NR565 Week 2 Study Guide (Page 1)
Chapter 1: The Role of the Nurse Practitioner as Prescriber
Roles and Responsibilities of APRN Prescribers
APRN prescriber is responsible for the final decision on which drug to use and how to use it. 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. Nurse practitioner prescriptive authority is regulated by the State Board of Nursing for
each state.
• Advanced Knowledge
o Additional knowledge, critical thinking, and assumption of a higher level of legal responsibility
are required to assume the prescriber role
o Knowledge of medicine, pharmacology, and nursing intertwine in the NP role
o As a prescriber, it becomes the role and responsibility of the NP to determine the diagnosis for
which the drug will be ordered, prescribe the appropriate drug, monitor the expected outcome of
the drug, and incorporate a holistic assessment of the impact of disease and therapy on patient
lives
• Benefits of an APRN as Prescriber
o Alternative treatment options are also part of the armamentarium that can be used to treat a given
disorder and may interact with the pharmacotherapeutic intervention
o APRN look at the big picture and consider alternative treatment options and lifestyle changes
o Patients are looked at in a holistic approach and include the patient in decision making regarding
their care.
o NP practice may thrive under healthcare reform because of the demonstrated ability of nurse
practitioners to control costs and improve patient outcomes
Clinical Judgment in Prescribing
• Prescribing drug results from:
o Clinical judgment based on a thorough assessment of the patient and the patient's environment
o Determination of medical and nursing diagnoses
o A review of potential alternative therapies, and specific knowledge about the drug chosen and
the disease process it is designed to treat
o NPs factoring in the cost to the patient of the medication prescribed
• Is there a clear indication for drug therapy?
o In the age of health-care reform and increased awareness of the limitations of drugs, whether a
medication is the best option for treatment has become an important question.
• What drugs are effective in treating this disorder?
o Several drugs may be effective in treating a condition, so which one is best for a particular
patient?
▪ Even if only the most effective class of drug is considered, few classes of drugs include
only one drug
o How does one determine “best”; what are the criteria? Are there nationally recognized guidelines
that can be used?
▪ The Agency for Health Care Quality (AHCQ), the National Institutes of Health (NIH),
and many specialty organizations publish disease-specific treatment guidelines that
include both pharmacological and nonpharmacological therapies
▪ Consult nationally recognized guidelines for disease management
• What is the goal of therapy with this drug?
o What is the best drug to achieve treatment goals?
, NR565 Week 2 Study Guide (Page 2)
▪ Various goals are possible in the choosing of therapy
• Under what conditions is it determined that a drug is not meeting the goal and a different therapy
or drug should be tried?
o At the onset of therapy, the provider and patient should have a clear understanding of what
outcome or goal is expected of the medication prescribed
o Follow-up and monitoring times are established to see how well treatment with the drug is
meeting the goal
• Are there unnecessary duplications with other drugs that the patient is already taking?
o The patient’s medication history should be reviewed at each encounter to detect duplications or
medications that may be discontinued
• Would an OTC drug can be just as useful as a prescription drug?
o Increasing numbers of drugs are being moved from prescription to over-the-counter (OTC) status
• What about cost?
o Who will pay for this drug? Can the patient afford it? Will the cost of the medication affect
adherence to the treatment regimen?
▪ Cost is an issue for several reasons
• Many insurance policies do not cover the cost of drugs or only provide partial
coverage, so the patient must pay “out of pocket”
• The newer the drug, the more likely the cost is too high based on the drug
manufacturer’s need to reclaim research and development costs while the
corporation still holds the patent on that drug
• Newest is not always best, and condition of cost is a major factor in choosing
between newer drugs and ones that have been around long enough to be available
in generic form
• Many insurance plans have larger copays for name-brand drugs than for generic
medications
• Multiple national retail pharmacies have developed $4 prescription formularies
• Awareness of what is on the local discount formulary may save the patient
hundreds of dollars in prescription costs and may increase compliance
• Factors likely to lead to poor adherence include a drug that is expensive in
relation to a patient's finances, a drug that must be taken daily as part of a
complex regimen, and a drug that is not covered by insurance.
• Where is the information to answer these questions?
o Wide array of professional literature that ranges from the well-reputed journals to literature from
specialty and professional organizations, the multitude of computerized drug databases
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.
