Acts and Categories

Question 1

HIPAA

Answer 1

privacy act, no sharing of information unless is authorize by the patient or requested from the public authorities

Question 2

DATA

Answer 2

prescribed controlled substances

Question 3

Combat Methamphetamine Epidemic Act

Answer 3

control pseudoephedrine, which can be used to make methamphetamine.

Question 4

FDA

Answer 4

Department of Health, enforce the guidelines for manufacturers to ensure the safety and effectiveness of medications.

Question 5

DEA

Answer 5

Department of Justice, prevent illegal distributions and misuse of controlled substances

Question 6

NDC

Answer 6

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.

Question 7

Recalled Drugs

Answer 7

FDA request manufacturer to recall unless manufacturer refused

Question 8

What does Class 1 drug indicate?

Answer 8

highest level, products could cause serious harm, live-saving drugs, and foods containing toxins or labels with missing ingredients that could cause allergies.

Question 9

What does Class 2 drug indicate?

Answer 9

products found to cause temporary health problem or a slight threat of serious harm, not include drugs used in life-threatening events

Question 10

What does Class 3 drug indicate?

Answer 10

lowest level, for products that may have a minor defect that would not harm the patient, container defect, strange color or taste

Question 11

How does Controlled Substances labelled and when does it being used?

Answer 11

usually have a “C” printed on the label, used for substances that are addictive and have a potential to be abused.

Question 12

What is a C-I drug?

Answer 12

highest abuse potential, no accepted medical use in U.S, not available in pharmacies

Question 13

What is a C-V drug?

Answer 13

lowest, may be kept OTC in some states,drugs can be refilled as often as prescribed on the prescription.

Question 14

Can C-II be refill?

Answer 14

drugs may not be refilled

Question 15

How many time C-III and C-IV can be refill?

Answer 15

can be refilled up to 5 times in 6 months after the date the prescription was written.

Question 16

What does C-III,C-IV, and C-V drugs required for refill?

Answer 16

pharmacist’s initials, refill date, amount of drug that is refilled.

Question 17

What does for Pregnancy Categories indicate?

Answer 17

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.

Question 18

What is the Category A of the Pregnancy Categories?

Answer 18

no risk to the fetus in the first trimester of pregnancy ( no risk in later trimesters).

Question 19

What is the Category B of the Pregnancy Categories?

Answer 19

no found risk in animal and no adequate and well-controlled studies in pregnant women

Question 20

What is the Category C of the Pregnancy Categories?

Answer 20

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

Question 21

What is the Category D of the Pregnancy Categories?

Answer 21

positive evidence of human fetal risk from investigational or marketing experience or studies, still potential benefits may warrant use of drug.

Question 22

What is the Category X of the Pregnancy Categories?

Answer 22

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.

Question 23

What are some prescription regulation?

Answer 23

➢ 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.

Question 24

OSHA

Answer 24

occupational safety and health administration provide a safe workplace for employees.

Question 25

MSDS

Answer 25

Material Safety Data Sheets, how to store, handle the chemical.