Clinical Pharmacology Basic Principles Review | Part One Study Guide
Medication Therapy Management (MTM) routine, scheduled (ex: monthly) follow-up on medication compliance, disease
state symptoms, and questions about medications.
Formulary a group of specific drugs from each medication class that a hospital chooses to
keep on-hand typically based on purchase price and/or efficacy
P&T Committee committee responsible for maintaining/updating formulary, writing policy and
procedures involoving medications, and general hospital policy and procedures
Adverse Drug Event (ADE) any injury or harm associated with the use of a medication, whether or not the
medication caused the harm directly.
Preventable ADE ADE occurs when a breach of standard professional behavior, practice, or
technique was identified or when the event could have been avoided by
modifying the behavior (ex: medication error)
Non-Preventable ADE ADE that is an unintended reaction without known mitigation strategies, which
result in patient harm (ex: Adverse Drug Reaction, ADR).
Adverse Drug Reaction (ADR) a harmful, unintended response to a drug when it is used at normal doses for the
correct indication.
Type A Reaction ADR that is an exaggerated pharmacologic action that is usually dose dependent
and predictable
Type B Reaction ADR that is unrelated to the pharmacologic action of the drug that is usually
unpredictable and may or may not be dose dependent.
Side Effect a known or observed additional effect(s) of a medication in addition to the
therapeutic effect
Medication Error mishaps that occur during the medication use process (ex: order was filled for
the wrong patient)
Tracer Drug drugs that are routinely prescribed to treat ADEs, such as antidotes, or
physiological antagonists or agents for gastric decontamination.
Local Reaction adverse effect limited to a single site, typically to the site of drug administration.
(think of shot injection)
Systemic Reaction adverse effect that affects multiple body symptoms
Allergic Drug Reaction an immune-mediated ADR that occurs when the immune system recognizes a
mediation (or medication metabolite) as a foreign antigen, resulting in a
reproducible hypersensitivity response upon re-exposure.
Anaphylaxis rapid-onset severe, systemic hypersensitivity reaction characterized by life-
threatening airway, breathing, and/or circulatory compromise.
, Clinical Pharmacology Basic Principles Review | Part One Study Guide
Type I Hypersensitivity an immune, IgE-mediated mast cell and basophil degranulation reaction that
occurs within minutes to hours
Type II Hypersensitivity a cytotoxic, IgG or IgM antibody reaction against cell-bound antigens that
occurs within days to weeks
Type III Hypersensitivity an immune complex reaction with complement activation that occurs
within 1-3 weeks
Type IV Hypersensitivity a delayed, T-cell mediated allergic reaction that occurs within 48 hours to
several weeks later
Warning potentially more serious adverse effect that is common with medication
use and may require additional monitoring
US Boxed Warning severe adverse effect that is common enough that the FDA required a
specific warning be issues alerting patients to risks before use
Contraindication clinical reason that dictates a drug cannot be used in a patient or
population due to the risk of using the drug not outweighing the benefit
Prescribing step in the medication administration process that involves choosing an
appropriate medication, dose, route, and frequency for a given clinical
situation, and taking individual patient factors into account such as
allergies
Transcribing step in the medication administration process that involves the process of
order verification by pharmacy and reviewing the order for appropriateness
Dispensing step in the medication administration process that involves providing
access to the medication
Administering step in the medication administration process that involves obtaining the
medication, preparing for administration, and giving the right medication to
the right patient, in the right dose, via the right route, at the right time
Monitoring step in the medication administration process that involves observing the
patient to determine if the medication is working, being used correctly, and
not harming the patient
Patient Compliance the extent to which a patient’s behavior aligns with the healthcare
provider’s prescribed medication regimen
Transitions of Care the movement of a patient between healthcare settings, providers, or levels
of care as their condition and healthcare needs change
National Coordinating Council for Medication Error an independent coalition of healthcare organizations that developed
Reporting and Prevention (NCC MERP) standardized definitions and classifications for medications errors that is
the most commonly used and widely recognized severity classification
system for medication errors in the United States
Punitive culture culture around medication errors that punishes the individual(s) who made
the error rather than improving systems
Medication Therapy Management (MTM) routine, scheduled (ex: monthly) follow-up on medication compliance, disease
state symptoms, and questions about medications.
