Phase 1: Drug discovery and development Phase 2: Preclinical research and development Phase 3: Clinical trial Phase 4: FDA reviews NDA Phase 5: Manufacturing

Drug approval process: Phase 1: 2-10 years

Drug Discovery and development

Drug approval process: Phase 2: Initial synthesis of substance; Laboratory studies and animal testing; Institutional review boards 3-6 years

Preclinical research and development

Drug approval process: Phase 3 Research and development (all trials approved by IRD)'; Testing in healthy subjects; Testing in healthy individuals with the diseases; Larger scale testing in individuals with the disease 6-7 years

Clinical trial

Drug approval process: Phase 4: FDA expects review data; Company addresses FDA concerns; Advisory hearing may be called 1-2 years

FDA reviews NDA

Drug approval process: Phase 5: Drug appears on the market; Postmarket surveillance; Follow-up studies and inspections

Manufacturing

The comprehensive drug abuse prevention and Control Act was passed in ??? and regulates the manufacturing and distribution of substances with a potential for abuse

1970

Enforces the law and requires all individuals and companies that handle controlled substances to provide storage security, keep accurate records, and include the provider number assigned by the DEA on all prescriptions for controlled substances

The Drug Enforcement Agency (DEA)

Controlled Substances Categories Designated by the U.S. Government:

Schedule: I II III IV V

Controlled Substances Categories Designated by the U.S. Government: Dispensing Requirements: Drugs not approved for medical use, except specific protocols: high abuse potential

Schedule I

Controlled Substances Categories Designated by the U.S. Government: Dispensing Requirements: Drugs approved for medical use: high abuse potential. Must be kept in locked safe. No refills without a new prescription.

Schedule II

Controlled Substances Categories Designated by the U.S. Government: Dispensing Requirements: Less potential for abuse than Schedule I or II drugs but may lead to psychological or physical dependence. Prescription expires in 6 months.

Schedule III

Controlled Substances Categories Designated by the U.S. Government: Dispensing Requirements: Some potential for abuse. Prescription expires in 6 months.

Schedule IV

Controlled Substances Categories Designated by the U.S. Government: Dispensing Requirements: Written prescription requirements vary with state law.

Schedule V

Legal-Ethical Aspects of drug therapy: The legal responsibilities of nurses for medication administration are defined in

State nurse practice acts and healthcare organization policies and procedures.

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration:

1. The right drug is given 2. The right patient 3. The right dose 4. The right route 5. The right time 6. The right reasons 7. The right documentation 8. The right response Additional rights: 9. Right education 10. Right to refuse

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 1.

The right drug is given

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 2:

The right patient

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 3:

The right dose

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 4:

The right route

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 5:

The right time

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 6:

The right reasons

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 7:

The right documentation

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: 8:

The right response

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: Additional rights: 9:

Right education

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: Additional rights: 10

Right to refuse

Legal-Ethical Aspects of drug therapy: 8 rights of Medication Administration: Most medication errors result from?

Failure to follow one of these "rights".

Ethical aspects of nursing care were identified by the American Nurses Association (ANA) in the?

2001 code of ethics.

Ethical aspects of nursing care were identified by the American Nurses Association (ANA) in the 2001 code of ethics. The guidelines provide ethical principles to be adhered by every professional nurse:

1. Respect the dignity of all patients, regardless of ethnicity, socio-economic status, or specific health problem; 2. Participate in activities to support maintenance of their professional competence 3. Protect patient's privacy and confidentiality 4. Make a commitment to providing quality patient care in every setting.

Respect the dignity of all patients, regardless of ethnicity, socio-economic status, or specific health problem;

Participate in activities to support maintenance of their professional competence.

Protect patient's privacy and confidentiality

Make a commitment to providing quality patient care in every setting.

9 provisions to 2015 Code of Ethics for Nurses with Interpretive Statements:

1. Respect for human dignity 2. Primacy of patient interest 3. Protection of patient privacy and confidentiality 4. Authority, accountability, and responsibility for nursing practice. 5. Duty to self and others 6. Maintaining an ethical environment 7. Contributions through research and scholarly inquiry. 8. Health as a universal right 9. Articulation and assertion of nursing values.

Medication errors: Errors can occur during the?

Prescribing, dispensing, administration, or right documentation phases of medication administration.

How can errors be prevented?

1. During patient transfer 2. Patient identification 3. Environmental factors

Patient teaching is also a key to preventing errors - an informed patient will

Question his or her nurse if the medication looks different from the usual pill

Is the branch of medicine and biology concerned with the study of drug action - or "how a drug works" Studies how chemical substances affect living organisms The study of the interactions between a living organism and a Chemical substance that result in a visible change so the organisms normal or abnormal biochemical functions.

