Child-resistant Closures Research Articles

Unravelling the Risk of Poisoning From Nicotine-Containing Tobacco Products in Children Less Than Five Years of Age.

For decades, young children in the United States have been accidentally poisoned by traditional tobacco products and the yearly incidence has slowly increased. More poisonings have accompanied the introduction of new products such as e-cigarettes and dissolvable tobacco, with renewed public attention. Using toxicological principles of human health risk assessment, published data from prior exposures, and information about the content and characteristics of specific products, I estimated the acute toxicological risk from exposure to various types and quantities of tobacco products for children <5 years old. Approximate reference levels for a non-lethal oral dose of nicotine were derived: A higher level potentially requiring medical care (0.2mg per kg) and a lower level not potentially requiring medical care (0.04mg per kg). A weight-based oral lowest lethal dose (LDLO) of 1-14mg per kg in children <5 years old is estimated from the cited LDLOs in adults. I provide tables relating e-liquid concentration and volume to the oral LDLO in children <5years old by weight and describing the amount of other tobacco products expected to result in lethality. Communications about safe storage practices should focus on the benefits of keeping any nicotine-containing product out of the reach of young children, and adults can be reminded to always reengage child-resistant closures on packages and call a poison center for accidental exposures. Healthcare providers, families, or any member of the public can also make reports about unexpected health or safety concerns related to tobacco products to the FDA using its online Safety Reporting Portal at https://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm377563.htm. Tobacco products, particularly electronic nicotine delivery system (ENDS) liquids are highly toxic to children <5 years old in small amounts. Given that the concentration of nicotine in ENDS is 3 to 72mg per mL, the lethal dose (LDLO) is expected to be 13-40mL in a bottle containing a solution of 3mg per mL liquid nicotine but may be as low as ½-2mL in a bottle containing a highly concentrated solution of 72mg per mL liquid nicotine. Features such as flow restrictors, child-resistant closures, and communication of safe storage practices to parents can help to lessen the morbidity and mortality from poisoning.

Consumer experiences and perception with reclosable pharmaceutical child resistant closures in Ghana, West Africa

AbstractChild resistant closures (CRCs) are an effective deterrent in preventing inadvertent poisoning in young children. Nevertheless, investigations since their debut have shown that users in different parts of the world do not embrace this safety package due to their opening mechanism. In this study, consumers who have interacted with pharmaceutical CRCs in Ghana within the West African sub‐region were interrogated to assess their experiences and perception. The assessments centred on consumer attitudes towards using CRCs generally, as well as their understanding of and importance for CRCs, the types that are available, observed cases of unintended medicinal child poisoning, ease of opening and injuries/accidents caused by them. The two observed CRCs used in the region were push and turn and squeeze and turn closures, with the former being the most popular. Regardless of educational level, consumers within the region had little understanding of how CRCs worked and how important they were. Due to their imprecise instructions and unpleasant opening mechanisms, CRCs were generally assessed by consumers as being challenging to open. Consumers unable to open CRCs employed their teeth, knives and sharp objects, resulting in injuries and casualties such as cuts and scratches. To maintain safe containment and limit children's exposure to medications, consumers identified CRCs as their top choice for pharmaceutical packaging. In conclusion, consumers oppose changing the design of CRCs but advocate for better opening instructions and pharmacist education for correct use.

Seeing household chemicals through the eyes of children—Investigating influential factors of preschoolers’ perception and behavior

Introduction: Children who encounter household chemicals run the risk of unintentional injury. The aim of this study was to understand which factors heighten children’s attention or misguide their decision-making concerning household chemicals. We hypothesized that certain product attributes (i.e., label, packaging, closure types), storage context, and parental beliefs play a role in this setting. Method: We conducted a laboratory study with N = 114 children (M = 45 months, SD = 6.5) and their parents (M = 38 years, SD = 4.92). Children completed a series of behavioral tasks in which they had to choose between products with different attributes, identify products in different storage contexts, and sort household chemicals. Results: The results confirmed that the children preferred products with cartoon-style labels compared to products without such labels. However, children’s decision-making did not differ for products with different closure types (child-resistant vs sprayer-type closures). Regarding the storage context, our results showed that the children particularly struggled to identify dishwashing tabs when they were stored with other food items rather than household chemicals. In terms of parental beliefs, our study found that parents rated more household chemicals as child-safe than their children did. Practical Application: Parents should buy household chemicals with neutral labels and pay attention to how their household chemicals are stored. Manufacturers should consider potential adverse effects when developing new product designs.

