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

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 Outcome Evaluation The acute pain treatment algorithm can be used as a guideline to develop and monitor the pain management plan and responses to treatment. For patients who have relief of symptoms and are pain free, no further treatment is indicated. For those who remain symptomatic, further changes in the treatment plan can be made based on a reassessment of the patient's needs. A specific drug could be continued, the dose changed, or a different combination of nonopioid and opioid drugs could be used. Nonpharmacological therapies could also be tried. Questions to consider at this phase of treatment could be: • What pain relief measures are currently being used? Should additional or different measures be tried? • When is the pain medication being used? Is it timely? Is the individual waiting until the pain becomes severe before taking the medication? Fixed intervals have been shown to be more effective in controlling pain than “as-needed” dosing. • Does the individual believe the treatment plan is effective? There tends to be a placebo effect for pain treatment and if a patient believes a drug will be effective, it likely will be; and if he or she believes a drug will not be effective, the expected outcome will likely not occur. If the response to initial or readjusted therapy is not successful, or if complications related to the pain source arise, the individual may need consultation with a specialist. If the complications are related to the pain medication, referral to a pain specialist may be prudent, especially in the case of dependency or addiction, even if pain relief is accomplished. Patient Education The practitioner should provide education about the drug, its side effects, dosing regimen, and the expected length of time the drug should be taken. The patient should also be informed about follow-up visits, particularly if complications occur. See the box “Patient Education: Acute Pain Management.” CHRONIC PAIN According to the IOM (2011) report, nearly 120 million people in the United States suffer from chronic pain. The effect of chronic pain is profound on ability to function and on quality of life. In addition, chronic pain leads to higher utilization of health care, lost productivity, and other societal costs. Pharmacodynamics NSAIDs and opioids are commonly prescribed for patients with chronic pain. Due to an added psychological factor associated with chronic pain, patients who exhibit signs of depression or anxiety may require medications such as SNRIs or TCAs to manage those symptoms. Patients with neurogenic pain may benefit from the use of anticonvulsants. The transmission of pain impulses is inhibited by the presence of norepinephrine in the rostral pons and serotonin in the PAG. These neurotransmitters also play a role in mood stabilization. Decreased levels of norepinephrine and serotonin are common in depression. SNRIs inhibit the reuptake of serotonin and norepinephrine into nerve terminals thus making more of the transmitter available at the synapses. Originally developed to treat depression, TCAs are now more commonly used to treat neuropathic pain syndromes and insomnia, which can accompany chronic pain. Full analgesic effect may take several weeks or months. TCAs also block the reuptake of norepinephrine and serotonin but have a more significant side-effect profile due to their additional blockage of histaminergic, dopaminergic, adrenergic, and muscarinic receptors. Of particular note is the risk for dysrhythmias and suicidal thoughts. Goals of Treatment The goal of treatment for all pain is elimination. In cases of chronic pain this is less likely to occur and a more realistic goal might be to reduce the pain to a tolerable level to maximize function and quality of life. As with acute pain management, it is desirable to meet treatment goals with minimum side effects. A comprehensive approach is needed and multimodal forms of pain relief should be incorporated into the plan of care. Mutual decision making between the patient and practitioner should be employed when choosing the drug, dosing, pain relief goals, and follow-up. Spiritual and cultural factors should be incorporated into the plan to make pain management patient-centered. Pawar and Garten (2010) concluded that children should have chronic pain managed in the same manner as adults. Treatment is aimed at the underlying cause and associated symptoms. Oral medication is preferred and on a scheduled rather than a prn basis. It is important to consider the neurodevelopmental age of the child as well as to know how to assess pain in different age groups so that the most effective treatment plan can be implemented. A young infant may have a central respiratory problem, so opioid use should be minimized. A toddler or older child may require less medication and use play or other distraction methods to cope with pain. No analgesia should be withheld from a child due to practitioner bias or insufficient assessment. Rational Drug Selection An algorithm for the management of chronic pain is depicted in Figure 52-5. Treatment is not solely based on the use of drugs. Multimodal interventions are available to attain the treatment goal of reducing chronic pain while maintaining maximum function. Drug Therapy In 1986, the World Health Organization (WHO) developed a conceptual analgesic ladder to help guide the management of pain. Initially developed for cancer pain, it has since been more broadly used in the treatment of all types of pain. The ladder consists of three steps: (1) nonopioids + adjuvants such as antidepressants or antiepileptics that do not have primary indications for pain management, (2) adding an opioid for mild to moderate pain, and (3) adding a stronger opioid for moderate to severe pain. Use of these principles can help the practitioner and patient select the best treatment plan based on the overall severity of the pain and the desired outcomes. Anti-Inflammatories As discussed in the acute pain section, anti-inflammatory