Exam 4 - Law

Question 1

FDA pregnancy and lactation labeling

Answer 1

Still use the A, B, C, D, X categories

OTC products are not affected by the new FDA pregnancy and lactation labeling

Question 2

Age restriction for emergency contraception

Answer 2

NONE

You do NOT have to have an ID to purchase

Question 2

OTC labeling for vaginal contraceptive and spermicide use containing nontoxynol 9 as the AI

Answer 2

STD alert: this product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner

Question 3

Where are emergency contraceptives kept

Answer 3

Often kept behind the counter

FDA requests that it be kept w/ family planning section w/ the condoms

Question 3

Who may purchase emergency contraceptives

Answer 3

Males and females may purchase

Question 4

OTC labeling special warning requirements of mineral oil

Answer 4

Requires warning to only be taken at bedtime and not to be used in infants unless under advice of physician

Question 5

Plan-B One Step

Answer 5

Single pill of 1.5 mg levonorgestrel

Question 5

What happens if you use mineral oil during pregnancy

Answer 5

It predisposes the newborn to hemorrhagic diseases

Question 6

Plan B restrictions

Answer 6

Currently no states restrict the sale of Plan B

May change due to overturning of Roe v Wade

Question 7

Why can you not use mineral oil near meal time

Answer 7

It interferes w/ absorption of fat soluble vitamins and provitamin A

Question 7

OTC labeling for mineral oil cannot

Answer 7

Encourage use during pregnancy

Question 8

What happens when mineral oil is given to infants?

Answer 8

The infant is at greater risk of aspiration and lipoid pneumonia

Question 9

Sodium phosphates

Answer 9

Saline laxative used PO and as a rectal enema

Question 10

Limits for sodium phosphate oral solution

Answer 10

Not more than 90 mL per OTC container and has additional specific warnings

Question 10

Effect/use of PSE

Answer 10

Precursor to meth

Question 11

How are sodium phosphates ALSO marketed

Answer 11

As rx products (OsmoPrep) and are used for bowel cleansing prior to colonoscopy

Question 12

Legislative/regulatory action of PSE

Answer 12

Combat Meth Act of 2005

Question 12

OTC products of abuse

Answer 12

Class v controls (cough syrup)
Antihistamines (dimenhydrinate)
Laxatives
Loperamide
Dextromethorphan
Pseudoephedrine

(CALL Da Police)

Question 13

Why are sodium phosphate products limited w/ specific warnings?

Answer 13

Due to the risk of using to much

It can cause severe changes in hydration and electrolytes, resulting in:
- harm to kidney
- harm to heart
- death

Question 13

Effect/use of dextromethorphan

Answer 13

Intoxication
Altered mental status

Question 14

Legislative/regulatory action of dextromethorphan

Answer 14

Many products have been reformulated to omit abuse

Question 15

Effect/use of class V controls (cough syrup)

Answer 15

Opioid abuse

Question 16

Effect/use of laxatives

Answer 16

Anorexia

Cause electrolyte imbalances and GI complications

Question 17

Legislative/regulatory action of laxatives

Answer 17

NONE

Question 18

Effects/use of loperamide

Answer 18

Used to stop diarrhea from opioid withdrawal

May cause:
- QT/QRS prolongation
- Cardiotoxicity
- Arrhythmias

Question 18

Legislative/regulatory action of loperamide

Answer 18

NONE

Local stores were putting it in anti-theft packages

Question 19

Effects/use of OTC antihistamines (dimenhydrate)

Answer 19

Intoxication and stimulant-like effects

Euphoria and hallucination

Question 20

Legislative and regulatory action of OTC antihistamines (dimenhydrate)

Answer 20

NONE

Question 21

(T/F): the ABCDX pregnancy categories have been removed completely from all FDA approved products

Answer 21

False

Question 22

(T/F): drugs are not impacted by the new FDA pregnancy/lactation category labeling

Answer 22

True

Question 23

Sodium phosphate oral solutions are limited to not use more than ____ mL per OTC container

Answer 23

90 mL

Question 24

Which categories replaced the ABCDX pregnancy categories

Answer 24

• Females and males of reproductive potential
• Pregnancy
• Lactation

Question 25

(T/F): there are no controlled substances available for OTC purchase

Answer 25

False

Question 26

PSE is a _____ in WV

Answer 26

C5