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Weeks 1-4 Notes for Pharmacology (NUR 326)

by: Emily

Weeks 1-4 Notes for Pharmacology (NUR 326) NUR 326

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About this Document

These notes cover the information for the first exam.
Amy Beasley
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This 74 page Bundle was uploaded by Emily on Monday September 12, 2016. The Bundle belongs to NUR 326 at University of Alabama - Tuscaloosa taught by Amy Beasley in Fall 2016. Since its upload, it has received 6 views. For similar materials see Pharmacology in NURSING at University of Alabama - Tuscaloosa.


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Date Created: 09/12/16
Chapter 6 Nurses’ Responsibility in Medication Administration - Closely monitor patient’s status - Detect mistakes made by pharmacists and prescribers - First member of the healthcare team to observe and evaluate drug responses and intervene if required - Must know the response that a medication is likely to elicit - Last line of defense for the patient - Ethically and legally unacceptable to administer drug that is harmful to the patient- even though the medication has been prescribed by a licensed prescriber and dispensed by a license pharmacist - Pre-administration assessment - Dosage and administration - Evaluating and promoting therapeutic effects - Minimizing adverse effects - Minimizing adverse interactions - Making PRN decisions - Managing toxicity The Nursing Process - The nursing process is used to ensure safe, effective, and individualized medication administration and outcomes for patients. - Assessment: baseline data, subjective/objective data, health history, physical assessment, self-care ability Table 6.1 - Page 63 - Ask about allergies - “What exactly happens?” - Reproductive history - Breastfeeding - Diagnosis: NANDA nursing diagnosis vs. medical diagnosis; Nsg dx provide basis for establishing goals, outcomes, planning interventions, and evaluating effectiveness - Planning: Involves establishing goals and outcomes, prioritizes diagnoses and interventions, focuses on planning med administration and patient teaching! 1 - Implementation: The action part of administering medication; requires continued assessment and monitoring, and patient teaching! - Evaluation: Did the medication have the desired effect? Outcomes and Goals for Patients Receiving Medications - Before administering medications, nurses want to establish clear, realistic goals and outcomes to measure the effectiveness of interventions. - Goals are broad statements that describe a desired change in a patient’s condition or behavior. - Each goal is time limited so the health care team has a common time frame for problem resolution. 2 - Example: “The patient will express relief from pain by day of discharge.” Or, “Patient will be tobacco free within 60 days.” - Outcomes are the specific, measurable criteria used to measure attainment of the selected goals. They are written to include: - Subject (usually the patient) - Actions required by the subject - Under what circumstance - The expected performance - Specific time frame the subject will accomplish the performance GOALS OUTCOMES May be short-term or long-term The objective measures of a goal Focuses on what client will achieve or do, Should be specific and measurable not what the nurse will do Should be patient centered Specifically define: - Discuss and involve the patient and/or - What the patient will do caregiver - Under what circumstance - Within a specified timeframe - Example: Patient (subject) will demonstrate the injection of enoxaparin (Lovenox; action required by subject), using the preloaded syringe provided (circumstance), given subcutaneously into the anterior abdominal areas (expected performance) one day prior to discharge (specific time frame). Monitoring Drug Effects is Primary Intervention - Monitor for identified therapeutic effect - Reassessing the client - Physical condition - Vital signs - Body weight - Lab values - Serum drug levels - Patient statements - For any nursing intervention we do, we want to evaluate its effectiveness. To do this, we reassess. So, after giving a medication, we need to reassess to see if the medication we gave was effective. - Therapeutic effect = What results are desired? This falls under “Implementation” in the nursing process 3 - To monitor drug effects, you must know the actions of each medication… if you don’t know, LOOK IT UP! - In our reassessment, if no therapeutic effect was achieved, then we need to reassess the need for that medication. Is there another medication that would work better? Would a different dose work better? - Adverse Drug Reaction: any noxious, unintended, and undesired effect that occurs at normal drug does (WHO). - Can be mild or life threatening. - Dramatic rise in recent years. Why? - Side Effect: nontherapeudic reaction to a drug - Pertinent Questions in Assessment in Reducing Adverse Drug Reactions: - Did symptoms appear shortly after the drug was first used? - Did symptoms stop when the drug was discontinued? - Did symptoms reappear when the drug was reinstituted? - Is the illness itself sufficient to explain the event? - Are other drugs in the regimen sufficient to explain the event? Potentially Fatal Drug Reactions - Stevens-Johnson Syndrome (SJS) - Usually within 1 to 14 days after therapy initiation - Blister-like lesions - Toxic Epidermal Necrolysis - Epidermal sloughing - Multiple body systems - Liver fails to break down a drug normally - With these drug reactions, you would stop the medication immediately - See Pharm Facts on page 22 Documentation of Medication Administration - Administration of medication - Therapeutic and adverse effects - Client statements - Objective assessment data - Could use labs, observation, pain scale, measure swelling, etc. - Collection of subjective and objective data is needed to evaluate the effectiveness of the medication for the disease 4 - Could chart subjective patient statements in quotes like: “My pain is so much better” - IT CAN BE ASSUMED THAT IF IT WASN’T DOCUMENTED, IT WASN’T GIVEN! Patient Teaching - Primary role for nurses - Directly related to - Knowledge deficit - Noncompliance - Provide written material to patient - Elderly and pediatric clients are a special challenge - May need to co-teach client’s caregiver - Drug and name - If you don’t understand all aspects of a medication you won’t be able to teach the patient. This is why so many NCLEX questions have this focus. - Every nurse-patient interaction is an opportunity for patient education! - Small portions given over time are more effective than huge “chunks” of info all at once. - What should the nurse teach? - Drug name and category - Dosage size and schedule - Technique of administration - Expected therapeutic response and when it should develop - Nondrug measures to enhance therapeutic responses - Duration of treatment - Method of drug storage - Symptoms of major adverse effects and measures to minimize discomfort and harm - Major adverse drug-drug and drug-food interactions - Whom to contact in the event of therapeutic failure, severe adverse reactions, or severe adverse