Definitions
Adverse Drug Event (ADE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment
Reportable health products
- prescription drugs
- otc drugs
- natural health products
- blood products
- organs
- vaccines
- sanitizers
- radiopharmaceuticals
Proof that a health product caused an undesirable patient effect (causality) is NOT a requirement for ADR reporting
True
Patient related factors
Age
• pediatrics and elderly
• Gender
• Pregnancy and
breastfeeding
• Fetal development
• Allergy
• Prior history of ADRs
• Body weight and fat
distribution
• Altered physiology
• Genetic predisposition
• Race and ethnicity
factors
Why do Nurses play a pivotal role in ADR reporting
Nurses can play a pivotal role in ADR reporting
» Caregivers, educators and final point of medication administration
» Form the largest proportion of health-care staff
» Changing scope of practice
Adverse Drug Reaction (ADR)
A noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function.
What are other reportable events?
- overdose
- drug interactions
- unusual lack of efficacy
-teratogenic effect
- exaggerated response
- unintended response
- abuse
Hospitals are required to report serious ADRs and MDIs to Health Canada, in writing, within 90 calendar days of first documentation of the reaction or incident within the hospital.
False - 30 days
Social Factors
• Alcohol drinking
• Smoking
• Recreation drug use
• Diet
We should suspect and ADR when a patient experiences a new symptom and a medication:
- has been recently started
- dose change
- substitution from other med
- is used longer than indicated
- has been abruptly d/c'd
Serious ADR
A noxious and unintended response to a drug that occurs at any dose and that:
‒ requires in-patient hospitalization
‒ prolongation of existing hospitalization
‒ causes congenital malformation
‒ results in persistent or significant disability or incapacity
‒ is life-threatening or results in death
Mandatory reporting criteria for adverse drug reactions
The ADR caused or prolonged hospitalization, caused a congenital malformation, caused persistent/significant disability, was life threatening, caused death or important medical events
Adverse reactions involving cannabis are not reportable to health canada
False! - whether for medical or non medical purposes should be reported
Drug Related Factors
• Polypharmacy
• Inappropriate
medication
prescribing, use, or
monitoring
• Extent (dose) and
duration of exposure
• Drug interactions
Suspect and ADR if:
- sudden need for rescue drug
- sudden need for additional therapies, procedures or surgeries
Medication Incident
A medication incident is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.
Who is required to report adverse medical events?
Hospitals
Nurse practitioners
Nurses
In the case of a serious ADR where a patient has died, hospitals should always select "death" as the outcome on the reporting form
False - death should only be selected as the reason for seriousness and "died" as an outcome on the mandatory form if it is directly relevant to the ADR (difference between "death" and "died")
Disease Related Factors
• Multiple co-morbid conditions
Vanessa's Law is:
A law that caused the following amendments to the food and drugs act:
1. Power to require information, tests or studies
2. Power to require a label change/package modification
3. Power to recall unsafe therapeutic products
4. Ability to require and disclose information in certain circumstances
5. Tougher measures for those that do not comply
6. Mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions
Name 5 designated medical events (Targeted monitoring strategies)
Acute pancreatitis
» Acute renal failure
» Agranulocytosis
» Anaphylactic reactions
» Convulsions
» Haemolytic disorders
» Haematopoietic cytopenia
» Hepatic disorders
» Rhabdomyolysis/myopathy
» Severe cutaneous adverse
reactions
Torsades de pointes/QT prolongation
» Guillain-Barré syndrome
» Infections specific (Herpes virus,
Papilloma virus, Polyomavirus, Prionassociated
disorders, Tuberculosis)
» Posterior Reversible Encephalopathy
Syndrome (PRES)
» Thrombotic Thrombocytopenia Purpura
» Serotonin Syndrome
» Neuroleptic Malignant Syndrome
What are the mandatory reporting criteria for medical devices?
Involves failure, deterioration or inadequacy of labelling/directions of a medical device which resulted in death, serious deterioration of health or potential for serious harm
What is a voluntary ADR report?
"No" to all serious criteria