HYMR General Drug Information Flashcards
A hospital committee has been reviewing two proposals for patient care services for which it will fund only one of them. The first service would be a smoking cessation program that provides smoking cessation counseling along with bupropion for 14 days. The second service is an anticoagulation program that uses low molecular weight heparin and warfarin for the management of DVT. Costs of program determined from an institutional point of view with limited resources. What type of pharmacoeconomic analysis is this hospital committee performing or using to make its decision?
A. Cost-benefit analysis
B. Cost-effectiveness analysis
C. Cost-minimization analysis
D. Cost-utility analysis
A. Cost-benefit analysis
- Cost-benefit analysis is the best answer choice
- Cost-benefit analysis occurs when a hospital or healthcare group with use of limited resources and ability to only fund one of the programs, even though both would be good for patient care.
Summary of Method and Outcome Unit
A P&T Committee is reviewing the addition of a new drug (A) compared to a standard drug (B) also in the same drug class of antihypertensive medications. The new drug A can lower the blood pressure (BP) by 10 mmHg and can be given once a day, but costs three times as much as the current therapy. Drug B can lower the BP by only by 7 mmHg of pressure and is taken twice a day, but is much cheaper. Which type of pharmacoeconomic analysis would be best to use to determine which of the drugs should go on the formulary?
A. Cost-minimization analysis
B. Cost-effectiveness analysis
C. Cost-impairment analysis
D. Cost-avoidance analysis
B. Cost-effectiveness analysis
- When two interventions have known differences in efficacy or effectiveness, then a cost- effectiveness analysis should be down. This is different from a cost-minimization
analysis where the two interventions are the same and you just pick the cheapest intervention.
A prospective, randomized clinical trial is being conducted comparing two-treatment regimens the impact on quality adjusted life years (QALY). The first group is to receive bupropion 150 mg twice daily for 14 days and the second group is to receive nicotine patches once daily for 14 days. The costs associated with the study are being determined from a societal point of view. What type of pharmacoeconomic analysis best represents what is being done?
A. Cost-benefit analysis
B. Cost-effectiveness analysis
C. Cost-minimization analysis
D. Cost-utility analysis
D. Cost-utility analysis
- This best describes a cost-utility analysis (CUA).
- CUA questions usually mention something related to “quality adjusted life years”.
- It would be important to be basically familiar with the chart below for board exams.
All of the following are true about MedWatch, the FDA Safety Information and Adverse Event Reporting Program, EXCEPT:
A. MedWatch receives adverse event reports from health care professionals and
consumers
B. MedWatch was designed to overcome the lack of voluntary reporting by the medical community
C. MedWatch forms can be submitted online, through the mail, or in person
D. MedWatch collects data on adverse events that are fatal, life-threatening, as well as teratogenic
C. MedWatch forms can be submitted online, through the mail, or in person
- MedWatch forms cannot be submitted in person, but can be submitted, online, through the mail, or by fax.
A P&T Committee is reviewing the addition of a new antihypertensive drug (A) compared to a standard antihypertensive drug (B). Drug A is in the same drug class as drug B, can lower the blood pressure (BP) by 10 mmHg, and can be given once a day by mouth, but costs three times as much as the current therapy. Drug B can lower the BP by only by 7 mmHg of pressure and is taken twice a day, but is much cheaper. When 2 treatment options of similar type may offer different efficacy, what type of pharmacoeconomic analysis would be best to use?
A. Cost-minimization analysis
B. Cost-effectiveness analysis
C. Cost-impairment analysis
D. Cost-avoidance analysis
B. Cost-effectiveness analysis
- This is a common analysis for this type of case.
- The key words in a case will be the comparison of two “similar medications” that have slight differences in efficacy”.
- As a clinician working in a place with limited resources, you want to balance the treatment with efficacy, cost, and the likelihood that the patient will be adherent to the medication.
Which of the following pieces of legislation created an abbreviated pathway for approval of biosimilar products?