Pharmacology

Pharmacology is derived from the Greek word?

Pharmakon; and -logia meaning "the knowledge gained through study"

Pharmakon, the word derived from to Pharmacology translates into?

Poison in classic Greek; and drug in modern Greek,

The resultant change in pharmacology is called a?

Drug action

Is the study of "what a drug does to the body" It describes the molecular interactions of a drug with a specific biological molecules that lead to a desired therapeutic response.

Pharmacodynamics

Is referred to as "what the body does to the drug" and quantifies the rate of drug movement in the body. Studies characterize the speed of drug absorption, distribution, metabolism and drug elimination (excretion).

Pharmacokinetics

Is a substance or chemical capable of altering a biochemical or physiological processes in the body

Drug

Drug responses or altering biochemical or physiological process in the body may be?

Desirable (therapeutic) or undesirable (adverse)

Is defined as a drug that is used for the purpose of restoring a dysfunctional or pathologic process in the body to its desired function or process.

Medication

Is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or animals.

Active ingredient

The goal of medication therapy is to?

Restore a dysfunctional or pathological biochemical or physiological process.

Every drug has at least three names:

1. The chemical name 2. The generic name 3. The brand name

Every drug has at least three names: Is designated according to rules of nomenclature of chemical compounds. It's precise description of a chemical composition and molecular structure of a compound.

The chemical name

Every drug has at least three names: Refers to a common established name regardless of its manufacturer. There is only one one of it for a drug.

The generic name

Every drug has at least three names: Is selected by the manufacturer and always capitalized. Also known as the trade name or proprietary name.

The brand name

The Liver: Anatomical First Stop for Orally administered Drugs: The first pass effect:

Oral drugs -> absorbed by small intestines -> Portal venous system -> Delivers absorbed molecules -> to the liver -> transforms most of the chemicals by a series of liver enzymes -> breaks the drugs into metabolites -> some will cause effect and some will be deactivated and readily excreted from the body -> as a result, large percentage of the oral dose is destroyed and never reaches the tissues. -> the portion of the drug that gets through is delivered to the circulatory system for transport throughout the body.

Means that the medication produces a beneficial effect for the patient.

Therapeutic response

Are responses in tissues where the drugs effects are neither needed nor wanted causing problematic but not harmful symptoms such as nausea, fatigue, headache, and similar uncomfortable responses.

Side effects

Side effects range in:

Severity from mild to nuisance - to at worst-severe.

Is the study and characterization of the adverse effects caused by excessively high concentrations of drug in the body and harmful, potentially fatal results.

Toxicology

Dermatological Reactions:

Adverse reactions involving the skin. Drugs deposit toxic chemical reaction causing irritation to the tissue.

Dermatological Reactions: Drugs deposit ______ causing irritation to the tissue

Toxic chemical reaction.

Dermatological Reactions: Can range from:

Simple rash to potential fatal exfoliative dermatitis.

Dermatological Reactions: Assessment:

Hives, rashes Exfoliative dermatitis: -rash -scaling -fever -enlarged lymph node -enlarged liver -fatal erythema multiforme exudativum (Stevens-Johnson Syndrome)

Dermatological Reactions: intervention:

-In mild cases, discomfort of skin lesions: provide frequent skin care. -Instruct patient to avoid rubbing, avoid rough and tight clothing, avoid harsh soaps or perfumed lotion -administer antihistamines as appropriate. -in severe cases, D/C drug and notify AP -topical corticosteroids, antihistamines and emollients are used.

Stomatitis:

Inflammation of the mucous membranes. Direct toxic reaction to the drug deposits in the end capillaries in the mucous membranes, leading to inflammatin.

Stomatitis: Assessment:

- Swollen gums - Inflamed gums (gingivitis) - Swollen and red tongue (glossitis) - Difficulty swallowing - Bad breath -Pain in the mouth and throat

Stomatitis: Interventions:

-Provide frequent mouth care - Frequent small meals -Dental consultation -Antifungal agents and/or local anesthetics are sometimes used.

Superinfections:

When normal flora are destroyed by drugs (antibiotics)

Superinfections: Assessment:

Fever, diarrhea, black or hairy tongue, inflamed or swollen tongue, mucous membrane lesions, vaginal discharges with or without itching.

Superinfections: Interventions:

Provide supportive measures: - Frequent mouth care - Skin care - Access to bathroom facilities - Small, frequent feeding - Antifungal agents as appropriate - D/C drug responsible for superinfection.

Blood Dyscrasia:

Any abnormal condition of the blood Is bone marrow suppression Bone marrow cells multiply rapidly Multiple Cell division, highly susceptible to any agents that disrupts cell function.

