Child-resistant Packaging Research Articles

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Soluble-Films

A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16mg, n = 18) or B/N (16/4mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.

Medical toxicology: Need for recognition as a subspecialty

Medical toxicology: Need for recognition as a subspecialty

Pattern and determinants of poisoning in a teaching hospital in Riyadh, Saudi Arabia

Background The Drug and Poison Information Center (DPIC) at King Khalid University Hospital, Riyadh, Saudi Arabia, was founded in 1983. Since then it has responded adequately to queries from medical and non-medical callers from all over the Kingdom. Queries ranged from simple material identification to poisoning cases. Objectives To assess the pattern and circumstances of poisoning in the Kingdom of Saudi Arabia through reviewing data from DPIC in King Khalid University hospitals. Methods This is a retrospective study of referred cases and calls received by DPIC. All records and documentation forms during the study period were investigated. Results This study included 1161 cases. There were 7.9% infants, 52.9% under 5 years old, 7.2% between 6–12 years old and 32.0% more than 12 years old. Number of males with toxic exposure was almost equal to that of females. More than 92% of cases were toxic exposure through oral route. Causes of poisoning include drugs among 76.7% of cases followed by household chemicals (6.8%). Suicidal intention was reported among 25.6% of cases. Using multivariate regression analysis, significant predictors of suicidal attempts are more than 12 years old, patients who were exposed to more than one toxin and patient who came to the hospital within 1–3 h since poisoning. Recommendations Establishing and operating DPIC centers throughout the kingdom, in addition to implementing of legislations to ban over the counter selling of medications and to sell potentially dangerous chemicals in childproof containers.

The epidemiology of childhood poisonings in Cyprus

Information on childhood poisonings in Cyprus is limited. Our objective was to examine the epidemiology of poisonings among children in Cyprus. All children up to 15 years of age admitted for poisoning to the Archbishop Makarios Hospital in Nicosia, Cyprus between 2005 and 2008 were included in our study. All hospital poisoning records were reviewed. A total of 257 children were admitted for poisoning. The mean age of children was 3.1 years, of which 83.7% were below the age of 5 years old, while 53% were boys. The poisoning hospitalizations accounted for about 3% of all admissions to the pediatric department during the study period (4 years). The annual cumulative incidence of childhood poisoning hospitalizations was 116 per 100,000 children. Medications accounted for 46.1% of all poisonings, the most frequent cause being paracetamol (9.8%), cardiovascular medications (5.3%), antitussive medications (4.5%), and other painkillers (4.1%). Another 37.6% of hospitalizations involved household products such as household cleaning products (11.8%), petroleum products (11.0%), and rodenticides (5.7%). Among children who ingested petroleum distillates, 55.6% developed clinical symptomatology. The vast majority of cases were accidental (93.8%). Suicidal cases involved children 8-14 years old, mainly girls, and the most frequent poisoning ingested was paracetamol (46.7%). Poisoning hospitalizations represent an important cause of morbidity among children in Cyprus. Preventive strategies should include the education of caregivers on the handling of medications and household products as well as legislation requiring child-resistant packaging for all medications and household products including petroleum distillates.

Is the test of senior friendly/child resistant packaging ethical?

Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the 'senior friendliness' of CR designs that are used throughout the world disallow people with 'overt or obvious' disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision.

Unintentional Child Poisonings Treated in United States Hospital Emergency Departments: National Estimates of Incident Cases, Population-Based Poisoning Rates, and Product Involvement

The goals were to develop national estimates of unintentional child poisoning cases treated in US hospital emergency departments, to determine population-based poisoning rates, and to evaluate characteristics of the victims and the products involved. Cases reported through the US Consumer Product Safety Commission National Electronic Injury Surveillance System, involving a national probability sample of US hospital emergency departments, were used as a basis for developing national estimates of product-related poisonings involving children<5 years of age treated in US hospital emergency departments in 2004. There were an estimated 86194 child poisoning incidents treated in US hospital emergency departments in 2004, amounting to 429.4 poisonings per 100000 children. Approximately 70% of the poisonings involved children 1 or 2 years of age, slightly more than one half involved boys, and 13.3% resulted in hospital admission. Approximately 59.5% of the poisonings involved oral prescription drugs, oral nonprescription drugs, or supplements. Other major product categories resulting in poisonings included cleaning products (13.2%), drugs and ointment preparations intended for external use (4.9%), and personal care products (4.7%). Approximately 54.7% of the poisonings involved products already subject to child-resistant packaging requirements under the Poison Prevention Packaging Act. Despite advances in recent years, unintentional child poisonings remain an important public health concern. The circumstances surrounding poisonings need to be evaluated further, and intervention strategies need to be developed.

