Laws and Amendments
Help!
|
|
||||
|---|---|---|---|---|---|
| Which law made label requirements for OTC products? | FDA-Food, Drug, and Cosmetic Act
🗑
|
||||
| When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before becoming commercially available. | NDA- New Drug Application
🗑
|
||||
| product contains decomposed substance | adulterated
🗑
|
||||
| the label may be false or misleading | mis-branding
🗑
|
||||
| The Durham-Humphrey Amendment is also called the | prescription drug amendment
🗑
|
||||
| proper warning and directions are absent | mis-branding
🗑
|
||||
| manufacturer name and place of business absent | mis-branding
🗑
|
||||
| stock label fails to say "warning-may be habit forming" if med is habit forming | mis-branding
🗑
|
||||
| product has been packaged under unsanitary conditions | adulterated
🗑
|
||||
| product has different strength or purity than whats indicated on label | adulterated
🗑
|
||||
| What is the amendment that requires manufacturers to dispense medications with labels to the patient? | Kefauver-Harris Amendment
🗑
|
||||
| What are requirements for manufacturers as outlined by the Kefauver-Harris Amendment? | 1. requires manufacturers to register annually
2. be inspected every 2 years
3. report any drug interactions
🗑
|
||||
| requires all medication on the U.S market to be pure, safe, and effective | Kefauver-Harris Amendment
🗑
|
||||
| PPI's are regulated by the FDA. What are these? | Patient Package Inserts
🗑
|
||||
| PPI's MUST be supplied to patients receiving what medications? | oral contraceptives
estrogen
progestin
isotetinoin (accutane)
intrauterine devices ( IUD's)
inhalers
🗑
|
||||
| Information on the PPI MUST include: | product description
indications for use
contraindications (when/ and what it interacts with)
warnings (extreme side-effects)
precautions (less sever side-effects)
Dose (how much and how often)
🗑
|
||||
| The Occupational and Safety Act of 1970 gave rise to | OSHA- Occupational Safety and Health Administration
🗑
|
||||
| What does OSHA do? | ensures job safety and an injury reporting system for job related injuries or illnesses
🗑
|
||||
| OSHA requires the pharmacy to | post the number to poison control
have a reference guide for toxicities
must have Material Safety Data Sheets (MSDS) for any "hazardous materials" in pharmacy
🗑
|
||||
| The Poison Prevention Packaging Act was enacted to | reduce accidental poisonings in children
🗑
|
||||
| The Poison Prevention Act requires pharmacies to | use child resistant containers
🗑
|
||||
| Exceptions to the PPA | medical emergency meds
written requests from DRs or patients
🗑
|
||||
| According to the PPA, OTC meds must | be labeled "package not child resistant" of the package is not child-resistant.
🗑
|
||||
| Examples of medication exempt from the PPA include: | nitroglycerin sublingual (for chest pain)
betamethasone, mebendazole, methylprednisolone (<85 mg), oral contraceptives, pancrelipase, cholestyramine
🗑
|
||||
| A Poison Log must include: | date of sale
name and address of purchaser
name and quantity of poison dispensed
full name of dispenser
🗑
|
||||
| Poisonous 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
🗑
|
||||
| What is Syrup of Ipecac and how much should be ingested? | used in the emergency treatment of certain kinds of poisoning
15ml or 1 tablespoon
🗑
|
||||
| What does activated Charcoal do? | absorbs and eliminates poison in the body
(not to be taking with Syrup of Ipecac as this will either not work or make the person vomit)
🗑
|
||||
| Who enforces the Controlled Substances Act of 1970? And what do they do? | The DEA- regulates use and distributes drugs with high abuse potential and/or addiction into one of the five schedules
🗑
|
||||
| Every pharmacy must make a complete inventory of controlled substances every ___ years and kept on record for ___ years. | two, two
🗑
|
||||
| A DEA number contains how many letter and numbers? | Two letters, seven numbers
🗑
|
||||
| DEA letters usually | start with A, B or M for residents
2nd letter is Drs initial to last name
🗑
|
||||
| Is this DEA number valid? Why? BB10066123 | Do math and answer.
🗑
|
||||
| Can CII medications be refilled? | No, new prescription is required with every fill
🗑
|
||||
| CIII and CIV scripts cannot be filled more than ___ times in a ____ month period. | Five, Six (also CVs)
🗑
|
||||
| CII and CIV scripts can be filled verbally with what exception? | A written script follows verbal.
🗑
|
||||
| CV meds can be dispensed without script is state allows but this must | be recorded in the CV log.
🗑
|
||||
| Schedule I medications are | not accepted for medical use in the U.S
lack of accepted safety use under medical supervision, and a high potential for abuse
🗑
|
||||
| Some examples of CI meds include: | crack
heroin
lysergic acid (LSD)
marijuana
peyote
methaqualone (Ecstasy)
🗑
|
||||
| Schedule II medications | have a high potential for abuse which may lead to sever psychological or physical dependence.
🗑
|
||||
| Some examples of CII meds include: | hydromorphone
methadone
meperidone
oxycodone
fentanyl
morphine
opium
codeine
hydrocodone
🗑
|
||||
| Schedule III medications | has a potential for abuse, less than CI and CII. May lead to moderate or low physical dependence or high psychological dependence.
🗑
|
||||
| Some examples of CIII meds include: | products containing not more than 90 milligrams of codeine per dosage unit --Tylenol 3 & 4, Suboxone
🗑
|
||||
| Schedule IV medications | low potential for abuse
🗑
|
||||
| Some examples of CIV meds include: | Xanax, Klonopin, Valium, Ativan, Restoril
🗑
|
||||
| Schedule V medications | have a low potential for abuse, contain limited quantities of certain narcotics
🗑
|
||||
| Some examples of CV meds include: | Robitussin AC
Phenergan w/ codeine
Ezogabine
cough preparations containing note more than 200 mg of codeine per 100 ml or per 100 grams
🗑
|
||||
| Limitations of Pharmacy Technician duties: | -varies by state
cannot take verbal scripts
cannot give consultations
cannot take or transfer prescriptions
🗑
|
||||
| Drugs are recalled if | it was improperly made or labeled and causes severe adverse reactions
🗑
|
||||
| Class I drug recall: | exposure will cause extreme health hazards or death
🗑
|
||||
| Class II drug recall: | exposure may cause temporary health hazards
🗑
|
||||
| Class III drug recall: | not likely to cause health hazards
🗑
|
||||
| OBRA is also known as the | Omnibus Reconciliation Act of 1990
🗑
|
||||
| The function of OBRA: | directed toward pharmacists but require technician assistance
improves quality of drug therapy and saves healthcare costs
(requires pharmacists to give consultations)
🗑
|
||||
| OBRA requires counseling that 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 info
action to take if missed dose
🗑
|
Review the information in the table. When you are ready to quiz yourself you can hide individual columns or the entire table. Then you can click on the empty cells to reveal the answer. Try to recall what will be displayed before clicking the empty cell.
To hide a column, click on the column name.
To hide the entire table, click on the "Hide All" button.
You may also shuffle the rows of the table by clicking on the "Shuffle" button.
Or sort by any of the columns using the down arrow next to any column heading.
If you know all the data on any row, you can temporarily remove it by tapping the trash can to the right of the row.
To hide a column, click on the column name.
To hide the entire table, click on the "Hide All" button.
You may also shuffle the rows of the table by clicking on the "Shuffle" button.
Or sort by any of the columns using the down arrow next to any column heading.
If you know all the data on any row, you can temporarily remove it by tapping the trash can to the right of the row.
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Created by:
braswell1994
Popular Pharmacology sets