The Nursing Process and Drug Therapy

1. The Nursing Process and Drug Therapy

2. The Nursing Process (cont'd) Assessment Nursing diagnosis Planning (with outcome criteria) Implementation Evaluation Let�s review how the nursing process applies to the pharmacology of nursing.Let�s review how the nursing process applies to the pharmacology of nursing.

3. The �Six Rights� Right drug Right dose Right time Right route Right patient Right documentation Nurses learn the basic five rights of medication administration early on in their education. It is important that we not forget them as we progress in our learning. What step did the nurses for get or leave out when they made that heparin mistake with the twin babies�������. Many sources cite a sixth right of medication administration � right documentation. This is part of what we call constant system analysis.Nurses learn the basic five rights of medication administration early on in their education. It is important that we not forget them as we progress in our learning. What step did the nurses for get or leave out when they made that heparin mistake with the twin babies�������. Many sources cite a sixth right of medication administration � right documentation. This is part of what we call constant system analysis.

4. Another �Right��Constant System Analysis A �double-check� The entire �system� of medication administration Ordering, dispensing, preparing, administering, documenting Involves the physician, nurse, nursing unit, pharmacy department, and patient education Constant system analysis is an ongoing process that has but one goal � elimination of medication errors. System analysis begins when the provider orders the medication. It continues when the pharmacist dispenses the medication, and culminates when the nurse prepares, administers and documents administration of the drug. System analysis includes client education, as well. It is important for the nurse to remember to utilize each medication administration time as an opportunity for teaching.Constant system analysis is an ongoing process that has but one goal � elimination of medication errors. System analysis begins when the provider orders the medication. It continues when the pharmacist dispenses the medication, and culminates when the nurse prepares, administers and documents administration of the drug. System analysis includes client education, as well. It is important for the nurse to remember to utilize each medication administration time as an opportunity for teaching.

5. Other �Rights� Proper circumstance Proper drug storage Accurate dosage calculation Accurate dosage preparation Careful checking of transcription of orders Patient safety The nurse must understand the importance of proper drug storage in order to maintain medications at their optimum potency. Some drugs must be refrigerated, some kept away from direct light, and some (narcotics) must be secured under double lock. Documentation of medication administration should only be completed after the client has taken the medication. If the nurse documents the medication as given and then the client refuses the medication, it is essentially a medication error. Calculation of drug dosages is the responsibility of the nurse. We will review the procedures for drug calculation a bit later. Dosage preparation involves pouring the medication or drawing it up in a syringe for administration. Some medications must be crushed and mixed with food or liquid for clients with difficulty swallowing. Transcription is an area that has a high potential for error. Most facilities are moving from handwritten orders to computer generated ones to reduce the error rate. Each of these interventions has patient safety as its goal.The nurse must understand the importance of proper drug storage in order to maintain medications at their optimum potency. Some drugs must be refrigerated, some kept away from direct light, and some (narcotics) must be secured under double lock. Documentation of medication administration should only be completed after the client has taken the medication. If the nurse documents the medication as given and then the client refuses the medication, it is essentially a medication error. Calculation of drug dosages is the responsibility of the nurse. We will review the procedures for drug calculation a bit later. Dosage preparation involves pouring the medication or drawing it up in a syringe for administration. Some medications must be crushed and mixed with food or liquid for clients with difficulty swallowing. Transcription is an area that has a high potential for error. Most facilities are moving from handwritten orders to computer generated ones to reduce the error rate. Each of these interventions has patient safety as its goal.

