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Federal Food, Drug, and Cosmetic Act (FDCA)
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Pure Food and Drug Act of 1906
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All Notes for Final
ALL notes for Final
| Question | Answer |
|---|---|
| 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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