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Membranes and Receptors > Lecture 10.1: Adverse Drug Reactions and Pharmacovigilance > Flashcards

Lecture 10.1: Adverse Drug Reactions and Pharmacovigilance Flashcards

1
Q

What is an Adverse Drug Reaction?

A

Unwanted or harmful reaction following administration of a drug or combination of drugs under normal conditions of use suspected to be related to the drug

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2
Q

How can ADRs be catagorised?

A
  • Those that occur at concentrations within therapeutic
    range (side effects)
  • Those that occur beyond the therapeutic range (toxic
    effects)
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3
Q

What are the 2 classifications of adverse drug reactions?

A
  • Adverse affects related to the known pharmacological
    action of the drug
  • Adverse affects unrelated to the known
    pharmacological action of the drug
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4
Q

Type A: Augmented Reactions

A
  • Predictable from knowledge of how a medication
    works
  • Dose related
  • Reversible
  • Adjust dose
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5
Q

Examples of Type A (Augmented Reactions) (4)

A
  • Opioid induced constipation: predictable consequence
    of opiate action on opioid receptors in the gut
  • Postural hypotension with alpha antagonists
  • Bleeding with anticoagulants
  • Hypoglycaemia with insulin
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6
Q

Type B: Bizarre Reactions or Idiosyncratic Reactions

A
  • Not related to the pharmacological action of the drug
  • Not predictable, uncommon, often fatal
  • Not dose dependent in the therapeutic range
  • Often immunological
  • Often linked to genetic variation
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7
Q

Examples of Type B (Bizarre Reactions or Idiosyncratic Reactions) (5)

A
  • Anaphylaxis and penicillin
  • Aplastic anaemia and chloramphenicol
  • Peripheral neuropathy and isoniazid
  • Agranulocytosis and carbimazole
  • Malignant hyperthermia and hepatitis from
    anaesthetic agents
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8
Q

Type C: Continuous Reactions

A
  • Persist relatively long time
  • Steroid therapy and osteoporosis
  • Prolonged steroid use and adrenal suppression
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9
Q

Type D: Delayed Reactions

A
  • Apparent sometime after use of a medicine
  • Azathioprine immunosuppression and malignancy
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10
Q

Type E: End of Use Reactions

A

E.g insomnia, anxiety, perceptual disturbances following
benzodiazepine withdrawal

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11
Q

Type F: Failure

A

Failure of oral contraceptive and enzyme inducer

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12
Q

What is the DoTS System?

A
  • Dose
  • Timing
  • Susceptibilities
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13
Q

What is Hypersusceptibility?

A

ADR at much lower than therapeutic doses

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14
Q

What are Collateral Effects?

A

ADR at therapeutic doses

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15
Q

What are Toxic Effects?

A

ADR at doses higher than therapeutic

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16
Q

Types of Time Dependent Reactions (6)

A
  • Rapid Reactions
  • Early Reactions
  • First Dose Reactions
  • Intermediate Reactions
  • Late Reactions
  • Delayed Reactions
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17
Q

What are Rapid Reactions? Example?

A
  • Occur when a drug is administered too rapidly
  • Red man syndrome following rapid infusion of
    vancomycin
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18
Q

What are Early Reactions? Example?

A
  • Occur early in treatment and then abate with time
    (tolerance)
  • Nitrate induced headache
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19
Q

What are First Dose Reactions? Example?

A
  • Occur after first dose
  • Hypotension after ACEI
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20
Q

What are Intermediate Reactions? Example?

A
  • Occur after some delay, if reaction does not occur
    after a certain time then little or no risk is posed
  • Some allergic reactions
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21
Q

What are Late Reactions? Example?

A
  • Risk of ADR increases with continued repeated
    exposure, including withdrawal symptoms
  • Withdrawal reactions following long-term
    corticosteroids
22
Q

What are Delayed Reactions? Example?

A
  • Occur sometime after exposure, even if drug
    withdrawn
  • Teratogens (thalidomide)
23
Q

Drug Development Process (5)

A
  • Drug Discovery (2-5 yrs)
  • Preclinical Development (1.5yrs)
  • Clinical Development (3 Phases) (5-7yrs)
  • Regulatory Approval (1-2yrs)
  • Post Marketing Surveillance
24
Q

What are the Stages of Clinical Trials/Development (3)

A
  • Phase 1 (human volunteers)
  • Phase 2 (few hundred patients with target disease)
  • Phase 3 (controlled clinical trial – several thousand
    patients with target disease)
25
Q

Medical Product Characteristics (SPC): What are Contraindications?

A

Defines the patient populations who must not take the medicine

26
Q

Medical Product Characteristics (SPC): Undesirable Effects

A

Summary of safety profile of the medicine informing on the most serious and/or most frequently occurring adverse reactions. A tabulated list of all adverse reactions with their respective frequency

27
Q

What does it mean when the Frequency of Side-Effects is Very Common?

