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Class Notes for Pharmacology Connections to Nursing Practice, 2nd Edition

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition C HAPTER 1 I NTRODUCTION TO P HARMACOLOGY : C ONCEPTS AND C ONNECTIONS L EARNING O UTCOME 1 Identify key events in the history of pharmacology. Concepts for Lecture 1. Over 3.6 billion prescriptions are dispensed each year in the United States, with the number rapidly increasing. 2. Pharmacology has evolved over the centuries and is a key aspect of nursing care. 3. Pharmacology started with early man using plants and herbs to relieve disease symptoms. 4. One of the oldest forms of health care, herbal medicine has been practiced in virtually every culture dating to antiquity. 5. Many early remedies were accidental discoveries. 6. First prescriptions written in the year 3,000 BC by the Babylonians. The Chinese have the first recorded volume of plant remedies in the year 2,700 BC. 7. Pharmacology was probably reviewed as magic and superstition during the Dark Ages. There is very little recorded data from the Dark Ages. 8. First began to be practiced as a science in the 17th century and the first text with the word pharmacology was published in 1693. 9. In the 19th century, chemists were able to make remarkable progress in separating specific substances and the first active agents such as morphine, colchicines, curare, cocaine, and other early drugs were discovered from their natural plant products. 10. Early pharmacologists studied the effects on both animals as well as themselves. 11. First recognized as a discipline in Estonia in 1847. In the United States, the first pharmacology department was at the University of Michigan in 1890. 12. The 20th century saw great progress and development of new drugs. We are now able to synthesize drugs from “scratch” in the laboratory. 13. The current practice of pharmacology is complex, but the application has not changed. The goal of pharmacology is to relieve human suffering. L EARNING O UTCOME 2 Compare and contrast the terms drug, pharmacology, and pharmacotherapy. Concepts for Lecture 1. The definition of a drug is difficult but important to the nurse.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 2. A drug is any substance that is taken to prevent, cure, or reduce symptoms of a medical condition. 3. Using examples discussed in text, discuss how water, vitamin C, cola, or natural hormones can be a drug. 4. The word pharmacology came from the Greek pharmakon, which means “medicine” or “drugs” and logos, which means “study.” 5. Pharmacotherapy or pharmacotherapeutics is the application of drugs for the purpose of disease prevention and treatment. 6. The subject of pharmacology is an expansive subject that involves understanding what a drug is given for, how it is administered, where it travels in the body, the actual response it produces, and how it is eliminated. 7. Drugs are one form of medical intervention in which the nurse plays a major role. a. The nurse designs interventions for desired health goals. b. Pharmacotherapy is a critical intervention. 8. There are over 11,000 brand, generic, and combination agents, each with its own application, interactions, side effects, and actions. 9. Many drugs have more than one use. They may be prescribed for more than one disease and many produce multiple effects in the body. 10. Drug responses can differ in individual patients. 11. Patient factors that can cause drugs to elicit a different response are age, gender, race, body mass, health status, and genetics. 12. New drugs are introduced each year. 13. Staying current and up - to - date with new drugs is critical for the patient and health care provider. Proper application of a drug can improve quality of life while an improperly applied drug can cause disability or even death. L EARNING O UTCOME 3 Explain the importance of pharmacotherapy to clinical nursing practice. Concepts for Lecture 1. Many people believe that there are perfect drugs and that the perfect drug should and can always be selected for the patient. 2. Characteristics of the perfect or ideal drug: a. Effective b. Given at low doses c. Works quickly