Formulary a group of specific drugs from each medication class that a hospital chooses to
keep on-hand typically based on purchase price and/or efficacy
P&T Committee committee responsible for maintaining/updating formulary, writing policy and
procedures involoving medications, and general hospital policy and procedures
Adverse Drug Event (ADE) any injury or harm associated with the use of a medication, whether or not the
medication caused the harm directly.
Preventable ADE ADE occurs when a breach of standard professional behavior, practice, or
technique was identified or when the event could have been avoided by
modifying the behavior (ex: medication error)
Non-Preventable ADE ADE that is an unintended reaction without known mitigation strategies, which
result in patient harm (ex: Adverse Drug Reaction, ADR).
Adverse Drug Reaction (ADR) a harmful, unintended response to a drug when it is used at normal doses for the
correct indication.
Type A Reaction ADR that is an exaggerated pharmacologic action that is usually dose dependent
and predictable
Type B Reaction ADR that is unrelated to the pharmacologic action of the drug that is usually
unpredictable and may or may not be dose dependent.
Side Effect a known or observed additional effect(s) of a medication in addition to the
therapeutic effect
Medication Error mishaps that occur during the medication use process (ex: order was filled for
the wrong patient)
Tracer Drug drugs that are routinely prescribed to treat ADEs, such as antidotes, or
physiological antagonists or agents for gastric decontamination.
Local Reaction adverse effect limited to a single site, typically to the site of drug administration.
(think of shot injection)
Systemic Reaction adverse effect that affects multiple body symptoms
Allergic Drug Reaction an immune-mediated ADR that occurs when the immune system recognizes a
mediation (or medication metabolite) as a foreign antigen, resulting in a
reproducible hypersensitivity response upon re-exposure.
Anaphylaxis rapid-onset severe, systemic hypersensitivity reaction characterized by life-
threatening airway, breathing, and/or circulatory compromise.
, Clinical Pharmacology Basic Principles Review | Part One Study Guide
Type I Hypersensitivity an immune, IgE-mediated mast cell and basophil degranulation reaction that
occurs within minutes to hours
Type II Hypersensitivity a cytotoxic, IgG or IgM antibody reaction against cell-bound antigens that
occurs within days to weeks
Type III Hypersensitivity an immune complex reaction with complement activation that occurs
within 1-3 weeks
Type IV Hypersensitivity a delayed, T-cell mediated allergic reaction that occurs within 48 hours to
several weeks later
Warning potentially more serious adverse effect that is common with medication
use and may require additional monitoring
US Boxed Warning severe adverse effect that is common enough that the FDA required a
specific warning be issues alerting patients to risks before use
Contraindication clinical reason that dictates a drug cannot be used in a patient or
population due to the risk of using the drug not outweighing the benefit
Prescribing step in the medication administration process that involves choosing an
appropriate medication, dose, route, and frequency for a given clinical
situation, and taking individual patient factors into account such as
allergies
Transcribing step in the medication administration process that involves the process of
order verification by pharmacy and reviewing the order for appropriateness
Dispensing step in the medication administration process that involves providing
access to the medication
Administering step in the medication administration process that involves obtaining the
medication, preparing for administration, and giving the right medication to
the right patient, in the right dose, via the right route, at the right time
Monitoring step in the medication administration process that involves observing the
patient to determine if the medication is working, being used correctly, and
not harming the patient
Patient Compliance the extent to which a patient’s behavior aligns with the healthcare
provider’s prescribed medication regimen
Transitions of Care the movement of a patient between healthcare settings, providers, or levels
of care as their condition and healthcare needs change
National Coordinating Council for Medication Error an independent coalition of healthcare organizations that developed
Reporting and Prevention (NCC MERP) standardized definitions and classifications for medications errors that is
the most commonly used and widely recognized severity classification
system for medication errors in the United States
Punitive culture culture around medication errors that punishes the individual(s) who made
the error rather than improving systems
