Harm to a patient caused by a therapeutic or preventive intervention. It could be due to a medication error or adverse drug reaction.
Define
Adverse drug reaction
An undesirable response to a drug by a patient. It may vary in severity from mild to fatal.
Define
Agonist
A drug that brings about a specific action by binding with the appropriate receptor.
Define
Antagonist
A drug that inhibits a specific action by binding with a particular receptor.
Define
Compounding
Any manipulation (e.g., diluting, combining) performed to produce a dosage-form drug, other than the manipulations described in the directions for use on the labeling of an approved drug product.
Define
Drug
A substance used to diagnose, prevent, or treat disease.
Define
Efficacy
The extent to which a drug causes the intended effects in a patient.
Define
Extralabel use
The use of a drug that is not specifically listed on the U.S. Food and Drug Administration (FDA)-approved label.
Define
Half-life
The amount of time (usually expressed in hours) that it takes for the quantity of a drug in the body to be reduced by 50%.
Define
Manufacturing
The bulk production of drugs for resale outside of the veterinarian–client–patient relationship.
Define
Metabolism
The biochemical process alters a drug from an active form to a form that is inactive or that can be eliminated from the body.
Interchangeable with Biotransformation
Define
Biotransformation
The biochemical process that alters a drug from an active form to a form that is inactive or that can be eliminated from the body.
Interchangeable with Metabolism.
Define parenteral administration
By a route other than the alimentary canal (e.g., intramuscular, subcutaneous, intravenous).
Define
Parenteral
The route of administration of injectable drugs.
Define
Partition coefficient
The ratio of the solubility of substances (e.g., gas anesthetics) between two states in which they may be found (e.g., blood and gas, gas and rubber goods).
Define
Legend drug
A drug that is limited to use under the supervision of a veterinarian because of potential danger, difficulty of administration, or other considerations. The legend that designates a prescription drug states the following: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
Interchangeable with Prescription drug
Define
Prescription drug
A drug that is limited to use under the supervision of a veterinarian because of potential danger, difficulty of administration, or other considerations. The legend that designates a prescription drug states the following: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
Interchangeable with Legend Drug
Define
Regimen
A program for administration of a drug that includes the route, the dose (how much), the frequency (how often), and the duration (for how long) of administration.
Define
Residue
An amount of a drug still present in animal tissue or products (e.g., meat, milk, eggs) at a particular point (slaughter or collection).
Define
VCPR
The set of circumstances that must exist between the veterinarian, the client, and the patient before the dispensing of prescription drugs is appropriate.
Define
Withdrawal time
The length of time it takes for a drug to be eliminated from animal tissue or products after it is no longer used.
Define
contraindications
Anything (including a symptom or medical condition) that is a reason for a person to not receive a particular treatment or procedure because it may be harmful.
Define
indications
a symptom that suggests certain medical treatment is necessary.
Define
pharmacotherapeutics
the application of pharmacological information together with the knowledge of the disease for its prevention, mitigation or cure.
Define
pharmacokinetics
the branch of pharmacology concerned with the movement of drugs within the body.
Define
pharmacodynamics
the branch of pharmacology concerned with the effects of drugs and the mechanism of their action
Define
toxicity
Toxicity refers to how poisonous or harmful a substance can be. In pharmacology, drug toxicity occurs when a patient has accumulated too much of a prescription drug in their bloodstream, leading to negative effects.
Traditional sources of drugs are:
plants and minerals
The names of alkaloids usually end in
-ine
The names of glycosides usually end in
-in
Examples of alkaloids include
Atropine
Caffeine
Nicotine
Examples of glycosides are
Digoxin
Digitoxin
Define
Inactive ingredients
An inactive ingredient is any non-active ingredient in a medicine. These might mask a bitter taste or preserve a medicine until its expiration date. Some inactive ingredients are essential for a medicine to function as intended.
What are the 12 classifications of inactive ingredients as defined by the Wanamaker textbook
Glycerin, glycerol, glycerol triacetate, and sorbitol
Examples of the inactive ingredient Preservatives
Citric acid, glycerol, potassium benzoate, sodium benzoate, and others
Examples of the inactive ingredient Sweetening agents
Aspartate, fructose, glycerin, sorbitol, sucrose, and xylitol
Examples of the inactive ingredient
Methylcellulose, povidone, sorbitol, and others
Federal law and sound medical practices dictate that prescription drugs should not be dispensed indiscriminately. Before prescription drugs are issued or extralabel use is undertaken, a valid veterinarian–client–patient relationship must exist.
