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Pharmacology > Pharmacovigilance > Flashcards

Pharmacovigilance Flashcards

1
Q

what is the sceince and activities relating to the detection, assessment, understanding, and preventio of adverse effects or any other drug-related problems?

A

pharmacovigilance

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2
Q

what are the 4 aspects that differ from PH & other countries?

A

drug production
distribution & use
genetics, diet, traditions
pharmaceutical quality & composition

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3
Q

pharmacovigilance is needed for?

A
  1. humanitarian concern
  2. meds must save lives
  3. ADRs are expensive
  4. Promotion of rational use of drugs & adherence
  5. ensuring public confidence
  6. ethics
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4
Q

what are the limitations of clinical trials?

A
  1. small sample size
  2. restricted populations
  3. narrow indications for the drugs
  4. short duratio of drug exposure
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5
Q

What are the reasons why ADRs are expensive?

A
  1. INC hospitalizations/ER consult
  2. Prolngation of hospital stay
  3. Addtl clinical investigations in more serious cases (labs & clin tests)
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6
Q

What are the reasons why ADRs are expensive?

A
  1. INC hospitalizations/ER consult
  2. Prolngation of hospital stay
  3. Addtl clinical investigations in more serious cases (labs & clin tests)
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7
Q

what are the most common types of irrational medicine use?

A
  1. polypharmacy
  2. over-use of parenterals
  3. failure to prescribe in accordance w clinical practice guidelines
  4. Inappropriate self-medication
  5. Inappropriate use of antimicrobials
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8
Q

what are the goals of pharmacovigilance?

A
  1. early detection of unknown safety problems
  2. detection of increases in frequency
  3. Identification of risk factors
  4. Quantifying risks
  5. Preventing px from being affected nessarily
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9
Q

what are sapects of pre-marketing safety concerns?

A

animal experiments
clinical trials
limitations of pre-marketing trials

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10
Q

what are the diff phases of clinical trial and its purpose?

A

phase 1 = safety
phase 2 = efficacy
phase 3 = confirm results
phase 4 = post marketing surveillance

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11
Q

what are the limitations of pre-marketing trials?

A
  1. narrow population
  2. narrow indication
  3. short duration
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12
Q

should we monitor the increase in frequency of drug-related reports?

A

yes

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13
Q

what are the diff px risk factors?

A
  1. mechanisms of idiosyncratic ADRs
  2. risk factors in the vulnerable groups
  3. genetic factors
  4. systems failure
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14
Q

what are the diff mechanisms of idiosyncratic ADRs?

A
  1. pharmaceutical variation
  2. abnormalities in drug metabolism
  3. Immunological
  4. Drug-drug itneractions
  5. Multifactorial
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15
Q

What are the diff risk factors in the vulnerable grps?

A
  1. pediatric = spuitting of oral drugs
  2. geriatric = forgetfulness of drug intake
  3. Pregnancy & lactating = warned to consult their physician on whateer drug to take
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16
Q

what are the diff hospital monitoring committees & its use?

A
  1. pharmacy & therapeutics committee = drug safety
  2. ADR monitoring committee = concerns related to ADRs
  3. Antimicrobial surveillance committee = guidelines for rational antimicrobial use
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17
Q

what is indicated in the pharmacovigialnce drug safety management wheel?

A
  1. strategy = pharmacovigilance & risk management
  2. Network & communication = for compliance
  3. operations = for pharmacovigilance quality system
  4. governance = risk mitigation and communication
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18
Q

what are the diff strategies for phamacovigilance & risk management?

A
  1. safety reports and product labeling
  2. safety monitoring and pharmacoepidemiology
  3. px and disease characterization
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19
Q

what is the primary agency that deals with drug issues?

A

FDA

includes ADR monitoring

20
Q

what are other drug-related problems?

A
  • availability & rational distribution of drugs
  • loss of confidence in physicians
21
Q

what are the principles of achieving goals?

A
  • human well-being
  • equal respect
  • global equity
  • national equity
  • reciprocity
    *legitimacy
22
Q

what are the specific aims of pharmacovigilance?

