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28 Cards in this Set
- Front
- Back
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FDA - Federal, Drug, and Cosmetic Act |
-Protects the public health-Label requirements for safe consumer use of OTC products- prohibits the sale of “adulterated” or “misbranded” foods and drugsadulterated - presence of any decomposed substance, packaging under unsanitary conditions or if theproduct’s strength or purity is different from what is indicated on the label.misbranding – when the label is false or misleading or when proper warnings and directions are absent. -if the label does not have the name and place of business of the manufacturer. -fails to carry a “Warning – May be habit forming.” if it is habit forming. |
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NDA - New Drug Application |
- When a drug is in the process of being made or discovered, this application must be filed with the FDA to proveefficacy and safety before being commercially available. |
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Durham - Humphrey Amendment |
-Separates drugs into 2 categories: LEGEND AND NON-LEGEND (OTC) -Also called the “Prescription Drug Amendment” -Allows verbal new prescriptions to be called in over the phone and allows refill okays to be done over the phone. *Legend – Requires a prescription because the person requires supervision of a physician. The stock bottleis not required to have directions of use but must have on bottle label, “Caution: Federal law prohibits dispensingwithout a prescription.” *Non-legend – Requires that all products to have directions of use. Does not require a prescription. |
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Kefauver - Harris Amendment |
- Label requirements for manufacturers and dispenser to the patients - Regulates proper drug advertising and package inserts issued by the manufacturer - Requires manufacturers to: 1) register annually 2) be inspected every 2 years 3) report any drug reactions - Requires all medication on the U.S. market to be pure, safe, and effective. |
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PPI’S - Patient Package Inserts |
- Regulated by the FDA- Must supply a PPI to patients receiving the following medications: • Oral contraceptives • Estrogen • Progestin • Isotretinoin (Accutane) • Intrauterine devices • Inhalers |
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Information on the PPI : |
-product description - indications for use - contraindications (when/what it interacts with) -warnings (extreme side effects) - precautions (less severe side effects) - dose (how much to take and how often) |
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Occupational And Safety Act of 1970 |
- ensures a safe and healthful workplace for employees by reducing hazards in the workplace. Audits showcompliance. - gave rise to Occupational Safety and Health Administration (OSHA) -ensures job safety standards and an injury reporting system for job-related injuries or illnesses. - all pharmacies should: - post the phone number to poison control- have a reference guide for toxicities - must have Material Safety Data Sheets (MSDS) for any “hazardous materials” in pharmacyThe impact on pharmacy: air contaminants, flammable/combustible liquids, and eye/skin protection. |
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Poison Prevention Packaging Act |
-enacted to reduce accidental poisonings in children - requires pharmacies must use child resistant containers (and most OTCs) - defined as: difficult for 80% of children under 5 yrs. to open and allows 90% of adults to open. - prohibits re-use of child resistant containers- because the wear and tear of normal use may decrease theeffectiveness |
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Exceptions to PPPA: |
- medications used as medical emergencies such as nitroglycerin sublingual tablets for chest pain - written requests from Drs or patientsi.e.. arthritic patients cannot open bottles -OTC mediations must be labeled “package not child resistant” if it is not child resistant -betamethasone, mebendazole, methylprednisolone (<85 mg), Oral Contraceptives, Pancrelipase,cholestyramine |
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Poison Log |
Log must include: - date of sale - name and address of purchaser - name and quantity of poison dispensed - reason for purchase - full name of dispenser *Poison substances must be labeled with: - complete name of poison - the word “POISON” boldly imprinted on label- place of business of the seller- proper directions of use |
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Controlled Substance Act of 1970 (CSA) |
The CSA is enforced and regulated by the DEAregulates use and distributes drugs with high abuse potential and/or addiction into one of five schedules (CI – CV) |
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Exceptions for Schedule 5 Drugs |
If the state wishes, it may permit C-V’s to be dispensed without a prescription if the following standardsare met: - person is 21 years or older - drug is sold by pharmacist - log of sale must be kept in a logbook containing: name, address and full signature of purchaserdate and time of salename, strength, and quantity of drug soldfull signature of R.Ph. -no more than l20ml or 120 gm of drug sold in 4 days |
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How long does each pharmacy must make a complete inventory of controlled substances? |
Each pharmacy must make a complete inventory of controlled substances every 2 years and kept for 2 years. |
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Each medication label on a control medication should state what? |