Gripping strategies employed by young children aged 3–5 years when interacting with child-resistant push and turn closures used by pharmacies in the United States

Archived video footage from a previous task analysis study where children attempted to open prescription vials outfitted with 42 mm (diameter) push and turn closures was reviewed and grip postures were characterized based on a grip taxonomy presented by Rowson & Yoxall which investigated adult grips (2011). Video review was conducted to identify the types of grip postures children aged 3–5 years utilized when attempting to open continuous thread polypropylene vials outfitted with push and turn, child-resistant closures and compared with grip postures identified with the adults. Children tended to utilize only 3 grip postures (spherical, cylindrical, and pronated cylindrical grips), while adults utilized seven different postures. If children utilize a more limited set of grip postures when opening child resistant closures than their adult counterparts, this difference could be exploited when designing child resistant packaging systems. That said, our study utilized a limited number of CRC designs and confounds existed between the package sizes the children in the archived video footage attempted to open and those that served as the point of comparison which identified grip postures utilized by adults. As such, further investigation is needed across a range of package diameters. Potential implications for child-resistant packaging design are discussed.

Gasoline-related injuries and fatalities in the United States, 1995-2014

ABSTRACTThis descriptive study examines twenty years of gasoline-related fatalities and emergency department treated injuries in the United States, based on data from the US Consumer Product Safety Commission. Thermal burns consistently accounted for the majority (56%) of gasoline-related injuries and for most (82%) gasoline-related deaths, and were commonly (57–71%) associated with the use of gasoline as an accelerant. Poisoning accounted for 13% of injuries and 17% of deaths. The primary poisoning injury pattern was ingestion; the primary fatality pattern was inhalation, with about half of those associated with deliberate abuse. The estimated number of ingestions decreased from 60 to 23% of poisoning-related injuries, while injuries associated with inhalation abuse increased from 6 to 23%. Chemical burns and dermatitis were less represented in the injury data and were primarily associated with gasoline spills or splashes.Gasoline cans reportedly ignited or exploded in about 5% of thermal burn injuries and fatalities.While mandatory requirements for child resistant closures on gasoline cans (a primary intervention) have potentially impacted poisonings, the use of flame mitigation devices to address thermal injuries, if successful, would be a secondary intervention, and could address only a small percentage (about 5%) of injuries and deaths.

Prevention of Unintentional Injuries: A Global Role for Pediatricians

In spite of many proven ways to prevent childhood injuries, the relative prevalence of unintentional injury continues to plague the health and well-being of children worldwide. No population groups are spared, with children living in all social and economic circumstances at risk. Dr Hollwarth describes the extent of this injury pandemic. He also cites practical approaches for pediatricians to help advocate for evidence-based injury prevention policies and more consistent inclusion of anticipatory guidance in their daily practice. The simple truth is that children are much more susceptible to unintentional injuries than adults and the societal costs are unacceptably high. This column serves as a call to arms for pediatricians everywhere to work on combating this growing public health challenge. —Jay E. Berkelhamer, MD, FAAP Editor, Global Health Monthly Feature Primary care pediatricians serve as physicians for the entire family because they accompany children from infancy through adolescence, and quite often into adulthood. The pediatrician may be primarily consulted in cases of diseases, but his or her advice with regard to vaccination, healthy nutrition, and a safe environment is usually appreciated by families. Thus, pediatricians can play a significant role in injury prevention, too. Why is injury prevention important? Unintentional injuries constitute a global public health problem and are the leading cause of death in children and adolescents between the ages 5 and 18 years. More than 800 000 children younger than 18 die every year as a result of unintentional injuries.1 In the United States, this is the leading cause of death among children aged 18 and younger, claiming more than 12 000 lives annually.2 For each child who dies as a result of injury, another 553 children are treated at emergency departments, a further 11.2 children need to … Address correspondence to Michael E. Hollwarth, Univ. Prof. Dr., Department of Paediatric and Adolescent Surgery, Medical University, Auenbruggerplatz 34, A-8036 Graz, Austria. E-mail: michael.hoellwarth{at}medunigraz.at