Guideline for End-of-Life Care Released

Agency officials continue to consider the safety and efficacy of over-thecounter cold and cough products for children aged 2 to 11 years, and whether regulatory actions regarding these products should be taken. Among the considerations are whether products targeting children aged 2 to 5 years should be removed from the market or their labels revised, as well as how to prevent caregivers from giving liquid medicines intended for older children to younger ones, according to Ganley. In the meantime, while the agency weighs issues related to the use of overthe-counter cold and cough products in children aged 2 years and older, parents who choose to use these drugs in older children should take several precautions to prevent overdose, said Lisa Mathis, MD, associate director of the Office of New Drugs, Pediatric and Maternal Health Staff in the FDA’s Center for Drug Evaluation and Research. Such precautions include • Reading the labels and taking note of the active ingredients. Many products have the same ingredients and giving a child more than one product may result in an inadvertent overdose. • Measuring doses using only dosing cups or spoons provided with the medication or those specially designed for administering drugs because household spoons vary in size and may lead to an incorrect dose. • Using products with childproof caps and storing them out of children’s’ reach. • Consulting a physician or other clinician about any questions concerning the use of these drugs in children aged 2 years or older. More information about the FDA’s recommendations are available online (http://www.fda.gov/cder/drug/advisory /cough_cold_2008.htm), as well as information for consumers (http://www .fda.gov/consumer/updates/coughcold011708.html).

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.

Success through failure: the paradox of design

Design pervades our lives. Everything from drafting a PowerPoint presentation to planning a state-of-the-art bridge embodies this universal human activity. But what makes a great design? In this compelling and wide-ranging look at the essence of invention, distinguished engineer and author Henry Petroski argues that, time and again, we have built success on the back of failure--not through easy imitation of success. Success through Failure shows us that making something better--by carefully anticipating and thus averting failure--is what invention and design are all about. Petroski explores the nature of invention and the character of the inventor through an unprecedented range of both everyday and extraordinary examples--illustrated lectures, child-resistant packaging for drugs, national constitutions, medical devices, the world's tallest skyscrapers, long-span bridges, and more. Stressing throughout that there is no surer road to eventual failure than modeling designs solely on past successes, he sheds new light on spectacular failures, from the destruction of the Tacoma Narrows Bridge in 1940 and the space shuttle disasters of recent decades, to the collapse of the World Trade Center in 2001. Petroski also looks at the prehistoric and ancient roots of many modern designs. The historical record, especially as embodied in failures, reveals patterns of human social behavior that have implications for large structures like bridges and vast organizations like NASA. Success through Failure--which will fascinate anyone intrigued by design, including engineers, architects, and designers themselves--concludes by speculating on when we can expect the next major bridge failure to occur, and the kind of bridge most likely to be involved.

Safety issues relating to paraffin usage in Eshane, Kwazulu-Natal

This study describes results of a household survey conducted in Eshane in the rural Kwazulu-Natal Midlands in April 2002, including baseline sociodemographic, energy usage, paraffin-related injury and safety knowledge information. A total of 404 interviews were conducted in five villages that fell within a 10-kilometre radius of the proposed Eshane integrated Energy Centre. Paraffin usage was high (86.6%) and there were no significant differences between electrified and non-electrified villages. Paraffin ingestion by children and paraffin-related fires were reported in 3.6% and 6.3% of households respectively. The majority of respondents had heard safety messages, but message retention was only demonstrated for messages relating to fires, and not ingestion. It seems that safety education may have a role to play in the prevention and response to paraffin-related fires, but that child-resistant packaging may be the only viable intervention for the reduction of ingestion among children.