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition d. No side effects e. Convenient f. Given once a day g. Inexpensive h. Easily eliminated i. No interactions 3. There is no such thing as a perfect drug, but most prescription medications do have a degree of effectiveness. 4. Conditions for which drugs are approved are called indications. All prescription drugs have at leas t one indication and some have multiple indications. 5. Some drugs are used for conditions for which they do not have an approved indication; this is called an unlabeled or off - label use. 6. Drugs that are used most often are ones that are close to the perfect drug profile. Drugs that have a profile that strays furthest from the perfect drug profile are used infrequently. 7. Most drugs may be easily used at home by the patient, but some drugs may be only administered in the clinical setting. L EARNING O UTCOME 4 Using specific examples, explain the difference between the pharmacological and therapeutic methods of classifying drugs. Concepts for Lecture 1. Nurses need to understand how a drug works both therapeutically as well as pharmacologically. 2. Drug therapy is a large part of nursing care. 3. Understanding how patient variables affect drug therapy is a critical part of understanding drug therapy. 4. Stay up - to - date on changes in drug indications as well as new drugs is part of ongoing nursing education. L EARNING O UTCOME 5 Identify the advantages of using prototype drugs to study pharmacology . Concepts for Lecture 1. The Food and Drug Administration (FDA) publishes a document called the “Approved Therapeutic Equivalence Evaluation,” which is also called the “Orange Book.” This document currently lists over 11,000 approved drugs. The list includes both prescription and nonprescription drugs.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 2. Drugs are categorized two ways: a therapeutic classification and a pharmacologic classification. 3. The therapeutic classification is how the drug is used in treating a specific disease; many drugs have different types of therapeutic classes. The key to therapeutic classifications is which condition the particular drug is treating. For example, one drug may lower blood pressure and also relieve chest pain. 4. The pharmacological classification is the mechanism of drug action or how the drug produces its effects in the body. Different drugs can all treat the same condition but they may do it differently. This classification is considered more specific than the therapeutic classification. Again, many drugs have multiple pharmacological classifications. The pharmacological classification may use the drug’s chemical name. 5. Drugs may also have multiple therapeutic and pharmacological classifications that are dependent on the clinical use of the drug; the student must understand all of these classifications. L EARNING O UTCOME 6 Classify drugs by their chemical, generic, and trade names. Concepts for Lecture 1. The prototype drug is usually the first and best understood drug in its class. 2. Sometimes the prototype may be a new or clinically more useful drug. 3. By learning the prototype drug, nurses can understand the depth, actions, and adverse effects of other drugs in the same class. 4. Studying by prototype helps the nurse to understand a classification of drug therapy by studying a single drug. 5. Prototypes are easily identified in the textbook, which gives the therapeutic effects, mechanism of action, adverse effects, and nursing responsibilities for each prototype. L EARNING O UTCOME 7 Compare the advantages and disadvantages of a pharmaceutical company being granted exclusivity for the development of a new drug. Concepts for Lecture 1. Drugs are identified by multiple names, which can be confusing to both the patient and health care provider. 2. Chemical names are assigned by using standard nomenclature established by the International Union of Pure and Applied Chemistry (IUPAC). Each drug has only one chemical name. 3. Drugs can be named and classified by a portion of their chemical structure, known as the chemical group name. 4. Generic names are assigned by the U.S. Adopted Name Council. Generic names are usually less complicated and are easier to remember than chemical names. Each drug has only one generic name.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 5. Trade names are also called proprietary, product, or brand names. The trade name is assigned by the pharmaceutical company. 6. Trades names are usually short and easy to remember. 7. The term proprietary suggests ownership and in the United States, the FDA grants the pharmaceutical companies exclusive rights for naming and marketing a drug for a fixed number of years after the new drug application is approved. 8. This process allows the drug company to recoup the cost of research and development of the drug. 9. When this patent expires, competing companies may sell a generic equivalent drug. They may give it a different trade name, which the FDA must approve. 10. Trade names may be difficult to learn, because many products with different names may contain the same drug. 11. Combination drugs are drugs with more than one active generic ingredient. 12. Because of the potential confusion with trade names, it is important that the nurse identifies drugs by their trade names. L EARNING O UTCOME 8 Analy ze possible differences between generic drugs and their brand - name equivalents . Concepts for Lecture 1. Pharmaceutical companies market their brand of drug. The exclusivity for marketing and selling the drug under its trade name is limited for a certain period of time. 2. When this period of time or patent expires other companies may market the drug under its generic name or create a new brand name for the drug. 3. Pharmaceutical companies often lobby aggressively against laws that might restrict the routine use of certain brand name drugs. They claim that there is a difference between a trade name drug and its generic equivalent and that switching to a generic may be harmful to the patient. 4. Consumer advocates argue that generic substitutions should always be permitted because they provide cost savings to the patient. 5. Some states in the United States allow the pharmacist to routinely substitute a generic drug when the prescription calls for a brand name drug. In other states, pharmacists must dispense as written or obtain approval before providing a generic substitution. Many pharmacies provide lists of generic drugs. L EARNING O UTCOME 9 Assess the responsibilities of the nurse in drug administration. Concepts for Lecture 1. Generic drugs may have identical doses, but their formulations or inert ingredients may differ.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 2. This difference may change the bioavailability of the drug. 3. Bioavailability is defined by the Federal Food, Drug, and Cosmetic Act (see Chapter 2), as the rate and extent to which the active ingredient is absorbed from the drug product and then becomes available at the site of the drug action to produce the desired effects. 4. Bioavailability may be affected by formulation, inert ingredients, and tablet compression. All of these factors can affect the absorption and/or distribution of the drug. 5. Bioavailability is measured by the time it takes for the drug to exert its effect; it is also known as onset time. 6. Bioavailability may differ between trade and generic drugs. This difference could be important with drugs with critical care uses and those with a narrow safety margin. However, for most other drugs the generic equivalent may be safely substituted. 7. Internet sites may allow patient to purchase drugs at substantial savings. However, the danger of this is that the drugs may be sold from other countries and these countries may not have the same quality control standards as the United States. These drugs may be harmful or not effective. The nurse must help patients understand the differences and the potential dangers. G ENERAL C HAPTER C ONSIDERATIONS 1. Have students study and learn key terms listed at beginning of chapter. 2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing Student Resources website. Marginal Notes P OWER P OINT S LIDES 5 – 12 S UGGESTION FOR C LASSROOM A CTIVITIES • Make a time line with students to demonstrate how the science of pharmacology has had great progress in the last two hundred years. Discuss what the future might hold. R EFERENCE • The American Chemical Society website: http://pubs.acs.org/subscribe/journals/mdd/v04/i05/html/05timeline.html P OWER P OINT S LIDES 13 – 18 Figure 1.1 Rationale for Pharmacotherapy S UGGESTION FOR C LASSROOM A CTIVITIES • Using the examples of water, vitamin C, and natural hormones, discuss how a patient may be confused about the difference between a substance for everyday use or one that naturally occurs in the body, and how these change when used in drug therapy. P OWER P OINT S LIDES 19 – 25

