week 2 - lecture notes.pdf
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2023-09-17 Objectives Discuss ethical and legal considerations in pharmacology Explore the various acts and programs that govern nursing pharmacological practice Understand the College of Nurses of Ontario Standard of practice: Medication administration 1 Pharmacology Basics Continued Modul...
2023-09-17 Objectives Discuss ethical and legal considerations in pharmacology Explore the various acts and programs that govern nursing pharmacological practice Understand the College of Nurses of Ontario Standard of practice: Medication administration 1 Pharmacology Basics Continued Module 2 Recognize the importance of age and ethnocultural consideration in drug administration. Legal and Ethical Considerations – CH. 3 Identify and comprehend the nursing role in preventing and responding to medication errors. Differentiate between medication errors, adverse drug events, & adverse drug reactions Med Errors – CH. 6 Develop a plan of care for drug therapy that incorporates ethical and legal considerations, as well as any age and ethnocultural concerns for antiinflammatory and antigout drugs Patient considerations – CH. 4 1 2 3 4 Canadian Food and Drug Act Primary piece of legislation governing foods, drugs, cosmetics, and medical devices The Health Products Food Branch Inspectorate of Health Canada federally administers which Act? The Food, Drug and Cosmetic Act of 1938 was the first legislation to regulate drug safety According to the Act, drugs must comply with official prescribed standards A. Personal Health Information and Protection Act B. Controlled Drugs and Substances Act C. Information Access Act Recognized formularies creates the standards D. Electronic Personal Information Act Various schedules Government of Canada Justice Laws Website i.e. prohibited sales, drug labelling, trade standards, samples, etc. 3 4 1 2023-09-17 5 Additions to the food and drugs act Schedule 6 Prescription drug list A list of medicinal ingredients in a drug that requires a prescription (excludes drugs in the controlled drugs and substances act schedules that need a prescription) Part G Controlled drugs that affect the CNS. Categorizes controlled drugs into 3 parts Narcotic drugs and preparations Drugs with a high misuse potential Part J Restricted drugs with high-misuse potential, they have dangerous physiological and psychological adverse effects but no recognized medical use (ie. LSD, magic mushrooms) Benzodiazepines and other targeted substances regulations Either a controlled substance included in Schedule 1 or a product/compound that contains a controlled substance that is included in schedule 1. these are drugs with misuse potential Controlled Drugs and Substances Act (CDSA) The Controlled Substances Act, passed in 1970, set rules for the manufacture and distribution of drugs considered to have potential for abuse. Description CDSA replaced the Narcotic Control Act in 1997. regulates the possession, production, distribution, and sale of controlled substances to protect public health and safety. Provides requirements for the control and sale of narcotics, controlled drugs, and substances of misuse The letter N and the symbol every narcotic drug. are printed on the label of Ontario’s Narcotic Strategy: Ministry of Health of Long-Term Care Public Information about Ontario's Narcotic Strategy 5 6 So how are new drugs approved in Canada? 8 Our system of drug research and development is one of the most stringent in the world and is an ongoing process New Drug Development: Patient safety & drug efficacy Four Clinical Phases of Investigational Drug Studies Phase I: small number of healthy subjects (usually fewer than 100) Phase II: larger numbers of volunteers who have the disease or ailment (usually 100 to 300) There is a four-phase process to approve drugs for use in Canada 1. Chemical and Biological Research. Laboratory tests are carried out in tissue cultures and with a variety of small animals to determine the effects of the drug. Phase III: larger number of patients who are followed by medical research centres (1 000 to 3 000) 2. Pre-Clinical Development given to animals in various amounts and over different periods of time. Identifies no serious or unexpected harm at which doses required to have an effect. Phase IV: post-marketing studies voluntarily conducted by drug companies to obtain information of the therapeutic and adverse effects of the new drug 3. Clinical Trials — Phase 1... Clinical Trials — Phase 2... Once approved, drug is assigned a Drug Identification Number (DIN). Clinical Trials — Phase 3... 4. New Drug Submission. 