61 terms

BCPS - Policy, Practice, Regulatory Issues

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JCo requirements for a hospital formulary
criteria must include inidcations, effectiveness, interactions, potential for errors and abuse, ADE's sentinel event advisories, populations, other risks, costs
DUE
Process used to assess the appropriateness of drug therapy by evaluating data on drug use
in a given health care environment compared with predetermined criteria and standards
MUE
Performance improvement method that focus on improving patient outcomes by preventing actual or potential medication related problems
Medication error
error occurring anywhere in the process
ADE
injury from medication use. May or may not be d/t error
ADR
Injury not caused by error, nonpreventable
Patient safety and quality improvement act of 2005 (Patient Safety Act)
authorized patient safety organizations (PSO)
encourage voluntary reporting
Who created Patient Safety Organization Privacy Protection Center?
AHRQ - ensures events are non-identifiable
ADE reporting
Report to FDA Adverse Event Reporting System
Medwatch form FDA 3500
healthcare professionals report serious adverse event or product issue with FDA regulated drug, biologic, device or supplement - voluntary
Medwatch form FDA 3500A
Industry following IND and biologic regulations or facilities (hospital, nursing home) - mandatory
Medwatch form FDA 3500B
consumer reporting
What NOT to report to Medwatch
veterinary, vaccine, internet sales of Rx
Institute for Safe Medication Practices
non-profit PSO since 1975
4 med safety alert newsletters
University Healthsystem Consortium
UHC Safety Net - event reporting system
Vaccine Adverse Event Reporting System
Managed by CDC and FDA
USP
develops standards
Required chapters < 1000
USP 795
non-sterile compounding
USP 797
Sterile compounding
low-med-high risk stratification
USP 800
hazardous drug handling in healthcare settings
HITECH
Health Information Technology for Economic and Clinical Health Act
- promotes secure electronic transfer of PHI
- penalties for breaches in HIPAA and PHI
ONC
Office of the National Coordinator for Health Information Technology created by HITECH
HIE
Health information exchange
local, regional, state level
BPCI
biologics price competition innovation act 2009
Provision of ACA to streamline approval of biosimlars
Sunshine Act
have to report stuff given to you by drug reps/companies
Safe and Secure Drug Disposal Act of 2010
Rules for pt and LTCF disposal of controls
The FDA Safety and Innovation Act of 2012
amends Food, Drug, Cosmetic act
life saving drug mfgr must report to DHHS before ceasing production
drug shortage lists, etc
Drug Quality and Security Act of 2013
503B - compounding facility may voluntarily register as outsourcing facility with FDA
labeling requirements, PIC, report Q6 months
Medicare Access and CHIP Reauthorization Act (MACRA) of 2015
fee-for-service shifted to pay-for-performance
Reauthorized CHIP
DHHS
FDA, CMS, AHRQ, CDC, HRSA
FDA
Safety of most foods and cosmetics, drugs, biologics, devices, animal drugs
CMS
medicare, Medicaid, State Children's Health Insurance Program, EHR incentive program
AHRQ
research support - better-informed decision and quality for healthcare consumers
HRSA
builds healthcare workforce to improve access
DOJ
over DEA
ORYX
JCo measurement for AMI, HF, PNA, surgical care, children's asthma, VTE, substance abuse, tobacco, ED, immunization, psych services, stroke
All worked into accreditation process
NCQA
national committee for quality assurance
accreditation, certification, recognition programs
establish criteria for ACO's based on ACA
HEDIS
Healthcare effectiveness Dada and Information Set - from NCQA
effectiveness, access, experience, utilization measurement in healthcare delivery
ANDA
Abbreviated New Drug Application
generic approval
What goes on a biologics license application
mfg process, chemistry, pharmacology, clinicaly pharmacology, effects
biologic product
monoclonal antibodies, enzymes, immunomodulators, growth factors, cytokines
INDA
New drug, new indication, off-label use
The Pure Food and Drug Act of 1906
prohibited interstate commerce of adulterated, misbranded drugs
labeling
USP/NF official standard
The FD&C Act of 1938
Evidence of Safety
FTC over advertising
USP/NF official compendia
The Durham-Humphrey Amendment of 1951:
amended FD & C
Rx vs OTC
The Kefauver-Harris Amendments of 1962
efficacy as well as safety `
The Comprehensive Drug Abuse Prevention and Control Act of 1970
controlled substances
The Orphan Drug Act of 1983
grants, tax incentives, fed support for drugs <200,000 potential patients
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
ANDA process for generics
The FDA Modernization Act of 1997
Clinical trials.gov
The FDA Amendments Act of 2007
Authority to require REMS
The BPCI Act passed as a provision within the ACA.
biosimilars
Phase I drug trial
introduction to humans - 2-80 healthy
Safety, PK/PD study
Phase II drug trial
several hundred humans
effectiveness study
Phase III drug trial
several hundred +
safety, efficacy, appropriate dose
Phase IV drug trial
postmarketing study
Generic requirements
identical in active ingredient, dosage formand strength, route of administration, quality, and intended use
Orange book
Approved drug products with therapeutic equivalence evaluations
Uses A or B to assess similarity of generics
biologics
Follow-on biologics or biosimilars are drugs or vaccines that have been produced in living cells.
REMS
med guide/pkg insert
communication plan to HCP
elements to assure safe use (ETASU)
implementation system
biosimilars approval evidence required
purity, safety, potency, and clinical trial data. This is
different from the generic ANDA approval pathway