NR565 Week 2 Study Guide
Chapter 1: The Role of the Nurse Practitioner as Prescriber
Roles and responsibilities of APRN prescribers
o The nature of this responsibility depends on whether the APRN can prescribe
medications. States vary in their laws related to prescriptive authority for APRNs
o The benefits to the patient of having an Advanced Practice Registered Nurse (APRN)
prescriber include: Nurses care for the patient from a holistic approach & include the
patient in decision making regarding their care.
o Nurse practitioner practice may thrive under health-care reform because of: The
demonstrated ability of nurse practitioners to control costs & improve patient outcomes
Clinical judgement in prescribing
o Prescribing a drug results from clinical judgment based on a thorough assessment of the
patient and the patient’s environment, the determination of medical and nursing
diagnoses, a review of potential alternative therapies, and specific knowledge about
the drug chosen and the disease process it is designed to treat
o In general, the best therapy is the least invasive, least expensive, and least likely to cause
adverse reactions
o Clinical judgment in prescribing includes: Factoring in the cost to the patient of the
medication prescribed
Collaboration with other providers
o No one member of the health-care team can provide highquality care without
collaborating with other team members.
o They most often 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
o More states are broadening and expanding the legal, reimbursement, and prescriptive
authority to practice for all APRNs, including NPs.
o Nurse practitioner prescriptive authority is regulated by: The State Board of Nursing
for each state
Drug databases
o PharmGKB Micromedix, Lexicomp, information from the U.S. Food and Drug
Administration, and formula programs that can be accessed via a handheld device or
computer.
o Criteria for choosing an effective drug for a disorder include: Consulting nationally
recognized guidelines for disease management
Medication adherence
Chapter 4: Legal and Professional Issues in Prescribing
New drug approval process including clinical phases I-IV
, o it takes 8.5 years on average for an experimental drug to travel from laboratory
preclinical trials to FDA approval
o Phase 1
clinical evaluation is the first testing of a new compound in subjects, for the
purpose of establishing the tolerance of healthy human subjects at different
doses; defining its pharmacological effects at anticipated therapeutic levels; and
studying its absorption, distribution, metabolism, and excretion patterns in
humans.
o Phase II
evaluation is controlled studies performed on patients with the target disease
or disorder to determine a compound’s potential usefulness and short-term
risks. A relatively small number of patients, usually no more than several
hundred subjects
o Phase III
Phase III trials are controlled and uncontrolled clinical trials of a drug’s safety
and efficacy in hospital and outpatient settings. Phase III studies gather precise
information on the drug’s efficacy for specific indications, determine whether
the drug produces a broader range of adverse effects than those exhibited in
the small study populations of phases I and II studies, and identify the best way
of administering and using the drug for the purpose intended
o Phase IV
Drug approved
Adverse reaction reporting, inspections, surveys/sampling
Phase IV clinical trials in the United States are also known as: Postmarketing
research
o The U.S. Food & Drug Administration approval is required for: Medical devices, including
artificial joints
o An Investigational New Drug is filed with the U.S. Food & Drug Administration: Prior to
human testing of any new drug entity
U.S. FDA regulatory jurisdiction: Official labelling vs off-label use of drugs
o The FDA’s jurisdiction over the uses of marketed drugs and doses extends only to what
the manufacturer may recommend and must disclose in its labeling.
o Off-label use
Offlabel use includes use of an FDA-approved drug in a dose or route for which it
was not approved or for a clinical indication other than the FDA-approved use.
Clinical support can be demonstrated for off-label use if the proposed use is
based on rational scientific theory or controlled clinical studies.
An example of off-label use is that of trazodone, which is an antidepressant, for
sleep. In this example, a side effect of the medication (drowsiness) has been
shown to have clinical efficacy for patients with difficulty sleeping whether or
, not they are clinically depressed. Although not FDA approved for insomnia,
trazodone is commonly prescribed for this indication.
o Off-label prescribing is: Legal if there is scientific evidence for the use
o The U.S. Food & Drug Administration regulates: The official labeling for all prescription &
over-the-counter drugs
o Nurse practitioners (NPs) are responsible for knowing the FDA indication and approval
status of any drug they prescribe. However, a prescribing decision on how to use a drug
must be based on what is best for the patient and then supported by available evidence
Controlled substance laws
o The Controlled Substance Act (CSA) Title II of the Comprehensive Drug Abuse Prevention
and Control Act of 1970 is a federal policy under which the manufacture, importation,
possession, use and distribution of certain chemicals, considered dangerous, are
regulated.
o The federal department known as the Food & Drug Administration (FDA) is tasked with
regulating and supervising prescription and non-prescription drugs; foods; biologics; and
medical devices.
o The mission of the FDA is to establish safety and efficacy of the products it regulates.
Title 21 of the Code of Federal Regulations (CFR) outlines the laws as they pertain to
food and drug.
o The U.S. Drug Enforcement Administration: Registers manufacturers & prescribers of
controlled substances
Controlled drug DEA schedules (Table 4-1)
Schedule Controls required Drug examples
I No accepted medical use Heroin, LSD, mescaline,
peyote, marijuana
No legal use permitted
For registered research
facilities only
II No refills permitted Narcotics (morphine,
codeine, meperidine, opium,
No telephone orders unless hydromorphone, oxycodone,
true emergency and oxymorphone, methadone,
followed up by written fentanyl)
prescription within 7 days
Stimulants (cocaine,
Electronic prescribing amphetamine,
permitted as of 2011 with methylphenidate)
specific software and
secure identification Depressants (pentobarbital,
processes secobarbital)
III Prescription must be Narcotics (codeine in
rewritten after 6 mo or 5 combination with non-
Chapter 1: The Role of the Nurse Practitioner as Prescriber
Roles and responsibilities of APRN prescribers
o The nature of this responsibility depends on whether the APRN can prescribe
medications. States vary in their laws related to prescriptive authority for APRNs
o The benefits to the patient of having an Advanced Practice Registered Nurse (APRN)
prescriber include: Nurses care for the patient from a holistic approach & include the
patient in decision making regarding their care.