7 8 2 2023-09-17 Use of Placebos in/out of Studies Legislation & Regulation Placebo is a drug dosage form without pharmacological activity. • What legislates my actions as a nurse when providing care (surrounding medications) to patients? used frequently in experimental drug studies. • The Nursing Act & Regulated Health Professions Act Except in new drug studies, placebo use is considered unethical, creating mistrust among the nurse, the prescriber, and the patient. • How is this regulated? • Entry-to-practice competencies • CNO Practice Standards Clinical Trials: It’s not just a phase! Informed consent process must be followed. Patients are informed of their right to • What is my legal responsibility in administering medications? leave the study without pressure or coercion. • Controlled act(s) delegation (procedures that can only be performed by an authorized healthcare professional) leave the study with no consequences to medical care. • administering a substance by injection or inhalation, dispensing a drug, etc. receive full and complete information about the study. • Employer policies be made aware of alternative options and receive information on all treatments, including placebo therapy 9 • What ethical guidelines guide my practice? 10 11 Legal Nursing Considerations A Nurses’ Accountability Nursing practice standards of care Three principles outline the expectations related to medication practices that promote public protection. Providing safe, compassionate, competent, ethical care Promoting health and well-being The principles are: Promoting and respecting informed decision making Honouring dignity Maintaining privacy and confidentiality authority Promoting justice competence Being accountable safety. Scope of practice Canadian Nurses Association (CNA) is the national voice for nurses. CNO Medication Practice Standard.pdf Accreditation Canada requires accredited hospitals to fulfill certain standards regarding nursing practice. 11 12 3 2023-09-17 Is Competency measurable? Competency is measurable in: 13 a nurse’s display of clinical and pharmacological knowledge, clinical experience, and the ability to perform comprehensive, situational assessments of the patient before medication administration. Competency Framework https://www.cno.org/globalassets/docs/reg/41037-entry-to-practicecompetencies-2020.pdf 14 Observe the multiple roles nurses assume when providing, safe, competent, ethical, compassionate and evidence-informed nursing care in any practice setting. Identify competencies within each role that align with a nurse’s engaging in medication practices i.e., administration, dispensing, med storage, disposal, etc. 15 16 4 2023-09-17 17 18 19 Ethical Considerations 20 Ethical principles are useful strategies for health care providers and include standards or truths on which ethical actions are made. Areas of Potential Liability Failure to assess or re-evaluate Autonomy Beneficence Nonmaleficence Failure to ensure safety Justice Fidelity Veracity Medication errors CNA Code of Ethics for registered nurses (RNs) International Council of Nurses (ICN) Code of Ethics for Nurses 19 20 5 2023-09-17 Recall - The “Ten Rights” of Medica on Administra on 22 Right of Nurse to Refuse Care Violates the nurse’s personal ethical principles • • • • • Right drug (or Right Medica on) Right dose Right time Right route Right pa ent • • • • • Right reason Right documentation Right evalua on (or right assessment) Right pa ent educa on Right to refuse Nurse speaks to supervisor or manager to request unit transfer, although must not abandon the patient. Nurse is responsible for providing nonjudgemental nursing care. Nurse always acts in the best interest of the patient while remaining an objective patient advocate. What about critical thinking? 21 22 23 23 24 A nurse administers a medication to a patient as ordered. What is the primary purpose of re-evaluating the patient after medication administration? A nurse has been asked to participate in an elective procedure that violates the nurse’s personal ethical principles. The nurse should A. To determine if the patient experienced immediate relief from symptoms. B. To document the medication administration in the patient's chart. C. To assess if the medication is still within its expiration date. D. To monitor the patient for any adverse effects or changes in condition A. refuse to participate. B. ask to switch assignments with another nurse. C. speak to the manager or supervisor. D. perform the procedure. 24 6 2023-09-17 25 A research group is conducting an investigational drug study on a promising new drug for osteoporosis. It has been difficult to find research participants who meet the criteria. Just before the conclusion of the study, four participants approach the researchers and express their desire to withdraw from the study. The researcher should first What is a medication error? Why is it important to report a medication error? Chapter 6 A. inform them that they waited too long to withdraw from the study. In clinical what do we do if an error occurred? B. explore with them the reasons for withdrawing from the study. C. acknowledge that they can withdraw at any time from the study. Medication Errors: Preventing and Responding D. request that they try to remain with the study until it is completed. 