1 - Self Care / Non-RX Regulations / Patient Assessment & Consultation Flashcards Preview

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1

NAPLEX Addition

May 2005

OTC agents 

now given as much weight as = RX Agents

+ compentency for dietary Supplements

2

What is an OTC Drug?

3 criteria

Defined by the Durham-Humphrey Act

  1. Non-Habit Forming
  2. SAFE when used as directed
    1. ​Appropriate for SELF-treatment
      1. self-administration / can be fixed by self-treatment
    2. Lack of side effects that require medical monitoring
  3. Not Declared to be Prescription

3

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

4

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

5

3 Phase Review of OTC Drugs

  • Phase 1 
    • Classificaition of ~700 drug ingredients
      • ​3 Categories = GRASE+RASE / NRASE / not acceptable
  • Phase 2 
    • Development of tentative Final Monographs
      • for cat 1 & 3 ingredients
    • Time period for hearings/ objections / new data presention
  • Phase 3
    • FINAL MONOGRAPHS
      • 3 Categories,
      • NEW OTC CAN ME MARKETED WITHOUT APPROVAL

6

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

7

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

8

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

9

Active Ingredient

Active Ingredient can be a DS/Vitamin

this would consider it a DRUG!

 

Ex. Calcium Carbonate

in Antacid

10

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

11

How a RX drug becomes OTC

OTC Drug Monograph Process

 

Direct to OTC Approval

 

RX--> OTC Switch

Complete or PARTIAL switch

12

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

13

RISKS of OTC Drug Use

  • Potential for Innapropriate Self-Care
    • Misdiagnosis
      • wrong drug, not diagnosed correctly
  • Potential for DRUG TOXICITY
    • not monitored by HCP (provider)
    • overuse / misuse

14

ATC

Role of the Pharmacist in OTC

 

ASSESSMENT

TRIAGE

COUNSELING/Patient Education

15

A in ATC

ASSESSMENT

  • Ask Questions
    • Patient Focused
      • Who?
    • Problem Focused
      • Where when what how?
  • Determine level of patient risk
    • Peds / Geriatric / PREG / Breastfeeding

16

T in ATC

TRIAGE

  • Decision-Making part of OTC
  • Recommend appropriate non-drug therapy
  • Recommend an OTC-Agent​​ if appropriate
    • Active & or Specific product
      • beware of sound-alkies / brand-line extentions
  • ​​REFERRAL, if appropriate
    • EMERGENCY / URGENCY (24-48 hours)
    • Routine

17

at ATC

Counseling & Patient Education

  • Verbal / Written
    • Patient appropriate level = Layman's terms
  • Content:
    • Proper use of rec therapy
      • Dose etc
      • Expectations
      • Duration
      • PC / CI / ADR
      • Follow up?