DAPH 800: Pharmacology for the APN - Syllabus PDF

DAPH 800: Pharmacology for the APN Michael D. Gooch DNP, APRN, FAASTN, FAANP, FAEN Faculty - MTSA Assistant Professor - VUSN Syllabus Class on Wednesdays Exams Live and Pre-recorded lectures 1/29 Case Studies & Review 2/19 Sess...

DAPH 800: Pharmacology for the APN Michael D. Gooch DNP, APRN, FAASTN, FAANP, FAEN Faculty - MTSA Assistant Professor - VUSN Syllabus Class on Wednesdays Exams Live and Pre-recorded lectures 1/29 Case Studies & Review 2/19 Sessions 3/5 Quizzes 3/26 8am Sun - 7am Wed CT Total 9 4/15 Lowest grade dropped  Grading Nine quizzes (lowest grade dropped) and five examinations will be given Questions will be taken from lecture and will consist of multiple choice and True/False questions. Questions will focus on knowledge recall, analysis, synthesis, and clinical application. Please refer to the MTSA Student Handbook for the Testing Policy and Procedure. The final course grade will be determined by the following method: Quizzes 50% Exams 50% Total 100%  Late Work Students are expected to complete all work during the scheduled testing period. Any student who does not complete a quiz or exam at the specific time will receive a “0” for the test, unless they have received prior approval from the course coordinator. If a student absolutely cannot take a quiz or an examination on the date/time it is scheduled, he or she must make arrangements in advance with the course coordinator to take the quiz or exam at an alternative time. The request to take a quiz or exam at an alternative day/time must be submitted via email at least 72 business hours before the scheduled day/time. The request must state the reason for requesting an alternative date/time. Emergencies are handled on a case by case basis. Prescriptive Authority Varies by state Granted by State Boards of Nursing and/or Medicine Most Require a graduate nursing degree Most Require a national APRN certification Pharmacology Education Requirement Importance of Collaborative Practice Physicians, Pharmacists, other clinicians  CRNA Independent Practice https://www.ncsbn.org/nursing-regulation/practice/aprn/aprn-consensus-implementation-status/crna-independent-practice-map.page  CRNA Independent Prescribing https://www.ncsbn.org/nursing-regulation/practice/aprn/aprn-consensus-implementation-status/crna-independent-prescribing-map.page Tennessee Requirements 3 credit hour Pharmacology Course Certificate of Fitness to Prescribe Temporary Certificate Supervising Physician Prescriptive Formulary and Protocols Must have an assessment and documentation for all patients that you prescribe medications To renew: 2 hr of CE on controlled substances Medication Labeling FDA approved The condition or population in which the medication was approved for “Off-label” use When a medication is used legally to treat a condition or population in which it was not approved by the FDA Based on evidence, expert opinion Manufacturers can not market off-label use Food and Drug Administration The FDA regulates Approval process for new drugs or new indications Official labeling Surveillance of adverse drug events Methods of manufacture and distribution Medical devices Advertising of prescription medications The FDA does not regulate prescribing REMS Risk Evaluation and Mitigation Strategies Required for known or potential high risk medications May be required before or after initial approval, to ensure the benefits outweigh the risks Serious infection, hepatic insult, birth defects, severe anaphylaxis All must include a Communication Plan to inform prescribers, pharmacists, and patients of the risk and resources available REMS Some may require an Elements to Assure Safe Use (ETASU) May require special certification or training for the prescriber Medication may only be administered in certain facilities May require special monitoring or labs before and during therapy May require special registration of the patient REMS Examples of Medications All Opioid Analgesics Phentermine/topiramate (Qsymia) Isotretinoin Clozapine Mifepristone Various immunological and chemotherapeutic agents www.accessdata.fda.gov/scripts/cder/rems/index.cfm Terminology OTC Medications Brand vs. Generic Only a minimal difference in bioavailability is allowed Legend Medications Biosimilars A biologic product that is very similar to an approved biologic product with no clinically meaningful differences in safety, purity, or potency Differences in clinically inactive compounds is allowed Must have the same MOA, route of administration, dosage form, and strength Controlled Substances Authority & Requirements may vary state to state DEA Number required for prescriptions but not inpatient orders E-prescribing of controlled substances (EPCS) is now required, requires use of software which meets state and DEA standards, waivers do exist Requires actual signature in ink, if on paper Scheduling may vary state to state Should be used for legitimate medical purposes  Control Substance Schedules I – no medical use, very high abuse potential II – very high abuse potential, very high