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NR565: Week 2 Complete Study Guide for chapter 1 to chapter 52

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Course
AIT Nursing (NR565)

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Thompson River University (TRU )

Chapter 1: The Role of the Nurse Practitioner 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 ...

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nr565 week 2 study guide
chapter 1 the role of the nurse practitioner as prescriber
roles and responsibilities of aprn prescribers
clinical judgement in prescribing
collaboration with other providers

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NR565 Week 2 Study Guide
Chapter 1: The Role of the Nurse Practitioner 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.
 All states have title protection for NPs.
 Only Oregon has mandated third-party reimbursement parity for NP services.
 In all but five states, the control of practice and licensure is within the sole authority of the
state's board of nursing. These five states have joint control in the board of nursing and the
board of medicine.
 Scope of practice is determined by the individual NP's license under the nurse practice act
of the licensing jurisdiction. Some have a graduated scope based on experience level. New
prescribers need to understand that their employment sites may restrict this legal scope of
practice but cannot extend it.
 In 17 states and the District of Columbia, NPs have independent scope of practice and
prescriptive authority without a requirement or attestation for physician collaboration,
consultation, delegation, or supervision.
 Six states have full autonomous practice and prescriptive authority following a period of
postlicensure/postcertification supervision or collaboration.

Clinical judgement in prescribing
 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. In general, the best therapy is the least invasive, least expensive, and least likely to
cause adverse reactions. Frequently, the best choice is to have lifestyle, nonpharmacological, and
pharmacological therapies working together. When the choice of treatment options is a drug, several
questions arise.
 As APRNs prescribe a drug for a given pathophysiology, their nursing background leads them to
place equal emphasis on understanding the impact the drug will have on the patient.
 Patient education is a central focus of nursing and APRN practice.
 Knowledge and clinical experience shared from the mingling of medical and nursing perspectives
are mutually beneficial to the providers and the patient.
 The APRN can benefit from the in-depth knowledge about the drugs in the physician's specialty
area. The physician can benefit from APRNs’ focus on the impact of the drug on the patient and from their
patient education skills. In the age of health-care reform, increasing emphasis is being placed on these
latter issues.

Collaboration with other providers

,  NPs and physicians do work together very effectively on an individual basis and in collegial care
teams. In an era of health-care reform, our joint concerns about patient care decisions require us to
be allies.
 Physicians may offer insight or advice on pharmacological management from their experience.
 A physician's expertise related to pharmacology is based on understanding biochemistry and
prescribing for a given pathophysiology. The emphasis is on the disease and the drug, with less
emphasis on the impact on the patient. Patient education by physicians may be limited or left to a
nurse or pharmacist.
 Collaboration with other NPs and APRNs who have prescriptive privileges has two major
advantages.
o 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.
o 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.
 Collaboration with pharmacists requires an understanding of the educational preparation for and
evolution of the role of the pharmacist. The profession of pharmacy requires graduate-level
preparation for all pharmacists with the granting of a practice doctorate, the Doctor of Pharmacy
(PharmD). PharmDs have extensive knowledge about pathophysiology and take an active role in
determining the best drug to prescribe. A PharmD can assist by offering expertise on the clinical
management of patients, including available dosage forms, potential adverse reactions, and drug
interactions.
 Both physicians and APRNs increasingly consult PharmDs for their knowledge of pharmacokinetics
and pharmcotherapeutics when prescribing for complex patients.

Autonomy and prescriptive authority
 By January 2004, all states had recognized the NP title, scope of practice, and prescriptive
authority in legislation. Momentum to full autonomy is gaining, with 26 states allowing independent
practice for NPs and 21 states allowing independent full prescribing as of January 2015 (National
Council of State Boards of Nursing [NCSBN], 2015). APRNs in other states have also gained
recognition, although the scope of practice and prescriptive authority is often more restricted.
 These gains are not written in stone, however, and can be reversed. Despite continuing research
studies (Newland, 2009; Pearson, 2009; Gielen, 2013) that demonstrate the effectiveness of the
role of the APRN in improving patient outcomes, barriers remain. Major concerns related to
prescriptive authority must continue to be addressed. Not all states have legislation that permits
APRNs to prescribe independently of any required physician involvement. Turf battles continue
between APRNs and physicians at national and many state levels over physician supervision
requirements and co-signatures on prescriptions. The advent of the doctorate of nursing practice
(DNP) degree with its comparable level of education to that of other health-care providers and a
focus on independent practice may address some of these issues about supervision. However, the
American Medical Association continues to stress the need for physician supervision and final
authority for the patient, even for APRNs who hold the DNP (Partin, 2008; AMA, 2010, 2013). This
push for physician control occurs despite data from malpractice and malfeasance ratios that clearly
show that the rationale for physician supervision is unfounded (Pearson, 2009).