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition S UGGESTION FOR C LASSROOM A CTIVITIES • Have students look at current media marketing for prescription drugs — television, print, and radio are suggestions. Discuss what parts of the ad attempt to make the drug appear to be the “perfect” drug for that condition. P OWER P OINT S LIDE 26 S UGGESTIONS FOR C LASSROOM A CTIVITIES • Have students discuss various ways of finding up - to - date drug therapy information. Suggestions include reference books, evidence - based Internet sites, ongoing clinical education, and pharmacists. • Suggested sources include the drug information handbook assigned for the course, plus the following websites: www.ptcommunity.com www.nlm.nih.gov/medlineplus/druginformation.html www.drugs.com P OWER P OINT S LIDES 26 – 33 Table 1.1 Therapeutic Classifications Table 1.2 Pharmacologic Classification S UGGESTION FOR C LASSROOM A CTIVITIES • Go to the FDA Orange Book website: http:/ / www.fda.gov/cder/ob/. Engage students in using the website to search for various drugs. Use the FAQ link to demonstrate how to stay updated on new drugs. S UGGESTION FOR C LINICAL A CTIVITIES • Have the students compare and contrast medication therapy used for patients who have the same disease state, but are being treated with different drugs. Compare the drug’s pharmacological and therapeutic classifications. P OWER P OINT S LIDES 34 – 35 S UGGESTION FOR C LASSROOM A CTIVITIES • Have the students use the textbook to locate a prototype drug. Discuss how it is easily identifiable and what important nursing considerations are listed for each prototype. S UGGESTION FOR C LINICAL A CTIVITIES • Have students look at a medication administration record for an assigned patient. Compare which drugs are prototypes and which are not. Students could also discuss how different or similar the drug is to the prototype. P OWER P OINT S LIDES 36 – 42

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition Table 1.3 Brand Names S UGGESTION FOR C LASSROOM A CTIVITIES • Have students look at popular generics such as acetaminophen, aspirin, or ibuprofen. Have them identify possible trade names that are popular for these drugs. Then look at which products may represent a combination of drugs. S UGGESTION FOR C LINICAL A CTIVITIES • Have students take a drug history from a patient. Discuss if the patients identify their medications by generic or trade names. Have students discuss how this could lead to possible medication errors. S UGGESTION FOR C LASSROOM A CTIVITIES • Using Internet pharmacy sites, compare and contrast the differences between prices for trade and generic drugs. Example sites include: http://www.pharmacychecker.com/ http://www.drugstore.com http:/ / drx.com S UGGESTION FOR C LINICAL A CTIVITIES • Have the students interview a hospital or neighbor pharmacist to find out what the law in their state is regarding substitution of generic drugs. P OWER P OINT S LIDES 43 - 48 S UGGESTIONS FOR C LASSROOM A CTIVITIES • Give examples of drugs that may be available to the patient in both trade and generic names. Suggestions could be ibuprofen, loratadine, and pseudoephedrine. Discuss what could change the bioavailability of the drug. • Have the student role - play a scene where a patient asks the nurse if generic substitutions are safe, and how the nurse would respond. Role - play another scene where the patient asks the nurse about using an overseas Internet pharmacy. P OWER P OINT S LIDES 49 – 52 S UGGESTIONS FOR C LASSROOM A CTIVITIES • The students should take the core responsibilities for safe drug administration and discuss how each concept can prevent medication errors. • Have the students work in small groups and interview each other. Have them identify differences in their own demographics that would influence safe drug therapy. S UGGESTION FOR C LINICAL A CTIVITIES • Have the student shadow a nurse in the hospital or clinic setting who is assigned to administer medications. Have the student observe how the nurse checks to make sure the medications are correct for that patient, if the drugs are dispensed in trade or generic names, what checks the nurse completes

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition before dispensing the medication, and what teaching the nurse offers the patient about the medication. P EARSON N URSING S TUDENT RESOURCES ( WWW . NURSING . PEARSONHIGHERED . COM ) • Web Links • NCLEX ® - style review questions • Case studies • Making the Patient Connection • Mechanism of Action Animations M Y N URSING L AB ( WWW . MYNURSINGLAB . COM ) • Knowledge Quick Check • Pre/Posttests • Customized study plans • Separate purchase P RENTICE H ALL N URSE ’ S D RUG G UIDE • Separate purchase P EARSON E T EXT • Students can search, highlight, take notes, and more all in electronic format . • Separate purchase M Y T EST

