Regulatory Complicance Flashcards
Describe the FDA Amendments Act (2007)
-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
What does ARRA (2009) stand for?
American Recovery and Reinvestment Act
Describe the ARRA (2009)
American Recovery and Reinvestment Act
-aka the Health Information Technology for Economic and Clinical Health (HITECH) Act
-“meaningful use” of electronic health records
What does ACA (2010) stand for?
Patient Protection and Affordable Care Act
Describe the ACA (2010)
-improved pharmacists ability to complete MTM serves
-Physician Payments Sunshine Act
Describe the Safe & Secure Drug Disposal Act (2010)
-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
Describe the Reducing Prescription Drug Shortages Executive Order (2011)
-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
Describe the FDA Safety & Innovation Act (2012)
-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
What does DQSA (2013) stand for?
Drug Quality & Security Act
Describe the DQSA (2013)
-contains Drug Supply Change Security Act
-adds new section to FD&C
-product tracing requirements
What is the DHHS?
Department of Health and Human Services
What is the FDA?
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
What does AHRQ stand for?
Agency for Healthcare Research and Quality
What is the AHRQ?
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)
What does NCQA stand for?
National Committee for Quality Assurance
What is the NCQA?
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
What does TJC stand for?
The Joint Commission
What is the TJC?
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
What is the Medication Management (MM) Standards of TJC?
-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
What is Antimicrobials Stewardship?
-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
What is the NPSG?
National Patient Safety Goals
-purpose: “to improve patient safety”
-focus on problems in healthcare safety and how to solve them
What is a Sentinel Event?
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
Are hospitals required to report Sentinel Events to the TJC?
no, but is encouraged! BUT must report in 45 days if TJC in 45 days
What does CMS stand for?
Centers for Medicare and Medicaid Services
