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Pharm 558 > Introduction > Flashcards

Introduction Flashcards

1
Q

1906: Pure Food and Drug Act

A
  • 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
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2
Q

1914: Harrison Narcotic Act

A
  • **Made narcotics prescription only **
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3
Q

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

A
  • Mandates drug safety
  • Influenced by 100 deaths of children taking elixir of sulfonamide with di-ethylene glycol (antifreeze)
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4
Q

1951: Durham-Humphrey Amendment

A
  • 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
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5
Q

1962: Kefavuer-Harris Amendment

A
  • Mandates drug efficacy
  • In response to thalidomide children
  • Signed by JFK
  • Led to DESI; drug efficacy study implementation
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6
Q

1994: Dietary Supplement and Education Act

A
  • Vitamins, minerals, herbs (except tobacco), fiber, fatty acids, amino acids that may be missing form diet
  • Not therapeutic
  • No prevention or cure claims
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7
Q

Advisory Review Panel: Category I

A
  • Category I: GRASE
  • Generally recognized as safe and effective
  • Caffeine, theobromine, flax seed, krill oil, plant sterol esters, dioctyl sodium sulfococcinate
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8
Q

Advisory Review Panel: Category II

A
  • Category II: NRASE
  • Not recognized as safe and effective
  • Prescription (couldn’t think of any examples)
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9
Q

Advisory Review Panel: Category III

A
  • 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
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10
Q

Options for Self-Medication

A
  • 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
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11
Q

OTC Labeling Requirements: “Drug Facts”

The 9 to Know

A
  • 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 **
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12
Q

OTC Labeling Requirements: Warnings

A
  • 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…
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13
Q

OTC Regulations

  • New OTC
  • RX-OTC switch
  • BTC drugs
A
  • 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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14
Q

Factors to Consider Rx vs. OTC

A
  • Self-diagnosable
  • Self-treatable
  • Misuse/abuse potential
  • Habit forming
  • Benefits outweigh risks
  • Adequate directions possible
  • Treatment of short-term, self-limited symptom
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15
Q

Benefit of OTC over RX

  • Patients
  • Industry
  • Pharmacy
A

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

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16
Q

Problems of Rx to OTC Switch

A
  • Reimbursement
    • Not covered by insurance
  • Patient confusion
  • Physician resistance
  • Pharmacist preparation
17
Q

OTC to BTC

Rx to BTC

A
  • Comprehensive Methamphetamine Control Act of 1996 (MCA)
    • Pseudoephedrine
  • Codeine, dextromethorphan
  • Plan B, Ella
18
Q

Opportunities and OTC

A
  • 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
Q

Role of Pharmacist w/ OTC

A
  • 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
Q

Consumer Behaviors

A
  • 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
Q

OTC’s and Pharmacists

A
  • 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
Q

Patient Information on Drugs

A

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

23
Q

Pharmacists: Self-Treatment

A
  • 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
Q

Consequences of Bogus Therapy

A
  • Economic losses
  • Direct hazards
  • Indirect hazards
    • Withholding getting proper care
25
Q

Recognize Bogus Therapy

A
  • 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
Q

Role of Pharmacists with OTCs

A
  • 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
Q

Diagnosing and Prescribing?

A
  • 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
Q

Problem Solving Model

A
  • 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
Q

Gather Patient Information

CODARA MOAP FLEaS

A
  • 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
Q

Gather Patient Information

QuEST/SCHOLAR

A
  • 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
31
Q
A

Pharm 558 (11 decks)

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