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SBA PY2 Fall > Adverse Reaction Reporting > Flashcards

Adverse Reaction Reporting Flashcards

1
Q

what reporting is mandatory by hospitals?

A

all serious ADRs and MDIs

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2
Q

what is an adverse drug event?

A

any negative or harmful occurrence that takes place during treatment , that may or may not be associated with a medicine

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3
Q

what is an adverse drug reaction (ADR)?

A

a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis

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4
Q

what is a serious ADR?

A

a noxious and unintended response to a drug that occurs at any dose and that:

  • requires hospitalization
  • prolongation of current hospitalization
  • Causes congenital malformation
  • results in persistent or significant disability
  • is life-threatening or results in death
  • requires significant medical intervention
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5
Q

what is a medication incident?

A

any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the HCP or patient

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6
Q

medication incidents can be in relation to what things?

A
  • professional practice
  • drug products
  • procedures
  • systems
  • prescribing
  • order communication
  • product labelling
  • packaging
  • nomenclature
  • compounding
  • dispensing
  • distribution
  • admin
  • education
  • monitoring
  • use
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7
Q

what is the simplified definition of a medication incident?

A

a mistake with medication, or a problem that could cause a mistake with medication

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8
Q

what are the 3 main reasons to monitor pharmacovigilance

A

safety, efficacy, quality

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9
Q

what are some barriers to reporting?

A
  1. resource and time limitations
  2. lack of familiarity
  3. lack of awareness
  4. lack of technology supports
  5. complacency
  6. uncertainty
  7. fear of consequences
  8. limited feedback
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10
Q

it is estimated that only __% of ADRs are reported

A

6%

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11
Q

what NAPRA standard of practice dictates that Phc must report ADRs

A

standard #3 (safety and quality)

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12
Q

what NSCP standard of practice dictates that Phc should report ADRs?

A

standard #7: contribute to social health and the effectiveness of the health care system

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13
Q

ADRs reporting should be done for what types of products?

A
  • Rx drugs
  • non-rx drugs
  • NHP
  • biologics (niotech, vaccines, fractionated blood products, human blood, cells, tissues, organs
  • disinfectants
  • radiopharmaceuticals
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14
Q

aside form ADRs, what other events are considered reportanble?

A
  • abuse
  • overdose
  • interactions
  • unusual lack of efficacy
  • teratogenic effects
  • exaggerated response
  • any unintended response
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15
Q

t/f ADRs are most often “suspected” associations

A

t

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16
Q

is proof that a health product caused an undesirable effect required for ADR reporting?

A

NO!

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17
Q

clinicians should report all clinically significant suspected ADRs, but especially those that are one or multiple of what 3 things?

A
  1. unexpected
  2. serious
  3. product has been on the market for less than 5 years
18
Q

what are the two ways you can report an ADR to the Canada vigilance office?

A

mail or online

19
Q

what details will a good case report include (if the info is known)?

A
  1. patient characteristics and relevant Hx
  2. drug details (formulation, strength, dose, epiry etc/)
  3. therapy dates (start and stop, ADR date etc.)
  4. changes to therapy and impact on the patient (ex: dechallenge or rechallenge etc.)
  5. clear description of events (onset, signs, Sx, clinical course and resolution)
  6. documentation of diagnosis and outcomes
  7. lab values
  8. treatment given for the ADR
20
Q

what are some risk factors for experiencing an ADR?

A
  • age
  • multiple medications
  • multiple co-morbid conditions
  • inappropriate medication prescribing, use, or monitoring
  • end-organ dysfunction
  • altered physiology
  • prior Hx of ADRs
  • extent (dose) and duration of exposure
  • genetic predisposition
21
Q

what are some signals that should alert you that the sx a patient may be experiencing may be due to an ADR?

A
  • newly started
  • dosage is changed
  • subbed for another drug in the same family
  • duplication
  • inetractions
  • used with no apparent indication
  • is used to treat adverse sx/side effects
  • is used for too long or too little
  • sudden need for rescue drug (ex: naloxone)
22
Q

what is the purpose of the Naranjo ADR probability scale?

A

ranks how liley the Sx are due to an ADR

23
Q

t/f organizations need to have a process in place for monitoring and reporting ADRs in order to gain accredidation from accreditation Canada

A

t

24
Q

what is the purpose of Vanessa’s law?

A

to have the government be more careful about which medications they allow to go on the market

25
Q

t/f mandatory reporting of serious ADRs and ADIs by hospitals is part of Vanessa’s law

A

t

26
Q

what is a medical device incident?

A

an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or directions that has led to death or serious deterioration or could recur

27
Q

what does serious deterioration mean in the context of health?

A

life-threatening dx, disorder or abnormal physical stat, the permanent impairment of a body function, permanent damage to a body structure, requiring unexpected medical or surgical intervention to prevent a dx or abnormal physical state or permanent impairment or damage

28
Q

how soon after a serious ADR must hospitals report?

A

within 30 days of first documentation of ADR within the hospital

29
Q

what products are excluded from mandatory reporting by hospitals?

A
  1. vaccines given as part of routine immunization
  2. NHPs
  3. cannabis
  4. blood & components
  5. cells, tissues, organs
  6. semen & ova
  7. drugs for clinical trials, devices for investigational testing and drugs/devices accessed via Special Access
30
Q

what information is required for serious ADR reporting?

A
  1. reporter contact information
  2. suspect product info
  3. patient age, sex, and medical hx
  4. SADR info (documentation date, start/end of therapy dates, start and stop of ADR dates, oucome)
31
Q

t/f hospitals are exempt from needing to report a serious ADR if it does not have the control to provide teh information of the 4 essential data elements

A

t

32
Q

what are the 4-point mandatory reporting criteria for ADRs?

A
  1. does your report include a drug w/i the scope of the federal regulations for mandatory reporting?
  2. is the ADR considered serious?
  3. was the ADR documented in the hospital?
  4. does your facility meet the definition of “hospital”?
33
Q

what information is required for MDI reporting?

A
  1. reporter contact info
  2. suspect product info (name, manufacturer name, lot/serial #)
  3. MDI infromtion (what happened and when and what was the outcome?
34
Q

what are the 4-point mandatory reporting criteria for MDIs?

A
  1. does the incident involve a medical device
  2. is there a suspected failure of the device, deterioration in its effectiveness, or any indequacy in its labelling or directions or use?
  3. has the incident resulted in death or serious deterioration or could recur?
  4. was the incident documented w/i a hospital?
35
Q

what is a signal?

A

reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information

36
Q

a signal consists of a _____ together with ____ and _____

A

hypothesis; data; arguments

37
Q

what is signal detection?

A

the search for and selection of possible relevant associations between a health product and a reaction (hypothesis generation)

38
Q

what is included in a signal assessment?

A

causality assessment, review of available data, literature review, biological plausibility, periodic safety update report review or other MAH data

39
Q

what are the steps for management of AR and MDP reports?

A
  1. AR or MDP report received by Health Canada
  2. AR or MDP report processing
  3. signal detection
  4. signal prioritization
  5. signal assessment/safety review
  6. risk mitigation
  7. possible risk communication
40
Q

health canada has multiple mechanisms to share learning from reported ADRs and MDPs, such as the ______ and _____

A

Drug and Health Product Register and MedEffcet Canada

41
Q

health canada recalls & safety alerts include recalls & safety alerts for what types of products?

A
  1. health products
  2. consumer products
  3. vehicles
  4. food

SBA PY2 Fall (13 decks)

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