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Labeling & Packaging Issues OTC Drug Labelling 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 OTC Drug Labelling Readability: 1. 2. 3. Provision of essential information in the same order and area Uniformity in print size, pictograms, icons, colours, numbering, margins etc. Special populations: a threshold print size of 4.5, has been suggested as minimum,while not optimal. OTC Drug Labelling Essential Information (In order): 1. 2. 3. 4. 5. 6. The product’s active ingredients including amounts Purpose of the active ingredient The uses (indications) for the drug Specific warnings including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that could occur and substances or activities to avoid. Dosage instructions: when, how and how often The product inactive ingredients 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 1 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 arise Effectiveness: 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 ! ! 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 ExtraStrength Tylenol! Tamper-evident Packaging The FDA defines a tamper-evident rather than 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 Packaging Tamper-resistant packaging may involve immediate container/closure systems or secondary container carton systems. The OTC drug products that are covered by these regulations include oral, nasal, otic, ophthalmic, rectal, and vaginal drug products. Cosmetic products covered include liquid oral hygiene products (mouthwash), and vaginal products. Tamper-evident Packaging OTC 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 Packaging Examples 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 Packaging Examples 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 Packaging Examples 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 Packaging Examples 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. A generic "Sealed for your protection" print is acceptable. Vitamins are currently excluded from tamper-resistant requirements because of their classification by the FDA as a food. Marketing Issues Product Line Extensions 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 Nonprescription Drug Advertising Federal Trade Commission (FTC) is responsible for matters involving claims made in advertisements for OTC drug products FDA handles matters involving labeling NOT advertisements of OTC drugs 1970: FTC Act amended to prohibit advertisers from using language to describe the therapeutic benefits of an OTC drug product that differs from language approved by FDA for use in labeling of the product Nonprescription Drug Advertising FTC Requirements: Advertising must be truthful and nondeceptive Back up claims with competent and reliable scientific evidence, including tests, studies or other objective data 1973: National Association of Broadcasters and the Consumer Healthcare Products guidelines for TV advertising- updated periodically TV advertising guidelines for OTC products 1 Advertisement should: Comply with all relevant applicable laws and regulation Urge the consumer to read and follow label directions Contain no claims of product effectiveness unsupported by clinical or other scientific evidence, responsible medical opinion or experience through use TV advertising guidelines for OTC products 3 Present no negative or unfair reflections about competing nonprescription drug products, unless those reflections can be supported scientifically, and presented in a manner so consumers can perceive differences in the uses. Dietary Supplements Are not regulated as “drugs” under the FD& C Act cause they are not intended to diagnose, cure or treat a medical disease or condition; Consequently, they do not follow the Drug Facts format They are not regulated by the FDA or any other state or federal governmental agency,as stringently as prescription or OTC drugs Dietary Supplements Dietary supplements are regulated under the federal Dietary Supplement Health and Education Act of 1994 (DSHEA)