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1

1906: Pure Food and Drug Act

  • Standards for strength, quality and purity
  • Federal inspection of meat and food
  • Muckrakers: Upton Sinclair, Teddy Roosevelt
  • Forbade poisonous patent medications
  • Required patent medications to be labeled with content
  • Alcohol, cocaine, morphine, cannabis were legally available, but not labeled as patented medication
  • Led Coke to switch from cocaine to caffeine
  • Paved the way for the FDA

2

1914: Harrison Narcotic Act

  • Made narcotics prescription only 

3

1938: Federal Food, Drug and Cosmetic Act (FD&C Act)

 

  • Mandates drug safety
  • Influenced by 100 deaths of children taking elixir of sulfonamide with di-ethylene glycol (antifreeze)

 

4

1951: Durham-Humphrey Amendment

 

  • Established OTC vs. prescription only
  • Legend: “Caution: Federal law prohibits dispensing without prescription.”
  • Humprey: former VP, senator from S. Dakota, pharmacist
  • Durham: Pharmacist from N. Carolina 

 

5

1962: Kefavuer-Harris Amendment 

  • Mandates drug efficacy
  • In response to thalidomide children
  • Signed by JFK
  • Led to DESI; drug efficacy study implementation 

6

1994: Dietary Supplement and Education Act

  • Vitamins, minerals, herbs (except tobacco), fiber, fatty acids, amino acids that may be missing form diet
  • Not therapeutic
  • No prevention or cure claims 

7

Advisory Review Panel: Category I

  • Category I: GRASE
  • Generally recognized as safe and effective
  • Caffeine, theobromine, flax seed, krill oil, plant sterol esters, dioctyl sodium sulfococcinate 

8

Advisory Review Panel: Category II

  • Category II: NRASE
  • Not recognized as safe and effective
  • Prescription (couldn’t think of any examples) 

9

Advisory Review Panel: Category III

  • Category III: Insufficient evidence to prove safety or effectiveness
  • Only OTC
  • Not for prescription drugs
  • Ex: Dimetap
    • Cough/cold decongestant and antihistamine
    • Given at 0.5 dose
    • Reformulated to full dose
    • III: phenylephrine
      • Proved cough suppressor 

10

Options for Self-Medication 

  • Nonprescription Medications
    • FDA blessed: safe and effective
    • $17.5 billion in 2010
  • Nutritional Dietary Supplements
    • Over half of nonprescription medications
  • Natural products, supplements, etc.
    • Prevalent
      • 36-74% of surveyed indicate use
    • Not approved for anything

11

OTC Labeling Requirements: "Drug Facts"

The 9 to Know

  • The 9 to know are on the box
  1. Active Ingredients
  2. Purpose
  3. Uses
  4. Warnings
  5. Directions
  6. Inactive Ingredients
  7. Expiration Date
  8. Drug Facts
  9. Other Information 

12

OTC Labeling Requirements: Warnings 

  • Ask a doctor before use if you have…
  • Ask a doctor or pharmacist before use if you are taking…
  • Ask a health professional before use if pregnant or breastfeeding…

13

OTC Regulations

  • New OTC
  • RX-OTC switch
  • BTC drugs 

  • New OTC
    • Manufacturer requests via a NDA (supplemental)
      • New Drug Application
  • RX-OTC Switch
    • Company asks to be done
  • Restricted to sale by pharmacies
    • Behind the Counter (BTC) drugs
    • Done for safety reasons
    • Ex: Pseudoephedrine

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Factors to Consider Rx vs. OTC

  • Self-diagnosable
  • Self-treatable
  • Misuse/abuse potential
  • Habit forming
  • Benefits outweigh risks
  • Adequate directions possible
  • Treatment of short-term, self-limited symptom 

15

Benefit of OTC over RX

  • Patients
  • Industry
  • Pharmacy 

To patient: No doctor copay
To industry: Advertise and get money
To pharmacy: get sales 

16

Problems of Rx to OTC Switch 

  • Reimbursement
    • Not covered by insurance
  • Patient confusion
  • Physician resistance
  • Pharmacist preparation 

17

OTC to BTC

Rx to BTC

  • Comprehensive Methamphetamine Control Act of 1996 (MCA)
    • Pseudoephedrine
  • Codeine, dextromethorphan
  • Plan B, Ella  