6. Other �Rights� (cont'd) Close consideration of special situations Prevention and reporting of medication errors Patient teaching Monitoring for therapeutic effects, side effects, toxic effects Refusal of medication

7. Evaluation � Ongoing part of the nursing process Determining the status of the goals and outcomes of care Monitoring the patient�s response to drug therapy Expected and unexpected responses During the evaluation phase of the process, the nurse must determine how much progress the client has made toward the previously determined goals. The nurse needs to ask: Is the medication doing what it was ordered to do? Is it doing it as well as expected? Are there any unexpected effects? Should the medication be changed, or continued as ordered?During the evaluation phase of the process, the nurse must determine how much progress the client has made toward the previously determined goals. The nurse needs to ask: Is the medication doing what it was ordered to do? Is it doing it as well as expected? Are there any unexpected effects? Should the medication be changed, or continued as ordered?

8. Pharmacologic Principles

9. Drug Names Chemical name Describes the drug�s chemical composition and molecular structure Generic name (nonproprietary name) Name given by the United States Adopted Name Council Trade name (proprietary name) The drug has a registered trademark; use of the name restricted by the drug�s patent owner (usually the manufacturer) Each drug has three given names. The chemical name describes the drug�s chemical makeup and its structure. The generic name, commonly seen in practice, is the name the drug has been given by the US Adopted Name Council. The trade name is the name by which most people know the drug. This name is given by the patent owner of the drug and has a registered trademark. Each drug has three given names. The chemical name describes the drug�s chemical makeup and its structure. The generic name, commonly seen in practice, is the name the drug has been given by the US Adopted Name Council. The trade name is the name by which most people know the drug. This name is given by the patent owner of the drug and has a registered trademark.

10. Drug Names (cont'd) Chemical name (+/-)-2-(p-isobutylphenyl) propionic acid Generic name ibuprofen Trade name Motrin�, Advil� Here�s an example of a drug�s three names.Here�s an example of a drug�s three names.

11. Figure�2-1 The chemical, generic, and trade names for the common analgesic ibuprofen are listed next to the chemical structure of the drug.

12. Pharmacologic Principles Pharmaceutics Pharmacokinetics Pharmacodynamics Pharmacotherapeutics Pharmacognosy There are five pharmacologic principles. We�ll discuss each one separately.There are five pharmacologic principles. We�ll discuss each one separately.

13. Pharmaceutics The study of how various drug forms influence pharmacokinetic and pharmacodynamic activities Pharmaceutics is the study of how various forms of a drug influence its pharmacokinetic and pharmacodynamic activities in the client�s body. It examines the difference between injectable medications, oral formulations such as capsules and tablets, and control-release medications.Pharmaceutics is the study of how various forms of a drug influence its pharmacokinetic and pharmacodynamic activities in the client�s body. It examines the difference between injectable medications, oral formulations such as capsules and tablets, and control-release medications.

14. Pharmacokinetics � The study of what the body does to the drug Absorption Distribution Metabolism Excretion It�s important to understand the difference between pharmacokinetics (drug movement) and pharmacodynamics (drug action). Pharmacokinetics involves how a drug is absorbed, distributed in the body, metabolized, and excreted.It�s important to understand the difference between pharmacokinetics (drug movement) and pharmacodynamics (drug action). Pharmacokinetics involves how a drug is absorbed, distributed in the body, metabolized, and excreted.

15. Pharmacodynamics � The study of what the drug does to the body The mechanism of drug actions in living tissues Pharmacodynamics examines how a drug effects living tissues within an organism. This is why we say to you, you have to know the action of the drug in the body what it does.Pharmacodynamics examines how a drug effects living tissues within an organism. This is why we say to you, you have to know the action of the drug in the body what it does.

16. Pharmacokinetics: Absorption The rate at which a drug leaves its site of administration, and the extent to which absorption occurs Bioavailability Bioequivalent Let�s talk about the phases of pharmacokinetics. The first phase is absorption. Absorption rate is the rate at which a drug leaves the site of its administration. Bioavailability measures the extent to which the drug is absorbed. When two drugs have the same bioavailability and same concentration of active ingredient, they are said to be bioequivalent. An example of this is brand name vs. generic medications. Let�s talk about the phases of pharmacokinetics. The first phase is absorption. Absorption rate is the rate at which a drug leaves the site of its administration. Bioavailability measures the extent to which the drug is absorbed. When two drugs have the same bioavailability and same concentration of active ingredient, they are said to be bioequivalent. An example of this is brand name vs. generic medications.

