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Pharm Tech CHP 1 B

Pharm Tech 1

Panacea Goddess of Medicinal Herbs; Daughter of Greek God of Medicine, Aesculapius
Imhotep Egyptian God of Medicine; 3000 B.C.
Pharmaceutical of or about drugs; also a drug product
Pharmacognosy Study of physical, chemical, biochemical & biological properties of drugs
Shen Nung Pen Tsao 200 B.C. listing of 365 herbs
Penicillin 1st Antibiotic; 1928, Alexander Fleming (Britian)
Hormone Progesterone 1st reliable Birth Control; 1943, Russell Maker
Pasteur 1864; heat kills microorganisms associated with food spoilage
James Watson & Francis Crick Indentified the structure of DNA; 1951
PHI Protected Health Information
Aesculapius Greek God of Medicine
cocaine Local anesthetic found in coca leaves
quinine drug for malaria found in cinchona bark
OBRA, 90' US legislation - require pharmacist to provide consulting services to Medicaid patients
ether used in 1st publicized operation using general anesthesia
biotechnology field resulting from study of human genome
Galen advocated "bleeding" to maintain balance of the "humours"
Banting & Best showed an extract of insulin could lower blood sugar in dogs
HIPAA Health Insurance Portability & Accountability Act
Food & Drug Act of 1906 Prohibited interstate commerce in adulterated or misbranded food, drink or drug; government pre-approavl of drugs is required
1938 Food, Drug & Cosmetic (FDC) Act response to fatal poisoning of 107 people by untested sulfanilmide concoction; requires new drugs be provin safe
1951 Durham-Humphrey Amendment law defines what drugs require a prescription; requires label: "Caution: Federal Law prohibits dispensing w/o a prescription."
1962 Kefauver-Harris Amendments requires proof of safety & effectiveness before marketing
1970 Poison Prevention Packaging Act child-proof packaging on all controlled & prescription drugs dispensed by pharmacies
1970 Controlled Substances Act (CSA) Classifies easily abused drugs and restricts distribution
1996 Health Insurance Portability & Accountability Act HIPAA
minimum requirements for prescription drug labels name\address-Dispenser, script serial #, date\filling, Prescriber, PT, directions & cautionary statements
NDC National Drug Code
National Drug Code NDC; number assigned by manufacturer; 3 parts
3 parts of NDC manufacturer #; medication, strength/dosage; package size
controlled substances drug which has potential to be abused; distribution controlled by 1 of 5 "schedules"
DEA number/formul number all prescribers of controlled substances are assigned; must be used on all prescriptions
DEA formula 2 letters followed by 7 single-digit numbers; AB1234563
Schedule 1 high potential for abuse; no med use in US; may NOT be prescribed
Schedule 2 high potential for abuse; may lead to dependence; accepted med use in US
Schedule 3 potential for abuse is less than previous schedules; current med use in US; abuse may lead to LOW physical or HIGH psychological dependence
Schedule 4 low potential for abuse; accepted medical use in US; abuse may lead to limited dependence
Schedule 5 low potential for abuse; accepted medical use in US; abuse may lead to limited dependence; some compounds containing limited amts of a narcotic
Heroin, opium derivatives & hallucinogenic substances --- Schedule? Schedule I
Amphetamines, opium, cocaine, methadone, & various opiates are included on this schedule Schedule II
Anabolic steroids & various compounds containing limited quantities of narcotic substances such as codeine -- schedule? Schedule III
Phenobarbital, sedative chloral hydrate & anesthetic methohexital are included in this scheudle. Schedule IV
Schedules III-V perscriptions May be refilled up to 5 times within 6 months (state regulations may vary)
Schedule II prescription refills are limited and no refills are allowed (generallY)
On Controlled Substance Prescriptions DEA number must appear on form & PT's full street address
Orange Book provides a two letter evaluation code
"A" drug products FDA considers to be therapeutically equivalent
"B" drug products FDA considers not to be therapeutically equivalent; often problem with specific dosage forms
AA conventional dosage forms not presenting biroequivalence problems
AB meeting bioequivalence requirements
AN Solutions & powders for aerosolization
AO Injectable oil solutions
AP Injectable aqueous solutions
AT Topical products
BC Ex-tended-release tablets, capsules and injectables
BD Active ingredients & dosage forms with DOCUMENTED bioequivalence problems
BE Delayed-release oral dosage forms
BN Products in aerosol-nebulizer drug delivery systems
BP Active ingredients & dosage forms with POTENTIAL bioequivalence problems
BR Suppositories or enemas for systemic use
BS Products with drug standard deficiencies
BT Topical products with bioequivalence issues
BX Insuffient data
DAILY LIMIT FOR Pseudoephedrine base products 3.6 grams per purchaser (regardless of number of transactions)
Combat Methamphetamine Epidemic Act (CMEA) Federal law sets daily & monthly limits on OTC sale of pseudoephedrine and ephedrine
Appropriately trained pharmacy technicians may be allowed to sell this OTC medication - Those containing ephedrine or pseudoephedrine
Written or electric record are held for two years for this OTC medication ephedrine or pseudophedrine
What 6 things need to be recorded for ephedrine or pseudophedrine Product name, Quantity, Name/address Purchaser, Date & Time, Proof of ID, Sig of Purchaser
Exempt narcotics medications that contain habit-forming ingredients but can be sold by a pharmacist w/o presciption
30 mg Pseudoephedrine HCI 146 Tablets
60 mg Pseudoephedrine HCI 73 Tablets
120 mg Pseudoephedrine HCI 36 Tablets
240 mg Pseudoephedrine HCI 18 Tablets
Watson & Crick DNA 1951
CMEA Combat Methamphetamine Epidemic Act; 3.6 g pseudoephedrine
15 mg/1.6 ml Pseudoephedrine HCI 468 Milliliters (ml)
7.5 mg/ 5 ml Pseudoephedrine HCI 2929 Milliliters (ml)
15 mg / 5 ml Pseudoephedrine HCI 1464 Milliliters (ml)
30 mg / 5 ml Pseudoephedrine HCI 732 Milliliters (ml)
60 mg / 5 ml Pseudoephedrine HCI 366 Milliliters (ml)
Dual Marketing Status of medications like Plan B - classified as presciption & OTC
Created by: jlauderman



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