interactions Chapter 7 Defining Medication Errors - “Any error that occurs in medication administration process, whether or not it harms the patient” 5 - “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.” (page 71) - May be applied to - Misinterpretations or miscalculations - Misadministration - Handwriting misinterpretation - Misunderstanding of verbal orders - Errors are most commonly linked to communication issues. What other factors contribute to medication errors by the health care provider? - RBV: Read Back Verified - For documentation - Review the bullet points on page 71. - Medication Error Index classifies medication errors Figure 7.1 - Med. Error Index: categorizes medication errors by evaluating the extent of the harm an error can cause - Nurses should know most frequent types of drug errors and severities of reaction - Nurse should never administer a medication unless familiar with uses and side effects - PDAs now help with this - Even in an emergency you must know the desired effect, dosage, and route of the prescribed medication. - If a medication error is made, it’s critical to report and document it in the patient’s medical record, and through an Incident Report. - Refer to Page 74 for Strategies for reducing medication errors. Reporting Medication Errors - Reporting agencies: - Adverse Event Reporting Program (MedWatch) - NCC MERP - Index for categorizing medication errors - FDA Safety Information - Up-to-date Clinical Information - Reporting system - The FDA is the federal coordinator for reporting medication errors - FDA’s Division of Medication Error Prevention and Analysis (DMEPA) is responsible for gathering and analyzing data from MedWatch, the NCC MERP and other patient safety organization 6 - DMEPA then makes recommendations such as changing product names or product labels that may be causing medication errors. Sentinel Events - Unexpected occurrences involving death or serious physical or psychological injury, or risk thereof - Not all errors are sentinel events… and not all sentinel events occur because of an error. - Always investigated - Interventions taken to ensure there is no repeat - Hospitals are graded on the number of sentinel events reported by the Joint Commission. - Safeguards are in place in the acute care setting, but what about at home? - One-half of fatal medication errors occurred in clients older than 60 years of age. - Elderly are at an increased risk for errors because they often take numerous medications, have multiple HCPs, and experience normal age-related changes in physiology. - Children are another vulnerable population due to smaller dosages. - Children receive their medication dosages based on weight, which increases the possibility of dosage miscalculations. The therapeutic dosages are also much smaller. Medication Reconciliation - The process of “keeping track” of a patient’s medications as they proceed from one health care provider to another - Many serious medication errors are tracked to poor reconciliation - Polypharmacy: patients to receive multiple prescriptions that have conflicting pharmacologic actions - Reconciliation lists all medications a patient is taking to reduce errors (duplication, omissions, dosing errors, drug interactions, etc.) - Hospitals are encouraged to document complete lists when patient is admitted or even when they change units - Knowing what you are taking where, when, how, how much…. - These lists are also checked again by nurses whenever the patient is moved to different units within the hospital, and at the time of discharge. 7 Chapter 8 Treating Pregnant and Lactating Patients - Pregnant Patient: - There are two patients during pregnancy: the nurse must consider the effects of the drug on both the mother and on the growing fetus. - Some substances readily pass from mother to fetus through the placenta; others are blocked. - In general, drugs that are water soluble, ionized, or bound to plasma proteins are less likely to cross the placenta. - A teratogen is any substance that produces permanent abnormality in the structure or function of an embryo or fetus, causing growth retardation or death. Fortunately, the number of prescription drugs known/suspected of being teratogenic is relatively small. - There are some physiological Changes during pregnancy that impact pharmacotherapy: - Absorption of drugs -- Abdominal/gastric changes affect absorption; inhaled drugs may be absorbed faster - Distribution and Metabolism -- Changes in cardiac output, plasma volume, and regional blood flow change distribution and metabolism - Drug excretion rates may increase - There is a unique physiology to pregnancy: Blood volume, cardiac output increase. - This may dilute some medications so that higher doses are required. An example of this is seizure medications. - Recall the FDA Pregnancy Categories from Chapter 2 (A, B, C, D, X). FDA drug pregnancy categories classify medications according to their risks during pregnancy. - There is no way around memorization of these categories. - Refer to Table 8.1 - These guide the health care team & patient in selecting drugs that are least hazardous for the fetus - Testing drugs in human subjects to determine teratogenicity is unethical and prohibited by law - Most drugs fall under category C - “No prescription drug, OTC medication, herbal product, or dietary supplement should be taken during pregnancy unless the physician verifies that the therapeutic benefits to the mother clearly outweigh the potential risks for the unborn.” (page 83, bottom, in italics) 8 - Lactating patient: - A large number of drugs are secreted through breastmilk, however, many are relatively safe. - Risk benefit idea is used again to determine the need for a drug. - Infants that are premature, neonates, and seriously ill infants may be at greater risk for adverse effects. - General recommendations: - Postponed and use non-pharmacological therapies. - Administer the drug immediately after breastfeeding. - Avoiding illicit drug use. - Shorter half-life drugs are preferable. - Eliminates from the system faster - OTC herbal products and dietary supplements should be avoided. Treating the Infant - Decimal points matter, especially with neonates - The drug guide for the neonatal period is called a neofax - Nursing interventions: - Hold and cuddle the infant while medications are being administered. - Use the dropper in the inner check for oral medications, allowing time for swallowing. - If rectal suppositories are used the buttocks should be held together for 5-10 minutes. - Caution when administering IM or IVE due to little muscle mass. - Only the vastus lateralis muscle is available, and it is not developed - IVs may be used in the feet and scalp. Treating the Toddler, Preschooler, and School-aged Child - Growth and development principles must be used when medications are utilized with children - Toddler: - Ages 1 to 3 years - Biggest age group of childhood poisonings - Because they put everything in their mouths - Educate parents regarding ways of protecting their children from poisonings. - Keep bad things up high and lock cabinets 9 - When giving medicine to this child - Short, concrete explanations followed by immediate drug