MN553 Advanced Pharmacology and
Pharmacotherapeutics:GRADED A.
Clinical Judgment in Prescribing - answer Is a prescription the right treatment? What
are the effective drugs for the disease?
What are the goals of therapy? Monitoring to see if drug is meeting goals? Duplications
in medications patient is taking?
Over-the-counter vs. prescription drugs Cost?
Sources of information
The Process of Rational Drug Prescribing - answer Define the patient's problem.
Specify the therapeutic objective. Collaborate with the patient.
Choose the treatment.
Educate the patient.
Monitor effectiveness.
Specify the Therapeutic Objective - answer Goal of treatment
Cure the disease?
Relieve symptoms of disease? Replacing deficiencies (e.g., insulin)? Long-term
prevention?
I Can PresCribE A Drug Mnemonic - answer Indication
Contraindications
Precautions
Cost/Compliance
Efficacy
Adverse effects Dose/Duration/Direction
Monitor Effectiveness - answer Passive monitoring: Patient is educated on expected
outcome and instructed to contact provider.
Active monitoring: follow-up laboratory tests or monitoring to measure therapeutic
effectiveness
Drug Factors Influencing Drug Selection - answer Pharmacokinetic factors
Pharmacodynamic factors
Therapeutic factors
Safety
Cost (to patient and to society)
Patient factors
Provider factors
Pharmacokinetic Factors - answer Bioavailability
CYP 450 metabolism
Renal elimination
Dose-concentration curve
Half-life
, MN553 Advanced Pharmacology and
Pharmacotherapeutics:GRADED A.
Pharmacodynamic Factors - answer Ease of titration
Therapeutic index
A narrow therapeutic index is more difficult to manage.
A wider therapeutic index is safer and requires less monitoring.
Therapeutic Factors - answer Evidence for therapeutic impact
Clinical trials
Clinical practice guidelines
Systematic reviews
Randomized controlled trials
Extrapolate with caution
Safety - answer Safety profile is taken into consideration. Safety profile varies by
population.
Teratogens
Liver or renal disease
Drug allergy
MedWatch report
U.S. Food and Drug Administration advisories
Patient Factors - answer Previous ADRs
Health beliefs
Current drug therapy
Drug interactions
Consult PharmD regarding complex drug regimens.
Patient age
Pregnancy
Federal Food and Drug Act of 1906 - answer Due to children dying from tainted food
products
The 1938 Amendment to the Federal Food and Drug Act - answer After more than 100
children died after taking sulfanilamide
1962: Harris-Kefauver Amendment - answer Mandated preclinical animal trials before
testing drugs in children
FDA Modernization Act of 1997 - answer The U.S. Food and Drug Administration
(FDA) can make a request for pediatric data on drugs that may be used in children.
Provides a 6-month extension of the patent of medications that are studied in children
Implications for pediatric practice
More drugs studied for effectiveness in children
Pharmacotherapeutics:GRADED A.
Clinical Judgment in Prescribing - answer Is a prescription the right treatment? What
are the effective drugs for the disease?
What are the goals of therapy? Monitoring to see if drug is meeting goals? Duplications
in medications patient is taking?
Over-the-counter vs. prescription drugs Cost?
Sources of information
The Process of Rational Drug Prescribing - answer Define the patient's problem.
Specify the therapeutic objective. Collaborate with the patient.
Choose the treatment.
Educate the patient.
Monitor effectiveness.
Specify the Therapeutic Objective - answer Goal of treatment
Cure the disease?
Relieve symptoms of disease? Replacing deficiencies (e.g., insulin)? Long-term
prevention?
I Can PresCribE A Drug Mnemonic - answer Indication
Contraindications
Precautions
Cost/Compliance
Efficacy
Adverse effects Dose/Duration/Direction
Monitor Effectiveness - answer Passive monitoring: Patient is educated on expected
outcome and instructed to contact provider.
Active monitoring: follow-up laboratory tests or monitoring to measure therapeutic
effectiveness
Drug Factors Influencing Drug Selection - answer Pharmacokinetic factors
Pharmacodynamic factors
Therapeutic factors
Safety
Cost (to patient and to society)
Patient factors
Provider factors
Pharmacokinetic Factors - answer Bioavailability
CYP 450 metabolism
Renal elimination
Dose-concentration curve
Half-life
, MN553 Advanced Pharmacology and
Pharmacotherapeutics:GRADED A.
Pharmacodynamic Factors - answer Ease of titration
Therapeutic index
A narrow therapeutic index is more difficult to manage.
A wider therapeutic index is safer and requires less monitoring.
Therapeutic Factors - answer Evidence for therapeutic impact
Clinical trials
Clinical practice guidelines
Systematic reviews
Randomized controlled trials
Extrapolate with caution
Safety - answer Safety profile is taken into consideration. Safety profile varies by
population.
Teratogens
Liver or renal disease
Drug allergy
MedWatch report
U.S. Food and Drug Administration advisories
Patient Factors - answer Previous ADRs
Health beliefs
Current drug therapy
Drug interactions
Consult PharmD regarding complex drug regimens.
Patient age
Pregnancy
Federal Food and Drug Act of 1906 - answer Due to children dying from tainted food
products
The 1938 Amendment to the Federal Food and Drug Act - answer After more than 100
children died after taking sulfanilamide
1962: Harris-Kefauver Amendment - answer Mandated preclinical animal trials before
testing drugs in children
FDA Modernization Act of 1997 - answer The U.S. Food and Drug Administration
(FDA) can make a request for pediatric data on drugs that may be used in children.
Provides a 6-month extension of the patent of medications that are studied in children
Implications for pediatric practice
More drugs studied for effectiveness in children
