Science which deals with the interactions between the chemical components of living systems and the foreign chemicals including drugs that enter those systems

- Involves the study of absorption, distribution, metabolism, biotransformation and excretion of drugs - Include onset of drug action, drug half life, timing of the peak effect, duration of drug effects, metabolism or biotransformation of the drugs and site of excretion

- Study of the biological effects of the chemicals. - Focus on how chemicals act on living organism.

SOURCES OF DRUGS

To become a drug, a chemical must have a demonstrated therapeutic value of efficacy without severe toxicity or damaging propertiesTo become a drug, a chemical must have a demonstrated therapeutic value of efficacy without severe toxicity or damaging properties

It is a products are used to replace human chemicals that fail to be produced due to disease or genetic problems

(LEAVES) The leaves of Digitalis Purpurea are the source of

(LEAVES) TOBACCO leaves give

(LEAVES) ATROPA BELLADONNA gives

(FLOWERS) POPPY PAPAVER SOMNIFERUM gives

(FLOWERS) VINCA ROSEA gives

(FLOWERS) ROSE gives

(FRUITS) SENNA POD gives

(FRUITS) CALABAR BEANS give

(SEEDS) Seeds of NUX VOMICA give

(ROOTS) IPECACUANHA ROOT

(ROOTS) RAUWOLFIA SERPENTINA gives

(BARK) CINCHONA BARK gives

(BARK) HYOSCYAMUS NIGER gives

(STEM) CHONDRODENDRON TOMENTOSUM gives

it is used to replace human chemicals that fail to be produced due to disease or genetic problems

Cow and pig pancreas tissue is a source of Insulin, used in treatment for?

it is used as a source of vitamin A and D

suspensions of killed, modified, or attenuated microorganisms

• Antacid to decrease gastric acidity • Management of hyperphosphatemia • Prevention of the formation of phosphate urinary stones

Prevention of dental caries

Treatment of rheumatoid arthritis

Treatment of iron deficiency anemia

Scientist used genetic engineering to alter bacteria to produce chemicals that are therapeutic and effective

This process is timely controlled by the United States Food and Drug Administration, an agency of the United States Department of Health and Human Services that regulate the development and sale of drugs

carefully monitors new drug development

(PHASES OF NEW DRUG DEVELOPMENT) Test on laboratory animals (a) to determine whether they have the presumed effects in living tissue (b) to evaluate any adverse effects

(PHASES OF NEW DRUG DEVELOPMENT) • Test on healthy human volunteers • Are tightly controlled that pre-clinical trials and are performed by specially trained clinical investigators • The volunteers are fully informed of the possible risk and may be paid for their participation • Usually, the volunteers are healthy, young men

(PHASES OF NEW DRUG DEVELOPMENT) • Trials with people who have the disease which drug is thought to be effective • Patients are told about the possible benefit about the drug and are invited to participate in the study • Those who consent to participate are fully informed about possible risk and are monitored very closely • After the Phase II studies

(PHASES OF NEW DRUG DEVELOPMENT) • Use drug in vast clinical market for surveillance of drug’s therapeutic effects • Prescribers are informed of all the known reactions to the drug and precautions required for its safe use • Prescribers observe patients very closely, monitoring them for any adverse effects • Sometimes, prescribers ask patient to keep journals and record any symptoms they experience • Prescribers then evaluate the reported effects to determine whether they are caused by the disease or by the drug • This information is collected by the drug company that is developing the drug and shared with the FDA

(PHASES OF NEW DRUG DEVELOPMENT) • FDA continually evaluates drugs in the market • Prescribers are obligated to report to the FDA any untoward or unexpected adverse effects associated with the drugs they are using • The FDA continually evaluates this information • Some drugs cause unexpected effects that are not seen untoward distribution occurs. Sometimes, those effects are therapeutic

• also called trade or proprietary name • given by the pharmaceutical company that developed it

original designation that the drug company applied for the approval process

reflect the chemical structure of a drug

the drug _________, sleeping aid by pregnant women, many babies were born with limp deformities (Kefauver-Harris Act, 1962)

1930s – the drug _________ (sulfanilamide) was distributed in a vehicle of Ethelyn Glycol which was toxic to humans (Federal Food, Drug and Cosmetic Act, 1938)

(PREGNANCY CATEGORIES) • 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. • levothyroxine, folic acid, magnesium sulfate

(PREGNANCY CATEGORIES) 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. • Metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin

(PREGNANCY CATEGORIES) • Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; 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. • tramadol, gabapentin, amlodipine, prednisone

(PREGNANCY CATEGORIES) • Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; 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. • tramadol, gabapentin, amlodipine, prednisone

(PREGNANCY CATEGORIES) • 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. • Lisinopril, alprazolam, losartan,

(PREGNANCY CATEGORIES) • Studies in animals or humans demonstrate fetal abnormalities or adverse reaction; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit. • Atorvastatin, simvastatin, warfarin, methotrexate

it is responsible for the enforcement of these regulations

(DEA SCHEDULES OF CONTROLLED SUBSTANCES) High abuse potential and no accepted medical use [heroin, marijuana, lysergic acid diethylamide (LSD), ecstasy]

(DEA SCHEDULES OF CONTROLLED SUBSTANCES) High abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates)

(DEA SCHEDULES OF CONTROLLED SUBSTANCES) Less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

(DEA SCHEDULES OF CONTROLLED SUBSTANCES) Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and non-narcotic analgesics)

(DEA SCHEDULES OF CONTROLLED SUBSTANCES) Limited abuse potential. Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals.

