o Definition of Terms Pharmacology refers to the study of drugs, its chemical and biochemical properties, and its physiologic

c effects to the body. Toxicology the study of the adverse effects of chemicals (e.g., drugs) in living organisms. Pharmacotherapeutics area/branch of pharmacology that deals with the use of specific drugs to prevent treat or diagnose diseases. Drugs Any substance or group of substances that is used as medicine o Sources of Drugs Plants Sources Examples include digitalis (foxglove plant) and opium (opium poppies). Animal Sources Glandular products from animals are used, such as insulin and thyroid. Inorganic Compounds These are elements that have therapeutic effects in the human body like aluminum that act as antacid. Synthetic Sources These are artificially produced or duplicated substances using different compounds. Examples include barbiturates, amphetamines, sulfonamides and aspirin o Uses of Drugs To maintain health To reverse a disease process To relieve symptoms To prevent disease To prevent pregnancy o Drug Evaluation The process at which drugs are classified as either therapeutic or nontherapeutic depending on the process of evaluation the drugs undergo and the approval of the governing agency. Drug Approval Process The Food and Drug Administration (FDA) of the United States is the agency in-charge of monitoring the use of drugs as well as its development. In the Philippines, the counterpart of FDA is The Bureau of Food and Drug Administration (BFAD). The concerns of these agencies are two-fold: Whether the drugs are effective Whether the drug is safe for human use Drugs for approval should pass through four stages of new drug development. Stages of New Drug Development Preclinical study Begins with the discovery, synthesis and purification of the drug. Preclinical testing uses laboratory studies to know whether the experimental drug has therapeutic value and whether these drugs appear to be safe in animals. Clinical Study This is the testing in humans stage. Clinical study is subdivided into three phases: 1. Phase I - drug is tested in relatively small number of healthy volunteers. Initial information about the effects of the drug on humans is determined. 2. Phase II - drug is tested in a small, selected population (10 to 150 subjects) to evaluate the therapeutic effect of the drug in treating a specific disease or pathologic condition. 3. Phase III - clinical study is expanded to include more clients (several hundredths to several thousandths) as well as more evaluators. It provides information on proper dosing and safety. New Drug Application (NDA) review If the result of the clinical study indicates that the drug being study is safe and effective, the drug is submitted to FDA for new drug application. Post clinical study 1. Known as the postmarketing surveillance it is the final stage of drug approval process. 2. It surveys the drugs harmful effects.

o Drug Classifications Therapeutic Use or Clinical Indications example: antibiotics, laxatives, diuretics, and antacids Physiologic or Chemical Action example: beta-adrenergic blockers, anticholinergics, cholinergics, and calcium channel blockers Prescribed (Ethical) Drugs are drugs considered to be requiring prescriptions. They are ordered or dispensed only by an authorized practitioner. Non-prescription (Non-ethical) Drugs Drugs available over the counter (OTC) or not requiring any prescription for use and can be purchased directly by the consumer. Illegal drugs It is sometimes referred to as recreational drug. Illegal drugs are substances that have not been approved by FDA/BFAD. o Legal Regulations of Drugs Pregnancy Categories reviews drug labeling information on pregnancy and risk effects to the fetus. Controlled Substances The Comprehensive Drug Abuse Prevention and Control Act of 1970 commonly known as the Controlled Substance Act is designed to improve the administration and regulation of manufacturing, distribution, and dispensing of drugs found necessary to be controlled. The Drug Enforcement Administration (DEA) is organized to enforce the Controlled Substances Act, gather intelligence, train and conduct research in the area of dangerous drug and drug abuse. The Controlled Substances Act consists of five classifications or schedules of controlled substance. The degree of control, the condition of record keeping, and the particular order form required, and other regulation depends on these classifications. Generic Drugs A drug which is produced and distributed without patent protection. These are drugs which may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. Orphan Drugs these are drugs that have been discovered but are not financially viable and therefore have not been adopted by any drug company o Drug Nomenclature Chemical Name Refers to the specific chemical structure (atomic or molecular) of the drug. Chemical names of drugs are quite confusing due to the long and complicated chemical terms that are difficult to remember. Generic Name The original distinction given to a drug when the drug company applied for the approval process. Also known as the official name or nonproprietary name. Trade Name Assigned to the chemical compound by the pharmaceutical company which may or may not bear any reference to the chemical or generic names. Marketed when the drug is under patent. Trade names often suggest a characteristic of the drug. For example, Lopressor lowers blood pressure, Vivactil is an antidepressant that might make a person more vivacious, Glucotrol controls high blood sugar (glucose) levels, and Skelaxin relaxes skeletal muscles. Sometimes, the trade name is simply a shortened version of the drug's generic name for example, Minocin for minocycline DRUG FORMULATIONS AND ROUTES OF ADMINISTRATION o Drug Formulation Drug formulation is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. o Route of Administration Route of administration is a way of administering a drug to a site in a client

