8/20/20

INTRODUCTION TO SELF-CARE
TRACI M. POOLE, PHARM.D., BCACP, BCGP
AUGUST 20, 2020

¡ Describe the history of the development of

regulation of nonprescription products.
¡ Explain regulatory processes that govern self-
care.
¡ Define misbranding and adulteration.
¡ Compare and contrast how the requirements
for dietary supplement labels differ from those
for other nonprescription medications.

OBJECTIVES ¡ Explain how the manufacturing of dietary

supplements is regulated by the Dietary
Supplement Health and Education Act of 1994.
¡ List the 4 important aspects of the regulations
of dietary supplements that pharmacists
should understand and be familiar with.
¡ Describe the limitations of the current
regulatory process in terms of ensuring that
dietary supplements are a) safe and b)
effective?
¡ Explain product line extensions to consumers.

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SELF CARE

¡ Defined as “the independent act of preventing, diagnosing, and treating

one’s illnesses without seeking professional advice”
¡ Driving factors:
¡ Growth of the aging population
¡ Decreased availability to primary care providers
¡ Increased healthcare costs
¡ Decreased access to care (i.e. under/uninsured)

¡ $102 billion in annual savings relative to

alternatives and increased access to medications
¡ $6-$7 of savings to the overall health care system
for every $1 spent on nonprescription
IMPACT OF medications
SELF-CARE ¡ Reduction of patients seeking care from a
physician or extender by 180 million people
¡ 79% of consumers (240 million) took a
nonprescription medication in the last 12
months

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¡ Allergy/sinus (45%)
¡ Pain (78%)

SEEKING ¡ Minor infections (12%)

¡ Cough/Cold/Flu (52%)

SELF-CARE ¡ Heartburn/indigestion (21%)

¡ Constipation/diarrhea/gas (21%)
¡ Skin problems (10%)

SELF-CARE OPTIONS

NONPRESCRIPTION NUTRITIONAL NATURAL PRODUCTS

MEDICATIONS DIETARY SUPPLEMENTS AND HOMEOPATHIC
REMEDIES

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REGULATION OF OTCS

"OTC Review" process began

Pure Food and Drugs Act of 1906 • 800 active ingredients of 300,000
• Medications only had to meet strength, nonprescription formulations
FDCA Amendment - Durham-
quality, and purity that was claimed by the • Banned ~500 compounds
manufacturer
Humphrey Act • Recognized 270 as generally safe and effective
• Prohibited misbranding and adulteration • Created Rx and O TC categories (“GRASE”)

1906 1951 1971

1938 1962

Federal Food, Drug, and Cosmetic FDCA Amendment - Kefauver-

Act of 1938 (FDCA) Harris Act
• Mandated safety • Required all new drugs to be safe AND
effective
• FDA undertook review of effectiveness of
4500 drugs (512 O TCs)

REGULATORY AGENCY - NONPRESCRIPTION

¡ United States Food and Drug

Administration
¡ Center for Drug Evaluation and
Research (1991)
¡ Regulates prescription and
nonprescription drugs

¡ The Food and Drug Modernization

Act of 1997
¡ Established inactive ingredient labeling
requirements

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REGULATION OF OTCS

¡ Nonprescription Status
¡ Using the product label, the consumer can self-diagnose, self-treat,
and self-manage the condition
¡ No healthcare provider is needed for the safe and effective use of
the product
¡ Must be low abuse/misuse potential
¡ Nonprescription availability benefit must outweigh the risks
¡ States may restrict OTC availability

REGULATION OF OTCS

¡ Nonprescription drugs fall into 1 of 3 categories:

¡ Approved through the drug approval process

¡ Switched from Rx
¡ Approved directly as OTC

¡ Marketed in accordance with the OTC monograph for the active

ingredient
¡ Marketed pending review by the OTC Drug Review

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REGULATION OF OTCS

¡ OTC Monograph Process

¡ “GRASE” medications

¡ Required to have an OTC monograph that supports the safety and

efficacy of the product
¡ Primarily addresses active ingredients

¡ Company responsible for manufacturing or distribution must have

their name appear on the label
¡ This entity is responsible for reporting adverse events related to their
product to the MedWatch program.

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LABELING REQUIREMENTS - NONPRESCRIPTION

¡ Standardized drug label format

¡ Expiration date
¡ No expiration date if no max dosing is required and ingredients are stable for
up to 3 years
¡ Tamper-evident packaging

¡ Must have at least one barrier to entry that alerts consumers to

tampering
¡ Package must contain unique designs/characteristics that typically
cannot be duplicated
¡ Statement that is prominently placed to identify the safety measure
¡ Ex. “For your protection, this bottle has an imprinted seal around the neck”

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REGULATION OF OTCS

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REGULATION OF SUPPLEMENTS

¡ Dietary Supplement Health and Education Act of 1994

(DSHEA)
¡ Regulated by the FDA under the Center for Food Safety and Applied
Nutrition

¡ Regulates dietary and herbal supplements

¡ Not regulated like nonprescription products
¡ Excluded from purity and potency standards
¡ Must only meet standards that apply to food preparation

¡ Not required to demonstrate safety or efficacy

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¡ More than 80 ingredients, indications, or dosage strengths

have been switched since 1976
¡ FDA has the final word on reclassification
¡ 3 questions must be affirmed:
RX-TO-OTC ¡ Can the patient adequately self-diagnose the clinical
SWITCH abnormality?
¡ Can the clinically abnormal condition be successfully
treated?
¡ Is the self-treatment product safe and effective for
consumer use, under conditions of actual use?

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¡ FDA is considering a 3rd class of

medications
¡ Increase access to medications

BEHIND- ¡ Pharmacist would be

responsible to ensure

THE- appropriate use of medications

¡ The US currently uses a model

COUNTER
of this system, but no formal
process yet.
¡ Current examples:
pseudoephedrine, insulin,
syringes, codeine

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PRODUCT RECALLS

¡ If the FDA deems a product as a potential risk, removal may

be required
¡ Can be seized if deemed misbranded, adulterated, or post-market
surveillance data shows new risk of adverse effects
¡ Court injunction to halt further distribution

¡ Request to the manufacturer for voluntary removal

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PRODUCT RECALLS

Class I Class II Class III

Dangerous or defective Products that might cause a
products that could cause temporary health issue or
serious health problems or pose only a slight threat
death
Products that are unlikely
to cause any adverse health
reaction but violate the
FDA labeling or
manufacturing regulations

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PRODUCT
LINE
EXTENSIONS

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