to RCRA allows for FDA-approved nicotine replacement therapies such as patches and gum to be discarded as non-hazardous waste.
- Choice A is incorrect because warfarin is still listed as a U-listed hazardous waste drug per RCRA.
- Choice B is incorrect because cyclophosphamide is still listed as a U-listed hazardous waste drug per RCRA.
- Choice D is incorrect because melphalan is still listed as a U-listed hazardous waste drug per RCRA.
Which of the following is most correct about the practice settings in which USP<800> applies?
- a. Only applies in hospitals or cancer clinics that administer hazardous drugs
- b. Applies in every setting in which hazardous drugs are handled by healthcare personnel
- c. Applies in hospitals and ambulatory infusion clinics but not veterinary practices
- d. Only applies to licensed healthcare personnel in hospitals
Answer: B
- Choice B is correct because USP <800> requires handling hazardous drug per its standards regardless of practice setting.
- Choice A is incorrect because while USP<800> is enforceable in hospitals, it also enforceable in other non-hospital treatment settings such as physician-owned ambulatory infusion centers.
- Choice C is incorrect because USP <800> applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer HDs, including veterinary clinics.
- Choice D is incorrect because USP<800> also covers non-licensed personnel such as environmental services employees or home healthcare workers.
Which of the following characteristics is essential to qualify a drug as hazardous?
- a. Myelosuppression
- b. Genotoxicity
- c. Mucositis
- d. Immune-mediated hepatitis
Answer: B
- Choice B is correct because genotoxicity is one of the criteria listed by both ASHP and NIOSH are a characteristic of a hazardous drug.
- Choice A is incorrect because while myelosuppression is considered a dose-limiting toxicity with antineoplastic drugs, it is not a specified criterion for classifying a drug as hazardous.
- Choice C is incorrect because mucositis is a well-documented toxicity with classic cytotoxic chemotherapy drugs, but it is not a criterion used by ASHP or NIOSH to classify a drug as hazardous.
- Choice D is incorrect because immune-mediated hepatitis is likely to be secondary to an upregulation of the immune system as is the case with immune checkpoint inhibitors and not a direct cytotoxic effect of a drug.
Which is the most appropriate setting for admixing HD compounded sterile products (CSPs)?
- a. BSC (biologic safety cabinet) in a positive pressure room
- b. BSC in a negative pressure room
- c. LAFW (laminar air flow workbench) in a positive pressure room
- d. LAFW in a negative pressure room
Answer: B
- Choice B is correct because USP<800> defines the requirement for HD CSPs to be prepared in a BSC externally vented in a negative pressure environment.
- Choice A is incorrect because HD CSP must never be conducted in a positive pressure environment.
- Choice C is incorrect because a LAFW is never appropriate for compounding HD CSPs nor is a positive pressure environment.
- Choice D is incorrect because a LAFW is never appropriate for compounding HD CSPs.
According to USP<800>, which of the following PPE is required when compounding all sterile HDs?
- a. Two pair of chemotherapy gloves
- b. Face shield
- c. N-95 respirator
- d. Isolation gowns
Answer: A
- Choice A is correct because USP<800> requires double-gloving with the outer glove being sterile during all sterile compounding activities.
- Choice B is incorrect because a face shield is only required when there is a risk for spills or splashes or when an individual is working outside of a hood.
- Choice C is incorrect because an N95 respirator is only required attending to a chemotherapy spill, cleaning beneath the work surface of a C-PEC or where there is known or suspected airborne exposure to HD vapors.
- Choice D is incorrect because isolation gowns and/or surgical scrubs do not provide adequate protection against spillage of HDs.
The ASCO standards for safe handling of hazardous drugs call for more research to inform a recommended practice standard in which of the following areas?
