Module 1 Study Guide Fall 2022 PDF

**Study Guide Module 1** **Module 1 Unit A** 1. **What is \"Full prescriptive authority\"?** The legal right to prescribe independently without limitations 2. Primarily by the state of practice for the APRN 3. Safety and efficacy 4. Over the Counter Drugs sold dir...

**Study Guide Module 1** **Module 1 Unit A** 1. **What is \"Full prescriptive authority\"?** The legal right to prescribe independently without limitations 2. Primarily by the state of practice for the APRN 3. Safety and efficacy 4. Over the Counter Drugs sold directly to a consumer without a prescription ------------------------------ -------------------------------------------------------------------------------------------------------------------------- Prescription (noncontrolled) Drugs sold only to consumers possessing a valid prescription from a healthcare prescribed who is authorized to prescribe Controlled (Scheduled) Prescribed with a DEA number and records kept 5. Based on acceptable medical use and the abuse/dependency potential. Schedule I is the highest risk of dependency or abuse and may cause severe psychological and/or physical dependence-Schedule V represent the least potential for abuse 6. DEA Schedule Abuse Potential Examples of Drugs Some Effects (dependence) Medical Use RX writing Refills -------------- ------------------------------------------------------------------------- ----------------------------------------------------------------- ------------------------------------------------------------------------ ------------------------- ---------------------------------------------------------------------------------- ---------------------------------------------------------------------------------- I **Highest** Heroin, LSD Unpredictable, psychological or physical dependence, death No accepted medical use None- only researchers Not applicable II **High potential for abuse** Vicodin, cocaine, hydromorphone, oxycodone, fentanyl Use potentially leading to severe psychological or physical dependence yes Phone in emergency with written RX within 72 hours, electronic RX with secure ID No, a new Rx must be written III **Moderate to low potential for physical and psychological dependence** Tylenol with codeine, ketamine, anabolic steroids, testosterone Moderate to low yes Telephone or fax, electronic ok, rewrite RX after 6 months refilled up to 5 times within 6 months from the date the prescription was issues IV **Low potential for abuse and low risk of dependence** Xanax, soma, valium, Ativan, ambian, tramadol Low yes Telephone or fax, electronic ok, rewrite RX after 6 months Same as for III 7. 8. 9. Off-label use benefits the patient and is not illegal, contraindicated, or investigational practice. Therapeutic decision-making with off-label use depends upon the **best available scientific evidence and the importance of the benefit for the individual patient**. 10. 11. **Number of subjects** **What is the purpose?** --------- -------------------------- -------------------------------------------------- Phase 1 40-50 healthy volunteers A trial run to evaluate safety Phase 2 10-100 evaluate efficacy Phase 3 100-1000 Statistically test safety and efficacy Phase 4 (n/a) Post-market surveillance- difficult to implement 12. **Module 1 Unit B** **1. What are the elements of Rational Drug Selection?** Patients receive medications that are appropriate to their clinical needs in doses that meet their own individual requirements for an adequate period of time at the lowest cost to them in their community. **2**. **How does shared decision-making relate to prescribing?** Collaborative patient-directed decision-making process that helps the patient, together with family/caregivers/healthcare team set goals and priorities and make choices that meet patient needs while honoring the patient\'s values and preferences. Predicts therapeutic alliances and treatment attrition, yields better outcomes Explore evidence, convey information in unbiased, understandable terminology, and explore risks, benefits, and alternatives **3. What are the eight standard questions for safe and effective prescribing?** 1\. Goal of therapy: what pathology should be altered 2\. related drug classes: what categories of drugs are available to treat the pathology, and how are the categories different 3\. mechanism of action: how do the different drugs address the pathology? 