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Chamberlain University College : NR 565 SG Week 2 - Ch1.4.13.25.52_ LATEST UPDATED 2021,100% CORRECT

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Chamberlain University College : NR 565 SG Week 2 - Ch1.4.13.25.52_ LATEST UPDATED 2021 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?  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 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 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 o FDA regulates the official labeling for all prescription and OTC drugs • Off-Label Use of Drugs o 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 o Nurse practitioners (NPs) are responsible for knowing the FDA indication and approval status of any drug they prescribe o Prescribing is legal if there is scientific evidence for the use • Controlled Substance Laws o The most comprehensive federal drug legislation is the Controlled Substances Act of 1970 o 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) o NPs wanting authority to prescribe controlled substances must apply for state prescriptive authority prior to application for a federal DEA number o National Provider Identifier number (NPI)  The NP should obtain an NPI as soon as it is feasible  NPs must know the different classifications and schedules of controlled drugs as well as the associated prescribing rules and regulations • Controlled Substance Prescribing Precautions o Some states, NP's license number appear on the prescription in addition to that of any supervising/collaborating practitioner o DEA registration number must be designated on all controlled substance prescriptions o DEA registers manufacturers and prescribers of controlled substances o Prescription should be dated on the day it is written, indicating any authorized refills as allowed and clinically appropriate o As of 2009, tamper-proof prescription pads are required for prescriptions written for patients under Medicaid payment plans Controlled Drug DEA Schedules (Table 4-1) Schedule Controls Required Drug Examples I No accepted medical use No legal use permitted For registered research facilities only Heroin, LSD, mescaline, peyote, marijuana* II No refills permitted No telephone orders unless true emergency and followed up by written prescription within 7 days Electronic prescribing permitted as of 2011 with specific software and secure identification processes Narcotics (morphine, codeine, meperidine, opium, hydromorphone, oxycodone, oxymorphone, methadone, fentanyl) Stimulants (cocaine, amphetamine, methylphenidate) Depressants (pentobarbital, secobarbital) III Prescription must be rewritten after 6 mo or 5 refills Telephone or fax prescription okay Narcotics (codeine in combination with non-narcotic ingredients not to exceed 90 mg/tab; hydrocodone not to exceed 15 mg/tab) Stimulants (benzphetamine, chlorpheniramine, diethylpropion) Depressants (butabarbital) Anabolic steroids, testosterone IV Same as Schedule III Penalties for illegal possession are different Pentazocine, phentermine, benzodiazepines, meprobamate V Same as all prescription drugs May be dispensed without a prescription unless regulated by the state Loperamide, diphenoxylate Cough medications with less than 200 mg/100 mL Pregabalin *Marijuana may be classified under individual state law as a Schedule II drug and used for medical purposes. It may not be “prescribed,” however. Controlled Substance Misuse • Prescriber Education o Many opportunities for individuals to obtain excessive quantities of controlled drugs, either intentionally or as a result of duplicate prescribing o Principles for prescribers related to prescription drug misuse assessment include the following:  Acquisition and wide use of chemical dependence screening skills/tools  Early and firm limit setting regarding indications for controlled drug prescribing o Careful documentation of a confirmed diagnosis and the ruling out of chemical dependence before initiating a controlled prescription or drug subject to misuse o Practice in “just saying no” and feeling comfortable in being firm without escalating the discussion into an argument with the patient o Set limits • Behavioral Red Flags o Almost every practice experiences the chemically dependent patient who uses dishonest mechanisms to obtain increasing supplies of controlled prescriptions o Scams are generally conducted to obtain more medications, more potent or higher-dosage formulations, higher street-value brands of drugs, a controlled drug without a chart or visit note, or to avoid noncontrolled alternatives o Patient-generated pressure to prescribe in the face of clinician hesitancy is one classic sign of a scam o Prescription altering and forging are a frequently encountered scam o Stealing or borrowing another patient’s drugs • Pressure to Prescribe o Another factor that increases the demand for controlled substances is the pressure to prescribe at every visit and the expectation that patients deserve a prescription for something at each visit or for each symptom offered o This process results in two well-known adverse situations  Overprescribing of antibiotics and resulting antibiotic resistance  Polypharmacy  Complaints • Enabling o The powerful instinct in practitioners to do anything medically possible to enable patients with present or potential disability to live at a higher level of function When You Suspect a Patient is Misusing Medications • Communication Barriers o Clinical interview and practitioner–patient relationship-building skills  Skill building involves active learning strategies in the areas of verbal and nonverbal communication, empathy, and rapport building  Communication Skills • One strategy is to just say no and mean it. By making the statement “I am feeling pressured by you to write a prescription today that is not clinically indicated. Because of this I am really concerned about you, and we need to talk about your use of alcohol or other substances,” the NP can often effectively turn the tables and shift the discomfort to the patient while still refusing to prescribe • Systemic Solutions to Problems of Controlled Substance Prescribing o Careful charting and documentation habits are essential for prescribing controlled drugs  Document clearly in a progress note • Physical evaluation of the patient • The diagnosis • The clinical indications for treatment • The written treatment plan • The expected symptom outcomes • Informed consent and agreement for treatment from the patient • Consultation and/or collaboration necessary to meet treatment goals and objectives • These strategies reduce, but do not eliminate, the risk of controlled drug diversion from one's practice • Prescribing Tips o A few tips can help the practitioner reduce environmental facilitation of prescription misuse  Collect and document a complete history and examination before prescribing controlled substances • Do not rely on patient-supplied history, xrays, or medical records to confirm your assessment—obtain this information directly from the primary source • Passik and Weinreb (2000) advise use of the four “A’s” to guide initial and ongoing assessment of medication efficacy o Analgesia measurement by use of pain scales or other assessment tools o Activities of daily living (ADLs) as measured by levels of physical and psychological functioning o Adverse effects o Abuse issues  Prescribe limited quantities without refills on a first visit, allowing additional time for patient assessment and confirmatory documentation  Educate medical and assistive staff in reinforcement of consistent clinic policies and procedures related to scheduling, forms, urine drug screening, records view and release, and refills • It is not uncommon for patients who do misuse substances to quickly identify the “weak link” among the treatment team and focus their energies on this person or process • Standardize expectations regarding after-hours calls, use of multiple providers, and weekend or early refills and post them where they are readily available  Patients covered by insurance plans, including Medicaid and Medicare, can be limited to one pharmacy or one prescriber through their payment plan  Case managers can often be utilized to help review and manage medication use and advocate for access to additional options for pain management and control  Other tips • Prescribing generic, longer-acting formulations of drugs that have less stress value • Writing out the quantity prescribed rather than using only numerals, which can be altered • Use tamper-proof paper for all prescriptions written for controlled drugs • Medication Agreements/”Pain Medication Contracts” o Defining and implementing treatment objectives is the medication agreement  This written tool can be incorporated into treatment of chronic pain, particularly if long- term management with opioids is indicated o NPs are advised to familiarize themselves with urine drug and alcohol screens and their availability, cost, sensitivity, and specificity o In-office rapid screenings are now available that can be done quickly and without prior notice in order to confirm adherence to medication agreement criteria o Contract used universally for all prescribing for chronic pain • Prescription Drug Monitoring Programs o As of 2012, all but one state (Missouri) have an active or legislatively enabled Prescription Drug Monitoring Program (PDMP) o A PDMP enables practitioners to query a confidential database of controlled substances statewide to evaluate • State Law o Authority to prescribe is a function of state law o Prescriptive authority varies from state to state o A license is always required for practice as an NP o The state Nurse Practice Act specifies the exact title that must be used for practice and on a prescription o Independent authority permits the prescriber to exert autonomous judgment o Dependent authority exists when the primary prescriber delegates the authority to another through a collaborative or supervisory agreement status of prescribing in each state • Writing and Transmitting the Prescription o Use preprinted prescription pads/electronic templates that contain the name, address, and telephone number and NPI number of the prescriber o This will allow the pharmacist to contact the prescriber if there are any questions about the prescription  Designate the complete drug name, strength, dosage, and form  Indicate the date of the prescription  Use metric units of measure, such as milligrams and milliliters; avoid apothecary units of measure  Avoid abbreviations  Avoid the use of “as directed” or “as needed.”  Include the general indication, such as “for infection.”  Indicate “Dispense as Written” if generic substitution is not desired  Include the patient weight, especially if pediatric or elderly  Indicate if a safety cap is not required, as medications will be dispensed with them by default o Schedule II drugs may not be refilled and require a new prescription for each dispensed quantity o What May Be Prescribed  Legend drugs (approved by FDA, prescription medications)  Prescriptions are required for the majority of controlled drugs --medical devices, home- health and home-testing equipment, durable medical equipment, needles and syringes, and sometimes for Medicaid or Medicare coverage of OTC medications that are required for patient health  FDA approval is required for medical devices, including artificial joints o State-Specific Elements  NPs who prescribe in a state with mandated collaboration or supervision may need to indicate the name and information of this person on their prescriptions  A state can also designate that a drug is controlled and requires a DEA number o Electronic Prescribing and Secure Prescribing  The days of “writing” a prescription may soon be over  Electronic prescribing As of June 1, 2010, the DEA's revised “Electronic Prescriptions for Controlled Substances” regulation provides practitioners with the option of writing prescriptions for controlled substances electronically Ethical Aspects of Prescribing • Informed Consent o Provider who performs a specific service is responsible for obtaining consent  Referring provider is not responsible for getting consent for a procedure performed by another provider  Some exceptions may apply, Informed consent has four critical features • (1) a competent patient (2) who is provided adequate information with which to make a decision (3) and who voluntarily (4) consents to a proposed intervention  In general, an adult is presumed to be legally competent unless declared incompetent in formal legal proceedings • Clinical competence is also not an all-or-none phenomenon • Mental health medications have specific consent regulations due to the vulnerability of their target population. --elderly or minor patients • Parental or partner involvement in prescribing determinations related to sexually transmitted infections, family planning, and birth control may be limited under specific state law • Prescribing for Self, Family, or Friends