18

Opportunities and OTC

  • Health conscious value system
    • Public’s value system
    • Increasingly health conscious
    • Want better understanding of disease and disease management
    • Want more control over their personal health
  • Rx-OTC Switches
    • At any point in time, 50% of Rx drugs are in various stages of consideration by the FDA
  • Cost containment environment
    • Profit margin on $15-20 OTC is larger than that of $30-50 Rx sales
    • Cash and carry, no third party constraints
  • Aging America
    • Old folks take a disproportionate share of medications
    • >65=14% total population… they take 30% of Rx drugs and 40% of OTC drugs
  • 60% of medications consumed are OTC
  • 57% of health problems each year are treated by OTC
    • 57% of 3.5 billion health problems
  • $90/year per capita expenditure
  • High Benefit: Cost Ratio
    • $0.03 of every healthcare dollar spent, but vast benefit
  • Profit margins greater
  • 2003 IRS OTC ruling
    • Can claim OTC on taxes

19

Role of Pharmacist w/ OTC

  • Most accessible healthcare professional
  • 300,000 marketed products in US
  • Retail outlets:
    • Used to be 70% OTC sold in pharmacies, now only 40%
    • Pharmacies, food and department stores, convenience stores, dress shops, variety centers, airport and train stations, hotel lobbies, vending machines, and the internet
  • Direct to consumer advertising 

20

Consumer Behaviors 

  • 96% favor making their own health-related decisions
  • OTC drugs considered safe by 87% if follow directions
  • 84% consult PCP if problem considered major, before taking OTC
  • 7% consult pharmacist if problem considered minor
  • 57% hesitant to talk to pharmacist about health care needs 

21

OTC's and Pharmacists 

  • Traditionally 70% of OTC’s sold in pharmacy
  • Today - <40% of OTC’s sold in pharmacies
  • Casual and inappropriate use of OTC drugs leads to ADR’s, drug interactions, and delays in seeking medical health 

22

Patient Information on Drugs 

1st: Family, friends, coworkers
2nd: Advertisements, coupons
3rd: Physicians
4th: Pharmacists 

23

Pharmacists: Self-Treatment 

  • Assist in product selection
  • Assess patient risk factors
  • Counsel regarding proper drug use
  • Maintain OTC’s on patient profile
  • Monitor for efficacy and toxicity
  • Discourage “Quack” remedies
  • Assess potential of OTC to mask symptoms of more serious condition 

24

Consequences of Bogus Therapy 

  • Economic losses
  • Direct hazards
  • Indirect hazards
    • Withholding getting proper care

25

Recognize Bogus Therapy 

  • Lack of medical credentials
  • Perception of nontoxicity
  • Aura of natural medicine
  • Empowerment
  • Overblown claims
  • Appeal to easy answers
  • Absolute assurance
  • Simplicity
  • Sell direct to customer
  • Using the internet 

26

Role of Pharmacists with OTCs

  • Investigate patient’s problem
    • History, observation, exam
  • Differentiating self-treatable conditions from those requiring medical intervention
    • Sick vs. not sick
  • Advise/counsel/refer
    • (self-treat; referral, plan follow-up)

27

Diagnosing and Prescribing?

  • Civil liability
    • Negligence
      • Breach of warranty
    • Strict product liability
  • Primary role is to provide health care
    • Do the right thing
    • i.e., act reasonably, best interest of patient first 

28

Problem Solving Model 

  • Gather pertinent information
  • Identify the problem
    • Did the patient make the right diagnosis?
    • Pharmacists can diagnose
      • Diagnoses is 80% history and 20% hands on
    • Nothing says a pharmacists can’t examine
    • Need to diagnose in order to recommend a therapy
  • Identify exclusions for self-treatment
    • Is the condition self-treatable?
    • Pharmacists can’t prescribe…“recommend”
    • Prescribe “nondrugs”
  • Patient Assessment and Triage
  • Identify alternate solutions
  • Select optimal solution
  • Prepare and implement plan
  • Provide patient education
  • Evaluate patient outcome 

29

Gather Patient Information

CODARA MOAP FLEaS

  • Chief complaint
  • Onset/duration (acute, gradual)
  • Description (i.e. pain)
  • Aggravating factors
  • Relieving factors
  • Associated conditions
  • Medications/Treatments
  • Other medications
  • Allergies
  • Past medical history
  • Family History (exposure)
  • Last menstrual period
  • Effect on patient’s life
  • Summary 

30

Gather Patient Information

QuEST/SCHOLAR

  • Quickly and accurately asses the patient
  • Establish okay for self-care
  • Suggest OTC therapy
  • Talk with patient
  • Symptoms
  • Characteristics
  • History
  • Onset
  • Location
  • Aggravating Factors
  • Remitting Features

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