Module 1 521 Pharm.docx - PDF

Legal Issues - Why should APRNs have full prescriptive authority? 1. APRNs are educated to practice and prescribe independently without supervision; however, some state laws require that they practice in collaboration with or under the supervision of a physician...

Legal Issues - Why should APRNs have full prescriptive authority? 1. APRNs are educated to practice and prescribe independently without supervision; however, some state laws require that they practice in collaboration with or under the supervision of a physician 2. Advanced practice providers complete rigorous programs of study, largely in accredited programs that meet stringent national standards. 3. National examinations validate the ability to provide safe and competent care. Licensure ensures that providers comply with standards of practice that promote public health and safety. In short, advanced practice providers are prepared to fully implement the advanced practice role in their profession. 4. By 2025, the shortage of physicians will range between 46,100 and 90,400. - Who would benefit from this? 5. Those who have limited access to providers. 6. Taxpayers 7. Those covered by federal programs 8. APRNs working across state lines Controlled Substances Classification - What is the definition of each schedule? Can you provide an example drug that fits in each schedule? 9. [Schedule I: ] - The substances in this schedule are those that have no accepted medical use in the United States and have a high abuse potential. - Examples are heroin, marijuana, LSD, MDMA 10. [Schedule II:] - The substances in this schedule have a high abuse potential with severe psychic or physical dependence liability. - Consists of certain narcotic, stimulant and depressant drugs. - Examples are opium, morphine, codeine, Dilaudid, methadone, Demerol, and hydrocodone. 11. [Schedule III:] - The substances listed in this schedule have an abuse potential less than those in Schedules I and II, and include compounds containing limited quantities of certain narcotic drugs - Examples include products containing no more than 90 mg of codeine per dosage unit such as Tylenol with Codeine, buprenorphine (Suboxone®). 12. [Schedule IV:] - The substances in this schedule have an abuse potential less than those listed in Schedule III - Examples include barbital, phenobarbital, chloral hydrate, clorazepate (Tranxene), alprazolam (Xanax), Quazepam (Dormalin). 13. [Schedule V: ] - The substances in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant used for diarrhea, cough, and pain. - Examples are buprenorphine and propylhexedrine. Prescribing Medication - What components are necessary when writing a prescription? 14. Prescriber name, license number, and contact information 15. Prescriber U.S. Drug Enforcement Administration (DEA) number, if applicable 16. National Provider Identifier (NPI) number 17. Patient name and date of birth 18. Patient allergies 19. Name of medication 20. Indication of medication (e.g., atenolol for hypertension) 21. Medication concentration if liquid preparation (500 mg/mL) 22. Dose, Route, and frequency of medication (12.5 mg by mouth once daily) (Sig) 23. Number of tablets or capsules to dispense 24. Number of refills 25. If ok to use generic forms of drug - What factors should the APRN consider when prescribing medications? 26. A through History and Physical 27. Cost 28. Guidelines 29. Allergies 30. Availability 31. Side Effects 32. Interactions 33. Liver and Renal Function 34. Monitoring Parameters 35. Special Populations - What factors should the APRN considered when refilling medications? 36. Is this a newer medication? 37. Am I changing the dose or frequency? 38. Am I adding a new medication to their regimen? 39. Is the patient having side effects? 40. When was the last time I saw this patient? 41. Do I need ot see them again before refilling? 42. When do I plan to follow up? 43. Is this a schedule II medication? - What is the benefit of collaboration during drug selection and prescription writing? 44. **Pharmacist/Infectious disease MDs can help with additional information regarding drug interactions.** 45. **They have firsthand knowledge of formulary.** 46. **They can assist with dosing.** Patient Education - What information should be included in patient education material? 47. \(1) medication name, 48. \(2) purpose, 49. \(3) dosing regimen, 50. \(4) administration, 51. \(5) adverse effects, 52. \(6) any special storage needs, 53. \(7) associated laboratory testing, 54. \(8) food or drug interactions, 55. \(9) duration of therapy. - Why is patient education so important? 56. Probably no other provider action influences the patient\'s commitment to carry out a medication plan more than medication education. 57. This not only provides an opportunity to explain the importance of the medication but also allows the provider to dispel rumors about medications that often lead to therapy failures. 