What are three of these conditions that were stated in your textbook?
•The veterinarian has assumed responsibility for making clinical judgments about the health of the animal(s) and the need for treatment, and the client has agreed to follow the veterinarian's instructions.
•The veterinarian has sufficient knowledge of the animal(s) to issue a diagnosis. The veterinarian must have seen the animal recently and must be acquainted with its husbandry.
•The veterinarian must be available for a follow-up evaluation of the patient.
Define over-the-counter drugs
Drugs that do not have enough potential to be toxic or that do not require administration in special ways do not require the supervision of a veterinarian for administration.
Define controlled substances
Drugs that have the potential for abuse or dependence.
Must be kept in a locked storage area.
What are the seven responsibilities for carrying out verbal or written orders from a vet as outlined by your textbook?
1. Ensuring that the correct drug is being administered
2. Administering the drug by the correct route and at the correct time
3. Carefully observing the animal's response to the drug
4. Questioning any medication orders that are not clear
5. Creating and affixing labels to medication containers accurately
6. Explaining administration instructions to clients
7. Recording appropriate information in the medical record
Define
Loading Dose
a loading dose is an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose. A loading dose is most useful for drugs that are eliminated from the body relatively slowly, i.e. have a long systemic half-life
Define
Steady state
The point at which drug accumulation equals drug elimination.
This equilibrium represents the state where the amount of drug leaving the plasma for tissue equals the amount of drug leaving the tissue for the plasma.
Interchangeable with distribution equilibrium.
Define
distribution equilibrium
The point at which drug accumulation equals drug elimination.
This equilibrium represents the state where the amount of drug leaving the plasma for tissue equals the amount of drug leaving the tissue for the plasma.
Interchangeable with steady state.
Define
Therapeutic drug monitoring
Drug levels can be measured in blood, urine, cerebrospinal fluid, and other appropriate body fluids to help a veterinarian determine whether an appropriate level has been achieved
What are the 5 primary factors that influence blood concentration levels of a drug and the patient's response to it as outlined by your textbook?
•Rate of drug absorption
•Amount of drug absorbed
•Distribution of the drug throughout the body
•Drug metabolism or biotransformation
•Rate and route of excretion
What are the 5 ways the choice of administration is selected for a patient as outlined by your textbook?
•Available pharmaceutic form of the drug
•Physical or chemical properties (irritation) of the drug
•How quickly onset of action should occur
•Use of restraint or behavioral characteristics of the patient
•Nature of the condition being treated
Oral medications may be given via
placed directly in the mouth.
via a tube passed through the nasal passages (nasogastric tube).
via a tube passed through the mouth (orogastric tube).
Oral medications are absorbed via
The mucosa of the digestive tract is a large absorptive surface area with a rich blood supply.
Drugs given orally are absorbed slower than drugs administered via
any injection method
Factors that can influence drug absorption orally include:
• the pH of the drug
• the pH of the stomach
• its solubility (fat vs. water)
• the size and shape of the molecule
• the presence or absence of food in the digestive tract
• the degree of gastrointestinal (GI) motility
• the presence and nature of disease processes
Drugs given orally are not typically suitable for patients who:
are vomiting or have diarrhea
Drugs that are given medications orally typically have what length of effect compared to medications given via injection
Drugs given by this route generally produce a longer lasting effect than those given by injection.
Name the 10 parenteral injection routes as outlined by your textbook
• Intravenous (IV)
• Intramuscular (IM)
• Subcutaneous (SC)
• Intradermal (ID)
• Intraperitoneal (IP)
• Intraarterial (IA)
• Intraarticular
• Intracardiac
• Intramedullary
• Epidural/subdural
Drugs given by the intravenous route produce the most ______ onset of action, accompanied by the _____ duration
Drugs given by the intravenous route produce the most rapid onset of action, accompanied by the shortest duration
Medications that are irritating to tissue generally are given by this route because of the diluting effect of blood.
