Policy, Practice, & Regulatory Issues Flashcards
Authorization bills
grant authority for a program or agency to exist. Must be in place before funding decisions are made.
Appropriation
sum of money designated for a particular purpose by an act or bill
Entitlement spending
for programs like Medicare, Medicaid, and Social Security are automatically set based on eligible recipients. Levels of spending can only be changed by eligibility criteria changes.
Discretionary spending
represents annual spending levels determined by Congress; spending is optional.
Continuing resolution
continues funding for a program if the congressional fiscal year, ending Sept 30, ends without a new appropriation in place
Health information technology for economic and clinical health (HITECH) act
authorized US DHHS to create programs to improve health care quality, safety, and efficiency through the promotion of HIT, including EHRs
The Standards and Certification Criteria Final Rule
initial approach to adopting standards, implementing specifications, and providing certification criteria to enhance the interoperability, functionality, utility, and security of HIT and to support its meaningful use
The incentive program for electronic health records
issued by CMS to provide a financial incentive to eligible professionals, eligible and critical access hospitals, and Medicare Advatage Orgs that are “meaningful users” of EHRs
The Patient Protection and Affordable Care Act of 2010
several provisions, from protecting consumers to improving health care quality and lowering costs to increasing access to care
Accountable care orgs (ACOs)
set of providers with a defined population of patients accountable for the quality and cost of care delivered to that population
The Food and Drug Administration Safety and Innovation Act of 2012
revised and extended the user-fee programs for prescription drugs and medical devices to establish user-fee programs for generic drugs and biosimilars and other purposes. Addresses and regulates drug shortages.
Agency for Healthcare Research and Quality (AHRQ)
supports research that helps people make better-informed decisions and improves the quality of health care services
The Administration Procedure Act of 1946
granted agencies of DHHS the power to promulgate rules and regulations that have the effect of substantive law
Center for Drug Evlauation and Research (CDER)
part of the FDA that regulates prescription and nonprescription drugs
Center for biologics evaluation and research
part of the FDA that regulates vaccines, blood, and gene therapy
Abbreviated New Drug Application (ANDA)
submitted to FDA’s CEDER, Office of Generic Drugs. Allows the review and ultimate approval of a generic drug product; do not reuire preclinical or clinical data, only bioequivalence
Authorized generic drug
a listed drug that is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug
Investigational New Drug Application (IND)
submitted to FDA for a new drug, new indication, or an off-label use that will be used in a clinical investigation’s preclinical development for that new drug to be distributed across state lines before undergoing full FDA review
New Drug Application (NDA)
vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US
Drug Importation Act of 1848
prohibited the importation of unsafe or adulterated drugs at key ports of entry
FD&C Act of 1938
required firms prove evidence of safety to the FDA before marketing; placed drug advertising under the jurisdiction of the Federal Trade Commission
Durham-Humphrey Amendment of 1951
amended the FD&C Act of 1938 to statutorily differentiate prescription and nonprescription drugs
Kefauver-Harris Amendments of 1962
required drug firms to demonstrate efficacy as well as safety; requirement to obtain informed consent for research subjects; authorized FDA to regulate advertising of prescription drugs and establish good manufacturing practices
The Orphan Drug Act of 1983
established grants, fed assistance for research, and tax incentives to develop drugs targeted for a patient population of less than 200,000
FDA Modernization Act of 1997
Streamline clinical research on drugs and devices, exclusivity provisions for pediatric drugs, created clinicaltrials.gov
Food and Drug Administration Amendments Act of 2007 (FDAAA)
Requires REMS
Preclinical studies
laboratory and animal studies that assess safety and biologic activity in various model systems; toxicologic studies that assess effects of animal fetus. After these, IND is drafted and submitted to FDA.
Phase I drug trial
introduction of IND to humans (20-100); garner info on the pharmacokinetic and pharmacodynamic properties of the drug to design a well-controlled and robust phase II trial
Phase II drug trial
controlled clinical studies in no more than several hundred subjects; evaluated drug’s effectiveness for a particular indication in patients with the disease or condition under investigation and to determine the common short-term adverse effects and risks
Phase III drug trial
several hundred to several thousand patients to determine safety, efficacy and dose. Afterwards, submit an NDA.
