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Therapeutics > Rational Drug Use > Flashcards

Rational Drug Use Flashcards

1
Q

What is the process of Rational Drug Use?

A

Rational Drug Use involves ensuring that the correct drug is prescribed at the appropriate dose, via the right route of administration, for the correct duration of treatment, with proper advice and monitoring, tailored to the specific diagnosis for that particular patient.

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2
Q

What factors influence prescribing

A
  • Context
  • Prescriber
  • Patient
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3
Q

What prescriber factors can influence prescribing decisions?

A

Prescriber factors include knowledge deficits, prior experience, acquired habits, and cultural beliefs.

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4
Q

How can patient factors influence prescribing?

A

Patient factors that influence prescribing include patient demand and cultural beliefs.

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5
Q

What contextual factors affect prescribing practices?

A

Contextual factors include unbiased information versus pharmaceutical industry influence, authority, supervision, peer pressure, workload, and the availability of medicines and other resources

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6
Q

What are the benefits of using a limited range of carefully selected essential medicines?

A

Using a limited range of carefully selected essential medicines leads to better health care, improved drug management, and lower costs.

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7
Q

How are essential medicines defined?

A

Essential medicines are defined as those that satisfy the priority health care needs of the population.

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8
Q

6 steps to rational prescribing by WHO

A
  1. Define Problem
  2. Set Therapeutic Objectives
  3. Select Therapy
    - non-drug therapy
    - drug therapy
    –> P-drugs (generic treatment plans)
    –> Patient drugs (adapted treatment plans)
  4. Practical Aspects of Prescribing
    - prescription writing
  5. Information, Instructions and Warnings
  6. Monitor Therapy (alter, continue, stop)
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9
Q

What does it mean to monitor therapy

A

Are therapeutic objectives being achieved? Are medicines tolerated? Make timely decision to continue, change or stop the treatment.
Reinforce information, instructions and warnings. If needed, review diagnosis

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10
Q

What is a P-drug and what does it focus on?

A

A P-drug is a generic treatment plan that represents the prescriber’s first-line therapy. It focuses on efficacy, safety, suitability, and cost. It is selected based on evidence-based appraisal of risks and benefits and is a key pharmacotherapy learning tool for prescribers.

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11
Q

How is a P-drug personalized?

A

A P-drug is personal to the prescriber and is chosen based on its proven effectiveness, safety, and affordability, as assessed through evidence-based practices.

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12
Q

Why might an individual patient need a treatment different from the P-drug?

A

An individual patient might need a different treatment due to comorbidities, cautions and contraindications, concomitant medications and drug-drug interactions, as well as considerations of convenience and compliance.

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13
Q

What factors should be considered when adjusting treatment from the P-drug for an individual patient?

A

Factors include the patient’s comorbidities, cautions and contraindications, interactions with other medications, and aspects of convenience and compliance.

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14
Q

What is an Adverse Drug Event (ADE)?

A

An Adverse Drug Event (ADE) is a medical occurrence temporally associated with the use of a medicinal product but not necessarily causally related. It includes any new clinical experience after starting a medication, recorded without judgment on its causality.

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15
Q

How is an Adverse Drug Reaction (ADR) defined?

A

An Adverse Drug Reaction (ADR) is a noxious and unintended response to a drug that occurs at doses normally used for the prophylaxis, diagnosis, or therapy of disease, or for modifying physiological function.

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16
Q

What is the purpose of causality assessment in drug safety?

A

The purpose of causality assessment is to determine how closely a medicine is related to an adverse event and whether the medicine caused the event.

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17
Q

What are Bradford-Hill’s criteria for causation?

A

Bradford-Hill’s criteria for causation are 9 principles used to establish epidemiologic evidence of a causal relationship between a presumed cause and an observed effect

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18
Q

Principles of the Hill’s criteria for causation

A
  1. Strength of the association (effect size)
  2. Consistency of findings/reproducibility
  3. Specificity of the association
  4. Temporal sequence of association
  5. Biological gradient / dose-response relationship
  6. Biological plausibility
  7. Coherence
  8. Experiment
  9. Analogy
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19
Q

Strength of the Association

A

The stronger the association between the risk factor and outcome, the more likely the relationship is causal

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20
Q

Consistency of Findings

A

Have the same findings must be observed among different populations, in different study designs and different times?

