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Drugs – are chemicals that are introduced into the body to cause some sort of change.

Nursing responsibilities includes:


 administering drugs
 Assessing drug effects
 Intervening to make the drug regimen more tolerable
 Providing patient teaching about drugs and the drug regimen
Pharmacology- is the study of the biological effects of chemicals.
Pharmacotherapeutics or clinical pharmacology- The branch of pharmacology that uses drugs to
treat, prevent, and diagnose disease.
2 key concerns:
 The drug’s effects on the body (pharmacokinetics)
 And the body’s response to the drug (pharmacodynamics)
Adverse effects – negative or undesirable effects of the drug.
Core Ethical Principles
Three core ethical principles are relevant to research involving human subjects:
1. respect for persons- Patients should be treated as independent persons who are capable of
making decisions in their own best interests. Patients with diminished decision-making capacity
are entitled to protection.
2. Beneficence- is the duty to protect research subjects from harm. It involves assessing potential
risks and possible benefits and ensuring the benefits are greater than the risk.
3. Justice- requires that the selection of research subjects be fair. Research must be conducted so
that the distribution of benefits and burdens is equitable (i.e., research subjects reflect all social
classes and racial and ethnic groups).
Sources of DRUGS
 Plants
 Animal products
- Genetic Engineering is the process of altering DNA which permits scientists to produce
human insulin by altering Escherichia coli bacteria, making insulin a better product without
some of the impurities that come with animal products.
 Inorganic Compounds
Aluminum - to decrease gastric acidity, management of hyperphosphatemia, prevention of
formation of phosphate urinary stones
Fluoride – prevention of dental cavities, prevention of osteoporosis
Gold – treatment of rheumatoid arthritis
Iron – treatment of iron deficiency anemia
Phases of Drug Development
Preclinical Trials
Chemicals that may have therapeutic value are tested on laboratory animals for two main purposes:
1. To determine whether they have the presumed effects in living tissue
2. To evaluate any adverse effects
At the end of the preclinical trials, some chemicals are discarded for the following reasons:
3. The chemical lacks therapeutic activity when used with living animals
4. The chemical are too toxic
5. The chemical is highly teratogenic
6. The safety margins are so small
Phase I studies
- Use human volunteers to test the drugs
- Volunteers are fully informed of possible risks and may be paid for their participation.
At the end of phase I Studies, many chemicals are dropped from the process for the following
reasons:
- They lack therapeutic effect on humans
- They cause unacceptable adverse effects
- They are highly teratogenic
- They are too toxic
Phase II studies
Allow clinical investigators to try the drug in patients who have the disease that the drug is meant to
treat.
At the end of phase II studies, a drug may be removed from further investigation for the following
reasons:
- It is less effective than anticipated
- It is too toxic when used with patients
- It produces unacceptable adverse effects
- It has low low benefit-to-risk ratio
- It is no more effective than other drugs already on the market, making the cost of
continued research and production less attractive to the drug company
Phase III studies and Phase IV studies
- Involve use of the drug in a vast clinical market.
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- Continual evaluation of the drug
- An approved drug is given a brand name (trade name) by the pharmaceutical company that
developed it.
- The generic name is the original designation that the drug was given when the drug
company applied for the approval process.
- Chemical names are names that reflect the chemical the chemical structure of the drug.
FDA Pregnancy Categories
Category A - Adequate studies in pregnant women have not demonstrated a risk to the fetus in the
first trimester of pregnancy, and there is no evidence of risk in later trimesters
Category B - Animal studies have not demonstrated a risk to the fetus but there are no adequate
studies in pregnant women, or animal studies have shown an adverse effect, but adequate studies in
pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy,
and there is no evidence of risk in later trimesters.
Category C - Animal studies have shown an adverse effect on the fetus but there are no adequate
studies in the benefits from the use of the drug in pregnant women may be acceptable despite its
potential risks, or there are no animal reproduction studies and no adequate studies in humans.
Category D - There is evidence of human fetal risk, but the potential benefits from the use of the drug
in pregnant women may be acceptable despite its potential risks.
Category X - Studies in animals or humans demonstrates fetal abnormalities or adverse reactions;
reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any
possible benefit.
Drug Enforcement Agency (DEA) Schedules of Controlled Substances
Schedule I (C-I)
- High abuse potential and no accepted medical use (heroin, marijuana, LSD
– Lysergic acid Diethylamide)
Schedule II (C-II) - High abuse potential with severe dependence liability (narcotics, amphetamines,