risk for physiologic and psychological dependency, no refills, no phone prescriptions (except emergencies), may have other restrictions III – moderate abuse potential, moderate to low physiological but high psychological dependence, max of 5 refills/6 months IV – low abuse potential, limited physiologic dependence, may cause psychological dependence, max of 5 refills/6 months V – very low abuse potential, usually contains small quantities of substances, no limitation on number of refills, may not require a prescription or be scheduled in some states  Control Substance Schedules I – LSD, heroin, marijuana (THC), ecstasy (MDMA), GHB II – PCP, morphine, methadone, hydromorphone, oxycodone, fentanyl, medical cocaine, codeine, hydrocodone, some stimulants/amphetamines, some barbiturates III – codeine containing meds, buprenorphine, ketamine, anabolic steroids, some barbiturates, some stimulants, dronabinol (Marinol) IV – tramadol (Ultram), benzodiazepines, non-benzo sleep aides, carisoprodol (Soma), opioid agonist-antagonists V – low dose codeine in antitussives, diphenoxylate (Lomotil), pregabalin (Lyrica); gabapentin (Neurontin) and pseudoephedrine in some states Controlled Substance Monitoring Programs  Requirements for Prescriptions Tamper Resistant Pre-printed Paper/Pad Computerized or Hand Written in Ink Name, Address, and Phone Number of Practice Name of Prescriber and Credentials Name of collaborating physician, if required by state State License Number and/or NPI number, if required by state DEA number required for controlled substances Life of the Rx No federal time limit, some states may place limits Prescriptions are only valid in the state(s) in which the prescriber is licensed Max of 3 Rx for the same Schedule II at the same time Must assess abuse risk Must indicate on the Rx the earliest it can be filled Must be allowed by state law  Parts of the Prescription Superscription Date Written - Do NOT post date 2 Patient Identifiers – full name and DOB Address required if a Controlled Substance Rx (recipe, to take) Inscription Name of medication (Generic vs. Brand) and dose Subscription Medication formulation and number to be dispensed Requirements for Prescriptions Sig (Signa: to direct, to write, to label) Directions to the patient Example: Take 1 tablet by mouth once daily for blood pressure Take 1 tablet by mouth every 4 hrs as needed for nausea and/or vomiting Number of Refills Printed Name and Signature Line Dispense as Written (DAW) Substitution Allowed Example Example Example Considerations Legibility Pregnancy Status Limit/Avoid Cultural Considerations Abbreviations Medication Cost Patient’s Allergies, Limit Phone and Verbal Medication Orders Reconciliation, OTC and Informed Consent herbals Prescribing for Self, Possible Interactions Friends, and Family and Disease Processes Patient Centered Prescribing Focuses on the patient’s needs, values, wishes Shared decision making Use open-ended questions, listen without interrupting, use appropriate words and language Ask for feedback, be open to suggestions Set goals and boundaries Goals of Therapy Curative Symptom Management Replacing hormones or substances Long term management I Can PresCribE A Drug Indication Contraindications Precautions Cost/Compliance Efficacy Adverse effects Dose/Duration/Direction Abbreviations to Avoid MS or MSO4 qd → daily MG++ U → unit 1.0 μg → mcg 0.4 cc → ml tsp → 5 ml tbsp → 15 ml Management Problems Noncompliance May result from cost, patient’s understanding of the disease or benefit of medications, side effects Determine the cause and address Drug Seeking Behaviors Those who seek meds for their own abuse or for others to abuse Utilize monitoring programs For Pain Management Insist on a one provider-one pharmacy relationship Provider-Patient contract Practice Prescribe hydrocodone-acetaminophen 5/325 mg for Mary Smith DOB 5/2/80, who presents with an ankle injury. Recommendations: 1 tablet every 6 hrs as needed for pain for 5 days Name: DOB: Rx: Refill: Practice Refill Henry Jones’s hydrochlorothiazide prescription for hypertension. He takes 25 mg a day and gets a 3 month supply with enough refills for a year. DOB 6/30/50 Name: DOB: Rx: Refill: Practice Prescribe hydrocodone/acetaminophen liquid for Brandy Mitchell, DOB 9/15/53, she has NKDA. Recommendations: 5 mg every 4 hrs as needed for pain, prescribe 3 days Comes 7.5mg/325mg per 15 ml Due to prior CVA, meds are given via G tube Name: DOB: Rx: Refill: Inpatient Orders Written vs. Electronic Consider a time frame or limit for orders Ceftriaxone 1 gm IVPB daily x 5 days Morphine 4 mg IVP every 4hrs PRN for pain x 3 days Normal Saline at 100ml/hr x 2 days (or 3 liters) Remember home meds – Medication Reconciliation Definitions Pharmacology: study or knowledge of drug actions Pharmacy: the safe practice of compounding, utilizing, and dispensing medicines Pharmacotherapeutics: the study of the therapeutic use and effects of medications Pharmacogenomics: the study of how genes affect a patient’s response to medications Definitions Pharmacodynamics: what the drug does to the body