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21
Q

Specificity of the Association

A

There should be a one-to-one relationship between cause and outcome.

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22
Q

Temporal Sequence

A

The exposure must precede the outcome.

23
Q

Biological Gradient (Dose-Response Relationship):

A

Changes in disease rates should correspond with changes in exposure levels

24
Q

Biological Plausibility

A

There should be a potential biological mechanism for the observed effect.

25
Q

Coherence:

A

The relationship should align with current knowledge of the disease’s natural history and biology.

26
Q

Experiment:

A

Removal of the exposure should alter the frequency of the outcome.

27
Q

Analogy

A

The effect should be similar to other known effects produced by the same or similar agents

28
Q

WHO UMC Causality criteria

A
  1. Certain
  2. Probable/ Likely
  3. Possible
  4. Unlikely
  5. Conditional/ unclassified
  6. Unassessable/ Unclassifiable
29
Q

What does the “Certain” category in the WHO-UMC system indicate?

A

The “Certain” category indicates that a causal relationship between the drug and the adverse event is established.

30
Q

What criteria must be met to classify an adverse drug reaction as “Certain”?

A

To classify an adverse drug reaction as “Certain,” the following criteria must be met:

  1. The event or laboratory test abnormality occurs after drug administration.
  2. The reaction follows a known time course from drug exposure.
  3. The reaction is confirmed by objective evidence or the event resolves upon discontinuation of the drug.
31
Q

What does the “Probable” or “Likely” category in the WHO-UMC system suggest about the causal relationship?

A

The “Probable” or “Likely” category suggests that a causal relationship is likely, but not as firmly established as “Certain.”

32
Q

What criteria must be met to classify an adverse drug reaction as “Probable” or “Likely”?

A

To classify an adverse drug reaction as “Probable” or “Likely,” the following criteria must be met:

  1. The event or laboratory test abnormality occurs after drug administration.
  2. The reaction follows a known time course from drug exposure.
  3. The reaction improves on drug withdrawal or dosage reduction.
  4. Other causes of the event are unlikely or ruled out.
33
Q

What does the “Possible” category in the WHO-UMC system imply about the causal relationship?

A

The “Possible” category implies that a causal relationship is plausible but not clearly established.

34
Q

What criteria must be met to classify an adverse drug reaction as “Possible”?

A

To classify an adverse drug reaction as “Possible,” the following criteria must be met:

  1. The event or laboratory test abnormality occurs after drug administration.
  2. The reaction follows a known time course from drug exposure, but the link is less clear.
  3. Other potential causes are not excluded, but there is no strong evidence to confirm the drug as the cause.
35
Q

What does the “Unlikely” category in the WHO-UMC system indicate about the causal relationship?

A

The “Unlikely” category indicates that a causal relationship between the drug and the adverse event is unlikely.

36
Q

What criteria must be met to classify an adverse drug reaction as “Unlikely”?

A

To classify an adverse drug reaction as “Unlikely,” the following criteria must be met:

  1. The event or laboratory test abnormality does not follow a known time course from drug exposure.
  2. Other potential causes are more likely, and the reaction does not improve significantly upon discontinuation of the drug.
37
Q

What does the “Not Assessable” or “Unclassifiable” category in the WHO-UMC system indicate about the causal relationship?

A

The “Not Assessable” or “Unclassifiable” category indicates that there is insufficient information to assess the causal relationship.

38
Q
A
39
Q

What criteria must be met to classify an adverse drug reaction as “Not Assessable” or “Unclassifiable”?

A

To classify an adverse drug reaction as “Not Assessable” or “Unclassifiable,” the following criteria must be met:

  1. Information is incomplete or insufficient to make a clear assessment.
  2. There may be missing details about the drug exposure or the event.
40
Q

What are the main categories in the WHO-UMC system for classifying adverse drug reactions?