Pediatric Ingestions of House hold Products Containing Ethanol

Alcohol is present in a number of household items that are readily accessible to children. Ingestion of these household products containing alcohol can lead to significant health risks. To identify reported cases of ingestions of common household items that have led to ethanol intoxication, poisoning, or death in children up to the age of 18 years. The OVID MEDLINE database from 1948 to March 2011, Embase from 1980 to March 2011, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) from 1982 to February 2011 were searched for articles with the following key terms: alcohols(ethanol or ethyl alcohol) and ingest*(ingestion) or intoxic*(intoxication) or poisoning* or death. The search was limited to children (0-18 years). All articles that reported ingestion of household products that contained ethanol were included in the analysis. Results. Many household products, particularly mouthwashes, hand sanitizers, and cosmetics contain quantities of ethanol that are significant enough to induce intoxication and hypoglycemia. There were 17 publications directly reporting on children with alcohol intoxication from household products. Serious adverse events included hypoglycemia, seizures, and death. Child-resistant closures appear to have reduced the incidence of ingestion of ethanol-based products, including mouthwashes, and may be applicable to other products such as hand sanitizers. Ingestion of household substances containing alcohol continues to be a health care problem. Legislature to reduce alcohol content in household products and public education should be instituted to prevent poisonings in children.

Carpe diem, Carpe ampulla: A numerical model as an aid to the design of child-resistant closures

The population of most developed countries is ageing. Despite continuing medical advances, ageing brings with it a host of issues, not least a loss in strength and dexterity. One major area of concern is the ability of elderly consumers to access packaged goods such as food and medicines. In previous studies, the authors developed a numerical model of a human hand that was used to investigate the effect of physical dimensions and choice of grip on joint stresses to aid the understanding between physical effort, ability and discomfort. This previous work was supported by ethnographic studies and led to recommendations for packaging design.In this paper, a small ethnographic study is undertaken which identifies the grip types used to access to a product that is known to cause particular difficulties for the elderly, the “squeeze and turn” child-resistant closure or CRC, commonly used on medicines and cleaning products. One of the grip types used was chosen to be modelled using the numerical model developed in previous studies by the author. Model geometry and loading were adapted to simulate the “squeeze and turn” nature of the initial opening for closures of this type. A series of studies were then undertaken using different hand geometries; an average male hand, an average female hand and a fifth percentile female hand.The prediction from the model here is that female users with smaller hands will experience more discomfort when accessing squeeze and turn CRC's and that the turn process whilst maintaining the squeeze is problematic.

Child-Resistant Closures for Mouthwash

The Poison Prevention and Packaging Act of 1970 mandated that certain potentially hazardous drugs and other products be sold in child-resistant containers (CRCs). The Consumer Product Safety Commission estimates that CRCs for aspirin and oral prescription medicine saved the lives of about 700 children since the requirements went into effect in the 1970s. Under this Act, the Consumer Product Safety Commission issued a rule requiring child-resistant packaging for mouthwashes containing 3 g or more of ethanol per package. The effective date was July 24, 1995, and applied to all applicable products packaged on or after that date. To determine the effectiveness of this 1995 ruling, all American Association of Poison Control Center Toxic Exposure Surveillance System data involving children younger than 6 years who ingested ethanol-containing mouthwash 10 years before the implementation of this ruling, the transition year, and 10 years after were reviewed. Only single-substance exposures were included. Data reviewed included the total number of exposures per pre and post years and the outcome. A total of 61,185 cases met the criteria. There were 18,275 exposures from 1985 through 1994 prerequirement (0.12% of all exposures); 39,376 from 1996 to 2005 postrequirement years (AR) (0.17% of all exposures); and 3,534 cases reported in 1995 (0.17% of all exposures). Definitive outcomes were coded in 62.6% of the prerequirement group and 42.2% of the AR group. Numerous factors affect these results. However, in those cases where definitive outcomes were coded, the AR group has better outcomes.