17. Factors That Affect Absorption Administration route of the drug Food or fluids administered with the drug Dosage formulation Status of the absorptive surface Rate of blood flow to the small intestine Acidity of the stomach Status of GI motility Many factors affect absorption � r Route of administration Food and fluids Dosage formulation Status of absorptive surface (GI mucosa, skin) Rate of blood flow to small intestine Stomach acidity (higher acidity breaks drugs down faster) Status of GI motility (how fast does the drug move through the body)Many factors affect absorption � r Route of administration Food and fluids Dosage formulation Status of absorptive surface (GI mucosa, skin) Rate of blood flow to small intestine Stomach acidity (higher acidity breaks drugs down faster) Status of GI motility (how fast does the drug move through the body)

18. Routes A drug�s route of administration affects the rate and extent of absorption of that drug Enteral (GI tract) Parenteral Topical Enteral administration of a drug requires the drug be broken down in the GI tract and moved through the system. Parenteral administration involves injecting the medication into the body. Topical application requires the medication be absorbed through the skin.Enteral administration of a drug requires the drug be broken down in the GI tract and moved through the system. Parenteral administration involves injecting the medication into the body. Topical application requires the medication be absorbed through the skin.

19. First-Pass Effect The metabolism of a drug and its passage from the liver into the circulation A drug given via the oral route may be extensively metabolized by the liver before reaching the systemic circulation (high first-pass effect) The same drug�given IV�bypasses the liver, preventing the first-pass effect from taking place, and more drug reaches the circulation A medication given orally must first pass through the liver before reaching the circulation. If a drug is given IV, the liver is bypassed and more drug reaches circulation/ more of the drug is bioavailable.A medication given orally must first pass through the liver before reaching the circulation. If a drug is given IV, the liver is bypassed and more drug reaches circulation/ more of the drug is bioavailable.

22. Metabolism(Also Known As Biotransformation) The biologic transformation of a drug into an inactive metabolite, a more soluble compound, or a more potent metabolite Liver (main organ) Kidneys Lungs Plasma Intestinal mucosa

23. Metabolism/Biotransformation (cont'd) Delayed drug metabolism results in: Accumulation of drugs Prolonged action of the drugs Stimulating drug metabolism causes: Diminished pharmacologic effects Delayed drug metabolism causes a build-up of drugs in the system and creates a prolonged action. If drug metabolism is stimulated, the drug is used up more quickly and has a decreased effect.Delayed drug metabolism causes a build-up of drugs in the system and creates a prolonged action. If drug metabolism is stimulated, the drug is used up more quickly and has a decreased effect.

24. Excretion The elimination of drugs from the body Kidneys (main organ) Liver Bowel Biliary excretion Enterohepatic circulation Most drugs are eliminated from the body in the urine. The liver also contributes to drug excretion. With biliary excretion, drugs are taken up by the liver, released into bile, and eliminated in the feces. With enterohepatic recirculation, drugs in the bile are reabsorbed into the bloodstream, returned to the liver, and secreted a second time into the bile.Most drugs are eliminated from the body in the urine. The liver also contributes to drug excretion. With biliary excretion, drugs are taken up by the liver, released into bile, and eliminated in the feces. With enterohepatic recirculation, drugs in the bile are reabsorbed into the bloodstream, returned to the liver, and secreted a second time into the bile.

25. Half-life The time it takes for one half of the original amount of a drug in the body to be removed A measure of the rate at which drugs are removed from the body A drug�s half-life is used to determine how often a drug must be administered in order to maintain its therapeutic level. Half-life measures the rate at which a drug is removed from the body. It measures the time it takes for half of the original drug concentration to be removed.A drug�s half-life is used to determine how often a drug must be administered in order to maintain its therapeutic level. Half-life measures the rate at which a drug is removed from the body. It measures the time it takes for half of the original drug concentration to be removed.