A

Greater than 1 in 10 (10% +)

28
Q

What does it mean when the Frequency of Side-Effects is Common?

A

1 in 100 to 1 in 10 (1-10%)

29
Q

What does it mean when the Frequency of Side-Effects is Uncommon?

A

1 in 1000 to 1 in 100 (0.1 – 1%)

30
Q

What does it mean when the Frequency of Side-Effects is Rare?

A

1 in 10 000 to 1 in 1000 (0.01 – 0.1%)

31
Q

What does it mean when the Frequency of Side-Effects is Very Rare?

A

Less than 1 in 10 000 (0.01% or less)

32
Q

What does it mean when the Frequency of Side-Effects is Frequency Not Known?

A

Frequency is not defined by product literature or the side-effect has been reported from post-marketing surveillance data

33
Q

What is Pharmacovigilance?

A

The practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions

34
Q

What is the Yellow Card Scheme?

A

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency to ensure safe and effective use

35
Q

What does a Black Triangle indicate about a medication?

A
  • Highlight medicines that are subject to intensive safety
    monitoring
  • The black triangle alerts both patients HCPs that the
    medicine is being closely monitored by European
    regulatory authorities
36
Q

How is Toxicity Testing carried out? (6)

A
  • Animals: assumption is toxicity similar in humans but
    may be interspecies differences in drug metabolising
    enzymes
  • Biochemistry, post mortem
  • Doses well above therapeutic: target organs for
    toxicity
  • Reversible or irreversible carcinogenesis/
    neurodegeneration)
  • Liver: hepatocytes exposed to metabolites
  • Kidney: renal tubule
37
Q

What drugs can cause altered intraglomerular haemodynamics? (3)

A
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Angiotensin-converting enzyme inhibitors (ACEi)
  • Angiotensin receptor blockers (ARB)
38
Q

What is Tubular Cell Toxicity?

A
  • Tubular cells exposed to high levels of toxins
    (concentrating reabsorbing)
  • Metabolically active
  • Toxins impair mitochondrial function and tubular
    transport
39
Q

What drugs can cause Tubular Cell Toxicity? (4)

A
  • Gentamicin
  • Iodinated contrast agents
  • Antiretrovirals
  • Cisplatin
40
Q

What drugs can cause Inflammatory Changes in the renal system? (7)

A
  • Allopurinol
  • Antibiotics (beta lactams, quinolones, sulfonamides,
    and vancomycin)
  • Antivirals (acyclovir)
  • Diuretics (loop, thiazides);
  • NSAIDs
  • Phenytoin
  • PPIs (lansoprazole)
41
Q

What drugs can cause Crystal Depositions in the renal system? (5)

A
  • Ampicillin
  • Ciprofloxacin
  • Acyclovir
  • Methotrexate
  • Chemotherapy for lymphoproliferative disease -
    tumour lysis syndrome - uric acid and calcium
    phosphate crystal deposition
42
Q

What drugs can cause Rhabdomyolysis? (2)

A
  • Statins
  • > 150 medications and toxins have been implicated -
    cocaine, heroin)
43
Q

What drugs can cause Thrombotic Microangiopathy? (5)

A
  • Platelet thrombi in the microcirculation
  • Antiplatelet agents (clopidogrel)
  • Cyclosporine
  • Mitomycin-C
  • Quinine
44
Q

What is Thrombotic Microangiopathy?

A

Clinical syndromes defined by the presence of hemolytic anemia (destruction of red blood cells), low platelets, and organ damage due to the formation of microscopic blood clots in capillaries and small arteries

45
Q

Mutagenesis

A
  • Modification of DNA bases
  • Chromosomal damage
  • Mutation in proto-oncogenes and tumour suppressor
    genes
46
Q

Teratogenesis

A

A process that causes birth defects or malformations in an embryo or foetus

47
Q

Taking what supplement can reduce spontaneous and drug induced neural tube defects?

A

Folate/Folic Acid

48
Q

Effects of Antiepileptic Drugs in Pregnancy

A
  • Congenital malformations 2-3 X in mums with epilepsy
  • Phenytoin – cleft lip and palate
  • Valproate – neural tube defects
  • Valproate rate of congenital abnormality 10% and a
    30% to 40% chance of a wide range of early.
    developmental problems that can lead to learning
    disabilities
  • Carbamazepine - spina bifida
49
Q

Rifampin, antituberculosis drug is an inducer of isoenzyme CYP2C9 which leads to…?

A

Decreased plasma levels of HIV protease inhibitors, disabling suppression of HIV replication

50
Q

Omeprazole is an inhibitor of CYP2C9 which may lead to increased warfarin plasma levels leading to …?

A

Bigger anticoagulant effect and greater risk of
bleeding

Membranes and Receptors (19 decks)

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