Drug databases
 Nurses evaluate sources of drug information and learn which ones to trust. For an APRN, the
sources of drug information expand to include the 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 (e.g., Micromedix, Lexicomp, Epocrates), information

, from the U.S. Food and Drug Administration, and formula programs that can be accessed via a
handheld device or computer.
 The APRN prescriber needs to evaluate how reliable the drug information is. How can reliability be
determined? Is the information source written by someone who may benefit from presenting biased
information? Is the information source current? Today's “wonder drug” may be removed from the
market tomorrow. Is the information relevant to the specific patient for whom the drug will be
prescribed? If the information is a research report, what type of research design was used? Are
there questions about the validity and reliability of the data? Are national or international guidelines
used to inform prescribing or does the reference suggest prescribing outside established
guidelines? To prescribe drugs appropriately, APRNs must be able to answer these questions; to
answer them, they must master sources of information and use them on a regular basis.

Medication adherence
 Multiple national retail pharmacies have developed $4.00 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.

Chapter 4: Legal and Professional Issues in Prescribing
New drug approval process including clinical phases I-IV
The process of synthesis and extraction identifies new molecules with the potential to produce a desired
change in a biological system
 Phase I 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.
 Phase II clinical 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, are enrolled in phase II studies.
 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. If the drug is approved, this
information forms the basis for deciding the content of the product label. Phase III trials verify that
the acceptable risk/benefit ratio seen in phase II persists under conditions of anticipated usage and
in groups of patients large enough to identify statistically and clinically significant responses.

U.S. FDA regulatory jurisdiction: Official labelling vs off-label use of drugs
 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.
 The FDA is not charged with dictating how a prescriber should practice.
 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. The proper and
efficacious therapeutic use of these drugs is the responsibility of the prescriber.

,  Official labeling:
o a prescription drug, the manufacturer's directions or FDA-approved labeling (the package
insert) is intended for the prescriber, pharmacist, or nurse and provides a summary of
information about the chemical and physical nature of the product, pharmacological
indications and contraindications, means of administration, dosages, side effects and
adverse reactions, how the drug is supplied, and any other information pertinent to safe and
effective use. This summary, or official labeling, is developed through discussion between
the FDA and the drug manufacturer. The material in the Physician's Desk Reference (PDR)
is a verbatim presentation of the official labeling.
 Off label use:
o The prescription of an FDA-approved drug for an off-label (unlabeled) indication may be
initiated by patient need. Off-label 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. The FDA has made it clear that it
neither has nor wants the authority to compel prescribes to adhere to FDA-approved use in
all clinical situations. 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 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. In
professional liability suits, FDA-approved drug labeling may have evidentiary weight, but
drug labeling is not intended to set the sole standard for what is good clinical practice. NPs
must also be aware that Medicare and other insurers rarely cover off-label prescriptions and
that consequently the patient may bear greater cost. Off-label prescribing can also result in
increased or unknown risk to the patient

Controlled substance laws
 Every person who manufactures, distributes, prescribes, procures, or dispenses any controlled
substance must register and obtain a registration number with the U.S. Drug Enforcement
Administration (DEA).
 Must maintain and keep on file for a minimum of 2 years accurate records of controlled drugs they
purchase, distribute, administer, and dispense.

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 true hydromorphone, oxycodone, oxymorphone,
emergency and followed up by written methadone, fentanyl)
prescription within 7 days Stimulants (cocaine, amphetamine,
Electronic prescribing permitted as of methylphenidate)
2011 with specific software and secure Depressants (pentobarbital, secobarbital)

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