Enteral Drugs Refers to drugs that are administered through the alimentary canal, (orally, sublingually or rectally) which undergoes the processes of absorption, distribution, metabolism, and excretion. Oral (per orem, PO) Formulations of Oral Drugs 1. Tablet usually a compressed preparation that contains: a. 5-10% of the drug (active substance) b. 80% of fillers, disintegrants, lubricants, glidants, and binders c. 10% of compounds which ensure easy disintegration, disaggregation, and dissolution of the tablet in the stomach or the intestine. Advantages a. Easy and convenient to use. b. Accurate in measured dosage in a portable convenient package. c. It is designed to protect unstable medications or disguise unpalatable ingredients. d. Colored or stamped coatings for easy recognition. Disadvantage: Tablets cannot be used adequately in emergency cases because its rate in which the active ingredient reaches the site to be treated is slow. 2. Capsule a small soluble container usually made of gelatin, which encloses a dose of an oral medicine or a vitamin. Advantages a. Bad taste is eliminated. b. Can contain time-released drug that will not cause abdominal upset. c. Can be stored easily. Disadvantages a. Difficult to swallow. b. There is delay in absorption and effect of the drugs. 3. Liquid a substance in a fluid form and having no fixed shape but with fixed volume Types a. syrup a thick, sweet, sticky liquid b. powder suspension drugs that has to be mixed with water or fluid c. ready-mixed suspension forms drugs that are available in pre-mixed form, all it needs is to be shaken d. elixir is a sweet flavored liquid used in compounding medicines to be taken orally in order to cover an unpleasant taste and intended to cure one's disease Advantages a. The easiest method for self-administration. b. Safest route of administration because drugs enter the system in controlled manner which avoids large, sudden increase in plasma levels that can occur in intravenous injection. Disadvantages a. Highly lipid soluble in order to pass through the gastric mucosa into the blood stream. b. Drug tends to degrade and be destroyed before absorption due to acid environment of the digestive tract. c. These drugs also suffer the first-pass effect where the drugs in the blood stream absorbed from the alimentary canal are transported directly to the liver through the portal vein. d. Some drugs are highly irritating to the gastric mucosa that leads to discomfort such as nausea and vomiting. e. The amount and rate at which the drug eventually reaches the blood stream is less predictable compared with direct routes such as injections. f. Gastric absorption is altered by intestinal infection, presence of food, gastric emptying and amount of visceral blood flow. Sublingual (SL) and Buccal Sublingual route - drugs are placed under the tongue and are absorbed through the oral mucosa into the venous system. Buccal route drugs are placed in the oral cavity between the gum and cheek Formulations of Sublingual Drugs