drugs can be quite useful to reduce mild to moderate pain and inflammation. NSAIDs are often the first-line drugs of choice in Step 1 of the analgesic ladder, but all carry risk of serious adverse effects, especially in the elderly who are more likely to have comorbid conditions. The patient's risk for cardiovascular disease, GI bleeding, and renal dysfunction should be assessed before recommending this class of drugs. The risk for renal insufficiency increases with chronic NSAID use, especially in diabetics. Piroxicam and indomethacin are of high risk in older adults due to CNS side effects, GI bleeding, and drug-induced hepatitis. Naproxen may be safer than diclofenac and ibuprofen when the risk of cardiovascular disease is high. Celecoxib also carries a Black-Box Warning about cardiovascular disease and should be used with caution. One specific drug should not be considered for chronic pain—ketorolac (Toradol)—which is meant only for short-term use that should not exceed 5 days. Acetaminophen may be a good choice for older adults but liver function should be monitored with long-term use. All patients should be cautioned to read labels for common OTC remedies also containing acetaminophen to avoid accidental overdosing. Adjuvant Analgesics Adjuvant drugs are used for treating conditions other than pain. However, in combination with analgesics, they have a synergistic effect to reduce multiple types of pain. Corticosteroids such as prednisone and dexamethasone can be helpful in relieving the discomfort of inflammation but are generally used short-term for this purpose. Chronic use can cause adrenal suppression, GI bleeding, or thromboembolism. Depression or anxiety can be managed with SNRIs or TCAs along with pain modulation. Of the SNRIs, duloxetine (Cymbalta) 30 mg daily (titrated to 60 mg daily) can be useful for diabetic peripheral neuropathy with results in approximately 1 week; venlaxafine (Effexor) has also shown to be effective at doses of 150 to 225 mg daily. TCAs are effective for several types of neuropathic pain but can take up to 6 weeks for full analgesic effect. Avoid amitriptyline in older adults due to its anticholinergic effects. TCAs are contraindicated in patients with heart disease because sudden death can occur. A baseline ECG for patients over the age of 40 should be obtained prior to treatment with any TCA. Tramadol (Ultram) is a nonopioid analgesic that binds to the μ receptor and has weak opioid and serotonin-norepinephrine reuptake inhibitor (SNRI) activity. Because of its opioid-like activity, tramadol should not be used in patients recovering from narcotic addiction. Dosing of tramadol is usually 50 to 100 mg every 4 to 6 hours and should not exceed 400 mg/d; the maximum dose in patients older than 75 years is 300 mg/d. Seizures and serotonin syndrome are adverse effects. Safety has not been established in children. Cyclobenzaprine or other skeletal muscle relaxants are useful for fibromyalgia. Muscle relaxants are also helpful in the short-term management of acute exacerbations of muscle spasms associated with chronic low back pain. They are not helpful for long-term use due to their sedating properties. Topical applications of anesthetics or capsaicin can be useful for neuropathic pain at peripheral sites without significant systemic effects. Other drug classes for neuropathic pain include anticonvulsants; gabapentin (Neurontin) and pregabalin (Lyrica) are recommended for diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Gabapentin is more efficacious than TCAs in treating post-herpetic neuralgia. It is initially dosed at 300 mg 3 times a day and titrated to 900 to 1,800 mg 3 times a day; it is a suitable drug for children over the age of 3 at initial doses of 10 to 15 mg/kg 3 times a day and titrated based on age and weight. Pregabalin also has anxiolytic effects, which are helpful for mood stabilization in patients with neuropathic pain. The starting dose of pregabalin for the pain of diabetic neuropathy is 50 mg 3 times a day, then titrated over the next 7 days to 100 mg 3 times a day. The dose for fibromyalgia is 75 mg twice a day initially, then may be increased over the next 7 days to 150 mg twice a day. Patients may also wish to use complementary or alternative therapies for chronic pain relief. Herbal preparations are not regulated nor do they undergo the rigorous testing done on pharmaceuticals; however, they may play a role in treating chronic pain conditions. Internet consumers can find multiple Web sites that list “natural pain killers” such as turmeric (fibromyalgia), feverfew (rheumatoid arthritis), eucommia (connective tissue disorders), kava kava (arthritis and neuropathic pain), capsaicin (neurogenic pain), or Devil's claw (muscle and low back pain), to name a few. Practitioners should educate themselves about herbs and the possible interactions between herbs and pharmaceuticals. For instance, turmeric interacts with anticoagulants, antidiabetic agents, antihypertensives, and hepatotoxic agents, which would increase the risk of bleeding, hypoglycemia, higher blood pressure, and liver damage; feverfew interacts with antiplatelets and antidepressants, which would increase the risk of bleeding and may worsen depression (Ulbricht, 2011). Opioids Opioids are added in Step 2 of the analgesic ladder when pain is persistent or not well controlled with nonopioids. Step 2 opioids are indicated for mild to moderate pain; Step 3 opioids are used for moderate to severe pain. Opioids can be administered by a variety of routes and have a wide range of drug duration. An initial trial should be made and if the drug of first choice is not effective, a trial of a different opioid or route is warranted. For patients with episodic or breakthrough pain episodes, short-acting opioids (4 to 6 hr) are appropriate and can be taken as needed. Examples are codeine, hydrocodone, or oxycodone. For patients with persistent and unrelenting pain, long-acting opioids (8 to 12 hr or more) provide a more steady state of analgesia and should be taken on a regular schedule. Examples are OxyContin or MS