A

safety
patient care & safety
public healthy safety
assessment of benefit, harm, effectiveness, and risks
Safe, rational, and more effective use

23
Q

what are selected areas of pharmacovigilance?

A

product quality
ADRs
Medication errors

24
Q

what are the diff suggestions to prevent medication errors?

A
  1. correct faulty systems, proecsses, and conditions
  2. clarification of poorly handwritten prescriuptions
  3. create systems to overlook drug interactions
  4. double checking for sound-alike and look-alike products
25
Q

what are the diff types of medication errors?

A
  1. patient-related error
  2. prescriber-related and general errors
  3. drug-related errors
  4. dosage form-related errors
  5. therapeutics-related errors
26
Q

what are the 3 probles to watch out for when accepting drug donations during calamities?

A
  1. poorly labeled packaging
  2. expired/expiring mediactions
  3. drugs sent had nothing to do with the medical probelms ont he ground
27
Q

what are the possible misinterpretation for “IU”?

A

IV or 10

28
Q

what are the responsibilities of pharmacovigilance?

A
  1. timely collection of data
  2. appropriate assessments
  3. expedited and perioding reporting
29
Q

what is the signal management lifecycle?

A

signal detection -> signal prioritization –> signal evaluation –> signal detection

30
Q

what are the principles of causality assessment?

A

consistency - similar rxns
specifictiy = specific rxns to specific agents
biological plausibility = possible mechanism

31
Q

what are the criteria of causality?

A
  1. time to onset
  2. time independent rxns
  3. time-dependent rxns
  4. comedication
  5. past medical hx
  6. pharmacology
32
Q

what are the diff factors that strengthen a causal relationship?

A
  1. dechallenge & rechallenge
  2. positive dechallenge
  3. positive rechallenge
33
Q

what are postiive dechallenge and rechallenge?

A

(+) dechallenge = ADR resolves completely ff the drug’s discontinuation

(+) rechallenge = adverse event re-occurs after the drug is restarted

34
Q

what are the 5 factors necessary in causal assessment?

A
  1. consistency
  2. specificity
  3. biological plausability
  4. temporal relation
  5. strength & association
35
Q

what should be done once safety signal has become a true concern?

A
  1. label changes/boxed warnings by coimpany have to be mandated by FDA
  2. targeted outreach & education
  3. product withdrawals
36
Q

what should be done in risk management plan?

A

detect
assess
intervene

37
Q

what is an important part of a report?

A

identifiable reporter

name, contact details of the reporter

38
Q

what are diff strategies to improve drug safety?

A
  1. avoid chemical functional groups
  2. develop pharmaceutically & metabolically inert drugs
  3. development of stuiable in vitro & in vivo systems
  4. INC use of in vitro systems
  5. development of suitable in vitro & in vivo systems
  6. computer-based schemes
  7. encourage ADR reporting
  8. idetnify risk factors
  9. identify mult-genetic predisposing factors
39
Q

what is the ave am tof time for experiemntal drugs to travel from lab to medicine chest?

A

12 yrs

40
Q

what are the phases of product development?

A

drug discovery (3-5 yrs)
pre-clinical (1-2 yrs)
clinical trials (6-7yrs)
regulatory approval (1-2 yrs)
Post-marketing surveillance

41
Q

what is the main goal?

A

further improvement of drug use for px care and safety

42
Q

what is the field name for WHO collaborating center for international drug monitoring?

A

Uppsala monitoring center (UMC)

43
Q

what are works of UMC?

A
  1. collect, assess, and communicate info from member countries
  2. collab with member countries
  3. coordination, collection, and collaboration in relation to international drug activities
  4. coordinate the WHO program
44
Q

whata re indicators for quality of pharmacovigilance landscape?

A
  1. good manufacturing practices
  2. bioequivalence
  3. safewty issues that arise
  4. need for pharmacovigilance
45
Q

what are the cGMP guidelines?

A
  1. choice of raw materials
  2. manufacturing process
  3. validation
  4. packaging
46
Q

What is Bioequivalence test?

A

check to see if serum therapeutic level (80-90%) has been reaches

Pharmacology (19 decks)

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