1. Tablets a small and usually round hard piece of medicine. 2. Gels a solid, jelly-like material that can have properties ranging from soft and weak to hard and tough. A colloidal form of matter having a jelly-like texture, usually formed by cooling a colloidal solution into a solid. Advantages a. Highly absorbent. b. Shows degree of flexibility similar to natural tissues. Disadvantages: Becomes liquid or fluid when agitated 3. Thin Film a. A thin sheet drug formulation. b. It is also referred as orally dissolving thin film. c. Has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with prescription and OTC (over-the counter) medications. Similar in size, shape and thickness to a postage stamp, thin film strips are typically designed for oral administration, with the person placing the strip on or under the tongue or along the inside of the cheek. Advantages a. They are carried directly into the heart and into the systemic system without being subjected to the first pass inactivation in the liver. b. Being more direct, drug action is often faster, and it ensures that the substance will risk degradation only by salivary enzymes before entering the bloodstream. c. Offers enteral administration for individuals who have difficulty swallowing or where rectal administration is not possible. Disadvantages a. Amount of drug to be administered is limited. b. Must be able to pass through the oral mucosa to reach the venous drainage of the mouth. Rectal drugs that are administered via the anus or rectum Types of Rectal Formulation 1. Rectal Suppositories a small plug of medication designed for insertion into the rectum where it melts to induce defecation. Advantages a. Given to clients where oral administration is contraindicated, like in clients who are vomiting or unconscious. b. Most often used for treating local conditions such as hemorrhoids. Disadvantages a. Less favorable route as drugs are poorly or incompletely absorbed. b. Irritation of rectal mucosa occurs. Parenteral Drugs Drugs that are administered other than the alimentary canal is considered to be parenterally administered: Inhalation route by which medication is inhaled or breathed in. Any drug or solution of drugs administered (by means of nebulizers or aerosols) by the nasal or oral respiratory route. Forms of Inhalation 1. Gaseous or volatile drugs. 2. Suspended tiny droplets in an aerosol. 3. An inhaler or puffer is a medical device used for delivering medication into the body via the lungs. 4. A nebulizer is a device used to administer medication to people in the form of a mist inhaled into the lungs. It is commonly used in treating cystic fibrosis, asthma, and other respiratory diseases. 5. Jet nebulizers or atomizers turn liquid medication into an aerosol, by means of a pressurized air with high velocity, which is then inhaled by the client. Advantages of Inhalation a. Pulmonary administration offers large surface alveolar area for diffusion of drug into pulmonary circulation. b. Rapid entry of drug to the blood stream. c. Direct application of drug to the bronchial tree and alveolar tissues. d. Fastest method, 7-10 seconds for the drug to reach the brain.

e. User can titrate (regulate) the amount of drug they are receiving. Disadvantages of Inhalation a. Difficult to administer; some clients have difficulty in using inhalers. b. Particles are trapped in the cilia and mucus in the respiratory tract. c. There are drugs that serve as irritant to alveoli and respiratory tract. d. Unpredictable amount of drugs delivered to the lungs. e. Most addictive route of administration because it hits the brain so quickly. f. Difficulties in regulating the exact amount of dosage. Injection The drug is introduced to the body either systemically or locally. The liquid form of the drug is administered by means of a syringe puncturing the body and administered in the veins termed as intravenous (IV), in the muscle or intramuscular (IM), and subcutaneous (subcutaneously or below the epidermis). Forms of Injection 1. Liquid for injection intravenously (within the veins). 2. Liquid for injection intra-arterially (within the arteries). 3. Liquid for injection subcutaneously (directly beneath the skin). 4. Liquid for injection intramuscularly (within the large muscles). 5. Liquid for injection intrathecally (within the sheath or at the spinal subarachnoid space) Advantages of Injection 1. Outcome can be predicted in a short period of time. 2. Reach the target sites rapidly. 3. Drugs given intra-arterially are used to localize drugs into certain tissues with few exposure of drug to other tissues. 4. Effective for administration of radio opaque dyes for diagnostic purposes. 5. Effects seen within few minutes. 6. Convenience in one time administration that has a long acting effect (e.g., Depo-Provera, a birth control shot that works for three months). Disadvantages of Injection 1. Self-administration may be difficult with most of the injection routes. 2. There could be high risk for addiction due to the quick onset of action of most injectable drugs. 3. There is risk of HIV and other infectious diseases transmission if needles are accidentally shared. 4. It is the most dangerous route of administration because the drug is not screened by the body's natural defenses, placing the client at risk of developing hepatitis, abscesses, and infections, from undissolved particles or additives/contaminants. 5. Risk of air boluses (bubbles) which can be fatal may occur during drug administration especially when drugs are not prepared properly. 6. Need for observing strict asepsis as this provided a port of entry for microorganisms that can cause infection. Topical/Dermatologic these are drugs that are applied to the surface of the skin or mucous membranes 1. Iontophoresis use of electric current to drive the ionized form of medications through the skin 2. Phonophoresis use of ultrasound waves as driving force to propel the drug through the dermis. Forms of Topical/Dermatologic Drugs a. Ointments i. A viscous semisolid preparation used topically on a variety of body surfaces (skin, mucous membranes of the eye, vagina, anus, nose). ii. An ointment may or may not be medicated. iii. Combination of oil (80%) and water (20%). iv. Effective barrier against moisture loss. b. Cream emulsion of oil and water in approximately equal proportions. Penetrates stratum corneum and outer layer of skin. c. Gel liquefies upon contact with the skin. d. Paste i. Combines three agents oil, water, and powder ii. An ointment in which a powder is suspended.

