Study ch 3 Flash Cards

 
Pile Management Card
ch 3

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NDC (national drug code)
the number of a manufacturers label indicating the manufacturer and product info.
recall classifications
1 where there is a strong likelihood that the product will cause serious adverse effects or death

2where the product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects.

3 where a product is not likely to cause adverse effects.
schedule V
each drug has a low potential for abuse relative to schedule 4 drugs and there is a current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amounts of narcotic such as codeine are included in this group.
schedule 1V
each drug has a low potential for abuse relative to schedule 3 drugs and there is a current accepted medical use in the US but abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group.
Schedule 3
each drug's potential for abuse is less than those in schedule 1 and 2 and there is a currently accepted medical use in the US, but abuse may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids and various compounds contain limited quantities of narcotic substances such as codeine are included on this schedule.
schedule 2
each drug has a high potentials for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US> Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule.
Schedule 1
each drug has a high potential for abuse and no accepted medical use in the US. It may not be prescribed. heroin, various opium derivatives, and hallucinogenic substances are included on this schedule.
testing phase in humans
1: -20-100 patients
-time: several months
-purpose: mainly safety

2:-up to several hundred patients
-time:several months to two years
-purpose: short-term safety but mainly effectiveness

3-several hundred to thousands patients
-time: one to four years
-purpose: safety, dosage, and effectiveness.
therapeutic equivalent
pharmaceutical equivalents that produce the same effects in patients.
pharmaceutical equivalent
drug products that contain identical amounts of the same active ingredients in the same dosage form.
Combat Methamphetamine epidemic act (CMEA)
federal law that sets daily and monthly limits on OTC sale of pseudo ephedrine and ephedrine.
exempt Narcotics
Medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least eighteen years of age.
Dual marketing
Status of medications like Plan B that are classified as both prescription drugs and OTC drugs.
control substance mark
the mark (C!!-CV) which indicates the control category of a drug with a potential for abuse.
controlled substances
5 groups of drugs identified by the 1970 Controlled Substance Act (CSA) as having the potential for abuse and whose distributions therefore strictly controlled by 5 control schedules set forth in the CSA
recall
the action taken to remove a drug from the market and have it returned to the manufacturer.
injunction
a court order preventing a specific action, such as the distributions of a potentially dangerous drug.
adverse effect
an unintended side effect of a medication that is negative or in some way injurious to the patients health.
protocol
specific guideline for practice.
compliance
doing what id required.
negligence
failing to for something that should or must be done.
DRug regulation
>In the US, the leading enforcement agency at the federal level for regulations concerning dug products is the Food and Drug Administration.

>The distribution of drugs that may be easily abused is controlled by the Drug Enforcements administration within the Justice dep.

>Manufacturers containers for prescription drugs must have this legend on the label :"Rx only".

>pharmacists must offer counseling to patients regarding medications.
new Drug Approval
>before it is approved for marketing, a new drug must be shown to be noth safe and effective and that its benefits substantially outweigh its risks.

>placebos are inactive substance, not real medications, that are used to test the effectiveness of drugs.
marketed drugs
>Once a patient for a brand a drug expires, other manufactures may copy the drug and release it under its generic name.
OTC medications
>Some OTC medications are kept behind the counter even if they do not require a prescription. These include OTC me4diations contain ephedrine and pseudo ephedrine; exempt narcotic and emergency contraceptives.
sample labels
the minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescriptions serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements.
Controlled Subs
>manufacturers must clearly label controlled drugs with their control classification.

>All prescriber's of controlled subs must be registered with the DEA and are assigned a DEA number which must be used on all controlled drug prescriptions.
Additional DEA forms
>Although DEA Form 222 is the most frequently used DEA form, manufacturers, distributors and dispensers of controlled substances are also required to use specific DEA forms to register with the DEA and otherwise monitor inventory.
Public Safety
>recalls are, with a few exemptions, voluntary on the part of the manufacturer.
law and the technician
>federal laws provide a foundation for the sate laws which govern pharmacy practice in every state.

>State boards of pharmacy are responsible for licensing all prescriber's and dispensers and administering regulations for the practice of pharmacy in the state.

>Legal liability means you can be prosecuted for the misconduct, including, negligence.
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