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18 Cards in this Set
- Front
- Back
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Pure Food and Drug Act of 1906 |
Prohibited interstate commerce of misbranded and adulterated drugs, foods, and drinks. Focus was on purity, not safety. |
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Federal Food, Drug and Cosmetic Act of 1938 |
Required drug labeling to include directions for use, warnings, and safety concerns. Mandated pre marketing approval of all drugs. Ensured FDA oversee all misbranding and adulteration (eg omission of important info on label, does not comply with color additive provisions, label doesn't include name of manuf., req'd wording isn't displayed, etc.,) |
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Prescription Drug Label Requirements (FFDCA of 1938) |
-Highlights -Limitations Statement -Product Name and initial FDA approval date -Boxed warning -Recent major changes -Indications and usages -Dosage and administration, dosage form and strength -Warnings and precautions, adverse reactions, drug interaction, contraindications -Use in specialized populations -Patient counseling information |
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OTC Drug Label Requirements (FFDCA of 1938) |
-Active drug and inactive ingredients -Uses and warnings -Purpose and directions -Storage requirements -Expiration date -Batch or NDC number -Name and add. of manuf. -Quantity of Product in package -Instructions in case of overdose |
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Comprehensive Druge Abuse Prevention and Control Act of 1970 (Controlled Substances Act) |
Required registration, record keeping and rules regarding dispensing of controlled drugs. Divided controlled drugs into five schedules. |
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Poison Prevention Packaging Act of 1970 |
Required child resistant containers (no more than 20% of children should be able to open the container). Exceptions: Properly labeled OTCs, Subling NTG, inhalation aerosols, oral contraceptives, hormone replacement therapy, etc,. |
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Omnibus Reconciliation Act (OBRA) of 1990 |
Requires pharmacist of offer counseling and perform drug utilization reviews (DUR) for all Medicaid prescriptions. Many states require counseling for Medicaid and non-Medicaid patients) |
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Required Counseling information under OBRA 1990 |
-Drug name, description, intended use, and action -Route, dosage for, dose, and duration -Common side effects, adverse effects, interactions -Techniques for self monitoring -Proper storage -Refill information -Action to be taken in the even of missed dose |
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Health Insurance Portability and Accountability Act (HIPPA) of 1996 |
Required privacy safeguards for protected health information. |
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Isotretinoin Safety and Risk Management Act of 2004 |
Created because the use of Isotretinoin can cause spontaneous abortions and fetal abnormalities. -Req. practitioners, PharmDs and patients be included in iPLEDGE registry -Rx written for 30 days, can't be faxed, phoned or sent electronically. -Reqs blood testing before and after 30 day treatment. -Patient must complete consent form and obtain counseling and comply with req'd pregnancy tests. |
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Combat Methamphetamine Epidemic Act of 2005 |
Created restrictions on ephedrine, pseudo ephedrine, and phenylpropanolamine. -Sales: max limit of 3.6 g/day and 9 g/mo of base product. -Storage: Product must be maintained behind the pharmacy -Records: Written or e-logbook must be maintained with info on product name, quantities sold, patient ID info (name, and address of purchase) and time of sale. |
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Risk Evaluation and Mitigation Strategies (REMS) Program |
Encourages safe and effective medication use. Medications are selected based on adverse effects, teratogenicity, abuse potential, and the necessity for appropriate dosing. FDA may require manufacturers to submit to a REMS program upon drug approval this may include use of medication guides, communication plans, etc., |
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Infection Control and Hazardous Chemical Standards |
Process used to prevent nosocomial infections. Facilities should implement infection prevention and control processes. Occupational Safety and Health Administration (OSHA) requires hand washings, use of personal protective equipment (gloves, gowns, googles, etc.,) Counting trays and spatulas must be disinfected using 70% isopropyl alcohol. Use of MSDS. |
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Comprehensive Druge Abuse Prevention and Control Act of 1970 Registration |
New pharmacies must first obtain a state license. |
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DEA Form 222 |
Used for ordering Schedule II medications. Triplicate form that must be handwritten or typed then signed by the individual registered with DEA. (Copy for supplier, copy forwarded to DEA and copy received by purchaser) Valid for 60 days. Record of all DEA 222 forms (including incomplete forms) must be kept for min of 2 years. Max of 10 items ordered per form. |
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DEA Form 224 |
Facilities that dispense controlled substances register using DEA form 224. Certificate registration should be maintained at the registered location and kept in an accessible place for inspections. Registration valid for 3 years and renewed with DEA Form 224a. Request a duplicate of certificate using DEA Form 223. |
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Comprehensive Druge Abuse Prevention and Control Act of 1970Registration Inventory Requirements |
All controlled substances must be inventoried on the first day pharmacy opens. Biennial inventory of controlled substances must be kept in a retrievable location and maintain for 2 years. Schedule II drugs must be physically counted and inventory counts needs to be kept separate. Schedule III, IV, and V drug counts can be estimated. |
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Comprehensive Druge Abuse Prevention and Control Act of 1970Registration Prescription Restrictions |
Schedule II drug Rxs may be written or computer generated buy must be presented in person at the pharmacy. Schedule III or IV Rxs can be sent electronically and can be faxed or phoned in depending on the state. |