58. Moreover, education reduces medication errors by empowering patients with accurate information and clear guidelines. Promotion of Safe Outcomes (drug monitoring and adherence) - What is the best way to promote positive outcomes with drug therapy? 59. Ensuring positive outcomes requires establishing a medication education plan, monitoring positive and negative patient responses, identifying and addressing issues of nonadherence, and managing the patient\'s complete medication regimen. - Why do we monitor drug therapy? 60. determining therapeutic dosage, 61. evaluating medication adequacy, 62. \(3) identifying adverse effects. - What are reasons that patient's will not take their medications? 63. Forgetfulness 64. Lack of planning 65. Cost 66. Dissatisfaction 67. Altered Dosing - How can you address these as a provider? 68. Patients need adequate drug education to take drugs correctly and to avoid complications associated with therapy. 69. Monitoring provides a method of ensuring safe and effective therapy. 70. Promoting adherence, by addressing common causes of nonadherence proactively, can ensure ongoing therapy without interruption. 71. Scheduled medication reviews with the intent to optimize medication regimens, based on patient experiences and needs, can help promote positive outcomes. Pharmacokinetics (is the study of drug movement throughout the body.a There are four basic pharmacokinetic processes: absorption, distribution, metabolism, and excretion), Pharmacodynamics (is the study of the biochemical and physiologic effects of drugs on the body and the molecular mechanisms by which those effects are produced)., and Drug Interactions (drug interaction occurs when another substance alters a drug\'s efficacy, effects, or safety. These are usually the result of interactions with other drugs, food, or supplements.) - Be able to define each of the four processes in Pharmacokinetics: 72. Absorption: defined as the movement of a drug from its site of administration into the systemic circulation. - The rate of absorption determines how soon effects will begin. - The amount of absorption helps determine how intense effects will be. - Two other terms associated with absorption are chemical equivalence and bioavailability 73. Distribution: is defined as the movement of drugs from the systemic circulation to the site of drug action. - Drug distribution is determined by three major factors: - blood flow to tissues, - the ability of a drug to exit the vascular system, and, - to a lesser extent, the ability of a drug to enter cells. 74. Metabolism: also known as biotransformation, is defined as the enzymatic alteration of drug structure. - Most drug metabolism takes place in the liver. - is performed by the hepatic microsomal enzyme system, also known as the P450 system. - The term P450 refers to cytochrome P450, a key component of this enzyme system. 75. Excretion: defined as the removal of drugs from the body. - Drugs and their metabolites can exit the body in urine, bile, sweat, saliva, breast milk, and expired air. - The most important organ for drug excretion is the kidney. - What is bioavailability? refers to the amount of an active drug that reaches the systemic circulation from its site of administration. - What are some factors that can affect bioavailability? Factors such as tablet disintegration time, enteric coatings, and sustained-release formulations can alter bioavailability and can thereby make drug responses variable - Explain how the same drug manufactured by different drug companies can have different absorption rates. Different formulations of the same drug can vary in bioavailability. Factors such as tablet disintegration time, enteric coatings, and sustained-release formulations can alter bioavailability and can thereby make drug responses variable. - What happens when a patient takes a drug that is metabolized by P450 enzymes if an inducing OR an inhibiting drug is added to the current drug regimen? When a patient takes a drug that is metabolized by **cytochrome P450 enzymes** (CYP450) and a second drug is added that either **induces** or **inhibits** the activity of these enzymes, it can significantly impact the metabolism of the original drug. This can lead to changes in drug levels and effects, and potentially result in adverse outcomes or therapeutic failure. **1. Enzyme Induction:** - If the added drug is an **enzyme inducer**, it will increase the activity of the CYP450 enzymes. This leads to: 76. **Faster metabolism** of the original drug. 77. **Decreased plasma levels** of the original drug, because it is broken down more quickly. 78. **Reduced therapeutic effect** of the original drug, as lower concentrations reach the site of action. 