and barbiturates)
Schedule III (C-III) - Less abuse potential than schedule II drugs and moderate dependence liability
(nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
Schedule IV (C-IV) - Less abuse potential than schedule III and limited dependence liability (some
sedatives, antianxiety agents, and non – narcotic analgesics)
Schedule V (C-V) - Limited abuse potential. Primarily small amounts of narcotics (codeine) used as
antitussives or antidiarrheals.
(01) Heroin- A highly addictive analgesic drug derived from morphine, often used illicitly as a narcotic
producing euphoria.
(02) Marijuana- “cannabis” is a psychoactive drug that produces pleasant feeling of being relaxed
(03) LSD- Psychedelic drug wherein its effects typically include intensified thoughts, emotions, and
sensory perceptions
(04) Narcotics- Are also called opioid pain relievers. Often used for pain that is severe.
(05) Morphine- An analgesic and narcotic drug obtained from opium and used medicinally to relieve
pain
(06) Amphetamines- Stimulator of the Central Nervous System
(07) Barbiturates- CNS depressants. They reduce the activity of nerves causing muscle relaxation.
Usually barbiturates can reduce heart rate, breathing, and blood pressure.
(08) Sedatives- Promoting calm or inducing sleep
(09) Antianxiety- Medications that reduces anxiety
(10) Antiitussive- Medicines that suppress coughing also known as cough suppressants
Over – the – counter drugs (OTC) – are products that are available without prescription for self-
treatment of a variety of complaints.
Several problems related to OTC drug use that nurses should consider:
- Taking these drugs could mask the signs and symptoms of underlying disease, making diagnosis
difficult
- Taking these drugs with prescription medications could result in drug interactions and interfere with
drug therapy
- Not taking these drugs as directed could result in serious overdose.
Pharmacodynamics- Is the science dealing with interactions between the chemical components of
living systems and the foreign chemical, including drugs that enter the systems.
Drug usually work in four ways:
1. To replace or act as substitutes for missing chemicals
2. To increase or stimulate certain cellular activities
3. To depress or slow cellular activities
4. To interfere with the functioning of foreign cells, such as invading microorganisms or neoplasm.
Receptor sites
- The receptor sites react with certain chemicals to cause an effect within the cell.
- The interaction between the chemical and the receptor site affects enzyme systems within the cell.
- The activated enzyme systems then produce certain effects, such as increased or decreased cellular
activity, changes in cell membrane permeability, or alterations in cellular metabolism.
Pharmacokinetics- Involves the study of absorption, distribution, metabolism, and excretion of the
drugs.
Critical Concentration- The amount of a drug that is needed to cause a therapeutic effect.
Dynamic Equilibrium
-The actual concentration that a drug reaches in the body results from a dynamic equilibrium
involving several factors:
 Absorption from the site of entry
 Distribution to the active site
 Biotransformation (matabolism) in the liver
 Excretion from the body
Absorption- Refers to what happens to a drug from the time it is introduced to the body until it
reaches the circulating fluids and tissues.
Drugs can be absorbed into cells through various processes, which include:
Passive diffusion – the major process through which the drugs are absorbed in the body.
Active transport – is a process that uses energy to actively move a molecule across a cell
membrane.
Filtration – involves movement through pores in a cell membrane, either down a
concentration gradient or as a result of the pull of plasma protein.
Administration
Route:
 IV (Intravenous)- Drugs that are injected IV reach their full strength at the time of
injection, avoiding initial breakdown.
 IM (Intramuscular)- Drugs that are injected IM are absorbed directly into the capillaries
in the muscle and sent into circulation.
 SC (Subcutaneous)- Subcutaneous injections deposit the drug just under the skin, where
it slowly absorbed into circulation.
 PO (oral)- Patients can easily continue their drug regimen at home when they are taking
oral medications.
 PR (rectal)- Uses rectum as a route for medication administration which are absorbed by
the rectum’s blood vessel and flow into the body’s circulatory system which distributes
the drug to the body system.
 Mucous membranes (sublingual, buccal)
 Topical (skin)-Topical administration can be made available directly at the intended site
of action and because systemic circulation is not reached in great concentration, the risk
of systemic side effects is reduced.
 Inhalation- Medication administered through inhalation are dispersed via an aerosol
spray, mist, or powder that patients inhale Into their airways.
Distribution- Involves the movement of a drug to the body tissues.
Factors affecting the distribution
 Drug’s lipid solubility
 Ionization
 Perfusion of the reactive tissue
Blood-Brain Barrier
 The blood brain barrier is a protective system of cellular activity that keeps foreign
invaders, poison, etc away from the CNS.
Placenta and Breast Milk
 Must be given if it outweighs the risk

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