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Definition
| Medicinal drugs available to the public only when approved by a medical professional and dispensed by a licensed pharmacist. |
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| Over-the-counter (OTC) Drugs |
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Definition
| Medicinal drugs available to the public without the requirement of a prescription. They are often referred to as nonprescription drugs. |
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| Products (other than tobacco), distributed with the intention of supplementing the diet, that contain a vitamin, mineral, amino acid, herb or other botanical product, enzyme, organ tissue, metabolites, or any combination of these substances. |
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| stage of clinical testing, in which an experimental drug is administered to healthy volunteers to check for possible side effects and determine patterns of absorption and elimination. |
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Definition
| stage of clinical testing, in which an experimental drug is given to a small population of patients who have the medicinal condition for which the drug is considered a possible treatment. |
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Definition
| stage of clinical testing, in which an experimental drug is given to a large population of patients, through which issues of safety, effectiveness, and proper dosage levels are finalized. |
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Definition
| stage of clinical testing, in which possible adverse reactions to a drug that is already available to the public are monitored by physicians who have prescribed it. |
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| The exclusive right of a drug company to market a particular drug. The duration of which is 20 years. |
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Definition
| A characteristic of two drugs in which all pharmacological and physiological effects are identical. |
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Term
| Nonsteroidal Anti-Inflammatory Drug (NSAID) |
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Definition
| Any of a group of OTC analgesics (including aspirin, ibuprofen, and naproxen) or prescription analgesics (Celebrex) that are unlike cortisone-based drugs but nonetheless reduce pain and swelling caused by injury or disease. |
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Definition
| A drug developed in the nineteenth century to treat mild to moderate pain; it is extremely irritating to the stomach. |
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| Acetylsalicylic Acid (ASA) |
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Definition
| A modification of salicylic acid that makes the drug less irritating to the stomach without reducing its analgesic powers. |
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Term
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Definition
| Any analgesic drug containing Acetylsalicylic Acid (ASA) |
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Definition
| Having an effect that reduces inflammation and soreness. |
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Definition
| Having an effect that reduced body temperature and fever. |
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Definition
| Hormone-like substances that are blocked by many OTC analgesic drugs. |
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| A rare but very dangerous childhood disorder that has been associated with the administration of ASA-type analgesic drugs for the treatment of certain viral infections. |
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Definition
| A type of OTC analgesic drug. A major brand name is Tylenol. |
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Definition
| A type of OTC analgesic drug. Major brand names include Advil, Motrin, and Nuprin. |
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Definition
| An analgesic drug, formerly available only by prescription (brand names: Naprosyn and Anaprox). It is now available as an OTC drug under the brand name Aleve. |
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Definition
| One of two FDA-approved active ingredients in OTC sleep-aid products, such as Nytol and Sleepinal. |
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Definition
| One of two FDA-approved active ingredients in OTC sleep-aid products, such as Unisom. |
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| The US Food and Drug Administration (FDA) |
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Definition
| Responsible for setting the standards of safety, effectiveness, and honesty in labeling for Prescription and OTC drugs. |
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| Kefauver-Harris Amendment 1962 |
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Definition
| Required that new drugs be effective as well as safe, before this time people would market drugs for purposes they weren’t designed for. |
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Definition
| The FDA process for the approval of new prescription drugs begins with … to determine their safety limits and relative toxicity. |
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Definition
| Experimental drug is administered to healthy volunteers to study side-effects, absorption and elimination. |
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Definition
| Experimental drug is given to a small population of patients having the medical condition for which the drug is considered a possible treatment. This is the hardest phase to surpass because there are a lot of rules and regulations. |
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Term
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Definition
| Experimental drug is given to a large population of patients, through which issues of safety, effectiveness and proper dosage levels are finalized. |
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Definition
| Available to the public, but physicians must monitor any adverse effects and report to the FDA. |
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Definition
| Fixed duration of 20 years from the time that the original “new drug” document is submitted. |
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Definition
| … of new compounds developed by drug companies make it successfully through these clinical trials and are eventually approved by the FDA for marketing as new prescription drugs. |
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Definition
| Generally Recognized as Safe |
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Definition
| Generally Recognized as Effective |
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Definition
| Generally Recognized as Honestly Labeled. |
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Term
| Acetylsalicylic Acid, Acetaminophen, Ibuprofen & Naproxen |
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Definition
| Four types of OTC analgesic drugs available to the public. |
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Term
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Definition
| Aspirin, Ibuprofen and Naproxen are ... |
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Term
| Sleep Aids & Cough-and-cold Medicines |
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Definition
| Two classes of OTC drugs notable for their popularity and their potential for misuse. Involve Diphenhydramine and antihistamine & decongestant. |
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Definition
| The recreational use of cough-and-cold remedies containing … is a continuing drug abuse problem. |
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Definition
| Unlike OTC preparations, … have not been evaluated by the FDA for safety and efficacy. |
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