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition C HAPTER 2 D RUG R EGULATIONS L EARNING O UTCOME 1 Explain the role of pat ent medicines in the history of pharmacology and the legislation of drugs. Concepts for Lecture 1. In the United States and Canada laws govern all aspects of drug approval, labelling , manufacturing, marketing, and distribution. 2. Consumers expect that the drug they are taking is effective and that the label is clear and accurate. 3. Consumers expect that the drug they are taking is safe. 4. It is only since the 20 th century that standards and regulations exist to protect the consumer. 5. In early America, patent medicine was widely used and available. 6. There were no laws to regulate these medicines and products could make any claim to health or cure. 7. Many patent medicines contain addictive and at times dangerous additives, such as morphine and cocaine. Such addictive additives guaranteed repeat sales. 8. Several early patent medicines have gone through drug regulation and change and are still available today. L EARNING O UTCOME 2 Outline the key U.S. drug regulations and explain how each has contributed to the safety and effectiveness of the medications. Concepts for Lecture 1. Drug legislation began in the 1900s to make drugs safer and more effective. 2. The first national law was the Drug Importation Act passed in 1848. 3. This was spurred on deaths of children in 1901 who were given a contaminated antitoxin. 4. The Biologics Control Act was passed in 1902 to regulate era, antitoxins, and blood - related products. 5. The Pure Food and Drug Act (PFDA) was passed in 1906 to control labelling of medicines. 6. The PFDA required accuracy in drug labeling. 7. In 1912 the Sherley Amendment to the PFDA addresses false therapeutic claims on drug labels. 8. The Sherley Amendment did not address the issue of proving that the drug company knew that their false claim was intentional. 9. The Harrison Narcotic Act of 1914 required prescriptions for higher doses of narcotic drugs.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 10. States and the federal government have passed additional laws regulating drugs of abuse. This is covered in Chapter 8. 11. Two issues with early regulations were that the drug companies did not have to prove that the drug was effective and did not require testing before marketing. 12. After deaths in 1937 due to a contaminated drug, the Food, Drug, and Cosmetic Act (FDCA) was passed by Congress in 1938. 13. The FDCA required that drugs be tested for safety before marketing and drug labels to contain instructions for use. 14. The FDCA did not define what was considered a prescription drug. 15. In 1951 the Durham - Humphrey Amendment to the FDCA defined the difference between prescription drugs and over - the - counter (OTC) drugs. 16. In the late 1950s, there was a high number of birth defects from the drug thalidomide, which was prescribed to pregnant women by their physicians. Because these physicians received the drug from the manufacturer with FDA approval, the Kefauver - Harris Amendment to the FDCA was passed in 1962. 17. The Kefauver - Harris Amendment required that manufacturers prove their drugs safe and effective by conduction of adequate and controlled studies. 18. The Kefauver - Harris Amendment also required adverse effects be reported to the FDA and included in literature given to health care providers. 19. The Kefauver - Harris Amendment also required informed consent of those patients participating in drug research. 20. In 1966, the FDA began evaluating the effectiveness of previously approved drugs. 21. In, 1972 the FDA began reviewing over - the - counter drugs for safety and effectiveness. 22. In 1983, the Orphan Drug Act became law to assist with development of drugs for serious, but rare, diseases. 23. The Prescription Drug User Fee Act (PDUFA) of 1992 assessed fees from manufacturers to reduce drug review time. 24. The 1997 passage of the Food and Drug Administration Modernization Act reviewed medical devices and health claims for food. 25. The Dietary Supplement Health and Education Act of 1994 aimed to control claims of dietary supplements. 26. The Medicare Prescription Drug Improvement and Modernization Act of 2003 aimed to assist patients with prescription drug costs. L EARNING O UTCOME 3 Describe how the United S tates Pharmacopeia - National Formulary (USP - NF) controls drug purity and standards.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition Concepts for Lecture 1. When drugs were prepared from plants, purity and strength varied due to the ingredients and preparer. 2. Pharmacists began using formularies to list products and recipes. 3. In 1820 the U.S. Pharmacopeia (USP) was established. 4. For over 100 years, the USP and the National Formulary (NF) maintained drug standards in the United States by setting standards for drug purity and strength. 5. The USP covered drug products and the NF covered nondrug ingredients. 6. In 1975 they were merged into the USP - NF, which is published annually. 7. The USP label is found on many medications. 8. Drugs marketed in the United States must conform to USP - NF standards. L EARNING O UTCOME 4 Evaluate the role of the U.S. Food and Drug Administration in the drug approval process. Concepts for Lecture 1. The Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs and medical devices. 2. The FDA started in 1906, making it the oldest drug regulatory agency in the world. It has eight branches. 3. The Center for Drug Evaluation and Research (CDER) covers drug safety. 4. The Center for Biologics Evaluation and Research (CBER) regulates biologic safety. 5. The Center for Food Safety and Applied Nutrition (CFSAN) over sees herbal products, dietary supplements, and cosmetics, but does not require testing of herbals and dietary supplements before marketing. 6. CFSAN regulates cosmetics that are not considered drugs. L EARNING O UTCOME 5 Categorize the four stages of new drug approval. Concepts for Lecture 1. The drug approval process in the United States was established by the FDA. 2. The drug approval process ensures drugs sold in the United States are safe and effective. 3. There are four stages to new drug approval. 4. The first stage is preclinical investigational. This is laboratory research by the pharmaceutical