o Nurse practitioner practice may thrive under health-care reform because of: The
demonstrated ability of nurse practitioners to control costs & improve patient outcomes
Clinical judgement in prescribing
o Prescribing a drug results from clinical judgment based on a thorough assessment of the
patient and the patient’s environment, the determination of medical and nursing
diagnoses, a review of potential alternative therapies, and specific knowledge about
the drug chosen and the disease process it is designed to treat
o In general, the best therapy is the least invasive, least expensive, and least likely to cause
adverse reactions
o Clinical judgment in prescribing includes: Factoring in the cost to the patient of the
medication prescribed
Collaboration with other providers
o No one member of the health-care team can provide highquality care without
collaborating with other team members.
o They most often 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
o More states are broadening and expanding the legal, reimbursement, and prescriptive
authority to practice for all APRNs, including NPs.
o Nurse practitioner prescriptive authority is regulated by: The State Board of Nursing
for each state
Drug databases
o PharmGKB Micromedix, Lexicomp, information from the U.S. Food and Drug
Administration, and formula programs that can be accessed via a handheld device or
computer.
o Criteria for choosing an effective drug for a disorder include: Consulting nationally
recognized guidelines for disease management
Medication adherence
Chapter 4: Legal and Professional Issues in Prescribing
New drug approval process including clinical phases I-IV
, o it takes 8.5 years on average for an experimental drug to travel from laboratory
preclinical trials to FDA approval
o Phase 1
clinical evaluation is the first testing of a new compound in subjects, for the
purpose of establishing the tolerance of healthy human subjects at different
doses; defining its pharmacological effects at anticipated therapeutic levels; and
studying its absorption, distribution, metabolism, and excretion patterns in
humans.
o Phase II
evaluation is controlled studies performed on patients with the target disease
or disorder to determine a compound’s potential usefulness and short-term
risks. A relatively small number of patients, usually no more than several
hundred subjects
o Phase III
Phase III trials are controlled and uncontrolled clinical trials of a drug’s safety
and efficacy in hospital and outpatient settings. Phase III studies gather precise
information on the drug’s efficacy for specific indications, determine whether
the drug produces a broader range of adverse effects than those exhibited in
the small study populations of phases I and II studies, and identify the best way
of administering and using the drug for the purpose intended
o Phase IV
Drug approved
Adverse reaction reporting, inspections, surveys/sampling
Phase IV clinical trials in the United States are also known as: Postmarketing
research
o The U.S. Food & Drug Administration approval is required for: Medical devices, including
artificial joints
o An Investigational New Drug is filed with the U.S. Food & Drug Administration: Prior to
human testing of any new drug entity
U.S. FDA regulatory jurisdiction: Official labelling vs off-label use of drugs
o The FDA’s jurisdiction over the uses of marketed drugs and doses extends only to what
the manufacturer may recommend and must disclose in its labeling.
o Off-label use
Offlabel use includes use of an FDA-approved drug in a dose or route for which it
was not approved or for a clinical indication other than the FDA-approved use.
Clinical support can be demonstrated for off-label use if the proposed use is
based on rational scientific theory or controlled clinical studies.
An example of off-label use is that of trazodone, which is an antidepressant, for
sleep. In this example, a side effect of the medication (drowsiness) has been
shown to have clinical efficacy for patients with difficulty sleeping whether or
, not they are clinically depressed. Although not FDA approved for insomnia,
trazodone is commonly prescribed for this indication.
o Off-label prescribing is: Legal if there is scientific evidence for the use
o The U.S. Food & Drug Administration regulates: The official labeling for all prescription &
over-the-counter drugs
o Nurse practitioners (NPs) are responsible for knowing the FDA indication and approval
status of any drug they prescribe. However, a prescribing decision on how to use a drug
must be based on what is best for the patient and then supported by available evidence
Controlled substance laws
o The Controlled Substance Act (CSA) Title II of the Comprehensive Drug Abuse Prevention
and Control Act of 1970 is a federal policy under which the manufacture, importation,
possession, use and distribution of certain chemicals, considered dangerous, are
regulated.
o The federal department known as the Food & Drug Administration (FDA) is tasked with
regulating and supervising prescription and non-prescription drugs; foods; biologics; and
medical devices.
o The mission of the FDA is to establish safety and efficacy of the products it regulates.
Title 21 of the Code of Federal Regulations (CFR) outlines the laws as they pertain to
food and drug.
o The U.S. Drug Enforcement Administration: Registers manufacturers & prescribers of
controlled substances
Controlled drug DEA schedules (Table 4-1)
Schedule Controls required Drug examples
I No accepted medical use Heroin, LSD, mescaline,
peyote, marijuana
No legal use permitted
For registered research
facilities only
II No refills permitted Narcotics (morphine,
codeine, meperidine, opium,
No telephone orders unless hydromorphone, oxycodone,
true emergency and oxymorphone, methadone,
followed up by written fentanyl)
prescription within 7 days
Stimulants (cocaine,
Electronic prescribing amphetamine,
permitted as of 2011 with methylphenidate)
specific software and
secure identification Depressants (pentobarbital,
processes secobarbital)
III Prescription must be Narcotics (codeine in
rewritten after 6 mo or 5 combination with non-