79. **Possible therapeutic failure** if the drug levels fall below the therapeutic range, making the drug less effective. - **Example**: If a patient is taking a medication like warfarin (an anticoagulant), which is metabolized by CYP450 enzymes, and an enzyme inducer like rifampin (an antibiotic) is added, warfarin will be metabolized more quickly, leading to lower drug levels and reduced anticoagulant effects. This could increase the risk of blood clotting. - **2. Enzyme Inhibition:** - If the added drug is an **enzyme inhibitor**, it will decrease the activity of the CYP450 enzymes. This leads to: 80. **Slower metabolism** of the original drug. 81. **Increased plasma levels** of the original drug, because it is broken down more slowly. 82. **Enhanced therapeutic or toxic effects** of the original drug, as higher concentrations accumulate. 83. **Risk of toxicity** if drug levels rise too high, exceeding the therapeutic window. - **Example**: If a patient is taking a drug like simvastatin (for cholesterol control), which is metabolized by CYP450 enzymes, and an enzyme inhibitor like ketoconazole (an antifungal) is added, the simvastatin will be metabolized more slowly, leading to increased drug levels. This can heighten the risk of side effects such as muscle damage or liver toxicity. - **Clinical Implications:** **Inducers** decrease drug levels: The original drug may need a higher dose to maintain its therapeutic effect. **Inhibitors** increase drug levels: The original drug may need a lower dose to avoid toxicity. - What is the difference between an agonist and antagonist? 84. **Agonists:** molecules that **ACTIVATE** receptors. Examples include neurotransmitters, hormones, and other endogenous regulators. Drugs that are agonists, bind to receptors and mimic the action of the body. Agonists have both affinity and high intrinsic activity. - Example: Dobutamine is a drug that mimics the action of NE at receptors on the heart à increased HR and force of contraction 85. **Antagonists: Prevent receptor activation** by endogenous regulatory molecules and drugs. - Has affinity for a receptor, but no intrinsic activity à - it can attach but it can't activate the receptor. - These work by **PREVENTING** the bodies response. - Example: antihistamines are histamine receptor antagonists that suppress allergy symptoms by binding to receptors for histamine, preventing activation of these receptors by histamine released in response to allergens. 86. **Partial Agonists:** have moderate intrinsic activity. These can act as both antagonist and agonist. - Some drugs do not involve receptors, but work through physical or chemical interactions. - Examples include antacids, antiseptics, saline laxatives. What drug interaction clinical pearl did you learn from the lecture? - **The safest practice is to check for drug interactions in a reliable software application.** Adverse Drug Reactions - An ADR, as defined by the World Health Organization, is "any noxious, unintended, and undesired effect that occurs at normal drug doses." - Range from mildly annoying to life threatening. - Mild examples: nausea, itching, rash, drowsiness - Severe examples: neutropenia, liver injury, cardiac dysrhythmias, anaphylaxis, and hemorrhage What are ways to minimize adverse drug reactions? - Monitor liver, kidney, and bone marrow function by obtaining lab work - Monitor for signs and symptoms - FDA special alerts - Medication Guide (next slide): FDA approved medication education for patients - Black Boxed Warning: Strongest safety warning a drug can carry. These drugs require a MedGuide [Risk Evaluation and Mitigation Strategy (REMS)](https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm): plan to minimize drug-induced harm. For most drugs, MedGuide is all that is needed. - How do you handle a patient complaint about a side effect of a medication? 87. Did symptoms appear shortly after the drug was first used? 88. Did symptoms abate when the drug was discontinued? 89. Did symptoms reappear when the drug was reinstituted? 90. Is the illness itself sufficient to explain the event? 91. Are other drugs in the regimen sufficient to explain the event? Because newly released drugs may have yet unreported adverse effects, you should be alert for unusual responses when prescribing new drugs. If the patient develops new symptoms, it is wise to suspect that the drug may be responsible---even if the symptoms are not described in the literature. It is good practice to initially check post-market drug evaluations at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htm to determine whether serious problems have been reported. - Medication Errors - What factors contribute to medication errors? 92. **Prescribing Practices** - Inappropriate drug selection - Error in drug dosage - Lack of clear instructions - Illegible writing 93. **Oversight** - Failure to keep an up-to-date medication list - Failure to continue or discontinue medications - Absence of medication reconciliation 94. **Communication** - Inadequate or unclear instructions - Failure to verify drugs that sound alike - Inadequate patient education - How can a provider minimize the risk for medication errors? 