Term
| Pure Food & Drug Act (1906) |
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Definition
Fed. gov. (FDA) may enforce standards of drug strength & purity as officially designated by the United States Pharmacopoeia (USP) & National Formulary (FP)
Prohibits mislabeling & adulteration of drugs |
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Term
| Food, Drug, & Cosmetic Act (1938) |
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Definition
Enforced by FDA through registration of all parties involved in manufacture, sale, & distribution of drugs
Required adequate testing of a compound to prevent marketing of a possibly toxic substance. New drugs must be safe as well as pure in order to be introduced into interstate commerce
Still does not require proof of effectiveness |
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Term
| Kefauver-Harris Amendments (1962) |
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Definition
Required proof of efficacy as well as safety before any new drug could be placed in interstate commerce
Guidelines for conducting clinical trials
Established the Drug Efficacy Study Implementation (DESI) |
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Term
| L. Omnibus Budget Reconciliation Act of 1990 (OBRA '90 - amended many times) |
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Definition
Amended 1965 Medicaid Law; implemented by the Health Care Financing Administration (HCFA)
New regulations & requirements
Participation of states in federal Medicaid program
Development of drug utilization review (DUR)
Patient counseling - pharmacist must offer counseling to patient. If patient refuses they sign paper admitting so |
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Term
| Food & Drug Administration Modernization Act (FDAMA) (1997) |
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Definition
Allows for fast tracking of drugs for serious illnesses to market
Drug manufacturers have to give patients 6 months notice before they discontinue making a drug
Established clinical trial database for drugs for critical illnesses
Informs of "off-label" uses (Erythromycin off-label use is stimulation of bowel movement)
Incentives for pediatric drug research |
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Term
| Best Pharmaceuticals for Children Act (BPCA) (2002) & Pediatric Research Equity Act (2003) |
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Definition
Both promote drug studies in children
See how existing drugs work in children and determine safety
Set up pediatric drug trials |
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Term
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Definition
High abuse potential & no accepted medical use in the US
Investigational drugs - drug study |
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Term
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Definition
Currently accepted medical use in US w/ high abuse potential resulting in severe physical or psychological dependence
Written prescription required w/ prescribers actual, legal signature
Must be dated same day as signed
No refills allowed
In emergency, verbal order may be given for limited quantity adequate to treat emergency, but must be followed by written prescription w/i 72 hrs. (However, not in AL --> state law) |
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Term
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Definition
Abuse potential less than schedule II (but more likely to be abused b/c less stringent rules)
Written or verbal prescriptions allowed; valid for 6 months from date written
Limit of 5 refills |
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Term
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Definition
Abuse potential less than Schedule III, but same rules
Written or verbal prescriptions allowed; valid for 6 months from date written
limit of 5 refills |
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Term
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Definition
Lowest abuse potential
Some drugs are non-legend both fed and state; purchase still subject to state regulations (ie: sudafed) |
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Term
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Definition
Oral (peroral, po)
Sublingual (sl) - tablets placed under tongue & allowed to dissolve; sometimes divided in 2, the 2nd being buccal (cheek)
Rectal (pr)
Capsules & tablets have rate limiting effects |
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Term
| Parenteral Route - Injectables |
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Definition
Intravenous (iv)
Intramuscular (im)
Subcutaneous (sc; subQ)
Requires sterile dosage forms
Faster onset of action
Skill & training required
Used for drugs which do not undergo GI absorption, or which are unstable in GI tract |
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Term
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Definition
| 1 hr before or 4 hr after eating. Usually just tell patients 2 hr before or after b/c hard to remember last time you ate |
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Term
| First Pass Effect (pre-systemic metabolism) |
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Definition
| During process of absorption from GI tract drug may be altered (metabolized) in 1)gut wall and 2)liver. If drug gets metabolized as it passes through either of these sites it will likely not be effective before reaching systemic circulation |
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Term
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Definition
Must be sterile
Drops
Ointment
Disk insert
Used for local effects, diagnosis, & treatment of eye disorders |
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Term
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Definition
Drops (solution, suspension)
Contraindicated in perforated eardrum |
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Term
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Definition
Drops
Sprays
Used primarily for local effects (decongestants)
May be used for systemic effects
Nose can get "hooked on" nasal sprays; withdrawals include stuffyness |
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Term
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Definition
Metered-dose inhaler (MDI) - nebulizer
Intended for local effects
Some systemic absorption may occur & cause side effects |
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Term
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Definition
Creams, ointments, lotions, shampoos, transdermal systems (patches),
May be used for either local or systemic effects (nitroglycerin ointments, patches..) |
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Term
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Definition
Study of how genetic variations affect individual responses to drugs
Impacts therapeutic & adverse effects
Clinically relevant for several drugs thus far, though testing is only required for a few |
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Term
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Definition