o NO SELF Prescribing o Limited family/friends--may not be ethical • Sale of Pharmaceuticals and Supplements o Can not sell samples provided for free o May stock and sell limited commonly prescribed med o May sell supplements –vitamins Chapter 13: Over-the-Counter Medications OTC Medication Characteristics and Regulation • Characteristics o Must be safe o Has low potential for misuse or abuse o Can be labeled o Patient must be able to self-diagnose the condition for which the drug is being taken o Must be for a condition that the patient can manage without supervision by a licensed health professional • Regulation o FDA Center for Drug Evaluation and Research (CDER) is responsible for ensuring that OTC drugs are properly labeled and that their benefits outweigh their risks o New OTC drug ingredients must undergo the New Drug Application process, just like prescription drugs OTC Medication Sales • The Consumer Healthcare Products Association (CHPA) o $33.1 billion in 2013 in sales of OTC medications o Proposes that every dollar spent on OTC medications by consumers saves the U.S. healthcare system $6-$7, based on cost savings in clinical visits and drugs • Pharmaceutical companies may apply for the drug to change to OTC status in order to continue making large profits from their blockbuster brand-name drug • Cough and colds are the ailments that generates the greatest OTC annual drug sales Hazards of OTC Self-Medication • Self-Prescribing o The treatment of common health problems with medicines especially designed and labeled for use without medical supervision and approved as safe and effective for use • Interactions o OTC medications may be harmful if misused or may cause harmful interactions with prescription drugs  Ex: A patient may accidentally overdose on acetaminophen by taking two OTC medications that both contain acetaminophen or by taking OTC acetaminophen with prescription drugs that contain acetaminophen such as Vicodin or Percocet Adverse Effects of OTC Self-Medication • Adverse Effects o All medications have predictable and unpredictable adverse effects o May be mild such as GI upset, or severe, such as GI bleeding associated with NSAID or aspirin use • Treatment Duration o Exceeding treatment duration or taking the wrong dose increases the likelihood of adverse reactions • Patient Education o Patients must be educated regarding the adverse effects of OTC medications o Education includes reading the label carefully and asking questions of a pharmacist or the provider o Patients must be educated about disclosing intermittent OTC medication use as part of their drug history Drug Interactions • Antacids o Consist of a metallic cation and basic ion (calcium carbonate, magnesium hydroxide), which neutralize acidity in the stomach by raising the pH o Basic property of these drugs causes them to interact with most medications by either binding with the drug molecule or altering pH and thus the absorption of drugs that need an acidic environment for optimal absorption o Most interactions can be avoided by separating the dosing of antacids by at least 2 hours from the dosing of the other oral medications  Ex: tetracycline. Aluminum hydroxide and magnesium hydroxide have a strong affinity for tetracycline and form an insoluble and inactive chelate. This interaction can reduce bioavailability of tetracycline by 90% • Anticholinergics o The primary adverse effects of diphenhydramine and doxylamine are anticholinergic, such as dry mouth, constipation, blurred vision, and tinnitus o Older male patients may have difficulty in urinating o Older patients may develop delirium from modest doses of diphenhydramine • CNS Depressants o OTC medication taken with prescribed medication can cause additive CNS sedating effects o OTC medications that contain alcohol, antihistamines, antitussives, or antidiarrheals may all cause additive sedation when taken with CNS-sedating medications • NSAIDS & ASA o The cyclooxygenase inhibitors (aspirin & NSAIDS) have a well-documented risk of GI bleeding o When combined with antiplatelet or anticoagulant medications, the risk is significantly increased and may be life-threatening o Patients who are taking antiplatelet or anticoagulant medications should be educated to not taking any OTC medication without consulting with a pharmacist or their provider Abuse of OTC Medications • Combat Methamphetamine Epidemic Act o Concern over the use of OTC decongestant medications to manufacture methamphetamine has led to changes in how the drugs are sold in the U.S o The Combat Methamphetamine Epidemic Act (2006 Patriot Act) restricts the sales of all cough and cold products that contain methamphetamine precursor chemicals ephedrine, pseudoephedrine, or phenylpropanolamine o The law includes a daily and 30-day limit on retail store and internet purchases of known methamphetamine precursors o All potential precursors are to be stored behind the counter in retail stores and retailers are required to ask for ID and keep a log of who is purchasing the drugs Patient Education Regarding OTC Medications • Patients should be educated on reading the label and following the label instructions • If the patient does not understand the label, they should ask for assistance from a pharmacist or provider • Educating patients that even though a medication is available OTC, it still has the same concerns for adverse effect, drug interactions, and toxicity as prescription medication Chapter 25: Anti-inflammatories: NSAIDs, Acetaminophen & Aspirin Pharmacodynamics Two cyclo-oxygenase isoenyzmes have been identified: COX-1 and COX 2. • COX-1 o Expressed systemically and synthesized continuously so that it is present all the time in all tissues and cells, especially platelets; endothelial cells; the GI tract; and renal microvasculature, glomeruli, and collecting duct o It has roles in homeostatic maintenance, such as platelet aggregation, the regulation of blood flow to the kidney and stomach, and the regulation of gastric acid secretion and production of protective mucus, especially in the stomach o Inhibition of these activities by NSAIDs accounts for their adverse reactions, especially on the renal and GI tracts • COX-2 o An inducible enzyme that is synthesized mainly in response to pain and inflammation o Nonspecific NSAIDs inhibit both COX-1 and COX-2. Most NSAIDs (aspirin, ketoprofen, flurbiprofen, indomethacin, piroxicam, sulindac) are mainly selective for COX-1 o Some (ibuprofen, naproxen, diclofenac) are slightly selective for