administration is most appropriate. - Physical comfort or verbal praise should be offered. - Preschooler: - Ages 3 to 5 years - Poisoning safety is still a concern. - These children now understand basics of health and illness - When giving medicine to this child - Short, concrete explanations followed by immediate drug administration is most appropriate. - May use play for the child to better understand the medication. - School-aged Child: - Ages 6 to 12 - When giving medicine to this child - More detailed explanation is appropriate, dosing choices and child involvement is appropriate. Treating the Adolescent, Younger, Middle-aged Adult - Adolescent: - Ages 13 to 18 years - Educate parents on keeping drugs put away and S/S of illicit drug use. - Common pharm: skin problems (acne), menstrual symptoms, eating disorders, contraception, alcohol and tobacco use, and sport-related injury - Young Adult: - Ages 18 to 40 years - Common pharm: vitamins, minerals, and herbals, contraception, STD treatment - Substance abuse if common in 18 to 24 year olds - Middle-Aged Adult: - Ages 40 to 65 years - Health promotion is needed-Rx may be taken for disease that could be improved with lifestyle modifications - Common pharm: HTN, cholesterol, obesity, anxiety, cancer, arthritis, erectile dysfunction, antidepressants, and respiratory medications 10 Treating the Older Adult - “Older adult” is defined as someone over 65 years. The majority of medications in the US are given to people over 65. - It takes more patience to teach this group. Visual and auditory impairments are common. - Polypharmacy is when patient’s take multiple medications concurrently (often from multiple doctors) - It can easily result when a patient visits with multiple physicians or uses different pharmacies. - Each MD or pharmacist may not be aware of all the drugs ordered by others. - This increases the risk for interactions and side effects. - With older adults, there are some predictable physiological and psychosocial ailments, but much variability remains - There are more adverse drug events in geriatric patients than any other lifespan population. - Adverse drug events in older adults are often related to degeneration of organ systems, multiple/severe illnesses, polypharmacy, unreliable compliance - Reminder aids for administration may be used - Vision and hearing may be a problem so creativity may be required to give instructions Chapter 11 Emergency Preparedness and Poisonings - After 9/11 attacks, awareness of outbreaks and treatments expanded to include bioterrorism - Bioterrorism: intentional use of biologic agents, chemical substances, or radiation to cause widespread harm or illness and has the goal to create public panic and to cause as many casualties as possible - Bioterrorism is essentially destruction of human life to make a point. - Cooperation between different health care professionals is essential during a bioterrorist attack. - Emergency Preparedness is not a new concept. In fact, nurses have been doing this for about 30 years. The Homeland Security and military coordinate drills with the acute care community. Disaster plans exist for natural disasters (as well as accidents) that could cause multiple casualties. Bioterrorism was most recently added in 1990s. 11 - Hospitals are now required to have disaster plans, and these plans have changed recently to include how a health care system might change during a crisis. - Table 11.1 on page 1 h1a4 the most dangerous infectious diseases in the world and the biological agents in the table are listed in degree of severity Strategic National Stockpile (SNS) - Stockpile consists of antibiotics, vaccines, and medical, surgical, and client supplies - Designed to ensure immediate deployment of essential medical materials in case of biological or chemical attack - The strategic national stockpile is managed by the US Centers for Disease Control and Prevention (CDC). - Important data for every nurse to know. - Push package—first component - Supplies and pharmaceuticals for unknown chemical or biological threat. - Arrives within 12 hours after attack - Vendor-managed inventory (VMI) package—second component - Supplies and pharmaceuticals for specific chemical or biological agent. - Arrives within 24 to 36 hours 12 - Should a chemical or biologic attack occur, it would likely be rapid and unexpected, producing multiple casualties. - The local community would be overwhelmed, and shortages of needed drugs, medical equipment and supplies would be needed. - Strategic national stockpile addresses this concern. Anthrax - Used as part of bitterest attacks in 2001 - Caused by Bacillus anthracis - Can cause serious damage to body tissues - Table 11-2 on page 116 - Know category A, B, C - Anthrax is the prototype infectious disease that we will study for this chapter. - In the fall of 2001, 5 people died as a result of exposure to anthrax. 13 US citizens were infected, including several governmental employees, and it affected the US postal service for several weeks. - Bacillus anthracis normally affects domestic and wild animals (sheep, goats, horses, donkeys, pigs, antelopes) 13 - Can be transmitted to humans by exposure to an open wound, through contaminated food, or by inhalation - Symptoms usually appear 1-6 days after exposure. - Table 11. d 3escribes the clinical manifestations of anthrax. Anthrax Survivability and Treatment - Bacterium can form spores - Spores can be viable in soil for hundreds or thousands of years - Resistant to drying, heat, and some harsh chemicals - Found in contaminated animal products such as wool, hair, dander, and bonemeal, but it can also be packaged in other forms - Ciprofloxacin (Cipro) - Prophylaxis—500 mg PO, every 12 hours for 60 days - Confirmed case—400 mg IV, every 12 hours - Other antibiotics that are effective - Penicillin, vancomycin, ampicillin, erythromycin, tetracycline, and doxycycline - These antibiotics are not curative. - General symptoms associated with almost every form of anthrax - Necrosis, accumulation of exudate, which lead to pain, swelling, restriction of activity - Spore bearing diseases are the hardest to treat and eliminate from the environment. - An anthrax vaccine is available, but only recommended for select populations: - Lab personnel who work with anthrax, military personnel deployed to high-risk areas, those who deal with animal products imported from areas with a high incidence of the disease. Other Examples of Bioterrorism - Nerve Agents (i.e. Chemical Warfare agents) - Chemical warfare agents have been around since WWI, but few drug antidotes are available. - Most were created to cause mass casualties; others designed to cause so much discomfort the soldiers would be unable to continue fighting. - Nerve gases can cause paralysis of the neuromuscular junction, severe choking and vomiting, and/or severe blistering. - Exposure can cause convulsions and loss of consciousness within seconds; respiratory failure within minutes 14 - Atropine is the treatment and works to increase the release of acetylcholine. - Immediate Treatment: - Give atropine injection - Flush eyes with water - Apply sodium bicarbonate or 5% liquid bleach solution to skin - Do not