1 - Self Care / Non-RX Regulations / Patient Assessment & Consultation Flashcards
NAPLEX Addition
May 2005
OTC agents
now given as much weight as = RX Agents
+ compentency for dietary Supplements
What is an OTC Drug?
3 criteria
Defined by the Durham-Humphrey Act
- Non-Habit Forming
-
SAFE when used as directed
- Appropriate for SELF-treatment
- self-administration / can be fixed by self-treatment
- Lack of side effects that require medical monitoring
- Appropriate for SELF-treatment
- Not Declared to be Prescription
Requirements for ALL OTC Drug products
Standards for SAFETY & EFFICACY
(same stds as RX drugs)
Good Manufacturing Practices (GMP
LABELING
as required by 21 CFR 201.66
OTC DRUG ADS: there is NO “fair Balance” req
benefits vs warnings/CIs
What is NOT an OTC drug?
NOT Vitamin / Mineral / Herbal Supplement
(Dietary Supplements = DS)
These are regulated by the DSHEA
Federal law does NOT require DS to be
proven safe before marketed
NOR
claim to treat/cure disease
3 Phase Review of OTC Drugs
- Phase 1
-
Classificaition of ~700 drug ingredients
- 3 Categories = GRASE+RASE / NRASE / not acceptable
-
Classificaition of ~700 drug ingredients
- Phase 2
-
Development of tentative Final Monographs
- for cat 1 & 3 ingredients
- Time period for hearings/ objections / new data presention
-
Development of tentative Final Monographs
- Phase 3
-
FINAL MONOGRAPHS
- 3 Categories,
- NEW OTC CAN ME MARKETED WITHOUT APPROVAL
-
FINAL MONOGRAPHS
Category 1 Ingredient
Classified during PHASE 1
Recognized as safe & effective = RASE
or Generally….. = GRASE
In Phase 3 Final Monographs:
Considered CAT1 ingredients as ACCEPTABLE
Category 2 Ingredient
Classified during PHASE 1
Not Recognized as safe and effective = NRASE
In Phase 3 Final Monographs:
Considered CAT2 ingredients not safe
Had to be removed fro Products
Category 3 Ingredient
Classified during PHASE 1
Insufficient data or Unacceptable Indication
to classify into CAT1 or CAT 2
In Phase 3 Final Monographs:
Considered CAT3 ingredients to:
Undergo Further Review
can be included in marketed products
Active Ingredient
Active Ingredient can be a DS/Vitamin
this would consider it a DRUG!
Ex. Calcium Carbonate
in Antacid
OTC Drugs & RX Drugs
Some might have STRENGTHS THAT ARE STILL RX
but other strengths are OTC
ex.
- }Ibuprofen*
- }Naproxen*
- }Nicotine replacement patch
- }Miconazole vaginal cream
- }Pseudoephedrine
- }Ranitidine*
- }Hydrocortisone Cream*
- }Terbinafine topical cream
How a RX drug becomes OTC
OTC Drug Monograph Process
Direct to OTC Approval
RX–> OTC Switch
Complete or PARTIAL switch
Benefits of OTC Switch
- Improved Patient Self-Care
- FASTER access to medication
-
COST SAVINGS:
- Health care system benefits a lot
- but maybe not the patients, due to cost of OTC
- Health care system benefits a lot
RISKS** **of OTC Drug Use
- Potential for Innapropriate Self-Care
-
Misdiagnosis
- wrong drug, not diagnosed correctly
-
Misdiagnosis
- Potential for DRUG TOXICITY
- not monitored by HCP (provider)
- overuse / misuse
ATC
Role of the Pharmacist in OTC
ASSESSMENT
TRIAGE
COUNSELING/Patient Education
A in ATC
ASSESSMENT
-
Ask Questions
-
Patient Focused
- __Who?
-
Problem Focused
- __Where when what how?
-
Patient Focused
- Determine level of patient risk
- Peds / Geriatric / PREG / Breastfeeding