4\. distinguishing features of specific drugs in the class 5\. How does the drug get into the body? How well is it absorbed? 6\. How is the drug distributed and metabolized in the body? What are the influencing factors? 7\. How does the drug leave the body? Are there issues with clearance or excretion? 8\. The safety profile of the chosen drug: side effects, drug interactions, pregnancy, breastfeeding, patient education for correct use? **4. What is the role of patient history in prescribing?** Safe prescribing requires a detailed review of a patient's medication history **AVOID mistakes**: - Allergies? - Vitamins and herbs? - Old drugs and OTC - Interactions - Dependence? Do you need a contract? - Mendel- family history of benefits or problems with any drugs? **5. What is medication reconciliation, and how does it improve patient care?** The process of creating the most accurate list possible of all of the medications a patient is taking, including drug name, dosage, frequency, and route. Must occur for every patient at every encounter. Drug-to-drug interaction analysis **6. What is bioavailability and chemical equivalence? How does that apply to prescribing brand versus generic meds?** [Bioavailability]: the rate and extent to which the active ingredient (API) is absorbed from the drug product and becomes available at the site of action. (really how much and how quick that drug is available at the site of action)- some meds that require tight control may need brand only to ensure consistent bioequivalence (ex: thyroid) [Chemical equivalent:] two drugs preparations with the same amount of identical chemical compounds Bioequivalence: the absence of a significant difference in the rate and extent to which the active ingredient in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action. Generic drugs must contain the same amount of "active drug" as the previous brand name version. HOWEVER, bioequivalence and therapeutic efficacy may not necessarily be the same. The drug must have the same amount of the active principle, the same route of administration, and the same therapeutic effectiveness as demonstrated by a bioequivalence study. **Module 1 Unit C** 1. **Know pharmacokinetics: the movement of a drug through the body. There are four processes involved. (Absorption, distribution, metabolism, excretion)** **Pharmacokinetics**- a drugs movement through the body; influences the route of administration or drug, the amount, and dosing intervals **Absorption**- movement of the drug from the site of administration into the systemic circulation **Distribution**- movement of drugs from the systemic circulation to the site of drug action **Metabolism**- enzyme alteration of drug structure **Excretion**- removal of the drug from the body Diagram, schematic Description automatically generated 2. +-----------------------------------+-----------------------------------+ | Lipid Solubility | 1. Highly lipid-soluble drugs | | | absorbed more rapidly | | | | | | 2. Lipid-soluble drugs can | | | readily cross the membranes | | | that separate them from the | | | blood, whereas drugs of low | | | lipid-solubility cannot | | | | | | 3. *They easily cross the | | | placenta and breastmilk to | | | fetus and infant* | +===================================+===================================+ | Blood-brain barrier | 1. Has tight junctions that | | | prevent drug passage | | | | | | 2. Only lipid-soluble drugs or | | | drugs with transport systems | | | can cross BBB | | | | | | 3. Has PGP (P-glycoprotein) | | | transporter pump (page 14) | | | (PGP transports drugs OUT of | | | the cells) | | | | | | 4. *BBB not fully developed at | | | birth, making neonates | | | vulnerable to CNS toxicity* | +-----------------------------------+-----------------------------------+ | Placental drug transfer | - DO NOT constitute an absolute | | | barrier to the passage of | | | drugs | | | | | | - Simple diffusion, lipid | | | soluble, and non-ionized | | | compounds cross placenta to | | | infant | | | | | | - Ionized, highly polar drugs | | | do not reach fetus | +-----------------------------------+-----------------------------------+ | Protein binding | Drugs have to fill the binding | | | sites before entering a free | | | state to be able to activate; use | | | consideration with multiple | | | protein binding drugs as | | | stopping/starting one will affect | | | the other | | | | | | - Albumin is the most important | | | protein to which drugs can | | | bind, large molecules | | | | | | - Binding between albumin and | | | drugs is reversible (bound or | | | unbound) | | | | | | - If a drug is **protein | | | bound** it is **INACTIVE** | | | | | | - Albumin is TOO large to leave | | | bloodstream | | | | | | - Can restrict drug | | | distribution and a source of | | | drug interaction | | | | | | Stopping or starting a drug that | | | binds to plasma proteins changes | | | the free drug levels of other | | | protein bound drugs (stopping | | | coumadin can cause a seizure by | | | removing Dilantin from free state | | | to protein bound sites that were | | | occupied by Warfarin) | +-----------------------------------+-----------------------------------+ 3. +-----------------------------------+-----------------------------------+ | Hepatic Drug Metabolizing Enzymes | - Cytochrome P450 (group of 12 | | | enzyme families) | | | | | | - CYP1, CYP2, and CYP3: | | | metabolize drugs | +===================================+===================================+ | Prodrug | - Drug that begins as inactive | | | and must be metabolized by | | | the liver to become active | +-----------------------------------+-----------------------------------+ | Special consideration in age | - Infants: have limited | | | metabolizing ability due to | | | immature liver, sensitive to | | | drugs; larger body water | | | | | | - Older adults: metabolism is | | | decreased d/t decreased liver | | | mass and may need reduced | | | drug doses to avoid toxicity, | | | less total body water as well | +-----------------------------------+-----------------------------------+ | CYP induction | - Stimulate enzyme synthesis | | | | | (induction-removal from body) | - Increase the rate of | | | metabolism | | | | | | - Amount of **active drug** is | | | decreased and plasma drug | | | levels fall | | | | | | - [May NOT achieve therapeutic | | | drug levels d/t quick | | | excretion] | +-----------------------------------+-----------------------------------+ | CYP inhibition | - Slow the rate of metabolism | | | | | (inhibition-inhibit removal from | - Increase in active drug | | body) | accumulation (stays in the | | | body longer) | | | | | | - [May cause adverse effects | | | and toxicity] | +-----------------------------------+-----------------------------------+ | Substrate | Drugs being observed | +-----------------------------------+-----------------------------------+ | First Pass Effect | - PO meds only | | | | | | - Liver alters the drug by | | | reducing dose before it ever | | | gets to systemic circulation | | | | | | - Oral bioavailability of drug | | | is reduced | | | | | | - \*if you bypass GI tract you | | | avoid first pass effect\* | +-----------------------------------+-----------------------------------+ | Competition between drugs | - Two drugs are metabolized by | | | the same metabolic pathway | | | | | | - Decreases the rate of one or | | | both drugs | +-----------------------------------+-----------------------------------+ | | | +-----------------------------------+-----------------------------------+ 4. +-----------------------------------+-----------------------------------+ | Renal Drug Excretion | **Kidneys account for a majority | | | of drug excretion** | | | | | | 1. GFR: moves drugs from blood | | | to tubular urine: does NOT | | | filter large molecules like | | | blood and protein | | | | | | 2. Passive tubular reabsorption: | | | distal to glomerulus; distal | | | to glomerulus; lower drug | | | concentrations; lipid soluble | | | drugs undergo passive | | | reabsorption | | | | | | Active tubular excretion | +===================================+===================================+ | Nonrenal excretion | - [Breastmilk]: | | | lipid-soluble drugs in | | | breastmilk | | | | | | - [Bile]: secreted | | | in the small intestine, drugs | | | that do not undergo | | | enterohepatic recirculation | | | leave the body in the feces | | | | | | - [Lungs:] volatile | | | anesthetics, some ETOH | | | | | | - [Sweat/saliva:] | | | little significance | +-----------------------------------+-----------------------------------+ | What is the GFR, and what is its | - Moves drugs from blood to | | impact on drug metabolism? | tubular urine | | | | | | - Does