induce vomiting - Ionizing Radiation (i.e. Nuclear bombs) - Ionizing Radiation: results from hundreds of different radioisotopes that are created by nuclear explosion. - Nuclear bombs are capable of mass destruction. The greatest number of casualties would be due to the physical blast itself, but survivors would be exposed to high levels of ionizing radiation - Some of these radioisotopes can persist in the environment for years - Treat patients with potassium iodine and isolate them until they are no longer radioactive. - Immediate Symptoms of Acute Radiation Syndrome: - Occur hours or days after exposure - Nausea, vomiting, diarrhea Basic Supportive Care for Toxicity - One of the first elements of toxicity treatment - Maintain airway, breathing, and circulation - Proper blood glucose levels and arterial blood gases - Treatment of any developing seizures - Management of acid-base imbalances - Agents may be used to facilitate removal of some toxins - First steps of any emergency triage. - Surface decontamination: remove the patient’s clothing and cleanse contaminates from the body flush eyes with water; wash hair with soap and water - Agents: syrup of Ipecac with induce vomiting with certain poisonings; contraindicated if the agent was caustic (drain cleaners) burn tissue again as they are vomited - Gastric lavage and aspiration: must be done within 60 minutes of ingestion; contraindicated if airway protective reflexes are lost 15 - Activated charcoal: given if poison is carbon based; molecules adhere to activated charcoal and minimize poison from being absorbed; greatest benefit 60 minutes after - Table 12.6 on page 1 sh3ws examples of specific antidotes for overdosed substances. We will refer back to it when talking about certain drug overdoses. 16 Chapter 1 Learning objectives - Paraphrase the properties of an ideal drug. - Examine the nurse’s role as advocate in regards to pharmacology in nursing practice. - Describe the process for new drug development. - Compare and contrast a drug’s chemical name, generic name, and trade name. - Outline major differences between prescription and over-the-counter (OTC) drugs. - Explain the applications of pharmacokinetics to clinical practice. - Describe the applications of a drug's onset, peak, and plasma half-life to duration of pharmacotherapy. - Apply principles of pharmacodynamics to nursing practice. - Describe drug receptor bindings and interactions. - Discuss the consequences of drug-drug interactions, the basic mechanisms of drug- drug interactions, and the critical steps in minimizing adverse drug-drug interactions. Basic Terms - See Page 5 (Table 1-1 and 1-2) - A drug is defined as any chemical that can affect living processes. - Virtually all chemicals can be considered drugs then, but we only will focus on drugs that have therapeutic applications. - The therapeutic objective is to provide maximum benefit with minimal harm - Pharmacology is the study of drugs and their interactions with living systems. - This encompasses the study of the physical and chemical properties of drugs, as well as their biochemical and physiologic effects. - Includes knowledge of the history, sources, and uses of drugs, as well as knowledge of drug absorption, distribution, metabolism, and excretion. - Clinical pharmacology refers to the study of drugs in humans, which includes the study of drugs in patients as well as healthy volunteers (during new drug development). - Therapeutics (or, also known as pharmacotherapeutics), is the use of drugs to diagnose, prevent, or treat disease, or to prevent pregnancy. - This is also referred to as the medical use of drugs. - Therapeutics is our main concern, and as nurses, we need to understand: - how drugs produce their effects (both therapeutic and adverse) - The reasons for giving a particular drug to a particular patient - The rationale underlying selection of dosage, route, and schedule of administration - Therapeutic classification is one name used in classifying a medication that is based upon the usefulness in treating particular diseases or disorders. - i.e. anticoagulant (influences blood clotting) 1 - Pharmacologic classification refers to the way a drug works at the molecular, tissue, or body system level. - i.e Diuretic (lowers plasma volume) - Mechanism of action identifies how the drug produces it physiological effect. - i.e. lowers plasm a volume (R/T pharmacologic classification) - Prototype drug is a “drug model” that represents a class of drugs. - i.e lorazepam (Ativan) = benzos Properties of an Ideal Drug - The big three - Effectiveness - An effective drug elicits the responses for which it is given. - If the drug isn’t effective, there is no reason to give it. - US law requires that all new drugs be proved effective prior to their release for marketing. - Safety - A safe drug is one that cannot produce harmful effects, even if administered in very high doses and for a very long time. - All drugs have the ability to cause injury, especially with high doses and prolonged use. - The chances of producing adverse effects can be reduced by proper drug selection and drug dosing, however the risk of adverse effects can never truly be eliminated. - Selectivity - A selective drug is one that elicits only the response for which it is given. - There truly is no wholly selective drug because all drugs cause side effects. - Additional properties - Reversible action - Like an antidote: to reverse the action of a drug - Predictability - What the drug will do based on a clinical trial - Ease of administration - Freedom of drug interactions - To prevent adverse reactions - Low cost - Due to insurance payments and benefits - Chemical stability - Able to be transported in a container - Simple generic name - Recognizability 2 Drug Names - Chemical Name: uses the nomenclature of chemistry to describe its physical and chemical properties - A drug has only one chemical name - Can be complicated, difficult to remember and pronounce - Drugs are sometimes classified by a portion of their chemical structure (chemical group name), which can become invaluable to nurses and students! - Examples: Cephalosporins, phenothiazines, benzodiazepines - Generic Name: is assigned by the U.S. Adopted Name Council - A drug has only one generic name - Less complicated and easier to remember - Written in lower case, Example: diazepam - In many cases, the final syllables of the generic name indicate a drug’s pharmacologic class (see Table 3-4 on page 19). - Trade Name: (also called proprietary or brand name) - The names under which a drug is marketed. These names are created by drug companies with the intention that they be easy for consumers to recall and pronounce. - The drug developer has exclusive rights to name and market a new drug for 17 years in the United States. - After 17 years, competing companies may sell a generic equivalent drug, sometimes using a different name, which the FDA must approve. - A drug may have several trade names - Trade name is capitalized; Example: a trade name for diphenhydramine is Benadryl. - Generic vs. Brand-Name Drugs: Problems with Trade Names 1. A single drug can have multiple trade names 2. Over-the-counter (OTC) products with the same