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a PR3145 > LEC 9 Pharmacovigilance lll > Flashcards

LEC 9 Pharmacovigilance lll Flashcards

1
Q

Causes of ADR (8)

A
  1. Inherent drug characteristics
  2. Quality problems
    - counterfeits
    - contamination with THM
  3. Adulteration
    - with potent medicinal ingredients or their analogues
  4. Substitution of ingredients
  5. DDI & FDI
  6. Long term exposure / high dose
  7. Individual susceptibility
    - genetics
  8. In-use issues
    - ReNu lens solution
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2
Q

Reactions that most likely signify a drug association (6)

A
  • SJS
  • TEN
  • agranulocytosis
  • acute dystonias
  • drug induced liver injury
  • cushing syndrome
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3
Q

SJS causes

A
  • drug induced

- infections

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4
Q

Liver toxicity causes (4)

A
  • viral diseases
  • drug induced liver toxicity (DILI)
  • autoimmune disorders
  • daily alcohol intake >20g
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5
Q

DILI

A

Drug Induced Liver Injury

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6
Q

Diagnosis of DILI (5)

A
  1. Exclude viral serology
    eg anti-HAV lgM, anti-HCV lgM
  2. Negative metabolic screen
    - autoimmune disease
  3. Daily alcohol intake <20g
  4. Absence of biliary or focal liver pathology on U/S or CT scan of abdomen
  5. History of ingestion of drugs / CPM within 12months of onset
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7
Q

Cushing Syndrome

A

Hormonal disorder resulting from long term exposure of high doses of steroids

  • weight gain
  • insomnia
  • increased BP & blood glucose
  • decreased immunity
  • bone loss
  • cataracts
  • cushing appearance
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8
Q

Cushing appearance (5)

A
  • moon face
  • buffalo hump
  • truncal weight gain
  • skin thinning
  • purplish striae
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9
Q

Causes of Cushing syndrome (4)

A
  1. Adrenal tumours
  2. Cushing disease (pituitary tumour)
    - common cause
  3. Ectopic ACTH-producing tumour
    eg lung tumour
  4. Exogeneous source
    eg drugs
    - MOST common cause
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10
Q

Pharmacovigilance of COVID-19 vaccination

A
  • anaphylaxis

- median time for onset of anaphylaxis is 30min

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11
Q

Why cannot observe patients receiving COVID-19 vaccination for 20min only instead of 30min?

A
  • anaphylaxis occurs after 20min for all age group except 60-69y/o (meaning 60-69y/o median time for anaphylaxis is less than 20min)
  • a reduction from 30min to 20min would result in only 1/3 of anaphylaxis cases being detected instead of 2/3 (30min)
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12
Q

THM

A

Toxic Heavy Metals

  • lead
  • arsenic
  • mercury
  • cadmium
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13
Q

THM contamination limits for complementary medicines

A
  1. Lead 10ppm
  2. Arsenic 5ppm
  3. Mercury 0.5ppm
  4. Cadmium 0.3ppm

LAMC

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14
Q

Lead poisoning signs & symptoms (4)

A
  • anemia with basophilic stippling (red spots on RBC)
  • burton’s line (black gum line)
  • abdominal pain
  • elevated blood lead levels
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15
Q

Mercury poisoning signs & symptoms (4)

A

Inhibit formation of melanin by competing with copper on tyrosinase

  • facial burns
  • skin discoloration
  • neurological toxicities
  • kidney toxicities
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16
Q

Complementary Health Products prone to adulterations (3)

A
  1. Virility products
    - sildenafil
    - vardenafil
    - tadalafil
    - gibenclamide
  2. Slimming products
    - sibutramine
  3. Anti-inflammatory products
    - dexamethasone
    - NSAIDs
17
Q

Illegal aphrodisiacs

A

Adulterated products to treat sexual dysfunction

18
Q

Signs & symptoms of hypoglycemia (7)

A
  • dizziness
  • cold sweat
  • loss of consciousness
  • increased plasma insulin
  • increased serum C-peptide
  • decreased blood sugar level
  • elevated blood/urine level of gibenclamide & its metabolites
19
Q

Cause of insulinomas (1)

A

Pancreatic tumours
- insulin secretion not properly regulated by glucose but the tumours secrete excessive insulin, resulting in glucose levels to decrease further

20
Q

Relationship between proinsulin, insulin & C-peptides (3)

A

Proinsulin = Insulin + C-peptides

  • cleavage of proinsulin produce insulin & C-peptides which are stored in beta cells
  • when insulin is required, insulin & C-peptides are released into bloodstream in equal amounts
  • hence C-peptides is useful as a marker of insulin
21
Q

Complications of hypoglycemia

A
  • coma

- death

22
Q

Future of pharmacovigilance (5)

A
  1. Opportunities in genomic era
  2. Emergence of Complementary Medicines
  3. Registries for biological products & gene therapy
  4. Forging closer ties with international counterparts
    - international data for pharmacovigilance
  5. Maximising IT tools for signal detection & communication
23
Q

Examples of Quality Problems leading to ADR (2)

A
  1. Counterfeit products
    - Eyemo
  2. Contaminated products with THM
    - Endopile (indian traditional medicine)
24
Q

Examples of Adulterated products leading to ADR (3)

A
  1. Illegal aphrodisiacs
    - gibenclamide
    - sildenafil
    - vardenafil
    - tadalafil
  2. Slimming products
    - sibutramine
  3. Anti-inflammatory products
    - dexamethasone
    - NSAIDs
25
Q

Example of In-use Issues leading to ADR (1)

A

ReNu contact lens solution

26
Q

In-use Issues (4)

A
  • GMP compliance
  • passed product testings
  • no counterfeit products
  • problem arise due to poor patient hygiene/habits which reduces margin of efficacy
27
Q

Anaphylaxis definition

A
  • rare but potentially life-threatening systemic hypersensitivity reaction
28
Q

SJS / TEN presentation (3)

A
  • severe mucosal erosions
  • epidermal detachment
  • widespread erythematous macules
29
Q

Can you get anaphylaxis on 2nd dose even though 1st dose don’t have?

A

Yes, it is possible

30
Q

Reporting of ADE relating to CPM

A
  • include batch number as mostly are due to batch issues
31
Q

Example of substitution of products (1)

A
  • Travacalm by Pan Pharmaceuticals with hyoscine
32
Q

Why companies use analogues of therapeutic compounds in adulterated products?

A
  • to avoid lab detections as their structures are slightly different
33
Q

Causes of hypoglycemia (3)

A
  • insulinomas (pancreatic tumours)
  • drug-induced hypoglycemia
  • autoimmune insulin syndrome
34
Q

Diagnosis of illegal aphrodisiacs containing hypoglycemic agents (5)

A
  • normal imaging of pancreas (rule out insulinomas)
  • blood glucose level low
  • high blood levels of insulin, C-peptide
  • blood/urine tests positive for gibenclamide
  • sampled drug tests positive for gibenclamide

a PR3145 (14 decks)

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