COX-1, and others (etodolac, nabumetone, meloxicam) are slightly selective for COX02 • COX-2 Selective Drugs o Three COX-2 selective drugs (celecoxib, rofecoxib, valdecoxib) have been developed that appear not to inhibit COX-1  These drugs were used for patients who had higher risks for GI bleeding  In 2004 research indicated that the overall risk for GI bleeding was not sufficient to compensate for the increased risk of cardiovascular events that occurred with these drugs  Rofecoxib and valdecoxib are no longer on the market  At this time, a Black-Box Warning was placed on all NSAIDs and on celecoxib related to this risk • Label Changes o In 2005, the FDA requested that sponsors of all NSAIDs and celecoxib add to the labeling a boxed warning about cardiovascular risk events and the well-described, serious GI bleeding associated with their use o Medication Guide must now be provided with each prescription • Acetaminophen o Analgesic and antipyretic with limited anti-inflammatory activity o Although its mechanism of action is unknown, it is thought to act by inhibiting central and peripheral prostaglandin synthesis o Central inhibition is almost as potent as that of aspirin, but its peripheral action is minimal o Reduces fever by direct actions on the hypothalamic heat-regulating centers, which increase dissipation of body heat via vasodilation and sweating o Has advantages of minimal GI irritation and of not affecting bleeding times, uric acid levels, or respiration Pharmacokinetics • After oral administration, NSAIDs are rapidly and almost completely absorbed • All NSAIDs are more than 90% protein bound • Widely distributed in tissues, cross the placenta, and enter breast milk in low concentrations • NSAIDs are all metabolized by the liver and excreted by the kidneys, primarily as metabolites • Acetaminophen is extensively metabolized by the liver and excreted by the kidneys, primarily as inactive metabolites • When it is taken regularly or in large doses, the stores of one hepatic conjugate become depleted, and hepatic necrosis may occur Pharmacotherapeutics • Only relative contraindications are for ketorolac, mefenamic acid, flurbiprofen, and nabumetone in the presence of preexisting renal impairment • Because NSAID metabolites are excreted primarily by the kidneys, all others should be used with caution in the presence of renal function impairment • The liver extensively metabolizes NSAIDs • Naproxen may exhibit an increase in unbound fraction and reduced clearance of free drug in cirrhotic patients • A reduced dose may be necessary • Acetaminophen Poisoning o Common cause of poisoning, either intentional or accidental, due to the lay public underestimating the toxicity of the drug o A single dose of 150mg/kg of acetaminophen in children or 7.5 g to 10g in adults may be toxic o Drugs that induce CYP2E1 enzymes (carbamazepine, phenobarbital, phenytoin, isoniazid, and rifampin) or alcohol ingestion may cause hepatotoxicity when combined with acetaminophen o Stages  Stage 1: 0.5-24 hours: Nausea, vomiting, diaphoresis, pallor, and anorexia. Some patients may be asymptomatic initially.  Stage 2: 25-72 hours: Clinically improved; AST, ALT, bilirubin, and prothrombin levels begin to rise.  Stage 3: 72-96 hours: Peak hepatotoxicity; jaundice, confusion, AST of 10,000 not unusual.  Stage 4: 4-14 days: Death or recovery. Patients who survive enter a recovery phase. o Treatment  Should be referred to a poison control center hospital  If this is not possible, the following treatment regimen may be followed • If the acute ingestion is more than 150mg/kg or the dose cannot be determined, obtain a serum acetaminophen assay 4 hours after ingestion • If the level is more than 300mg/mL, hepatic damage has occurred in 90% of patients  Minimum hepatic damage results from a level below 120mg/mL  Treatment is by gastric lavage in all cases, preferably within 4 hours of ingestion  Oral N-acetylcysteine is a specific antidote for acetaminophen toxicity  Contact a poison control center for correct dosing of the antidote Drug Interactions • NSAIDs decrease the effectiveness of antihypertensive drugs because of their tendency to cause fluid retention and increased extracellular fluid volume • Coadministraction with anticoagulants may prolong prothrombin time because both drugs affect platelet aggregation (ex. Warfarin) • Drugs that have adverse reactions associated with increased risk for GI bleeding or ulcerations associated with increased risk for GI bleeding or ulceration have an even higher risk if taken with NSAIDs • Drugs that require glucuronidation for metabolism may affect the metabolism of acetaminophen by competing for metabolic sites Rational Drug Selection • There is no clear difference in efficacy between NSAIDs, although there may be individual differences in response • The rationale for choices is provided in the Clinical Use and Dosing section below • Acetaminophen is used for fever and for mild to moderate pain not associated with inflammation! Monitoring • Required for long-term therapy • Because NSAIDs may produce acute renal insufficiency, assess renal function (serum Cr) before initiation of therapy and annually throughout long-term therapy • A CBC prior to initiation of therapy and annually is appropriate because of the risk for GI bleeding Patient Education • Take the dose exactly as prescribed • A missed dose should be taken as soon as the patient remembers unless it is almost time for the next dose • For drugs taken more than once daily, ideally the missed dose should be taken within 1-2 hours of the time it was scheduled • Doses should not be doubled • Taking higher doses than prescribed dose not increase efficacy and may increase adverse reactions • Patients should be informed if there is a prescribed length of time beyond which the drug may not be taken. • Taking the drug with food or a full glass of fluid and remaining in an upright position for 15-30 minutes may reduce GI discomfort and adverse reactions • Remind patients to avoid aspirin, alcohol, or other GI irritants while taking these drugs • Patients should be aware of products that may contain acetaminophen, including cough and cold products and combination opioid products to avoid accidental overdose of acetaminophen Clinical Dosing for RA • Initial drug treatment involves the use of salicylates, NSAIDs, or celecoxib to reduce join pain and swelling and to improve joint function • They have analgesic and anti-inflammatory properties but do not alter the course of