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition company. 5. The FDA does not regulate the preclinical investigation. 6. If the preclinical investigation is positive, the company may submit an Investigational New Drug (IND) application to the FDA. 7. Once approved by the FDA, the drug can start clinical phase trials. 8. Phase 1 involves testing on 20 to 80 healthy volunteers. 9. Phase 2 involves testing several hundred patients with the particular disease for the drug. 10. Phase 3 involves a large number of patients with the disease for patient variability. 11. If the clinical phase trials are positive, the company will submit a New Drug Application (NDA) to the FDA. 12. The FDA will then approve or not approve a drug. 13. If approved, the drug can begin post marketing surveillance, which is stage 4. 14. Stage 4 looks for harmful drug effects in a large population. 15. Post marketing surveillance helps the FDA discover any serious problems. The Adverse Event Reporting System and FDA public meetings allow patients and health care providers to report problems. 16. Although more diverse populations are used to test drugs, most drugs are not tested in children and pregnant women, as these populations are not used in drug testing. 17. Off - label use is when a drug is discovered to be useful for an indication that was not approved by the FDA. 18. The FDA does not regulate off - label use. About 20% of prescription drugs are used off - label. L EARNING O UTCOME 6 Explain the role of a placebo in new drug testing. Concepts for Lecture 1. A placebo or inert substance is used in phase 2 of clinical drug trials. 2. The placebo serves as a control or nontreatment group. L EARNING O UTCOME 7 Discuss how recent changes to the approval process have increased the speed at which new drugs reach consumers. Concepts for Lecture 1. The process of developing and testing a new drug can take many years.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 2. The FDA review process can take several years. 3. The estimated cost to bring a new drug to market can be over $802 million U.S. dollars. 4. Pharmaceutical companies are anxious to recoup the high expenses. 5. The public is also anxious for new medications, especially for diseases with a high mortality rate. 6. In 1992 the PDUFA was passed, which provided yearly product user fees. 7. This income allowed the FDA to restructure and hire more employees. 8. This restructuring decreased the ir view process by half. 9. Priority drugs now receive accelerated approval. 10. These priority drugs are for serious and life - threatening conditions. L EARNING O UTCOME 8 Compare and contrast prescription and over - the - counter drugs. Concepts for Lecture 1. The Durham - Humphrey Amendment of 1951 established the difference between prescriptions and over - the - counter (OTC) drugs. 2. A patient must have authorization, a “prescription” to receive a prescription drug. 3. Prescription drugs are considered to be potentially addictive or too harmful for self - administration. Prescription drugs require skill to administer correctly. 4. Prescription drugs allow the patient to be examined and properly diagnosed. 5. Prescription drugs allow for patient teaching and disease monitoring. Prescription drugs treat complex conditions. 6. OTC drugs do not require a prescription for a health care provider. 7. OTC drugs are safe if the patient carefully follows the instructions. 8. OTC drugs are easier to obtain. 9. Choosing the correct OTC drug can be a problem for the patient. 10. Patients may not be aware of food, drug, and herbal interactions with OTC drugs. 11. Self - treatment with OTC drugs can be ineffective. 12. Prescription drugs can undergo a review process by the FDA which can reclassify a prescription drug to be an OTC drug. In order for a prescription drug to be reclassified as an OTC drug, a high margin of safety must exist. 13. Herbal and dietary supplements are available over the counter.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 14. Herbal and dietary supplements are not considered drugs. They are not subjected to the same regulatory process as prescription drugs. 15. The FDA does not test herbal and dietary supplements for safety. These products can cause side effects and interact with medications. L EARNING O UTCOME 9 Explain how scheduled drugs are classified and regulated. Concepts for Lecture 1. Some drugs have a high potential for dependence. 2. Some drugs are frequently abused. 3. The sale and distribution of these drugs are highly restricted. 4. Drugs with a high potential for abuse are called scheduled drugs. 5. These drugs are placed into one of five categories called schedules. 6. Dependencies and drug schedules are discussed in Chapter 8. 7. The Comprehensive Drug Abuse Prevention and Control Act of 1970 restricts these controlled substances. 8. The Drug Enforcement Administration (DEA) requires hospitals and pharmacies to use registration numbers to purchase these drugs. 9. Complete records must be maintained of qualities purchased and sold. 10. Drugs with the highest abuse potential have additional restrictions. 11. These restrictions may include special order forms, no telephone orders, and no refills. 12. There are strict penalties for not following the laws. L EARNING O UTCOME 10 Describe the Canadian drug approval process and identify similarities to the drug approval process in the United States. Concepts for Lecture 1. There are many similarities between U.S. and Canadian regulations for drugs. 2. Health Canada is the federal department and the Health Products and Food Branch (HPFB) of Health Canada is the regulatory body for health products and food safety. 3. The HPFB regulates the use of therapeutic products by directorates. 4. The Therapeutic Products Directorate (TPD) authorizes marketing of drugs and medical devices. 5. The Biologics and Genetic Therapies Directorate (BGTD) regulate biological drugs and radio

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition pharmaceuticals. 6. The Natural Health Products Directorate (NHPD) regulates natural products. 7. The Canadian Food and Drugs Acts is a regulatory document that specifies that drugs cannot be marketed without a Notice of Compliance (NOC) and Drug Identification Number (DIN) from Health Canada. 8. If a drug does not comply with standards set in the United States, Europe, Britain, or France, they cannot be sold, labeled, packaged, or sold in Canada. G ENERAL C HAPTER C ONSIDERATIONS 1. Have students study and learn key terms listed at beginning of chapter. 2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing Student Resources website. Marginal Notes P OWER P OINT S LIDES 6 – 11 Figure 2.1 Patent Medicines Contained a Name Brand That Clearly Identified the Product and Claimed to Cure Just about Any Symptom or Disease Figure 2.1 Patent Medicines S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss with students how patent medicines have “survived” over along period of time. Use examples given in the textbook such as Smith Cough Drops, Fletcher’s Castoria, Doan’s Pills, Vick’s Vapo Rub, and Phillip’s Milk of Magnesia. Why are these products still popular and widely used? What could be some of the reasons that they survived regulations? P OWER P OINT S LIDES 12 – 18 Table 2.1 Historical Time Line of Regulatory Acts, Standards, and Organization Figure 2.2 USP Labels S UGGESTION FOR C LASSROOM A CTIVITIES • Using the time line in Table 2.1, have the students add any future regulations they believe are needed or forthcoming. S UGGESTION FOR C LINICAL A CTIVITIES • Have students teach assigned patients in the clinical setting what U.S. regulations ensure the safety and effectiveness of their drug therapy. P OWER P OINT S LIDES 19 - 20 S UGGESTION FOR C LASSROOM A CTIVITIES

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition • Have the students explore the USP website (www.usp.org). Have the students look at what type of information is available such as reference standards, healthcare quality and information, seminars, workshops, and drug safety review. Discuss how they could use this information in clinical practice. P OWER P OINT S LIDES 21 – 23 Figure 2.3 U.S. Food and Drug Administration S UGGESTIONS FOR C LASSROOM A CTIVITIES • Have the students log onto the FDA website (http://fda.com). Then, have the students explore the consumer links and resources. Assign a different link or resource to each student; have them give a brief summary if they thought there source would be helpful to the general patient population. Students can choose an FDA industry link to explore. Break students into groups and assign one of the following to each group: CDER, CBER, CFSAN, Med W atch, Health Care Professional, Food Nutrition Industry, and Cosmetic Industry. Have the students report back to the group what information is available. S UGGESTION FOR C LINICAL A CTIVITIES • Have the students explain to their assigned patients how the FDA oversees drug products in the United States. If Internet access is available, the student can demonstrate the consumer links on the FDA website (http://fda.com). P OWER P OINT S LIDES 24 – 29 Figure 2.4 Drug Development Time Line S UGGESTION FOR C LASSROOM A CTIVITIES • Break the students into groups, give each group one of the three phases of the clinical drug trial, have them develop a patient teaching tool to provide teaching to the patient involved in that phase of the trial. How would they explain safety, adverse effects, and patient variables? S UGGESTION FOR C LINICAL A CTIVITIES • If possible in your clinical setting, have the students interview either a healthcare professional or patient involved in a clinical drug trial. They should ask questions about stages and phases of the trial, preclinical investigation, goal of the trial, possible adverse effects, and patient consents and compensations. Have them report back to their clinical group what they learned in their interview. Did it change their thoughts about clinical drug trials? Why or why not? S UGGESTION FOR C LASSROOM A CTIVITIES • Build off the activity for Learning Outcome 5 and continue to discuss clinical drug trials. Why do some patients receive the placebo? Is there a risk with placebos? How would the patient feel about getting the placebo if the drug was very effective? Discuss the moral issues regarding controlled drug trials. P OWER P OINT S LIDES 30 – 32 S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss with the class which disease states could require priority drug approval. Make a list on the classroom blackboard. Ask the students then to prioritize their list. Discuss how difficult it is to decide