26. Onset, Peak, and Duration Onset The time it takes for the drug to elicit a therapeutic response Peak The time it takes for a drug to reach its maximum therapeutic response Duration The time a drug concentration is sufficient to elicit a therapeutic response It is important for the nurse to know the onset, peak, and duration of each drug. The onset is the time it takes for the drug to start working. The peak is the time the drug is at its most effective. The duration is the time that the drug lasts in the body.It is important for the nurse to know the onset, peak, and duration of each drug. The onset is the time it takes for the drug to start working. The peak is the time the drug is at its most effective. The duration is the time that the drug lasts in the body.

27. The Movement of Drugs Through the Body Drug actions The cellular processes involved in the drug and cell interaction Drug effect The physiologic reaction of the body to the drug

28. Ways Drugs Produce Therapeutic Effects Once the drug is at the site of action, it can modify the rate (increase or decrease) at which the cells or tissues function A drug cannot make a cell or tissue perform a function it was not designed to perform

29. Drugs work on the cells of the body by using a �lock and key� action. Drugs that fit completely into a cell�s receptor site are called agonists. Drugs that create a response, but don�t completely fit a cell�s receptor site are called antagonists. Drugs that slightly fit a cell�s receptor site, create a slight response and block other responses are called partial agonists or agonist-antagonists.Drugs work on the cells of the body by using a �lock and key� action. Drugs that fit completely into a cell�s receptor site are called agonists. Drugs that create a response, but don�t completely fit a cell�s receptor site are called antagonists. Drugs that slightly fit a cell�s receptor site, create a slight response and block other responses are called partial agonists or agonist-antagonists.

30. Pharmacotherapeutics: Types of Therapies Acute therapy Maintenance therapy Supplemental therapy Palliative therapy Supportive therapy Prophylactic therapy Empiric therapy Acute therapy drugs are used to sustain life or treat disease Maintenance therapy drugs are used to prevent the progression of chronic diseases, such as hypertension Supplemental drugs supply substances not available to the body, such as insulin for diabetic clients Drugs used for palliative therapy are used to maintain comfort Supportive drug therapy helps maintain body functions Prophylactic drugs help prevent illness and have scientific evidence to support their use Empiric drugs are used based on past experience with their actions rather than scientific evidenceAcute therapy drugs are used to sustain life or treat disease Maintenance therapy drugs are used to prevent the progression of chronic diseases, such as hypertension Supplemental drugs supply substances not available to the body, such as insulin for diabetic clients Drugs used for palliative therapy are used to maintain comfort Supportive drug therapy helps maintain body functions Prophylactic drugs help prevent illness and have scientific evidence to support their use Empiric drugs are used based on past experience with their actions rather than scientific evidence

31. Monitoring The effectiveness of the drug therapy must be evaluated One must be familiar with the drug�s: Intended therapeutic action (beneficial) Unintended but potential side effects (predictable, adverse reactions)

32. Other Drug-Related Effects Teratogenic Mutagenic Carcinogenic Teratogenic effects cause structural defects in a fetus. The nurse should check the pregnancy category of a medication to ensure that it is not a teratogen. Mutagenic drugs cause permanent changes in the genetic structure. Such changes can be caused by exposure to radiation or heavy metals. Carcinogenic drugs are known to cause cancer. Teratogenic effects cause structural defects in a fetus. The nurse should check the pregnancy category of a medication to ensure that it is not a teratogen. Mutagenic drugs cause permanent changes in the genetic structure. Such changes can be caused by exposure to radiation or heavy metals. Carcinogenic drugs are known to cause cancer.