e. Powder a solid substance or medicine in the form of tiny loose particles that has been pulverized f. Liniment a medicinal liquid that is rubbed into the skin to relieve muscular stiffness and pain. g. Lotion a liquid preparation having a soothing or antiseptic or medicinal action when applied to the skin. h. Transdermal patch Medication placed on a piece of soft material that is applied directly through the skin and are absorbed by percutaneous means. i. Epicutaneous application onto the skin (e.g. allergy testing, typical local anesthesia). Advantages of Topical/Dermatologic Drugs 1. Applied directly to skin or to membranes to treat itself. 2. Bypasses systemic absorption. 3. Direct action 4. Easy to apply 5. Safe and effective method of administering medications. 6. Provides a slow, controlled release of the drugs into the body. 7. Effective in maintaining plasma levels at constant levels for prolonged period of time. Disadvantages Topical/Dermatologic 1. Poorly absorbed systemically through epidermis and are not intended for systemic treatment. 2. Some drugs applied to the mucous membranes are also absorbed to some degree that may cause adverse effects. 3. Drugs that cannot penetrate the skin will unlikely be an effective agent administered by this route. 4. Drugs that are easily degraded by the enzymes present in the skin will cause failure of the drug to meet its therapeutic effects. Instillations and Irrigations instillation is the route of administration for drugs in drop form or drugs administered into the body cavity by means of catheter and stays in place after administration, while irrigation is a means of administering drugs that stays for a while and are removed minutes after it is administered. 1. Ophthalmic Administration route of administration for eye medications. Eye drops are saline-containing liquid used as a vector to administer medication in the eye. Depending on the condition being treated, they may contain steroids or topical anesthetics. Advantages Direct contact of the drug on the target site. Disadvantages a. Intolerance to bright light. b. Excess and over frequent application of eye drops can often discourage the eyes to make tears naturally, resulting in an increasing reliance on the drug. 2. Otic administration ear drops, such as antibiotics and corticosteroids, for otitis externa. Advantages Has direct contact to the affected site. Disadvantages Client has to be kept in position (head tilted slightly toward the unaffected side) for 2-3 minutes to facilitate the drops to reach the affected area. 3. Nasal administration intranasal route (into the nose), e.g., decongestant nasal sprays. Advantages Has direct contact to the affected site. Disadvantages Client may become uncomfortable when asked to maintain position (head tilted backward) for 5 minutes after instillation of drops. 4. Vaginal administration vaginal, e.g. topical estrogens, antibacterial medications. Advantages Has direct contact to the affected site. Disadvantages May cause severe vaginal wall irritation. 5. Rectal administration (please refers to the discussion on rectal under enteral drugs). Advantages a. Direct contact of the drug on the target site.

b. Ease in application. Disadvantages a. Excess application cannot be prevented. b. Vaginal and rectal suppositories melts easily even before application.

