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Over-the-counter (OTC) medications are defined as safe and effective drugs available to use by the general public without a doctor’s prescription (FDA).

They play an increasingly vital role in our healthcare system and are the most prevalent means of treating the majority of common health problems in the United States.

There are over 80 therapeutic categories of OTC drugs which can be grouped in 12 broad therapeutic classes.

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Durham-Humphrey Amendment of 1951 In the US, the term OTC drugs was legalized in 1951 via Durham-Humphrey Amendment.

The law distinguished between legend (prescription) drugs and over-the-counter (OTC) (nonprescription) drugs

It also authorized:verbal prescriptions prescription refills

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The benefits of over-the-counter availability include:

Direct, rapid access to effective medicines

Wide availability

Decreased healthcare system utilization (fewer physician visits, lower healthcare system costs)

Allowing individuals to be in charge of their own health

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Risks associated with OTC useIncorrect self-diagnosis delaying diagnosis

and treatment of serious illnesses (delay in seeking advice from a healthcare professional)

Increased risk of drug-drug interactions.

Increased risk of adverse events when not used appropriately.

Potential for misuse and abuse6

Important Definitions.Misuse: An unintentional improper or incorrect use of a substance by deviating from the prescriber’s directions for reasons other than the pursuit of a psychotropic or euphoric effect.Intentional misuse: An exposure resulting from the intentional improper or incorrect use of a substance for reasons other than the pursuit of a psychotropic or euphoric effect.Abuse: An exposure resulting from the intentional improper or incorrect use of a substance where the individual was likely attempting to achieve a euphoric or psychotropic effect. The term abuse also applies to intentional or purposeful use of a drug for an indication NOT approved by the Prescriber for a perceived benefit that the patient desires.

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Therapeutic (Medication) error: An unintentional Preventable deviation from a proper therapeutic regimen that results in the wrong dose, incorrect route of administration, administration to the wrong person, or administration of the wrong substance.

Medication vs Drug (homework)

Dependence Vs Addiction. (homework)

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FDA defines drugs as follows:

A drug is a substance that exerts an action on the structure or function of the body by chemical action or metabolism and is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A new drug is defined as one that is not generally recognized as safe and effective for the indications proposed.

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A herb is a plant or part of a plant used for its flavor, scent, or potential therapeutic properties. Includes flowers, leaves, bark, fruit, seeds, stems, and roots.

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Dietary Supplements (including Herbal Ingredients):A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Permitted ingredients of dietary supplements include vitamins, minerals, herbs or other botanicals, and amino acids.

Cosmetics:Cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance."

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Dietary Supplement Health and Education Act (DSHEA) of 1994

Provided definitions and guidelines on diet supplements

manufacturers are not required to prove safety, efficacy, or standardization to the FDA as they are with prescription and nonprescription drugs

The FDA may only review “false claims” advertisements and monitor safety of diet supplements

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Adulteration(1) (1) If it consists in whole or in part of any filthy, putrid, or If it consists in whole or in part of any filthy, putrid, or decomposed substance.decomposed substance.

(2) If it has been prepared, packed, or held under insanitary (2) If it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to filth, or whereby it may have been rendered injurious to health.health.

(3) (3) If it is a drug and the methods used in, or the facilities If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or or holding do not conform to or are not operated or administered in conformity with administered in conformity with current good current good manufacturing practice (CGMP)manufacturing practice (CGMP)

(4) If it bears or contains, for purposes of coloring only, (4) If it bears or contains, for purposes of coloring only, a color additive which is unsafe.a color additive which is unsafe.

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MisbrandingOccurs when the labeling or advertising is misleading.

The term ''label'' means a display of written, printed, or graphic matter upon the immediate container of any article.

The term ''immediate container'' does not include package liners.

The term ''labeling'' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article

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GenerallyIf a drug is mislabeled—

It is MisbrandedIf drug not manufactured according to

CGMPsIt is adulterated

If Drug does not conform to compendial standards and is labeled “USP”It is adulterated

Drugs can be both misbranded and adulterated at the same time

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Interesting Facts!FDA does not use the term “OTC medications,”. The official term is OTC drugs.

