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87 Cards in this Set

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Labeling Requirement for Children
-Statements on pediatric use of a drug for an INDICATION approved for adults must be based on substantial evidence derived from adequate and well-controlled studies, unless the requirement is waived.
Midazolam (Versed) in children
-higher risk of serious life-threatening situations in children with 1. Congenital Heart Disease and 2. Pulmonary Hypertension who need lower doses than predicted to prevent respiratory compromise.
Etodolac (Lodine) in children
-Recognition of a need for a dose of two (2) to three (3) times (in mg/kg) the dose used in adults for effective treatment of childhood arthritis
Gabapentin (Neurotin) in children
-Need to use HIGHER doses in children less than five (5) years old in order to control seizures and new adverse events such as hostility and aggression identified in children less than twelve (12) years.
Propofol (Diprivan) in children
-Increased mortality when used for pediatric ICU sedation; concomitant administration with fentanyl MAY result in serious slowing of the heart rate
Sevoflurane (Ultane) in children
-NEW PRECAUTION about the potential of the product to cause seizures in children without a previous history of such
Buspirone (Buspar) in childen
-efficacy NOT ESTABLISHED AT THE DOSE STUDIED IN PEDIATRIC CLINICAL TRIALS.
What is a neonate?
-a newborn infant, especially one less than four (4) weeks old
What is an Infant?
-birth to twelve (12) months
What is a Toddler?
-12 to 36 months (1 to 3 years)
What are "Children" ?
-individuals less than 12 years old.
---children 6-12 months
---children 1-12 years of age
What is an Adolescent?
-Teenagers, age 13-19
Over-the-Counter for Pediatrics
-How much to give
-How often to give it
-What is the medication
-WARNINGS about the medication
-IS THE DRUG SAFE FOR KIDS? ...if no dose for children under 12, ask doctor of pharmacist
-If the medication has ALCOHOL in it, (ie cough and cold syrups) may want to double-check with DR
Cough and Cold Products in children under 2 years
-DO NOT USE unless given SPECIFIC directions to do so by a healthcare provider
Giving Children meds packaged for Adults
-Do not give children medications that are packaged and made for adults
Too Much Medicine for Children
-too much medicine may lead to serious and life-threatening side effects, especially in children aged 2 years and younger
Liquid products for kids
-Use the measuring device that is packaged with the medicine.

-a Kitchen teaspoon is NOT appropriate for measuring child's meds
What if you don't have a measuring device for your child's medication?
-Purchase one at the pharmacy!
-Make sure the dropper has markings on it that match the dosing that is in the DIRECTIONS in the "Drug Facts" box on the package label or is recommending by the child's health care provider
Do cough and cold medicines treat the common cold?
-NO. Cough and cold medicines only treat the SYMPTOMS of the common cold such as runny nose, congestion, fever, aches, and irritability.
-Children get better with time. :)
What if my child's condition worsens or does not improve?
-STOP USING THE PRODUCT and immediately take the child to a HCP for evaluation
"OFF-LABEL" Use
-using a drug that has not been tested in children.

-Most drugs have NOT been tested in children

-Only 20-30% of drugs approved by the FDA are labeled for pediatric use
Off-Label Use and the Pediatric Patient
-the child is "IN AN EXPERIMENT" with every use
Consequences of "Off-Label" Use
-UNDERTREATMENT: failure of therapy
-OVERTREATMENT: toxicity

-Inappropriate dose and use may lead to effect on GROWTH and DEVELOPMENT

-Drug safety for pediatric patients cannot be adequately assessed from adult studies!
BEST PHARMACEUTICALS FOR CHILDREN Act
-an Act to amend the Federal Food, Drug and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children
Considerations for Pediatric Patients regarding medications
-Difficulty swallowing Tablets

-NPO

-Poor GI absorption

-Need to discharge or problematic, IV access

-Flavor/taste
What is so special about Children?
-Children are a work in progress

-Vast changes occur in :
=Physiology
=body size/composition
=growth and development
=cognitive/motor function
=Special Organ System Maturation
How "Growth and Development" can affect drug disposition and action in Children?
-Developmental changes in metabolism (includes the phase I and phase II enzyme activities)

-Body composition (water and lipid partitions)

-Receptor expression and function

-Growth Rate

-Organ functional capacity
Increased Toxicity in Children
-Chloramphenicol in the newborn

-tetracyclines in infants and children

-benzyl alcohol containing IV fludis in premies/neonates
Decreased Toxicity in Children
-aminoglycosides in the newborn

-acetaminophen acute overdose in young children
Aspirin and Children
-Children and Teenagers should NEVER take aspirin or products containing other salicylates if:
--they have chickenpox
-flu symptoms
-recovering from these or other viruses
Reye Syndrome
-associated with aspirin use in children

-can result form aspirin use during or after viral infections such as flu or chickenpox.

