Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Controlled substance
| Question | Answer |
|---|---|
| Orange book | Approved drug products with therapeutic equivalence evaluations |
| Red book | Drug prices |
| State board of Pharmacy | Each state has it's own board of pharmacy that is responsible for protecting the health, safety and welfare |
| Food and Drug Administration (FDA) | Enforces drug manufacturing laws and regulates prescription drug advertising |
| Drug Enforcement Administration (DEA) | Enforces the federal controlled substance act (CSA) and makes decisions the classification of certain drugs as controlled substances |
| Occupational Safety and Health Administration (OSHA) | Enforces occupational health and safety laws |
| Federal Trade Commission (FTC) | Regulates advertising for over-the-counter drugs (OTC), medical devices, cosmetics, food products |
| 1 section of NDC #s | Manufacturer |
| 2 set of NDC #s | Drug (strength and form) |
| 3rd set of NDC #s | Packaging size |
| Schedule 1 | Not accepted medically Not legal High potential for abuse |
| Schedule 2 | Accepted medically Rx only High potential for abuse |
| Schedule 3 | Accepted medically Rx only Moderate potential for abuse |
| Schedule 4 | Accepted medically Rx only Mild potential for abuse |
| Schedule 5 | Accepted medically Rx, limited OTC in some states Low potential for abuse |
| Schedule 1 | Heroin, LSD, marijuana |
| Schedule 2 | Methadone (Dolophine), oxycodone (oxycontin), cocaine, Adderall (amphetamine/dextroamphetamine) |
| Schedule 3 | Burprenorphine (buprenex), codeine (tylenol ll3), benzphetamine (didrex), testosterone (androgen testim, axiron) |
| Schedule 4 | Xanax (alprazolam), ambien (zolpidem), tramadol (ultram) |
| Schedule 5 | Pregabalin (lyrica), robitussin (codeine w/gualfenesin) |
| Controlled substance prescription | Pt's name and address Prescribers name, work address and DEA # Drug name, date, and dosage form Quantity, directions and # of refills l |
| Pseudoephedrine 30 day limit | 9 for 30 days 7.5 mail order 3.6 daily |
| Controlled substances | Keep all records for 2 years Faxed c-ll rx's are valid for home Infusions, long-term care, and hospice pts Verbal c-ll rx's are valid as long as the prescribing MD provides a hard copy in 7 days |
| Refills | C-ll refills not permitted C-lll to lV 5 refills for 6 months C-V refills premitted, no max |
| DEA 41 | Reporting destruction of controlled substance |
| DEA 104 | Reporting a pharm closure or surrender of a pharm permit |
| DEA 106 | reporting loss or theft of controlled substances |
| DEA 222 | ordering schedule 2 controlled substances |
| DEA 224 | Applying for a DEA registration # |
| DEA 222 form 1st page | Brown (original) Retained by drug supplier |
| DEA 222 form 2nd page | Green (1st carbon copy) Forwarded to DEA by drug supplier |
| DEA 222 form 3rd page | Blue (2nd carbon copy) Retained by pharamacy |
| DEA # | Prescriber identification #. Required by practitioners who prescribe controlled substances |
| NPI # | National provider identifier #, 10 digit # |
| Poison Prevention Packaging Act 1970 | Requires child resistant packaging. Nitroglycerin and birth control are exempt because it restores blood flow to the heart, and could cause someone having a heart attack to struggle with packaging. Difficult to open for pts under 5. |
| Omnibus Budget Reconciliation Act of 1990 | Requires drug utilization reviews (DUR) and pharmaceutical care for Medicaid pts. Offers counseling to make sure all pts were receiving same level of service |
| Health Insurance Portabilty and Accountability Act 1996 (HIPPA) | To protect the privacy of individual health info, PHI. |
| Combat Methamphetamine Epidemic Act of 2005 (CMEA) | The reason pseudoephedrine is stored behind the counter. Info must be recorded when buying: product name, quantity, name and address of pt, date and time, signature of pt |
| Safety Data sheets (SDS) | OSHA requires by manufacturers |
| Kefauver-Harris Admendment | Requires manufacturers to provide proof of safety and effectiveness. Requires manufacturers to provide accurate info of side effects |
| Durham-Humphrey Amendment | Requires any drugs habit forming, be prescribed under supervision of licensed practitioner |
| Fair packaging and Labeling Act | Requires drugs to be labeled: The identity of product Name of distributor The net quantity of drug |
| IPledge | REMS program: ensuring pts who begin Isotretinoin are not pregnant and preventing pregnancy in pts recieving treatment |
| T.I.P.S | REMS program designed to communicate the risk of cardiac arrhythmia associated with Tikosyn |
| Clozaril National Registry | A database for recording and referencing the white blood cell count of pts who recieved clozapine |
| Clinical trial phase 1 | Small study 20-80 of healthy male volunteers Low doses are tested |
| Clinical trials phase 2 | Study involving 40-300 pts with the disease of interest Minimum effect dose and max toxic dose determined |
| Clinical trial phase 3 | Study involving 300-3000 pts of various gender, race, lifestyle and age Risks and benefits using the drug Drug formulation refined Placebo studies are conducted |
| FDA recall class 1 | Serious adverse health consequences |
| FDA recall class 2 | Temp or medically reversible adverse health consequences |
| FDA recall class 3 | Products unlikely to have adverse health consequences |
| Prescription Drug Marketing Act 1987 | Requires whole distributors to be licensed |
| Drug Listings Act 1972 | |
| Established rules for all drug manufacturers to supply a current drug list to FDA | |
| Prescription Drug Marketing Act 1987 | Requires wholesale distributors to be licensed |
| How to get DEA # | 2nd letter is dm's last name. 1st+3rd+5th, and get the sum. 2nd+4th+6th and get the sum then times by 2. Last digit of DEA # is the last digit in the sum of both numbers |
Created by:
Ashley824