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CP - 1 > 16 - Adverse Drug Reactions > Flashcards

16 - Adverse Drug Reactions Flashcards

1
Q

ADR

A

Response to a drug that is noxious and unintended and which occurs at doses normally used. Most are mild, severe reactions are uncommon

Any unexpected, undesired, unintended, excessive response to a medicine that requires clinically significant action

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2
Q

How do ADRs relate to medication errors?

A

Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence or monitoring a drug. More common but result in harm less than 1% of the time.

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3
Q

Adverse drug event?

A

An adverse drug EVENT is an injury that results from the use of a drug (incl. OD, ADRs, dose reductions.

Adverse drug events can rseult from medication errors but MOST do not.

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4
Q

Allergy?

A

An allergy IS and adverse drug reaction. It is specifically and ADR that is mediated by an immune response.

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5
Q

Side effect?

A

A side effect is also an ADR - but it is an expected and known effect that is NOT the intended therapeutic outcome

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6
Q

Classification of ADRs according to DoTS (dose, timing, susceptibility)

A

Dose

  • supratherapeutic (toxic effects)
  • standard therapeutic (collateral effects)
  • Subtherapeutic doses in susceptible people
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7
Q

Classification of ADRs according to DoTS (dose, timing, susceptibility)

A 
Timing
- Timing independent reactions
- Timing dependent reactions
Rapid 
First dose
Early (i.e. opiates and nausea)
Intermediate
Late
Delayed
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8
Q

Classification of ADRs according to DoTS (dose, timing, susceptibility)

A

Susceptibility

- reasons for hypersensitivity include genetics, age, sex, disease etc

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9
Q

4 reasons that ADRs are important

A
  1. Cause death and serious harm
  2. Hospital admission or prolonged stay
  3. Cost
  4. Many are preventable (often occur IN hospital)
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10
Q

Elderly on warfarin with intracerebral haemorrhage - what makes her susceptible to an ADR

A

age

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11
Q

What patients are at higher risk to ADRs

A
  • younger children (need to tailor doses) and elderly (comorbidities, reduced physiological reserve, use more drugs)
  • comorbidities (esp renal impairment - clearance/elimination)
  • polypharmacy
  • women (lower body weight and organ size)
  • race and genetic polymorphism
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12
Q

Dr based strategies to prevent ADRs

A
  • avoid and be aware of high risk drugs and conditions
  • stop unnecessary drugs
  • if there is a new symptom consider that it could be the drug
  • avoid treating side effects with another drug
  • avoid drug-drug interactions
  • adjust dosing based on CLcr
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13
Q

Systems based strategies to prevent ADRs i.e. healthcare

A
  • computerised order system
  • electronic medication administration record
  • bar coding
  • smart pumps
  • education programs (MODEST effect)
  • accurate allergy list
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14
Q

2 places to find out about ADRs

A
  1. Nz Formulary

2. Medsafe (data sheets) - drug regulatory authority in NZ. Contains every approved drug in NZ

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15
Q

What 2 places does knowledge about ADRs come from?

A
  • drug development and clinical studies

- surveillance (post market and prescription event monitoring and reporting of ADRs)

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16
Q

Phase 1

A

Tolerability

- note the dose at which adverse effects occur

17
Q

Phase 3

A

Safety

- learn the adverse effects in the target population

18
Q

Phase 4

A

Post Marketing

  • confirm the common adverse effects
  • learn the less common adverse effects
19
Q

What 4 things for safety does Medsafe contain

A
  1. education and information
  2. Alerts
  3. recalls
  4. report a problem

On NZ Formulary there is also a patient information sheet for every drug. If extensive info then should be discussed with the patient

20
Q

How can you tell if its an ADR

A
  • ALWAYS consider the possibility that a drug may be associated with worsening of a condition or a new medical problem
  • is the drug KNOWN to cause such a reaction
  • rule out alternative explanations
  • timing; is there a temporal link between onset of rx and drug administration
  • probability assessment tool (naranjo probability scale)
21
Q

What 4 things do you do when you suggest an ADR

A
  1. withdraw the medicine
  2. record the suspected ADR in the drug chart
  3. inform the patient, care giver, family dr
  4. Complete a CARM ADR form
22
Q

CARM reporting?

A

WHAT
- ADR only has to be suspected not known
- do not need evidence of association of cause
WHO
- health professionals, pharm companies, consumers
HOW
- record patient details, medicine and event
- yellow form on ward
- return by email, post, fax

23
Q

What are some strategies to avoid ADRs

A
  • do not give a drug unless absolutely indicated
  • use a familiar drug if possible
  • look out for DRs when prescribing a new med
  • prescribe as few as possible
  • give very clear instructions on taking the medicine
  • assess if taking other medications incl herbal
  • have they had previous reactions
  • warn the patient of side effects/potential ADRs

CP - 1 (11 decks)

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