“Caution, Federal law prohibits the transfer of this drug to anyperson other than the patient for whom it was prescribed.” Do not cover with an auxiliary label. |
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Refilling Controlled Substances |
- Control II’s are not refillable - Patient must have a new written prescription each time from the doctor - Control III and IV - no more than 5 times in a 6 month period. - oral prescriptions are allowed over the phone with the Dr responsible to provide a written “cover’prescription - Control V- recorded in the Schedule V log book if state allows no prescription - or no more than 5 times in 6 months |
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Limitations of Pharmacy Technician Duties |
- varies by state- Federal law: may perform all functions of pharmacy practice under the direction of the pharmacist except: 1) pharmacy technician shall not receive oral prescriptions over the phone 2) shall not exercise professional judgment in any matter of pharmacy practice 3) can not transfer prescriptions. |
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Drug Recalls: |
A drug is recalled if it was improperly made or labeled and causes severe adverse reaction. 3 classes of drug recalls - Class I - where exposure to the product will cause severe health problems/death - Class II - where exposure to the product may cause temporary (meaning reversible) adverse health hazard - Class III - where exposure to the product is not likely to cause adverse health hazards |
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Federal vs. State Law |
Think of it as Federal law is more laid back and State law is very strict.State law can be stricter than Federal law but not more laid back than Federal.Always follow the more strict law if the two differ. |
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Repackaging of medications |
1) Labeling:- generic name of drug- strength- dosage form- manufacturer and lot number- expiration date after repackaging- repacked medication is 50% of expiration date on stock bottle to max of 1 year. 2) Repackaging Log – documentation -reviewed by R.Ph - date of repackaging - name of drug - manufacturer - exp. date of manufacturer and lot # - quantity repacked - R.Ph. initials or signature |
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OBRA 90- Omnibus Reconciliation Act of 1990 |
-Directed toward the pharmacist but the pharmacist cannot do this without the help of the technician. -Improves quality of drug therapy and saves health care costs. *Counseling must include: - name and description of medication - dosage form, dose, route of administration and duration of therapy - special directions/precautions - side effects and ways to prevent - techniques for self-monitoring - storage - refill information - action to take if missed a dose |
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Drug Use Evaluation |
- ensures medications are used safely, effectively, and appropriately. - required by JCAHO - Joint Commission on Accreditation of Health Care OrganizationsJCAHO is quality control. This organization makes sure the procedures and end product meet standards. They helpprevent errors by enforcing log books and inspections.Pharmacy Technicians roles are review patient charts, computer reports, prepare DUE reports |
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Adverse Drug Reaction (ADR) |
Any undesirable or unexpected event that requires stopping a drug, modifying the dose, prolonging hospitalization, or providing supportivetreatment. -Type A ADR - expected from the known properties of the medicationmost ADRs are Type Aunlikely life-threatening -Type B ADR - infrequent and not predictable allergic reactionsmay cause cancer and birth defects serious and life-threatening Pharmacy Technician roles: identifying, documenting, analyzing and reporting ADR to the FDA |
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DEA 41 |
Destruction of outdated or damaged controlled substances.Must be sent to the DEAMust indicate name, strength, and quantities of controlled substances, date & method of destruction and witnesses. |
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DEA 106 |
Theft of controlled substancesPharmacy must notify: the nearest DEA office, the local police, and complete for 106 and send original to DEA office and keep a copy in pharmacy. |
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DEA 224 |
Pharmacy’s registration to the DEAMust re-new every 3 years. |
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DEA 222 |
How Schedule II’s are ordered. Form must be signed by the individual in whose name the DEA registration is listed.Triplicate order form = Brown, Green, Blue. Must be completed by typewriter, pen, or indelible pencil.Valid for only 60 days. The number of lines ordered must be written on the form and signed by the pharmacist.Only 10 lines so only 10 orders per formmaximum.Brown copy goes to supplier, green goes to DEA, blue stays in pharmacy.Unused forms must be kept secure. Upon receipt of shipment, the product must be checked in against the blue copy. Must be signed anddated by the pharmacist. Must be stamped with red C stamp if filed with other than 222 forms. Must bekept 2 years |
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Formulary System |
- lists the product name, dosage form, concentration, and package size - drugs that are to be maintained in stock - controls drug costs - updated every 12-18 months - in a institutional setting (hospital) the formulary is developed by the Pharmacy and Therapeutics Committee |
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P & T Committee |
-The P & T Committee consists of physicians, pharmacists, nurses, dietitians, and administrators - third-party payers also develop a formulary on which drugs they will reimburse |