Pharmacokinetics: what the body does to the drug, how the drug moves through the body Absorption Distribution Metabolism (Biotransformation) Elimination Question What property is required for a drug to move through the body? A. A negative electric charge B. A transport protein C. The ability to cross membranes D. A selective affinity Question When ordering an oral medication, you know that only a portion of the dose actually reaches systemic circulation because of what process? A. Hepatic First Pass B. Renal Biotransformation C. Protein Binding D. Receptor Affinity Question A patient reports becoming “immune” to a medication because it no longer works to alleviate symptoms. You recognize that this decreased effectiveness is most likely caused by: A. Antagonists produced by the body that compete with the drug for receptor sites. B. Decreased selectivity of receptor sites, resulting in a variety of effects. C. Desensitization of receptor sites by continual exposure to the drug. D. Synthesis of more receptor sites in response to the medication. Pharmacodynamics Receptors (macromolecules) The component of the cell or organism that the medication binds with to achieve its therapeutic effect The receptors’ affinity to a medication determines the needed dose or concentration Chemical structure, shape, and charge of the medication determines where and how it will bind to the receptor(s) Types of Receptors 1: Cell Membrane embedded enzymes 2: Gated ion channels 3: G protein coupled receptors 4: Intracellular Receptors (Transcription factors) Receptor Terms Sensitivity The receptors response to the medication Altered by other medications or endogenous agents Selectivity The medication’s ability to prefer/select one receptor over another Specificity The medication’s ability to bind with only one specific receptor Receptor Terms Affinity The strength of attraction between the receptor and medication The degree to which the medication is attracted to the receptor Intrinsic Activity The ability of the medication to bind to and activate the receptor Terminology Efficacy The degree to which a medication treats a condition Maximum Efficacy The degree to which the medication causes its maximum therapeutic effect Potency Determined using (EC50) - the amount of the medication needed to produce 50% of the maximum response Used to compare medications in the same class A medication is considered potent when it has a high intrinsic activity at a low dose Receptor Terms Agonist (mimic and activate) A medication that binds to the same receptor as naturally occurring substances and activates the receptor and causes some type of process to occur Strong (full) – high intrinsic activity → maximal response possible Partial – moderate intrinsic activity → submaximal response  Receptor Terms Antagonist (blocks) A medication that prevents the stimulation of that receptor or cell by another medication or naturally occurring substance Competitive vs. Non-competitive Reversible vs. Irreversible Active vs. Allosteric Chemical (nonreceptor) Medications bind directly to other medications Physiological (nonreceptor) Occurs between regulatory pathways Antagonists Summary Receptor Terms Desensitization Receptors become less responsive over time Homologous – single type of receptor Heterologous – two or more types of receptors Inactivation Loss of the ability of the receptors to respond Receptors are removed or the signaling activity is blocked Receptor Terms Up-regulation Number of cell receptors may increase, may result from prolonged antagonism Down-regulation Number of cell receptors may decrease, usually related to prolonged stimulation Adverse Drug Reactions (ADRs) or Undesired Effects FDA MedWatch www.fda.gov/Safety/MedWatch Serious and unexpected events can be reported by clinicians and consumers Type A – Predictable (intrinsic) Side Effects – known effects Toxic Effects – related to excess medication levels Adverse Drug Reactions (ADRs) or Undesired Effects Type B – Unpredictable Hypersensitivity - < 10% of ADRs Anaphylaxis – antigen-antibody complex reaction, IgE mediated, Type I Hypersensitivity, occurs rapidly Serum Sickness – immune complex activation, IgG mediated , Type III Hypersensitivity, may take up to 7 days to occur Idiosyncratic Reaction – unusual, rare medication reaction, genetic related Other ADRs Paradoxical effects Effect is opposite of the intended response Iatrogenic effects Ill effects from the medication Carcinogenic effects Teratogenic effects Pharmacodynamic Terms Contraindications – known reasons to not use a medication Tolerance – decreased response to the medication over time related to increased clearance, down regulation, or decreased receptor sensitivity Dependence – physiologic need for this medication to function normally Withdrawal – symptoms experienced when a medication is discontinued Pharmacodynamic Terms Cross Tolerance/Dependence – develops in similar medication classes Tachyphylaxis – rapidly develops tolerance and decreased benefit Placebo Effect – patient experiences benefit of a non-medication, probably psychological