trade name may have different active ingredients 3. Trade names can endanger international travelers Over-the-counter (OTC) Drugs - These are drugs that can be purchased without a prescription - The decision to be made OTC is made by the FDA - Just because a drug is considered available OTC does not necessarily mean the drug is considered “safe” - Advantages to Prescription Drugs: - Health care provider examines the patient and orders the proper drug. - Amount and frequency of drug is controlled. - Instructions on use and side effects of drug are discussed. - Disadvantages to Prescription Drugs: - Require a prescription to obtain - Need for health care provider appointment 3 - Advantages to OTC Drugs: - No health care provider appointment required - Often less expensive than prescription drugs - Disadvantages to OTC Drugs: - Patient may choose wrong drug. - Patient may not know reactions or interactions. - Ineffective treatment may result in progression of disease. Trade-name vs. Generic Equivalents - Unclear determinations to blanket all drugs as equal - Drug formulation variations - Bioavailability - How much of the drug is available to be used by the body Chapter 2 Drug Approval and Regulation - Randomized controlled Trial - An expensive an lengthy process that could require 10-15 years for completion - Rigorous procedures for testing have been established so newly released drugs might be both safe and effective. - Although testing can determine effectiveness, it cannot guarantee that a new - drug will be safe Significant adverse effects may evade detection during testing, only to become apparent after a new drug has been released for general use - Stages of new drug development: - 1. Preclinical Investigation involves laboratory research. Tests are done on animals to determine toxicity, pharmacokinetics, and possible useful effects. - When sufficient data has been gathered, the drug developer may apply to the FDA for permission to begin testing in humans. - If approved, the drug is awarded Investigational New Drug status - 2. and 3. Clinical Investigation takes place in three different stages termed clinical phase trials - This is the longest part of approval process (2-10 years), but evaluates human benefits - Tests are done on healthy volunteers first (Phase I), then on patients with the target disease (Phase II and III) - If results of clinical investigation are positive, even if precautions are noted, a New Drug Application is the next step. The average review time 17–24 months. - If the drug is approved: process continues; if drug is rejected: process suspended - 3. Post-marketing Surveillance: The new drug is placed on market and surveyed for harmful effects in larger population 4 - FDA holds annual public meetings, and will withdraw a drug if serious problem found - Nurses participate most in the drug approval process during the post-marketing surveillance period of Phase IV. All nurses administering medications monitor for therapeutic effects and adverse reactions from the drugs, and are responsible for reporting adverse reactions. - Limitations of the testing procedure - Limited information on women and children Medication Guidelines - Commonly referred to as MedGuides - FDA approved documents - Required when the FDA has determined that (1) patient adherence to directions for drug use is essential for efficacy and (2) patients need to know about potentially serious effects when deciding whether to use a drug - Example: - - These were created to educate patients about how to minimize harm from potentially dangerous drugs Black Box Warning - Strongest safety warning a drug can carry and still remain on the market - Purpose of the warning is to alert prescribers to: - Potentially sever side effects (for example, life-threatening dysrhythmias, suicidality, major fetal harm) - Ways to prevent or reduce harm (for example, avoiding a teratogenic drug during pregnancy) Controlled Substances - The Controlled Substances Act of 1970 (also known as Comprehensive Drug Abuse Prevention and Control Act): - Restricts the use of drugs with potential for abuse - Restricted drugs are placed into one of five schedules - Hospitals and pharmacies must maintain complete records of scheduled drugs. - The DEA is the agency responsible -- along with the Board of Medicine and Nursing in each state -- to regulate who, where, and what can be prescribed by independent licensed healthcare providers. - Hospitals and pharmacies must register with DEA, and must use an assigned registration number to purchase scheduled drugs - Anyone convicted of unlawful manufacturing, distributing, and dispensing of controlled substances faces severe penalties. 5 - A medication’s potential for abuse and misuse determines the level of restriction in number and type of providers who may “order” a medication. - Drugs that have a significant potential for abuse are placed into five categories called schedules. - Schedule I drugs have the highest abuse potential, Schedule V the lowest. - The 2009 death of Michael Jackson called for a greater restriction on the use of the anesthesia agent called propofol (Diprovan). - Schedule I Drugs: - Restricted to situations of medical necessity, if allowed at all - Little or no therapeutic value; mostly used for research - Examples include heroin, LSD, methaqualone - Schedule II-V Drugs: - May be dispersed only in cases where therapeutic value has been determined - Some Schedule V drugs may be dispersed without a prescription. - Schedule II Drugs: - High abuse potential and high potential for physical and psychological dependence - May have a therapeutic use with prescription, although some drugs are no longer used - Have more restrictions: - Need special order form to obtain - Orders must be written. - Orders must be signed by health care provider. - Telephone orders to pharmacies are not permitted. - No refills are permitted; patient must see health care provider first. - Examples include Morphine, PCP, Cocaine, Methadone, Methamphetamine - Schedule III Drugs: - Moderate abuse potential; moderate physical dependence; high potential for psychological dependence 6 - Therapeutic use with prescription - Examples include Anabolic steroids, Codeine with aspirin or Tylenol, Hydrocodone with aspirin or Tylenol, Some barbiturates - Schedule IV Drugs: - Lower abuse potential; lower potential for physical and psychological dependence - Therapeutic use with prescription - Examples include: Dextropropoxyphene, Pentazocine, Meprobamate, Diazepam, Alprazolam - Schedule V Drugs: - Lowest abuse potential, lowest physical and psychological dependence - Therapeutic use without prescription - Examples include OTC cough medicines with codeine - Not all drugs with abuse potential are regulated! - Examples include Tobacco, alcohol, and caffeine Teratogenic Drug Classification - FDA classifies medications by their teratogenic effects to the fetus - Birth defects are most probable in the first trimester - Most medicines are Category C - Teratogenic classifications are found on the drug boxes