25 26 #1 they are ______________ Common cause of adverse health care outcomes 28 Drugs commonly involved in severe medication errors: Errors can occur during any step of medication process central nervous system drugs anticoagulants, Medication Errors Procuring chemotherapeutic drugs Prescribing More potential for harm with “high-alert” medications Transcribing Dispensing SALAD (sound-alike, look-alike drugs) Administering LASA (look-alike, sound-alike) Monitoring Clarification = TALLman lettering 27 28 7 2023-09-17 29 A Just Culture… Just Culture “A Just Culture focuses on identifying and addressing systems issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior. It distinguishes between human error (e.g., slips), at-risk behavior (e.g., taking shortcuts), and reckless behavior (e.g., ignoring required safety steps), in contrast to an overarching “no-blame” approach still favored by some. In a Just Culture, the response to an error or near miss is predicated on the type of behavior associated with the error, and not the severity of the event.” Recognizes that systems are generally at fault when error occurs Need for accountability Remediation of Workplace culture Reporting structure Management behaviour When professionals do not follow policies or have repeated errors Need for accountability Remedial education https://www.ismp.org/system/files/resources/2021-05/White-Paper-A-BetterPrescription-for-Preparing-Nursing-Students.pdf 29 30 31 Types of Medication Errors Near miss, No-harm error Medication error Critical incident 31 Let’s Think… • although circumstances or events occurred that could have led to an error. To ensure the safe just culture: • medication error that causes no harm What would you do if a physician writes an order that you feel is not appropriate or safe for the patient, you decline to give it and they come back saying that you have to? • causes harm • medication error that results in serious harm 32 8 2023-09-17 34 Just Culture Competency Plan What would you do if the order isn't clear, and the previous nurse who initially received the order has already left from the floor? Differentiate between three human behaviors: 1. Human error, which involves an inadvertent action, slip, lapse, or mistake 2. At-risk behavior, which entails a conscious drifting away from safe behavior without recognizing the risk or believing the risk is justified 3. Reckless behavior, which entails a conscious disregard of a substantial and unjustifiable risk https://www.ismp.org/system/files/resources/2021-05/White-Paper-A-BetterPrescription-for-Preparing-Nursing-Students.pdf 33 34 Medication Error Prevention Nurses spend 40% of their time administering medications 38% of all medication errors occur during administration step Adverse drug events: harm experienced by a pt as a result of exposure to a medication General term: Encompasses all types of clinical problems resulting from medication us Medication errors Adverse drug reactions (ADRs) i.e., Allergic reaction, Idiosyncratic reaction Second Victim Support There is exposure to emotional turmoil caused by patient tragedies in healthcare No different when medical errors occur Can be deep and long-lasting; psychological and physical We are human and fallible Know where resources exist and how to access them 35 36 9 2023-09-17 Responding to, Reporting, and Documenting Medication Errors Professional responsibility Notify most responsible caregiver Follow facility policy. Complete all necessary forms. Nurses' highest priority is patient’s physiological status and safety. Safe Reporting Ask re: follow-up procedures or tests Note observed changes in patient’s physical or mental status. Document with factual information; accurate, thorough, and objective. Avoid using judgemental words (e.g., error). Document that the prescriber was notified and any follow-up actions or orders that were implemented 37 38 Medication Reconciliation Continuous assessment and updating of patient medication information Verification Clarification Reconciliation Should be done at each stage of health care delivery: Admission Status change (e.g., from critical to stable) Patient transfer within or between facilities or provider teams Discharge (the latest medication list should be provided to the patient to take to the next health care provider) 39 40 10 2023-09-17 Preventing Medication Errors Preventing Medication Errors Assessment (Think 10 Rights!) Avoid abbreviations. Two patient identifiers (_________, ______) Never assume anything about items not specified in a drug order (e.g., route). R/A for allergies Do not administer if you did not draw up or prepare yourself. Do not hesitate to question a medication order for any reason when in doubt. Minimize verbal or telephone orders. Do not try to decipher illegibly written orders; contact the prescriber for clarification. Repeat order to prescriber. Spell drug name aloud. Speak slowly and clearly. Always listen to any concerns expressed by patient regarding medications List indication next to each order. 