NOT filter large | | | molecules like blood and | | | proteins (albumin) | | | | | | - GFR is decreased by drugs | | | that decrease cardiac output | | | which will decrease the rate | | | of excretion | +-----------------------------------+-----------------------------------+ 5. +-----------------------------------+-----------------------------------+ | Plasma drug level | - Direct correlation between | | | therapeutic and toxic | | | responses and the amount of | | | drug present in the plasma | | | | | | - Highly predictive of | | | therapeutic and toxic | | | responses | +===================================+===================================+ | Minimum Effective Concentration | - The plasma drug level less | | (MEC) | than which therapeutic | | | effects will not occur | | | | | | - To benefit: a drug must be | | | present in concentrations at | | | or greater than MEC | +-----------------------------------+-----------------------------------+ | Toxic Concentration | - Plasma drug levels climb too | | | high and toxic effects begin | | | | | | - Doses must be kept small | | | enough so that toxic | | | concentration is NOT reached | +-----------------------------------+-----------------------------------+ | Therapeutic range | - Range of plasma drug levels | | | between MEC and toxic | | | concentration | | | | | | - The objective of drug dosing | | | is to maintain drug levels | | | within the therapeutic range | | | | | | - Narrow therapeutic range: | | | difficult to safely | | | administer (risks for | | | drug-drug interaction and | | | toxicity) | | | | | | - Wide therapeutic range: safe | | | and easier to administer | | | | | | - Therapeutic range is | | | quantified and measure by | | | therapeutic index | +-----------------------------------+-----------------------------------+ | **Drug half-life** | - Time required for the amount | | | of drug in the body to | | | decrease by 50% | | | | | | - [Percentage] not | | | a specific amount of drug is | | | lost during one half-life | | | | | | - Half-life of a drug | | | determining dosing interval | | | (BID, TIB, etc.) | +-----------------------------------+-----------------------------------+ | Area under the curve (AUC) | **Total body exposure to the | | | substrate**; so for inhibited | | | drugs with a high level in the | | | body AUC is high, for induced | | | drugs it is low | +-----------------------------------+-----------------------------------+ 6. +-----------------------------------+-----------------------------------+ | Maximal efficacy | - "the largest effect a drug | | | can produce" | | (page 23) | | | | - Indicated by height of | | | dose-response curve | | | | | | - Meperidine (Demerol) has | | | greater maximal efficacy than | | | pentazocine (Talwin) (both | | | are morphine-like pain | | | relievers) | | | | | | - Always match the intensity of | | | the response to the patient's | | | need: mild headache give | | | aspirin instead of morphine | +===================================+===================================+ | Relative potency | - Refers to the amount of drug | | | we must give to elicit an | | | effect | | | | | | - A potent drug produces its | | | effect at low doses | | | | | | - The potency of a drug implies | | | NOTHING about its maximal | | | efficacy (morphine is more | | | potent than meperidine, but | | | they have identical maximal | | | degrees of pain relief) | +-----------------------------------+-----------------------------------+ 7. +-----------------------------------+-----------------------------------+ | **Affinity** | **Strength of attraction between | | | a drug and its receptor** | | | | | | Drugs with **high affinity** are | | | strongly attached to their | | | receptors and can bind to their | | | receptors when present in low | | | concentrations | | | | | | Drugs with high affinity are very | | | potent and effective in low doses | | | (morphine) | +===================================+===================================+ | **Activation** | **Drugs ability to cause the | | | receptor to activate after | | | binding to the site** | +-----------------------------------+-----------------------------------+ | **Agonist** | Binds to and activates the | | | receptor | | | | | | (dobutamine mimics norepinephrine | | | at receptors of the causing | | | increased HR and force of | | | contraction) | +-----------------------------------+-----------------------------------+ | **Antagonist** | Binds to and prevents the | | | activation of a receptor | | | | | | Has affinity (attraction) but NO | | | intrinsic activity (activation) | | | | | | **[If there is no agonist | | | present, the administration of an | | | antagonist will have no | | | observable effect]** | | | | | | **Does produce pharmacologic | | | effects: antihistamines are | | | histamine receptor antagonists | | | that suppress allergy symptoms by | | | binding to receptors of | | | histamine** | | | | | | **Narcan: opioid antagonist | | | blocks opioid receptors in event | | | of overdose** | +-----------------------------------+-----------------------------------+ | **Partial Agonist** | **moderate expression of the | | | endogenous regulatory molecule** | | | | | | Moderate intrinsic activity | | | (activation of receptor) | +-----------------------------------+-----------------------------------+ 8. The measure of a drug's safety, the ratio of the lethal dose to effective dose: Wide index= safe Narrow index= unsafe When there is an overlap in the curve, it tells us that high doses are needed to produce a therapeutic effect in some people and large enough to cause death in others Hepatotoxic drugs: Tylenol is a hepatoxic drug and can cause damage to the liver when taken in excess. If the drug is taken with two or three alcoholic beverages, severe liver injury can result. **Module 1 Unit D** 1. **Define and apply the following terms** +-----------------------------------+-----------------------------------+ | **Side effect** (common or | Secondary drug effect produced at | | serious) | therapeutic drug doses; | | | unavoidable; intensity is dose | | | dependent | | | | | | Includes nausea, headache, and | | | dizziness; would not preclude the | | | patient from taking the | | | medication, and sometimes these | | | side effects are helpful, ie | | | ibuprofen for menstrual cramps | | | also reduces menstrual flow and | | | length. | +===================================+===================================+ | Adverse effect | A noxious, unintended, undesired | | | effect that occurs at normal drug | | | doses. **Serious side | | | effects/Adverse side** effects | | | are a reaction that results in | | | any of the following: death, a | | | life-threatening event, inpatient | | | hospitalization, a persistent or | | | significant incapacity or | | | substantial disruption of the | | | ability to conduct normal life | | | functions, and/or congenital | | | anomaly or birth defects | | | | | | [Serious side | | | effects] include | | | prolonged QT interval, GI bleed, | | | or anaphylactic shock | +-----------------------------------+-----------------------------------+ | Precaution | Identify and describe a discrete | | | set of adverse reactions and | | | other clinically significant | | | reactions because they have | | | implications for prescribing and | | | management | +-----------------------------------+-----------------------------------+ | Black Box Warning | FDAs most stringent warning for | | | drugs and medical devices to | | | alert the public and health | | | providers to serious side effects | | | such as injury or death | +-----------------------------------+-----------------------------------+ | Relative contraindications | The risk of not using the | | | medication may outweigh the risk | | | of using the medication. (Ex: | | | prescribing tetracycline to a 7yo | | | with Rocky Mountain Spotted Fever | | | b/c risk of death outweighs risk | | | of spotted teeth) | +-----------------------------------+-----------------------------------+ | Absolute contraindication | Do NOT prescribe the medication | | | EVER, as use could cause severe | | | or life-threatening conditions | +-----------------------------------+-----------------------------------+ 2. **Drug interactions (receptor sites)** Agonist Binds and activates ----------------- ------------------------------- Antagonist Binds and blocks Partial agonist Binds and partially activates 3. **Drug to Drug interactions (CYP induction and inhibition)** - Drug A is administered with Drug B. Drug A** INDUCES CYP to increase the metabolism **of drug B. - Drug A is administered with Drug B. Drug A** INHIBITS CYP to decrease the metabolism **of drug B. - **Substrate:** the drug being observed. In this