• When a drug received approval from marketing from the FDA, the drug formula is given a time limited patent • The length of time on which the patent is good depends on the type of chemical involved • When the patent runs out on a brand name drug, the drug can be produced by other manufacturers • Generic drugs are chemicals that are produced by companies involved solely in the manufacturing of drugs because they don’t have the research, advertising or sometimes the quality control departments that pharmaceutical companies have, they can produce the generic drugs more strictly • Are drugs no longer protected by patent and can be produced by companies other than the one that developed it • Sold under their chemical names not brand names • Production is cheaper = cheaper meds

Have been discovered but not financially viable because of limited market or narrow margin of safety

• Available without prescription • Are deemed safe when used as directed • For self-treatment of various complaints • The FDA is currently testing the effectiveness of many of these products and in time will evaluate all of them

Package inserts (drug literature)

Interaction at the cellular level between a drug and cellular components

Response resulting from this drug action

• Specific areas on cell membranes that react with certain chemicals to cause an effect within the cell. • In many situations, nearby enzymes breakdown the reacting chemicals and open the receptor sites for further

Reacts with certain chemicals to cause an effect within the cell

Reacts with receptor sites but block normal stimulation producing no effect

Reacts with specific receptor sites on a cell and , by reacting there, prevent the reaction of another chemical with a different receptor site on that cell

Ability of the drug to attack only those systems found in foreign cells (pathogen or neoplastic) without affecting healthy human cells

• After a drug is administered, its molecules first must be absorbed into the body; then they make their way to the reactive tissues. If a drug is going to work properly on these reactive tissues, and thereby have a therapeutic effect, it must attain a sufficiently high concentration in the body. • Amount of drug that is needed to cause a therapeutic effect • Basis of the recommended dosage

Amount of drug to immediately provide a therapeutic effect or reach critical concentration

a drug used to increase the strength of heart contractions—and many of the xanthine bronchodilators (e.g., theophylline) used to treat asthma attacks are often started with a loading dose (a higher dose than that usually used for treatment) to reach the critical concentration. ABSOR

refers to what happens to a drug from the time it is introduced to the body until it reaches the circulating fluids and tissues.

→ Requires no cellular energy → Moves from a higher to lower concentration → Oral drugs (from GIT blood stream) → _________is the major process through which drugs are absorbed into the body.

• Requires cellular energy to move drugs from lower to higher concentration • Used to absorb electrolytes such as Na & K • Transport fat soluble vitamins (ADEK) • is a process that uses energy to actively move a molecule across a cell membrane.

• If only a few cells separate the active drug from systemic circulation, absorption occurs rapidly, and drug quickly reaches therapeutic level • Sublingual, IV, Inhalation

• Oral, IM, SQ - slower rate of absorption • Due to complex membrane systems of GI mucosal la

slow rate at which contents leave stomach and enter intestine

cause interactions that may increase or decrease absorption

Refers to movement of a drug from the systemic circulation into tissues.

it is a protective system of cellular activity that keeps many things away from the CNS.

• Also called Biotransformation • Process by which body change a drug from its dosage form to a more water-soluble form that can be excreted

• A mechanism wherein liver metabolizes much of the drug before it enters circulation • Lower the amount of active drug released into systemic circulation

• Elimination of drugs from circulation • Kidneys through urine-major site • Other exit points of drugs → liver, lungs, into breast milk, through saliva, tears & sweat

•Time it takes for the plasma concentration of a drug to fall to half of its original value •Time it takes for one half of the drug to be eliminated by the body

Time from administration until therapeutic effect begins

varies depending on route of administration and other pharmacokinetic properties

Maximum blood concentration level achieved through absorption

Length of time the drug produces its therapeutic effect

Unwanted or potentially harmful drug effects (all drugs have one or MORE adverse reactions in addition to producing a desired effect).

TYPES OF DRUG EFFECTS → overdosage, extension of the desired effect → One of the most common occurrences in drug therapy is the development of adverse effects from simple overdose. In such cases, the patient suffers from effects that are merely an extension of the desired effect. For example, an anticoagulant may act so effectively that the patient experiences excessive and spontaneous bleeding. This type of adverse effect can be avoided by monitoring the patient carefully and adjusting the prescribed dose to fit that particular patient’s needs.

TYPES OF DRUG EFFECTS undesired effects produced in addition to the pharmacologic effect

TYPES OF DRUG EFFECTS excessive response to primary or secondary effect of drug

TYPES OF DRUG EFFECTS Occurs when the body forms antibodies to a particular drug, causing an immune response when the person is re-exposed to the drug.

TYPES OF DRUG EFFECTS • A sudden, potentially life-threatening allergic reaction that involves the whole body • An emergency condition • This allergy specific sites in the body to cause the release of chemicals, including histamine, that produces immediately reactions (mucous membrane swelling and constricting bronchi) that can lead to respiratory disease stress and even respiratory arrest

TYPES OF DRUG EFFECTS • Causing cell death • Not immediate but may be seen over a few days • This allergy involves antibodies that circulate in the blood and attack antigens (the drug) on cell sites, causing death of that cell. This reaction is not immediate but may be seen over a few days.

TYPES OF DRUG EFFECTS • Occurs a week or more after exposure to a medication • This allergy involves antibodies that circulate in the blood and cause damage to various tissues by depositing in blood vessels. This reaction may occur up to 1 week or more after exposure to the drug

TYPES OF DRUG EFFECTS • Occurs after several hours of exposure • This reaction can occur several hours to days after exposure and involves anti- bodies that are bound to specific white blood cells