41 42 Preventing Medication Errors Do not use 1.0 mg; use 1 mg. The nurse is administering a drug that has been ordered as follows: “Give 10 mg on odd-numbered days and 5 mg on even-numbered days.” When the date changes from May 31 to June 1, what should the nurse do? 1.0 mg could be misread as 10 mg, resulting in a 10-fold dose increase. A. Give 10 mg because June 1 is an odd-numbered day. Never use a “trailing zero” with medication orders. B. Hold the dose until the next odd-numbered day. C. Change the order to read: “Give 10 mg on evennumbered days and 5 mg on odd-numbered days.” Always use a “leading zero” for decimal dosages. Do not use .25 mg; use 0.25 mg. D. Consult the prescriber to verify that the dose should alternate each day, no matter whether the day is odd or even numbered .25 mg may be misread as 25 mg. 43 44 11 2023-09-17 Spot the Error The nursing student realizes that she has given a patient a double dose of an antihypertensive medication. The tablet was supposed to be cut in half, but the student forgot and administered the entire tablet. The patient’s blood pressure just before the dose was 146/98 mm Hg. What should the student nurse do first? 1. "Give the red pill to the patient." 2. "Administer 10 mg of Labetalol every hour." 3. "Start Patient A on hydromorph for pain." 4. "Inject Vitamin B12 into the patient's left arm." 5. "Administer advil as needed.“ A. Notify the patient’s physician. B. Notify the clinical faculty or preceptor. 6. "Apply Nitro topically and orally.“ C. Take the patient’s blood pressure. 7. "Take acetaminophen whenever you feel like it." D. Continue to monitor the patient. 45 46 Changes Across the Lifespan Age related changes have a dramatic effect on pharmacokinetics 47 47 Increased risk of adverse effects and toxicity at both ends of spectrum of life Chapter 4 48 Consider ADME for different populations Patient-Focused Considerations 48 12 2023-09-17 Drug Therapy During Pregnancy 49 Drugs cross the placenta primarily by diffusion. Factors affecting safety: FDA Categorization of Drugs for use in Pregnancy Drug properties:________________________________________________________ Fetal gestational age: __________________________________________________ Maternal factors: ______________________________________________________ Many different substances can cross the placenta and enter the baby’s bloodstream. These include: Prescription drugs including opioids Over-the-counter medications Herbal products Topical creams Inhalers Nicotine Alcohol Cannabis Street drugs 49 MEDICATIONS AND DRUGS BEFORE AND DURING PREGNANCY 50 Compare Differences Drug Therapy During Breastfeeding Breastfed infants are at risk for exposure to drugs consumed by the mother Consider risk–benefit ratio Prescription and non-prescription medications Many medicines are safe to use while breastfeeding, including certain pain relievers, antibiotics, antidepressants, anticoagulants, and endocrine medicines (such as insulin). Neonatal & Pediatric Considerations Older Adult Considerations Absorption If harmful to baby or harmful to mother to not have Distribution Metabolism Excretion 51 52 13 2023-09-17 53 Neonatal and Pediatric Considerations: Pharmacokinetics (1 of 2) Absorption Distribution Gastric pH less acidic until 1 to 2 years of age Greater total body water means lower fat content. Gastric emptying slowed Decreased level of protein binding First-pass elimination reduced Immature blood–brain barrier means more drugs enter the brain. Reduced bile salt formation decreases bioavailability 54 Metabolism Excretion Liver immature; does not produce enough microsomal enzymes Kidney immaturity affects glomerular filtration rate and tubular secretion. Older children may have increased metabolism, requiring higher doses or more frequent administration than infants. Decreased perfusion rate of the kidneys may reduce excretion of drugs. Other factors: liver enzyme production, genetic differences, and substances to which the mother may have been exposed during pregnancy Intramuscular absorption faster and irregular 53 Neonatal and Pediatric Considerations: Pharmacokinetics (2 of 2) 54 55 Methods of Dosage Calculation for Pediatric Patients 56 Nomogram Body surface area method Uses the West nomogram Always use weight in kilograms, not pounds. Always use height in centimeters, not inches. Body weight dosage calculations Uses mg/kg 55 56 14 2023-09-17 57 58 When administering medications to pediatric patients, the nurse understands that the dosage calculations for pediatric patients are different than for adults, because pediatric patients When teaching a pregnant woman about the use of drugs during pregnancy, which statement will the nurse include? A. Exposure of the fetus to drugs is most detrimental during the second trimester of pregnancy. B. Pregnant women must never take drugs to control high blood pressure. A. are more likely to develop edema. C. Drug transfer to a fetus is most likely to occur during the last trimester of pregnancy. B. have more stomach acid. C. have skin that is less permeable. D. A fetus is at greatest risk for drug-induced developmental defects during the second trimester of pregnancy. 57 D. have immature liver and kidney function, resulting in impaired drug metabolism and excretion. 