Phase IV drug trial
aka postmarketing studies; may be required by the FDA to verify effectiveness or focus tx on special pops
Drug Price Competition and Patent Term Restoration Act of 1984
aka Hatch-Waxman Act
defined bioequivalence as a means to approve a generic drug
Health Insurance Portability and Accountability Act of 1996
provide protection of privacy of certain individually identifiable health data (PHI)
Minimal risk
probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves compared with those ordinarily encountered in daily life or during the performance of routine physical or psychological exams
IRB members
at least 5; at least one who is primarily scientific; at least one who is primarily nonscientific; at least one who is not affiliated with the institution and is not an immediate family member of someone affiliated with the institution
Investigational drug service
purpose is to procure, manage, prepare, dispense, and dispose of investigational drugs according to protocol and in compliance with the state and federal requirements that govern investigational drug activities
Targeted solutions tool
created by Joint Commission; process for accredited hospitals to measure performance, identify barriers to excellent performance, and implement proven solutions
Tracer methodology
used by Joint Commission on site surveyor to evaluate a patient’s medical record and evaluate its compliace with standards and systems to provide care and services
The national committee for quality assurance (NCQA)
private, not-for-profit, mission to improve the quality of health care through measurement, transparency, and accountability; produces HEDIS
Healthcare Effectiveness Data and Information Set (HEDIS)
tool that health plans use to measure performance and focus improvement efforts
National Quality Forum (NQF)
nonprofit; improve quality through building consensus on national priorities; endorsing national standards; promoting national goals
Comparative effectiveness research (CER)
systematic research comparing diff interventions and strategies to prevent, diagnose, treat, and monitor health conditions
The consumer assessment of healthcare providers and systems (CAHPS)
assesses consumer experiences with healthcare.
The Pharmacy Quality Alliance (PQA)
mission to improve the quality of med use across health care settings through collaborative process for measuring and reporting
FDA Adverse Event Reporting System (FAERS)
database; Medwatch form fda 3500 for voluntary reporting by consumers and healthcare professionals
Code of Federal Regulations (definition) Title 21 Title 37 Title 42 Title 45; common rule (part 46); part 160 and subparts A and E of 164
Agencies of DHHS make rules and adjudicate them. Final rules are published in the CFR and updated every year on a staggered basis.
Title 21: Food and Drugs
Title 37: Patents, trademarks, & copyrights
Title 42: Public Health
Title 45: Public welfare
Title 45, common rule (part 46): Federal Policy for the Protection of Human Subjects (defines research and human subjects)
Title 45, part 160 and subparts A and E of 164: Health Insurance Portability and Accountability Act
Pure Food and Drug Act of 1906
Prohibited interstate commerce of adulterated or misbranded drugs.
Required labeling of selected dangerous and addictive substances.
Identified United States Pharmacopoeia and the National Formulary as official standards for drugs.
Biologics Control Act of 1902
Mandated annual licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in interstate commerce.
Authorized Hygienic Laboratory, precursor of the NIH, to conduct regular inspections for purity and potency.
The Food and Drug Administration Act of 1988
officially established the FDA as an agency in DHHS
Prescription Drug User Fee Act (PDUFA) of 1992
Requires drug, biologics, and medical device (MDUFA) manufactueres to pay fees for product applications, supplements, and other services.
Reathorized every 5 years.
The Dietary Supplement Health and Eucation Act of 1994
allows nutritional supplements and vitamins to be regulated.
The Family Smoking Prevention and Tobacco Control Act of 2009
gave the FDA authority to regulate tobacco products
Act that established a regulatory approval pathway for biosimilars or follow-on biologics
The Patient Protection and Affordable Care Act of 2010
The Reducing Prescription Drug Shortages Executive Order
signed by Obama on 10/31/11
Requires the FDA to:
- broaden reportings of manufacturing discontinuances that may lead to shortages of drugs that are life-supporting or sustaining.
- expedite regulatory review of suppliers and manufacturing sites to avoid drug shortages.
- communicate to the department of justice any evidence of or behaviors by market participants that may have contributed to stockpiling or exorbitant prices.
The Food and Drug Administration Safety and Innovation Act of 2012
Reathorized PDUFA
