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25 Cards in this Set
- Front
- Back
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NPSG
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2009 National Patient Safety Goals
3C: ID a list of look/sound alike drugs 3D: labeling medications 3E: decr harm from anti-coagulation tx |
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ISMP
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Institute for Safe Medication Practices
def = org devoted to medication error prevention & safe med use - voluntary error-reporting pgm to assist hlt-care org |
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Sentinel Events
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1. unexpected occurrence involving death or serious physical/psychological injury
2. serious injuries specifically including loss of a limb or function 3. when sentinel events occur, hlth-sys = req to complete a thorough & credible Root Cause Analysis (RCA) |
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RCA
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Root Cause Analysis
- process for IDing the basic/causal factors that underlie variation in performance, including occurrence or possible occurrence of a sentinel event - goal is NOT to determine the cause of incident - RCA = to make a proactive approach to ID gaps & inadequacies in the organization's process - usu conducted by a committee |
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What form is used to report serious AE associated w/ use of
- FDA approved drugs - biological agents - MEDICAL DEVICES - nutritional products/cosmetics |
Med Watch Form 3500
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What AEs should not be reported on the Med Watch Form 3500?
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- vaccines
- investigational drugs |
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What are the 6 rights?
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1. Drug
2. Dose 3. Route 4. Time 5. Patient 6. Documentation |
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Medication Reconciliation
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1. 2009 NPSG 8
2. assists in optimizing med tx & preventing med errors 3. pts are to have medication reconciled w/in 24 hrs of admission 4. monthly audits required by TJC 5. audits usu completed by Medication Safety Officer (usu a pharmacist) |
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What does SPEAK UP stand for?
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Speak up abt questions/concerns
Pay attn to hlth-care & meds Educate yourself abt your dx Ask a family member to be you advocate Know the medications you tk & why Use a TJC accredited hospital/clinic Participate in decision making process |
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Drug Importation Act of 1848
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1st Fed Law = deals w/ drug quality & safety
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Pure Food & Drug Act of 1906
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prohibits misbranding & adulterating foods/drinks/drugs
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Sherley Amendment of 1912
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no false therapeutic claims
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Food, Drug, & Cosmetic Act of 1938
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- all drugs must be tested for safety prior to marketing
- need to submit NDA w/ DRUG USAGE & evidence of SAFETY - as a result of the Sulanilamide tragedy |
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Durham-Humphrey Amendment of 1951
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defines OTC vs Rx
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Kefauver-Harris Drug Amendment
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- must prove EFFECTIVENESS to FDA
- resulted from Thalidoide Tragedy ( sleeping pill that caused thousands of babies to be born w/ defects) |
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Upjohn vs. Finch
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- commercial success alone does NOT constitute substantial evidence of drug safety & efficacy
- upheld Kefauver-Harris Drug Amendment of 1962 |
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Orphan Drug Act of 1983
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Enables FDA to speed up & streamline approval & marketing of drugs needed for tx of rare diseases (effects < 200K in USA)
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NME
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- New Molecular Entity
- submit to FDA if want drug to be used for new indication |
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Phase I Clinical Trial Studies
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- dose finding studies + AE, toxicity & drug safety (ADME)
- use low dose - 20 - 100 volunteers - lasts 6months to 1.5yrs |
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Phase II Clinical Trial Studies
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- eval EFFECTIVENESS in DISEASED pts + determine short-term SE + risk assoc w/ drug
- 100 - 500 pts - lasts abt 2yrs |
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Phase II Clinical Trial Studies
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- further define EFFICACY & SAFETY
- freq compares drug to current drug therapy or placebo - multicentered - 1000 - 5k pt volunteers - lasts abt 3.5 yrs - after Phase 3 completion --> can submit an NDA |
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Methods & Procedures to provide meds to desperately ill pts
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- Treatment IND
- Oncology Initiave - Emergency Use IND - Accelerated Drug Approval Pgm - Special Meetings of FDA w/ study sponsors |
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IRB
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- Institutional Review Board
- Aka IEC (Independent Ethics Committee) or ERB (Ethical Review Board) |
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Who is in IRB?
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- at least 1 mem specialized in sci area (usu. physician)
- non-sci (law / ethics / religion) - not affiliated w/ institution where research is being conducted - gen examples: MDs, RPhs, nurses, lawyers, clergy, & lay person |
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Nuremberg Code
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- 1st internationally recognized code of research ethics
- developed by Nazi War Crime Tribunal in 1947 - result from 23 Nazi physicians who experimented on POW (1946) |