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition which disease is “more important.” Discuss if the list would be different in another part of the country or world. P OWER P OINT S LIDES 19 – 39 S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss some of the recent drugs that have been reclassified from prescription to over the counter, such as loratadine (Claritin), cetirizine (Zyrtec), Omeprazole (Prilosec), famotidine (Pepcid), naproxen sodium (Aleve), and cromolyn sodium nasal spray (Nasalcrom). Discuss the potential for use and misuse by the consumer. Why are these drugs safer than other drugs in the same category that are still prescription drugs? Does the ir classification help or harm the consumer? S UGGESTION FOR C LINICAL A CTIVITIES • Assign the students to a patient who is prescribed a drug that is available over the counter. Have the students develop a patient teaching plan that will teach the patient how to use the drug safely and how to follow the guidelines. S UGGESTIONS FOR C LASSROOM A CTIVITIES • Provide the students with a list of some controlled substance medications. Have the student pick one drug and investigate its use and safety. Have them report back to the class if they think the assigned schedule is appropriate or not. Discuss the arguments presented in class. • Refer to the DEA website for a list of controlled substances: http://www.usdoj.gov/dea/pubs/scheduling.html S UGGESTIONS FOR C LINICAL A CTIVITIES • Have the students shadow a nurse or pharmacist who prepares controlled substance medications. Have the student note the regulations in that clinical setting for recording and dispensing the drugs. Have the students report if they think the regulations are appropriate or not. What would they change, if anything? • Refer to the DEA website about the controlled substance act: http://www.usdoj.gov/dea/pubs/scheduling.html P OWER P OINT S LIDES 40 – 46 Table 2.2 Steps for Approval for Drugs Marketed Within Canada S UGGESTIONS FOR C LASSROOM A CTIVITIES • Explore the Health Canada website with the students: http://www.hc - sc.gc.ca/index - eng.php • Compare and contrast information found on that site against U.S. sites, such as the FDA (www.fda . gov) or the Centers for Disease Control (www.cdc.gov). • What information is provided on the websites for healthcare professionals? What information is provided for the consumer? • Discuss if information is easy to find and to understand. Focus on drug standards and safety.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition P EARSON N URSING S TUDENT RESOURCES ( WWW . NURSING . PEARSONHIGHERED . COM ) • W EB L INKS • NCLEX ® - STYLE REVIEW QUESTIONS • C ASE STUDIES • M AKING THE P ATIENT C ONNECTION • M ECHANISM OF A CTION A NIMATIONS M Y N URSING L AB ( WWW . MYNURSINGLAB . COM ) • Knowledge Quick Check • Pre/Post tests • Customized study plans • Separate purchase P RENTICE H ALL N URSE ’ S D RUG G UIDE • Separate purchase P EARSON E T EXT • Students can search, highlight, take notes, and more all in electronic format • Separate purchase M Y T EST

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition C HAPTER 3 P RINCIPLES OF D RUG A DMINISTRATION L EARNING O UTCOME 1 Outline a plan for improving patient adherence to the medical regimen. Concepts for Lecture 1. Medication adherence involves determining whether the patient is taking the medication correctly. 2. Patient nonadherence to medication use is a major problem causing significant problems and even death. Factors influencing nonadherence include: a. Forgetting doses of drugs b. Expense c. Side effects d. Self - adjustment of dosages e. Discontinues use when feeling better 3. The nurse plays a significant role in determining patient adherence to drug use, including: a. All medication is taken b. Medication is taken at correct time c. Correct dose of medication is taken 4. The nurse needs to formulate a care plan which involves the patient, and is designed to improve adherence with medication use. Elements of the personalized plan of care include such essential information as: a. Name of medication b. Reason for use c. Expected drug action d. Side effects e. Significant interactions with medications, food, and herbal supplements f. Assess ability for self - administration L EARNING O UTCOME 2 Describe how the storage of drugs can affect their effectiveness. Concepts for Lecture

