Continuing Education Activity

The Poison Prevention Packaging Act of 1970 is a law enacted by the 91st United States Congress focused on reducing unintentional poisoning caused by medications and common household products. The law requires that prescription medications, over-the-counter medications, hazardous material, and other household products be packaged with child-resistance packaging. This activity reviews the Poison Prevention Packaging Act and highlights the purpose of the interprofessional team in evaluating and treating patients who may require special packaging.

Objectives:

• Describe the Poison Prevention Packaging Act of 1970.
• Review the effect of the Poison Prevention Packaging Act on the current population.
• Identify the exemptions Poison Prevention Packaging Act.
• Explain the importance of the joint decision-making process between physicians, pharmacists, and pharmaceutical companies.

Introduction

The Poison Prevention Packaging Act (PPPA) was established in 1970 by President Richard Nixon. The law’s primary goal is to ensure child safety by preventing accidental ingestion of harmful chemicals. The law states items such as prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous products must utilize child-resistant packaging. The nature of this packaging would avert children of the age of five and younger from easy access and provide a protected container. This has proven to avoid inadvertent prescription poisonings. This law has impacted numerous parties, including children, the elderly, and persons with disabilities.

However, retrospective concerns have been drawn that the elderly and the disabled may struggle to open their medication due to the packaging style. As a result, several supplemental changes have been enacted that allow certain medications to exempt the restrictions under the Poison Prevention Packaging Act. These changes have been made in the best interest of the patient, patient’s family, and national safety at the core of the discussion. As a direct result of the PPPA, children 5 years of age and under deaths decreased by 1.4 per million.[1][2][3][4]

As listed on the legislative portion on Title 15 of the United States Code of Commerce and Trade, the bill includes but is not limited to the following substances:

Substances: The Commission has determined that the degree or nature of the hazard to children in the availability of the following substances, because of their packaging, is such that special packaging meeting the requirements of § 1700.20(a) is required to protect children from serious personal injury or serious illness resulting from the handling, using, or ingesting such substances, and the special packaging herein required is technically feasible, practicable, and appropriate for these substances:

(1) Aspirin: Any aspirin-containing preparation for human use in a dosage form intended for oral administration shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except the following:

 (i) Effervescent tablets containing aspirin, other than those intended for pediatric use, provided the dry tablet contains not more than 15 percent aspirin and has an oral LD-50 in rats of 5 grams or more per kilogram of body weight.

 (ii) Unflavored aspirin-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 15.4 grains of aspirin per unit dose and that contain no other substance subject to the provisions of this section.

(2) Furniture polish: Nonemulsion type liquid furniture polishes containing 10 percent or more of mineral seal oil and/or other petroleum distillates and having a viscosity of less than 100 Saybolt universal seconds at 100 °F., other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (d).

(3) Methyl salicylate: Liquid preparations containing more than 5 percent by weight of methyl salicylate, other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c).

(4) Controlled drugs: Any preparation for human use that consists in whole or in part of any substance subject to control under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801 et seq.) and that is in a dosage form intended for oral administration shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c).

(5) Sodium and/or potassium hydroxide: Household substances in dry forms such as granules, powder, and flakes, containing 10 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide, and all other household substances containing 2 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(6) Turpentine: Household substances in liquid form containing 10 percent or more by weight of turpentine shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(7) Kindling and/or illuminating preparations: Prepackaged liquid kindling and/or illuminating preparations, such as cigarette lighter fuel, charcoal lighter fuel, camping equipment fuel, torch fuel, and fuel for decorative or functional lanterns, which contain 10 percent or more by weight of petroleum distillates and have a viscosity of less than 100 Saybolt universal seconds at 100 °F., shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(8) Methyl alcohol(methanol): Household substances in liquid form containing 4 percent or more by weight of methyl alcohol (methanol), other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(9) Sulfuric acid: Household substances containing 10 percent or more by weight of sulfuric acid, except such substances in wet-cell storage batteries, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(10) Prescription drugs: Any drug for human use that is in a dosage form intended for oral administration and that is required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by law to administer such drug shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c). 

(11) Ethylene glycol: Household substances in liquid form containing 10 percent or more by weight of ethylene glycol packaged on or after June 1, 1974, except those articles exempted by 16 CFR 1500.83, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

 (12) Iron-containing drugs: With the exception of (i) Animal feeds used as vehicles for the administration of drugs, and (ii) those preparations in which iron is present solely as a colorant, noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental iron, from any source, in a single package, equivalent to 250 mg or more elemental iron in a concentration of 0.025 percent or more on a weight to volume basis for liquids and 0.025 percent or more on a weight to volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous products, such as pastes and ointments, etc.) shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c).

(13) Dietary supplements containing iron: Dietary supplements, as defined in § 1700.1(a)(3), that contain an equivalent of 250 mg or more of elemental iron, from any source, in a single package in concentrations of 0.025 percent or more on a weight-to-volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous products, such as pastes and ointments, etc.) shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except for the following:

(i) Preparations in which iron is present solely as a colorant; and

(ii) Powdered preparations with no more than the equivalent of 0.12 percent weight-to-weight elemental iron.

(14) Lidocaine, Dibucaine, and Minoxidil: These products come in topical form l preparations are sold with applicators (i.e., droppers or spray pumps) that require special packaging for the lifetime of the product. 

