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All Notes for Final

ALL notes for Final

QuestionAnswer
Federal Food, Drug, and Cosmetic Act (FDCA) everything had to be properly labeled; everything is the perscription is labeled
Pure Food and Drug Act of 1906 Law prohibited the adulteration and misbranding of foods
Food, Drug, and Cosmetic Act of 1938 Sulfanilamide elixir tragedy; 107 deaths; reqired no new drug could be marketed until proven safe for use when used according to directions on the label
Durham-Humphrey Amendment of 1951 also refered to as the Prescription Drug Amendment; Federal Ledgend; established two classes of drugs - perscription and over the counter; allows pharmistics to take perscription orders over the phone
Kefauver-Harris Amendment of 1962 Thalidomide; caused serious birth defects; also known as the Drug Efficacy Amendment; required that all new drugs had to be proven both safe and effective
Orphan Drug Act of 1983 allows manufactuers a 7 year window to be the only people to make and sell drug; treat relatively rare diseases
DEA form 224 Distribution and Registration form; attaches is a federal drug stamp
DEA form 222 Ordering Controlled Substances; errors are voided, filed and kept for 2 years, all forms must be kept for 2 years; only allowed a certain number each year; valid 60 days after pharmasist signs
DEA form 106 Lost or stolen drugs; can have many; for stolen drugs you must have a police report
DEA form 41 Destruction of controlled substances; one perscpriton per each; destruction - exoired, unsafe, RECALLS, broken glass container, or adulterated
Poison Prevention Packaging Act Child-resistant containers; drugs that are exempt from this law are nitroglycerin
Omnibus Budget Reconciliation Act of 1990 (OBRA) states that counsilling be made available on all new and refills for medicare and medicaid patients
Health Insurance Portability and Accountability Act of 1996 (HIPAA) protects health insurance coverage for workers and their families when they change or lose their jobs; also requires the adoption of security and privacy standards in order to protect personal health care information
1st medicines available over the counter were: spirits, potions, elipsers (still contain alcohol today)
Food and Drug Administration (FDA) responsible to ensure that everything used is safe and effective and are responsible for all recalls
Drug Enforcement Administation or Agency (DEA) enforce all drug trafficing laws; we answer to them; Administration -> Federal; Agency -> State
Do we follow the federal or the state law? we follow the more stringent law...the tougher law
DEA Drug Enforcement Administration (Federal) Agency (State)
FDA Food and Drug Administration
What does PTCB stand for? Pharmacy Technician Certification Board
What does WHO stand for? World Health Organization
What did CSA do? Classified Drugs into schedules based on their abuse potential; Passed in 1970, Enacted in 1986
Federal Ledgend? Caution: Federal Law prohibits dispense Without a Prescription
Two Orange Lables on Schedule 2 drugs? Caution: Controlled substance; dangerous unless used as directed.Caution: Federal Law prohibits the transfer of drug to anyone other than the person it is perscribed
Kefauver-Harris Amendment Cont. Provided: The oversight of perscription drug advertising by the FDA, The establishment of Good Manufacturing Practices (GMP) requirements, Informed consent of patients for clinical drug investigations, and Implimentation of reporting of adverse drug rx
Auxillary Labels are what? Additional Directions (Take w/ food; do not take w/ food)
What is a Pharmacy Technition? "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"
What is Pharmaceutical Care? Better living through the help of drugs
Who are we governed by and which organization do we obide by their code of ethics? American Association of Pharmacy Technicians (AAPT)
What was the 1st medical code and who developed it? Hippocratic Oath; Hippocratis
What are the 6 Ethical Principles? Honesty, Promise-Keeping, Jusice, Beneficence, Autonomy, and Nonmaleficence