Serious injuries from dishwasher powder ingestions in small children

To describe patterns and severity of caustic injuries sustained from dishwasher powder ingestion and highlight need for national safety standards. Retrospective chart review of admissions for caustic ingestion to Starship Children's Hospital from January 2003 to January 2005 and review of New Zealand National Poisons Centre data. Between January 2003 and January 2005, the National Poisons Centre recorded 610 dishwashing powder ingestions, with 88% of children less than 2 years old. Twenty-three children were admitted to Starship Children's Hospital following caustic ingestion, of whom 11 were identified as having ingested dishwasher powder (9 boys and 2 girls) and were aged 11 to 30 months (mean 17.5). Five children (45%) were admitted to the Paediatric Intensive Care Unit over 4 months (October 2004 to January 2005), requiring intubation for airway control. Two children needed tracheostomy. Three of the 11 children (27%) required repeated oesophageal dilatation, and two underwent gastrostomy formation. One brand of dishwasher detergent and container type was implicated in over half of the cases. Dishwasher detergents are highly corrosive substances that cause potentially life-threatening injuries and ongoing morbidity. The recent surge of incidents may be related to change in product constituents or non-compliance with New Zealand safety standards. Efforts to limit product alkalinity, legislative requirement of Child-Resistant Packaging and public education may reduce injuries from these common household substances.

Final Report of the Safety Assessment of Methacrylic Acid1

Methacrylic Acid is an organic acid used at concentrations between 50 and 88 percent to pretreat the nail and maximize the adhesion between the nail and artificial nail extender. Methacrylic Acid is readily absorbed through mucous membranes of the lungs, the gastrointestinal tract, and the skin; and is distributed to all major tissues. Oral LD50 values for rats ranged from 277 to 2260 mg/kg; acute toxicity symptoms included severe gastric irritation, gasping, labored respiration, prostration and hematuria. In a short-term inhalation study, rats exposed to Methacrylic Acid at 1300 ppm showed nose and eye irritation and weight loss, while necropsy results and blood and urine tests were normal. Methacrylic Acid is an ocular toxicant in animals. Undiluted Methacrylic Acid is corrosive to the skin of rabbits and guinea pigs. Exposure as limited as 3 minutes can cause severe erythema and slight to moderate edema. Exposure from 15 minutes to 24 hours under occlusive patches can cause marked to severe discoloration, slight to severe subcutaneous hemorrhages, necrosis, ulcerations, severe erythema, edema and concave eschar. Methacrylic Acid was irritating and caused strong rubefaction and scab formation in a guinea pig maximization test at challenge concentrations from 10 to 100 percent. It was difficult to determine if the results were type IV hypersensitivity reactions or simple irritation. In three other studies, guinea pigs were not sensitized. Methacrylic Acid was not a reproductive/developmental toxicant in rats or mice. Methacrylic Acid was negative in Salmonella typhimurium mutagenicity tests using strains TA98, TA100, TA1535 and TA1537 both with and without metabolic activation, but was positive in a DNA-cell-binding assay. Case reports involving Methacrylic Acid often involve children. Effects from ingestion include drooling, gagging, and vomiting. Children exposed to Methacrylic Acid as a result of accidental spills caused first and second degree burns to the eyes, face, hands, arms, and chest. The Consumer Product Safety Commission has required child-resistant packaging for liquid household products containing more than 5 percent Methacrylic Acid (weight-to-volume) in a single package. Since Methacrylic Acid is an extremely corrosive chemical, a primary concern about its use as a cosmetic ingredient was the ability to limit exposure to the nail when pretreating the nail prior to application of an artificial nail extender. A videotape presentation demonstrated that a trained professional could use a small applicator brush to dab a limited volume of Methacrylic Acid only to the center of the nail, allowing the monomer liquid to diffuse down the nail without any exposure to the skin. There were no available data to demonstrate that an individual consumer could apply Methacrylic Acid and avoid inadvertent skin contact. In order to minimize any exposure to the acid, the Expert Panel concluded that nail primers containing Methacrylic Acid could be used safely by trained individuals instructed to ensure that there be no contact with the skin. The CIR Expert Panel recognized that there are no chronic inhalation toxicity data on Methacrylic Acid, but was concerned that inhalation of Methacrylic Acid could affect the respiratory tract. Since the inhalation exposure time is significantly increased in a commercial setting, the Panel was more concerned about the safety of the nail technician than the consumer. The Expert Panel concluded that the current NIOSH recommended exposure limit of 20 ppm would provide adequate protection.