Female individuals are more likely to use OTC medications. In a 2002 survey, 87% of women reported the use of an OTC pain medication in the past year compared to 80% of men.

A study conducted in 2011 confirmed that OTC medications are American’s most popular treatment choice for common ailments such as headache, heartburn, allergies, and colds.

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Poison Prevention Packaging Act of 1970Passed to prevent accidental childhood

poisonings from prescription and nonprescription products

Enforced by the Consumer Product Safety Commission

Requires most over-the-counter (OTC) and legend drugs be packaged in child-resistant containerscannot be opened by 80% of children under five can be opened by 90% of adults

Older patients may request a non-child-resistant container; other exceptions are provided for by law 18

Evaluation of OTC DrugsOver-the-counter (OTC) drugs play an increasingly vital role in most health care systems. As with prescription drugs, FDA Center of Drug Evaluation and Research (CDER) oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. 

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Characteristics of Eligibility for OTC Approval

OTC drugs generally have these characteristics:(They have to meet ALL of the characteristics to be eligible for OTC approval).

Their benefits outweigh their risks The potential for misuse and abuse is lowConsumer can use them for self-diagnosed conditionsThey can be adequately labeledHealth practitioners are not needed for the safe and Effective use of the product

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Orange BookThe FDA publishes a list of all approved drugs

called, Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book" because of its orange cover. It lists marketed drug products that are considered by the FDA to be safe and effective and provides information on therapeutic equivalence evaluations for approved multisource prescription drug products monthly.

The Orange Book rates drugs based on their therapeutic equivalence. For a product to be considered therapeutically equivalent, it must be both pharmaceutically equivalent (i.e., the same dose, dosage form, strength), and bioequivalent (i.e., the rate and extent of its absorption is not significantly different than the rate and extent of absorption of the drug with which it is to be interchanged).

What does FDA do with regard to OTC drugs?a) Review OTC products for safety and

effectivenessb) Responsible for establishment of

regulations of OTC drugs labelingc) Responsible for the reclassifying process of

OTC drugs from prescription status

Drug Reclassification:Classes of drugs limited to Rx:

Certain habit-forming drugs listed by name;Drugs not safe for use except under the supervision of a licensed practitioner because of toxicity or other potential for harmful effect, the method of use etc;Drugs limited to prescription under an NDA

Drug Reclassification:Rx OTCReclassification Criteria:The indication(s) for which the drug to be used on an OTC basis should be similar to those on Rx and must permit easy diagnosis and monitoring by the patient.A favourable adverse-event and drug interaction profiles, relatively low toxicity and a low potential for abuse.The drug should not have properties that make it impractical for OTC use, e.g. narrow therapeutic index.

The need for NEW labeling?“switch” from Rx OTC: the need for

more sophisticated self-diagnostic and self-monitoring evaluation;

The older population is increasing in the USA

The new format helps pharmacists to readily find information on the label and point it to the patient

OTC “Drug Facts” boxFrom May 2002: Most OTC medicines

manufactured after this date carried the new Drug Facts label.

However, certain products e.g. sunscreens were not required until 2006

Many manufacturers voluntarily used the new OTC label before the effective date

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The new Drug Facts labeling requirements do not apply to dietary supplements, which are regulated as food products, and are labeled with a Supplement Facts panel.

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The Tylenol Cyanide crisis!

In 1982, Johnson and Johnson experienced a major crisis when it discovered that numerous bottles of its Extra-Strength Tylenol capsules had been laced with cyanide. By the end of this major crisis, seven people had passed away from the use of the laced Extra-Strength Tylenol!

