Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

NURA-661-01 Anesthesia Pharm > Drug Regulatory Process, Resources and Order/Prescription Writing > Flashcards

Drug Regulatory Process, Resources and Order/Prescription Writing Flashcards

1
Q

Hospital measurement sets that can be used to report quality

A 
AHRQ Quality Indicators 
National Hospital Quality Measures
CAHPS Hospital Survey (pt satisfaction) 
ORYX® (J-Co)
The Leapfrog Group’s Measures
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

National Hospital Quality Measures

A

Combined Effort to publish a uniform set of national hospital quality measures:

Centers for Medicare & Medicaid Services (CMS)

  • TheInpatient Quality Indicators(IQIs)
  • ThePatient Safety Indicators(PSIs) identify adverse events occurring during hospitalization. They provide information on potential in-hospital complications and adverse events following surgeries, procedures, and childbirth.
  • ThePediatric Quality Indicators(PedQIs)

The Joint Commission Now uses “Oryx” Performance Measures

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

The Leapfrog Group

A

An employer-based coalition, develops and maintains a measure set that focuses on hospital quality and safety practices.

Hospitals voluntarily submit information on the extent to which they adhere to certain quality and safety practices using theLeapfrog Hospital Surveytool.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Data for the National Hospital Inpatient Quality Measures are available from______________, a public Web site hosted by the Department of Health & Human Services.

A

Hospital Compare

www. medicare.gov
search: hospital compare

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

National Hospital Quality Measures: Anesthesia related

Your charting and appropriate actions will determine your clinical site’s outcomes (and patient outcomes)– very important!

Examples of Data element list you will contribute to with your charting:

A

Anesthesia start and end time and date
Surgical incision time
Antibiotic name, dose, route, time, allergy
Beta-blocker current medication, last dose, peri-op administration
Reasons for not administering a beta-blocker peri-operative
Temperature

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Hospital Quality Alliance (HQA): Improving Care Through Information

Check this site regularly for the Hospital Inpatient Quality Reporting Program Measures (i.e. Surgical care improvement measures retired now on to new measures)

A

www.qualitynet.org

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Surveillance: Medication Errors
Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the U.S.

Can occur anywhere in the distribution system:

A 
Prescribing 
Repackaging 
Dispensing 
Administering 
Monitoring
*CRNAs do all of this!!!!
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q 
Institute for ?
List of high risk medications 
*pretty much all of our med cart!
List of dangerous abbreviations 
Can search recent med. safety info 
Report med errors and ADRs 
Direct link to FDA’s “ Medwatch” reporting site
A

Safe Medication Practices

www.ismp.org

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

AANA and Medication Safety:
Safe Practices for Needle and Syringe Use (Position Statement 2.13) =
Securing Propofol (Position Statement 2.14) =

A

Syringes and needles must only be used once!

New June 2009

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Major Legislation Affecting FDA Regulation

A

Pure Food and Drugs Act = Requires truthful labeling for all drugs
-Amendment to the Pure Food and Drugs Act = Prohibits fraudulent advertising claims

Food, Drug and Cosmetic Act = Requires proof of a drug’s safety and purity
- *Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act Requires proof of efficacy as well as safety for new drugs and drugs approved since 1938; also establishes guidelines for adverse event reporting, clinical testing, and advertising

  • Durham-Humphrey Amendment = Grants FDA authority to determine which drugs may be sold without a prescription
  • Orphan Drug Amendments = Provides incentives to manufacturers of drugs that treat orphan diseases

Drug Price Competition and Patent Restoration Act (HatchWaxman Act) = Abbreviates and modifies New Drug Applications (NDAs) 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

*Expedited Drug Approval Act = Allows accelerated FDA approval for drugs of significant medical need but requires detailed postmarketing surveillance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Division of Drug Development?

Divided into three areas?

A

Food and Drug Administration (FDA)
- Center for Drug Evaluation and Research (CDER) Mission statement: To assure that safe and effective drugs are available to the American people.

Divided into three areas:

New Drug Development Process

Investigational New Drug (IND) Review Process
- clinical trials in humans

New Drug Application (NDA) Review Process
- manufacturing, etc

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Ethics in Clinical Drug Investigation: A partnership between researcher and subject

Balance of risk and benefit for the subject by?

4 major principles = ?

A

Limit enrollment to patient who could potentially benefit (offsets potential often “unknown” risks)

  1. The trial must minimize the risks for subjects
  2. Provisions must be made for overall care of the patient
  3. The investigator must terminate the trial when risk becomes incompatible w/goals
  4. Adverse events must be reported immediately to an ethics or safety committee
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q 
Informed consent
Not just a signature. 
Patient must be: 
Aware of B/R/A?  
Well informed before making a \_\_\_\_\_\_\_\_\_\_\_ choice to participate
A

If patient terminal must understand they are probably doing this for the benefit of future patients instead of for their own welfare (no false hope)

Well informed before making a voluntary choice to participate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Institutional Review Boards (IRB)/Independent Ethics Committees:

Located at hospitals & research institutions

Mandated & monitored by?