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition 1. Proper storage of medications is needed to protect medications from deterioration. 2. Nurses need to check that medications are properly stored and check for expiration dates before administering. 3. Do not use any medications that are past expiration date; dispose of them properly. 4. Exposure to light and moisture can be damaging to some drugs. 5. Medication storage principles include: a. Store at recommended temperature b. High humidity enhances deterioration c. Schedule drugs have restricted access d. Check drugs for unusual color or textures 6. Access to scheduled drugs is restricted and requires adherence to institution policy. L EARNING O UTCOME 3 Describe the components of a legal prescription and the abbreviations associated with drug orders. Concepts for Lecture 1. Prescriptions may be written in different formats, but all must include the three elements of heading, body, and closing. 2. The heading must include: a. Date b. Patient’s name c. Prescriber’s name, address, phone number 3. The closing must include: a. Prescriber’s signature b. Refill amount, if applicable c. Generic equivalent substitution 4. States differ on the specific requirements to be included in a prescription. 5. Certain abbreviations can lead to errors and must be avoided. 6. Prescriptions for controlled substances require a Drug Enforcement Administration (DEA) number. L EARNING O UTCOME 4 Relate the importance of dosing schedules to successful pharmacotherapeutic outcomes.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition Concepts for Lecture 1. Dosage scheduling and intervals are determined by the health care provider based on the chemical characteristics of a drug, purpose and action of the drug, and frequency with which it should be taken. 2. The usual dosing is 1 – 4 times/day. Many drug dosing schedules are determined by agency protocol. 3. The administration time should enhance therapeutic effectiveness. Patients must avoid skipping doses or double dosing. 4. Some drugs have an irregular schedule, such as drugs ordered to be given STAT and prn. L EARNING O UTCOME 5 Compare and contrast the three systems of measurement used in pharmacology. Concepts for Lecture 1. Dosages are labeled by weight and volume. 2. Measuring systems used in pharmacology include metric, apothecary, and household. 3. The metric system is the most common. 4. Metric volume = liter (L) or milliliter (mL). 5. Metric weights are as follows: a. Kilogram b. Milligram c. Microgram 6. In the household system, the tablespoon, teaspoon, and cup are the most common measurements. 7. Conversions between household and metric are as follows: a. 240 mL = 8 ounces b. 5 mL = 1 tsp 8. The apothecary system is the most infrequently used system: a. Basic unit is the grain (gr) b. Unit dosing is common c. Knowledge of dosage calculation important 9. Although many drugs are dispensed in unit doses from the pharmacy, it is still important for the nurse to have a working knowledge of dosage calculations. 10. The volume of a drug is expressed differently in each of the measuring systems.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition L EARNING O UTCOME 6 Explain the importance of properly documenting medication administration. Concepts for Lecture 1. Proper documentation of drug administration by the nurse is essential. This includes recording initials/signature after the medication is given. 2. Documentation of a drug is done on the medication administration record (MAR). 3. Documentation of medication administration is done after the drug is given to the patient. 4. Documentation also includes patient refusals, concerns, and any adverse effects. L EARNING O UTCOME 7 Compare and contrast enteral, topical , and parenteral drug administration. Concepts for Lecture 1. Drugs are administered via different routes: parenteral , topical, and enteral. 2. Oral drugs are often enteric coated and designed for absorption in the small intestine. 3. Extended release tablets provide a longer duration of action and allow for the convenience of once - or twice - daily dosing. a. Most are absorbed in small intestine b. Common endings: XR, X., LA, SR, - dur c. Allow for longer duration of action d. Do not crush, open, or chew e. Exposure to stomach acid destroys medication f. Some coated to mask a taste or prevent staining 4. Sublingual and buccal medications: a. Extensive capillaries provide excellent absorption b. Prevents exposure to stomach acids c. Do not undergo hepatic first - pass metabolism d. Sublingual provides rapid onset: i. Administer after other medications ii. Avoid eating or drinking until drug is dissolved 5. Nasogastric (NG) and gastrostomy medication administration:

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition a. Used for long - term treatment b. NG route used for short - term treatment c. Liquid drug formulation is best to use d. Avoid crushing slow release (SR) tablets e. Flush tubes to maintain patency f. May crush and dissolve some tablets 6. Topical medications can be applied for local and systemic effects. 7. Topical medications include transdermal patches and creams/lotions, and ophthalmic, otic, vaginal, and rectal routes. 8. Topical routes: a. Dermatological topical medications are applied to skin b. Instillations and irrigations are placed in body cavities and orifices c. Inhalations are applied to respiratory tract: i. Inhalations ii. Nebulizers iii. Positive pressure breathing machine 9. Topical drugs: a. Can produce a local or systemic effect b. Examples: i. Local effects: nasal steroids ii. Systemic effects: nitroglycerin patch c. Identify desired effect of drug d. Avoid application to abraded or open skin 10. Transdermal delivery systems: a. Deliver specific amount of drug through skin b. Rotate site of application c. Check that previous patch is removed d. Dispose of used patches properly 11. Other topical routes:

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition a. Ophthalmic b. Otic c. Nasal d. Vaginal e. Rectal 12. Enteral route: a. Drug given through the GI tract b. The safest route c. Consider patients’ ability to swallow d. Oral drug forms: i. Tablet ii. Capsule iii. Enteric coated tablets 13. Parenteral administration requires the use of a needle to inject medications into the intradermal, subcutaneous, intramuscular, or intravenous site. 14. Parenteral routes: a. Administers drug into skin layers: i. Intradermal ii. Subcutaneous iii. Intramuscular iv. Intravenous b. More invasive c. Specialized equipment and techniques needed d. Avoids digestive enzymes and first - pass effect 15. Intradermal and subcutaneous routes: a. Dermis may contain blood vessels b. Intradermal route mostly used for allergy testing i. Injection contains only 0.1 to 0.2 mL c. Subcutaneous site is easily accessible:

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition i. Delivers drug to deepest skin layer ii. Injection volumes range from 0.5 to 1.0 mL 16. Intramuscular route: a. Drug is delivered into muscle b. More rapid response than oral or subcutaneous c. Select site away from bone, nerves, and large blood vessels d. Injection volume should not exceed 3 mL: i. Deltoid site is limited to 1 mL 17. Intravenous route: a. Drug is delivered directly into bloodstream b. Rapid onset of drug action c. Most dangerous route d. Three basic types: i. Large volume infusion ii. Intermittent infusion iii. Bolus administration G ENERAL C HAPTER C ONSIDERATIONS 1. Have students study and learn key terms listed at beginning of chapter. 2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing Student Resources website. Marginal Notes P OWER P OINT S LIDES 4 – 10 S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss the necessary elements to include when developing an individualized teaching plan and ways to include the patient and family. S UGGESTION FOR C LINICAL A CTIVITIES • Have students develop a personalized medication teaching plan for a patient they have had in clinical. R EAL N URSING S KILLS Medication Administration Videos.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition P OWER P OINT S LIDES 1 1 – 1 2 S UGGESTIONS FOR C LASSROOM A CTIVITIES • Discuss the effect that heat and humidity have on the storage of medications. • Relate the effect of medication storage to shelf life. S UGGESTION FOR C LINICAL A CTIVITIES • Have students check where different medications are stored at the clinical site. R EFERENCE • Proper Disposal of Prescription Drugs: Federal Guidelines. (n.d.). Drug Facts: Office of National Drug Control Policy Guidelines. Retrieved April 18, 2008 from www.whitehouse.gov/ondcp P OWER P OINT S LIDES 1 3 – 1 6 Figure 3.1 Sample Prescription S UGGESTION FOR C LASSROOM A CTIVITIES • Have students practice writing a sample prescription with all the required components. S UGGESTION FOR C LINICAL A CTIVITIES • Have students choose a recently written prescription on a patient chart; identify and determine if all the required components are present. If any component is missing or incorrect, discuss what action should be taken by the nurse. R EAL N URSING S KILLS Medication Administration Videos. R EFERENCE • The ISMP’s List of Error - Prone Abbreviations, Symbols, and Dose Designations . (2006). Retrieved April 18, 2008 from www.ismp.org/tools/errorproneabbreviations.pdf P OWER P OINT S LIDES 1 7 – 1 9 S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss the nurse’s responsibility when a patient in apparent pain refuses to take a prn pain medication. Another scenario could involve a patient who has an elevated temperature and refuses to take the prn acetaminophen. Discuss how the nurse can best handle these types of situations. S UGGESTION FOR C LINICAL A CTIVITIES • Choose a patient assigned to one of the students and examine the rationale for the dosing schedule of their prescribed medications. P OWER P OINT S LIDES 2 0 – 2 4

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition S UGGESTION FOR C LASSROOM A CTIVITIES • Have students practice converting some common drugs from one system to another, such as metric to household or metric to apothecary. S UGGESTION FOR C LINICAL A CTIVITIES • Look for examples of drugs that may come packaged in a different system of measurement than was ordered by the health care provider, such as levothyroxine or nitroglycerin, and illustrate these examples. P OWER P OINT S LIDES 2 5 – 2 6 S UGGESTION FOR C LASSROOM A CTIVITIES • Discuss some of the possible consequences that can occur when medications are not properly charted, such as a patient receiving a double dose of medication. S UGGESTION FOR C LINICAL A CTIVITIES • Have students identify what is most important to document following a medication that they have just administered. Discuss any significant information or assessment data that needs to be included, such as vital signs or a patient complaint. P OWER P OINT S LIDES 2 7 – 4 3 Figure 3.2 Sublingual Medication Administration Figure 3.3 Transdermal Patch Administration Figure 3.4 Ophthalmic Administration Figure 3.5 Vaginal Medication Administration Figure 3.6 Intradermal Drug Administration Figure 3.7 Subcutaneous Drug Administration Figure 3.8 Intramuscular Drug Administration S UGGESTIONS FOR C LASSROOM A CTIVITIES • Give an example of a drug, such as morphine, that can be administered by the subcutaneous, intramuscular, and intravenous routes. Discuss when each site would be the more appropriate choice. • Discuss the differences in sublingual and buccal medications. Demonstrate proper placement using OTC lozenges or candy. S UGGESTION FOR C LINICAL A CTIVITIES • Assign each student a parenteral medication, checking that it is prepared in the correct size syringe with correct needle length and gauge. Discuss why the size and gauge of the needle is appropriate for the particular medication and the specific patient.

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition P EARSON N URSING S TUDENT R ESOURCES ( WWW . NURSING . PEARSONHIGHERED . COM ) • WebLinks • NCLEX ® - style review questions • Case studies • Making the Patient Connection • Mechanism of Action Animations M Y N URSING L AB ( WW W . MYNURSINGLAB . COM ) • Knowledge Quick Check • Pre/Posttests • Customized study plans • Separate purchase P RENTICE H ALL N URSE ’ S D RUG G UIDE • Separate purchase P EARSON E T EXT • Students can search, highlight, take notes, and more all in electronic format • Separate purchase M Y T EST

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    Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice , 2nd Edition C HAPTER 4 P HARMACOKINETICS L EARNING O UTCOME 1 Identify the four primary processes of pharmacokinetics. Concepts for Lecture 1. Pharmacokinetics is what the body does to drugs. Pharmaco means “medicines,” and kinetics means “movement.” 2. The four phases of pharmacokinetics are: absorption, distribution, metabolism, and excretion. 3. A drug must go through all phases before being eliminated by the body. L EARNING O UTCOME 2 Explain mechanisms by which drugs cross plasma membranes. Concepts for Lecture 1. Various mechanisms are used by drugs to reach target tissues. These can involve passive diffusion, active transport, and facilitated diffusion. 2. Passive diffusion involves movement from an area of high concentration to one of low concentration. 3. Facilitated diffusion involves utilization of a carrier protein. 4. Active transport involves movement against a concentration gradient, which requires energy. L EARNING O UTCOME 3 Discuss factors affecting drug absorption. Concepts for Lecture 1. The first phase of pharmacokinetics, absorption, is affected by many different factors. 2. Factors affecting absorption: a. Oral meds must undergo dissolution b. Topical drugs can have slow or rapid absorption c. Drug concentration/dose d. Physical and chemical condition of GI tract: i. Motility ii. Presence of food/fat in stomach

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