the disease or prevent joint destruction, so they should not be used as the sole treatment for RA • Choice is determined by adverse reactions, cost, duration of action, and patient preference. See Table 25-9 page 823. Clinical Dosing for OA • No known cure for OA • Treatment can help to maintain or improve join mobility and limit functional impairment • Drug therapy includes acetaminophen, NSAIDs, and COX-2 inhibitors • Topical agents such as capsaicin (hand OA only) and trolamine salicylate may also be used • Initially, acetaminophen in doses 650mg 4x/day or 1g 3x/day (maximum 3g/24hrs) are given to manage joint pain • If this drug fails to control pain, NSAIDs are prescribed • All NSAIDs except ketorolac and mefenamic acid have an indication for treatment of OA. See Table 25- 9 page 823. Clinical Dosing for Gout • Indomethacin, naproxen, and sulindac list acute gout as an indication. See Table 25-9 page 823. • Low dose colchicine can be prescribed o May cause diarrhea • If patient is taking allopurinol, monitor BUN, creatinine, and creatinine clearance labs • Febuxostat (Uloric) may worsen gout with therapy when starting medication Clinical Dosing for Mild to Moderate Pain • Ibuprofen is the most commonly used because it is inexpensive, available OTC, and short-acting so that acute pain can be managed without long-term effects and adverse reactions • Acetaminophen is useful in treating mild to moderate pain that is not accompanies by or caused by inflammation • It is not intended for pain management for more than 5 days in children or 10 days in adults because of the increased risk for hepatic adverse reactions • For adults, a dose of 325 to 650mg every 4-6 hours usually suffices • Children’s doses are based on weight: 10-15mg/kg per dose every 4-6 hours • After age 14 adult dose is used. See Table 25-9 page 823. Clinical Dosing for Dysmenorrhea • Ibuprofen, diclofenac potassium, ketoprofen, meclo-fenamate, mefenamic acid, and naproxen are the drugs used for dysmenorrhea • The best response occurs if NSAIDs are starting with the onset of menses symptoms. See Table 25-9 page 823. Clinical Dosing for Tendinitis/Bursitis • Indomethacin SR, naproxen, and sulindac are used • Naproxen and sulindac both are intermediate-acting and provide longer duration of action than indomethacin • Naproxen is less likely to produce GI adverse reactions • These same three drugs are used to manage the pain in gout because it is associated with inflammation. See Table 25-9 page 823. Clinical Dosing for Fever • Ibuprofen is the NSAID of choice for fever in children over age 6 months and adults • Acetaminophen may also be used for this purpose, but for no longer than 3 days • Patients should be well hydrated if using ibuprofen for fever to decrease renal toxicity. See Table 25-9 page 823. Aspirin • Pharmacodynamics o All salicylates have analgesic, anti-inflammatory, antipyretic, and antiplatelet actions o Salicylates lower body temperature through their effect on the hypothalamic thermostat and vasodilation of peripheral vessels, thus enhancing dissipation of heat • Prostaglandin o The anti-inflammatory and analgesic activities are mediated through inhibition of prostaglandin synthesis in the same manner as NSAIDs o However, aspirin more potently inhibits prostaglandin synthesis and has greater anti- inflammatory activity than the NSAIDs o The acetyl group of the aspirin molecule is thought to be responsible for these differences • COX Inhibitor o Aspirin acetylates the cyclo-oxygenase enzyme in the prostaglandin biosynthesis pathway; therefore, it may be theoretically classified as a COX inhibitor • Antiplatelet o Aspirin also irreversibly inhibits platelet aggregation o Single analgesic-level doses prolong bleeding time o Acetylation of platelet cyclo-oxygenase prevents synthesis of thromboxane A, which is a potent vasoconstrictor and inducer of platelet aggregation for the life of the platelet o This drug has shown success as an antiplatelet agent for patients with thromboembolic disease Pharmacokinetics • Salicylates are rapidly and completely absorbed after oral administration • Bioavailability depends on the dosage form, gastric emptying time, gastric pH, presence of antacids or buffering agents, and particle size • Salicylic acid is eliminated by renal excretion of salicylic acid and by oxidation and conjugation of metabolites by the liver • Include H2 blockers if patient complains of heartburn to prevent GIB Pharmacotherapeutics • Taking salicylates, especially aspirin, by children or adolescents with influenza or chickenpox has been associated with the development of Reye Syndrome (vomiting, lethargy, delirium and coma) • The mortality rate is 20-30%, and permanent neurological deficits have been reported in survivors • Long term therapy should have CBC checked annually • Hepatic Impairment o Salicylates should be used cautiously for patients with hepatic impairment o Reversible hepatic encephalopathy has occurred after even therapeutic doses for RA • Renal Impairment o Cautious use is also required for patients with renal insufficiency because salicylates may cause a transient decrease in renal function and aggravate chronic kidney diseases • Uric Acid Accumulation o In low doses (2g/day), they decrease urate excretion and raise serum uric acid levels o At high doses (3-5g/day), they have a uricosuric effect; however, they are rarely tolerated at this high a dose • Gout o Salicylates should be used with caution in the presence of gout • ADRs o Most common adverse reaction to salicylates is GI irritation and bleeding o The amount of blood lost from GI bleeding secondary to salicylate use is usually clinically insignificant, but with prolonged use it can result in IDA o Hypersensitivity to salicylates or NSAIDs contraindicates aspirin use and requires extremely cautious use of the other salicylates o Aspirin sensitivity is more prevalent in patients with asthma, nasal polyps, or chronic urticaria o Ototoxic at increased blood levels  Should be discontinued if dizziness, tinnitus, or impaired hearing develops  Temporary hearing loss disappears gradually when the drug is stopped • Toxicity o The acute lethal dose of salicylates in adults is 10-30g, and in children it is 3 g o Chronic salicylate toxicity can occur when more than 100mg/kg is ingested daily for 2 or more days o Signs of salicylate poisoning appear at serum levels of 30-60mg/dL o Early sign of toxicity is tinnitus o Respiratory alkalosis is seen initially o Hyperpnea and tachypnea