95. **Prescribing Practices** - **Inappropriate drug selection** - Verify that the drug selected is the drug intended. (See Table 5.4 for a list of drugs that look or sound like other drugs.) - Drug information changes frequently; make sure that drug references are authoritative and up to date. - Verify allergies when ordering new medications. Display allergies prominently in the patient record. - Check for interactions of new medications against all currently prescribed medications, over-the-counter medications, herbal remedies, nutritional supplements, and recreational drugs that the patient is taking. Authoritative drug interaction application software is recommended. - Verify that patients can afford the medication; otherwise, this increases the likelihood of errors due to taking subtherapeutic doses, if filled at all. - Consider individualized patient factors (e.g., age, pregnancy, comorbidities) when selecting the most appropriate drug. - Consider whether drug therapy is necessary; use nonpharmacologic interventions when practical to do so. 96. **Error in drug dosage** - Verify unit of measure (e.g., milligram vs. microgram). - Verify height and weight and verify unit of measure (e.g., kilograms vs. pounds) for dosage calculations. - Verify decimal placement; follow the ISMP recommendations in Table 5.5. 97. **Lack of clear labeling instructions** - Incorporate ISMP-recommended substitutions for any error-prone abbreviations. (See Table 5.5.) - Write precise and detailed instructions. Avoid "Take as directed" and similar nonspecific labeling. - Request large font labeling for patients who have difficulty reading small print. 98. **Illegible writing** - Use print instead of cursive writing. - Check spelling, placement of decimals, and clarity of numerals. - Convert to computerized provider order entry at earliest possibility. 99. **Oversight** - Failure to keep an up-to-date medication list - When taking a medication history, assess not only how a medication is prescribed to be taken but also how the patient actually takes it in order to identify discrepancies and why they occur. - Include dates when drugs are stopped, started, or altered, as well as the reasons for these changes. 100. **Failure to continue/discontinue medications** - Update patient medications at every visit and compare this list with prior lists to identify drugs that should have been continued or that should be discontinued or weaned. - Avoid polypharmacy when possible; determine whether all drugs prescribed are necessary and if new drugs are truly needed. 101. **Absence of medication reconciliation** - Medication reconciliation should occur any time there is a transfer of patients to another provider or to another facility (see Box 5.2). - Develop interprofessional relationships to facilitate communication regarding reconciliation needs. 102. **Communication** - Inadequate or unclear instructions - Reserve verbal orders for emergency situations. - When verbal orders are required, have the nurse repeat them to ensure that they are understood and are what you intended. 103. **Inadequate patient education** - Develop strong collaborative partnerships with patients (or their caretakers) and consider their perspectives and preferences when making treatment decisions. - Verify patient understanding of teaching by repeating instructions or demonstrating procedures. - Provide handouts to reinforce teaching. These should be written at the 5th grade level or, at most, the 8th grade level. - Individual Drug Responses - Think about patient scenarios where each of the individual variations in drug responses might occur. 104. Prescribing and managing drug therapy would be much simpler if all patients responded to medications in the same way. 105. The reality is that drugs' effects vary widely among individuals. 106. Factors such as age, gender, body size, genetics, and co-morbidities play a large role in individual variation in drug responses. 107. Understanding these factors and anticipating how they affect drug responses can inform prescribing practices and guide wise drug management so that therapy is safer, and outcomes are improved. - Genetic Considerations - What is the purpose of genetic testing? 108. Genetic testing is recommended to identify how a patient will respond to a drug and not to design a drug specific to an individual. 109. The National Institutes of Health define pharmacogenomics as the study of how genes affect a person\'s response to drugs. 110. The purpose of pharmacogenomics is to combine the sciences of genomics and pharmacology to provide individualized, targeted, safe drug therapies to patients. 111. A patient\'s unique genetic makeup can lead to drug responses that are qualitatively and quantitatively different from those of the population at large. 112. Adverse effects and therapeutic effects may be increased or reduced. - Provide examples of genetic variations that affect drug responses. 