Intravenous
Intravenous medications should be administered slowly to lessen the possibility of ______________________
Intravenous medications should be administered slowly to lessen the possibility of a toxic or allergic reaction
Oil-based drugs and those with suspended particles (i.e., those that look cloudy or thick) generally should not be given __________
Oil-based drugs and those with suspended particles (i.e., those that look cloudy or thick) generally should not be given intravenously
Define phlebitis
Phlebitis is the inflammation of a vein, which results in redness, swelling, and pain
The intramuscular route of administration produces a ________ onset of action than the intravenous route and usually provides a ________ duration of action
The intramuscular route of administration produces a slower onset of action than the intravenous route but usually provides a longer duration of action
For IM injections, onset of action are relatively fast with _____ forms but can be slower with other forms or vehicles such as ________.
The onset of action by this route can be relatively fast with a water-based form (aqueous) and is slower with other diluents (vehicles) such as oil or with other forms such as microfine crystals.
Define
depot preparation
special preparation of the medication, which is given by injection. The medication is slowly released into the body over a number of weeks.
The subcutaneous route produces a _______ onset of action and a _______ duration than the intramuscular route.
The subcutaneous route produces a slower onset of action but a slightly longer duration than the intramuscular route.
Irritating or hyperosmotic solutions (i.e., those with a greater number of suspended particles than are found in body fluid) should not be given by this route.
subcutaneous
Quantities of medications that are appropriate for the species or individual being treated should be used to prevent possible dissection of the skin from underlying tissue, which could lead to ________________
Quantities of medications that are appropriate for the species or individual being treated should be used to prevent possible dissection of the skin from underlying tissue, which could lead to death or loss (sloughing) of surface skin.
The intradermal route involves injecting a drug into the skin. This route is used in veterinary medicine primarily for testing for _______ and _________.
The intradermal route involves injecting a drug into the skin. This route is used in veterinary medicine primarily for testing for tuberculosis and allergies.
The onset and duration of action of drugs given by this route are variable
intraperitoneal
This route is used to administer fluids, blood, and other medications when normal routes are not available or are not practical.
intraperitoneal
Problems such as adhesions and puncture of abdominal organs may be caused by this method.
intraperitoneal
intraarterial route involves injecting a drug directly into an
intraarterial route involves injecting a drug directly into an artery.
This route seldom is used intentionally, but this may happen by mistake.
intraarterial
Administration of drugs into the jugular vein of a horse must be done with caution to avoid injection into this underlying structure.
carotid artery.
Intracarotid injection results in delivery of a high concentration of the drug directly to the brain,which can result in :
seizures or death
This method is used primarily to treat inflammatory conditions of the joint.
intraarticular
This route is used to inject drugs through the chest wall directly into the chambers of the heart.
intracardiac
This provides immediate access to the bloodstream and ensures that the drug is delivered quickly to all tissue in the body. This method is often used in cases of cardiopulmonary resuscitation and in euthanasia.
intracardiac
This method is often used in cases of cardiopulmonary resuscitation and in euthanasia.
intracardiac
This route is seldom used in veterinary medicine and involves injecting directly into the bone marrow
intramedullary route
The bones most often used fro the intramedullary route are
humerus and femur
This route usually is used to provide blood or fluids to animals with very small or damaged veins or for treatment of animals with very low blood pressure.
intramedullary
When spinal anesthesia is provided, drugs may be injected into what two spaces
epidural or subdural space
Where is the epidural space
he epidural space is outside the dura mater (meninges) but inside the spinal canal
Where is the subdural space
The subdural space is inside the dura mater
Another name an injection into the subdural space
intrathecal route
Examples of drugs that may be given via inhilation
anesthetics, antibiotics, bronchodilators, and mucolytics.
Topical medications can be be given via these routes
the skin, applied to the mucosa of the oral cavity (sublingual), the rectum (suppositories), the uterus, the vagina, the mammary glands, the eyes, and the ears.
define
proud flesh
Research has found that horses have the ability to produce granulation tissue in wounds quite rapidly when compared to other animals. When granulation tissue grows out and protrudes from the wound, then the granulation tissue is known as proud flesh.
