Drug Regulation Flashcards
What is the National Hospital Quality Measures?
- First organization with role in quality
- joint effort by CMS and JCAHO to set quality standard
- now use “Oryx” performace measures
- started surgical care improvement project
- hold organization accountable for abx 1 hour before incision (ex)
What is the AHRQ Quality Indicators?
- Measures quality and supports research to lead to higher quality care
- came out of “to err is human” report
- Measures assess clinical effectiveness and 30 day mortality associated with major health conditions
What is CAHPS hospital survey?
The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospital Survey, commonly known as Hospital CAHPS or HCAHPS, is a standardized survey instrument for measuring adult patients’ perspectives on care they experience during a hospital stay. HCAHPS addresses critical aspects of the hospital experience, including:
- Communication with doctors and with nurses.
- Responsiveness of hospital staff.
- Hospital cleanliness and quietness.
- Communication about medicines.
- Discharge information and patients’ understanding of care when leaving the hospital.
- Patients are also asked to rate the hospital overall and their willingness to recommend the hospital to others.
What is leapfrog?
- Employer-based coalition
- develops and maintains measure set that focuses on hospital quality and safety practices
- Measure crucial areas or “leaps” looking at patient safety such as:
- do physicians enter Rx and other orders in computerized system
- how many high-risk sx at hospital?
- does it provide appropratie care to women giving birth and newborns
- ICUs staffed by specialists?
- “Are we getting our money’s worth”
What is ORYX?
- Set of performance measures required by JCAHO. Hospitals seeking accrediation from JACHO must submit some combination fo ORYX measures to fulfull requirements
- Meant to support organizations in quality improvement efforts
How do national hospital quality measures relate to anesthesia?
- Your charting and appropriate actions determine your clinical site’s outcomes (and patient outcomes)- very important
- Examples of data element list you will contribue to with your charting
- anesthesia start and end time and date
- sx incision time
- abx name, dose, route, time, allergy
- beta blocker current med, last dose, periop admin
- reasons for not administering beta blocker
- temperature
- Four measure areas:
- inpatient
- inpatient quality indicators- (IQI) inpatient mortality for certain procedures and medical conditions
- utuilization of procedures (look at overuse/misuse of procedures)
- prevention
- patient safetyPatient Safety Indicators (PSI)
- ID adverse events during hospitalization
- Provide infor on potential in hospital complication and adverse events
- pediatric care
- Pediatric Quality Indicators (PedQIs) include measures of inpatient quality and patient safety specifically for the pediatric population.
What is the Hospital Quality Alliance?
- “Improving Care through Information”
- www.qualitynet.org
- check site regularly for hospital inpatient quality reporting program measures
- i.e. sx care improvement measures retired, now on to new measures
How many people are affected by medication errors?
- 1 death every day
- injure approximately 1.3 million people annually in US
What information can be found at institute for safe medication practices?
- List of high risk medications
- List of dangerous abbreviations
- Can search recent med safety info
- report med errors and ADRs
- Direct link to FDA’s medwatch reproting site
What is AANA’s position on needle and syringe use safe practices?
- NEVER
- administer meds form same syringe to multiple pt, even if needle is changed
- Reuse a needle, even on same pt
- Refill a syringe once it has been usd, even for same patient
- use infusion or IV administration sets on more than one patient
- reuse a syringe or needle to withdraw meds from multi-dose med vial
- reenter a single use med vial, ampule or solution
- SYRINGES AND NEEDLES USED ONLY ONCE!
What is AANA’s position for securing propofol?
- Ease of access may contribute to abuse, addiction, and death in anesthesia practitioners
- Facilities who have propfol on formulary need ot develop progras to prevent diversion of propofol and potential abuse of the drug
When did FDA start?
- From Pure Food and Drugs Act of 1906
- requires truthful labeling for all drugs
What was the 1912 admendment to the pure food and drugs act?
Prohbitied fradulent advertising claims
What did Food, Drug and Cosmetic Act of 1938 state?
- Requires proof of drug’s safety and purity
- after antifreeze was used as additive in abx. 100 deaths
What was the Durham-Humphrey Amendment?
Grants FDA authority to determine which drugs may b esold without a prescription
What was the Kefauver-Harris Amendment to Food, Drug and Cosmetic Act?
- Requires proof of efficacy as well as safety for new drugs and drugs approved since 1938
- establishes guidelines for adverse event reporting, clinical testing, advertising
- after thalidomine in UK causing severe birth defects
What was the orphan drug amnedment of 1983?
Provides incentives for manufacturers of drugs to treat orphan diseases
What was the Drug Price Competition and Patnet REstoration Act (Hatch-Waxman Act)?
- Abbreviates and modifies New Drug Application for generic drugs; creates patent life extensions for delay caused by FDA review
- extensions are limited to 5 extra years or 14 years post NDA approval
What is the expedited drug approval act of 1992?
- Allows accelerated FDA approval for drugs of sig medical need, but requires detailed postmarketing surveillance
What is the Center for Drug Evaluation and Research (CDER)?
- Housed in FDA
- Determines which new drugs make it to pharmacies
- Assures that safe and effectiv edrugs are available to american people
- New Drug Development Process
- Investiagtional New Drug Review Process
- New Drug Application Review process
- after phase III clinical trials
What are 4 majors principles in ethics in clinical drug investigation?
- Trial must minimize the risks for subjects
- Provisions must be made for overall care of the patient
- Investigator must terminate the trial when risk becomes incompatible with goals
- Adverse events must be reported immediately to ethics or safety committee
Need to limit enrollement to patient who could potentially benefit (offsets potential oftern “unknown” risks)
What is informed consent for clinical trial?
- Not just a signature
- must be aware of benefit/risk analysis
- if patient terminal, the must understand they are probalby doing this for benefit of future pt instead of their own welfare
- Needs to be well informed before making voluntary choice to participate
Where are IRBs located?
- Located at hospitals and researhc institutions
- mandated and monitored by FDA
- Review ethical and legal issues with research protool
- Ensure
- participants are fully informed and have given their written consent before studies ever begin
- oversee that the rights and welfare of people participating in clinical tirals both before and during are protected