- a. The need for negative pressure rooms when compounding hazardous drugs
- b. Use of double-gloving with an outer sterile gloves when compounding sterile hazardous drug products
- c. Generation of an institutional hazardous drug list
- d. Use of closed-system transfer devices
Answer: D
- Choice D is correct because ASCO states in the guidelines that a certified standard is needed to gauge the effectiveness of the commercially available CSTDs.
- Choice A is incorrect because negative pressurization is required by USP<800> and ASCO states that in their guidelines that unless otherwise stated that they endorse the USP<800> standards.
- Choice B is incorrect because double-gloving when handling HDs is required by USP<800> and ASCO states that in their guidelines that unless otherwise stated that they endorse the USP<800> standards.
- Choice C is incorrect because creation of an institutional HDs list is required by USP<800> and ASCO states that in their guidelines that unless otherwise stated that they endorse the USP<800> standards.
Which of the following is most correct regarding core measures assessed by QOPI?
- a. On-site reviewers from ASCO will abstract chart data for compliance
- b. Reported core measures are the sole criteria for QOPI certification
- c. Core measures are required for each malignancy that has treatment guidelines written by National Comprehensive Cancer Network (NCCN)
- d. Institutions are required to self-report compliance with core measures to ASCO ahead of an on-site visit
Answer: D
- Choice D is correct because institutions are required to collate data from select patient chart on compliance with QOPI core measures and submit to ASCO for review prior to an on-site certification visit.
- Choice A is incorrect because institutional staff are required to do the data abstraction for core measures from patient charts, not ASCO staff.
- Choice B is incorrect because performance with core measures is only part of the criteria for QOPI certification. An on-site visit by an ASCO surveyor assessing practice compliance with ASCO/ONS safety standards also is an important determinant of certification.
- Choice C is incorrect because the number of diseases represented in the core measure reporting is limited to lung, prostate, breast, colon and gynecologic oncology.
Which of the following are quality metrics that oncology practices, participating in the Center for Medicare and Medicaid Services (CMS) Oncology Care Model, are required to submit to CMS?
- a. Appropriateness of prescribing erythroid colony stimulating factors
- b. Percentage of patients that utilize the emergency room during cancer treatment
- c. Number of patients that a practice enrolls in NCI-sponsored Phase III clinical trials
- d. Patient compliance with oral oncolytic therapy
Answer: B
- Choice B is correct because the OCM has set the number of visits to the emergency room during a specific treatment episode and the usage of the emergency department during the last 30 days of life as reportable quality metrics.
- Choice A is incorrect because the OCM is not focused on reviewing drug prescribed within a certain class of medications.
- Choice C is incorrect because OCM is focused more so on continuity of care issues and not whether patients are participating in a clinical trial.
- Choice D is incorrect because OCM is not focusing on specifics of drug therapy such as adherence.
Which of the following characteristics of clinical pathways is being advocated by national professional oncology societies?
- a. Oncology pathways should include issues beyond drug treatment regimens such as survivorship and end-of-life care
- b. Pathway compliance should approximate 100% with well-written pathways
- c. Commercial entities such as drug wholesalers should not draft/support oncology clinical pathways
- d. Diversity and variation in application of commercially pathways supports physician autonomy in therapeutic decision making
Answer: A
- Choice A is correct because ASCO has advocated that clinical pathways provide guidance to medical oncologists beyond drug prescribing such as recommendations for end-of-life care, survivorship, surgical intervention and radiation therapy.
- Choice B is incorrect because ASCO and pathway developers both acknowledge that compliance with clinical pathways reaching 70 to 80% is a best case scenario given patient-specific factors such as end-organ function and performance status.
- Choice C is incorrect because most of the commercially available pathways are written by corporate entities such as drug wholesalers (e.g. Cardinal, McKesson) and large publication houses (e.g. Elsevier).
- Choice D is incorrect because ASCO is advocating for a more uniform approach to pathway development and application, not divergent.
Which of the following characteristics is most reflective of a drug that would be dispensed by a specialty pharmacy?