Drugs generally are absorbed more ______ through the skin than through other body membranes
slowly
This method is used most commonly to administer an analgesic in a slow, continuous manner or to administer compounded drugs to animals when oral administration may be difficult (e.g., cats).
Transdermal
a form of topical administration that involves the use of a patch applied to the skin to deliver a drug through intact skin directly into the blood.
Transdermal
define
bioavailability
the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect.
Explain the difference between a generic drug and a trademark drug
Because of manufacturing differences, the generic equivalent form of a drug may differ somewhat from a trademark form in overall efficacy
Name some f actors that affect the absorption process
• Mechanism of absorption
• pH and ionization status of the drug
• Absorptive surface area
• Blood supply to the area
• Solubility of the drug
• Dosage form
• Status of the GI tract (motility, permeability, and thickness of the mucosal epithelium)
• Interaction with other medications
Define
passive absorption
Passive absorption (transport) occurs by simple diffusion of a drug molecule from an area of high concentration of drug on one side of the membrane to an area of lower concentration on the other side. This method requires no expenditure of energy by the cell.
The drug may pass through small pores in the cell membrane or may dissolve into the cell membrane on one side, pass through the membrane, and exit on the other side.
For example, a disintegrated tablet or capsule results in a high concentration of drug in the GI tract.
This concentration then passes through the cellular membranes of intestinal villi and adjacent capillaries, and the drug then appears in lesser concentration in the bloodstream.
Alternatively, a drug may cross a membrane passively with the help of a carrier.
What is P-glycoprotein (P-gp)
Best described drug transporter.
Produced a t MDR1 (ABCB1 gene)
Uses ATP as an energy source to pump drugs from cells
Found in most mammalian tissue.
Useful in intestinal, renal, placental, liver and brain tissue where it pumps drugs away from these protected sites.
Pumps drugs into the intestine, bile, or urine for elimination or away from the fetus or brain.
Define
Active Transportation
drugs across cell membranes moves molecules from an area of lower concentration to an area of higher concentration and requires that the cell use energy.
The usual mechanism for the absorption of sodium, potassium, and other electrolytes
Active transport
Define
Pinocytosis
the ingestion of liquid into a cell by the budding of small vesicles from the cell membrane.
Third method of passive transport
The method of absorption that occurs in a particular situation depends on whether the drug is fat soluble or water soluble, the size and shape of the drug molecule, and the degree of ionization of the drug.
Pinocytosis
The absorption of basic (pH) drugs is more favorable in an ______ environment
alkaline
If a drug is placed in an environment in which it readily ionizes, such as a mildly acidic drug in an alkaline environment or a mildly alkaline drug in an acidic environment, it ______________.
it does not diffuse and may become trapped in that environment.
One of the largest absorptive surfaces in the body is found in the _________ because the ______________
One of the largest absorptive surfaces in the body is found in the small intestine because the efficient design of the villi maximizes the surface area.
Drugs are absorbed from an intramuscular site at a _______ rate than from a subcutaneous site because _________________
Drugs are absorbed from an intramuscular site at a faster rate than from a subcutaneous site because of the proportionately greater blood supply to the muscle.
The lipid (fat) solubility of a drug tends to be directly proportional to the ________________
degree of drug nonionization
a nonionized form of a drug is ______
one that usually is absorbed
A high lipid partition coefficient indicates ___________
enhanced drug absorption.
Define
spansule
a capsule which when swallowed releases one or more medicinal drugs over a set period.
Factors that can affect the absorption of PO medications.
• degree of intestinal motility
• emptying time of the stomach,
• irritation or inflammation of the mucosa (e.g., gastritis, enteritis),
• damage to or loss of villi (e.g., viral diseases),
• composition and amount of food material,
• changes in intestinal microorganisms can affect the rate
• extent of absorbance of medications
Define
First-pass effect
The first pass effect is a phenomenon of drug metabolism at a specific location in the body which leads to a reduction in the concentration of the active drug, specifically when administered orally, before it reaches the site of action or systemic circulation.
This refers to the fact that substances are absorbed from the GI tract into the portal venous system, which delivers the drug to the liver before it enters the general circulation
Antacids may reduce the absorption of
phenylbutazone or iron products
Drugs move from the absorption site into the __________, then into the _______ that surrounds cells, then into the ______, where they combine with cellular receptors to create an action.