33. Toxicology The study of poisons and unwanted responses to therapeutic agents Clinical toxicology provides information on the care of the poisoned client. The nurse the must prioritize the care of the poisoned client: - preserve vital functions - prevent absorption or increase rate of elimination * ipecac * activated charcoal * catharticsClinical toxicology provides information on the care of the poisoned client. The nurse the must prioritize the care of the poisoned client: - preserve vital functions - prevent absorption or increase rate of elimination * ipecac * activated charcoal * cathartics

35. Life Span Considerations

36. Life Span Considerations Pregnancy Breast-feeding Neonatal Pediatric Geriatric

37. Pregnancy First trimester is the period of greatest danger for drug-induced developmental defects Drugs diffuse across the placenta FDA pregnancy safety categories

38. Table 3-1 Pregnancy safety categories

39. Breast-feeding Breast-fed infants are at risk for exposure to drugs consumed by the mother Consider risk-to-benefit ratio

40. Table 3-2 Classification of young patients

41. Pediatric Considerations: Pharmacokinetics Absorption Gastric pH less acidic Gastric emptying is slowed Topical absorption faster through the skin Intramuscular absorption faster and irregular

42. Pediatric Considerations: Pharmacokinetics (cont'd) Distribution TBW (total body water) 70% to 80% in full-term infants, 85% in premature newborns, 64% in children 1 to 12 years of age Greater TBW means fat content is lower Decreased level of protein binding � immature liver Immature blood-brain barrier Total body water is high in full term infants. It decreases as a person ages. Water soluble drugs, therefore, are available in greater concentrations. There is a decreased level of protein binding because of the decreased production by the immature liver. This results in greater concentrations of medications in the body. An immature blood-brain barrier allows more drugs to enter the brain. For all these reasons, drug doses need to be lower for children. Total body water is high in full term infants. It decreases as a person ages. Water soluble drugs, therefore, are available in greater concentrations. There is a decreased level of protein binding because of the decreased production by the immature liver. This results in greater concentrations of medications in the body. An immature blood-brain barrier allows more drugs to enter the brain. For all these reasons, drug doses need to be lower for children.

43. Pediatric Considerations: Pharmacokinetics (cont'd) Metabolism Liver immature, does not produce enough microsomal enzymes Older children may have increased metabolism, requiring higher doses Other factors There are other factors that play a part in the metabolism of drugs in the pediatric population. The production of enzymes by the liver is less than in an adult. Genetic factors determine individual metabolic rates. Maternal exposure to substances that alter fetal development can affect the child�s ability to metabolize medications.There are other factors that play a part in the metabolism of drugs in the pediatric population. The production of enzymes by the liver is less than in an adult. Genetic factors determine individual metabolic rates. Maternal exposure to substances that alter fetal development can affect the child�s ability to metabolize medications.

44. Pediatric Considerations: Pharmacokinetics (cont'd) Excretion Kidney immaturity affects glomerular filtration rate and tubular secretion Decreased perfusion rate of the kidneys Kidneys in children have not developed the full filtration ability of the mature kidney. Decreased perfusion rate leads to decreased renal function, decreased ability of the kidney to concentrate urine, and decreased excretion of drugs.Kidneys in children have not developed the full filtration ability of the mature kidney. Decreased perfusion rate leads to decreased renal function, decreased ability of the kidney to concentrate urine, and decreased excretion of drugs.

45. Summary of Pediatric Considerations Skin is thin and permeable Stomach lacks acid to kill bacteria Lungs lack mucus barriers Body temperatures poorly regulated and dehydration occurs easily Liver and kidneys are immature, impairing drug metabolism and excretion

46. Methods of Dosage Calculation for Pediatric Patients Body weight dosage calculations Body surface area method There are several methods of calculating drug dosages for children. Dosages can be calculated by body weight or by body surface area. There are several methods of calculating drug dosages for children. Dosages can be calculated by body weight or by body surface area.

