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exp in drug compounding Galenicals |
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first official pharmacopia collaboration of guild of apothecaries and med society |
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Societies of Apothecaries of London |
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Philly Elizabeth marshal becomes first woman pharmacist in US became a training school |
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first alkoloid chemist morphine from opium |
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father of American Pharmacy APA served on USP |
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Stanardization fo Pharmacuetics |
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1883 first list of 20 standardized liquids |
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antispasmodic for GI helps with eye exams (pupils dialate) |
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stimulant used in weight loss supplements |
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antioxidant and anti-inflamatory |
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stops maternal bleeding after childbirth partial treatment of migranes |
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Sulfa-Drugs fights bacterial infections |
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Chem substance used in treatment, cure, prevention or diagnosis of a disease or otherwised used to enhance physical or mental well-being
in pharmacopia affects structure or function of body |
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treats a diseas by administration of minute doses of drug that produce similar symptoms
like cures like induce symptoms, flush out symptoms, become healthy |
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contain more than 1 ingredient supplement ones diet vitamins, minerals, herbs, botanicals, amino acids |
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United States Pharmacopia |
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USP: standars for medicines, dosage forms, drug substances, exipients, medical devices, and dietary supplements
NF: the book that contains the exipients and formulas for making the preparations |
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Homeopathic Pharmacopeia of US |
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HPUS official standards for homeopathic medicines data on safety and efficacy |
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US dept of health and human services regulate and supervise safety regulate advertising protect agains misbranding and adultering |
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made on lable must be approved for exact wording! |
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changing the strenght, purity, or quality -can be from contamination |
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1906 products had to be labled correctly focused on misbranding and adulterating |
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Food, Drug and Cosmetic Act |
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1938 FDCA approval of new drugs ,med devices, and costmetics had to have adequate directions WARNINGS must be present |
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Durham-Humphrey Admendment |
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1951 Prescription drug amendment difference between OTC and Rx |
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Kefauver-Harris Amendment |
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1962 Drug Efficacy established GMP products had to be safe and effective |
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1983 Gave incentives to manufacturers to develop high expense drugs for chronic diseases |
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Drug Price Competition and Patent-Term Restoration Act |
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1984 streamline generic drug process incentives for making new drugs |
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Prescription Drug Marketing Act |
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1987 recordkeeping and requirements for samples porhibits reselling pharm purchases |
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1997 streamlining of regulations FDA had to define scope or responsibility |
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ensures safety, adequate directions, appropriate expiration dating, and tamper-evident packaging
FTC regulates advertising for OTC procuts |
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Dietary Supplement Health and Education Act |
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1994 DSHEA -FDA must prove that product is unsafe before removing it from market |
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Components of Package Insert |
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Decsription, chem structure, mech of action, pharm-kinetics, clinical studies, indication, contraindications, warnings, precations, pregnacny cats, special pops, adverse reactions, dosage administration, how supplied,how stored, manufacturer, date last revised |
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-no risk in animals -no evidence of risk in humans |
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-no evidence in animal study -no adequate human studies -no evidence of risk |
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-animal studies show risk -no adequate studies in humans -benefits may outweigh risks |
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-positive in animals -positive in humans for adverse affects benefits may outweigh RISKS |
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-Animal Studies show abnormalities -Human fetus shows abnormalities -benefits DO NOT outweigh risks |
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1970 enforced by DEA 5 categories for potential for abuse and accepted med usage |
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-can prescribe without DEA if working under another doctor with a valid DEA -1st letter = A or B (most likely B) -2nd letter is last name -7 numbers |
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Lawful order from a practitioner for a drug or device for a specific patient that is communicated firectly to a pharmacist in a licensed pharmacy |
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Patients in hospitals Destined for administration to patient |
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Components of Prescriptions (NON-CONTROLLED) |
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Name, Date, Prescriber, DRUG (name, strenght, dosage form, quantity), SIG, refills, signature |
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COMPONTENTS OF A PRESCRIPTION ( CONTROLLED) |
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all of the non-controlled plus DEA#, written out, PT address, date and quantity written out! |
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No legal requirements good practice: (height and weight, dosage schedule, prescriber ID, Pt location, date and time) |
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Components of a prescription lable (Inpatient) |
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name or product, route of administration, strenght and concentration, volume, control/lot #, ID of packager, special conditions, beyond use date |
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Components of Prescription Lable (OUTPATIENT) |
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name and adress of pharmacy, pt name, prescribers name, directions, date dispensed, cautionary statements, Rx ID#, name and strenght of drug, manufacturer name, expiration date, quantity, refills |
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U=unit IU=international unit QD= once daily QOD= every other day X.0 mg= X mg MS=morphine sulfate or magnesium sulfate <,> drug name abbreviations apothecary units @,cc,ug |
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the responsible provision of drug therapy for the purpose of acheiving definite outcomes that improve a patients quality of life |
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1st Element of Pharmaceutical Care |
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Responsive provision of care |
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2nd element of pharm care |
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3rd element of pharm care |
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4th element of pharm care |
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Acheiving positive outcomes |
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5th Element of Pharm Care |
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improving the patients of QoL |
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6th Element of Pharm Care |
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-resolution of medcation-related problems |
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Six Types of medication-related problems |
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1. unnecessary medication therapy 2. additional medication therapy warranted 3. Wrong Medication 4.Dose too high/low 5.Adverse Drug Reaction (ADR) 6.Non-Adherence |
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4 Major Steps towars pharmaceutical care process |
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1. identify problem 2. establish treatment goals 3. Create a care plan 4.Monitor and follow-up |
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History and phsyical cheif complaint demographics past med history family history social history medication history drug allegies review of systems (Physical examination) Lab data/tests |
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head ears eyes nose throat |
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7 major chemicals checked in blood/urine Na, K, Cl, HCO3- Glucose Creatine sometimes Ca2+ |
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CBC white blood cells, hemoglobin, platelets, hematocrit hematocrti( packed cell volume) |
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Reasons for Med Documentation |
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perm record review info before next appointment communication lecgal record reimbursement personal thought process |
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What Med Documentation Provides |
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accurate patient-relation history current care plan instructions for next encounter |
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What med documentation needs to be |
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retrievable available and understandable clear, concise, true timely, organize, chronological legible and non-alterable confidential |
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