Drug Approval & Classification
This U.S. government agency is responsible for approving drugs and deciding whether they can be marketed and used in patients.
What is the FDA (Food and Drug Administration)?
These medications can be purchased directly by a consumer without a prescription from an authorized health care provider.
What are over-the-counter (OTC) drugs?
This common pharmacological acronym stands for the four primary pharmacokinetic processes that describe how the body handles a drug.
What is ADME (Absorption, Distribution, Metabolism, and Excretion)?
While often arbitrarily defined as taking five or more medications, this term is more accurately defined as a patient's medication regimen containing at least one unnecessary or inappropriate medication.
What is polypharmacy?
This phrase is defined as any unwanted, noxious, or potentially harmful effect that occurs when a medication is administered at normal, recommended therapeutic dosages.
What is an adverse drug reaction (ADR)?
This is the first step in the drug testing process, typically conducted on mice and rats, lasting approximately 1–2 years.
What are pre-clinical (animal) trials?
This tells us the safety of a medication, where a higher number indicates a wider margin of safety before toxic effects appear.
What is the Therapeutic Index (TI)?
This term is defined as the time required for the active form of a drug in the body or bloodstream to be reduced by 50%.
What is half-life (𝑡1/2)?
Although older adults (age 65+) make up approximately 17% of the U.S. population, they consume approximately this percentage of all prescription medications.
What is 34% (or roughly one-third)?
Compared to younger adults, older individuals are this many times more likely to experience an adverse drug reaction that requires medical intervention or a medication change.
What is 2 to 3 times more likely?
This phase of clinical trials is the first time a drug is tested on a small sample of patients — roughly 200–300 — who actually have the condition the drug is designed to treat.
What is Phase 2 clinical trials?
This ongoing phase of drug evaluation occurs after FDA approval to monitor for adverse effects in the general population that may not have appeared in earlier clinical trials.
What is post-marketing surveillance?
This term describes the phenomenon where a drug accumulates in body tissues such as fat or bone over time, and can slowly leak back into the bloodstream long after the original dose was administered.
What is drug storage (or the storage effect)?
These two primary organs responsible for drug metabolism and excretion experience a 30% to 40% decline in physiological function and blood flow during normal, healthy aging.
What are the liver and kidneys?
First developed in 1991 by a geriatrician, this continuously updated clinical inventory lists medications (such as benzodiazepines) that should generally be avoided or used with extreme caution in older adults.
What is the Beers List (or Beers Criteria)?
This special FDA program subsidizes drug companies to produce medications for conditions affecting fewer than 200,000 people in the United States.
What is the Orphan Drug program?
On a dose-response curve, this term describes the point where increasing the dose yields no further increase in therapeutic response, also known as maximal efficacy.
What is the ceiling effect (or ceiling dose)?
When comparing two drugs that produce the same clinical effect, this property describes the drug that requires a lower dose to achieve that specific magnitude of response.
What is potency (or drug potency)?
This term describes the phenomenon where a drug-induced side effect is mistakenly treated with an additional medication, which itself may cause another side effect, leading to an ever-growing and unnecessary medication regimen.
What is the prescribing cascade?
Because aging blunts cardiovascular homeostatic reflexes, medications that lower vascular tone commonly trigger this specific adverse response, characterized by a sudden drop in blood pressure upon standing.
What is orthostatic hypotension (or postural hypotension)?
This type of FDA review process — which includes fast track, priority review, and accelerated approval — allows exceptionally needed drugs to reach the market sooner, but requires drug testing to continue even after the drug enters general use.
What is expedited review?
This term refers to the legal clinical practice of prescribing an FDA-approved drug for a condition, dose, or population other than the specific indication for which it was originally approved.
What is off-label prescribing?
Calculated as the amount of drug administered divided by the plasma concentration, this ratio is compared against a reference value of 42 liters (total adult body water) to determine if a drug is sequestered in the bloodstream, distributed evenly, or retained in tissues.
What is Volume of Distribution (𝑉𝑑)?
In the aging kidney, reduced drug excretion is driven by a 30% to 40% decline in renal blood flow and a decrease in this specific physiological rate of fluid filtration through the renal corpuscle.
What is Glomerular Filtration Rate (GFR)?
To minimize adverse drug reactions in older adults, this 4-word clinical prescribing guideline advises healthcare providers to initiate therapy at the lowest feasible dose and titrate upward gradually.
What is "start low, go slow" (or low and slow prescribing)?