Tamper-evident PackagingThe FDA defines a tamper-resistant package as:

“one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred”

Tamper-evident PackagingOTC drug products must have one or more

barriers to entry that, if breached or missing from package, provide consumers with evidence that tampering may have occurred

Packages must have unique designs or characteristics that can not be duplicated

A statement that alerts consumers to this tamper-evident feature

e.g.“ For your protection, this bottle has an

imprinted seal around the neck”

You should encourage patients to look for tamper-evident features and if missing or breached to return the product to the pharmacy or store.

Tamper-evident PackagingThe agency stresses that “tamper-proof” OR

“tamper resistant” packaging is not possible.

A labeling statement suggesting that the package is tamper-proof, as contrasted with tamper-resistant will be considered false and misleading.

Tamper-evident PackagingExamples

Examples of acceptable packaging include but are not limited to:

Film Wrappers-The film is wrapped around the entire product and must be cut or torn to open the package.

Blister or strip packs-The individual compartment must be torn or broken to obtain the product.

Bubble packs-The product and container is sealed in plastic and mounted in or on a display card. The plastic must be torn or broken to remove the package

Tamper-evident PackagingExamples

Heat Shrink bands or wrappers-The bands, applied at the juncture of the cap and the container, must be torn or broken to open the package. Cellulose wet shrink seals are not considered an effective tamper-resistant mechanism.

Foil, paper or plastic pouches-The product is enclosed in an individual pouch that must be torn or broken to obtain the product.

Tamper-evident PackagingExamples

Bottle seals-Paper, foil or thermal plastic is sealed to the mouth of a container under the cap. The seal must be torn or broken to remove the product. Bottle seals applied with a pressure sensitive adhesive are no longer considered an effective tamper-resistant mechanism.

Breakable caps-The container is sealed by a plastic or metal cap that either breaks away completely when removed from the container or leaves part of the cap attached to the container. The cap must be broken to open the container.

Tamper-evident PackagingExamples

Sealed tubes-The mouth of a tube is sealed and the seal must be punctured to obtain the product.

Aerosol containers -Aerosol containers are inherently tamper-resistant.

All Metal and Composite Cans-The container cannot be pulled apart without visible evidence of entry.

Note: Barriers made from readily obtainable material such as plain tape, saran wrap, aluminum foil, etc. must be printed to distinguish themselves from a substitute available from a retail product. Vitamins are currently excluded from tamper-resistant requirements because of their classification by the FDA as a food.

OTC Drug Labelling1. Comprehensibility2. Readability3. Comprehensiveness

Comprehensibility:

FDA regulations require that OTC drug labelling contain terms likely to be read and understood by the average consumer

Counselling consumers on how to interpret product labels properly

Readability:

1. Provision of essential information in the same order and area

2. Uniformity in print size, pictograms, icons, colours, numbering, margins etc.

3. Special populations: a threshold print size of 4.5, has been suggested as minimum, while not optimal.

Limitations of package labelling:

A package label can never address the infinite management issues associated with drug use,particularly in the comorbidity or polypharmacy. Thus, package labelling should acknowledge and encourage dialogue with health professionals (pharmacist, doctor).

Expiration Date Labeling Expiration Date: is the date beyond which

the product should not be used because the stability, potency, strength, or quality may have been affected over time

FDA regulations govern how this date is determined and tested

Most OTC products are required to include an expiration date on the labeling

OTC drug products that do not have a dosage limit and are stable for at least 3 years are exempt from the requirement to include the expiration date on the label

e.g. topical drugs, skin protectants, lotions, and astringents

“Can I use it if expired?”

Safety: Rarely does a safety issue ariseEffectiveness: You should advise patients

that the product probably has lost some of its ability to work as effectively as possible of the particular symptom or medical problem and it should be discarded

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Marketing IssuesProduct Line Extensions

Nonprescription Drug Advertising (HOME WORK+ quiz)

Product Line ExtensionsReasons for product line extensions:

To capitalize on the loyalty created by consumer recognition and trust of a brand name

New doses, formulations, combinations of ingredients or even a totally different therapeutic entity (e.g. device) of a brand name product that has been originally marketed as single ingredient at a specific dose to treat specific symptom