58 Older adults: older than age 65 years 59 What does the nurse identify as a pharmacokinetic change that occurs in older adults? A. Gastric pH is more acidic. Considerations for Older Adult Patients 60 Polypharmacy Nonadherence Increased incidence of chronic illnesses B. Fat content is decreased because of increased lean body mass. Sensory and motor deficits C. There is increased production of proteins by the liver. BEERs List D. The number of intact nephrons is decreased. 59 High use of medications 60 15 2023-09-17 62 BEERs List Absorption Distribution Gastric pH less acidic ↓ total body water % Gastric emptying and movement through gastrointestinal (GI) tract slowed because of decreased muscle tone and activity ↓ production of proteins in liver, results in ↓ protein binding and ↑ circulation of free drugs Blood flow to GI tract reduced (2016) 61 Older Adults: Pharmacokinetics (1 of 2) Increased fat content Absorptive surface of GI tract reduced 62 63 Older Adults: Pharmacokinetics (2 of 2) 64 Ethnopharmacology Provides an expanding body of knowledge for understanding specific impact of cultural factors on patient drug response A person's cultural and religious background can greatly influence how they perceive and use drugs, be they legal or illegal. Such factors can both predispose a person to use drugs, or not. Hampered by lack of clarity in terms such as race, ethnicity Metabolism Excretion Aging liver produces fewer microsomal enzymes, affecting drug metabolism. Decreased number of intact nephrons Blood flow to the liver is reduced. Ethnocultural assessment needs to be part of the __________ phase of the nursing process. *Not every patient from the same country shares the same culture. Decreased glomerular filtration rate The influence of culture on health is vast. It affects perceptions of health, illness and death, beliefs about causes of disease, approaches to health promotion, how illness and pain are experienced and expressed, where when and how patients seek help, and the types of treatment patients prefer. Leads to a prolonged half-life of many drugs • Potential for accumulation if not monitored 63 64 16 2023-09-17 65 Ethnocultural Nursing Considerations & Drug Therapy Scenario: The Unauthorized Medication Request You are a student nurse on a busy medical-surgical unit. One evening, while preparing to administer medications, a patient's family member approaches you. The family member tells you that the patient has been experiencing severe pain for the past hour and requests a stronger pain medication than what is currently ordered. Recognition that patterns of communication may differ A thorough ethnocultural assessment is needed. Maintaining, protecting, and restoring health Health practices and beliefs Religious practices and beliefs The patient's chart clearly states that the patient should receive a specific pain medication every four hours. You know that the next dose is due in 45 minutes. The family member seems desperate, explaining that the patient is in excruciating pain and asks if you can give a stronger pain medication right away. Dietary habits Support for patient’s ethnocultural community Important to consider alternative natural health remedies, herbal treatment, folk or home remedies As a student nurse, you are aware of the importance of following medication orders precisely and not deviating from the prescribed treatment plan. However, you also empathize with the patient's suffering and the family member's concern. Recognize that they can inhibit or accelerate drug metabolism and alter a drugs response 65 66 Next Class…Preparation Ethical Dilemma Questions for Discussion: Patient Advocacy vs. Medication Protocol What do you know, from previous courses or clinical placements, about CNS medications? How can you balance your duty to advocate for the patient's comfort and pain relief with your responsibility to adhere to established medication protocols? Readings: Informed Decision-Making: Chapter 11: Analgesic drugs Chapter 12: General and local anaesthetics Should you consult the patient's primary nurse or the healthcare provider before making any changes to the pain management plan? What are the potential consequences of not doing so? Chapter 13: Central nervous system depressants and muscle relaxants Communication: Chapter 14: Central nervous systems stimulants and related drugs How can you effectively communicate with the patient's family member to explain the importance of following the prescribed medication schedule while also showing empathy for the patient's pain? Chapter 17: Psychotherapeutic drugs Ethical Principles Shadow Health: Complete: Analgesics Concept Lab Evolving as a Nurse Which ethical principles, such as beneficence (doing good), nonmaleficence (avoiding harm), and respect for autonomy (patient's right to make decisions), should guide your decision-making in this situation? Team Collaboration 67 How does the information in this Module influence your nursing practice? How can you involve other members of the healthcare team, such as the primary nurse and the healthcare provider, to ensure the best possible outcome for the patient while maintaining ethical and clinical standards? 68 17