occur as a results of increased CO2 production and a direct stimulatory effect of the salicylate on the respiratory center in the brain o Other symptoms include nausea, vomiting, hypokalemia, tinnitus, disorientation, irritability, seizures, dehydration, hyperthermia, thrombocytopenia, and other hematological disorders • Treatment o Induction of emesis or gastric lavage to remove any unabsorbed drug from the stomach o Activated charcoal diminishes salicylate absorption if it is given within 2 hours of ingestion o Salicylate levels and acid-blasé, fluid, and electrolyte balances are carefully monitored o Forced alkaline diuresis by administering sodium bicarbonate increases salicylate excretion. Hemodialysis for severe poisoning Clinical Use and Dosing for Fever • Aspirin is the salicylate of choice for reduction of fever in adults • Contraindicated for use with pregnant patients • Acetaminophen or ibuprofen are probably better for fever management in children because there is not the risk of Reye syndrome. See Table 25-12 page 832. Clinical Use and Dosing for Mild to Moderate Pain • Pain associated with inflammation is especially well managed with salicylates or NSAIDs • Aspirin, choline salicylate, choline magnesium salicylate, and diflunisal are all approved for this indication. See Table 25-12 page 832. Clinical Use and Dosing for RA • Salicylates or NSAIDs can be used as adjunctive treatment for RA • Serum levels can be measured to determine adherence and therapeutic efficacy, and it is the least expensive salicylate • Nonacetylated salicylates are less potent anti-inflammatory agents, but have fewer adverse reactions than aspirin • A therapy trial of 3-4g/day for 4-6 days is recommended because 70-80% of patients who will respond will do so within this time frame • Older adults are less tolerant to the adverse GI reactions, and their trial dose should be 2-3g/day • Blood levels should be drawn before changing drugs • If the salicylate level is too low but the patient has been adherent and tolerates the aspirin, the dose should be increased by 325-650mg/day until the desired anti-inflammatory level of the drug is reached. See Table 25-12 page 832. Clinical Use and Dosing for OA • Usually well tolerated in divided doses of 1.2-2.4g/day • NSAIDs tend to have more adverse reactions with no better pain relief when given at anti-inflammatory doses over the course of more than a few days • The nonacetylated salicylates are also effective and have fewer GI adverse reactions than aspirin • Diflunisal has the advantage of twice-daily dosing but may take up to 2 weeks to achieve full anti- inflammatory effects. See Table 25-12 page 832. Clinical Use and Dosing for MI Prophylaxis • Low dose aspirin (75-100mg daily) is recommended in patients age 50 years or older for primary prevention of cardiovascular disease • It is recommended that low dose aspirin (75-100mg/day) or clopidogrel be given in patients with established coronary artery disease, patients with coronary stenosis greater than 50% and those with evidence of cardiac ischemia. See Table 25-12 page 832. Clinical Use and Dosing for TIAs • Aspirin (50-325mg/day) monotherapy or a combination of aspirin and extended release dipyridamole are accepted therapy options for stroke prevention. See Table 25-12 page 832. Monitoring • A random salicylate level should be drawn 7-10 days after initiation of chronic therapy • Periodic salicylate levels should be drawn during long-term management to check maintenance of therapeutic levels and monitor for toxic manifestations • Elimination o Because all of these drugs are eliminated by the kidneys and dosage adjustments may be required based on renal function, serum Cr levels should be assessed before therapy is begun and annually throughout long-term therapy o Urinary pH should also be monitored regularly o Sudden acidification of urine can more than double the plasma salicylate level, resulting in toxicity • CBC o Salicylates interfere with homeostasis o A CBC should be drawn prior to initiating therapy and at least annually throughout long-term therapy o A CBC should also be drawn and fecal occult blood studies should be done as well if there is any indication of GI bleeding • Hepatic Function o Should be monitored prior to anti-rheumatic therapy and if hepatotoxicity symptoms occur o These problems are more likely in patients with rheumatic fever, juvenile RA, or preexisting hepatic diseases, especially children • Ophthalmic Effects o Have been reported in patients taking diflunisal o Ophthalmic studies are appropriate for patients who develop eye complaints during therapy Patient Education • Instruct the patient to take salicylates exactly as prescribed • Taking with food or a full glass of water and remaining in the upright position for 15-30 minutes after administration can reduce GI irritation. Food slows absorption but does not alter the total amount absorbed • Do not crush or chew enteric-coated tablets or take antacids within 1 hour of enteric-coated tablets • Chewable tablets may be chewed, dissolved in liquid, or swallowed whole • Instruct patients not to increase the dose beyond that prescribed • Increased doses increase the risk for salicylate poisoning • Most common adverse reactions are ototoxicity and GI irritation/bleeding • Advise patients to report tinnitus; unusual bleeding from the gums; bruising; black tarry stools; or fever lasting longer than 3 days • Patients taking salicylates should not use alcohol or other substances that increase GI irritation • Parents should be informed of the risk of Reye Syndrome and educated regarding not giving aspirin to a child with a viral illness Prednisone • If patient is taking 10mg daily 6 mo, monitor for osteoporosis, especially in women • If patient’s total dose will exceed 1 gram, patient will need a second prescription for omeprazole or a PPI to prevent peptic ulcer disease • When discontinuing prednisone, develop a tapering schedule to slowly wean pt off medication • Pt taking chronic low-dose prednisone with RA, will need co-treatment with bisphosphonate to prevent further adverse effects Corticosteroids • Patients starting chronic corticosteroid therapy will need monitoring of serum glucose • Educate patients to report black tarry stools and abdominal pain Chapter 52: Pain Management: Acute and Chronic Pain Overview of Pain Concepts Pain • Most common reason people seek medical attention (CDC and NIH) • Expect relief when seeking treatment • Brennan/Colleagues and Fishman (2007) o