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164 Cards in this Set
- Front
- Back
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The definition of a drug
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Substance intended for use in the diagnosis cure, mitigation, treatment, or prevention of disease in man or other animals
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The definition of a new drug
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Any drug in which the composition of which is such that this drug is not generally recognized among experts
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Device
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Not a medication
Instrument, apparatus, machine that is for the use in the diagnosis of disease or other condition |
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Prescription Drug
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habit forming
also known as Legend Drugs |
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Cosmetic
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Beautifying attractiveness
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Over the Counter Drugs
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-must contain "adequate directions for use"
-directions must be clear enough for a fifth grade reading level to understand |
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How long does a new drug application take to be approved?
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18 to 24 months
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What is the Abbreviated New Drug Application (ANDA)
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It allows companies to market generic drugs without having to prove safety and efficacy.
-must be bioequivalent |
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What is the Supplemental New Drug Application?
(SNDA) |
-A request for brand drugs to request a change in formulation.
-Have to show that it is improved, usually it is only tweaked a little bit -Do this to prolong their patent so that a generic version of it can't be made |
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What is a OTC Monograph?
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-regulation specifying the conditions under which specific ingredients may be formulated in OTC drug products without FDA approval
-they list the active ingredients ex-psuedophed is a decongestant ibuprofen is a pain releaver |
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National Drug Code (NDC)
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-number assigned when the drug is filed, to keep track of it.
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First section of the NDC # represents what?
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manufacturer or distributor
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Second Section of the NDC # represents what?
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the product
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Third Section of the NDC # represents what?
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packaging
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Adulteration
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- the physical conditions and environment of where the drugs are manufactured
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Misbranding
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concerned with the representations made by the manufactuer
-the labeling of the drug |
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Adulteration occurs when drugs are:
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dealt with in unsanitary conditions
-made not in conformance with GMP -has unsafe additives -a class III device without premarket approval -OTC drug not packaged in tamper-resistant packaging |
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Misbranding occurs when drugs have incorrect:
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labels or labeling
-statement of manufactuer and statement of quanitity on the label -doesnt bear adequate directions for use -doesn't bear the caution "warning:may be habit forming" if needed -doesn't bear generic name big enough -package or drug is misleading |
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Label
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Written on the container
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Labeling
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Information that goes along with the drug
-inserts, not attached |
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DEA 222
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CII drugs recieved and dispensed
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Invoices
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For CIII - CIV recieval and dispensing
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DEA 41
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Records of disposal
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DEA 106
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Records of theft
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DEA 224
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New Registration
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How long must CS records be kept for?
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2 years
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Inventory for CII
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Perpetual inventory
(up to date) Actual physical count |
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Inventory for CIII-CIV
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Estimate
Must be counted if a container that hols 1000 has been opened |
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How often does an inventory of all scheduled drugs need to be taken?
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Biennially
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How often can pharmacies dispose scheduled drugs?
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Once a year
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Copy 1 of DEA 222 form goes to?
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supplier
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Copy 2 of DEA 222 form goes to?
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DEA
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Copy 3 of DEA 222 form goes to?
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Pharmacy (purchaser)
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The supplier can not complete which part of the DEA form 222 if it is forgotten?
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Number of line items completed
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Schedule II precscriptions must be..
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hand written except for emergency reasons
1) patient is in LTCF 2) patient is on hospice 3) it is compounded for direct administration |
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Which drugs can be faxed and deemed an original prescription?
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CIII-CV, non controls, and only CII if emergency
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What drugs can be orally transmitted?
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CIII-CV, noncontrol, CIIs only with the 3 emergency reasons
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What drugs can be electronically transmitted?
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Noncontrols, CIII-CV
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What drugs can be transferred to another pharmacy?
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noncontrols, CIII-CV (only one transfer, unless its real time computer system), CIIs can NOT be transferred
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Concentration of Na inside the cell?
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14 mEq/L
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Concentration of Na outside the cell?
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142 mEq/L
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Concentration of K outside of the cell?
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4 mEq/L
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Concentration of K inside the cell?
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140 mEq/L
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Concentration of Ca outside the cell?
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3 mEq/L
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Concentration of Ca inside the cell?
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<1 mEq/L
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Concentration of Mg outside the cell?
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2 mEq/L
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Concentration of Mg inside the cell?
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40 mEq/L
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Concentration of Cl inside the cell?
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4 mEq/L
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Concentration of Cl outside the cell?
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103 mEq/L
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Concentration of HCO3 outside the cell?
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24 mEq/L
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Concentration of HCO3 inside the cell?
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10 mEq/L
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Concentration of phosphates outside the cell?
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4 mEq/L
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Concentration of phosphates inside the cell?
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75 mEq/L
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Concentration of Amino Acids outside the cell?
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30 mg/dL
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Concentration of Amino Acids inside the cell?
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200 mg/dL
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Concentration of Proteins outside the cell?
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5 mEq/L
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Concentration of Proteins inside the cell?
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40 mEq/L
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Concentration of Glucose outside the cell?
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90 mg/dL
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Concentration of Glucose inside the cell?
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14 mg/dL
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The ph outside the cell?
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7.4
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The ph inside the cell?
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7.0
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The ph outside the cell?
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7.4
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The ph inside the cell?
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7.0
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Which vitamins are fat soluble?
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K, A, D, E (fat guy Kade)
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Which vitamins are water soluble?
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C
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Function of Vitamins?
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Coenzymes
Helpers in the Metabolic Process |
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4 major cations?
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Na, K, Ca, Mg
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3 major anions?
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Cl, HCO3, PO4
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What are the three major dietary components?
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Carbohydrates
Lipids Proteins |
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Carbohydrate are is primarily used for...
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Used as fuel
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Lipids are primarily used for..
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stored fuel
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Carbohydrates are chains of polymers
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True
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Lipids are stored as...
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Tri glycerides
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tryglycerides are NOT
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Monomers (polymers)
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Proteins are composed of
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Amino acids
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Proteins are primarily..
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Functional
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Proteins are NOT
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Stored
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Nucleic Acids are monomers
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True
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Nucleic Acids are used for
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storing information
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Steroids role
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Structure and hormones
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Inorganic Materials are
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Electrolytes
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Drugs usually attain a
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heterocyclic ring
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Chemical term definition and examples
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Structure: steroid, peptide, amino acid, fatty acid, ion
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Functional term definition and examples
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hormone, neurotransmitter, enzyme, receptor, channel, pump, ligand, electrolyte
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What 3 biomolecules are macromolecules?
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Carbs, Proteins, and Nucleic acids
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Carbs polymers function:
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Glycogen-storage in animals cells
Starch-dietary carb component can be digested Fiber-dietary carb component can NOT be digested |
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Important feature of lipids
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insoluble in water
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Omega-6 fatty acids and Omega 3 fatty acids contain
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double bonds
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Nucleic acids are made up of
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Monomers
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Nucleic Acid monomers are
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nucleotides (sugar + base + phosphate)
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Nucleotides form
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polymers (DNA + RNA)
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Steroid refers to the
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chemical structure (4 membered ring)
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Steroides are
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Hydrophobic
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The major dietary steroid is
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cholesterol
(not a major part of the diet) |
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Function of Steriods
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Steroid Hormones
Bile Salts-aid in digestion of fat |
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Water soluble Vitamins
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B and C
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All electrolytes are ions
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Not all ions are electrolytes
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Aluminum
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3+
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Calcium
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2+
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Magnesium
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2+
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Carbonate
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2-
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Phosphate
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3-
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Sulfate
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2-
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Acid
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Proton Donor
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Base
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Proton Acceptor
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Hydrophobic
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Lipid soluble, lipophilic, apolar
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Hyrdophilic
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polar, water soluble
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OBRA 90
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Save money
•Drug Utilization Review Programs Prospective 3 components 1.Screening rxs prior to dispensing 2.Patient counseling by pharmacist 3.Pharmacist documentation of relevant information |
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Dietary Supplement Health and Education Act of 1994
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Regulates Dietary supplements
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Food and Drug Administration Modernization Act of 1997
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•Expedited availability of safe and effective drugs and devices
•Fast track approval process for drugs intended to treat serious or life-threatening diseases •Establishes a data base on clinical trials •Expands the rights of manufactures to disseminate unlabeled use information •Expands FDA’s authority over OTC drugs |
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HIPAA
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•Established to ensure security and privacy of patients’ medical records when electronically transmitted
•Congress initiated “Privacy Rule” in order to protect health information called “protected health information” (PHI) |
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Oral Emergency CII prescription must have written Rx recieved in
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72 hours
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Balance of CII partially filled Rx must be filled in
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72 hours
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CII rx expire..
