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33 Cards in this Set
- Front
- Back
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Drugs for sale must be effective, safe, and properly labeled
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Federal Drug and Cosmetic Act
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True or False: Claims made on the label of a food product must be documented by research studies
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False
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OTC
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Must be safe, efficacious and have NO abuse potential. Strength must be low to prevent overdosage
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What must be listed on OTC product labels?
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Various uses,adverse effects, contraindications and warnings
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Legend
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Federal law prohibits the dispensing of this drug without a prescription
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Transfer Warning
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State or federal law prohibits the transfer of this drug to any person other than to the person to whom it was prescribed
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No proven therapeutic benefit and are highly abusable (i.e heroin). Not commerically available
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C-I
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High potential for abuse, but therapeutically useful (i.e Morphine, Meperidine, Methadone)
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C-II
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Proven therapeutic benefit with less potential for abuse. May lead to dependence, but to a less degree. (i.e Benzodiazepines and modified opiates)
May be prescribed on a regular prescription form |
C-III
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Drugs have much less potential for abuse and require less special documentation (i.e Xanax, lorazempam, Darvocet)
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C-IV
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Low potential for abuse
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C-V
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Where are C-II drugs stored?
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In a locked cabinet in the pharmacy or in a locked area of the medication cart
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DEA Form 222
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C-II drugs must be written on this form, a triplicate form. Must be written in ink, no refills
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Federal Hazardous Substances Act
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Enforced by Consumer Product Safety Commission. Encompasses the Poison Prevention Packaging Act, OSHA
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Poison Prevention Packaging Act
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1970. substances available for home use must be in child-resistant packaging. Drugs may be dispensed in regular packing if 1.) the doctor or patient requests or 2.) the drug is exempt for this law, provided the label has a warning.
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Sublingual nitroglycerin
Sublingual or chewable isosorbide dinitatrate Oral contraceptives containing < 27 mg of conjugated estrogens or <50 mg of norethindrone Medroxyprogesterone tabs Oral suspensions of erythromycin containing <8 g of erythromycin Oral tabs of erythromycin containing <16 g of erthromycin Corticosteroids used for treatment of prevention of severe allergic reactions OTC products when labeled properly Institutional use |
Drugs exempt from PPPA
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passed to ensure safety of the worker
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OSHA
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If a flammable material is spilled...
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1st- contain, so that spill does not contact electrical outlets
2nd- ventilate the area 3rd- place absorbant material on spill, then sweep away and dispose |
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Caustic materials
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Must be neutralized before steps are taken to clean up
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Mandatory counseling of patients and monitoring of patient
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The Consolidated Omnibus Budget Reconciliation Act
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All personally identifiable information must be protected. Patients are allowed to access and request copies of their medical records. Healthcare providers must provide a written statement explaining how information will be used. Use of medical information is limited. Patients are entitled to discussion of options. Complaints may be made with Office for Civil rights
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HIPAA
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The Food, Drug, and Cosmetic Act provides for documentation of the safety and efficacy of drugs by reviewing what?
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data from clinical trials and animal studies
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Patient counseling
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teaching the patient self-monitoring techniques; done by pharmacist
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Package inserts must be distributed
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to any patient receiving estrogen before the first dose and every 30 days after.
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protects the public against unreasonable risks of injury associated with consumer products.
assists consumers in evaluating the comparative safety of consumer products. develops uniform safety standards for consumer products and to minimize conflicting state and local regulations. promotes research and investigation into the causes and prevention of product related deaths, illnesses, and injuries. |
Consumer Product Safety Commission
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Who chooses the drug formulary for the pharmacy?
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the Pharmacy and Therapeutics Committee
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Who sets standards for proper hospital administration?
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JCAHO
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Counseling includes:
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drug action.
basic physiology potential adverse effects foods and drinks to be avoided importance of proper dosing |
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MD
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medical doctor
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DO
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doctor of osteopathic medicine
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doctor of dentistry
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DDS
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nurse practitioner
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NP
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physicians assistant
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PA
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