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
MPJE - Federal
Federal Laws and Regulations - Pt 2
| Term | Definition |
|---|---|
| Colored Book Designations | Orange = Therapeutic Equivalents Green = Animal Drug Products Purple = Biologics Pink = Vaccine-Preventable Diseases Yellow = International Travel |
| Parts of Medicare | Part A = Hospital Insurance Part B = Medical Insurance for Physician Services Part C = Medicare Managed Care (Medicare Advantage) Part D = Prescription Drug Coverage |
| OBRA '90 | Established minimal requirements that states must adopt and requires that states must actually establish the standards in order to continue to receive federal funds for Medicaid Established DURs, offer to counsel, and record keeping |
| Poison Prevention packaging Act - 1970 | Created the Consumer Product Safety Commission Required use of safety caps Child-resistant packaging required for "hazardous household products" Regulated the packaging of iron products Failure to comply considered "misbranding" |
| Anti-Tampering Act-1982 | Resulted from Tylenol poisoning incident Tamper evident packaging for oral OTC and dietary supplements Exemptions: insulin, lozenges, toothpaste, and dermatologic products |
| Health Insurance Portability and Accountability Act (HIPAA) | Protects PHI PHI can be shared with patient, other providers on patient's healthcare team, entities for payment or operational purposes, law enforcement "Minimum necessary" Standard Covered entities: providers, health plans, HC facilities |
| Health Information Technology for economic and Clinical health Act (HITECH) | Increased penalties for misuse of PHI in marketing without proper authorization Established "breach" notification standards and response |
| National Drug Code (NDC) | All drugs marketed must have NDC XXXXX-XXXX-XX (Man. identifier-product identifier-package size identifier) |
| Drug Recalls | 1: Reasonable probability that the use or exposure will cause serious adverse health consequences or death 2: Use or exposure may cause temporary or medically reversible AHQ, or serious HQ are remote 3: Use or exposure not likely to cause serious AHQ |
| Controlled Substances Act (CSA) - 1970 | Established the DEA DEA has oversight and regulatory authority for controlled substances Closed system for manufacturing, distribution, dispensing, and reverse distribution Potential for abuse with psychological and physical dependence |
| CSA Scheduling | 1: No currently accepted medical use; high potential for abuse 2: High potential for abuse; severe dependence 3: lower abuse potential; moderate/low dependence 4: lower abuse potential; limited dependence 5: lowest abuse potential; limited dependence |
| Schedule 1 Substances | Street or illegal controlled substances Ex: heroin, GHB, LSD, marijuana, peyote, methaqualone, MDMA |
| Schedule 2 Substances | Narcotics and Stimulants Ex: morphine, codeine, opium, methadone, hydromorphone, amphetamine, methamphetamine, methylphenidate, lisdexamfetamine, cocaine |
| Schedule 3 Substances | Morphine combo < 50mg per 100 mL or g Buprenorphine containing products to treat OUD, benzphetamine, phendimetrazine, ketamine, anabolic steroids |
| Schedule 4 Substances | Tramadol, Benzodiazepines (Pentacozine is 4 federally, 2 in IL) |
| Schedule 5 Substances | Cough preparations containing not more than 200mg of codeine per 100 mL or g Diphenoxylate w/atropine Pregabalin |
| DEA Forms | 222-Ordering form for S1/2 106-Reporting theft or significant loss 41-Controlled substances destroyed 224-Pharmacies, hospitals, clinics, practitioners, and mid-level 225-Man.,dist.,& researchers 363- Narc. tx clinics 510- Bulk chemical man & dist |
| DEA 222 Form | 1&2: Drug's name, NDC, strength, package size, # of packages, lines completed, signature of agent, DEA # of pharmacy, date issued Max: 6 order form books- 7 numbered forms & 10 lines each Copies: 1-brown-supplier, 2-green-supplier/DEA, 3-blue-recipient |
| Requirements for written and oral prescriptions | C2: verbal in emergency, fax allowed for LTC and hospice. Pharmacist may change any element of the prescription (with provider approval) except: name of patient/prescriber/medication, and date C3-5: Written, verbal, or electronic. Fax= signed manually |
| CSA Recordkeeping | All records must be kept for 2 years Most can be kept at central location; however paper Rxs, inventories, and executed 222s must be stored in pharmacy Central location records must be made available in 2 business days |
| CSA Security | C1: must be locked in safe/cabinet C2-5: may be locked up or dispersed throughout the stock of non-controlled drugs, can't hire those convicted of drug-related felonies, notify theft within 1 business day of noticing |
| DEA Registration | A,B,F,G: Hospital, clinic, practitioner, pharmacy M: mid-level practitioner L: reverse distributors P,R: man,dist.,researcher, import, export, NTP X: addiction Tx on outpatient basis |
| Format of DEA Registration | Format: XX1234563 Add digits 1,3,5 Add digits 2,4,6 and multiply by 2 Add the results of the above and the last # of the summation should equal last # in the DEA# |
| Partial Filling of C2s | Rx may be partially filled, with the quantity supplied being documented, and the remaining quantity may be dispensed within 72 hours. Partials are allowed up to 30 days from date of Rx, 60 for LTCFs |
| Combat Methamphetamine Epidemic Act | Limits sale to no more than 3.6mg of ephedrine, PSE, or PPA to a single purchaser per day. No more than 9g within 30 days or 7.5 by mail order. Products must be stored behind counter or under lock and sales must be recorded |
Created by:
skelly46
Popular Law sets