- a. Drugs with multiple CYP450 mediated drug interactions
- b. Agents with a high likelihood of profound myelosuppression
- c. Any oral agent approved for the treatment of cancer
- d. Agents with specific handling, storage and delivery requirements
Answer: D
- Choice D is correct because specialty pharmacies provide intensive education to patients up front about not only the proper use and toxicity of a drug but also any unique handling/storage issues. In many instances, the specialty pharmacy coordinates the delivery of the drug to the patient’s home and manages any logistical issues related to shipping (e.g. refrigeration).
- Choice A is incorrect because many drugs have multiple drug-drug interactions that are mediated by CYP450 isoenzymes that are not managed as specialty medications such as azole antifungals, macrolide antibiotics and calcium channel blockers.
- Choice B is incorrect because designation of a drug is not predicated on the presence of a specific toxicity such as myelosuppression.
- Choice C is incorrect because there are a number of FDA approved anticancer agents that are not considered specialty medications such as hormonal therapy for breast and prostate cancer and older classic cytotoxic drugs such as cyclophosphamide and methotrexate.
Which of the following is most correct about the standards set forth in USP<800>?
- a. The term “must” indicates a requirement and “should” indicates a recommendation
- b. Only applies in hospital settings
- c. Outlines requirements for medical surveillance for health care workers handling hazardous drugs for the first time
- d. Recommendations mirror those in USP<797>
Answer: A
- Choice A is correct because the nomenclature consistently utilized by USP <800> for requirements is “must” and for recommendations is “should”.
- Choice B is incorrect because while USP<800> is enforceable in hospitals, it also enforceable in other non-hospital treatment settings such as physician-owned ambulatory infusion centers.
- Choice C is incorrect because USP <800> outlines recommendations for surveillance for healthcare professionals handling hazardous drugs but the recommendations are not requirements.
- Choice D is incorrect because the standards set forth in USP<800> have been removed from the updated USP<797> chapter.
According to USP<800>, which of the following is a requirement for nursing administration of HDs?
a. Use of a closed-system transfer device when the dosage form allows
b. A dedicated mortar and pestle for crushing HD oral dosage forms
c. N-95 respirator
d. Specialized IV tubing to allow for priming with HD solution
Which of the following is not addressed in the ASCO/ONS safety standards with relevance to oncology pharmacy practice?
a. Guidelines for preparation and handling of hazardous drugs
b. Adjudication of verbal orders for chemotherapy regimens
c. Policy requirements for preparation of intrathecal chemotherapy
d. Tracking of cumulative doses of chemotherapy drugs with significant end-organ toxicity
Under 340B, which of the following is considered a 'covered entity? (Select all that apply)
A) Rural hospitals
B) Cancer research centers
C) Children's hospitals
D) Teaching hospitals
Which of the following is not correct regarding cytotoxic drugs
handling ?
A. Negative pressure room is a must
B. When preparing,You must wear Two pairs of chemotherapy
resistant gloves
C. Surgical masks is enough when you handle spills
D. Administration of IV drugs requires CSTD
Which of the following is a group 1 NIOSH list drug?
A. Fluconazole
B. Tacrolimus
C. Azathioprine
D. Pertuzumab
Which of the following cabinet can be used in
preparing chemotherapy drugs?
A. Laminar Airflow Work Bench
B. Containment Aseptic Isolator
C. BSC class II type A1
D. Containment Aseptic Containment Isolator
Which of the following does not follow RCRA
requirements and is not considered hazard
waste(choose 2)?
A. Nicotine in gums
B. Expired Oxaliplatin vial
C. Nicotine in vapes
D.IND after study end
E.warfarin
Which of the following is under domain 3 of ASCO/ONS safety
standards ?
A. BLS certified person during administration
B. Verbal and written patient informations
C. Follow up of Cumulative chemotherapy dose toxicity
D. Out of standard regimens should be signed by another practitione