47. Geriatric Considerations Geriatric: older than age 65 Healthy People 2010: older than age 55 Use of OTC medications Polypharmacy The geriatric population uses the largest amount of medications of any population group. It is especially important for the nurse to review the OTC medications an older client uses, as they may interfere with prescription drugs ordered. Polypharmacy exists when two or more meds cause an interaction or adverse reaction, are used for the same purpose, or have no apparent clinical rationale for use Poly pharmacy is causes by: - Lack of information - Self-treatment - Multiple physicians - Use of folk remedies - Lack of communication with physicians - Overprescribing - Multiple chronic diseases needing meds The geriatric population uses the largest amount of medications of any population group. It is especially important for the nurse to review the OTC medications an older client uses, as they may interfere with prescription drugs ordered. Polypharmacy exists when two or more meds cause an interaction or adverse reaction, are used for the same purpose, or have no apparent clinical rationale for use Poly pharmacy is causes by: - Lack of information - Self-treatment - Multiple physicians - Use of folk remedies - Lack of communication with physicians - Overprescribing - Multiple chronic diseases needing meds

48. Table 3-4 Physiologic changes in the geriatric patient

49. Geriatric Considerations: Pharmacokinetics Absorption Gastric pH less acidic Slowed gastric emptying Movement through GI tract slower Reduced blood flow to the GI tract Reduced absorptive surface area due to flattened intestinal villi

50. Geriatric Considerations: Pharmacokinetics (cont'd) Distribution TBW percentages lower Fat content increased Decreased production of proteins by the liver, resulting in decreased protein binding of drugs

51. Geriatric Considerations: Pharmacokinetics (cont'd) Metabolism Aging liver produces less microsomal enzymes, affecting drug metabolism Reduced blood flow to the liver

52. Geriatric Considerations: Pharmacokinetics (cont'd) Excretion Decreased glomerular filtration rate Decreased number of intact nephrons

53. Geriatric Considerations: Problematic Medications Analgesics Anticoagulants Anticholinergics Antihypertensives Digoxin Sedatives and hypnotics Thiazide diuretics Analgesics � commonly cause confusion, constipation, urinary retention, nausea, vomiting, respiratory depression, decreased LOC, and falls Anticoagulants � major/minor bleeding, many drug interactions, dietary interactions Anticholinergics � blurred vision, dry mouth, constipation, confusion, urinary retention, tachycardia Antihypertensives � nausea, hypotension, diarrhea, bradycardia, heart failure, impotence Digoxin � visual disorders, dysrhythmias, hallucinations, weight loss Sedatives/Hypnotics � confusion, daytime sedation, ataxia, lethargy, forgetfulness, risk for falls Thiazide diuretics � electrolyte imbalance, rash, fatigue, leg cramps, dehydrationAnalgesics � commonly cause confusion, constipation, urinary retention, nausea, vomiting, respiratory depression, decreased LOC, and falls Anticoagulants � major/minor bleeding, many drug interactions, dietary interactions Anticholinergics � blurred vision, dry mouth, constipation, confusion, urinary retention, tachycardia Antihypertensives � nausea, hypotension, diarrhea, bradycardia, heart failure, impotence Digoxin � visual disorders, dysrhythmias, hallucinations, weight loss Sedatives/Hypnotics � confusion, daytime sedation, ataxia, lethargy, forgetfulness, risk for falls Thiazide diuretics � electrolyte imbalance, rash, fatigue, leg cramps, dehydration

54. Legal, Ethical, and CulturalConsiderations

55. U.S. Drug Legislation 1906: Federal Food and Drug Act 1912: Sherley Amendment (to the Federal Food and Drug Act of 1906) 1914: Harrison Narcotic Act 1938: Federal Food, Drug, and Cosmetic Act (revision of 1906 Act) 1906 � Federal Food & Drug Act � required manufacturers to list dangerous/addictive substances on the label; recognized US Pharmacopeia & National Formulary as printed standard reference for drugs 1912 � Sherley Amendment � prohibited fraudulent claims for drug products 1914 � Harrison Narcotic Act � established the term narcotic; regulated manufacture and sale of habit-forming drugs 1938 � Federal Food, Drug, & Cosmetic Act � manufacturers required to provide safety information with FDA review; established the process for new drug application process1906 � Federal Food & Drug Act � required manufacturers to list dangerous/addictive substances on the label; recognized US Pharmacopeia & National Formulary as printed standard reference for drugs 1912 � Sherley Amendment � prohibited fraudulent claims for drug products 1914 � Harrison Narcotic Act � established the term narcotic; regulated manufacture and sale of habit-forming drugs 1938 � Federal Food, Drug, & Cosmetic Act � manufacturers required to provide safety information with FDA review; established the process for new drug application process

