the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient's quality of life.
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
-vital partners in the delivery of pharmaceutical care to the patient population
-responsible to ensure that everything used is safe and effective, also responsible for all recalls
promulgates rules, regulation, and standards: inspects drug and food facilities to ensure public safety regarding drug products
DEA--Drug Enforcement Administration
enforce all drug-trafficing laws, (-we answer to)
Administration is federal
agency is state
FDCA--Federal Food, Drug, and Cosmetic Act
Products were often contaminated, were not consistent in strength, and were poorly labeled. 1906
-everything to be listed/labeled properly
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)
First OTC drugs
spirits, potions, and elixirs
all contained alcohol, now only elixirs contain alcohol(ETOH)
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.
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
Kefauver Harris Amendment aka Drug Efficacy Amendment
-all new drugs must be proven safe and effective
Medical Device Amendment
safety and efficacy of medical devices
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
Poison Prevention Packaging Act
-special packaging make it significantly difficult for children under 5 to open -nitroglycerin & isosorbide are exempt (Tylenol-sealed and wrapped)
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
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
Omnibus Budget Reconciliation Act - OBRA
-requires that counseling be made available on all prescriptions new & refills for medicare(caid) patients
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
protected health information - PHI
includes any individually identifiable health information, with the exclusion of employment records
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)
must come in contact with: -breastmilk -blood -semen/precum -vaginal secretions
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
-needlestick job injury only -sharing of sex toys
Acquired Immune Deficiency Syndrome - AIDS
-you must convert: ~HIV+ ~CD4 cell count 200 less ~PCP ~KS
DEA Form 41
1 disposed med per form (-expired, recalls, adulterated, etc.)
DEA Form 106
lost or stolen -any amount can be listed ~police report must be included for stolen
DEA Form 224
registration and distribution of drugs -Federal drug stamp
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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