example, the substrate is drug B +-----------------------------------+-----------------------------------+ | Substrate | The drug being observed **\*the | | | baby\*-**what is being affected | | | by the inhibitor or inducer | +===================================+===================================+ | Inhibitor | Inhibits the metabolism of a drug | | | | | | **\*think inhibits labor\*** will | | | retain MORE of the drug, Outcome | | | can be good or bad, but usually | | | is harmful and causes toxicity | | | | | | **Inhibitor drugs:** grapefruit | | | juice, acyclovir, COC, | | | amiodarone, fluoxetine, cipro | +-----------------------------------+-----------------------------------+ | Inducer | Induces the metabolism of a drug | | | | | | **\*think induce labor**\* will | | | remove the drug from the body | | | quicker than it should be removed | | | | | | Inducer drugs: ST. Johns Wort, | | | tobacco, phenytoin, ritonavir, | | | rifampin, phenobarbital, | | | carbamazepine | +-----------------------------------+-----------------------------------+ 4. **How does changing gastric pH and altering absorption** a. Enteric-coated drugs are designed to dissolve in the **[alkaline pH]** of the small intestine, they do NOT dissolve readily in acidic conditions unless they are altered or drug-drug interaction; absorption in the stomach can cause gastric ulcers d/t blocking prostaglandins that protect stomach lining (NSAIDs are designed to breakdown **[after]** leaving the stomach) b. **[Antacids will lower the pH in the stomach and break down enteritic-coated drugs. Do NOT crush enteric-coated medication or give it with antacids or else it will lower the pH in the stomach causing an ulcer.]** 5. Describe and differentiate reactions, including the type of reaction and risk. Can you give a different form of a medication to a person who previously had a type one reaction? -No other forms \* Focus on the types of allergies, not the drugs\* +-------------+-------------+-------------+-------------+-------------+ | | When do | Summary | Treatment | Example | | | they occur? | | | | +=============+=============+=============+=============+=============+ | **Type 1** | 30-60 | IgE | Epinephrine | Angio | | | minutes; | mediated, | , | edema, | | | will happen | Immediate | bronchodila | anaphylaxis | | | after | hypersensit | tors, | | | | SECOND | ivity | H1 | **HIVES\*\* | | | exposure | | blockers, | \*itchy** | | | | Causes mast | glucocortic | | | | | cells to | oids | | | | | break | | | | | | down-releas | | | | | | es | | | | | | Histamine | | | | | | (vasodilati | | | | | | on), | | | | | | vessel | | | | | | walls will | | | | | | get leaky, | | | | | | BP falls | | | | | | d/t smooth | | | | | | muscle | | | | | | spasm | | | +-------------+-------------+-------------+-------------+-------------+ | Type 2 | Delayed | Antibody-de | Stop the | Heparin-ind | | | onset | pendent | drug | uced | | | | cytotoxicit | | thrombocyto | | | | y | | penia | | | | (IgG, IgM) | | | +-------------+-------------+-------------+-------------+-------------+ | Type 3 | Delayed 1-3 | Immune | Stop the | Arthus | | | weeks | complex | drug | reaction to | | | | hypersensit | | tetanus | | | | ivity | | | +-------------+-------------+-------------+-------------+-------------+ | **Type 4** | Delayed, | Cell-mediat | | Stevens | | | 48-72 | ed | | Johnson | | | hours, | or delayed | | syndrome, | | | could be up | hypersensit | | toxic | | | to weeks | ivity | | epidermal | | | after the | | | necrolysis | | | treatment | | | | +-------------+-------------+-------------+-------------+-------------+ **Morbilliform rash**- not raised, less itchy, may happen after exposure to antibiotics or d/t viral illness 6. **What is an anticholinergic effect? Can you name the conditions that it is a poor idea to give an anticholinergic drug? Why?