Do child-resistant caps prevent school age children access to prescription medications?

Study objectives: We determine the ability of first- and second-grade children to open prescription medication bottles. Methods: Samples of child-resistant prescription medication bottles were obtained from 3 national vendors (CVS, Walgreen's, Wal-Mart). A convenience sample of first- and second-grade children at a local elementary school were the test subjects. After approval by school administration, parental consent forms were obtained for each participant. On separate occasions, participants present were given 1 style of bottle and asked to open it. Five minutes were allowed, and times were recorded for each child and each type of bottle. Grade level and sex were also noted for each subject. Children were not allowed to discuss opening techniques with other subjects. Results: Three brands of caps were tested. Two were push-down-and-turn style (CVS and Wal-Mart), and 1 (Walgreen's) had a tab that needs to be depressed to open the bottle. For Walgreen's bottles (push tab), 21 subjects attempted to open them. Twenty (95%) of the 21 were successful in an average of 1.8 minutes (range 0.5 to 5 minutes for successful opening). For Wal-Mart (push and turn) bottles, 20 subjects attempted to open them. Twelve (60%) of the 20 were successful in an average of 1.8 minutes (range 0.25 to 4.5 minutes for successful opening). For CVS (push and turn) bottles, 25 subjects attempted to open them. Fourteen (56%) of the 25 were successful in an average of 4.3 minutes (range 0.5 to 4.5 minutes for successful opening). Thirty-five first-grade children attempted to open bottles. Twenty-three (66%) of the 35 were successful in an average of 2.4 minutes (range 0.5 to 4.5 minutes for successful opening). Thirty-nine second-grade children attempted to open bottles. Thirty-two (82%) of 39 were successful in an average of 1.2 minutes (range 0.25 to 4 minutes for successful opening). Twenty-nine boys attempted to open bottles. Twenty-two (76%) of 29 children were successful in an average of 1.6 minutes (range 0.25 to 4 minutes for successful opening). Thirty-two girls attempted to open bottles. Twenty-two (68%) of 32 children were successful in an average of 2.2 minutes (range 0.25 to 5 minutes for successful opening). Conclusion: In a convenience sample of first- and second-grade children, most were able to remove a child-resistant cap in less than 5 minutes. Although children in this age group have some understanding of consequences of taking medications, these data reveal that reliance on resistant caps is not safe. Second-grade children were more adept at opening bottles, although first-grade children had a high success rate. It seems that the medication bottles with child-resistant closures may not provide the degree of safety assumed by many parents. Further testing with preschool children and a senior population is planned.

Can older adults use child resistant closures?

The objective of this study was to examine the design concepts used in child resistant closures with reference to ease of use by older adults. Included in the study design were a focus group (n=9) and user evaluation of a child resistant closure by a cross-section of older adults living independently in the community (n=103). A push and turn action seems to be the most favoured in comparison to a squeeze and turn action. Designers in consultation with older adults can arrive at easy-opening packaging for physically challenged people. Such a design is eligible for an award of the Owl Mark.

Poisoning pearls regarding the very young

Death caused by unintentional poisoning in children less than 6 years of age has decreased 20-fold over the past 50 years. There are many reasons for this, with the 2 most important being child-resistant closures and less hazardous ingested substances. The very young, those less than 15 months of age, compromise a special subset within this group. Their neurodevelopmental and anatomic differences result in unique ingestion scenarios with the potential for less severe outcomes. These can be enunciated as “Poisoning Pearls Regarding the Very Young.”

Eucalyptus oil poisoning among young children: mechanisms of access and the potential for prevention.