-Reye is a RARE but SERIOUS condition that can cause death.
Why Compound for Kids?
-extemporaneous formulations are important for infants and young children that cannot swallow tablets or capsules

-These patients also require DOSES BASED ON BODY WEIGHT, and fixed doses in tablets or capsules intended for adults CANNOT be given to infants or children.
Excessive use of Sorbitol or Propylene glycol in Child products
-should be avoided as sorbitol can lead to diarrhea and propylene glycol can lead to HYPEROSMOLARITY
Palatability of an extemporaneous formulation
-this should be assessed because a palatable formulation is more likely to improve a patients compliance and minimize SPILLAGE during administration of doses.
5-Point Scale of Facial Expressions
-used to assess palatability of formulations in peds
Suggested Flavors To Mask Salty
-Cinnamon, raspberry, orange, maple, butterscotch, licorice
Suggested Flavors to Mask Sweet
-Fruit, berry, vanilla
Suggested Flavors to Mask Sour/Acid
-fruit, citrus, cherry
Suggested Flavors to Mask Bitter
-cocoa, chocolate, mint, cherry, walnut, licorice, raspberry, tutti fruity
Suggested Flavors to Mask Oily
-wintergreen, peppermint oil, lemon, anise
Suggested Flavor for Metallic
-Mint, marshmallow
Suggested Flavor for Antibiotics
-cherry, maple, pineapple, orange
Suggested Flavor for Antihistamines
-apricot, cherry, cinnamon, grape, honey
Suggested Flavor for Decongestants and Expectorants
-anise, apricot, butterscotch, cherry
Suggested Flavor for electrolyte and geriatric solutions
-cherry, grape, lemon-lime
What do people use to measure liquid medicine??
-75% use household teaspoons
Common medication error in children
-ALL of them involve dosing errors
Common Dosing instruments for kids
-syringes
-droppers
-cylindrical dosing spoons
-dosage cups
Cherry Syrup NF
-Cherry Juice 475 mL
-Sucrose 800g
-Alcohol 20mL <-----
-purified water qs ad 1000mL
Alcohol in children 6-12 months
-5 to 10mL (1 to 2 teaspoons) preceded or followed by 120 to 240mL (1/2 to 1 cup) of water
Alcohol in children aged 1-12 years
-15mL (1 tablespoon) preceded or followed by 120 to 240 mL (1/2 to 1 cup) of water
Alcohol in adolescents and adults
-15 to 30 mL (1 to 2 tablespoons) FOLLOWED IMMEDIATELY by 240mL (1 cup) of water
Ethanol in Liquid preps for kids
-can cause major toxicity and neuronal dysfunction
Too much Alcohol concentration in children
25mg/100ml (25%mg)
Avoiding Alcohol Problems in Children
-Never give enough to produce ethanol concentration of 25mg/100mL

-Children < 6 years should be monitored by physicians when using products containing alcohol

-Change dosing interval to avoid alcohol accumulation

-SAFETY CLOSURES
When can we compound for ANIMALS?
-no effective FDA approved products available

-when available dosing forms are inappropriate

-multiple and concurrent disease states are present

-minimize side effects

-when economic realities would preclude treatment with the approved product (Vet driven)

-when compounding would encourage compliance of dosage/therapeutic regimens
A complete Vet Label requires
-Name and address of attending Vet
-Date dispensed
-Medically active ingredients
-Identity of animal(s) to be treated (species, class, group, or individual animals)
-Directions for use
-Cautionary statements if needed
-Slaughter-withdrawal times and/or milk withholding times, if appropriate
-ADDITIONAL INFO on LABEL:
---Disease conditions to be treated
---Expiration date
Acetaminophen and Animals
-should NOT be administered to CATS due to a deficiency in glucuronyl transferase, required to metabolize the drug.....death may occur
Differences in Animal Hydration
-during sickness, some animals maintain their hydration while others do not

-This alters the drug distribution within the bodies as well as metabolism and excretion
Metabolism of Drugs and Excretion Rates in Animals
-differs from animal to animal

-urinary pH of herbivores is slightly alkaline

-urinary pH of carnivores is slightly acidic
Dogs and their differences
-short GI tract (2hours)
-longer intestinal villi, resulting in greater absorption