56. U.S. Drug Legislation (cont'd) 1951: Durham-Humphrey Amendment (to the 1938 act) 1962: Kefauver-Harris Amendment (to the 1938 act) 1970: Controlled Substance Act 1951 � Durham-Humphrey Amendment � required prescriptions to carry the legend �Caution � Federal law prohibits dispensing without a prescription� 1962 � Kefauver-Harris Amendment � manufacturers required to demonstrate both therapeutic efficacy and safety 1970 � Controlled Substance Act � established schedules for controlled substances; promoted drug addiction education, research and treatment 1951 � Durham-Humphrey Amendment � required prescriptions to carry the legend �Caution � Federal law prohibits dispensing without a prescription� 1962 � Kefauver-Harris Amendment � manufacturers required to demonstrate both therapeutic efficacy and safety 1970 � Controlled Substance Act � established schedules for controlled substances; promoted drug addiction education, research and treatment

57. U.S. Drug Legislation (cont'd) 1983: Orphan Drug Act 1991: Accelerated drug approval 1983 � Orphan Drug Act � enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases 1991 � Accelerated drug approval � enabled faster approval process by the FDA for drugs used to treat life-threatening illnesses (AZT for AIDS)1983 � Orphan Drug Act � enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases 1991 � Accelerated drug approval � enabled faster approval process by the FDA for drugs used to treat life-threatening illnesses (AZT for AIDS)

58. Table 4-1 Controlled substances: schedule categories

59. Table 4-2 Controlled substances: categories, dispensing restrictions, and examples

60. New Drug Development Investigational new drug (IND) application Informed consent Investigational drug studies Expedited drug approval Investigation new drug application � completed after animal testing Informed consent � must be obtained for all human test subjects Investigational drug studies � can be completed only after FDA approval Expedited drug approval � a shortened process used for life-saving drugs; the medications must show early promise in Phases I & IIInvestigation new drug application � completed after animal testing Informed consent � must be obtained for all human test subjects Investigational drug studies � can be completed only after FDA approval Expedited drug approval � a shortened process used for life-saving drugs; the medications must show early promise in Phases I & II

61. Ethical Nursing Practice American Nurses Association (ANA) Code of Ethics for Nurses Provisions: Commitment Advocacy Responsibility/Accountability Duty to self and others Integrity Practice, education, administration & knowledge Collaboration � professional team Professional Associations � articulate nursing values, maintaining integrity of the profession & practice, shaping social policy

62. Cultural Considerations Assess the influence of a patient�s cultural beliefs, values, and customs Drug polymorphism � cultural safety Compliance level with therapy Environmental considerations Genetic factors Varying responses to specific agents The nurse must consider how strong an influence a client�s culture has on their use of medications. Drug polymorphism considers the effect of a client�s age, gender, size, body composition, and other characteristics on the pharmacokinetics of a drug. How does the client�s culture influence compliance? Are there factors in the environment that might affect a client�s drug use? There may be genetic factors present that affect how a drug is used by the body. African- Americans respond better to diuretics than beta blockers or ACE inhibitors. Calcium channel blockers work best, and usually need to be used in combination with other drugs. Asians & Hispanics respond better to lower dosages of antidepressants and other antipsychotics and antianxiety drugs.The nurse must consider how strong an influence a client�s culture has on their use of medications. Drug polymorphism considers the effect of a client�s age, gender, size, body composition, and other characteristics on the pharmacokinetics of a drug. How does the client�s culture influence compliance? Are there factors in the environment that might affect a client�s drug use? There may be genetic factors present that affect how a drug is used by the body. African- Americans respond better to diuretics than beta blockers or ACE inhibitors. Calcium channel blockers work best, and usually need to be used in combination with other drugs. Asians & Hispanics respond better to lower dosages of antidepressants and other antipsychotics and antianxiety drugs.