Contin, which can provide relief for up to 12 hours. More recent preparations of morphine (Kadian and Avinza) and hydromorphone (Palladone) can last 12 to 24 hours. The fentanyl transdermal patch can provide relief for up to 72 hours (Hattori, n.d.). It is necessary to start with lower doses of opioids and gradually titrate to the desired effect. If necessary to convert from a short-acting agent to a long-acting opioid, the transition should be done cautiously, especially in opioid-naïve patients and the elderly. Methadone should be used with extreme caution because of its unpredictable pharmacokinetics and accumulation from repeated doses. Treatment is best provided by a pain management expert. Patients should be weaned from opioid therapy for the following reasons: (1) there is little clinical benefit despite multiple dosing adjustments and opioid rotation, (2) the patient has poor tolerance to the opioid at doses required for analgesia, (3) there are ongoing adherence issues (e.g., drug-seeking behaviors or diversion) despite the use of a pain contract or other treatment limits set with the patient, and (4) the patient has a comorbid condition that makes opioid therapy more harmful than helpful (Argoff, 2011). Downward tapering of drug doses should be done over time by decreasing the opioid dose by 10% of the original dose each week over several weeks. Abrupt cessation or rapid tapering can precipitate seizures or withdrawal symptoms. Switching from a long-acting opioid to a short-acting one may also be helpful because some patients may do better with lower potency drugs. To decrease the possibility of nonadherence to the treatment plan, limit the opioid supply to 7 days at the new dose during tapering. Monitor the patient during the withdrawal period for signs of abstinence syndrome, such as nausea, diarrhea, muscle pain, and myoclonus. These symptoms can be managed with clonidine (Catapres) 0.1 to 0.2 mg every 6 hours or a clonidine patch 0.1 mg over 24 hours weekly during the transition period (Washington State Agency Medical Directors’ Group, 2007). Mild withdrawal symptoms may last up to 6 months after opioids have been discontinued; although the symptoms may be unpleasant, they are not serious. The patient should be monitored for behavioral changes during the tapering process and appropriate management strategies utilized. In general, Schedule II controlled substance prescriptions are written for a 30-day supply (subject to state laws and insurance carriers) without refills, which would ordinarily require an office visit for renewal. The Drug Enforcement Administration (2006) revised its regulations to allow multiple prescriptions for Schedule II drugs in some cases, authorizing a total of a 90-day supply under the following conditions: the practice of writing multiple prescriptions is permissible under applicable state laws, the practitioner indicates on each prescription the earliest date the prescription can be filled, and the practitioner concludes there is no risk of aberrant behavior or drug abuse. Schedule III and IV controlled substances may be refilled if authorized on the prescription. These prescriptions may only be refilled up to 5 times within 6 months of the original issue date; after that time a new prescription is required. Monitoring Periodic assessment should be made of patients treated for chronic pain. Assessment of progress toward goal attainment should include documentation of pain intensity, functional ability, and quality of life. The practitioner should observe mood, affect, and coping abilities along with a physical examination. If the patient's status is stable, these assessments can be brief; if worsening conditions or complications are encountered, a more in-depth assessment is necessary. The practitioner should always assess for changing conditions and the risk of aberrant behaviors. For patients with a high risk of aberrant drug use, such as patients who are only interested in obtaining oral pills or who “run out” of medication before the 30-day period, other strategies should be utilized. For instance, urine drug screens or frequent follow-up visits with pill counts could be initiated. A pain contract that clearly identifies goals, expectations, and responsibilities of both patient and practitioner may be useful for patients who have a history of substance abuse or fall in the high-risk category. Comanagement with or referral to an addiction specialist could also be arranged. Outcome Evaluation Goals of treatment should be negotiated when therapy begins and a baseline of acceptable pain level should be established. The outcome may not be total pain relief but should aim to restore as much function as possible. Quality of life is also a mainstay of therapy. Since psychological effects of chronic pain are prevalent, assessing mood and coping skills is also important. It is difficult to use physiological measures but other indicators such as sleep, appetite, amount of physical activity, participation in work or hobbies, and social relationships can give insight into the success or failure of the treatment plan. Patient Education As with treatment of acute pain, the individual should be educated about the specific choice of drug or combination drug therapy to address chronic pain, dosing regimens, and realistic goals about pain management. Complete relief may be an unrealistic expectation, yet there are not only drugs but also adjunct and alternative therapies that can be helpful in reducing the pain to an acceptable level. Common side effects with long-term use of an opioid should be explained along with adverse effects. Differences between drug dependence, tolerance, and addiction should be reviewed because many patients are fearful that addiction will occur. The practitioner should assure the individual's report of pain is believed and that there are multiple modalities that can address the pain as well as the accompanying symptoms. Establishing a therapeutic partnership for the control of chronic persistent and recurrent pain is key. See “Patient Education, Chronic Pain Management.”