Catalized by cytochrome P450 family in liver
Induction (taking other drugs that increase activity of liver enzymes) & inhibition (taking other drugs that inhibit liver enzymes) are variables that can effect this step |
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Term
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Definition
Gut wall & liver
Usually can't do this phase first year of our lives |
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Term
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Definition
Kidneys, bile (followed by fecal excretion), pulmonary, milk, saliva (swallowed, reabsorbed)
Renal function approaches adult levels after about 1 yr
Progressive decline in renal function as we age; resulting drug accumulation most common cause of ADRs in elderly |
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Term
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Definition
| drug which interacts with a receptor to produce a pharmacologic response that is the same response produced by the endogenous compound Lock & key fit - binds just like chemical would High affinity & efficacy |
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Term
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Definition
"blockers"
Drug which interacts with receptor to block the actions of the endogenous agonist
High affinity
Zero efficacy |
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Term
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Definition
Drug which can interact with a receptor but produces a much weaker pharmacologic response than a full agonist
These are sometimes used in pain management & anesthesia
Low affinity & efficacy |
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Term
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Definition
| Certain drugs & foreign chemicals stimulate the activity of drug metabolizing enzyme (P450) in the liver by inducing the synthesis of these enzymes. Net effect of induction is to increase metabolism of other drugs normally metabolized in the liver & to decrease pharmacological effects |
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Term
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Definition
| Certain drugs may inhibit the activity of drug metabolizing enzymes in liver. By interfering with metabolism of other drugs, inhibitors may increase or prolong activity of drugs normally metabolized in liver. Effects occur over a few days to a week |
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Term
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Definition
Unwanted effects that appear at normal doses required for therapeutic response
Expected & normal with most drugs |
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Term
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Definition
Rare adverse drug response resulting from genetic predisposition
Occurs w/ certain anesthetics |
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Term
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Definition
Response where a drug causes a disease-like state
Aspirin may cause gastritis |
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Term
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Definition
| Unwanted effects that appear due to drug dosage that is increased beyond dose required for therapeutic response |
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Term
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Definition
Lethal dose 50
Dose which is lethal to 50% of test subjects |
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Term
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Definition
Effective dose 50
Dose which produces desired therapeutic effect in 50% of test subjects |
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Term
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Definition
Ratio of LD50/ED50 - how safe drug is
Lower than TI - more unsafe
Higher than TI - more safe |
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Term
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Definition
May present as anaphylaxis with respiratory failure & shock
Quick, unpredictable, can cause death |
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Term
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Definition
| Autoimmune reaction, like rash |
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Term
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Definition
| Seen w/ injectables, inflamed blood vessels |
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Term
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Definition
| Skin, like a reaction to a glove |
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Definition
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Definition
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Definition
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Term
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Definition
| Usually induce or inhibit liver enzymes |
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Term
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Definition
Due to charcoal, kaolin-pectin (present in anti-diarrheals), & aluminum or magnesium-containing antacids
Activated charcoal is often put down an NG tube to bind to medicine so the body doesn't absorb it |
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Term
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Definition
Formation of a non-absorbable complex that reduces drug absorption.
Some drugs love Ca2+ (tetracycline) so you cannot eat any Ca2+ containing foods with it otherwise Ca2+ will complex w/ drug, often causing one to emesis |
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Term
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Definition
| Combo of 2 drugs producing a pharmacologic effect which is sum of 2 individual drug effects (Acetominophine + hydrocodone) 1+1=2 |
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Term
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Definition
Combo of 2 drugs producing pharmacological effect that is greater than sum of 2 individual effects. 1+1=3
CNS depression by combining alcohol & barbiturates |
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Term
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Definition
| Combined effect is less than effect produced by active drug alone. 2nd drug cancels out 1st. 1+1=0 |
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Term
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Definition
| Directions to patient; transcribed by pharmacist onto label of dispensed medication |
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Term
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Definition
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Term
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Definition
| Adherence to a recommended course of treatment |
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Term
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Definition
| Right patient, route, dose, time, drug, & to refuse |
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