Drugs move from the absorption site into the plasma of the bloodstream, from the plasma into the interstitial fluid that surrounds cells, and from the interstitial fluid into the cells, where they combine with cellular receptors to create an action.
Define
concentration gradient
as the gradient increases (difference), so does the tendency of the drug to move from the area of higher concentration to the area of lower concentration.
When a drug is bound to a protein, it becomes _________________
inactive and is unavailable for binding with cell receptors or for metabolism
Tissues such as fat, liver, kidney, and bone may act as storage sites for drugs such as ___________
barbiturates, inhalation anesthetics, and others.
When a drug moves from the storage tissue back into the blood and additional doses are given, an exaggerated or prolonged effect may result because of the additive effects.
A defect in the P-gp drug transporter in the blood–brain barrier has been identified in individuals of several dog breeds and can result in toxicity. These breeds include
collies, Old English sheepdogs, Australian shepherds, Shetland sheepdogs, and English shepherds
Kidney failure (uremia) can alter the plasma binding of some drugs such as
furosemide
phenylbutazone
Liver failure can cause a reduction in the amount of _____ available for binding
protein (albumin)
eptiles have a renal–portal system that can distribute potentially toxic levels of a drug to the kidney if __________
the drug is injected into the posterior one-third of the body.
What is the function of cytochrome P450 enzymes that are found in liver cells
These enzymes induce chemical reactions that change the drug chemically to allow elimination in the urine or bile
Define metabolite
a drug that has been biotransformed
Define
Oxidation
loss of electrons
Define
Reduction
gain of electrons
Define
Hydrolysis
splitting of the drug molecule and addition of a water molecule to each of the split portions
Define
Conjugation
the addition of glucuronic acid or similar compounds to the drug molecule; when these compounds are attached to a drug molecule, the drug becomes much more water soluble.
What is involved in phase I reactions
Oxidation
Reduction
Hydrolysis
What is involved in phase II reactions
conjugation
Drugs may be processed by
both phases or only phase II
phase I reactions make drugs more _______
water-soluble and more susceptible to phase II metabolism
Phase II reactions make drugs more ______
water soluble enough for elimination by the kidneys
Cats have a limited ability to metabolize _________
aspirin, narcotics, phenols, and barbiturates
Cats have a limited ability to metabolize certain medications because of their reduced ability to form __________
glucuronic acid
Young animals have a poor ability to biotransform drugs because their
liver enzyme systems are not fully developed until around 3 months of age
Old animals have a decreased capacity to biotransform because
their ability to synthesize needed liver enzymes may be impaired
Malnourished animals have a decreased capacity to biotransform because
they have fewer protein raw materials available for use in manufacturing enzymes for biotransformation
Animals with liver disease have a decreased capacity to biotransform because
they are not able to process the raw materials available for enzyme production
A glomerulus and its corresponding tubule make up the individual functional unit of the kidney, called a nephron. A glomerulus acts like a sieve to filter drug molecules (metabolites) from the blood into the glomerular filtrate, which is then eliminated as urine
Define
tubular secretion
Kidney tubule cells secrete metabolites from the capillaries surrounding the tubule and into the glomerular filtrate, which becomes urine as it exits the kidneys
Define
Tubular reabsorption
drug molecules may be reabsorbed from the glomerular filtrate back into the blood
Residues found in milk, eggs or meat products may be dangerous to people due to the following reasons
• People may be allergic to the drug.
• Prolonged exposure to antibiotic residues can result in resistant strains of bacteria.
• Residue of some drugs may cause cancer in humans.
Define
Affinity
The tendency for a drug to combine with a receptor
Define
drug efficacy
The degree to witch the drug binds with its receptor
Define
potency
the amount of a drug needed to produce a desired response and is represented by a position long the dose-responsive curve
Define
therapeutic index
Relationship between the ability of a drug to achieve the desired effects and its tendency to produce toxic effects.