(15) Solvents for paint or other similar surface-coating material: Prepackaged liquid solvents (such as removers, thinners, brush cleaners, etc.) for paints or other similar surface-coating materials (such as varnishes and lacquers) that contain 10 percent or more by weight of benzene (also known as benzol), toluene (also known as toluol), xylene (also known as xylol), petroleum distillates (such as gasoline, kerosene, mineral seal oil, mineral spirits, naphtha, and Stoddard solvent, etc.), or combinations thereof, and that have a viscosity of less than 100 Saybolt universal seconds at 100 °F., shall be packaged in accordance with the provisions of § 1700.15 (a) and (b).

(16) Acetaminophen: Preparations for human use in a dosage form intended for oral administration and containing in a single package a total of more than one gram acetaminophen shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except the following -

(i) Effervescent tablets or granules containing acetaminophen, provided the dry tablet or granules contain less than 15 percent acetaminophen, the tablet or granules have an oral LD-50 of 5 grams or greater per kilogram of body weight, and the tablet or granules contain no other substance subject to the provisions of this section.

(ii) Unflavored acetaminophen-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 13 grains of acetaminophen per unit dose and that contain no other substance subject to this § 1700.14(a).

(17) Diphenhydramine: Preparations for human use in a dosage form intended for oral administration and containing more than the equivalent of 66 mg diphenhydramine base in a single package shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), if packaged on or after February 11, 1985.

(18) Glue removers containing acetonitrile: Household glue removers in a liquid form containing more than 500 mg of acetonitrile in a single container.

(19) Permanent wave neutralizers containing sodium bromate or potassium bromate: Home permanent wave neutralizers, in a liquid form, contain more than 600 mg of sodium bromate or more than 50 mg of potassium bromate in a single container.

(20) Ibuprofen: Ibuprofen preparations for human use in a dosage form intended for oral administration and containing one gram (1,000 mg) or more of ibuprofen in a single package shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c).[5][6]

Issues of Concern

Relevant concerns about the Poison Prevention Packaging Act target the elderly or people with physical disabilities. This limited population must request special packaging if they desire a non-child-resistant container. The special packaging must abide by such guidelines:

Each special package will still have to remain senior-adult and younger-adult resistant. When applicable, a metal aerosol container can be utilized if compliant with other states of federal regulations. There shall be no reusable special packaging. Containers with liquid will be restricted to two milliliters if the container is activated, inverted, or squeezed.[6]

A label must be provided on the container stating, “This Package for Households Without Young Children.” This statement is required for any special packaging according to the act. The label should appear easily legible on the borderline of the principal display panel. The statement must be written in contrast to the other labels. For smaller containers unable to accommodate the label, a substitute label will proceed with the statement as “Package Not Child-Resistant.”[7][8]

Each special packaging standard must remain appropriate for the application and desired effect of the pharmaceutical for the particular patient. The following list is products that remain exempted from the PPPA.

• Sublingual and chewable isosorbide dinitrate less than 10mg per dosage strength
• Powdered unflavored aspirin
• Pencrelipase prepartion
• Effervescent aspirin
• Sublingual nitroglycerin
• Oral contraceptives
• Hormone replacement therapy
• Powdered iron preparations
• Effervescent acetaminophen
• Anhydrous cholestyramine in powder form
• Potassium supplements in unit dose form

Clinical Significance

The Poison Prevention Packaging Act has effectively reduced the number of deaths in children of the age of five and under. Before enacting the PPPA, unintentional deaths resulting from the consumption of pharmaceuticals and household products were among the leading causes of death in infants and young children. Once the Poison Prevention Packaging Act was successfully put into place in 1940, the accidental deaths related to unintentional poisoning in children 5 and under fell by a rate of 1.4 per million. The reduction in mortality rate among this population has been projected to be between 40-45 percent as a direct effect of the Poison Prevention Packaging Act.[4][9][10]

Enhancing Healthcare Team Outcomes

The Poison Prevention Packaging Act has critically impacted the procedures of providing prescriptions over the last century. This Act allows pharmacists the opportunity to discuss the proper handling of the storage of pharmaceuticals in the consumers' homes. By discussing these topics with the consumers, pharmacists will continue to protect children from potential hazards.

Simultaneously, efforts to properly provide for elders and persons with disabilities remain to provide a high-quality standard of care. The pharmacist must dispense oral prescription drugs in special packaging unless the drug is exempted or the patient or prescribing practitioner requests nonspecial packaging. However, in nursing homes, the staff is not required to give medication in a child-resistant container since nursing homes are an institution and are therefore exempt from the law.[1]

Nursing, Allied Health, and Interprofessional Team Monitoring

When a prescriber provides a written request for special packaging, the pharmacist's role is not only to fulfill the request but also to act as a knowledgeable resource for the patient. It is advisable for the dispensing pharmacist to periodically verify with all patients who have blanket waiver requests for non-special packaging to ensure that noncomplying packaging is the preferred packaging choice for the patients' prescription drugs. In case of suspected poisoning or childhood ingestion emergency, if a health care provider cannot provide the necessary emergency information for the caller or advise on the proper course of action, refer the caller to the Poison Control Center or nearest hospital emergency room. The National Poison Control Center phone number is 1-800-222-1222.

While one of the largest responsibilities of the Poison Prevention Act remains is those who manufacture and package the pharmaceutical and household products that are deemed poisonous to children, physicians and pharmacists hold an equally critical role. Whether through providing feedback to pharmaceutical companies, modifying the packaging of specific pharmaceuticals, or even altering a therapeutic regimen, the final assessment remains at the discretion of the clinician and pharmacist. Both parties as a team must keep the patient's best interests at the forefront of this decision.[1][2][3]