Review ethical and legal issues with research protocol

Ensure what?

Oversee what?

Specific criteria evaluated =

A

FDA

participants are fully informed and have given their written consent before studies ever begin

that the rights and welfare of people participating in clinical trials both before and during are protected

Minimizes potential risk to human subjects
Poses risks that are reasonable relative to the anticipated benefit and potential scientific gain
Includes equitable selection of subjects
Contains an effective informed consent process Safeguards vulnerable populations, such as children and the mentally disabled

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Composition of IRB = ?

An IRB must be able to evaluate proposals in the context of?

A

No less than five experts and lay people with varying backgrounds to ensure a complete and adequate review of activities

  • experts
  • one non-expert
  • one non-affiliate
  • institutional commitments and regulations applicable to law
  • standards of professional conduct and practice community attitudes
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Investigational New Drug Application:

Authorization from _______ to initiate clinical trials

Show that the drug is _______________ for use in initial small-scale clinical studies

  • Compile data from in vitro or animal studies
  • Proposed protocol – will it provide the evidence necessary to support the safety of administering the compound to humans?
A

the FDA - FDA reviews the preclinical data and decision to allow the clinical trials to proceed (30 days) = FAST!

reasonable and safe

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Preclinical Research:

Animal Testing

  • Short-term Testing ~ 2 wks. - 3 mo
  • Long-Term Testing ~ A few weeks - several years (Some animal testing continues after human tests begin to look for long-term AE (i.e. cancer or birth defects))

Prior to Human Trials use in vitro and in vivo lab animal testing (~__ years)

A

~8.5 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Phase I Clinical Trial:

A

Often nonblinded

20-100 healthy subjects
-Unless toxicity expected (cancer drugs)

Duration = several months

Purpose = Safety/ID adverse effects, Max dose, Pharmacokinetics

***If high levels of toxicity are expected, such as cancer drugs, patients with target condition may be used in place of healthy volunteers
Focus overall includes max dose, absorption, distribution, metabolism, and excretion
Help to inform needs from phase II study designs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Phase II Clinical Trial:

A

Single or Double blinded

50-Several hundred subjects

Duration = Several months - 2yrs

Purpose = 
Effectiveness for specific disease 
Dosing/dose response 
Short term safety 
Adverse effects

*we might see effects of a drug that only 70 have received

***Dose-response and dosing regimens
Several dosing options: optimum dose range and toxicity information
Usually involve a single-blind or double-blind trial
drug of interest is evaluated against placebo and/or an existing therapy.
Can pinpoint additional data that must be collected in phase III trials such as LFTs if phase II data suggest possible hepatotoxicity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Phase III Clinical Trial:

A

Randomized Double blinded
Multiple Arms

Several hundred – several thousand subjects
Multiple sites

Duration: 1-4 years

Purpose:
Specific clinical or surrogate endpoints
Safety, dosage, and effectiveness
Extrapolate results general population

***Results typically provide adequate basis for extrapolating results to the general population
Commence after a “End of Phase II meeting”
Safety of proceeding studies
Objective and study design review
Review of data up to this point and proposed labeling

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Phase IV …….?

A

May be required by the FDA (post drug approval):

  • More information about the side effects and safety of the drug when used in the general population
  • Long term risks and benefits
  • Efficacy when used in the general population
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

The New Drug Application (following clinical trials):

A

***Nml 10 months , priority review 6 months.

Formal proposal (usually >1000 pgs) from drug sponsors that the FDA approve a new pharmaceutical for sale in the US.
A drug manufacturer submits
-nonclinical (animal)
-clinical (human) test data and analyses
-description of manufacturing procedures

Must provide enough information to permit FDA reviewers to reach key decisions:
Is the drug safe & effective for its proposed use(s), with the benefits of the drug outweighing its risks?
Is the drug’s proposed labeling appropriate, and, if not, what should the labeling contain?
Are manufacturing methods and the quality controls used adequate to preserve the drug’s identity, strength, quality, and purity?

***Out of every 100 Investigational new drugs only
~33 make it through phase I trials
~25 make it through phase II and only
~20 are eventually marketed.

23
Q

Fast Track Status = ?

