Term | Definition |
DEA form 106 | Missing or lost controlled substances |
DEA number consists of: | 2 letters & 7 digits
A, B, F, M, P, R, second letter is the initial of the last name |
DEA number check | Sum the 1st, 3rd & 5th digits
Sum the 2nd, 4th, & 6th digits. Multiply by 2
Add the first 2 numbers. Last digit should match the seventh. |
Controlled Substance records must be kept for: | 2 years |
Controlled substances require this extra info on the label | Prescriber's DEA number |
Controlled Substance prescriptions may be written for up to : | A 6 month supply |
What is the Kefauver-Harris Amendment (Efficacy Amendment) | The first major update to the FDCA since the Durham-Humphry Amendment (11 years earlier) |
K-H Amendment provides: | the modern scenario for approving new drugs |
K-H Amendment 3 initial steps: | 1. Discovery 2. Preclinical (animal testing) 3. Investigational New Drug Application |
K-H Amendment Phases: | 1: 20-100 healthy people
2: 100-150 people w/ the ailment
3: 1,000-5,000 people with the ailment |
K-H Amendment: NDA | New Drug Application (FDA has 60 days to decided if it's files) Review can take 6 months to 2 years. |
K-H Amendment FDA approval includes: | 1: reviewing professional labeling
2: inspecting manufacturing facility
3: conducting post marketing study commitments (Phase 4) |
The Comprehensive Drug Abuse Prevention and Control Act of 1970 provides | for the classification, acquisition, distribution, registration/verification of prescribers and record keeping requirements of controls. |
The Comprehensive Drug Abuse Prevention and Control Actof 1970 provided the legal framework for | the creation of the Drug Enforcement Administration (DEA) |
The DEA is primarily tasked with: | enforcement responsibilities of the CSA. |
Pure Food & Drug Act of 1906 | Prohibits misbranded and adulterated foods, drinks & drugs. Considered the beginning of the FDA. |
Harrison Narcotics act of 1914 | Intended to curve the growing number of opium addictions within the U.S. |
The Food, Drug & Cosmetic Act of 1938 | Replaced the Pure Food & Drug Act of 1906. Requires new drugs to be safe. Authorized factory inspections. Provided safe tolerances for unavoidable poisonous substances among other things. |
Durham-Humphrey Amendment of 1951 | established two classes of drugs: Rx legend and OTC. |
Durham-Humphrey Amendment of 1951 gave guidance for what must be included on a prescription label: | 1. name & address of pharmacy
2. Serial number of Rx
3. Fill date
4. Name of prescriber
5. Name of patient
6. Directions for use
7. Applicable warning labels. |
Occupational Safety and Health Act of 1970 created (OSHA) strongly impacts pharmacy with | 1. Written hazard communication program
2. Material Safety Data Sheets (MSDS) ***
3. Air contaminants
4. Flammable and combustible liquids |
Orphan Drug Act of January 1983 (ODA) | Encourages researchers to develop drugs for rare diseases by rewarding with tax reductions marketing exclusivity for an extended time (7 years) post approval, |
Omnibus Budget Reconciliation Act of 1987 (OBRA 87) | Protected the rights of patients in long-term care facilities.
Gave CMS the authority to enact key measures to reduce costs & improve quality of patient care in long-term care facilities. |
Omnibus Budget Reconciliation Act of 1990 (OBRA 90) Goal: | to save the federal government money by improving therapeutic outcomes. |
Omnibus Budget Reconciliation Acct of 1990 implemented: | Pharmacist counseling obligations
Prospective drug Utilization Review (ProDUR) requirements
Record-keeping mandates |
Dietary Supplement Health & Education Act (DSHEA) of 1994 | Regulates dietary supplements as foods, not as drugs. FDA will take action only after a dietary supplement has been proven harmful, not ineffective. |
The Health Insurance Portability & Accountability Act of 1996 (HIPAA) | The first comprehensive regulation to safeguard the privacy of Protected Health Information (PHI) |
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) | Regulates retail OTC sales of ephedrine, pseudoephedrine & phenylpropanolamine. |
CMEA Limits: | Daily 3. 6 grams Monthly: 9 grams (7.5 g/mo for mail order) |
Medicaid Tamper-Resistant Prescription Law of 2007 | Requires physicians and pharmacists to use either electronic prescriptions or tamper resistant prescription pads for their medicaid patients. |
Medicaid Tamper-Resistant Prescription Law requires one or more: | 1. VOID pantograph background
2. Reverse Rx Symbol
3. Micro Printing
4. Artificial Watermark on back of script
5. Coin activated ink
6. Toner Grip Security Coating
7. Check & Balance" printed features |
DEA form 41 | Inventory of Drugs Surrendered |
DEA form 222 | Used to order C-II drugs |