Acts and Categories Flashcards
HIPAA
privacy act, no sharing of information unless is authorize by the patient or requested from the public authorities
DATA
prescribed controlled substances
Combat Methamphetamine Epidemic Act
control pseudoephedrine, which can be used to make methamphetamine.
FDA
Department of Health, enforce the guidelines for manufacturers to ensure the safety and effectiveness of medications.
DEA
Department of Justice, prevent illegal distributions and misuse of controlled substances
NDC
National Drug Code, 10 digit, 3 segments, 1St set: assigned by the FDA, 2nd set: identifies the specifics of the product, 3rd: package size and types.
Recalled Drugs
FDA request manufacturer to recall unless manufacturer refused
What does Class 1 drug indicate?
highest level, products could cause serious harm, live-saving drugs, and foods containing toxins or labels with missing ingredients that could cause allergies.
What does Class 2 drug indicate?
products found to cause temporary health problem or a slight threat of serious harm, not include drugs used in life-threatening events
What does Class 3 drug indicate?
lowest level, for products that may have a minor defect that would not harm the patient, container defect, strange color or taste
How does Controlled Substances labelled and when does it being used?
usually have a “C” printed on the label, used for substances that are addictive and have a potential to be abused.
What is a C-I drug?
highest abuse potential, no accepted medical use in U.S, not available in pharmacies
What is a C-V drug?
lowest, may be kept OTC in some states,drugs can be refilled as often as prescribed on the prescription.
Can C-II be refill?
drugs may not be refilled
How many time C-III and C-IV can be refill?
can be refilled up to 5 times in 6 months after the date the prescription was written.
What does C-III,C-IV, and C-V drugs required for refill?
pharmacist’s initials, refill date, amount of drug that is refilled.
What does for Pregnancy Categories indicate?
five categories that indicate the potential of a drug to cause fetal defects; categories are based on the ratio of risks versus benefits. These categories are set on drug based on extensive clinical trials by the manufacturer.
What is the Category A of the Pregnancy Categories?
no risk to the fetus in the first trimester of pregnancy ( no risk in later trimesters).
What is the Category B of the Pregnancy Categories?
no found risk in animal and no adequate and well-controlled studies in pregnant women
What is the Category C of the Pregnancy Categories?
animal studies shown an adverse (counter) effect on the fetus and no well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
What is the Category D of the Pregnancy Categories?
positive evidence of human fetal risk from investigational or marketing experience or studies, still potential benefits may warrant use of drug.
What is the Category X of the Pregnancy Categories?
both animal and human studies have demonstrated fetal abnormalities and positive evidence of human fetal risk based on adverse reaction data. The risks outweigh the potential benefits.
What are some prescription regulation?
➢ Physicians and medical prescribers are licensed by their individual state boards.
➢ Specific degree allowed prescribing specific medications.
➢ Some states allowed nurse practitioners and physician assistants to prescribe a limited number of medications/ devices.
➢ Pharmacy tech takes in prescriptions, enters them, fills the. Pharmacist is responsible for interpreting and reviewing the prescription before dispensing the medication.
➢ Two components for the prescription labels are the pharmacy information and patient information.
➢ All prescribers must be registered with the DEA to write prescriptions for controlled substances.
OSHA
occupational safety and health administration provide a safe workplace for employees.
MSDS
Material Safety Data Sheets, how to store, handle the chemical.