A

Accelerated development & approval status for life-threatening disease
*Post approval Phase IV trials often required

24
Q

Orphan Drug = disease that affect < _______ people in the US

A

Orphan Drug (disease that affect < 200,000 people in the US)
Exclusive approval for orphan indication for 7 yrs post approval
Infliximab – Crohn’s disease
Thalidomide – leprosy
Atovaquone – for PCP

25
Q

Compassionate use protocols

A

Expand access to investigational new drugs:

(1) Must show preliminary evidence of efficacy
(2) patients must be likely to die or suffer rapid disease progression within several months, or to die prematurely without treatment
(3) there must be no comparable approved therapy to treat the disease at that stage

26
Q

Generic Drug Review Process:

Abbreviated new drug application (ANDA) is filed.
To gain FDA approval, a generic drug must:
Contain the same ____________ as the innovator drug (inactive ingredients may vary)
Be identical in ___________________
Have the same ___ indications
Be bioequivalent
Meet the same batch requirements for identity, strength, purity, and quality
Be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products

A

active ingredients
strength, dosage form, and route of administration
use

27
Q

Post Drug Approval:
A vital part of ____’s mission is to monitor the safety and effectiveness of drugs that are currently available to the American people.

Division of _________________________ _________/Spontaneous Reporting System Pharmacoepidemiology Contracts/Cooperative Agreements with ____ Companies

A

CDER
Pharmacovigilance and Epidemiology
MEDWatch
Drug

***To capture serious adverse event data, CDER receives expedited and periodic reports of new information from the drug’s manufacturer
Spontaneous reporting system contains adverse drug reaction reports from hospitals, health care providers and lay persons that are sent either directly to the Agency (via MEDwatch) or first to the drug manufacturer, and then, by regulation, to the Agency by the manufacturer

28
Q

MEDwatch Program (effective since 1993)
Four goals:
1. Make it easier for _____________ to report serious events
2. Make it clearer to _____________ what types of adverse events FDA is interested in receiving
3. More widely disseminate information on the ____ actions that have resulted from adverse event and product problem reporting
4. Increase ______________ understanding and awareness of drug and device-induced disease

A
  1. Make it easier for healthcare providers to report serious events
  2. Make it clearer to health care providers what types of adverse events FDA is interested in receiving
  3. More widely disseminate information on the FDA’s actions that have resulted from adverse event and product problem reporting
  4. Increase healthcare providers’ understanding and awareness of drug and device-induced disease
29
Q

Post Marketing Surveillance:
Prescription Drug Advertising and Promotional Labeling

____’s mission is to assure that the prescription drug information provided by drug firms is truthful, balanced, and accurately communicated. Enforced by ?

A

CDER
the Promotional Materials Review Process (by CDER, of the FDA)
***class example given of Exparel’s off label use

30
Q

Over-the-Counter Drug Review:
6 of every 10 medications purchased
Available without a prescription – easy access
> 80 classes (therapeutic categories) of OTC drugs; >100,000 products marketed with 800 active ingredients

Ranging from acne drug products to weight control drug products.

FDA has been evaluating the ingredients and labeling as part of “_______________________.” OTC drug monographs are a “recipe book” covering acceptable ingredients, doses, formulations, and labeling. The _________________________ also meets regularly to assist the FDA in evaluating these products.

A

The OTC Drug Review Program
Nonprescription Drug Advisory Board
*note that herbals are not considered OTC and do not fall under this perview

31
Q

Prescription writing:

Divided into two main categories

A

Inpatient (institution)
-Preop and PACU for CRNAs generally
Outpatient
-pain management clinics, etc, but less comon for CRNAs

32
Q

Prescription Writing:

In-patient Requirements are?

A

Patient identification

Date and time the Rx written

Allergy status

Full name of medication (generic name preferably)

Dose (NOT mg, but micrograms, units) must be written

Frequency of administration (all prn meds must have a specified frequency, e.g.- 1 tab q4hrs prn for pain)

Duration of therapy when indicated (IV antibiotics)

The reason for administration on all PRN medication orders (e.g. prn pain)

Any special parameters for medication titration, monitoring or administration (e.g. clonidine 0.2mg po tid, hold for SBP < 100; lorazepam 2 mg IV q6h around the clock to maintain sedation at Ramsey Scale=2, hold if reparatory rate < 10 or for sedation >= Ramsey scale 3)

If ordered as weight based, include patient weight and actual dose to be administered (e.g. Give gentamicin 350mg IV q24h (5mg/kg, pt wt=70kg)

Round doses to the nearest dosing increment (e.g. Dalteparin 1300 units (200 units/kg) sq daily, patient weight=67 kg.)

Sign order with full name, title (SRNA), and pager number

For verbal or telephone orders, allow the receiver to read back the order

33
Q

Prescription Writing:

Outpatient Requirements

A 
Prescription must have: 
date
your name 
office address and telephone number 
patient’s name and address   
directions for the patient or to the pharmacist 
name of the drug (generic or brand name)  
quantity Refills if required
34
Q

Prescription Writing:

Outpatient Controlled Substances = Same requirements as other prescriptions PLUS……..