A. Patient Protection and Affordable Care Act of 2010
B. The HITECH Act of 2009
C. FDA Safety and Innovation Act of 2012
D. FDA Modernization Act of 1997
A. Patient Protection and Affordable Care Act of 2010
- The Affordable Care Act (ACA) includes the Biologics Price Competition and Innovation Act (BCPI), which created an abbreviated pathway for approval of biosimilars.
- The HITECH Act of 2009 focused on the development of secure and interoperable electronic medical records, including incentive payments for meeting meaningful use criteria.
The FDA Safety and Innovation Act created a mechanism to assess fees for submissions related to biosimilars.
The FDA Modernization Act helped streamline data collection regarding clinical trials and created the ClinicalTrials.gov website.
High-Yield Core Concept:
The BCPI is analogous to the Hatch-Watchman Act, which established regular abbreviated drug approval pathways in 1984. Since the act was approved, biosimilars such as InflectraR (infliximab biosimilar) and Granix® (pegfilgrastim biosimilar) have come to market.
What type of pharmacoeconomic analysis has the assumption that each medication within a particular drug class have the same/equivalent clinical outcomes or endpoints?
A. Cost-benefit analysis
B. Cost-effectiveness analysis
C. Cost-utility analysis
D. Cost-minimization analysis
D. Cost-minimization analysis
- This is the easiest one to recognize.
- Anytime there is evidence or they tell you the two medications being considered are clinically equal it is cost-minimization (ie., generally pick the cheapest of the two because they have the same efficacy).
- Cost-minimization analysis occurs when choosing the cheapest option among
medications with the same indications/uses and without any known relevant differences
in efficacy.
Main responsibilities for a Pharmacy & Therapeutics Committee include ___________
A. Preventing and monitoring medication errors as well as adverse reactions
B. Overseeing and evaluating use of investigational drugs
C. Disseminating to health care professionals and the local community information about institutional drug use
D. Planning and conducting medication use reviews for the institution
A. Preventing and monitoring medication errors as well as adverse reactions
- In addition to establishing and maintaining an institution’s formulary system, the P&T Committee also prevents and monitors adverse drug reactions and medication errors. While some P&T Committees delegate this duty to a subcommittee, it is still the responsibility of the P&T Committee to ensure safe medication use.
- P&T Committees may play a secondary role in supervising investigational drug use, but it is not one of the main responsibilities of the Committee.
- P&T Committees are required to distribute drug use information to health care professionals in the institution, but are not required to communicate this information to the community.
- P&T Committees evaluate medication use reviews but conducting the actual review is usually delegated to an individual member, pharmacy resident, or subcommittee.
An anesthesiologist requests that intravenous ibuprofen (Caldolor) be approved for use in a teaching hospital. It is decided that intravenous ibuprofen will be approved for use by the anesthesiologists in the teaching hospital. This is an example of a _______
A. An open formulary medication
B. A closed formulary medication
C. A non-formulary medication
D. A restricted formulary medication
D. A restricted formulary medication
- A formulary, or preferred drug list, is a continually updated list of medications selected based on the clinical judgment of health care staff to diagnose and/or treat disease and indorse health.
- An open formulary has no limits to medication access, while a closed formulary represents a list of medications that limits practitioner access to some medications. A nonformulary medication is a medication that is not included on the formulary list.
- A restricted formulary medication is one that is part of a closed formulary system and is restricted to specific physician groups, patient care areas or disease states.
It is prudent for health care providers to monitor adverse drug events during the post-marketing period because:
A. Trials conducted prior to marketing do not collect data on adverse events
B. Trials conducted prior to marketing do not contain enough patients to detect rare, serious adverse events
C. It is required by the manufacturer
D. It is the only way to identify adverse events for newly marketed drugs
B. Trials conducted prior to marketing do not contain enough patients to detect rare, serious adverse events
- Adverse events are required to be reported by the manufacturer to the FDA.