• Physicians
o Early in the development of the NP role, physicians were the teachers in the NP programs and
accepted NPs as physician-extenders
• Pharmacists
o Profession of pharmacy requires graduate-level preparation for all pharmacists with the granting
of a practice doctorate, the Doctor of Pharmacy (PharmD)
o A PharmD can assist by offering expertise on the clinical management of patients, including
available dosage forms, potential adverse reactions, and drug interactions
• Other APRNs
, NR565 Week 2 Study Guide (Page 3)
o Collaboration with other NPs and APRNs who have prescriptive privileges has two major
advantages
▪ On a one-to-one basis dealing with individual patient issues, NPs and APRNs can share
“clinical pearls” from their knowledge base and collaborate to improve the care of the
patient
▪ Collaboration on issues related to scope of practice and prescriptive privilege at the state
and national level is critical to obtaining and maintaining the autonomy of practice
needed to provide optimal patient care
• Physician Assistants
o The focus of the PA's practice is similar to that of the physician, so both the APRN and the PA
can benefit from interaction with each other in much the same way as from their interaction with
physicians
o Many PAs desire more autonomy in their practice, and the experience of APRNs in developing
autonomy may be helpful
• Nurses Not in Advanced Practice Roles
o APRNs regularly collaborate with other nurse colleagues who are not in advanced practice roles
o Some have specialized knowledge, such as Certified Diabetes Educators (CDEs) and Wound and
Ostomy Care Specialists (WOCS)
o These nurses and their assistants carry out the prescriptive orders of the APRN
Autonomy and Prescriptive Authority
More states are broadening and expanding the legal, reimbursement, and prescriptive authority to practice for
all APRNs, including NPs.
• Reimbursement
o Reimbursement is evolving, with the Affordable Care Act rollout creating an opportunity for
APRNs to address reimbursement parity
o The reimbursement by third-party payers continues to be a practice barrier for many nurses in
advanced practice
• Drug databases
o PharmGKB
o WAITING FOR CLARIFICATION
• Medication adherence
o WAITING FOR CLARIFICATION
Chapter 4: Legal and Professional Issues in Prescribing
New Drug Approval Process Including Clinical Phases I-IV
Costs a company approximately $2.6 billion. Takes 8.5 years on average for an experimental drug to travel from
laboratory preclinical trials to FDA approval.
• State One: Preclinical Research
o Process of synthesis and extraction identifies new molecules with the potential to produce a
desired change in a biological system
o Produced through artificial synthesis or extracted from natural sources Biological screening and
pharmacological testing use nonhuman studies pharmacological activity and therapeutic potential
, NR565 Week 2 Study Guide (Page 4)
of compounds-- animals, isolated cell cultures and tissues, enzymes, and cloned receptor sites, as
well as computer models
o Pharmaceutical dosage formulation and stability testing make up the process of turning an active
compound into a form and strength suitable for human use
o Toxicology and safety testing determines the potential risk a compound poses to people and the
environment
• Stage Two: Clinical Investigation
o Investigational new drug (IND) application is filed with the FDA prior to human testing of any
new drug entity--description of the clinical research plan -- clinical tests can begin 30 calendar
days after submission
▪ Phase 1: Establishing the tolerance of healthy human subjects at different doses; defining
its pharmacological effects (absorption, distribution, metabolism, and excretion).
▪ Phase II: Target disease or disorder to determine a compound's potential --small number
of patients.
▪ Phase III: Trials are controlled and uncontrolled clinical trials of a drug's safety and
efficacy in hospital and outpatient settings--drug's efficacy for specific indications--
broader range of adverse effects --best way of administering and using the drug for the
purpose intended.--verify that the acceptable risk/benefit ratio seen in phase II persists
under--must report in writing to the FDA within 10 working days any serious and
unexpected adverse reactions.
• Stage Three: NDA Review
o To market a new drug for human use, a manufacturer must have a new drug application (NDA)
approved by the FDA
o All information about the drug gathered during the drug discovery and development process is
assembled in the NDA
o During the review period, the FDA may ask the company for additional information about the
product or seek clarification of the data contained in the application
o The FDA has 60 days to determine whether the NDA will be filed for review
o Once filed, a team reviews the drug sponsor’s research on safety and effectiveness of the drug
o Usually, the FDA requests additional information, and the manufacturer needs from 1-5 years to
complete any additional well-controlled trials necessary to support the claimed indications or
prove the drug’s safety
• Stage Four: Postmarketing Research
o In order to detect rare adverse drug reactions, hundreds of thousands of patients have to have
taken the drug. Clinical trials conducted after a drug is marketed are an important source of
information for postmarketing evaluation
o Regulatory authorities can require companies to conduct phase IV studies as a condition of
market approval
o An important source of postapproval information is data collected and submitted by practitioners
in the field through programs such as MedWatch
U.S. FDA Regulatory Jurisdiction
• Official Labeling
o The legal distinction between a legend drug and an over-the-counter (OTC) drug is not founded
on relative safety per se but rather involves a regulatory decision on whether adequate directions
for the drug's proper use can be written for the layperson
o The FDA is concerned with the marketing and availability of drugs that have demonstrated
substantial evidence of an acceptable risk/benefit ratio for labeled indications
o The proper and efficacious therapeutic use of these drugs is the responsibility of the prescriber
Chapter 1: The Role of the Nurse Practitioner as Prescriber
Roles and Responsibilities of APRN Prescribers
APRN prescriber is responsible for the final decision on which drug to use and how to use it. 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. Nurse practitioner prescriptive authority is regulated by the State Board of Nursing for
each state.
