NR508 Midterm Outline
Chapter 1: The Role of the Advanced Practice Nurse as Prescriber
Roles and responsibilities of APRN prescribers
• The responsibility for the final decision on which drug to use and how to use it is in the
hands of the APRN prescriber.
• The degree of autonomy in this role and the breadth of drugs that can be prescribed
vary from state to state based on the nurse practice act of that state.
Clinical judgement in Prescribing
• Prescribing drug results from
o clinical judgment based on a thorough assessment of the patient and the
patient's environment,
o the determination of medical and nursing diagnoses,
o a review of potential alternative therapies,
o specific knowledge about the drug chosen and the disease process it is
designed to treat
Collaboration with other providers
• collaborate with physicians, pharmacists, podiatrists, mental health specialists,
therapists, and other providers, including APRNs who are not NPs, physician
assistants (PAs), and other nurses.
Autonomy and Prescriptive authority
• More states are broadening and expanding the legal, reimbursement, and
prescriptive authority to practice for all APRNs, including NPs.
Chapter 2: Review of Basic Principles of Pharmacology
,How Drugs are Developed
Preclinical Stage: Identification of promising drugs and their testing in animals
• Medicinal chemists - new chemical compounds.
, • Preclinical studies are performed on cells, isolated tissues and organs, laboratory
animals
• FDA Approval: Drugs approved by the FDA must be both safe and effective.
Screened by pharmacologists, toxicologists
Clinical Stage: The safety and effectiveness of new products in humans must
be established.
• Phase I Clinical Trials: Establish biological effects, safe dosages, and
pharmacokinetics in a small number of healthy patients.
• Phase II Clinical Trials: New drugs are used to treat disease in a small number of
patients and to determine the potential of the drug to improve patient outcomes. If the
drug looks promising phase III will occur.
• Phase III Clinical Trials: Comparison of the new medication to the standard therapy
in a larger number of patients at various sites across the country. New drugs must be
at least as good or better than other available drugs.
Post-Marketing Surveillance: Health professionals- report adverse events --
more people receive the drug than in the clinical trials, and sometimes much
more is learned about additional adverse effects that occur infrequently with
use of the drug.
Drug Responses
• before a drug can produce a response it must first overcome homeostasis
• Dose-Response Curves provide information on the relationship between
dosage or concentration and responses for one or more drugs.
o Graphs showing drug responses will show the response on the vertical axis
and the concentration or dose on the horizontal axis.
• Quantal Responses: May or may not occur. For example, seizures occur or they do
not. A rash occurs or it does not. A response that is either occurring or absent.
o Prediction of drug dosages or blood levels that produce quantal effects is more
reliable for a population of patients than for an individual patient.
o Data from a population of patients is used to establish appropriate doses or
blood levels to predict quantal effects in a large number of patients. Drug
examples: oral contraceptives and seizure medications.
• Graded Responses: Biological effects that can be measured continually up to the
maximum responding capacity of the biological system.
o Most drug responses are graded. For example, changes in BP are measured in
mmHg, and patients may experience small or large changes in BP following
treatment with drugs. If the patient’s BP is too high or too low, we can adjust
the dosage based on the patient’s individualized response to the medication.
Examples: BP, HR, diuresis, bronchodilation, pain scale 1-10).
, • Potency: Difference in concentration or dosage of different drugs required to
produce a similar effect.
o Drugs that are more potent require a lower dosage or concentration to
produce the same response.
o For example, compare doses of non- prescription drugs that relieve headache:
200 mg ibuprofen, 325 mg aspirin, and 50 mg ketoprofen. Because ketoprofen
requires the lowest dose, it has the highest potency.
• Efficacy: Expresses the ability of a drug to produce a maximum effect at any
dosage.
o There are many drugs that will relieve mild pain. No matter how high we
increase the dosage, drugs that work well for mild to moderate pain are
usually ineffective for treating more severe cancer-related pain, for example.
o Treatment of severe pain requires the use of stronger drugs, such as the
opioid analgesics morphine or oxycodone. Morphine or oxycodone have
higher efficacy for pain relief than ibuprofen.
o Drugs with high efficacy can produce greater effects than lower-efficacy
drugs can.
• Intrinsic Activity: The ability of a drug to produce a response once it has
occupied specific receptors.
o some drugs produce the maximum receptor stimulation once they occupy
receptors; their response is limited by how many drug molecules occupy
receptor sites.
o Other drugs with lower intrinsic activity can occupy the same number of
receptors but will produce a lesser response.
o Drugs can also occupy receptors and produce no receptor stimulation; they
merely block the action of neurotransmitters or other drugs.
• Drug Selectivity: A ratio of the dose or concentration producing the undesired
effect to the dose or concentration producing the desired effect.
o This is the same as determining how many times the therapeutic dosage needs
to be increased to produce the undesired effect.
o A medication that requires one tablet to produce the desired response and does
not produce undesirable effects unless five tablets are used would have a
selectivity ratio of 5.
• Therapeutic Index: Ratio of the lethal dose of a drug to the therapeutic dose of a
drug.
o The therapeutic index of drugs on the market is, of course, always greater than
1; a therapeutic index of less than 1 means that the drug kills before it cures.
o The therapeutic index ranges from 2 for some drugs (cancer
chemotherapy, lithium carbonate) to 6,000 for others (penicillin in
nonallergic patients)
Chapter 1: The Role of the Advanced Practice Nurse as Prescriber
Roles and responsibilities of APRN prescribers
• The responsibility for the final decision on which drug to use and how to use it is in the
hands of the APRN prescriber.
