Pharmacovigilance 3

Question 1

What are some causes of adverse drug reactions?

Answer 1

• inherent drug characteristics (active ingredient, excipients, formulation)
• quality problems (contamination with toxic heavy metals; counterfeits and substandard products)
• adulteration (with potent medicinal ingredients, analogs of potent medicinal ingredients)
• substitution of ingredients
• drug drug interactions; drug-food interactions
• long term exposure; high doses
• individual susceptibility (genetics eg HLA-B*1502 allele predisposes to severe skin reactions with carbamazepine)
• in-use issues

Question 2

What kind of ADRs most likely signify a drug association?

Answer 2

• SJS, TEN
• agranulocytosis
• acute dystonias
• drug induced liver injury
• cushing’s syndrome

Question 3

How is a diagnosis of an ADR arrived at?

Answer 3

After excluding all possible causes

Question 4

What is the presentation of SJS and TEN?

Answer 4

• severe mucosal erosions
• widespread erythematous macules
• epidermal detachment

Question 5

How do we diagnose DILI?

Answer 5

History of ingestion of drugs, including complementary medicines, within 12 months of onset of illness:

• exclusion of viral serology
• negative metabolic screen (autoimmune disorders or diseases which cause liver injury)
• daily alcohol intake < 20g
• absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen

Question 6

What is Cushing syndrome?

Answer 6

• a hormonal disorder due to long term exposure of high doses of steroids
• symptoms include: weight gain, increased appetite, insomnia can occur quite quickly. however, cushing appearance takes weeks to months to develop (moon face, buffalo hump, thinning of skin etc)
• other effects include increased BP, increased blood sugar, decreased immunity, bone loss and cataracts.

Question 7

What is the most common cause of Cushing syndrome?

Answer 7

Exogenous source eg adulterated products or ingestion of steroids knowingly

Question 8

What are the toxic heavy metals limits for complementary medicines?

Answer 8

arsenic - 5 ppm
cadmium - 0.3 ppm
lead - 10 ppm
mercury - 0.5 ppm

Question 9

What are some examples of adulterated complementary health products?

Answer 9

Virility products:

• sildenafil and analogues
• tadalafil and analogues

Anti-inflammatory products:

• dexamethasone
• NSAIDs

Slimming products:
- sibutramine