Blood Dyscrasia: Use of?

Antineoplastics and antibiotics.

Blood Dyscrasia: Assessment:

Fever, chills, sore throat, weakness, back pain, dark urine Decreased/low platelet count (thrombocytopenia) Decreased/low WBC (leukopenia) decreased/low cellular elements of CBC (pancytopenia)

Blood Dyscrasia: Interventions:

Monitor blood counts Provide supportive measures: - Rest - Protection from exposure to infections - Protection from injury - Avoidance of activities that might result in injury or bleeding - D/C drug or stop administration until the bone marrow recovers to a safe level.

Toxicity:

1. Liver injury 2. Renal injury

Toxicity: Most drugs are metabolized here, many "metabolites" are irritating or the toxic will affect its integrity.

Liver injury

Toxicity: Liver injury: Assessment:

Fever, malaise, nausea, vomiting, jaundice, change in color of urine or stools, abdominal or colic pain. "Increased/high Liver enzymes (AST & ALT)" Alterations in bilirubin levels Change in clotting factor (PTT).

Toxicity: Liver injury: Assessment: Liver enzymes:

AST and ALT

Toxicity: Liver injury: Intervention:

D/C drug and notify AP Supportive measures: -Rest -Small, frequent meals -Skin care -Cool environment

Toxicity: Drugs have the potential to directly irritate renal tubule and alter normal absorption and secretion process.

Renal injury

Toxicity: Renal injury: Enzymes or to watch for:

Crea or creatinine: 0.6 to 1.3 milligrams per deciliter (53 to 115 micromoles per liter) BUN- is an indication of renal health. Normal ranges 8-20 mmol/L

Toxicity: Renal injury: Assessment:

Increased or high BUN, creatinine concentration Decreased or low HCT Electrolyte imbalances Fatigue, malaise, edema, irritability Skin rashes

Toxicity: Renal injury: Intervention:

Notify AP and D/C drug Supportive measures: -Positioning -Diet and fluid restrictions - skin care, - electrolyte therapy - rest periods - controlled environment If severe, DIALYSIS!!!

Alterations in Glucose Metabolism:

1. Hypoglycemia 2. Hyperglycemia

Alterations in Glucose Metabolism: Drugs affect metabolism and use of glucose, causing a low blood glucose concentration.

Hypoglycemia

Alterations in Glucose Metabolism: Hypoglycemia: Assessment:

Fatigue, drowsiness, hunger, anxiety, headache; cold clammy skin; shaking; lack of coordination. Increased or high HR, Bp Numbness and tingling of mouth, tongue, lips. Confusion Rapid, shallow respirations Sever cases: Seizures or coma

Alterations in Glucose Metabolism: Hypoglycemia: Interventions:

Restore glucose, IV or P.O. Supportive measures: -skin care, environmental control of light and temperature, rest. Institute safety measures to prevent fall or injury.

Alterations in Glucose Metabolism: Drugs stimulate the breakdown of glycogen or alter metabolism causing high serum glucose levels. Examples: Ephidrine (aminophylline, chlorphenalamine, guaifenessin). Can breakdown stored glycogen and cause an elevation of blood glucose by its effect on sympathetic nervous system.

Hyperglycemia

Alterations in Glucose Metabolism: Hyperglycemia: Assessment:

Fatigue Polyuria Polydipsia Kussmaul respiration (deep respiration) Restlessness Polyphagia Nausea Hot or flushed face Fruity odor to breath

Alterations in Glucose Metabolism: Hyperglycemia: Intervention:

Administer insulin to decrease blood glucose Provide support to help the patient deal with S/S. -Access to bathroom -Controlled environment -Reassurance -Mouth care

Electrolyte Imbalances:

1. Hypokalemia 2. Hyper kalemia

Electrolyte Imbalances: Drugs affecting the kidney can cause the renal exchange system. Example: Loop diuretics -Loss of K+ -K+ is essential for the normal functioning of nerves and muscles.

Hypokalemia

Electrolyte Imbalances: Hypokalemia: Assessment:

- Lower K+ levels, decreased or lower than 3.5 milliequivalent/Liter - Weakness - Numbness and tingling in the extremities - Muscle cramps - N&V, diarrhea, decreased or low bowel sounds, irregular pulse, weak pulse. - Orthostatic hypotension - Disorientation - Severe cases, paralytic ileus, abdominal distention, absent bowel sounds, acute abdomen

Electrolyte Imbalances: Hypokalemia: Intervention:

- Replace serum K+ - Monitor serum K+ levels and patient response. - Provide support: - Safety precaution to prevent falls and injury -Orientation of the patient -Comfort measures for pain and discomfort.