A

DEA # number AND
CIII-V = Only allowed 5 refills or valid for 6 months, whichever comes first
C-II = No refills allowed, Hard copy required, Signature required
*Laws can vary from state to state

35
Q

Regulation of controlled substances (Classes) is done by

A

DEA

36
Q

Class I

A

High potential for abuse

No currently accepted medical use in treatment in the United States

Lack of accepted safety for use of the drug or other substance under medical supervision

  • heroin,
  • lysergic acid diethylamide (LSD)
  • marijuana (cannabis) - local regs differ, fed illegal, jury still out
  • 3,4methylenedioxymethamphetamine (ecstasy)
  • methaqualone
  • peyote.
37
Q

Class II

A

High potential for abuse

Currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions

Abuse may lead to severe psychological or physical dependence or fatality

Morphine, fentanyl, methadone

38
Q

Class III

A

Potential for abuse less than schedule I and II drugs

Currently accepted medical use in treatment in the United States

Abuse may lead to moderate or low physical dependence or high psychological dependence

  • Buprenorphine
  • Hydrocodone/APAP (Lortab)
  • Codeine/APAP (Tylenol 3)
  • Dronabinol (Marinol)
  • Testosterone products
39
Q

Class IV

A

Low potential for abuse relative to schedule III drugs

Currently accepted medical use in treatment in the United States

Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to schedule III drugs

  • Benzodiazepines
  • Zolpidem (Ambien)
  • Phenobarbitol
  • Propoxyphene/APAP (Darvocet-N)
40
Q

Pregnancy Categories:

A

Based on animal studies and/or human studies
- human trials can tend to be unethical

Many categories leave drugs up to the discretion of the practitioner/patient in terms of risk/benefit

1st trimester risks vs 3rd trimester risks

  • 1st: crucial developmental stage (benzos -> cleft palate)
  • 2nd: fetal to adult circulation (ibu/NSAIDs -> patent DA)

A, B, C, D, X

41
Q

Category A

A

Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy

Folic acid, vitamin B6, levothyroxine

42
Q

Category B

A

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women
OR
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Acetaminophen, prednisone, insulin, ibuprofen (before 3rd trimester), amoxicillin

43
Q

Category C

A

Animal studies have shown an adverse effect and there are no adequate and well controlled studies in pregnant women
OR
No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Many antidepressants, carbamazepine, ciprofloxacin, fluconazole

44
Q

Category D

A

Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus However,
the benefits of therapy may outweigh the potential risk.

The drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Alcohol, lithium, phenytoin, valproic acid, tetracyclines, ACEI, most cancer chemotherapy

45
Q

Category X

A

Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.

The use of the product is contraindicated in women who are or may become pregnant.

Isotretinoin (Accutane), thalidomide, misoprostil (Cytotec)

46
Q

High potential for abuse

No currently accepted medical use in treatment in the United States

Lack of accepted safety for use of the drug or other substance under medical supervision

  • heroin,
  • lysergic acid diethylamide (LSD)
  • marijuana (cannabis) - local regs differ, fed illegal, jury still out
  • 3,4methylenedioxymethamphetamine (ecstasy)
  • methaqualone
  • peyote.
A

Class I

47
Q

High potential for abuse

Currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions

Abuse may lead to severe psychological or physical dependence or fatality

Morphine, fentanyl, methadone

A

Class II

48
Q

Potential for abuse less than schedule I and II drugs

Currently accepted medical use in treatment in the United States

Abuse may lead to moderate or low physical dependence or high psychological dependence

  • Buprenorphine
  • Hydrocodone/APAP (Lortab)
  • Codeine/APAP (Tylenol 3)
  • Dronabinol (Marinol)
  • Testosterone products
A

Class III

49
Q

Low potential for abuse relative to schedule III drugs

Currently accepted medical use in treatment in the United States

Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to schedule III drugs

  • Benzodiazepines
  • Zolpidem (Ambien)
  • Phenobarbitol
  • Propoxyphene/APAP (Darvocet-N)
A

Class IV

50
Q

Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy

Folic acid, vitamin B6, levothyroxine

A

Category A

51
Q

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women
OR
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Acetaminophen, prednisone, insulin, ibuprofen (before 3rd trimester), amoxicillin

A

Category B

52
Q

are no adequate and well controlled studies in pregnant women
OR
No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Many antidepressants, carbamazepine, ciprofloxacin, fluconazole

A

Category C

53
Q

Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus However,
the benefits of therapy may outweigh the potential risk.

The drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Alcohol, lithium, phenytoin, valproic acid, tetracyclines, ACEI, most cancer chemotherapy

A

Category D

54
Q

animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.

The use of the product is contraindicated in women who are or may become pregnant.

Isotretinoin (Accutane), thalidomide, misoprostil (Cytotec)

A

Category X

NURA-661-01 Anesthesia Pharm (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions