flashcards pharmac CH 1.txt

"all preparations called by the same drug name must be of uniform strength, quality and purity"

• first gov attempt to establish consumer protection in the mfg of food & drugs
• "req'd uniform strength, quality and purity"
• req'd dangerous ingredients be on label
• established the US Pharmacopeia and Nat'l Formulary; specified the official US standards for making each drug

• established food & drug admn
• "est more specific regulations to prevent tampering with drugs, food & cosmetics"
• : all labels must be accurate and include list of all active and inactive ingredients
• : all new products must be approved by the FDA before public release
• : warning labels must be present on certain preparations (ie may cause drowsiness)
• ": created ""legend drugs"" - those drugs that cannot be sold w/o a prescription"
• : also designated which drugs did not need prescriptions
• : both prescr and non prescr drugs must be shown to be EFFECTIVE and SAFE

• est the Drug Enforcement Admin (DEA) to enforce provisions of the act
• set much tighter controls on specific drugs that needed to be controlled: ie drugs being abused by society
• : assigned abused and addicting drugs into five schedules: C1 (most addictive) - C5 (least addictive)
• : specified handling regs for controlled substances; records to be held for 2 years
• : set limitations on the use of prescription drugs; ie how many refills etc
• ": reqd prescribers to register with DEA for license; includes mfg, vets, pharmacists, physicians"

• high abuse potential
• not approved for use in US
• "ie heroin, LSD, mescaline, ecstasy"

• high abuse potential; may lead to severe dependence
• written prescription only; cannot be phoned in; new prescription every refill
• "can be faxed, but original must be presented when picking up med"
• "in an emergency, dr can phone in, but handwritten prescr must be presented at pharmacy within 7 days"
• "ie morphine, codeine, methadone, Percocet, Tylox, Dilaudid, Ritalin, cocaine, Oxycontin, meperidine (Demerol)"

• may lead to limited dependence
• written faxed or verbal prescriptions by physician only
• may be refilled up to five times in 6 months
• "ie codeine and hydrocodone w/ aspirin or tylenol, anabolic steroids"

• lower abuse potential
• "prescription can be written out by health care practitioner, but must be signed by the physician"
• prescription may be phoned in or faxed by health care practitioner
• may be refilled up to five times in 6 months
• "ie valium, ativan, xanax, phenobarbital, librium, darvocet, ristoril, ambien"

• low abuse potential
• primarily for preparations for cough suppressants containing codeine and preparations for diarrhea (ie diphenoxylate)
• "ie Promethazine w codeine, Cheratussin AC, Lomotil"

give pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people

• mandates that all Otc drugs a patient is taking must be documented as part of the medical record
• pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient

• oversees testing of all proposed drugs before public release
• "inspect plants where foods, drugs, medical devices or cosmetics are made"
• review new drug applications and petitions for food additives
• investigate and remove unsafe drugs from the market
• "ensure proper labeling of foods, cosmetics and drugs"

• established in 1970 to enforce the drug laws
• works with controlled substances only
• separate agency from FDA
• monitors need to move a drug from one schedule to another

• FDA recommends withdrawal when risks outweigh the benefits
• FDA has no authority to remove from market
• FDA can recommend to the manufacturer that it be pulled

• keep current drug reference book
• double lock controlled substances
• conceal & secure drug prescription pads
• "keep accurate records of contolled substances dispensed, received or destroyed. Keep records for 2 years."
• keep up to date with current news from FDA and DEA and controlled substances
• establish a working rapport with a pharmacist
• maintain a professional rapport with the pharmaceutical reps