-higher bile salt secretion, increasing the solubility of some poorly water soluble drugs
-dogs have a higher pH in the intestine...resulting in better absorption of drugs that are WEAK BASES
-Dogs have lower basal acid secretion than people
Food-Producing Animals and the Considerations
-Legal requirements concerning Drug Residues

-Short-half-life drugs are often chosen...they are readily eliminated from the animal prior to market

-Not only concerned with welfare of the animal, but also for public health.
Routes of Administration for Animals
-Oral
-Parenteral
-Implants
-Intramammary
-Topical
-Body Cavity
Novel Delivery Systems for Animals
-Boluses
-Lick Blocks
-Rumen Retention
-Collars that release toxins/meds that are absorbed into the animals subQ fat
Common Foods Poisonous or Dangerous for Dogs
-Alcohol = toxic
-Chocolate = CNS and cardiac toxicity
-Coffee and Tea = Caffeine
-Ham Fat Trimmings = Pancreatitis
-Grapes & Raisins = Kidney Damage
-Milk & Dairy Products = >50% of dogs are lactose intolerant
-Onions and Garlic = Hemolytic Anemia
BCP VetChews
-soft, easy to chew, medicated pet treats which are custom compounded to the vet's specifications
Popular VetChew Medications
-prednisolone
-methimazole
-metronidazole
-atenolol
-amlodipine
-diethylstilbestrol
-phenylpropanolamine
-cisapride
Amitriptyline for Pets
-used for behavior problems
-Urine spraying for male cats is a big problem that can be solved using this med
-Transdermal formulations of both buspirone and amitriptyline are routinely advertised by vet compounding pharmacies.
PLO Gel for Pets
-penetration enhancer

-"pleuronic lecithin organogel"

-ingredients in PLO act as surfactants, emulsifiers, and solubilizing agents
Vet Chews
-Shelf-life : 6 months
-store in a sealed plastic bag at room temp. Store away from extreme heat.

-Give directly as a treat or mix with food
Insulin for Dogs and Cats
-Porcine insulin has three amino acid differences and is structurally closest to canine insulin.

-Cats accept bovine insulin much better because it is most like their own.

-Desirable to administer one dose per day, better compliance
Zoonosis (Zoonotic disease)
-diseases that can be passed from animals, whether wild or domesticated, to humans
Methods of Transmission for Zoonosis
-coming in contact with ANIMAL WASTE
-direct contact with infected animals
-some diseases spread by drinking water that contains parasite eggs
-Tapeworms are spread by eating the infected flesh of animals
-insect vectors: flea or ticks
Anthrax Zoonotic Disease
-a disease of warm blooded animals, particularly cattle and sheep.

-causes severe skin and lung damage
Bovine Spongiform Encephalopathy
-progressive fatal disease of the nervous system of domestic animals.
-transmitted by eating infected food
Lyme Disease
-acute disease usually marked by skin rash, fever, fatigue, and chills

-if untreated, can result in cardiac and nervous system damage
Q-Fever
-high fever, chills, and muscle pain

-spread by drinking raw milk or tick bites
Bats Zoonotic Disease
-rabies

-carry several other viral infections that can be spread to humans
Cats Zoonotic Disease
-can carry the causative organisms for the plague, anthrax, cowpox, tapeworm, and many bacterial infections
Dogs Zoonotic Disease
-plague, tapeworm, rabies, Rocky Mountain Spotted Fever, and Lyme Disease
Horses Zoonotic Disease
-anthrax, rabies, and Salmonella infections
Cattle Zoonotic Disease
-anthrax, European tick-borne encephalitis, rabies, tapeworm, Salmonella infections and many bacterial and viral disease
Pigs Zoonotic Disease
-tapeworm, anthrax, influenza, and rabies
Sheep Zoonotic Disease
-rabies, European tick borne encephalitis, Salmonella infections and many bacterial and viral infections
Rabbits Zoonotic Disease
-plague and Q Fever
Birds Zoonotic Disease
-Chlamydia, Pasteurella, Histoplasma
What is "Compounding"
-The preparation of Components into a Drug product 1.) as the result of a Practitioner's Prescription Drug Order or initiative based on the Practitioner/patient/Pharmacist relationship in the course of professional practice or 2.) for the purpose of, or as an incident to , research, teaching or chemical analysis and not for sale or Dispensing. Compounding also includes the preparation of Drugs or Devices in anticipation of receiving Prescription Drug Orders based on routine, regularly observed prescribing patterns.