We studied unintentional paediatric eucalyptus oil poisoning to identify potential intervention strategies. The epidemiology of paediatric eucalyptus oil poisoning in Victoria was determined by analysis of four databases. The sequence of events preceding ingestion was examined by a telephone survey involving 109 parents or guardians of children under five years involved in an actual or suspected ingestion of eucalyptus oil. Such children were identified prospectively from all callers during a nine-month period to the Victorian Poisons Information Centre and those presenting to the emergency departments of the participating hospitals of the Victorian Injury Surveillance System. Eucalyptus oil was a leading agent associated with hospitalisation for poisoning among Victorian children aged under five years. In the telephone survey, 90 incidents were found to involve vaporiser solutions, 15 eucalyptus oil preparations, and the remainder other eucalyptus-oil-containing products of a medicinal nature. Regardless of the type of product, 74 per cent gained access via a home vaporiser unit, most frequently placed at ground level. Although amounts ingested are usually small, the reported range of toxic doses is wide, necessitating at least a medical assessment following ingestion. Potential countermeasures identified in a consultative workshop included: discontinuing the use of eucalyptus oil as a therapeutic agent; confirmation that vaporiser-well residues are nontoxic; removal of barriers to product reregistration following safety-related modifications; improved child-resistant closures; discouraging vaporiser use for respiratory infections among young children; and development and dissemination of protocols for treatment of suspected ingestion.

The successful introduction of child resistant closures for liquid paracetamol preparations

A liquid paracetamol preparation for pediatric use with a child resistant reclosable closure was recently introduced on the Swedish market. Objectives: To investigate the effect of this change on the number of poisoning incidents in children. A comparison was made between the number of inquiries to the Swedish Poison Information Centre concerning accidental overdoses of paracetamol among children before and after the introduction of the child resistant bottle. Efforts were also made to document the circumstances which led to the accidents. Results: During the three summer months of 1991, when the non child resistant bottle still was on the market, the centre received 90 questions concerning childhood poisoning incidents with liquid paracetamol. In 44% of all the cases the drug was in current use and the bottle had been removed from its normal storage place. During corresponding months in 1992, after introduction of the child resistant container, the number of relevant inquiries fell to 20. Six cases concerned children who could open the cap since it was not properly closed. Compared with 1991 the number of inquiries was reduced by more than 70%. Conclusion: Introduction of child resistant closures proved to be highly effective in reducing the frequency of poisoning accidents with liquid paracetamol in children. Such measures should be considered for any toxic drug, especially wren provided in liquid form form for pediatric use.

Automated Torque Sensing Equipment for Cosmetics and Pharmaceuticals

The limited accuracy of existing closure torque testers and the subjectivity of the measurements imparted by human operators has led to the development of an automated closure testing machine, the Auto-Torque.As packaging requirements become more stringent in order to provide Improved consumer safety and product integrity, improved quality control techniques become necessary. Torque testing of closures has relied for years on a manually operated spring scale with a claimed accuracy of plus or minus four percent (4%) full scale. The closure testing process becomes more inaccurate when you add to this error the inconsistencies due to reading errors, data entry/analysis errors, and operator technique (1). Automation of the closure torque testing process narrows the range of errors down to those of the machine itself which are easily quantified by a calibration procedure.Currently available spring scale closure testers have no provision for measuring downward force needed to engage child-resistant (CR) closures, requiring the user to develop their own apparatus (2). Currently, the Auto-Torque is being used for university research and by major pharmaceutical companies in both the package development and quality assurance test area to support the productivity of multiple lines.This paper describes the Auto-Torque's ability to provide the quality assurance needed In the closure torque testing process. Technical problems encountered and their solutions are viewed from a general systems automation perspective.

Accidental poisoning in childhood: a multicentre survey. 2. The role of packaging in accidents involving medications.

To assess the effectiveness of child-resistant closures (CRCs) and unit dose packaging in preventing childhood poisoning with medications, a survey by 14 hospitals of accidental suspected poisoning in children under 5-years-old, was compared with a survey of a representative sample of households with children under 5 living in the catchment areas of the hospitals. Nine hundred and thirty-eight medications thought to have been ingested by 877 children were compared with 5827 medications found in households with children. The relationship between availability of packs or medications in the home and their involvement in accidents was quantified by means of an Accident Association Index (AAI). A low AAI indicated that the involvement of a pack or medication was less than expected from availability and therefore safe. A high AAI indicated that involvement was greater than expected and therefore unsafe. Medications involved in suspected poisoning were most frequently packed in containers without CRCs (63%) or transparent blisters (20%); both had high AAIs. CRCs, strips, sachets and opaque blisters had low AAIs. Analgesics, expectorants and gastrointestinal medications, had low AAIs, while oral contraceptives, hypnotics, sedative/tranquillizers, antidepressants, anticonvulsants, anti-emetics, and anti-infectives had high AAIs. Prescription medications were more frequently involved in accidents than over-the-counter (OTC) medications and had a higher AAI. Comparison of the AAIs of different kinds of medication in each of their various pack types showed that safe packaging reduced the risk from medications which had a high average AAI. Only 40% of medications were in their normal storage place at the time of the accident. Medicine and bathroom cabinets, and kitchen cupboards and drawers were the safest places to store medications. Handbags, fridges, and shelves or ledges in the bathroom were the most unsafe places. No pack had a low AAI when stored on open shelves indicating that safe packaging cannot compensate for unsafe storage. Other factors which influenced the involvement of medications in accidents were the intended user and the duration of storage. The results of the study have important implications for design of packaging for medications and for education of the public.