• Advanced Knowledge
o Additional knowledge, critical thinking, and assumption of a higher level of legal responsibility
are required to assume the prescriber role
o Knowledge of medicine, pharmacology, and nursing intertwine in the NP role
o As a prescriber, it becomes the role and responsibility of the NP to determine the diagnosis for
which the drug will be ordered, prescribe the appropriate drug, monitor the expected outcome of
the drug, and incorporate a holistic assessment of the impact of disease and therapy on patient
lives
• Benefits of an APRN as Prescriber
o Alternative treatment options are also part of the armamentarium that can be used to treat a given
disorder and may interact with the pharmacotherapeutic intervention
o APRN look at the big picture and consider alternative treatment options and lifestyle changes
o Patients are looked at in a holistic approach and include the patient in decision making regarding
their care.
o NP practice may thrive under healthcare reform because of the demonstrated ability of nurse
practitioners to control costs and improve patient outcomes
Clinical Judgment in Prescribing
• Prescribing drug results from:
o Clinical judgment based on a thorough assessment of the patient and the patient's environment
o Determination of medical and nursing diagnoses
o A review of potential alternative therapies, and specific knowledge about the drug chosen and
the disease process it is designed to treat
o NPs factoring in the cost to the patient of the medication prescribed
• Is there a clear indication for drug therapy?
o In the age of health-care reform and increased awareness of the limitations of drugs, whether a
medication is the best option for treatment has become an important question.
• What drugs are effective in treating this disorder?
o Several drugs may be effective in treating a condition, so which one is best for a particular
patient?
▪ Even if only the most effective class of drug is considered, few classes of drugs include
only one drug
o How does one determine “best”; what are the criteria? Are there nationally recognized guidelines
that can be used?
▪ The Agency for Health Care Quality (AHCQ), the National Institutes of Health (NIH),
and many specialty organizations publish disease-specific treatment guidelines that
include both pharmacological and nonpharmacological therapies
▪ Consult nationally recognized guidelines for disease management
• What is the goal of therapy with this drug?
o What is the best drug to achieve treatment goals?
, NR565 Week 2 Study Guide (Page 2)
▪ Various goals are possible in the choosing of therapy
• Under what conditions is it determined that a drug is not meeting the goal and a different therapy
or drug should be tried?
o At the onset of therapy, the provider and patient should have a clear understanding of what
outcome or goal is expected of the medication prescribed
o Follow-up and monitoring times are established to see how well treatment with the drug is
meeting the goal
• Are there unnecessary duplications with other drugs that the patient is already taking?
o The patient’s medication history should be reviewed at each encounter to detect duplications or
medications that may be discontinued
• Would an OTC drug can be just as useful as a prescription drug?
o Increasing numbers of drugs are being moved from prescription to over-the-counter (OTC) status
• What about cost?
o Who will pay for this drug? Can the patient afford it? Will the cost of the medication affect
adherence to the treatment regimen?
▪ Cost is an issue for several reasons
• Many insurance policies do not cover the cost of drugs or only provide partial
coverage, so the patient must pay “out of pocket”
• The newer the drug, the more likely the cost is too high based on the drug
manufacturer’s need to reclaim research and development costs while the
corporation still holds the patent on that drug
• Newest is not always best, and condition of cost is a major factor in choosing
between newer drugs and ones that have been around long enough to be available
in generic form
• Many insurance plans have larger copays for name-brand drugs than for generic
medications
• Multiple national retail pharmacies have developed $4 prescription formularies
• Awareness of what is on the local discount formulary may save the patient
hundreds of dollars in prescription costs and may increase compliance
• Factors likely to lead to poor adherence include a drug that is expensive in
relation to a patient's finances, a drug that must be taken daily as part of a
complex regimen, and a drug that is not covered by insurance.
• Where is the information to answer these questions?
o Wide array of professional literature that ranges from the well-reputed journals to literature from
specialty and professional organizations, the multitude of computerized drug databases
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.
