Chapters 1 & 2

Mary Lloyd, MSN, RN, CNE

The Drug Approval Process

Pharmacology: the study of the effects of chemical substances on living tissues Apothecary system/metric system: the first set of drug standards and measurements (around 1240 AD) grains (gr), drams, minims to current use of metric system EX: apothecary gr V or gr X or gr iii

The Controlled Substances Act 1970

Purposes: Designed to remedy the escalating problem of drug abuse Promotes drug education and research related to drug dependence Strengthens enforcement authority Establishes treatment and rehab facilities Designates schedules (or categories) for controlled substances according to abuse liability *

The Controlled Substances Act 1970 (contd)

Designates schedules (or categories) for controlled substances according to abuse liability * Controlled substances in 5 schedules (I,II,III,IV,V): Schedule 1 not approved for medical use EX: heroin, LSD Schedule 2,3,4,5 have accepted medical use Note: Abuse potential decreases as you move down the schedule with Schedule 5 having only limited abuse potential

Examples of Controlled Substances in 5 categories or schedules

EX: Schedule I: (not approved for human use) heroin, LSD, marijuana except when prescribed for cancer treatment * Schedule II: (have accepted medical use) - demerol, morphine, methadone Schedule III: codeine preparations, non narcotic drugs propoxyphene (Darvon) Schedule IV: phenobarbital, valium, lorazepam (Ativan) Schedule V: opioid controlled substances for diarrhea or cough codeine in cough preparations

Nursing Interventions Controlled Substances

Account for all controlled drugs Keep a record for controlled substances (exception not kept in a Pyxis system) Countersign (two signatures) all wasted & discarded meds Check that records & drugs on hand match Keep all controlled drugs locked with narcotics under double lock Only authorized persons (RN) should have narcotic cabinet keys

Drug Names *
Chemical name: describes the drugs chemical structure Brand (trade name): proprietary name, chosen by the drug company and owned by that manufacturer Generic name: official or non proprietary name; is not owned by the manufacturer [recognized by United States Pharmacopoeia (USP)] EX: Narcan brand name naloxone generic name EX: Tylenol (acetaminophen) Advil/Motrin (ibuprofen) Aspirin (acetylsalicylic acid)

Drug Resources
American Hospital Formulary Service: provides accurate drug information on all prescription drugs marketed in U.S. PDR (Physician Drug Reference): drug information from pharmaceutical companies United States Pharmacopeia (USP): an official public standards-setting authority for all prescription and over-the counter meds available in hospitals & pharmacies

Food and Drug Administration Pregnancy Categories

Classification system related to the effects of drugs on the unborn child (fetus): Categories A and B: ** -considered to be within safe limits for drug use in pregnancy (first trimester) * Category C animal studies indicate a risk (risk vs benefit) Category D and X a risk to fetus has been proved (risk outweighs the benefit)

Did you know? approximately 80% of drugs are taken by mouth

There are 3 phases of drug action: Pharmaceutic Pharmacokinetic Pharmacodynamic

Chapter 1 Drug Action

Pharmaceutic Phase: Disintegration-breakdown of a tablet into
smaller particles

Dissolution- dissolving of the smaller

particles in the GI fluid before absorption

Pharmaceutic Phase
Drugs need to be in solution form to be absorbed (drugs in liquid form are more rapidly available for GI absorption than solids) Generally, drugs are disintegrated & absorbed faster in acidic fluids with a pH 1 or pH 2 The elderly & very young have less gastric acidity, so drug absorption is slower for drugs absorbed primarily in stomach

Pharmaceutic Phase Enteric coated drugs* Resist disintegration in the gastric acid of the stomach; disintegration does not occur until the drug reaches the alkaline intestine Can remain in stomach for a long time Should NOT be crushed WHY? Crushing would alter the place & time of absorption of the drug
Roles of Food in GI(diluent/protectant/interfence)

May interfere with dissolution & absorption of certain drugs Can also enhance absorption of other drugs Can be taken with some drugs as some drugs irritate gastric musosa