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6 months
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CIII-CV expire
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6 months or 5 refilss
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Pharmacist reregister every
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odd years
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Dietary Supplement Health and Education Act of 1994
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Regulates Dietary supplements
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Food and Drug Administration Modernization Act of 1997
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•Expedited availability of safe and effective drugs and devices
•Fast track approval process for drugs intended to treat serious or life-threatening diseases •Establishes a data base on clinical trials •Expands the rights of manufactures to disseminate unlabeled use information •Expands FDA’s authority over OTC drugs |
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HIPAA
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•Established to ensure security and privacy of patients’ medical records when electronically transmitted
•Congress initiated “Privacy Rule” in order to protect health information called “protected health information” (PHI) |
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A skillled nursery or facility can dispose drugs how often
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once a month
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in a facility if a drug is withdrawn when the pharmacist is gone he has how long to verify it
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72 hours in medical facility
96 in Correction insitution |
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in a facility if a drug is withdrawn when thepart time pharmacist is gone he has how long to verify it
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90 days physically or 30 days remotely
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A pharmacy with parenteral solutions must have what type of filtration system?
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Class 100 HEPA
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How often does the filtration system in a parenteral compounding pharmacy need to be ceritified?
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annually
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A pharmacist can't substitue a generic for a brand name if it is written
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Dispense as written
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A controlled substance in Nevada can NOT be
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Electronically submitted
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Advanced practitioners cant prescribe more than how many day supple
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30 day
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3 things that can't be chaned on prescription
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Name of the patient
Name of the drug Name of the doctor |
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For a "Do Not Fill" Rx what is the day supply limited to?
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90 days
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Do not fills apply only to
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CII
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A person can't have more than how many grams of Methamphetamine in a 30 day period?
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9 grams
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Pka < 2
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Stong acid; no basic properties
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pKa >12
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No acidic properites; strong conjugate base
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The stonger an acid
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the weaker its conjugate base
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proton acceptor
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deprotonated (base)
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proton donor
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protonated (acid)
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Base
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Amine
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Acid
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Carboxyllic acid
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charged =
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ionized
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The pH in the stomach is
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Low
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The ph in the intestines is
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High
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Where are acids absorbed
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stomach
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Where are bases absorbed
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Intenstine
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un-ionized =
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absorption
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ionized =
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soluble
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The most important extracellular buffering system
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bicarbonate buffer system
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Important buffer system inside the cell
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Phosphate buffer system
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Important buffer system in kidneys
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Ammonia Buffer system
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CO2 is acidic
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body must constantly be removing that (by breathing)
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Respiratory Acidosis Cause:
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Failure of lungs to adequately remove CO2
(respiration rate is slow or inefficient) |
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Respiratory Acidosis Example:
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Advanced Pulmonary Disease
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Respiratory Acidosis Measures:
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Low pH
Increased pCO2 Normal bicarbonate |
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The most common acid base disorder
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Metabolic acidosis
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Metabolic Acidosis Cause:
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Addition of acid to the body
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Metabolic Acidosis Example:
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Excess asiprin ingestion
Diabetic ketaacidosis diarrhea |
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Metablic Acidosis Measures:
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Low pH
normal pCO2 low bicarbonate |
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Respiratory alkalosis Cause:
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Excessive explusion of CO2 by the lungs
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Respiratory alkalosis examples:
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hyperventilation
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Respiratory alkalosis measures:
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high pH
Low pCO2 normal bicarbonate |
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Metabolic Alkalosis Cause:
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addition of base or loss of acid by the body
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Metabolic Alkalosis Examples:
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excessive ingestion of bicarbonate, protacted vommiting
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Metabolic alkalosis measures:
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high pH
normal pCO2 high bicarbonate |
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Anion gap
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distinguishes metabolic acidosis
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Fastest buffering systems
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Chemical buffering
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