PHARMACOKINETICS Pharmacokinetics is derived from two Greek words: pharmakon which means drug or poison and kinesis which means motion. Pharmacokinetics is the study of drug movement throughout the body. o Absorption This refers to what happens to a drug from the time it is introduced to the body until it reaches the circulating fluids and tissues. Definition of Terms Related to Pharmacokinetics o Critical concentration amount of a drug that is needed to cause therapeutic effect; this must be maintained in order for the drug to produce the desired therapeutic effect in the body. o Loading dose the starting dose that is higher than the dose usually used for treatment; this is given so that the time for a drug to reach its critical concentration will be hasten. o Dynamic equilibrium the result when the drug reaches in the body and actual concentration of the drug is achieved involving the processes of absorption, distribution, metabolism, and excretion. Processes involve in drug absorption Passive diffusion the major process through which drugs are absorbed in the body; movement is from higher concentration to lower concentration; does not require energy for a drug to move across a membrane. Facilitated diffusion requires a carrier (an enzyme or protein) to move the drug across a concentration gradient. Active transport a process that uses energy to actively move a drug molecule across a cell membrane. Pinocytosis a process by which cells carry the drug across their membrane by engulfing the drug particles. Factors that affect drug absorption in the body Circulation/blood perfusion on the site of absorption poor circulation due to shock, vasoconstrictor drugs, or disease hampers absorption. Temperature cold causes vasoconstriction and decreases absorption; heat causes vasodilation and increases absorption. Drug solubility the quality or condition of being soluble or the amount of a substance (water or oil) that can be dissolved in a given amount of solvent. Lipid-soluble drugs can be easily absorbed than watersoluble drugs that usually need a carrier to be able to pass through lipid membranes. Rate Limiting the time it takes the drug to disintegrate and dissolve to become available for the body to absorb it 1. Disintegration the breakdown of a tablet into smaller particles 2. Dissolution the dissolving of the smaller particles into the GI fluid before absorption; the rate of dissolution is affected by the acidity of the GI tract First-pass effect the process in which the drug passes to the liver first, which results to a large percentage of the oral dose being destroyed, never reaching the tissues. 1. Drugs taken orally are absorbed from the small intestine directly into the portal venous system. 2. The absorbed molecules from the drug is delivered by the portal vein into the liver, which instantly transforms most of the chemicals delivered to it by a series of liver enzymes. 3. The enzymes break the drug into metabolites, some of which are still active and cause effects into the body, while some are deactivated and can be excreted in the body.

o Distribution The process by which the drug becomes available to body fluids and body tissues. Factors affecting drug distribution Tissue permeability 1. The more lipid soluble the drug is, the higher its ability to reach all cells in the body. 2. A large non-lipid substance will remain primarily in the compartment or tissues to where it is administered. 3. Blood-brain barrier limits the movement of drugs out of the bloodstream and into the central nervous system tissue as the brain capillary endothelium have special characteristics that limit the passage of drugs. Blood flow If a drug is circulating in the blood stream, it will gain greater access to tissues that are highly perfused. Therefore, if the blood circulation is poor, the result is insufficient drug distribution. Binding to plasma proteins Certain drugs reversibly bind to circulating albumin proteins in the blood stream. The fraction of the drug that remains bound to the albumin is not available for therapeutic purposes in other tissues and organs. This fact is significant because only the unbound or free drug is able to reach the target tissue and exert its pharmacologic effect. Binding to sub-cellular components Similar to plasma protein binding, there are drugs that are bound within specific cells in which they are causing their effect and are unable to leave the cell to be carried in the blood stream. o Metabolism (Biotransformation) The process by which drugs are changed into new, less active chemicals. o Excretion This refers to the manner at which the drug leaves the body. Factors affecting drug excretion Urine pH this varies from 4.5 to 8; Blood flow decreased blood flow to the kidney may result to decrease glomerular filtration rate (GFR) or decreased renal tubular secretion making drug elimination slowed or impaired. Half-life (of a drug) is the time it takes for one-half of the drug concentration to be eliminated. PHARMACODYNAMICS This is the science dealing with interaction between the chemical components of living systems and the foreign chemicals, including drugs that enter the system. Primary Effect the desirable effect; the immediate and first action of the drug producing one group of symptoms. Secondary Effect may be desirable or undesirable; a response that is not primarily a drug effect but can be caused mainly by the organisms reaction to the primary effect/action. o Drug-Response and Maximal Efficacy Drug-response the relationship between the minimal versus the maximal amount of drug dose needed to produce the desired drug response.