63. Cultural Assessment Health beliefs and practices Past uses of medicine Folk remedies Home remedies Use of nonprescription drugs and herbal remedies OTC treatments

64. Cultural Assessment (cont'd) Usual response to treatment Responsiveness to medical treatment Religious practices and beliefs Dietary habits

65. Medication Errors:Preventing and Responding

66. Medication Misadventures Medication errors (MEs) Adverse drug events (ADEs) Adverse drug reactions (ADRs) Medication errors have been examined by the Institute of Medicine in their publication �To Err Is Human�. Medication errors have been examined by the Institute of Medicine in their publication �To Err Is Human�.

67. Medication Misadventures (cont'd) By definition, all ADRs are also ADEs But all ADEs are not ADRs Two types of ADRs Allergic reactions Idiosyncratic reactions Adverse drug reactions include allergic reactions and idiosyncratic reactions. Allergic reactions are usually predictable, while idiosyncratic reactions are usually unpredictable.Adverse drug reactions include allergic reactions and idiosyncratic reactions. Allergic reactions are usually predictable, while idiosyncratic reactions are usually unpredictable.

68. Medication Errors Preventable Common cause of adverse health care outcomes Effects can range from no significant effect to directly causing disability or death 68% of medication errors are preventable! They cost the US on average of 60 billion dollars 7000 patients died last year as a result68% of medication errors are preventable! They cost the US on average of 60 billion dollars 7000 patients died last year as a result

69. Box 5-1 Common classes of medications involved in serious errors

70. Preventing Medication Errors Minimize verbal or telephone orders Repeat order to prescriber Spell drug name aloud Speak slowly and clearly List indication next to each order Avoid medical shorthand, including abbreviations and acronyms

71. Preventing Medication Errors (cont'd) Never assume anything about items not specified in a drug order (i.e., route) Do not hesitate to question a medication order for any reason when in doubt Do not try to decipher illegibly written orders; contact prescriber for clarification

72. Preventing Medication Errors (cont'd) NEVER use �trailing zeros� with medication orders Do not use 1.0 mg; use 1 mg 1.0 mg could be misread as 10 mg, resulting in a tenfold dose increase

73. Preventing Medication Errors (cont'd) ALWAYS use a �leading zero� for decimal dosages Do not use .25 mg; use 0.25 mg .25 mg may be misread as 25 mg �.25� is sometimes called a �naked decimal�

74. Preventing Medication Errors (cont'd) Check medication order and what is available while using the �6 rights� Take time to learn special administration techniques of certain dosage forms

75. Preventing Medication Errors (cont'd) Always listen to and honor any concerns expressed by patients regarding medications Check patient allergies and identification

76. Medication Errors Possible consequences to nurses Reporting and responding to MEs ADE monitoring programs USPMERP (United States Pharmacopeia Medication Errors Reporting Program) MedWatch, sponsored by the FDA Institute for Safe Medication Practices (ISMP) Notification of patient regarding MEs

77. Medication Reconciliation Process to prevent medication errors: 1. Verification 2. Clarification. 3. Reconciliation Performed: Admission Status change Transfer Discharge Pt Assessment Open-ended questions Avoid medical jargon Clarify Current & complete medication list

78. Drug Administration

79. Preparing for Drug Administration Check the �6 rights� Standard Precautions: Wash your hands! Double-check if unsure about anything Check for drug allergies Prepare drugs for one patient at a time Check three times