Pain management is a basic human right o BUT standard of care for pain management is not an absolute science or free of risk o (2011) Undertreatment for pain widely reported in the literature = Significant problem • Failure to treat pain is • Unethical • Poor clinical practice • Violation of human rights (Appropriate management) IOM- examining pain as a national health problem and transforming the understanding, prevention, assessment and treatment of pain International Association for the Study of Pain (IASP) • Pain is the unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage or both • PAIN IS SUBJECTIVE Suffering • Emotional reaction to pain and can be manifested by feelings of helplessness or hopelessness • Understanding these terms can help APN to assess pain symptoms, consider cause and develop the best pain management plan with specific presentations Acute vs Chronic Pain can be acute or chronic, generally classified by duration of symptoms and presence or absence of sympathetic nervous system activity Acute Associated with tissue injury and resolves when healing occurs. (Subcategorized: Physiological) Chronic Last more than 6 months- well beyond expected time of healing. (Subcategorized: Pathological) IASP Taxonomy (2012) Pain Terms Characteristic Allodynia pain from a stimulus that does not normally produce pain Analgesia absence of pain in response to stimulation that would normally be painful Causalgia a syndrome of sustained burning pain after a traumatic nerve lesion Dysesthesia an unpleasant abnormal sensation, whether spontaneous or evoked Hyperalgesia increased pain from a stimulus that normally provokes pain Hyperesthesia increased sensitivity to stimulation Hyperpathia a painful syndrome characterized by an abnormally painful reaction to a stimulus, especially a repetitive stimulus, as well as an increased threshold Hypoalgesia diminished pain response to a normally painful stimulus Hypoesthesia decreased sensitivity to stimulation Neuralgia pain in the distribution of a nerve or nerves Neuritis inflammation of a nerve or nerves Neuropathic pain pain caused by a lesion or disease of the somatosensory nervous system Neuropathy a disturbance of function or pathological change in a nerve: in one nerve, mononeuropathy; in several nerves, mononeuropathy multiplex; if diffuse and bilateral, polyneuropathy Nociception the neural process of encoding noxious stimuli Nociceptive pain pain that arises from actual or threatened damage to nonneural tissue and is due to the activation of nociceptors Nociceptor a high-threshold sensory receptor of the peripheral somatosensory nervous systems that is capable of transducing and encoding noxious stimuli Paresthesia an abnormal sensation, whether spontaneous or evoked Sensitization increased responsiveness of nociceptive neurons to their normal input and/or recruitment of a response to normally subthreshold inputs Table 52-1 (p. 1352) Types of Pain Acute Chronic Etiology Physiological Pathological Onset Sudden Gradual Localization Generally, well identified Less easy to differentiate Duration Self-limiting with healing Last beyond 6 months Character Varies, More overt signs Varies, fewer overt signs Temporal Pattern Varies, Correctable symptoms Varies, Persistent symptoms Associated Symptoms Physical and Psychological (Anxiety/Irritability) Physical and Psychological (Depression, Insomnia, Lethargy) Prognosis Complete relief in most cases Complete relief generally not achieved The Experience of Pain • Stimulation of nociceptive system – physiological mechanisms of pain can occur with disease process without specific injury present • At other times pain may not be related to physical process, indicating the influence of emotional and psychological factors that produce subjective reports of pain • “Whatever the experiencing patient says it is and exists whenever he says it does” -McCaffery (1972) o It is important that the patient statements are believed by the APN o Comprehensive assessment vital BUT also understand nature of the pain (Table 52-1) including pathophysiology, relevant comorbid conditions and the impact on activities and Quality of Life (QOL) • Melzack and Casey (1968): Model for pain levels o Sensory-Discriminative: Location, intensity and quality of pain o Motivation-Affective: Depression/Anxiety associated with pain o Cognitive-Evaluation: Patient’s thought about significance of pain Pain Threshold and Pain Tolerance • Threshold o Lowest point at which a nociceptive stimulus is perceived as pain Varies between patients and within the individual o Perceptual dominance- extreme pain in one location raises threshold in other areas o Pain as a threat to well-being may also influence pain threshold (Ex. Chest pain = MI = Death= Patient seeks treatment) • Tolerance o Amount of intensity or time a patient will endure before taking steps to relieve pain o Past experience with pain is a factor o May decrease over time o Influenced by anger, fear, lack of sleep and other cognitive factors o May increase with medications, recreational drugs, alcohol, distraction, application of heat/cold, herbs or alternative therapies (Acupuncture, hypnosis, cultural beliefs/expectations/religious activities) Special Populations • Pain assessment should include detailed history: characteristics, symptom treatment prior to visit, impact on function/well-being, sleep, medical/psychiatric conditions, and current medications • Complete physical conducted with focus on neurological and musculoskeletal systems – identify sensory and functional deficits • Review medical record – ascertain previous conditions, diagnostic test results which may contribute to current pain complaint • Thorough data collection helps to formulate a working diagnosis for the etiology of the pain and help plan the best treatment for underlying cause and symptoms related to cause • Undertreatment in the very young and the elderly and minority populations has been an issue for decades • Unable to adequately report pain- may be part of APN lack of attention to evaluate further • Multifactorial sources of pain MUST be assessed and understood to provide the best practices • A review of past medical records and diagnostic studies should be included in the pain assessment o It is also important to obtain a history of potential substance abuse, which typically begins by asking about past or current smoking and use of alcohol and progresses to specific questions about recreational and prescription drug use o Other data may