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
2
Q
1914: Harrison Narcotic Act
A
- **Made narcotics prescription only **
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)
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
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
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
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
8
Q
Advisory Review Panel: Category II
A
- Category II: NRASE
- Not recognized as safe and effective
- Prescription (couldn’t think of any examples)
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
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
- Prevalent
11
Q
OTC Labeling Requirements: “Drug Facts”
The 9 to Know
A
- The 9 to know are on the box
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- Expiration Date
- Drug Facts
- **Other Information **
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…
13
Q
OTC Regulations
- New OTC
- RX-OTC switch
- BTC drugs
A
- New OTC
- Manufacturer requests via a NDA (supplemental)
- New Drug Application
- Manufacturer requests via a NDA (supplemental)
- RX-OTC Switch
- Company asks to be done
- Restricted to sale by pharmacies
- Behind the Counter (BTC) drugs
- Done for safety reasons
- Ex: Pseudoephedrine
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
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
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
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
31
Pharm 558
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