• The degree of autonomy in this role and the breadth of drugs that can be prescribed
vary from state to state based on the nurse practice act of that state.
Clinical judgement in Prescribing
• Prescribing drug results from
o clinical judgment based on a thorough assessment of the patient and the
patient's environment,
o the determination of medical and nursing diagnoses,
o a review of potential alternative therapies,
o specific knowledge about the drug chosen and the disease process it is
designed to treat
Collaboration with other providers
• collaborate with physicians, pharmacists, podiatrists, mental health specialists,
therapists, and other providers, including APRNs who are not NPs, physician
assistants (PAs), and other nurses.
Autonomy and Prescriptive authority
• More states are broadening and expanding the legal, reimbursement, and
prescriptive authority to practice for all APRNs, including NPs.
Chapter 2: Review of Basic Principles of Pharmacology
,How Drugs are Developed
Preclinical Stage: Identification of promising drugs and their testing in animals
• Medicinal chemists - new chemical compounds.
, • Preclinical studies are performed on cells, isolated tissues and organs, laboratory
animals
• FDA Approval: Drugs approved by the FDA must be both safe and effective.
Screened by pharmacologists, toxicologists
Clinical Stage: The safety and effectiveness of new products in humans must
be established.
• Phase I Clinical Trials: Establish biological effects, safe dosages, and
pharmacokinetics in a small number of healthy patients.
• Phase II Clinical Trials: New drugs are used to treat disease in a small number of
patients and to determine the potential of the drug to improve patient outcomes. If the
drug looks promising phase III will occur.
• Phase III Clinical Trials: Comparison of the new medication to the standard therapy
in a larger number of patients at various sites across the country. New drugs must be
at least as good or better than other available drugs.
Post-Marketing Surveillance: Health professionals- report adverse events --
more people receive the drug than in the clinical trials, and sometimes much
more is learned about additional adverse effects that occur infrequently with
use of the drug.
Drug Responses
• before a drug can produce a response it must first overcome homeostasis
• Dose-Response Curves provide information on the relationship between
dosage or concentration and responses for one or more drugs.
o Graphs showing drug responses will show the response on the vertical axis
and the concentration or dose on the horizontal axis.
• Quantal Responses: May or may not occur. For example, seizures occur or they do
not. A rash occurs or it does not. A response that is either occurring or absent.
o Prediction of drug dosages or blood levels that produce quantal effects is more
reliable for a population of patients than for an individual patient.
o Data from a population of patients is used to establish appropriate doses or
blood levels to predict quantal effects in a large number of patients. Drug
examples: oral contraceptives and seizure medications.
• Graded Responses: Biological effects that can be measured continually up to the
maximum responding capacity of the biological system.
o Most drug responses are graded. For example, changes in BP are measured in
mmHg, and patients may experience small or large changes in BP following
treatment with drugs. If the patient’s BP is too high or too low, we can adjust
the dosage based on the patient’s individualized response to the medication.
Examples: BP, HR, diuresis, bronchodilation, pain scale 1-10).
, • Potency: Difference in concentration or dosage of different drugs required to
produce a similar effect.
o Drugs that are more potent require a lower dosage or concentration to
produce the same response.
o For example, compare doses of non- prescription drugs that relieve headache:
200 mg ibuprofen, 325 mg aspirin, and 50 mg ketoprofen. Because ketoprofen
requires the lowest dose, it has the highest potency.
• Efficacy: Expresses the ability of a drug to produce a maximum effect at any
dosage.
o There are many drugs that will relieve mild pain. No matter how high we
increase the dosage, drugs that work well for mild to moderate pain are
usually ineffective for treating more severe cancer-related pain, for example.
o Treatment of severe pain requires the use of stronger drugs, such as the
opioid analgesics morphine or oxycodone. Morphine or oxycodone have
higher efficacy for pain relief than ibuprofen.
o Drugs with high efficacy can produce greater effects than lower-efficacy
drugs can.
• Intrinsic Activity: The ability of a drug to produce a response once it has
occupied specific receptors.
o some drugs produce the maximum receptor stimulation once they occupy
receptors; their response is limited by how many drug molecules occupy
receptor sites.
o Other drugs with lower intrinsic activity can occupy the same number of
receptors but will produce a lesser response.
o Drugs can also occupy receptors and produce no receptor stimulation; they
merely block the action of neurotransmitters or other drugs.
• Drug Selectivity: A ratio of the dose or concentration producing the undesired
effect to the dose or concentration producing the desired effect.
o This is the same as determining how many times the therapeutic dosage needs
to be increased to produce the undesired effect.
o A medication that requires one tablet to produce the desired response and does
not produce undesirable effects unless five tablets are used would have a
selectivity ratio of 5.
• Therapeutic Index: Ratio of the lethal dose of a drug to the therapeutic dose of a
drug.
o The therapeutic index of drugs on the market is, of course, always greater than
1; a therapeutic index of less than 1 means that the drug kills before it cures.
o The therapeutic index ranges from 2 for some drugs (cancer
chemotherapy, lithium carbonate) to 6,000 for others (penicillin in
nonallergic patients)