include the patient's mood, coping strategies, and pain interference with activities of daily living o The practitioner should develop a working diagnosis for the pain etiology and a plan of care that may include additional diagnostic studies and treatments Pediatric Patients • Nervous system is sufficiently developed prior to birth • Inflammatory response is robust in infants and young children- can produce a greater neural response following noxious stimuli • BUT enzyme systems that metabolize drugs is immature in preterm and neonates • Pain producing events have an impact on young nervous system- can have lasting effect and lower threshold for months • Older children have higher pain thresholds • Response to pain is always INDIVIDUAL Assessment • Pain assessment in infants and children younger than 18 months can be a challenge due to their inability to verbally express their discomfort • Validated pain scales for preterm and term infants can be used to monitor behaviors • The Premature Infant Pain Profile • CRIES Postoperative Pain combine physiological measurements along with facial expressions to determine the degree of pain • The FLACC (Face, Legs, Activity, Cry and Consolability) Scale (is a behavioral scale that can be used in children 2 months to 7 years in age • A pain score is calculated after observing the child for 5 minutes • Children as young as 18 months may be able to indicate their discomfort • Children ages 3 to 4 years and older have acquired words they can use to report the pain location and describe its characteristics o They can generally use self-report pain scales  Wong-Baker Faces Scale  Oucher Scale  Poker Chip Scale o School-age children may be able to use adult scales such as the Numeric Rating Scale or the Visual Analog Scale • Questionnaires have also been developed for children with chronic pain and include the Children's Comprehensive Pain Questionnaire and the Varni-Thompson Pediatric Pain Questionnaire Older Adults • 65yo+ have multiple causes of pain • May not be adequately identified, increasing risk for inadequate pain management • Aging = physiological changes, anatomical changes, and the underlying neurophysiological mechanisms of pain, coupled with comorbid conditions o Can lead to an increase in pain threshold o Arthritis is the most common persistent pain in people over 85 • Reluctant to report pain for many reasons, making assessment challenging especially if there is cognitive decline • APN may need to clarify words used by the elderly to describe discomfort, as they dismiss pain as part of the aging process, disease progression or fear additional costs and tests Assessment • Practitioners should take a thorough pain history and assess for pain as a routine part of the elderly patient's visit • The physical exam should focus on the musculoskeletal and neurological systems • Functional and range of motion testing should be included in the pain assessment • Cognitive ability is also an important part of the assessment process; look for new or worsening symptoms along with evaluation for depression or anxiety, which can accompany persistent pain • Using common visual analog or numeric rating scales are useful but geriatric pain assessment tools may better assist in the overall assessment of pain in the elderly • Patients with cognitive deficits may do better with the Faces Scale or other pictures • Pain has a significant impact on quality of life in the older adult and should not be overlooked Cognitive Impairment • Dementia and cognitive impairment common in the elderly but can occur at any age • Mental capacity may be reduced but that does not mean that physiological response to pain is reduced • Pain assessment is challenging when patient can’t communicate clearly (needs and symptoms) • Poor pain management can manifest as behaviors that mimic psychological disorders- leading to misdiagnosis and inappropriate treatment o Agitation, mood changes, withdrawal from activities, or other behavior disturbances can indicate pain/distress but is not recognized as a pain issue o Mini Mental Status Exam (Folstein, Folstein and McHugh-1975) has been used significantly o Pain assessment tools for dementia patients can be found at (Alzheimer’s) o Checklist for nonverbal pain indications- more recent specifically to measure pain in cognitively impaired patients o Pain Assessment in Advanced Dementia (PAINAD)- measures breathing vocalization, facial expressions, body language and consolability in non-verbal patients o Pictoral pain scales can be used in children and patient that can’t communicate Comorbid Chronic Illnesses • Older adults are more prone to having comorbid conditions (Arthritis, CVD, DM) requiring pharmacological therapies • NSAIDs o Mild to moderate pain from arthritis, has potential to interact with other commonly prescribed medications for this age group: antihypertensives, antidiabetic, etc o The risk of serous GI side effects and renal toxicity also contribute to complications o Aging process alters organ function- Important to absorption, distribution, metabolism and elimination o Patients should be screened carefully for GI disorders, hepatic and renal function, adrenal function and hypothyroidism o Contraindicated with those with a history of GI bleeds • Endocrine deficiencies o Prolonged and exaggerated response to opiates • Kidney dysfunction o Alters elimination – Dosing of analgesics is critical to avoid toxicity Pregnancy • General- pregnant women should avoid medications o Safe use of analgesics in pregnancy has not been well established  Most analgesics are Pregnancy Category C or D • Carefully weigh benefits vs. fetal harm o Research has shown the following drugs demonstrate no fetal risk Category B  Acetaminophen  Naproxen  Oxycodone  Topical analgesics • Mother addicted to opiates = Newborn is subject to respiratory depression or excessive sedation along with withdrawal symptoms • FDA (2013) o Relabeled ALL extended-release and long-acting opioids – boxed warning that maternal use could cause neonatal opioid withdrawal symptoms Substance Abuse • Overuse of alcohol or prescription drugs in prevalent in society and an issue • APNs who treat both acute and chronic pa

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Chamberlain University College : NR 565 SG Week 2 - Ch1.4.13.25.52_
LATEST UPDATED 2021

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?

, )
 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

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