 7 Chapter 3 Principles of Drug Administration - Nurses are expected to understand pharmocotherapeutic principles for all medications given to each patient - Six right used as the basis of safe delivery of care medications: - Right patient - Right medication - Right dose - Right route of administration - Right time of delivery - Right documentation - Nurse Responsibilities include: - Know classifications, actions, and side effects of drug - Know patient details and why drug was prescribed - Know how drug is acquired and pharmacy procedures - Know how to prepare and administer drug safely - Before drug is administered, the nurse must know all variables of the patient's condition. - Be prepared to recognize and react to adverse effects - Five Most Common Medication Errors: - Incomplete patient information - Unavailable drug information - Miscommunication of drug orders - Lack of appropriate drug labeling - Environmental distractions - Three Checks of Drug Administration: - Checking the drug with the MAR or the medication information system when pulling it from storage - Checking the drug when preparing it, pouring it, taking it out of the unit-dose container, or connecting the IV tubing to the bag - Checking the drug before administering it to the patient - Despite six rights and three checks, mistakes still occur. Nurses are held accountable for correct administration of drugs, but responsibility also rests on other positions like physician and pharmacist. Routes of Administration - There are multiple ways to administer medications. This is one of your psychomotor tasks you will learn in Fundamentals. - Routes - Enteral - Oral 8 - Parenteral - Subcutaneous injection (SubQ, SQ) - Intramuscular injection (IM) - Intravenous injection (IV) - Others - Intrathecal - Epidural - Intracardiac - Into joints or body cavities - Aerosol - Transdermal delivery - Installations - For the purposes of pharmacology, you will need to have a working knowledge of any barriers to absorption for each of the major routes of administration (PO, IV, IM, subQ). Additionally, you will need to know the different types of oral preparations (tablets, enteric-coated, and sustained release). Chapter 4 Pharmacokinetics - To understand pharmacokinetics, you also have to understand: - How the body handles medication - Actions and side effects of drugs - Obstacles that a drug faces to reach target cells. The greatest barrier for many drugs is crossing many membranes. - For example, in the enteral route, drugs are broken down by stomach acids and enzymes. The organs will attempt to excrete medicines. Phagocytes may attempt to remove medicines seen as foreign. - Absorption - Movement from site of administration, across body membranes, to circulating fluids - Primary factor in determining the length of time for the effect of the drug to occur - What are factors affecting drug absorption? - Liquid - Digestive motility - Route of administration - Drug to drug - Distribution - Distribution involves the transport of pharmacologic agents throughout the body. - What are factors affecting drug distribution? - The simplest factor determining distribution is the amount of blood flow to body tissues. 9 - Blood-brain barrier and fetal-placenta barrier: special anatomic barriers that prevent many chemicals and medications from entering - Makes brain tumors difficult to treat - Fetal-placenta barrier protects fetus; no pregnant woman should be given medication without strong consideration of condition. - Metabolism - The process of converting the drug to a form that can be more easily removed or excreted. - The liver is the primary site; kidneys and GI tract are others - What are factors affecting metabolism? - Drinking/alcohol - Genetics - Displaced or absent hepatic enzymes - Excretion - How drugs are removed from the body. - The concentration of a drug in the blood stream depends on the excretion rate. - The primary site of excretion is the kidney - Renal failure diminishes excretion of medications, and drugs are retained for extended times. Dosages must be reduced. - Other sites of excretion: respiratory system, glands, biliary system - Alternate first pass effect routes (see textbook) - Sublingual - Rectal - Parenteral routes 10 Plasma Drug Concentration and Therapeutic Response - Minimum effective concentration—amount of drug required to produce a therapeutic effect - Toxic concentration—level of drug that will result in serious adverse effects - Therapeutic range—plasma drug concentration between the minimum effective concentration and the toxic concentration - To reach/maintain therapeutic range: - Repeated doses of drug are given - Drug accumulates in bloodstream. - Plateau is reached. - Amount administered equals amount eliminated. - Sometimes a loading dose is given: - A higher amount of the drug given to help the plateau be met faster - Quickly produces the therapeutic response - Patient is then given the maintenance dose, which keeps the plasma-drug concentration in therapeutic range. Plasma Half-Life of Drugs - Most common description of a drugs duration - It is the length of time needed to decrease the drug plasm by one half - The greater the half-life, the longer it takes to excrete - Determines frequency and dosages of medications - Onset of drug action represents the amount of time it takes to produce a therapeutic effect after drug administration. - Peak plasma level occurs when the medication reaches its peak. - Duration of drug action is the amount of time a drug maintains its therapeutic effect. 11 Chapter 5 Pharmacodynamics - Pharmacodynamics is how drugs produce change in patients and helps predict the difference in patient responses to medications. - Further explanation can be found on page 51. Therapeutic Index - Measure of a drug’s safety - Ratio of the drug’s LD50 (average lethal dose to 50% of the animals treated) to its ED50 - The larger/higher the therapeutic index, the safer the drug. - The smaller/lower the therapeutic index, the less safe the drug. - Median effective dose: - Dose that produces therapeutic response in 50% of a group - Sometimes called “average” or “standard” dose - Many patients require more or less. - Median Lethal dose: - Used to assess safety of a drug, and is determined in preclinical trials - The does that will be lethal in 50% of group of animals - Cannot be experimentally determined in humans - Therapeutic index is the measure of a drug's safety margin - The higher the value, the safer the drug - Example: if a drug has a therapeutic index of 4, an error four times the dose would be needed to be lethal - The lower the value, the more dangerous the drug. If a drug has a low therapeutic index, it is a high-alert medication. - The margin for optimal response vs. toxic response is often a decimal point. - The skill of the nurse is critical in determining if the average dose is effective: - Patient observation - Taking of vital signs - Monitoring lab data Interpatient Variability in Drug Responses - The ED50 (aka: Median Effective Dose): - The dose that is required to produce a defined therapeutic response in 50% of the population. 