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Additional terms

CH 2 pg 44-51 terms

TermDefinition
Drug Interactions Instructions on how to prevent or lessen the interaction
Drug Abuse and Dependence Patient has shown addiction to the medication, or the medication has been found to be abused by the patient
Clinical Pharmacology How other drugs interact with the medication and alerts the prescriber to adverse reactions
How supples/storage and handling Information about how the medication is supplied often is in a chart. Lists varying strength, dosage forms, and if the medication has special requirements
Boxed Warning Drug warning that is placed in the prescribing information or package insert of the prodcuct and indicates a significant risk for dangerous side effects
MedGuides Paper handouts that address issues specific to particular drug and drug classes and contain FDA approved information
Pregnancy Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy
Pregnancy Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women
Pregnancy Category C Animal reproduction studies have shown an adverse effect on the fetus no adequate and well controlled studies in humans. Potential benefits may warrant use of the drug in pregnant women despite potential risk
Pregnancy Category D There is positive evidence of human fetal risk based on adverse reaction data from studies in humans
Pregnancy Category X Studies in animals and humans have demonstrated fetal abnormalities. and there is positive evidence of human fetal risk based on adverse reaction data from marketing experience and the risks involved in use of drugs in pregnant women
Special labeling and record keeping considerations Certain drugs require additional provided information to be given to a patient because of adverse effects from medication and teratogenicity to an unborn fetus
Veterinary Medications: Prescribers must be a licensed veterinarian and include the statement " Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian"
Repackaging Any medication taken from bulk packages and placed in blister packs or unit dosing devices must have the drug name, strength, dosage form, manufacturer, lot number and expiration date
Drug Enforcement Administration Verification Alpha Characters & meanings All prescribers must be registered with the DEA to write prescriptions for controlled substances. X= prescribers who order medication to treat opioid addiction
Risk Mangement Programs for Prescription Drugs (REMS) Manufactures to ensure that the benefits of a drug or biological product outweigh its risk
Ipledge Computer based risk management program designed to increase awareness of the danger of isotretinoin in an effort to eliminate fetal exposure to drugs
Adverse Reactions Harmful and unpleasant response to a medication
Created by: lamia23
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