113. Gene characteristics are known as biomarkers - A biomarker is a measurable substance that, when presented in an organism, indicates the presence of a specific phenomenon. - This tells practitioners about the existence of genetic variation. 114. Examples of some genetic variation\'s effects on drug responses - CYP2D6 variant: - Tamoxifen: - reduced therapeutic effect - women with inadequate CYP2D6 activity cannot convert tamoxifen to its active form, preventing protection from breast cancer. - HER2 overexpression: - Trastuzumab (Herceptin): - increased therapeutic effects: - Herceptin only acts against breast cancers that overexpress HER2. - Drug Therapy Across the lifespan (pregnancy, breastfeeding, older adults) - When are pregnant women most susceptible to teratogenic drugs? 115. **Gross malformations are produced by exposure to teratogens** during the **embryonic period** (roughly **[the first trimester]**). - This is the time when the basic shape of internal organs and other structures is being established. - Because the fetus is especially vulnerable during the embryonic period, pregnant patients must take special care to avoid teratogen exposure during this time. - Only a few drugs are considered proven teratogens. Drugs whose teratogenicity has been documented (or at least is highly suspected) are listed in the chart. - Lack of proof of teratogenicity does not mean that a drug is safe---it only means that the available data are insufficient to make a definitive judgment. - Conversely, proof of teratogenicity does not mean that every exposure will result in a congenital anomaly. - With most teratogens, the risk for malformation after exposure is only about 10%. - What are ways to minimize drug concentrations in breast milk? 116. Dosing: - Dosing immediately after breastfeeding (to minimize drug concentrations in milk at the next feeding) 117. Avoiding: - Avoiding drugs that have a long half-life - Avoiding sustained-release formulations 118. Choosing: - Choosing drugs that tend to be excluded from milk - Choosing drugs that are least likely to affect the infant - Drugs that are lipid soluble enter breast milk readily, whereas drugs that are ionized, highly polar, or protein bound tend to be excluded - [LactMed](https://www.ncbi.nlm.nih.gov/books/NBK501922/) is a comprehensive searchable site that provides the most current information on prescription and nonprescription drugs and their effects on breastfed infants and children - What changes occur in organ function of older adults? 119. Altered pharmacokinetics (secondary to organ system degeneration) 120. Multiple and severe illnesses 121. Multidrug therapy 122. Poor adherence  - How would this effect medications? Reduced kidney function 123. Decreased renal function impairs drug clearance, leading to potential drug accumulation and increased risk of toxicity. 124. Serum creatinine levels do not accurately reflect kidney function in older adults **because lean muscle mass (**which is the source of creatinine in serum) declines and may be low even with reduced kidney function. - How do you calculate GFR? - *[It is calculated by a formula using creatine clearance, sex, height and weight.]* 125. Glomerular filtration rate (GFR) is the best overall index of kidney function. Normal GFR varies according to age, sex, and body size, and declines with age. 126. National Kidney foundation offers a GFR calculator ([*https://www.kidney.org/professionals/gfr\_calculator*](https://www.kidney.org/professionals/gfr_calculator)) - Beers Criteria - What is this and why would you use it? - (Originally developed by Mark H. Beers in 1991, continue to be used by the American Geriatrics Society (AGS) to provide guidance regarding medications that should be avoided in most older patients or in certain situations.) - The criteria are organized into five categories: 127. [Medications to avoid] - These medications should be avoided by most older adults, except in hospice or palliative care settings. 128. [Medications to avoid with certain health conditions] - These medications should be avoided by older adults with specific health conditions. 129. [Medications to use with caution] - These medications should be used with caution because of the potential for harmful side effects. 130. [Medications to avoid due to drug interactions] - These medications should be avoided because they can cause harmful drug interactions when combined with other medications. 131. [Medications to adjust dosages for renal function] - These medications should be dosed differently or avoided by people with reduced kidney function. - Provide an example of when applying this information when prescribing medications would be helpful. 132. Pain control for moderate to severe pain in an older adult. Demoerol should be avoided because it is not ffetive a at normal doses and can cause neurotoxicity, confusion and delirium. 133. Consider instead, Morphine, Oxycodone, or hydrocodone.