Expressed as the ratio between LD50 and ED50
What is the LD50
dose of a drug that is lethal to 50% of the animal in a dose-related trial
What is the ED50
Dose of a drug that produces the desired effect in 50% of the animals in a dose-related trial
The formula for the therapeutic index is
therapeutic index = LD50 / ED50
The larger the number for the therapeutic index, the ______
safer the drug
Some patients may react to carriers or binders of the drugs rather than the drug themselves
True
Aminoglycosides can cause harm to the kidney or eighth cranial nerve and impair hearing
True
Define
idiosyncratic drug reaction
an unusual or unexpected reaction to a drug
All adverse drug reactions should be reported to _______
the drug manufacturer or the FDA
Define
drug interaction
an altered response to a drug that is caused by the presence to a second drug
Define
Pharmacokinetic interaction
Once in which plasma or tissue levels of a drug are altered by the presence of another.
This may be due to changes in the absorption, distribution, metabolism, or excretion of another drug
Antacids and Tetracyclines together can cause
reduced absorption of tetracycline
Ketoconazole and digoxin together can cause
Decreased metabolism of digoxin
Ketoconazole and cyclosporine together can cause
Decreased metabolism of cyclosporine
Ketoconazole and tricyclic antidepressants together can cause
Decreased metabolism of keotconazole
Sucralfate and Fluoroquinolones together can cause
Reduced absorption of quinolones
Fluroquinolones and Theophylline together can casuse
Decreased metabolism of theophylline
Omeprazole and Ketoconazole together can cause
Decreased oral absorption of ketoconazole
Omeprazole and itraconazole together can cause
Decreased oral absorption of itraconazole
Phenobarbital and theophylline together can cause
Increased metabolism of theophylline (cytochrome P-450 induction)
Phenobarbital and doxycycline together can cause
Increased metabolism of doxycycline (cytochrome P-450 induction)
Phenobarbital and beta-blockers together can cause
Increased metabolism of beta-blockers (cytochrome P-450 induction)
Cimetidine and diazepam together can cause
Decreased metabolism of diazepam (cytochrome P-450 inhibition)
Cimetidine and theophylline together can cause
Decreased metabolism of theophylline (cytochrome P-450 inhibition)
MAO inhibitors and amitraz together can cause
Dangerous accumulation of biogenic amines leading to serotonin syndrome or hypertensive state
MAO inhibitors and SSRIs together can cause
Dangerous accumulation of biogenic amines leading to serotonin syndrome or hypertensive state
MAO inhibitors and tricyclic antidepressants together can cause
Dangerous accumulation of biogenic amines leading to serotonin syndrome or hypertensive state
MAO inhibitors and other MAO inhibitors together can cause
Dangerous accumulation of biogenic amines leading to serotonin syndrome or a hypertensive state
Tetracyclines and Penicillins together can cause
Tetracyclines slow bacterial growth and inhibit penicillins that are most effective against rapidly growing bacteria
It generally is recommended that mixing of drugs in the same syringe or fluid administration system should be avoided unless the drugs are known to be compatible.
True
When two drugs metabolized by the liver are given, one should anticipate a drug interaction.
True
Concurrent use of drugs from the “behavior modifying” category can cause serious problems such as serotonin syndrome or hypertensive reactions.
True
Generic name for Heartguard
Ivermectin
Trade names for Ivermectin
Heartguard
Ivomec
Eqvalan
Generic name for Ivomec
Ivermectin
Generic name for Eqvalan
Ivermectin
Trade names for Ketamine hydrochloride
Ketaset
Ketaject
Vetalar
Generic name for KEtaset
Ketamine hydrochloride
Generic name for Ketaject
KEtamine hydrochloride
Generic name for Vetalar
Ketamine hydrochloride
Trade names for Amoxicillin
Amoxil
Amoxi-tabs
Trimox
Generic name for Amoxil
Amoxicillin
Generic name for Amoxi-tabs
Amoxicillin
Generic name for Trimox
Amoxicillin
Define
Chemical name
the name that describes the molecular structure of a drug. These names are scientifically very accurate, but they are complex and impractical for use in clinical settings.
Define
Code or laboratory name
the name given to a drug by the research and development investigators. It is used for communication between research teams and consists of abbreviations and code numbers.
Define
Compendial name
the name listed in the United States Pharmacopoeia (USP). The USP is the legally accepted compendium that lists drugs and standards for their quality and purity.
Define
Official name
usually the same as the compendial or generic name.
Define
Proprietary or trade name
the name chosen by the manufacturing company. When it is registered, it is the exclusive property of the company. A name that is short and can be easily recalled is usually selected for the proprietary name. Federal copyright and trademark laws protect this name. On drug container labels, in package inserts, and in drug references, the proprietary name can be distinguished by a superscript R with a circle around it after the name.
Define
Generic name
the common name chosen by the company. It is not the exclusive right of the company. It may be the same as the official or compendial name. These are drugs with patents that have expired, or they were never patented.
What six things have to be on a drug container label?
• Drug names (both generic and trade names)
• Drug concentration and quantity
• Name and address of the manufacturer
• Controlled substance status (if applicable)
• Manufacturer's control or lot number
• Drug's expiration date
• Instructions for use
• Possible adverse effects of the drug
Comprehensive Drug Abuse Prevention and Control Act of 1970
requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs
What is an NDC number
national drug code (NDC) number. The NDC is a 10-digit number that identifies the manufacturer or distributor, the drug formulation, and the package size.
What does the EPA regulate in relation to pharmacology
The EPA regulates the development and approval of animal topical pesticides
What does the USDA regulate in relation to pharmacology
USDA regulates the development and approval of biologics (vaccines, serums, antitoxins, and similar products).
What does the EPA regulate in relation to pharmacology
The FDA regulates the development and approval of animal drugs and feed additives through its Center for Veterinary Medicine.
What is FARAD?
Food Animal Residue Avoidance Databank
What does FARAD do
FARAD provides expert advice concerning the avoidance of drug residues in an effort to achieve its goal of producing “safe foods of animal origin.” FARAD produces a compendium of FDA-approved drugs and provides information about withholding times for milk and preslaughter withdrawal times for meat
Name the phases of development of a new drug
• Preliminary Trials
• Preclinical (Animal Safety) Trials
• Clinical Trials
• Submission of a New Animal Drug Application
• Final Review by the Food and Drug Administration
• Product Monitoring
What is the Green Book
list of all animal drug products that have been approved by the FDA for safety and effectiveness
What is AMDUCA
Animal Medicinal Drug Use Clarification Act passed in 1994
What does AMDUCA state
permits veterinarians to prescribe extralabel uses of certain approved new animal drugs and approved human drugs for animals under certain
conditions.
What 10 substances and drugs are prohibited for extra-label use in all food-producing animals
• Chloramphenicol
• Clenbuterol
• Crystal (Gentian) Violet
• Diethylstilbestrol or DES
• Dipyrone
• Fluoroquinolone-class antibiotics
• Glycopeptides—all agents including vancomycin
• Nitroimidazoles—all agents, including dimetridazole, ipronidazole, metronidazole and others
• Medicated feeds
• Nitrofurans—all agents, including furazolidone, nitrofurazone and others.
What 5 substances and drugs are restricted for extra-label use in all food-producing animals
• Antiviral agents
• Cephalosporin-class antibiotics except cephapirin (cattle, chickens, pigs, and turkeys)
• Phenylbutazone (all female dairy cattle 20 months of age or older)
What class of antibiotics are restricted for use in lactating dairy cattle
Sulfonamides
What drug is restricted in all female dairy cattle 20 months of age or older
Phenylbutazone
What class of antibiotics are restricted in cattle, chickens, pigs and turkeys
Cephalosporins except for cephapirin
What is the VFD
Veterinary Feed Directive
established a new category of drugs “as an alternative to prescription status” for certain antimicrobial animal feed additives
Minor Use and Minor Species (MUMS) Animal Health Act of 2004
specifically defines the provision of labeled drugs for minor species, including sheep, goats, game birds, emus, ranched deer, alpacas, llamas, deer, elk, rabbits, guinea pigs, pet birds, reptiles, ornamental and other fish, shellfish, wildlife, and zoo and aquarium animals. MUMS is also designed to provide major species (e.g., cats, dogs, horses, cattle, swine, turkeys, chickens) with needed drugs for uncommon indications (minor uses)
What are the AVMAs six basic practices for the disposal of unwanted pharmaceuticals
1. Incinerate unwanted drugs when possible.
2. Unused drugs should be sent to the landfill when incineration is not possible
3. Never flush unwanted pharmaceuticals down the toilet or drain.