(covered in prior lecture) Review of Pharmacokinetic Phase

Pharmacokinetics the process of drug movement to achieve drug action: Absorption Distribution Metabolism (biotransformation) Excretion (elimination)

Pharmacokinetic phase (contd)

Excretion (or Elimination)* Main route of elimination: kidneys* Urine pH influences drug excretion Excretion is slowed by kidney disease and/or glomerular filtration rate (GFR) * EX: GFR drug excretion Lab value: most accurate test to determine renal function = creatinine clearance 85-35ml/min* is a 12 or 24 hr urine collection & blood sample which with age * (WHY? Aging muscle mass nephrons) So, drug dosage in elderly may need to be

Pharmacokinetic phase (contd) *Half life: the time it takes for one half of the drug concentration to be eliminated
a drug goes through several half lives before 90% of the drug is eliminated EX: ASA 650 mg half life is 3 hrs (3hrs=short half life; long half life =24 hrs or >) Takes 3 hrs for the 1st half life to eliminate 325mg Takes 6 hrs for 2nd half life to eliminate 162 mg ( until the 6th half life (or 18 hrs) when 10 mg of the ASA is left By then, 90% of drug has been eliminated

Pharmacodynamic Phase*
Study of drug concentration on the body: Drug response can cause a primary or secondary physiologic effect EX diphenhydramine (Benadryl) Primary effect: desirable (treats allergies) Secondary effect: CNS depression leads to drowsiness - Undesirable=when client drives a car But Desirable= when drowsiness at bedtime

Dose Response and Maximal Efficacy

relationship between minimal vs maximal amount of drug dose, needed to produce the desired drug response different patients require different doses to reach the desired effect

EX: pain meds

Pharmacodynamic (cont.)
Onset of action: the time it takes to reach the minimum effective concentration after a drug is administered Peak action: the drug reaches its highest blood or plasma concentration Duration of action: the length of time the drug has a pharmacologic effect

EX: Insulins

Time Response Curve

Pharmacodynamic Phase (cont.) Receptor Theory

Most receptors (protein in structure) are found on cell membranes Drugs bind to the receptor (protein) to produce or initiate a response or to block or prevent a response. The activity of the drug is determined by the ability of the drug to bind to a specific receptor The better the fit at the receptor site, the more active the drug is EX: like fitting the right key in the lock

Pharmacodynamic Phase (cont.) *

Agonists: drugs that produce a response * EX: Isuprel (isoproteronol) an agonist, stimulates beta 1 receptor in heart; increasing cardiac output

Pharmacodynamic Phase (cont.) *

Antagonists: drugs that block a response *
EX: Tagamet (cimetidine) an antagonist blocks the histamine receptor (H2); preventing (blocking) excess gastric secretion

Pharmacodynamic Phase (cont.)

Nonspecific drugs drugs that affect various sites EX: Urecholine (bethanacol) for urinary retention increases bladder contraction, so the drug stimulates the cholinergic receptors in the bladder also stimulates the cholinergic receptors in others sites

Pharmacodynamic Phase (cont.)

Nonselective drugs drugs that affect various receptors: EX: Epinephrine acts on 3 different receptors(A1, B1, B2) a variety of responses result

Pharmacodynamic Phase (cont.)

Categories of Drug Action: Stimulation or Depression: rate of cell activity or gland secretions increase/decrease Replacement: drug replaces essential compounds EX: insulin Inhibit organisms (or kill): interfere with bacterial cell growth EX: PCN Irritation: mechanism of irritation EX: laxatives (irritation stimulates peristalsis)

Pharmacodynamic Phase (cont.)

Therapeutic Index and Therapeutic Range (Therapeutic Window): Therapeutic Index (TI): estimates the margin of safety of a drug Low therapeutic Index: narrow margin of safety High therapeutic index: wide margin of safety and less danger of producing toxic effects Therapeutic Range (therapeutic window): * Should be between minimum effective concentration in plasma for obtaining desired drug action & minimum toxic concentration (the toxic effect) (when range is given it includes both protein bound & the free drug in the plasma) EX: digoxin level 0.5 2 ng/ml) *

Pharmacodynamic Phase (cont.)