Tots Often Foil Child-Resistant Drug Packaging

Tots Often Foil Child-Resistant Drug Packaging

Herbal Product Contamination and Toxicity

Herbal poisoning exposures reported to poison centers increased by 344% after passage of the Dietary Supplement Health and Education Act, with 24412 exposures reported in 2003. Increased toxicity is speculated to be related to lack of child-resistant packaging, new issues of contamination, proliferation of multiple ingredient products, excessive concentration of active ingredients, and discovery of new drug-herb interactions. This review addresses contamination issues such as heavy metals, pharmaceuticals, homeopathic remedies, microbes, insects, environmental chemicals, and mis-identification of one plant for another. Toxicity issues covered include carcinogenicity, delay in seeking medical treatment when using herbs to treat serious illness, toxic components, hypersensitivity reactions, hepatotoxins, nephrotoxins, epileptogenic compounds, cardiac toxins, gastrointestinal toxins, and hematologic toxins. Common drug-herb interactions are discussed. The pharmacist plays an important role in patient education and evaluation of potential toxicities related to herbal supplements.

Unknown Poison

Unknown Poison

Factors Associated with Increased Risk for Acute Unintentional Childhood Poisoning among Children Living on the U.S.-Mexico Border

This study evaluated prevalence of unsafe storage of toxic products and evaluated the association of demographic-socio-cultural variables with risk of young-child exposure to household poisons. Interviews were conducted with 698 low-income caregivers living on the U.S./Mexico border. Multiple-ordinal regression was used to analyze associations between very unsafe storage of toxic products and household factors. At least one toxic product was accessible to children in 49.4% of households and 18.5% of these households' stored substances very unsafely in that products were accessible and stored either in non-original containers or without childproof caps. At-risk households were associated with U.S.-born caregivers who were single, employed, and live in more U.S. acculturated communities. These homes stored an increased number of toxins and were more likely to house a smoker. U.S./Mexico border childhood poisoning prevention programs should focus on potentially acculturated families with personal and household characteristics akin to the U.S. mores and customs.

Health promotion policy and politics: lessons from childhood injury prevention.

Health promotion policies--including laws that regulate safe products, environments, and behaviors--are among the most effective mechanisms for reducing childhood injuries for large segments of the population. In this article, five examples of safety legislation and regulation to reduce childhood injury are described. Two such efforts are aimed at preventing injury-producing events from occurring: child-resistant packaging for medications and hazardous substances, and graduated licensing for teen drivers. Three other examples illustrate the value and complexities of policies designed to prevent an injury once a hazardous event has occurred: bicycle helmet legislation, children's sleepwear standards, and child safety seat laws. One important role of health promotion is to tackle not only how health promotion policies and politics can improve child health, but also how to educate legislators and policy makers in the process.

With Politics and Mental Illness, The More Things Change. . .

With Politics and Mental Illness, The More Things Change. . .

Poisoning In Children: A Study Of 1120 Poisoned Patients Younger Than 12 Years At Loghman Hakeem Poison Control Center, Tehran, Iran, 2000-2001

Poisoning In Children: A Study Of 1120 Poisoned Patients Younger Than 12 Years At Loghman Hakeem Poison Control Center, Tehran, Iran, 2000-2001

What's new in toxicology?

Poisoning in children under 5 years of age is common, the majority of cases are accidental ingestions. Children may ingest pharmaceutical products, household substances, chemicals, plants or street drugs. Most children develop no clinical features or only mild effects and the challenge in managing these children is to identify the 1% who may go on to develop severe clinical effects and require specific management. The latest guidelines on gastric decontamination are reviewed together with developments in the management of poisoning with paracetamol, tricyclic antidepressants, iron, lead and ethylene glycol and methanol. Prevention of childhood poisoning is important and the use of child-resistant packaging and adequate supervision together with the secure storage of household substances are the basis of prevention of accidental childhood poisoning.