** - why? Because many classes of common drugs have anticholinergic effects - Visual/auditory/sensory hallucinations, tremors, memory impairment, cognitive impairment, tachycardia, dry eyes, sensitivity to light, reflux, constipation, dry mouth, impaired speech, tooth decay, difficulty swallowing - Not a good idea to give to elderly patients or those at risk for dementia/Alzheimer's  7. What is a prolonged QT? What are modifiable and nonmodifiable risk factors? - QT interval is a measure of the time required for the ventricles to repolarize after each contraction. A prolonged QT interval increases the risk of ventricular dysthymia and sudden death. Some drugs prolong the QT interval causing serious dysrhythmias (Torsade's de pointes) to fatal ventricular fibrillation. - **Modifiable risk factors:** hypokalemia, hypocalcemia, drug-drug interactions grapefruit juice, diuretic use, bradycardia, renal/hepatic dysfunction, digitalis, underlying heart disease - **Nonmodifiable risk factors:** Female, congenital QT syndrome, advanced age - Common drugs: Zofran, Zithromax, Diflucan 8. **Food and drug interactions** What does it affect and why? --------------------------------------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Grapefruit Blood pressure medicine and statins-grapefruit is a CYP inhibitor; This effect may last for up to 72 hours. Leafy greens Vitamin K, activates clotting factors; cannot take with Warfarin Explain chelation and give an example **Chelation is the bonding of ions between molecules to metal ions**. Thyroid medication and tetracycline can interact with dairy (avoid for 2 hours), calcium, iron, magnesium, aluminum, multivitamins, 9. **Define the term prophylactic. Be able to identify when a drug is given as prevention.** - Action/drugs taken to prevent disease, especially by specified means or against a specified disease - Immunizations, condoms, flu shots, etc. acyclovir given 400mg TID for 7-10 days is treatment, vs acyclovir given 400mg BID every single day is prophylactic **Module 1 Unit E** 1. **Identify the differences in Intermediate, poor, and ultra-rapid metabolizers.** - **Poor Metabolizers-** can cause accumulation of the drug and potentially toxic levels (and therefore the need for reduced dosage) - **Intermediate Metabolizers**- make some enzymes, but less than normal, which can cause accumulation of the drug and potentially toxic levels (and therefore the need for reduced dosage)- may lead to excessive accumulation of the metabolite (also resulting in toxic levels) - **Extensive metabolizers:** make [NORMAL amounts] of metabolic enzymes (metabolize drugs at a normal rate) - **Ultra-Rapid Metabolizers**- genetics increase metabolism and the need for an increased dosage of the drug to be effective 2. **Can you compare and contrast Drug to drug interactions with genetic alterations that impact drug metabolism?** 3. **Describe the pharmacotherapeutic considerations when providing medications to children, men, women, the elderly, pregnant, and lactating people. Are there any sex or age implications involved with prescribing? If so, what are they?** - Alcohol is metabolized more rapidly in men than in women. - Specific opioids work more effectively, and their potency is higher in women than men. - According to FDA guidelines, women require lower doses of zolpidem (Ambien) than men. - Women are more prone to QT interval prolongation in drugs that impact the QT interval, and therefore to cardiac arrhythmias. - Pediatrics: avoid ASA (Reyes Syndrome), immature organ systems, glucocorticoids cause growth suppression, tetracycline discolors teeth, sulfonamides cause kernicterus, AVOID topical agent-thin skin increases absorption - **Depending on their age, children may have a higher rate of metabolism than adults, drugs may become less protein-bound, and distribution is affected by a higher concentration of water in the pediatric client.** - Elderly: avoid anticholinergics, avoid NSAIDS, decreased liver mass and decreased renal function, polypharmacy, poor adherence - **Pharmacokinetics are altered in the aging population, as well. Significant changes that occur with aging include increased gastric pH, slower peristalsis resulting in increased length of the time for absorption to occur, decreased muscle mass, and decreased total body water (10-15%), which results in the decreased distribution of water-soluble drugs.** - Pregnancy: avoid meds when possible, start low and slow, avoid ACE and ARB, avoid heparin, renal excretion accelerated in 3^rd^ trimester, increase thyroid medications, Avoid ASA, Vitamin A (teratogenic in excess amt), statins, avoid medication during 1^st^ trimester if possible - Lactation: take medication immediately after breastfeeding the infant, avoid drugs with long half-life, AVOID controlled substances, nicotine, anticancer/immunosuppressive agents, lithium; uses lowest dose for shortest time 4. **Be able to define and apply the PLLR and Letter system for drug classification.