Peak and Trough Levels (blood is drawn):** * Peak drug level: highest plasma concentration of drug at a specific time; indicate rate of absorption of the drug EX: PO admin drug peaks in 1-3 hours EX: IV admin drug peaks in 10 minutes * Trough level: lowest plasma concentration of drug; measures the rate of elimination Trough levels are drawn immediately before the next dose of drug is given (regardless of route of administration) Peak and Trough Levels: generally ordered for drugs with a narrow TI (narrow margin of safety) which are considered toxic Ex: * antibiotics * (aminoglycoside)*

Pharmacodynamic Phase (cont.)*

Loading dose: * When immediate drug response is desired, a large initial dose (loading), achieves a rapid minimum effective concentration of the drug in the plasma EX: digoxin Side effects (SE): desirable or undesirable * Adverse Reactions AR): more severe than side effects sometimes term used interchangeably with SE always undesirable * should always be reported and documented EX: anaphylaxis Toxic effect = toxicity* (monitored with TI)

Medication Effects
Adverse Medication Effects - EX: 1. Central Nervous System 2. Extrapyramidal symptoms 3. Anticholinergic effects
4. CV effects 5. GI effects 6. Hematologic effects
Nursing Implication/Intervention

1. CNS stimulation or depression 2. Observe and report 3. Dry mouth, photophobia, urinary retention 4. Orthostatic hypotension 5. Constipation 6. Signs & symptoms of bleeding

Medication Effects (cont)

Adverse Medication Effects EX: 1. Hepatotoxicity 2. Nephrotoxicity
3. Toxicity 4. Allergic reaction 5. Anaphylactic reaction
Nursing Implication/Intervention

6. Immunosuppression

1. Liver function tests 2. Monitor serum creatinine and BUN levels 3. Liver damage 4. Minor to serious 5. Treat with epinephrine, bronchodilators, antihistamines 6. Depression, increased risk for infection

Pharmacogenetics
Pharmacogenetics Effect of a drug action that varies from a predicted drug response because of genetic factors or hereditary influence EX: African Americans & Caucasians respond differently to some antihypertensives Tachyphylaxis Drug tolerance to a frequently repeated med EX: narcotics Placebo effect A psychologic benefit from a compound that may not have the chemical structure of a drug effect; generally effective in 1/3 of the people who take it.

Nursing Process and Client Teaching Chapter 2

Assessment Subjective (what pt states)

Current health history Client symptoms Current meds dosage, frequency, route, knowledge, compliance issues, allergies, OTC meds?, herbal remedies? PMH, environment, readiness to learn, motivation to learn, frustration level, attention span

Assessment Objective

Lab tests Diagnostics Physical assessment

Assessment Is my patient compliant with his drug regimen?

Client compliance for drug therapy What things help you take your meds as prescribed? What things prevent you from taking your meds as prescribed? What do you do if you forget to take a dose of the medication? Medication Reconciliation

Nursing Diagnosis
Noncompliance related to forgetfulness Risk of injury related to side effects of drugs such as dizziness, drowsiness

Deficient knowledge about drug action, administration, and side effects related to language barrier, or speech, new drug information

Nursing Diagnosis
Ineffective protection related to effects of anticoagulant medication on clotting mechanism Pain related to hesitancy in taking prescribed pain med due to fear of addiction Ineffective health maintenance related to not having recommended preventive care

Planning/Implementing
Goal setting or expected outcomes EX: The patient will (do something)

Implementing Client Teaching

Client education is an ongoing process Regarding medications: general instructions administration, diet, side effects Assess education *** cultural considerations * tools for teaching Helpful and Healthful Points to Remember: Box 2-4 pg. 20 Checklist for Health Teaching in Drug Therapy Box 2-6 pg. 21

Evaluation
Has your goal been met?