An Evaluation of the Poison Prevention Packaging Act

This study investigated the effectiveness of child-resistant closures, required under the Poison Prevention Packaging Act of 1970, in reducing the incidence of accidental ingestions of 15 regulated substances among children less than 5 years of age. The regulated substances include aspirin, acetaminophen, prescription drugs, and household chemicals. Data from the National Electronic Injury Surveillance System and the National Center for Health Statistics were analyzed to determine ingestion and death rates associated with these substances over a five-year-period. The ingestion rate for all substances that require child-resistant closures has declined from 5.7/1,000 children in 1973 to 3.4/1,000 children in 1978. It is estimated that child-resistant closure have prevented nearly 200,000 accidental ingestions since 1973. Over the past 20 years, the death rate due to poisonings of children has declined from 2.0/100,000 children to 0.5/100,000.

Aspirin Fatalities—The New Taxonomy

For many years aspirin and aspirin-related products were the leading cause of accidental poisoning in children less than 5 years of age. In the mid 1950s 51% of all accidents in young children were due to accidental poisoning and aspirin was the leading offender. Aspirin ingestions accounted for 19% of total ingestions in 1958 and increased to 26% by 1965. In 1966-67, baby aspirin was limited to 36 per package and child-resistant closures were introduced by two major pharmaceutical companies on a voluntary basis.

Effect of Safety Packaging on Aspirin Ingestion by Children

The effectiveness of child-resistant closures, required under the Poison Prevention Packaging Act of 1970, in reducing the incidence of accidental ingestion of aspirin and aspirin-containing products among children less than 5 years of age has been investigated. Data from Poison Control Centers and the National Center for Health Statistics were analyzed to determine the ingestion level before and two to three years after safety closures were required. Baby aspirin and nonbaby aspirin products were analyzed separately. For baby aspirin. It is estimated that safety packaging has reduced the incidence of ingestions 45% to 55%. For nonbaby aspirin products, the reduction has been 40% to 45%.

Analyzing the Effectiveness of Child Resistant Closures by Studying Attempted Entry Behavior

The Poison Prevention Packaging Act of 1970 was the culmination of an effort lasting over a decade. The purpose of this act was “to protect children from serious personal injury or serious illness…” as the result of gaining access to hazardous household substances. The purpose of the investigation reported in this paper was to analyze three commonly available safety caps (plug-key), arrow line-up, and push-turn types), comparing them with one another and with standard types (snap and twist off) for a large group of children (99) aged 2, 3, 4, and 5 years, male and female. Testing procedures resembling those required under the federal standard were employed with two important exceptions: (1) children were not shown how to gain entry to the containers and (2) the period of attempted entry was reduced to two minutes. Incentives were placed in the containers to stimulate interest. Analysis of successful and unsuccessful entries was conducted with respect to container type, age, and sex. Several significant effects were noted. The push-turn type of safety cap proved most effective, followed by the arrow line-up and slot-key types. The percentage of successful entries was directly related to age. The statistics also revealed evidence questioning the effectiveness of some caps in meeting the federal standard. A detailed motion analysis was conducted on all subjects to study their investigative behaviors in attempting to gain entry to the containers. In testing subjects, all data were recorded on reel-to-reel video tape, permitting instant replay and micromotion analysis using slow motion and stop action viewing. A taxonomy and a frequency chart for these motions were then constructed.