Nonmaleficence Do no harm
Beneficence Do good
Autonomy Do as one sees fit; individual
What are Ethics? A code of conduct for a standard of care
What does HIV stand for? Human Immunodeficiency Virus
AIDS? Acquired Immune Dificiency Syndrome
What does ELISA mean and what does it test for? ELISA- Enzyme linked immuno-sorbant assay; it test the antibodies
What is the Confirmatory test and when is it used? Western Blot and its used when there are zero risk factors
How is AIDS diagnosed? If a person has a CD-4 cell count of 200 or lower; and/or is they have PCP or KS and if they are HIV +
How is AIDS spread? Blood, Semen, Vaginal Secretions, Brest milk, and Pre-cum
What is the National conversion rate and the LA conversion rate from HIV to AIDS? National- 17%; LA- 50%
3 Theories of how HIV was developed? Alien ubductions; Human had sex with apes or primates and since DNA is similar from Europe to the US; and It was developed in a lab by the US Government
Chain of Commands? Ms. Tine; Mrs. Rhonda, Mr. Richard, Mr. Mike, Coorporate
Who is the Number 1 people affected by AIDS? Africa; 3rd world countries
Scheduale 1 No perscriptions and/or refilles; no approved medical use in the US
Scheduale 2 No Refills allowed; Pharmacy can take emergancy orders over the phone by a perscription must be brought in within 7 days; the perscription must be filled within 72 hours of being written.
Who is the only exection to the rules applied to scheduale 2 drugs? Hospice
Schedule 3 and 4 5 refilles within a 6 month period
Schedule 5 No perscription necessary. Must be 18 years old, have a valid ID and must sign for it.
Out of all the Schedule 1 drugs, which is not a hallucingenic? Marijuana
Examples of Schedule 1 drugs? Peyote, Acid (LSD), Mushrooms, and PCP
Which drug can be used legally in the Schedule 1 catagory? Peyote- it is registered to native american tribes for religious cerimonial purposes (Vision Quests)
Who is in charge of monotoring Peyote? DEA and Tribal Counsule
What are common Schedule 2 drugs? Amphetamines (Adderall), Cocain in the liquid form, Ritalin, Oxycodone (#1), Percocet
What are the commone Schedule 3 drugs? Acetaminophen with Codeine (Tylenol w/ Codeine), Hydrocodone w/ APAP (Lortab), Hydrocodone w/ IVB and APAP (Vicoden); Lortab is #1
What are the common schedule 4 drugs? Xanax, Propoxyphene w/ APAP (Darvocet)
What is the #1 Schedule 5 drug? Sudafed
What does HIPPA stand for and what does it do? HIPPA-Health Insurance Portability and Accountabilty Act; and it protects for PHI (Patient Health Information) and it applies covered entities.
What are covered entities? Pharmacy, Pharmacist, Doctor, and Insurance Company
What does NDC stand for? National Drug Code
How many Numbers are on the NDC? 11
What do the first 5 digits stand for and what do the last six stand for? first 5- Manufacture and last 6 - identify drug name, package size, and type of drug
Class 1 recall Severe adverse health consequenses or death
Class 2 recall Temporary or medically reversible adverse health consequences
Class 3 recall Not likely to cause adverse health consequences
Who is responasible for notifiy the seller of the recalls? Manufactures
Who is responsible for notifiying the consumers if necessary? The sellers
What does JCAHO stand for? Joint Commision on Accreditation of Healthcare Organizations
What does it do? It offers Voluntary accreditation; if you don't have JCAHO then you can't bill Medicare or Medicaid for perscriptions
What are the 4 pieces of evidence that must be presented to grant prior approval for nonformulary drugs? 1. Patient intolerance of existing drug choices; 2. Treatment failures; 3. Diagnoses without any listed treatments on the formulary; 4. New drug modalities
Open Formulary Reimburse for all perscriptions medications
Closed Formulary Only reimburse for list of medications, generally low-cost alternatives
What is a formulary? Pharmaceuticals avaliable (Dispensed) and/or Approved (List)
Every Insurance Company has a what? A formulary
Created by: kpetitfils
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