NR565 Week 2 Study Guide

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NR565 Week 2 Study Guide NR565 Week 2 Study Guide (Page 1) Chapter 1: The Role of the Nurse Practitioner as Prescriber Roles and Responsibilities of APRN Prescribers APRN prescriber is responsi ... ble for the final decision on which drug to use and how to use it. Degree of autonomy in this role and the breadth of drugs that can be prescribed vary from state to state based on the nurse practice act of that state. Nurse practitioner prescriptive authority is regulated by the State Board of Nursing for each state. • Advanced Knowledge o Additional knowledge, critical thinking, and assumption of a higher level of legal responsibility are required to assume the prescriber role o Knowledge of medicine, pharmacology, and nursing intertwine in the NP role o As a prescriber, it becomes the role and responsibility of the NP to determine the diagnosis for which the drug will be ordered, prescribe the appropriate drug, monitor the expected outcome of the drug, and incorporate a holistic assessment of the impact of disease and therapy on patient lives • Benefits of an APRN as Prescriber o Alternative treatment options are also part of the armamentarium that can be used to treat a given disorder and may interact with the pharmacotherapeutic intervention o APRN look at the big picture and consider alternative treatment options and lifestyle changes o Patients are looked at in a holistic approach and include the patient in decision making regarding their care. o NP practice may thrive under healthcare reform because of the demonstrated ability of nurse practitioners to control costs and improve patient outcomes Clinical Judgment in Prescribing • Prescribing drug results from: o Clinical judgment based on a thorough assessment of the patient and the patient's environment o Determination of medical and nursing diagnoses o A review of potential alternative therapies, and specific knowledge about the drug chosen and the disease process it is designed to treat o NPs factoring in the cost to the patient of the medication prescribed • Is there a clear indication for drug therapy? o In the age of health-care reform and increased awareness of the limitations of drugs, whether a medication is the best option for treatment has become an important question. • What drugs are effective in treating this disorder? o Several drugs may be effective in treating a condition, so which one is best for a particular patient? ▪ Even if only the most effective class of drug is considered, few classes of drugs include only one drug o How does one determine “best”; what are the criteria? Are there nationally recognized guidelines that can be used? ▪ The Agency for Health Care Quality (AHCQ), the National Institutes of Health (NIH), and many specialty organizations publish disease-specific treatment guidelines that include both pharmacological and nonpharmacological therapies ▪ Consult nationally recognized guidelines for disease management • What is the goal of therapy with this drug? o What is the best drug to achieve treatment goals?NR565 Week 2 Study Guide (Page 2) ▪ Various goals are possible in the choosing of therapy • Under what conditions is it determined that a drug is not meeting the goal and a different therapy or drug should be tried? o At the onset of therapy, the provider and patient should have a clear understanding of what outcome or goal is expected of the medication prescribed o Follow-up and monitoring times are established to see how well treatment with the drug is meeting the goal • Are there unnecessary duplications with other drugs that the patient is already taking? o The patient’s medication history should be reviewed at each encounter to detect duplications or medications that may be discontinued • Would an OTC drug can be just as useful as a prescription drug? o Increasing numbers of drugs are being moved from prescription to over-the-counter (OTC) status • What about cost? o Who will pay for this drug? Can the patient afford it? Will the cost of the medication affect adherence to the treatment regimen? ▪ Cost is an issue for several reasons • Many insurance policies do not cover the cost of drugs or only provide partial coverage, so the patient must pay “out of pocket” • The newer the drug, the more likely the cost is too high based on the drug manufacturer’s need to reclaim research and development costs while the corporation still holds the patent on that drug • Newest is not always best, and condition of cost is a major factor in choosing between newer drugs and ones that have been around long enough to be available in generic form • Many insurance plans have larger copays for name-brand drugs than for generic medications • Multiple national retail pharmacies have developed $4 prescription formularies • Awareness of what is on the local discount formulary may save the patient hundreds of dollars in prescription costs and may increase compliance • Factors likely to lead to poor adherence include a drug that is expensive in relation to a patient's finances, a drug that must be taken daily as part of a complex regimen, and a drug that is not covered by insurance. • Where is the information to answer these questions? o Wide array of professional literature that ranges from the well-reputed journals to literature from specialty and professional organizations, the multitude of computerized drug databases Collaboration with Other Providers Collaborate with physicians, pharmacists, podiatrists, mental health specialists, therapists, and other providers, including APRNs who are not NPs, physician assistants (PAs), and other nurses. • Physicians o Early in the development of the NP role, physicians were the teachers in the NP programs and accepted NPs as physician-extenders • Pharmacists o Profession of pharmacy requires graduate-level preparation for all pharmacists with the granting of a practice doctorate, the Doctor of Pharmacy (PharmD) o A PharmD can assist by offering expertise on the clinical management of patients, including available dosage forms, potential adverse reactions, and drug interactions • Other APRNsNR565 Week 2 Study Guide (Page 3) o Collaboration with other NPs and APRNs who have prescriptive