A

The main categories are:

  1. Certain: Clear evidence of causality.
  2. Probable/Likely: Likely causality with reasonable evidence.
  3. Possible: Plausible but not strongly established.
  4. Unlikely: Unlikely causality, with other causes more probable.
  5. Not Assessable: Insufficient information to determine causality.
41
Q

Why are ADRs often referred to as “the great masquerader of disease”?

A

ADRs are referred to as “the great masquerader of disease” because they can present with symptoms that mimic or overlap with various medical conditions, making them challenging to identify and potentially leading to misdiagnosis.

42
Q

What is the impact of misdiagnosing an ADR as a new condition?

A

Misdiagnosing an ADR as a new condition can result in inappropriate treatment and potentially exacerbate the patient’s condition, leading to further complications and ineffective management of the original problem.

43
Q

Why is it important to conduct a comprehensive assessment of risk versus benefit when prescribing medication?

A

A comprehensive assessment of risk versus benefit is crucial to ensure that the potential benefits of a medication outweigh its risks, minimizing the likelihood of adverse drug reactions and maximizing therapeutic outcomes.

44
Q

How can familiarity with a medication contribute to its safety?

A

The safest medicines are those you know best because familiarity allows healthcare professionals to anticipate and recognize potential ADRs, understand appropriate dosing, and manage side effects more effectively.

45
Q

What role does the patient-practitioner relationship play in managing ADRs?

A

The patient-practitioner relationship is vital in managing ADRs because open communication allows patients to report adverse effects more effectively, and practitioners can provide better guidance, monitoring, and adjustments to treatment.

46
Q

Risk mitigation in rational drug use

A
  • Take a full history, including concomitant illness, medication (including OTC, CAT, SOA meds) and allergies
  • Heed contra-indications, cautions and warnings
  • Avoid unnecessary drugs
  • Avoid drug interactions
  • Use correct dose
  • Conduct appropriate monitoring
  • Report suspected ADRs
47
Q

The research steps before a new medicine can be approved for use (registered0

A
  1. drug research
  2. preclinical
  3. clinical trials
    - phase I
    - phase II
    - phase III
  4. evaluation/ approval
  5. phase IV studies
48
Q

Clinical trials: Phase 1

A

Drug or treatment is given to a small group of people (20-80) to evaluate its safety and identify side effects and safe dosage range

49
Q

Clinical trials: Phase 2

A

Drug or treatment is given to a medium group of people (100 -300) for further evaluation

50
Q

Clinical trials: Phase 3

A

Drug or treatment is given to a larger group of people (1000- 3000) to evaluate its safety

51
Q

Clinical trials : Phase 4

A

Phase IV studies occur after approval of a drug for marketing

Post marketing delineate additional information including the drug risk, benefits and optimal use

52
Q

What is the purpose of compiling and submitting preclinical, clinical studies, and manufacturing process data to regulatory authorities?

A

The purpose is to provide a comprehensive overview of the drug’s safety, efficacy, and quality to ensure that it meets regulatory standards before approval for public use.

53
Q

What is the primary purpose of conducting Phase IV clinical trials?

A

The primary purpose of Phase IV clinical trials is to gather additional information about a drug’s safety, efficacy, and overall performance once it is approved for public use and is on the market.

54
Q

Why is it necessary to conduct Phase IV clinical trials after a drug is approved?

A

Phase IV clinical trials are necessary to address several key areas not fully explored in earlier phases:

  1. Long-Term Effects: To assess the long-term effects of newly approved drugs, which may not be apparent in shorter-term studies.
  2. Rare Side Effects: To identify rare side effects that might not emerge in earlier phases due to smaller study populations.
  3. Cost-Effectiveness Comparison: To evaluate the drug’s cost-effectiveness compared to other conventional treatments or standard of care.
  4. Diverse Sub-Populations: To study the drug’s safety and efficacy across diverse sub-populations, including different age groups, genders, and ethnic backgrounds.

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