˚₊‧ʚ♡ɞ‧₊˚ OTCs & drug development ˚₊‧ʚ♡ɞ‧₊˚ Flashcards
What is the FDA? What are they responsible for?
Food & Drug Administration.
Responsible for dictating which drugs are safe (meaning low incidence of adverse reaction/side effects under adequate directions for use/warning about unsafe use; low potential for harm if abuse occurs)
How is the FDA regulation different for prescription drugs, OTCs, and supplements?
Prescription drugs are “controlled” substances controlled by the FDA. Requires appropriate signature & can only be dispensed by a pharmacist.
OTCs have unsupervised use.
Supplements are unsupervised & not regulated by the FDA; there is no need to be proven safe or effective.
How are OTCs & prescription drugs similar & different in the way they are used?
PRESCRIPTION: This requires a signature and ordering from someone. It is dispensed by a pharmacist and ordered for and used by ONE person.
OTCs: bought w/o dr.’s order; bought off shelves/no pharmacist required; can be used by more than one person.
BOTH: require directions for appropriate, effective, and safe usage; children should only use w/the permission of parent/guardian; a pharmacist can answer questions about both.
Phases of drug development?
Determine drug target; design drug; preclinical research (using cells, animals, computer models & studying pharmacokinetics & toxicity); testing w/ humans (“investigational new drug [IND] application”) w 3 broad categories 1) data must include all pre-clinical data & any available human data 2) manufacturing info to ensure an adequate supply & good quality control 3) clinical protocols & investigator info including IRB consent + qualifications of people doing the research; clinical trials phase I w/ safety as main concern, studying ADME, determine ROA, safe dosage range, toxicity, and side effects—done in healthy human subjects except developing life saving cancer drugs in a sample of 20-100; clinical trials phase II for safety and efficacy, finalizing optimal dose w/ sample of 100-600 in people w/ target disease; clinical trials III for safety, efficacy, and dosage, studies should be double-blind and placebo-controlled, close examination of side effects, sample of 1000-3000, & determination of labeling requirements; FDA review to gather all clinical trial data, lasts 6-10mo FDA can approve, deny, or request more research; Post market surveillance where drugs are indefinitely monitored & companies continue submitting safety data, FDA may pull drugs any time if needed.
OTC analgesics: how they work, what they’re used for, safety.
Non-steroidal anti-inflammatory drugs (NSAIDs) that block synthesis of prostaglandins by inhibiting COX enzymes. Tylenol is an OTC analgesic but not a NSAID. Tylenol OD can cause organ failure & death (most often liver), ODs are often accidental—many OTC drugs contain acetaminophen so individual could unknowingly be taking many drugs containing it; drinking alcohol & fasting increase risk of OD.
What is a dietary supplement? What is the FDA’s role in the regulation of these?
Supplement containing 1+ ingredient intended to supplement diet: minerals, vitamins, herbs, amino acids, some hormones. Labeling should include: “dietary supplement,” facts panel including amounts of all dietary ingredients; cannot make claims of diagnosis, treating, curing, or preventing diseases; quality indicators. FDA doesn’t have regulation—these are regulated as foods NOT drugs. Don’t get pulled if there’s evidence a supplement is ineffective since they technically cannot claim to do anything other a “support” functioning. FDA does not oversee the manufacturing process—the label accurately reflects substances in supplements & that no drug-like claims are on the label. FDA considers them safe until proven unsafe; not required to conduct clinical trials.