Some clients respond to a lower drug dose while others need a high drug dose to elicit the desired response. Maximal Efficacy all drugs have a maximum drug effect, although ones drug maximal efficacy can be higher or lower than another drug, this could depend on the chemical make-up of the drugs. o Onset, Peak and Duration of Action Onset of action the time it takes to reach the minimum effective concentration after a drug is administered Peak action occurs when the drug reaches its highest blood or plasma concentration Duration of action the length of time the drug has a pharmacologic effect. o Receptor Sites the specific areas in the cell membrane where drugs are thought to act Drug-binding sites in the cell membrane are primarily on proteins, glycoproteins, proteolipids, and enzymes. Drug acts through receptors by binding to the receptor to produce a response or to block a response. The activity of many drugs is determined by the ability of the drug to bind to a specific receptor. The better the drug fits at the receptor site, the more biologically active the drug is. Some types of drug effect: Agonists and Antagonists 1. Agonist binds with a receptor site where the drug has an affinity and activates the receptor resulting to a positive desired action or function of the cell mimicking the substance that normally activates the site. 2. Antagonist drugs that only bind with the receptor site so that the substance that normally binds to it and causes an action is prevented from binding, thus no changes in the functions of the cell will occur. They are also known as blockers of receptor sites. Nonspecific and Nonselective Drug Effects 1. Nonspecific drugs these are drugs that affect various sites and have properties of nonspecificity. These drugs also have nonspecific responses which evoke a variety of response throughout the body, which could be either desirable or harmful. 2. Nonselective drugs drugs that affect various receptors or have properties of nonselectivity. Categories of Drug Action Stimulation or depression the drug action in stimulation increases the rate of cell activity or the secretion from a gland; in depression, cell activity and function of a specific organ are reduced. Replacement drugs that replace essential body compounds (e.g., insulin) Inhibition or killing of organisms drugs that interfere bacterial cell growth Irritation drugs that act as irritants to increase specific organ functions (e.g., laxatives) o Therapeutic Index and Therapeutic Range Therapeutic Index (TI) estimates the margin of safety of a drug through the use of a ratio that measures the effective (therapeutic) dose in 50% of persons or animals and the lethal

dose in 50% of persons or animals. Low therapeutic index drugs that have a narrow margin of safety. With these, drug dosage might need adjustment and the serum (plasma) drug levels need to be monitored because of the small range of safety. High therapeutic index drugs that have a wide margin of safety and less danger of producing toxic effects; serum drug levels need not to be routinely monitored. Therapeutic Range (Therapeutic Window) this is measurement of drug concentration in the blood plasma, which should be between the maximum effective concentration and the minimum toxic effect. O Peak and Trough Levels Peak drug level the highest plasma concentration of drug at a specific time; indicates the rate of absorption of the drug. If the drug is given orally, the peak time might be 1 to 3 hours after drug administration. If the drug is given intravenously, the peak time may occur in 10 minutes. A blood sample should be drawn at the proposed peak time, according to the route of administration. Trough level the lowest plasma concentration of a drug, it measures the rate at which the drug is eliminated. These are drawn immediately before the next dose of drug is given, regardless of the route of administration. Peak and trough levels are requested for drugs that have narrow therapeutic index and are considered toxic. If either the peak or trough level is too high, toxicity can occur. If the peak is too low, no therapeutic effect is achieved. O Other (Toxic) Effects of Drugs in the Body Side Effects physiologic effects not related to the desired drug effects; even with a correct drug dosage, side effects occur and are predicted. Adverse Effects more severe than side effects; undesired effects that may be unpleasant or even dangerous, and can occur for a number of reasons such as: The drug may have other effects on the body besides the therapeutic effect. The client is sensitive to the drug being given. The drugs action in the body causes other responses that are undesirable or unpleasant. The client is taking too much or too little of the drug, leading to adverse effects. Primary Actions effects that are merely an extension of the desired effect Secondary Actions a wide variety of effects in addition to the desired pharmacologic effect Hypersensitivity excessive responsiveness to either the primary or secondary effects of a drug; this may result from a pathologic or underlying condition Drug Allergy occurs when the body forms from antibodies to a particular drug, causing an immune response when the person is exposed to the drug; there are different types of allergies such as: Anaphylactic Reaction this involves an antibody that reacts with specific sites in the body to cause the release of chemicals.