** 5. Be able to define and apply the following terms: +-----------------------------------+-----------------------------------+ | Teratogen | A teratogen is a substance such | | | as a food, drug, chemical agent, | | | or even a natural component in | | | the environment that causes | | | malformations by damaging fetal | | | growth, structure, or | | | development. **Teratogens are | | | characterized by their effect and | | | the time in gestation the | | | exposure occurs.**  A fetotoxic | | | substance does not cause | | | malformations but still causes | | | harm.  To be designated as a | | | teratogen three criteria must be | | | met: | | | | | | 1. 2. 3. | | | | | | Androgenic agents (testosterone), | | | ACE inhibitors, statins, warfarin | | | (Coumadin), phenytoin (Dilantin), | | | valproic acid (Depakote), lithium | | | carbonate, Methotrexate, large | | | doses of vitamin A (retinoic | | | acid), Tetracycline, and alcohol | | | are all examples of teratogenic | | | drugs. As a provider, keep in | | | mind that some infections are | | | also teratogenic. Varicella and | | | Rubella are examples of | | | vaccine-preventable infections | | | that cause congenital birth | | | defects. | +===================================+===================================+ | "All or nothing" | Pre-Implantation: This is the | | | period of time between | | | conception/fertilization and | | | implantation in the uterine | | | lining. It includes fertilization | | | in the fallopian tube, followed | | | by transport to the uterus, and | | | finally implantation in the | | | uterus. This is the **\"all or | | | none\" period\--the teratogen | | | will either cause a miscarriage | | | or resorption of | | | the **conceptus**, or | | | the **conceptus** will survive | | | without damage** | +-----------------------------------+-----------------------------------+ | Organogenesis | ***Embryogenesis* is when the | | | embryo forms, develops | | | and *undergoes | | | organogenesis*** **. This is the | | | most critical period of high | | | sensitivity and susceptibility to | | | major congenital anomalies, | | | miscarriage, or when more mild | | | but permanent defects can occur** | +-----------------------------------+-----------------------------------+ | Congenital malformation | Birth defects | +-----------------------------------+-----------------------------------+ 6. **Are there certain maternal conditions where medications MUST be taken while pregnant or breastfeeding despite potential fetal harm? Make a note of listed teratogens in this module.** Diabetes, hypothyroidism and asthma; it is safer for the pregnant person with asthma to use albuterol than to have uncontrolled asthma during pregnancy, and safest for the fetus as well. ACE inhibitors, ARBs and Accutane (isotrenitoin) are known teratogens. Androgenic agents (testosterone), ACE inhibitors, statins, warfarin (Coumadin), phenytoin (Dilantin), valproic acid (Depakote), lithium carbonate, Methotrexate, large doses of vitamin A (retinoic acid), Tetracycline, and alcohol are all examples of teratogenic drugs. 7. **What is the BEERs list, and what is its significance? Who does it apply to? Who does it not apply to? If a medication is on the BEERs list, can you still prescribe it?** - List of medications that could be potentially harmful in elderly patients to be used as a guide with risk/benefit analysis - Does NOT apply to hospice/palliative care patients 8. **Understand the definition and implications of polypharmacy.** **Module 1 Unit F** 1. **What are the requirements for FDA approval of over-the-counter medications? ** - the drug must be considered safe and have a low risk for misuse - patients must be able to self-diagnose to take it - the drug must be for a condition that can be self-managed - the product can be labeled 2. **Understand the definition and patient education regarding RDA.** 3. **Know the fat-soluble vitamins and their implications.** 4. **Know that excessive vitamin A intake is teratogenic.** 5. Understand the potential for contamination of unregulated supplements. 6. **Define and apply the term: Active pharmaceutical ingredients as it relates to unregulated supplements.** May have API that are unlabeled and can cause harm (sildenafil, NSAIDs, appetite suppressant)