Lecture 2 Flashcards
Regulations/Special Populations
Durham-Humphrey Amendment
Establish Rx and OTC classes of medications
Kefauver-Harris Drug Amendments, 1962
Efficacy requirements of marketed products
FDA + 1991
FDA created division of non-Rx drugs
Food & Drug Modernization Act, 1997
Inactive ingredient label requirements
Sunscreen Innovation Act
Alternative way to review OTCs
Non-Rx Medications
- 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
Pathway to OTC
- If a new ingredient or drug ==> NDA
- If the same ingredients/drug ==> Drug Monograph and Recipe Book
Safe Use of OTC
- 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)
Labeling
- Likely to read/understood by “ordinary individual”
- Standardized and specific
- Includes facts and warnings
- Foreseeable risks
- Truthful and not misleading
Packaging
- Tamper resistant
- Expiration date
Third Class Medication
- Pharmacist being able to prescribe with regulations of monitoring
- Pros: cheaper, easier access
- Cons: less follow-up
- Ex: Naloxone, nicotine
Are cosmetics drugs?
Yes
Homeopathic Medications
- Not marketed for conditions that need Rx
- Not evaluated for safety or efficacy
Dietary Supplements
- cGMP standards
- “Honor System”
- Liability - follow label directions
Regulation Summary
- If unsure, ask questions
- Consider safety and quality
- Practice within your license
- Follow packaging instructions
Special Population: Women Assessment
- Trimester = IMPORTANT
- Determine if self care is appropriate
- Risk to benefit
- ASK if they are pregnant, do NOT assume
FDA Revised Pregnancy Categories
- Rx & OTC that can be prescribed
- No more letters (A, B, C, D, X)
- Categories: Pregnancy Exposure Registry, Risk Summary, Clinical Considerations, Data
OTC + Preggo
- 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
Breast Feeding
- 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
Herbals + Homeopathics
- Safe for pregnant/breastfeeding depends on medication and its strength
- Supporting data and drug interactions need to be considered
- When unsure, proceed with caution
Special Population: Pediatrics Dosing Considerations
- 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”
Herbals in Pediatrics
USUALLY SAFE and recommended
Special Population: Elderly Considerations
- Social status
- Economic status - large user or non-Rx drugs
- Physiologic status - Impaired vision, hearing, memory loss, misbeliefs about health problems
Most Commonly Used Products in Elderly Population
- Analgesics
- Laxatives
- Nutritional supplements
- Herbal products, home remedies