privileges has two major advantages ▪ On a one-to-one basis dealing with individual patient issues, NPs and APRNs can share “clinical pearls” from their knowledge base and collaborate to improve the care of the patient ▪ Collaboration on issues related to scope of practice and prescriptive privilege at the state and national level is critical to obtaining and maintaining the autonomy of practice needed to provide optimal patient care • Physician Assistants o The focus of the PA's practice is similar to that of the physician, so both the APRN and the PA can benefit from interaction with each other in much the same way as from their interaction with physicians o Many PAs desire more autonomy in their practice, and the experience of APRNs in developing autonomy may be helpful • Nurses Not in Advanced Practice Roles o APRNs regularly collaborate with other nurse colleagues who are not in advanced practice roles o Some have specialized knowledge, such as Certified Diabetes Educators (CDEs) and Wound and Ostomy Care Specialists (WOCS) o These nurses and their assistants carry out the prescriptive orders of the APRN Autonomy and Prescriptive Authority More states are broadening and expanding the legal, reimbursement, and prescriptive authority to practice for all APRNs, including NPs. • Reimbursement o Reimbursement is evolving, with the Affordable Care Act rollout creating an opportunity for APRNs to address reimbursement parity o The reimbursement by third-party payers continues to be a practice barrier for many nurses in advanced practice • Drug databases o PharmGKB o WAITING FOR CLARIFICATION • Medication adherence o WAITING FOR CLARIFICATION Chapter 4: Legal and Professional Issues in Prescribing New Drug Approval Process Including Clinical Phases I-IV Costs a company approximately $2.6 billion. Takes 8.5 years on average for an experimental drug to travel from laboratory preclinical trials to FDA approval. • State One: Preclinical Research o Process of synthesis and extraction identifies new molecules with the potential to produce a desired change in a biological system o Produced through artificial synthesis or extracted from natural sources Biological screening and pharmacological testing use nonhuman studies pharmacological activity and therapeutic potentialNR565 Week 2 Study Guide (Page 4) of compounds-- animals, isolated cell cultures and tissues, enzymes, and cloned receptor sites, as well as computer models o Pharmaceutical dosage formulation and stability testing make up the process of turning an active compound into a form and strength suitable for human use o Toxicology and safety testing determines the potential risk a compound poses to people and the environment • Stage Two: Clinical Investigation o Investigational new drug (IND) application is filed with the FDA prior to human testing of any new drug entity--description of the clinical research plan -- clinical tests can begin 30 calendar days after submission ▪ Phase 1: Establishing the tolerance of healthy human subjects at different doses; defining its pharmacological effects (absorption, distribution, metabolism, and excretion). ▪ Phase II: Target disease or disorder to determine a compound's potential --small number of patients. ▪ Phase III: Trials are controlled and uncontrolled clinical trials of a drug's safety and efficacy in hospital and outpatient settings--drug's efficacy for specific indications-- broader range of adverse effects --best way of administering and using the drug for the purpose intended.--verify that the acceptable risk/benefit ratio seen in phase II persists under--must report in writing to the FDA within 10 working days any serious and unexpected adverse reactions. • Stage Three: NDA Review o To market a new drug for human use, a manufacturer must have a new drug application (NDA) approved by the FDA o All information about the drug gathered during the drug discovery and development process is assembled in the NDA o During the review period, the FDA may ask the company for additional information about the product or seek clarification of the data contained in the application o The FDA has 60 days to determine whether the NDA will be filed for review o Once filed, a team reviews the drug sponsor’s research on safety and effectiveness of the drug o Usually, the FDA requests additional information, and the manufacturer needs from 1-5 years to complete any additional well-controlled trials necessary to support the claimed indications or prove the drug’s safety • Stage Four: Postmarketing Research o In order to detect rare adverse drug reactions, hundreds of thousands of patients have to have taken the drug. Clinical trials conducted after a drug is marketed are an important source of information for postmarketing evaluation o Regulatory authorities can require companies to conduct phase IV studies as a condition of market approval o An important source of postapproval information is data collected and submitted by practitioners in the field through programs such as MedWatch U.S. FDA Regulatory Jurisdiction • Official Labeling o The legal distinction between a legend drug and an over-the-counter (OTC) drug is not founded on relative safety per se but rather involves a regulatory decision on whether adequate directions for the drug's proper use can be written for the layperson o The FDA is concerned with the marketing and availability of drugs that have demonstrated substantial evidence of an acceptable risk/benefit ratio for labeled indications o The proper and efficacious therapeutic use of these drugs is the responsibility of the prescriberNR565 Week 2 Study Guide (Page 5) 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)NR565 Week 2 Study Guide (Page 6) 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 drugsNR565 Week 2 Study Guide (Page 7) • 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 effectsNR565 Week 2 Study Guide (Page 8) 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 longterm 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 formNR565 Week 2 Study Guide (Page 9) ▪ 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, homehealth 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 [Show More]

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