• Physicians
o Early in the development of the NP role, physicians were the teachers in the NP programs and
accepted NPs as physician-extenders
• Pharmacists
o Profession of pharmacy requires graduate-level preparation for all pharmacists with the granting
of a practice doctorate, the Doctor of Pharmacy (PharmD)
o A PharmD can assist by offering expertise on the clinical management of patients, including
available dosage forms, potential adverse reactions, and drug interactions
• Other APRNs
, NR565 Week 2 Study Guide (Page 3)
o Collaboration with other NPs and APRNs who have prescriptive privileges has two major
advantages
▪ On a one-to-one basis dealing with individual patient issues, NPs and APRNs can share
“clinical pearls” from their knowledge base and collaborate to improve the care of the
patient
▪ Collaboration on issues related to scope of practice and prescriptive privilege at the state
and national level is critical to obtaining and maintaining the autonomy of practice
needed to provide optimal patient care
• Physician Assistants
o The focus of the PA's practice is similar to that of the physician, so both the APRN and the PA
can benefit from interaction with each other in much the same way as from their interaction with
physicians
o Many PAs desire more autonomy in their practice, and the experience of APRNs in developing
autonomy may be helpful
• Nurses Not in Advanced Practice Roles
o APRNs regularly collaborate with other nurse colleagues who are not in advanced practice roles
o Some have specialized knowledge, such as Certified Diabetes Educators (CDEs) and Wound and
Ostomy Care Specialists (WOCS)
o These nurses and their assistants carry out the prescriptive orders of the APRN
Autonomy and Prescriptive Authority
More states are broadening and expanding the legal, reimbursement, and prescriptive authority to practice for
all APRNs, including NPs.
• Reimbursement
o Reimbursement is evolving, with the Affordable Care Act rollout creating an opportunity for
APRNs to address reimbursement parity
o The reimbursement by third-party payers continues to be a practice barrier for many nurses in
advanced practice
• Drug databases
o PharmGKB
o WAITING FOR CLARIFICATION
• Medication adherence
o WAITING FOR CLARIFICATION
Chapter 4: Legal and Professional Issues in Prescribing
New Drug Approval Process Including Clinical Phases I-IV
Costs a company approximately $2.6 billion. Takes 8.5 years on average for an experimental drug to travel from
laboratory preclinical trials to FDA approval.
• State One: Preclinical Research
o Process of synthesis and extraction identifies new molecules with the potential to produce a
desired change in a biological system
o Produced through artificial synthesis or extracted from natural sources Biological screening and
pharmacological testing use nonhuman studies pharmacological activity and therapeutic potential
, NR565 Week 2 Study Guide (Page 4)
of compounds-- animals, isolated cell cultures and tissues, enzymes, and cloned receptor sites, as
well as computer models
o Pharmaceutical dosage formulation and stability testing make up the process of turning an active
compound into a form and strength suitable for human use
o Toxicology and safety testing determines the potential risk a compound poses to people and the
environment
• Stage Two: Clinical Investigation
o Investigational new drug (IND) application is filed with the FDA prior to human testing of any
new drug entity--description of the clinical research plan -- clinical tests can begin 30 calendar
days after submission
▪ Phase 1: Establishing the tolerance of healthy human subjects at different doses; defining
its pharmacological effects (absorption, distribution, metabolism, and excretion).
▪ Phase II: Target disease or disorder to determine a compound's potential --small number
of patients.
▪ Phase III: Trials are controlled and uncontrolled clinical trials of a drug's safety and
efficacy in hospital and outpatient settings--drug's efficacy for specific indications--
broader range of adverse effects --best way of administering and using the drug for the
purpose intended.--verify that the acceptable risk/benefit ratio seen in phase II persists
under--must report in writing to the FDA within 10 working days any serious and
unexpected adverse reactions.
• Stage Three: NDA Review
o To market a new drug for human use, a manufacturer must have a new drug application (NDA)
approved by the FDA
o All information about the drug gathered during the drug discovery and development process is
assembled in the NDA
o During the review period, the FDA may ask the company for additional information about the
product or seek clarification of the data contained in the application
o The FDA has 60 days to determine whether the NDA will be filed for review
o Once filed, a team reviews the drug sponsor’s research on safety and effectiveness of the drug
o Usually, the FDA requests additional information, and the manufacturer needs from 1-5 years to
complete any additional well-controlled trials necessary to support the claimed indications or
prove the drug’s safety
• Stage Four: Postmarketing Research
o In order to detect rare adverse drug reactions, hundreds of thousands of patients have to have
taken the drug. Clinical trials conducted after a drug is marketed are an important source of
information for postmarketing evaluation
o Regulatory authorities can require companies to conduct phase IV studies as a condition of
market approval
o An important source of postapproval information is data collected and submitted by practitioners
in the field through programs such as MedWatch
U.S. FDA Regulatory Jurisdiction
• Official Labeling
o The legal distinction between a legend drug and an over-the-counter (OTC) drug is not founded
on relative safety per se but rather involves a regulatory decision on whether adequate directions
for the drug's proper use can be written for the layperson
o The FDA is concerned with the marketing and availability of drugs that have demonstrated
substantial evidence of an acceptable risk/benefit ratio for labeled indications
o The proper and efficacious therapeutic use of these drugs is the responsibility of the prescriber
