1st Mod Exam Review
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| Pharmaceutical care | the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient's quality of life.
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| Pharmacy Technicians | an individual working in a pharmacy, who, under the supervision of a licensed pharmacist, assists in pharmacy activities that do not require the professional judgement of the pharmacist
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| -vital partners in the delivery of pharmaceutical care to the patient population
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| Hippocratic code | -first medical code -brought up by hippocrateese
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| 6 principles | -honesty -promise keeping -nonmaleficence -beneficence -autonomy -justice
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| honesty | be truthful in dealing with others
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| promise-keeping | doing what you say you are going to do
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| nonmaleficence | do no harm
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| beneficence | doing good
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| autonomy | having the right to do what you see fit
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| justice | all people recieve the same benefits
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| FDA--Food and Drug Administration | -responsible to ensure that everything used is safe and effective, also responsible for all recalls
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| promulgates rules, regulation, and standards: inspects drug and food facilities to ensure public safety regarding drug products
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| DEA--Drug Enforcement Administration | enforce all drug-trafficing laws, (-we answer to)
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| Administration is federal | agency is state
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| FDCA--Federal Food, Drug, and Cosmetic Act | Products were often contaminated, were not consistent in strength, and were poorly labeled. 1906
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| -everything to be listed/labeled properly
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| Pure Food and Drug Act 1906 | law prohibited the adulteration and misbranding of foods in interstate commerce. (adulteration- anything that alters the compoound of a chemical substance)
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| First OTC drugs | spirits, potions, and elixirs
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| all contained alcohol, now only elixirs contain alcohol(ETOH)
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| Food Drug and Cosmetic Act of 1938 | new law required that no new drug could be marketed until proven safe for use when used according to directions on the label. The new law applied to cosmetics and devices as well -107 deaths from antifreeze incident.
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| Durham Humphrey Amendment aka Rx Drug Amendment aka Federal Legend Act | -federal legend -established drugs into 2 classes: OTC & Rx -auxiliary labels--Caution: Federal law prohibits the dispensing without prescription. (-auxiliary labels--additional directions) -allowed scripts to be taken over the phone
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| Kefauver Harris Amendment aka Drug Efficacy Amendment | -all new drugs must be proven safe and effective
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| Medical Device Amendment | safety and efficacy of medical devices
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| Orphan Drug Act | -used to treat relatively rare diseases -allowed mfg's a 7 yr window to be only ppl to make & sell drug -allows to recoop all money that went into research and development
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| Poison Prevention Packaging Act | -special packaging make it significantly difficult for children under 5 to open -nitroglycerin & isosorbide are exempt (Tylenol-sealed and wrapped)
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| Emily's Law | passed in Ohio when 3 yr old girl who had cancer was given an iv with 10x the amount of sodium chloride(NaCl) & died -enacted January 7, 2009, must be nationally certified -passed January 2008 in LA
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| Occupational and Safety Act - OSHA | -passed do to concerns about catching hepatitis & HIV -federal law that assures every working man and woman in the nation safe and healthy working conditions -requires MSDS(material safety data sheets) on all toxic or hazardous chemicals
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| Omnibus Budget Reconciliation Act - OBRA | -requires that counseling be made available on all prescriptions new & refills for medicare(caid) patients
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| Health Insurance Portability & Accountability Act - HIPAA | -important law that requires the adoption of security & privacy standards in order to protect personal health care information -HIPAA regulations apply to covered entities--anyone involved in the care or treatment of a patient
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| protected health information - PHI | includes any individually identifiable health information, with the exclusion of employment records
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| Human Immunodeficiency Virus - HIV | -contracted through contact w/infected person -ELISA(Enzyme-Linked Immuno-Sorbent Assay) test for HIV antibodies -Western Blot--confirmatory only(zero risk factors)
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| must come in contact with: -breastmilk -blood -semen/precum -vaginal secretions
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| ways to come in contact with HIV: | -sexual(UNprotected anal, vaginal, or oral sex) -sharing needles(iV drug use, tattooing, piercing) -maternal/child(prevented by sesarian section or after 2 gain own immune system) -blood transfusion b4 1985 -donor products
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| -needlestick job injury only -sharing of sex toys
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| Acquired Immune Deficiency Syndrome - AIDS | -you must convert: ~HIV+ ~CD4 cell count 200 less ~PCP ~KS
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| DEA Form 41 | 1 disposed med per form (-expired, recalls, adulterated, etc.)
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| DEA Form 106 | lost or stolen -any amount can be listed ~police report must be included for stolen
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| DEA Form 224 | registration and distribution of drugs -Federal drug stamp
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| DEA Form 222 | ordering "controlled substances" -10 drugs per form -valid 60 days after pharmacist signs -must be kept for 2 yrs(if error void form and file and keep 2 yrs)
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