Lecture 2

Question 1

Durham-Humphrey Amendment

Answer 1

Establish Rx and OTC classes of medications

Question 2

Kefauver-Harris Drug Amendments, 1962

Answer 2

Efficacy requirements of marketed products

Question 3

FDA + 1991

Answer 3

FDA created division of non-Rx drugs

Question 4

Food & Drug Modernization Act, 1997

Answer 4

Inactive ingredient label requirements

Question 5

Sunscreen Innovation Act

Answer 5

Alternative way to review OTCs

Question 6

Non-Rx Medications

Answer 6

• Label needed to guide consumer for safety and efficacy - must be able to self diagnose
• Low potential for abuse/misuse
• Dosage may determine if drug is OTC versus prescribed
• Laxatives, cough medications, pain killers are all potentially abused OTC
• Not all OTC medications are safe

Question 7

Pathway to OTC

Answer 7

• If a new ingredient or drug ==> NDA

- If the same ingredients/drug ==> Drug Monograph and Recipe Book

Question 8

Safe Use of OTC

Answer 8

• Adulterations and misbranding is regulated by the FDA
• Adverse drug reporting: serious reactions for dietary supplements and non-Rx drug manufacturers
• Serious (regulatory) v.s. severe (mild, moderate, severe)
• Leads to safety alerts (Oragel in Pediatrics)

Question 9

Labeling

Answer 9

• Likely to read/understood by “ordinary individual”
• Standardized and specific
• Includes facts and warnings
• Foreseeable risks
• Truthful and not misleading

Question 10

Packaging

Answer 10

• Tamper resistant

- Expiration date

Question 11

Third Class Medication

Answer 11

• Pharmacist being able to prescribe with regulations of monitoring
• Pros: cheaper, easier access
• Cons: less follow-up
• Ex: Naloxone, nicotine

Question 12

Are cosmetics drugs?

Answer 12

Yes

Question 13

Homeopathic Medications

Answer 13

• Not marketed for conditions that need Rx

- Not evaluated for safety or efficacy

Question 14

Dietary Supplements

Answer 14

• cGMP standards
• “Honor System”
• Liability - follow label directions

Question 15

Regulation Summary

Answer 15

• If unsure, ask questions
• Consider safety and quality
• Practice within your license
• Follow packaging instructions

Question 16

Special Population: Women Assessment

Answer 16

• Trimester = IMPORTANT
• Determine if self care is appropriate
• Risk to benefit
• ASK if they are pregnant, do NOT assume

Question 17

FDA Revised Pregnancy Categories

Answer 17

• Rx & OTC that can be prescribed
• No more letters (A, B, C, D, X)
• Categories: Pregnancy Exposure Registry, Risk Summary, Clinical Considerations, Data

Question 18

OTC + Preggo

Answer 18

• Use non-pharmacologics first
• Consider if medication crosses the placenta, how it affects the infant
• Pregnant women should get the flu shot
• Antiemetics, vitamins, Unisom are common in pregnant patients

Question 19

Breast Feeding

Answer 19

• Medication crossing milk supply needs to considered
• Safe for infants is needed if it does enter milk supply
• PK & PD important
• Consider pumping
• Important if medication causes a reduction in milk supply

Question 20

Herbals + Homeopathics

Answer 20

• Safe for pregnant/breastfeeding depends on medication and its strength
• Supporting data and drug interactions need to be considered
• When unsure, proceed with caution

Question 21

Special Population: Pediatrics Dosing Considerations

Answer 21

• Supplementation for breast feeding
• Specialized formulas for certain populations
• Important to know medical history
• Infants eat constantly, so important to note if medications enter their food supply or affect their appetite
• Pedialyte is better for dehydration due to less sugar
• Children are dehydrated if they use less diapers, have a depressed fontanel, or their skin doesn’t “bounce back”

Question 22

Herbals in Pediatrics

Answer 22

USUALLY SAFE and recommended

Question 23

Special Population: Elderly Considerations

Answer 23

• Social status
• Economic status - large user or non-Rx drugs
• Physiologic status - Impaired vision, hearing, memory loss, misbeliefs about health problems

Question 24

Most Commonly Used Products in Elderly Population

Answer 24

• Analgesics
• Laxatives
• Nutritional supplements
• Herbal products, home remedies

Question 25

Elderly Preexisting Consitions

Answer 25

-May affect the use of some non-Rx drugs

EX: Emphysema, urinary retention (prostate hypertension), diabetes, hypertension, glaucoma

Question 26

Special Population Summary

Answer 26

• Many considerations for special populations
• Use available data
• If unsure, ask specialist
• PK/PD = IMPORTANT
• Use your references!!!