12 - This can be considered a standard dose, and is frequently the dose selected for initial treatment. - Subsequent doses must by “fine tuned” based on the patient’s response - ED50 in a patient may need to be increased or decreased after the patients’ response is evaluated. - The dose required to produce a therapeutic response can vary substantially - among patients, because people differ from one another. - It is not possible to predict how an individual patient will respond to a medication. - Each patient must be evaluated to determine his or her own actual response. - Med error - Assess patient FIRST! - Get baseline - Contact charge nurse and doctor - Check for antidote - Stay with patient Goldilocks’ Effect - There are so many medications that do almost the same therapeutic action. - But each medication dose with each patient is an experiment. - Like Goldilocks, each patient needs a nurse who will work to get the results just right for that patient at that moment. Maximal Efficacy and Relative Potency - Maximal Efficacy: The largest effect that a drug can produce (i.e. the maximum degree of pain relief with drug A, when compared with drug B. - One drug will have a greater maximal efficacy than another). - Watch the intensity of the response with the patient need - Very high maximal efficacy is not always more desirable - Don’t hunt squirrels with a cannon - Relative Potency: The amount of drug we must give to elicit an effect (i.e. drug strength) - Rarely an important characteristic of the drug - Can be important if we lack of potency foresee inconveniently large doses - Implies nothing about maximal efficacy - Refers to to the dosage needed to produce effects Drug-Receptor Interactions - Drugs are chemicals the produce effects by interacting with other chemicals - Receptors are special chemicals in the body that most drugs interact with to produce effects - A receptor is a part of the cell to which a drug binds to produce its effects. 13 - The binding of a drug to its receptor is usually reversible. - When a drug binds to a receptor, it will mimic or block the action of the endogenous regulatory molecules - This will increase or decrease the rate of physiologic activity normally controlled by that receptor - Important Properties of Receptors: - Receptors are normal points of control of physiologic processes. - Under physiologic conditions, receptor function is regulated by molecules supplied by the body. - Drugs can only mimic or block the body’s own regulatory molecules. - Drugs cannot give cells new functions. - Drugs produce their therapeutic effects by helping the body use its preexisting capabilities Receptors and Drug Selectivity - Receptors make selectivity possible. - Each type of receptor participates in the regulation of just a few processes. - Lock and key mechanism, but does not guarantee safety. - Body has receptors for each: - Neurotransmitter - Hormone - All other molecules in the body used to regulate physiologic processes - The more selective a drug is, the fewer side effects it will produce. - REVIEW AUTONOMIC NERVOUS SYSTEM, NEUROTRANSMITTERS, & ALPHA/ BETA Agonists vs. Antagonists - Agonist - Binds to receptor and activates a response - Produces a response that mimics the response of an endogenous substance - Antagonist 14 - Produce their effect by preventing receptor activations of endogenous regulator and/or drugs - Often compete with agonists for receptor - Important to consider with drug-drug and drug-food interactions Customized Drug Therapy - End of single-drug, one-size-fits-all policy - DNA test before receiving drug - Prevention of idiosyncratic responses (unpredictable and unexplained drug reactions) - Pharmacogenetics: area of pharmacology that examines role of heredity in drug response Chapter 9 Individual Variations in Drug Response - Holistic approach to pharmacology - Identify risk factors - Age - Genetics - Biologic characteristics - Personal habits - Lifestyle - - Environment Through assessment, we can gather these: - Psychosocial Influences: socioeconomic factors, illicit drug use, lifestyle preferences - Religious and Spiritual Influences: refusal of medications, blood, surgeries - Cultural and Ethnic Influences: influence beliefs and actions of patients in their medical decisions, dietary considerations, genetic differences in medication effects - Environmental and Community Influences: age distribution, industrial growth, access to healthcare, literacy rate - Genetics: Enzyme breakdowns, changing the function of medications, risk factors - Gender Influences: compliance, healthcare risk factors, body composition 15 Drugs for Lipid Disorders Types of Lipids - Triglycerides - Most (90%) of all lipids in the body are triglycerides. - Triglycerides are the major storage form of fat in the body. - Triglycerides are made up of a glycerol and three fatty acids. - Fatty acids can be either saturated (associated with heart disease) or unsaturated (cardiac benefits) - Phospholipids - Phospholipids: essential to building plasma membranes - Steroids: - Cholesterol is most widely known Steroid - Component of all cell membranes/membranes of intracellular organelles - Building block for certain hormones, vit. D, and bile salts - 25% of our cholesterol comes from diet (animal products) - 75% of our cholesterol comes from biosynthesis - Why focus on Cholesterol? - The CDC identifies heart disease (atherosclerotic cardiovascular disease [ASCVD]) as the leading cause of death in U.S. - Heart disease: 614,348 persons, in U.S., die each year from heart disease. - 4 major physiologic roles of cholesterol: - 1. component of cell membranes and membranes of organelles - 2. required for synthesis of estrogen, progesterone, & testosterone - 3. need it to synthesize bile salts (need these to absorb and digest fats) - 4. needed in skin to reduce evaporation of water and block transdermal absorption of water soluble compounds Lipoproteins - Three classes of lipoproteins relevant to coronary atherosclerosis - Very low-density lipoprotein (VLDL) - Triglycerides - VLDL: mostly triglycerides. VLDLs deliver triglycerides from liver to adipose tissue and muscle. Will eventually become LDL. - Low-density lipoprotein (LDL) - Primary contributor to coronary heart disease - Bad cholesterol - Contain cholesterol as their primary core lipid. - Deliver cholesterol to the body 1 - Greatest contributor to atherosclerosis. - Cholesterol-lowering drugs are aimed at reducing LDL levels! - High-density lipoprotein (HDL) - Good cholesterol - Carries cholesterol from the tissue back to the liver for removal. - The ‘good cholesterol’ - Elevation of HDLs reduces risk of ASCVD!!! - Oil and water do not mix! Lipids are not soluble in plasma, so lipids must become a complex lipoprotein for transport through the body. - Lipoproteins contain: cholesterol, triglycerides, phospholipids, and a protein carrier. - While there are 6 major classes of plasma lipoproteins only 3 are relevant to ASCVD and this lecture. Treatment of High LDL: Lifestyle Changes - Routine monitoring of blood lipid levels - Treatment of lipid levels comes in 2 forms: Lifestyle changes and drug therapy. - Younever put someone on drug therapy with also incorporating lifestyle changes. - Maintain healthy weight - Weight control and Exercise not only reduces LDL it also reduces risk of ASCVD! - Exercise - Exercise can also RAISE HDLs, improve CV performance, and lower B/P - Reduce dietary saturated