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ELM > Regulatory Complicance > Flashcards

Regulatory Complicance Flashcards

1
Q

Describe the FDA Amendments Act (2007)

A

-reauthorized Prescription Drug User Fee Act (PDUFA)
-authority to require Risk Evaluation and Mitigation Strategies (REMS)
-expanded clinical trials to the pediatric population
-expanded the authority to charge fees for approving drugs
-limited FDA advisory members with conflicts of interest

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2
Q

What does ARRA (2009) stand for?

A

American Recovery and Reinvestment Act

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3
Q

Describe the ARRA (2009)

A

American Recovery and Reinvestment Act
-aka the Health Information Technology for Economic and Clinical Health (HITECH) Act
-“meaningful use” of electronic health records

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4
Q

What does ACA (2010) stand for?

A

Patient Protection and Affordable Care Act

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5
Q

Describe the ACA (2010)

A

-improved pharmacists ability to complete MTM serves
-Physician Payments Sunshine Act

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6
Q

Describe the Safe & Secure Drug Disposal Act (2010)

A

-DEA
-amended the Controlled Substances Act
-rules for patients and long term care facility disposal of unused controlled substances
-allows transfer of unused substances from user to authorized collector
-voluntary drug take-back events

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7
Q

Describe the Reducing Prescription Drug Shortages Executive Order (2011)

A

-requires FDA to broaden reporting of possible drug shortages
-expedite revies to avoid existing/potential shortages
-communicate evidence of stockpiling or exorbitant prices to DOJ

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8
Q

Describe the FDA Safety & Innovation Act (2012)

A

-reauthorizes PDUFA
-amends the Federal Food, Drug, & Cosmetic (FD&C) Act from prescriptions and devices to also include generics, biosimilars, etc.
-address drug shortages (must notify DHHS at least 6 months prior)
-hospitals may repackage drugs to distribute within the health system

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9
Q

What does DQSA (2013) stand for?

A

Drug Quality & Security Act

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10
Q

Describe the DQSA (2013)

A

-contains Drug Supply Change Security Act
-adds new section to FD&C
-product tracing requirements

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11
Q

What is the DHHS?

A

Department of Health and Human Services

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12
Q

What is the FDA?

A

Food and Drug Administration
-federal agency
-approves new drugs to be sold in the united states
-processes new drug applications
-regulates product inserts
-regulates advertising of drugs
-issues recalls

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13
Q

What does AHRQ stand for?

A

Agency for Healthcare Research and Quality

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14
Q

What is the AHRQ?

A

Agency for Healthcare Research and Quality
-establish to produce evidence to make healthcare safer, high quality, more accessible, equitable, and affordable
-works with the US Department of Health and Human Services (HHS) and other partners
-created the Consumer Assessment of Healthcare Providers and Systems (CAHPS)
-health services research arm of the United States
-established guidelines.gov (National Guidelines Clearinghouse)

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15
Q

What does NCQA stand for?

A

National Committee for Quality Assurance

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16
Q

What is the NCQA?

A

National Committee for Quality Assurance
-seal of approval = exceptional management, high-quality care, and service
-meet more than 60 standards, over 40 areas
-primary agency for accrediting Managed Care Organizations
-audits health plan data; provides metrics to employers
-Healthcare Effectiveness Data and Information Set (HEDIS) measures used by > 90% of plans

17
Q

What does TJC stand for?

A

The Joint Commission

18
Q

What is the TJC?

A

The Joint Commission
-formally known as JCAHO
-a nonprofit organization founded by American Medical Association and American College of Surgeons
-a detailed survey and visit mostly process-oriented, but increasingly outcomes-based review
-failure to receive accreditation could jeopardize funding from federal agencies like CMS
-requires tracking of performance improvement data

19
Q

What is the Medication Management (MM) Standards of TJC?

A

-1/17 chapters in the Hospital Standards
-21 medication-related standards
-addresses: high-alert medications, look-alike-sound-alike medications, Antimicrobial Stewardship Program, sentinel events

20
Q

What is Antimicrobials Stewardship?

A

-implement services to ensure appropriate antibiotic use
-targeted interventions throughout all phases of healthcare
-educate as to when antibiotics are not needed
-goal= control costs, improve clinical outcomes, combat resistance

21
Q

What is the NPSG?

A

National Patient Safety Goals
-purpose: “to improve patient safety”
-focus on problems in healthcare safety and how to solve them

22
Q

What is a Sentinel Event?

A

a patient safety event that is not related to the natural course of the patient’s illness or underlying condition that results in death, permanent harm

23
Q

Are hospitals required to report Sentinel Events to the TJC?

A

no, but is encouraged! BUT must report in 45 days if TJC in 45 days

24
Q

What does CMS stand for?

A

Centers for Medicare and Medicaid Services

25
Q

What is the CMS?

A

Center for Medicaid and Medicare Services
-star rating system to measure how well Medicare Advantage and Part D plans preform
-establish conditions for a facility to be reimbursed for services rendered for beneficiaries
-recognizes accreditation by TJC as an acceptable alternative to conducting its own accreditation surveys

26
Q

What are the Boards of Pharmacy

A

-National Association of Boards of Pharmacy (NABP) oversight
-oversee the practice of pharmacy in each state
-define the regulations affecting roles, duties, and expectations
-has the power to impose sanctions on and discipline: pharmacies, pharmacists, technicians, students

27
Q

What is CQI?

A

continuous quality improvement (CQI) is the systematic process of identifying, describing, and analyzing strengths and problems and then testing, implementing, learning from, and revising solutions

28
Q

Why do we use CQI?

A

-improves efficiency
-more satisfied employees
-greater customer service satisfaction and loyalty
-lower costs
-higher profits
-new reimbursement opportunities
increased acknowledgement from health care plans

29
Q

What is the model for improvement PDSA?

A

Plan, Act, Study, Do

30
Q

What is the purpose of quality measures?

A

-mechanism to: help quantify the quality of care provided and evaluate the performance of health systems and providers
-goal: improving health care quality
-useful in pay-for-performance and value-based purchasing reimbursement programs

31
Q

How is quality measured?

A

-structure (raw production materials needed)
-process (method or procedure used)
-outcomes (Economic Clinical Humanistic Outcomes (ECHO) Model)
-patient experience

32
Q

What is the URAC?

A

Utilization Review Accreditation Commission
-established independently of other stakeholders
-consumers, providers, employers, regulators
-accreditation, education, and measurement
-it is imperative to help consumers make informed choices of health plans
-quality measures

33
Q

What does NQF stand for?

A

National Quality Forum

34
Q

What is the NQF?

A

National Quality Forum
-non-profit
-coalition of public and private sector leaders
-voluntary consensus standards setting organization
-“gold standard” for healthcare performance measures
-aims to define national goals, build a consensus around those goals, and standardize performance metrics and reporting

35
Q

What does PQA stand for?

A

Pharmacy Quality Alliance

36
Q

What is the PQA?

A

Pharmacy Quality Alliance
-non-profit, multi-stakeholder organization
-develops medication-uses measures (medication safety, adherence, appropriateness)
-utilized in pharmacies, health plans, physician offices, part D plans, accreditation programs

37
Q

What is the ISMP?

A

Institute for Safe Medication Practices
-nonprofit entirely dedicated to medication safety/error prevention
-promotes research, creation, awareness, and adoption of safe medication practices
-create medication safety tools

ELM (5 decks)

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