- The number of patients enrolled in clinical trials prior to drug approval is much smaller than the number of patients who actually use the medication once approved by the FDA.
- Consequently, while adverse events are monitored in drug clinical trials prior to approval, rare adverse events may occur in only every 1 in 10,000 or 1 in 100,000 patients and may not be observed in trials conducted prior to marketing.
High-Yield Core Concept:
* The FDA utilizes postmarketing surveillance and risk assessment programs to help identify adverse events that did not appear during the drug approval process via
the FDA Adverse Event Reporting System (FAERS). is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
What type of pharmacoeconomic analysis has a focus to incorporate humanistic (for example quality adjust life years (QALY’s)) concerns in its decision?
A. Cost-benefit analysis
B. Cost-utility analysis
C. Cost-minimization analysis
D. Cost-effectiveness analysis
B. Cost-utility analysis
- This best describes a cost-utility analysis (CUA).
- CUA questions usually mention something related to “quality adjusted life years”.
Which of the following publishing criteria or guidelines should be used when an author is writing up a randomized, controlled trial to submit to a journal?
A. CONSORT
B. PRISMA
C. STARD
D. STROBE
A. CONSORT
All of the following are true about a medication use review (MUR) process except:
A. The focus of MURS is typically on outliers whose medication practices exceed the norm or typical usage patterns for drug therapy
B. Criteria that describe acceptable use patterns of target medications/medication classes are created for the MUR process and approved by the health system organization, and the way in which the medications are actually used are compared to these criteria
C. MURS are conducted prospectively, not retrospectively, to aid health care systems in improving safe medication prescribing and administration practices
D. Cost-savings initiatives cannot be the sole motivation behind conducting an MUR
C. MURS are conducted prospectively, not retrospectively, to aid health care systems in improving safe medication prescribing and administration practices
Although prospective MURS may be preferred, MURS may also be conducted retrospectively to assist health care organizations in improving medication outcomes for future patients/future patient experiences.
An attending physician desires to have a new multiple sclerosis drug, teriflunomide, for regular use in the hospital with which he/she is affiliated. Which of the following scenarios is the best way for the physician to gain access to this medication?
A. Request the medication as a non-formulary item
B. Present a written request with evidence for effectiveness to the hospital pharmacy director
C. Present a written request with clinical experiences regarding the medication to hospital administrators
D. Present a written request with evidence for effectiveness to the P&T Committee
D. Present a written request with evidence for effectiveness to the P&T Committee
- The best scenario in this situation would be for the physician to submit a request for formulary addition to the P&T Committee, providing data supporting the safety and efficacy of teriflunomide in multiple sclerosis.
Continued use as a non-formulary item could be frustrating for the physician as well as more expensive for the institution, as a request would be necessary each time the physician desired to use the medication. - Neither the hospital pharmacy director nor the hospital administrators can give authority for the physician to have routine access to the medication; these requests must be submitted to the P&T Committee for review and consideration by health care
professionals, including physicians.
A Pharmacy & Therapeutics (P&T) Committee is comprised of which of the following individuals?
A. Physicians only
B. Physicians and pharmacists
C. Physicians, pharmacists, and members from other hospital areas
D. Physicians, pharmacists, and members from the community
C. Physicians, pharmacists, and members from other hospital areas
- P&T Committee membership was originally limited to physicians and pharmacists, but now has expanded to include physicians, pharmacists, nurses, administrators, risk and quality improvement managers, and other health care professionals as deemed appropriate.
- P&T Committees have predominantly been a component of institutional pharmacy, they are now also seen in managed care organizations, insurance companies and ambulatory clinics.
High-Yield Core Concept:
A P&T Committee is made up of not only physicians and pharmacists, but other health care professionals for the purpose of evaluating medications for inclusion on formularies as well as develop medication management strategies to ensure appropriate use of medications for the patients being served.