Cytotoxic Reactions this involves antibodies that circulate in the blood and attack antigens (the drug) on cell cite causing death of that cell; this reaction is not seen immediately. Serum Sickness Reaction this involves antibodies that circulate in the blood and cause damage to various tissues by depositing in blood vessels; may occur after a week or more after the exposure to the drug. Delayed Allergic Reaction this occurs several hours after exposure and involves antibodies that are bound to specific white blood cells. Drug-Induced Tissue and Organ Damage Dermatologic Reactions these are adverse reactions involving the skin, such as rashes, hives or stomatitis; many adverse reactions involve the skin because many drugs can deposit in the skin or cause direct irritation to the tissue. Superinfections occurs when several drugs like antibiotics, destroy the normal flora leading to the development of infections caused by the usually controlled organisms in the body. Blood Dyscrasia is bone marrow suppression caused by drug effects; this occurs when drugs that can cause cell death are used causing the rapidly multiplying bone marrow cells to die. Toxicity 1. Ototoxicity 2. Hepatotoxicity 3. Nephrotoxicity 4. CNS depression Alterations in Glucose Metabolism 1. Many common therapeutic agents influence glucose metabolism. Multiple mechanisms of action on glucose metabolism exist through pancreatic, hepatic, and peripheral effects. 2. Based on circumstances at the time of use, a drug may cause both hyper- and hypoglycemia to a client. 3. The client's previous pancreatic reserve, nutritional state, use of other medication, or exposure to alcohol may influence the direction of the plasma glucose alterations. Electrolyte Imbalances most commonly seen during diuretic use leading to hypokalemia, hyponatremia and hypochloremic alkalosis. DOSAGE CALCULATIONS o Posology the medical or pharmacological study of dosages of drugs; the study of dosage quantity and prescription. Usual recommended dose Minimum dose Maximum dose Toxic dose Lethal dose Single dose Daily dose Maintenance dose Loading dose o Systems of Measurement

Metric System The most widely used system of measurement. A decimal system based on the power of ten. This system uses the grams as the basic unit of solid measures and liter as the basic unit of liquid measure. (See Student Handout Table for the Metric Units of Measurement) Apothecary System This system uses Roman numerals instead of Arabic numbers to express quantity. A very old system of measurement that was specifically developed for use by apothecaries or pharmacist. The apothecary system uses the minim as the basic unit of liquid measures and grain as the basic unit of solid measure. Household System Household measurement is not as accurate as the metric system because of lack of standardization of spoons, cups and glasses. This system uses the teaspoon as the basic unit of fluid measure and the pound as the basic unit of solid measure. Body Surface Area (BSA) This method is considered to be the most accurate way to calculate the drug dose for infants, children, older adults, and clients who are on antineoplastic agents or whose body weight is low. The BSA, in square meters (m2), is determined by where the persons height and weight intersect the nomogram scale. (See Student Handout Nomogram) To calculate the drug dosage using this method, multiply the drug dose by the number of square meters. o Pediatric Considerations for Drug Calculations Frieds Rule Youngs Rule Clarks Rule Surface Area Calculation THE Rs (RIGHTS) OF DRUG ADMINISTRATION o Right Client o Right Drug o Right Dose o Right Time o Right Route o Right Assessment o Right Documentation o Right to Education o Right Evaluation o Right to Refuse the medication

FDA PREGNANCY CATEGORIES The Food and Drug Administration (FDA) has established five categories to indicate the potential for a systematically absorbed drug to cause birth defects. The key differentiation among the categories rests on the degree (reliability) of documentation and the risk-benefit ratio. 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 late 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 trimester. CATEGORY C 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 human. 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 demonstrate fetal abnormalities or adverse reaction; reports indicate evidence of fetal risk. The risk of use in pregnant women clearly outweighs any possible benefit. Regardless of the designated Pregnancy Category or presumed safety, no drug should be administered during pregnancy unless it is clearly needed. DEA SCHEDULES OF CONTROLLED SUBSTANCES SCHEDULE I (C-I) High abuse potential and no accepted medical use. Examples: heroin, marijuana, lysergic acid diethylamide (LSD) SCHEDULE II (C-II) High abuse potential with severe dependence liability. Examples: narcotics, amphetamines, and barbiturates SCHEDULE III (C-III) Less abuse potential than schedule II drugs and moderate dependence liability. Examples: nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of narcotics SCHEDULE IV (C-IV) Less abuse potential than schedule III and limited dependence liability. Examples: some sedatives, antianxiety agents, and non-narcotic analgesics SCHEDULE V (C-V) Limited abuse potential. Primarily small amounts of narcotics (codeine) used as antititusives or antidiarrheals. Under federal law, limited quantities of certain schedule V drugs may be purchased without prescriptions directly from a pharmacist. The purchaser must be at least 18 years of age and must furnish suitable identification. All such transactions must be recorded by the dispensing pharmacist.
Adapted from Karch, A.M. (2006). Focus on Nursing Pharmacology, 3rd edition. Philadelphia. Lippincott Williams & Wilkins