fats, trans fats, and cholesterol - Dietary intake of saturated fats and refined carbohydrates should be reduced. Why these not just a low cholesterol diet? - Remember only 25% of the blood cholesterol comes from diet. If the body detects a drop in cholesterol it will simply make more (feedback loop). So you have to eliminate the building blocks of cholesterol to reduce blood levels. - Increase fiber and plant stanols intake - Fiber: soluble fiber (oatmeal) and plant stanols (canola oil, nuts, fruits, beans) reduce cholesterol by reducing the amount of bile reabsorbed in the intestines. - How it works--- Fiber interferes with absorption of bile in intestines, the bile is excreted in the feces. - To make up for this loss of bile, the liver makes more bile salts. (The body uses cholesterol to make bile salts) - So in order to obtain the cholesterol necessary to make bile salts, the liver increases its production of LDL receptors. - These receptors are responsible for pulling cholesterol out of LDL molecules in the bloodstream. - Bottom line– more bile salts made in the liver, more LDL cholesterol pulled from the blood! - Eliminate tobacco use 2 - Smoking raises LDL cholesterol and lowers HDL cholesterol!!! Raises the bad and lowers the good Drugs for Lipid Therapy - Medications are used ONLY when lifestyle changes are inadequate - Drug therapy is a lifelong commitment. - If drug therapy is discontinued the LDL cholesterol with return to pre- treatment levels. - HMG-Co A reducatase inhibitors (Atorvastatin) - Bile acid sequestrants (Cholestyramine) - Nicotinic acid (Niacin) - Fibrates (reduces TGs, not LDLs) - Ezetimibe (Zetia)(blocks dietary cholesterol absorption) - You do not have a Fibrate drug or Ezetimibe as a prototype drug. I only provide them for your benefit. HMG-CoA Reductase Inhibitors: Statins - HMG-CoA Reductase is an enzyme essential to the biosynthesis of cholesterol. 3 - Through a negative feedback loop: - High levels of LDL in the blood will shut down production of HMG-CoA reductase. (Turns off cholesterol pathway.) - Less cholesterol biosynthesis and remember most of our blood cholesterol is obtained via biosynthesis. - Lowers LDL, Raises HDL - Statins are most effective if taken at night as normal biosynthesis of cholesterol occurs at night. (Atorvastatin your prototype may be taken anytime). - Adverse effects are usually mild and transient. Most people tolerate statins very well. - Rhabdomyolysis: Rare but serious breakdown of muscle fibers. The muscle cells spill into the circulation, and can cause a fatal renal failure. - S/S of rhabdomyolysis include: muscle pain or weakness, tea color urine. - Educate client to notify provider if unexplained muscle pain or tenderness develops. - Hepatotoxicity is a potential AE. - Avoid if client has Hx of alcoholism, nonalcoholic fatty liver disease. - FDA Pregnancy category X. - You need cholesterol for fetal development– remember cholesterol is necessary for cell membranes and membranes of intracellular organelles! - So with Atorvastatin what would be some teaching points? - Lifestyle changes, Diet & exercise, Notify provider if unexplained muscle pain, avoid during pregnancy, take with food (but not grapefruit)…….. - What baseline information would you want to get during assessment? (Look to the end of your chapter, page 337, for help with education and administration) - Health history, drug history, LFTs (what are some liver function lab tests? How about AST and ALT.) - (I do not expect you to know normal AST and ALT values but I do expect you to know what studies would evaluate liver function). - What would be some educational points with Atorvastatin? - Again go to the back of your chapter and read the Nursing Practice Applications Bile Acid Sequestrates - No longer the first line agent bile acid sequestrates are often used in multi-modal therapy or if the client cannot take a statin. - The BIND bile acids which contain a high concentration of cholesterol. - The bound bile acids and cholesterol are then excreted in the feces. - The liver responds to the loss of cholesterol by making more LDL receptors, which pull more cholesterol from the blood. - More AE than statins. But most are GI related as these drugs are not absorbed from the small intestine (therefore do not enter the systemic circulation). - Can BIND to other drugs, vitamins, and minerals ! - What other prototype drugs do you have in this CV section that may be affected? 4 - Digoxin? Warfarin? - Look at the peak action of this medication. - May take up to 3 weeks to produce maximum effect. - Comes in a powder. - So Mix with plenty of fluids (water, juice, applesauce…..) to avoid esophageal irritation or impaction. - Going to be cloudy because not water soluble! - How do you prevent constipation/impaction? - Increase fluids, fiber, exercise. All good things for cholesterol Nicotinic Acid (Niacin) - A B-complex vitamin. When used to lower cholesterol it is given in much higher doses (example: 2-3 Grams/day)(as a vitamin only 25mg/day) - Niacin is a component of 2 coenzymes necessary for lipid metabolism. It can raise your HDL!!! Remember HDL picks up cholesterol in your body and takes it to the liver for disposal. - Reduces LDL and Triglyceride (VLDL) levels - Decreases VLDLs and because LDL is synthesized from VLDL there is a reduction in LDLs. - Increases HDL more effectively than any other drug - AE: - Skin (flushing, itching) - Can cause intense facial flushing. 5 - To prevent this reaction educate client to pretreat with Aspirin 325mg 30 minutes prior to taking Niacin. - GI - Take with meals to reduce GI upset - Hepatotoxicity - Hyperglycemia - Gouty arthritis - ↑ blood levels of uric acid - Would you give this medication to a client with Diabetes Mellitus? Gout? Liver disease? The Function of the Kidneys - Anatomy - Basic functional unit of the kidney: Nephron - Four functionally distinct regions - Glomerulus: blood enters nephron via renal arteries, filtered through the glomerulus. - Water and small molecules pass through pores and enter Bomans Capsule. - Once in nephron this fluid is called the filtrate. - Proximal convoluted tubule - Loop of Henle - Distal convoluted tubule - Physiology - Basic functions of the kidney - Cleansing of extracellular fluid (ECF) and maintenance 
 of ECF volume and composition - Maintenance of acid-base balance - Excretion of metabolic wastes and foreign substances - Secrete renin ( B/P regulation) - Secrete erythropoietin (stimulates RBC production) - Responsible for production of calicitrol (active form Vit. D– bone homeostasis) - Notice in the image: once the filtrate leaves Boman’s Capsule it begins a series of reabsorption. 6 Diuretic Therapy - Filtration occurs at the glomerulus and is the first step in urine formation. - Be aware filtration is a nonselective process and therefore cannot regulate the composition of urine. - Reabsorption: 99% of all that is filtered is reabsorbed. Reabsorption of solutes (electrolytes and glucose) takes place by active transport. - Diuretics work primarily by interfering with reabsorption. - For the most part, diuretics share the same mechanism of action: blockage of sodi


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