1. Chapter 2Pharmaceuticals: Development,Safeguards, and DeliveryCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins

2. Sources of Drugs Plants Animals Synthetic chemicals Genetically engineered chemicalsCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 3. Plants Date to primitive times Classified according to their physical and chemicalproperties Alkaloids Glycosides Gums Oils ResinsCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 4. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsQuestion The advantage of genetically engineered drugs overthose made from animals is less drug reactions. A. True B. False 5. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsAnswer A. True Rationale: Genetically engineered drugs areconsidered to be purer, thereby causing less adversedrug reactions. 6. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsAnimals Traditionally, drugs from animal sources include agentssuch as insulin. Today, genetically engineered hormones are rapidlyreplacing animal-based drugs. The advantage of genetically engineered drugs is theirpurity. 7. Synthetic Chemicals Most drugs used today are either partially or whollysynthetic chemical compounds. A partially synthetic agent contains a derivative of anatural substance combined with a pure chemical. An advantage of synthetic drugs is that they are purechemicals.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 8. Genetically Engineered Chemicals Genetically engineered drugs are drugs developed usingDNA technologies. Genomics is the study and identification of genes andgene function. This new knowledge has enabled researchers tomanipulate the chemical formulas of drugs to producemore specifically targeted drugs with fewer adverseeffects. Proteomics is the study of protein structure and function. Proteomic technology is essential in biomarker discovery.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 9. Genetically Engineered Chemicals (cont.) Transcriptomics is the study of the transcriptome. Transcriptomics aids in understanding the developmentand differentiation of a cell. Metabonomics is the study of metabolic responses todrugs, environmental changes, and diseases. In pharmacotherapy, metabonomics can possibly predictan individual patients response to drug treatment.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 10. Drug Nomenclature Chemical name Precisely describes the drugs atomic and molecularCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkinsstructure Generic name Nonproprietary name; identifies the drugs activeingredient Trade name Brand or proprietary name 11. Drug Nomenclature (cont.)Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 12. Implications for Nursing A drug should be ordered by the generic name. Many trade names sound alike. The nurse should check the drug name at least threetimes. Pharmacy bar code systemCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 13. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsQuestion For the drug furosemide (Lasix), furosemide is the _____name of the drug. A. Chemical B. Trade C. Generic D. Therapeutic class 14. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsAnswer C. Generic Rationale: Lasix is the trade name of the medication,and furosemide is the generic name of themedication. 15. Drug Classifications Drugs that share similar characteristics are classified as apharmacologic group or family. Allows for increased understanding of medications Drugs that share similar characteristics can be classifiedby Chemical classification Physiologic classification Therapeutic classificationCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 16. Sources of Drug Information New drugs are continually being developed. Nurses need reliable and up-to-date drug reference. Where can nurses obtain information: Drug publications Pharmacists Internet-based drug guidesCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 17. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsQuestion As a new nurse, what would be the most appropriateaction to take when you administer a medication you areunfamiliar with? A. Go ahead and give the drug in an emergencysituation and look the drug up later B. Ask a co-worker to give the medication C. Ask the patient why he or she is taking themedication D. Look up the drug prior to administration 18. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsAnswer D. Look up the drug prior to administration Rationale: As the nurse, you are responsible for themedication you are administering. You need to knowthe purpose of the medication, dosage, and sideeffects prior to giving the medication. Many sourcesare available to you as a nurse to obtain informationabout medications. 19. Standards for Drug Purity and Content Pure Food and Drug Acts Federal Food, Drug, and Cosmetics Act of 1938 Kefauver-Harris AmendmentCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 20. Procedure for Drug Development andApproval The first step is in the discovery of a potential new drugmolecule. Preclinical trials are designed to provide basic safety,bioavailability, pharmacokinetic, and initial efficacy dataabout the drug. Clinical trials are performed on humans in severalphases. Only about 10% of new drugs that begin clinical trialsare approved.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 21. Procedure for Drug Development andApproval (cont.)Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 22. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsQuestion In this phase of clinical trials, the majority of the risksassociated with the new drug therapy are identified. A. Phase I B. Phase II C. Phase III D. Phase IV 23. Copyright 2012 Wolters Kluwer Health | Lippincott Williams & WilkinsAnswer C. Phase III Rationale: In phase III of drug trials, 1,000 to 3,000patient volunteers are enrolled in double-blindstudies and crossover design studies. These studiesare monitored closely to evaluate the safety andeffectiveness of the drug. 24. Legislation to Promote Truth inAdvertising In 1912, Congress passed the Sherley Amendment. The FFDCA of 1938 provided labeling requirements forthe first time. Today, the Federal Trade Commission regulates theadvertisement of medications aimed at the generalpublic.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 25. Legislation Regarding ControlledSubstances Harrison Narcotic Law of 1914 Provided regulation regarding the manufacture anddistribution of certain drugs The 1970 Comprehensive Drug Abuse Prevention andControl Act Established the Drug Enforcement Agency (DEA) Five categories, known as schedules, wereestablished.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 26. Controlled SubstancesCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 27. Nursing Management of ControlledSubstances The prescribing, dispensing, and storing of controlledsubstances is subject to governmental control. Procedures are precisely defined by law for every step,from manufacture to administration to wasting ordiscarding. Many hospitals use an automated system toelectronically track the use of stock drugs.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 28. Legislation Regarding Drug Distribution The Durham-Humphrey amendments (1952) Nonprescription drugs (over-the-counter drugs) Legend (prescription) drugs Labeled properly Procedures for the distribution of legend drugsCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 29. Online Pharmacies Increased usage of online pharmacies Not all online pharmacies are regulated The Ryan Haight Internet Pharmacy Consumer ProtectionAct of 2005Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 30. Nongovernmental Institutional Controls Additional regulations may be implemented by theinstitution. Accrediting bodies play an additional role in institutionalcontrols.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 31. Effect of Legal and Institutional Controlson Nursing Management of Drug Therapy Drug laws and nurse practice acts vary from state tostate. Nurses must be familiar with the current regulations intheir states and in their practice settings. In professional practice, nurses must adhere to and obeyestablished drug control laws and protocols. Nurses cannot provide drug therapy without properauthorization. Nurses are responsible for drug security and safeadministration.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 32. Patient Education as a Safeguard in DrugTherapy Educating patients is a key safeguard in drug therapy. Patient learning needs Teaching focus and content Evaluating and documenting educational outcomes Consumer drug information on the InternetCopyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 33. Importance of Nursing Management ofDrug Therapy Nurses are legally responsible for the drugs theyadminister. Safe drug administration requires a thoroughunderstanding of therapeutic drug actions and adversedrug reactions. In some clinical settings, nurses are allowed to modifydrug regimens. Application of the nursing process to the pharmacologicaspects of patient care is especially important becauselong-term use of drug therapy is frequently necessary tocontrol chronic disease processes. Nursing management of drug therapy may be consideredan applied science.Copyright 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins