Adverse Reaction Reporting

Question 1

what reporting is mandatory by hospitals?

Answer 1

all serious ADRs and MDIs

Question 2

what is an adverse drug event?

Answer 2

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

Question 3

what is an adverse drug reaction (ADR)?

Answer 3

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

Question 4

what is a serious ADR?

Answer 4

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

Question 5

what is a medication incident?

Answer 5

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

Question 6

medication incidents can be in relation to what things?

Answer 6

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

Question 7

what is the simplified definition of a medication incident?

Answer 7

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

Question 8

what are the 3 main reasons to monitor pharmacovigilance

Answer 8

safety, efficacy, quality

Question 9

what are some barriers to reporting?

Answer 9

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

Question 10

it is estimated that only __% of ADRs are reported

Answer 10

6%

Question 11

what NAPRA standard of practice dictates that Phc must report ADRs

Answer 11

standard #3 (safety and quality)

Question 12

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

Answer 12

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

Question 13

ADRs reporting should be done for what types of products?

Answer 13

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

Question 14

aside form ADRs, what other events are considered reportanble?

Answer 14

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

Question 15

t/f ADRs are most often “suspected” associations

Answer 15

t

Question 16

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

Answer 16

NO!

Question 17

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

Answer 17

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

Question 18

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

Answer 18

mail or online

Question 19

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

Answer 19

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

Question 20

what are some risk factors for experiencing an ADR?

Answer 20

• 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

Question 21

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

Answer 21

• 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)

Question 22

what is the purpose of the Naranjo ADR probability scale?

Answer 22

ranks how liley the Sx are due to an ADR

Question 23

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

Answer 23

t

Question 24

what is the purpose of Vanessa’s law?

Answer 24

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

Question 25

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

Answer 25

t

Question 26

what is a medical device incident?

Answer 26

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

Question 27

what does serious deterioration mean in the context of health?

Answer 27

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

Question 28

how soon after a serious ADR must hospitals report?

Answer 28

within 30 days of first documentation of ADR within the hospital

Question 29

what products are excluded from mandatory reporting by hospitals?

Answer 29

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

Question 30

what information is required for serious ADR reporting?

Answer 30

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)

Question 31

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

Answer 31

t

Question 32

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

Answer 32

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"?

Question 33

what information is required for MDI reporting?

Answer 33

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?

Question 34

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

Answer 34

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?

Question 35

what is a signal?

Answer 35

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

Question 36

a signal consists of a _____ together with ____ and _____

Answer 36

hypothesis; data; arguments

Question 37

what is signal detection?

Answer 37

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

Question 38

what is included in a signal assessment?

Answer 38

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

Question 39

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

Answer 39

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

Question 40

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

Answer 40

Drug and Health Product Register and MedEffcet Canada

Question 41

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

Answer 41

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