NCMA216 (Week 1-5)

Core Ethical Principles

Derived from the Belmont Report, the World Medical Association Declaration of Helsinki set this out for medical research that involves human subjects.

Respect for Persons Patient

Patient should be treated as independent persons capable of making decisions in their own best interests.

Autonomy

It is an integral component for persons. Patients can refuse any and all treatments.

1947 Nuremberg Code

The two most relevant aspects of this Code are the right to be informed and that participation is voluntary, without coercion.

Informed Consent

Has its roots in the 1947 Nuremberg Code.

Beneficence

It is a duty to protect research subjects from harm. It involves ensuring the risks and possible benefits from participating in a research study are clearly defined and ensuring the benefits are greater than the risk.

Risk-Benefit Ratio

It is one of the most complex problems faced by the researcher. All possible consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits.

Justice

It requires that the selection of research subjects be fair.

Preclinical Trials

Before the implementation of clinical research, the FDA requires this to determine a drug’s toxic and pharmacologic effects through in vitro and in vivo animal testing in the laboratory.

Genotoxocity

it is the ability of a compound to damage genetic information in a cell.

Phase I

Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II

The drug or treatment is given to a larger group of people to see whether it is effective and to further evaluate its safety.

Phase III

The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV

Studies are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long-term use.

American Nurses Association (ANA) Code of Ethics

was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.

Federal Legislation

attempts to protect the public from drugs that are impure, toxic, ineffective, or not tested before public sale.

The Sherley Amendment

It prohibited false therapeutic claims on drug labels.

Drug Abuse Control Amendments

Attempted to control the abuse of depressants, stimulants, and hallucinogens.

Schedule I

The drugs are not approved for medical use and have high abuse potential.

Schedule II

Through V drugs have acceptable medical use and decreasing potential for abuse leading to psychological and/or physiologic dependence.

Schedule III

Substances in this schedule have a potential for abuse less than substances in Schedules I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV

Substances in this schedule have a low potential for abuse relative to substances in Schedule III.

Schedule V

Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

Liberation

It is the first step in the process by which medication enters the body and liberates the active ingredient that has been administered.

Absorption

It is the movement of the drug into the bloodstream after administration.

Passive Transport Diffusion

Drugs move across the cell membrane from an area of higher concentration to one of lower concentration.

Active Transport Diffusion

It requires a carrier such as enzyme or protein to move the drugs.

Pinocytosis

It is the process by which cells carry a drug across their membrane by engulfing the drug particles in a vesicle.

Drug Solubility

Lipid soluble drugs pass readily through GI membrane, water-soluble drugs need an enzyme or protein.

Distribution

It is a process by which drug becomes available to body fluids and tissues. It is the movement of the drug from the circulation to body tissues.

Metabolism

It is the process by which the body chemically changes drugs into a form that can be excreted.

Half-life

The time it takes for one half of drug concentration to be eliminated Short t1/2= 4-8hrs: given several times a day (ex. Penicillin G).

Excretion

removal of the drug from the body. Drug is changed into inactive form and excreted by the body.

Kidney

Main organ for drug elimination.

Pharmacokinetics

it is the process of drug movement throughout the body that is necessary to achieve drug action.

Pharmacodynamics

It is the study of the effect of drugs on the body.

Dose-Response Relationship

It is the body’s physiological response to changes in drug concentration at the site of action.

Potency

It refers to the amount of drug needed to elicit a specific physiologic response to a drug.

Efficacy

Magnitude of effect a drug can cause when exerting its maximal effect.

Maximal Efficacy

It is the point at which increasing a drug dosage no longer increases the desired therapeutic response.

Therapeutic Index

It describes the relationship between the therapeutic dose of a drug (ED50) and the toxic dose of a drug (TD50).

Therapeutic dose of a drug (ED50)

It is the dose of a drug that produces a therapeutic response in 50% of the population.

Toxic dose of a drug (TD50)

It is the dose that produces a toxic response in 50% of the population.

Onset

it is the time it takes for a drug to reach the minimum effective concentration (MEC) after administration. Time from drug administration to first observable effect (T0-T1)

Peak

It occurs when it reaches its highest concentration in the blood/plasma concentration. T0-T2.

Duration of action

It is the length of time the drug exerts a therapeutic effect. Period from onset until the drug effect is no longer seen. T1-T3

Drug-Receptor Interaction

Certain portion of drug molecule (active site) selectively combines with some molecular structure (reactive site) on the cell to produce a biologic effect.

Receptor Site

The drugs act at specific areas on cell membranes; react with certain chemicals to cause an effect within the cell

Lock and Key Theory

Specific chemical (key) approaches a cell membrane and finds fit (the lock) at receptor site-affects enzyme system within cell-produce certain effects.

Drug-Enzyme Interaction

Interferes with enzyme systems that act as catalyst from various chemical reactions

If single step in one of enzyme system is blocked- normal function is disrupted.

Nonspecific Drug Interaction

Act by biophysical means that do not affect cellular/enzymatic reactions. Drugs do not bind to receptors but instead saturate the water or lipid part of a cell- drug actions occur based on the degree of saturation. Neutralization of stomach acid by antacids.

Selective Toxicity

Specific action on cellular structures that are unique to the microbe. All chemotherapeutic agents would act only in one enzyme system needed for life of a pathogen or neoplastic cell. It is essential to the pathogen but not to the host.

Stimulation

Increase rate of cell activity/secretion from the gland T3/T4 for hypothyroidism.

Depression

Decreased cell activity and function of a specific organ.

Replacement

It replaces essential body compounds.

Ex. Insulin

Inhibition/Killing of Organism

Interfere with bacterial cell growth

Irritation

Example: Laxative - irritate the inner wall of colon - increased peristalsis- increased defecation.

Additive Effect

2 drugs with similar actions are taken for a doubled effect 1+1=2.

Synergistic Effect

combined effect of 2 drugs is greater than the sum of the effect of each drug given alone; 1+1=3.

Potentiation

a drug that has no effect enhances the effects of the second drug. 0+1=2.

Antagonistic

One drug inhibits the effect of another drug. 1+1=0.

Side Effects

Results from the pharmacologic effects of the drug. Most common as a result of lack of specificity of action within the therapeutic range.

Allergic Reactions

Unpredictable adverse drug effects; more serious. Response to patient’s immunological system to the presence of the drug. Do not occur unless the patient has been previously exposed to the agent/chemical related compound.

Idiosyncratic Reaction

Occurs when the patient is first exposed to the drug. Abnormal reactivity to the drug caused by a genetic difference between the patient and normal individual. A patient with G6PD deficiency will have anemia by using antioxidants.

Toxicity

The degree to which a drug can be poisonous and thus harmful to the human body.

Iatrogenic Responses

Unintentional responses as a result of medical treatment Nephrotoxicity; ototoxicity.