Safer Lock

Safer Lock

Safer Lock is a patented locking prescription closure (LCP) device manufactured by Gatekeeper Innovation Inc.

Safer Lock uses a 4-digit combination locking cap that fits most standard pharmaceutical prescription bottles. Safer Lock is intended to prevent unauthorized and accidental access to powerful prescription medications, such as opioids, that can lead to poisoning, misuse, abuse, or overdose.

America's Opioid Epidemic

According to the U.S. Department of Health and Human Services, 116 people die each day from opioid-related drug overdoses. In 2017, HHS declared the opioid crisis a public health emergency after decades of increased prescription of opioid medications lead to widespread misuse of both prescription and non-prescription opioids. According to the CDC, deaths from drug overdose are up among both men and women, all races, and adults of nearly all ages. More than three out of five drug overdose deaths involve an opioid. Overdose deaths from opioids, including prescription opioids and heroin, have increased by more than five times since 1999.

Two trends are driving America’s opioid overdose epidemic: a 17-year increase in deaths from prescription overdoses, and a recent surge in illicit opioid overdoses driven mainly by heroin and illegally-made fentanyl.

Prescription Opioid Overdose Deaths

Prescription opioids continue to be involved in more overdose deaths than any other drug. More than 40% of all U.S. opioid overdose deaths in 2016 involved a prescription opioid, with more than 4 people dying every day from prescription opioid overdose. The most common drugs involved in prescription overdose deaths include Methadone, Oxycodone, and Hydrocodone.

Non-Prescription Opioid Overdose Deaths

Heroin use has been increasing in recent years among men and women in most age groups and all income levels. As heroin use has increased, so have heroin-related overdose deaths. Deaths from heroin-related overdose have increased fivefold from 2010 to 2016. Past misuse of prescription opioids is the strongest risk factor for starting heroin use. Among new heroin users, approximately 3 out of 4 report having abused prescription opioids prior to using heroin.

Overdose death rates from synthetic opioids such as fentanyl increased by 100% from 2015 to 2016. Fentanyl is a synthetic (man-made) opioid 50x more potent than heroin and 100x more potent than morphine. Synthetic opioid death rates increased across all demographics, regions, and across numerous states. In 2016, there were more than 19,000 deaths relating to synthetic opioids (other than methadone) in the United States. Illicitly manufactured fentanyl is often mixed with heroin and/or cocaine in order to increase the drug’s effect - often without the user’s knowledge.

Accidental Childhood Medication Poisoning

The opioid overdose epidemic isn’t just taking the lives of adults using prescription and non-prescription opioids. Every day, over 300 children in the United States under the age of 19 are treated in an emergency department as a result of being poisoned, and two children die. Accidental ingestion of medications, including opioids, are the biggest cause of childhood poisoning.

Approximately 60,000 emergency department (ED) visits result from unintentional medication overdoses among children under the age of 5. One out of every 150 two-year-olds is treated in an ED for an unintentional medication overdose. Over 90% of ED visits for unintentional medication overdoses among children under the age of 5 involve children who get into medicine on their own without caregiver oversight.

Opioids are most commonly implicated in medication poisonings. According to a study published in the journal Pediatrics, poison control centers received reports of 188,468 prescription opioid exposures among children under the age of 20 from 2000 to 2015. Hydrocodone accounted for the largest proportion of exposures. Another study published in the journal Pediatrics found that the US opioid crisis is leading to an increased rate of hospitalizations for pediatric opioid ingestions. The number of opioid-related hospitalizations doubled between 2004 and 2015.

Increasing Amounts of Medications found in American Homes

There is a staggering volume of medications in American homes. In 2014, retail pharmacies in the United States filled more than 4.0 billion prescriptions, which equates to more than 125 prescriptions per second. One study indicated that, in 2012, 59 percent of U.S. adults (ages 20 or older) took at least one prescription medication, and 15 percent took five or more.  The prevalence of multiple prescription drug use almost doubled between 2000 and 2012.

In 2017, a nationwide online survey among 2,000 parents with children under age 6 was conducted in order to better understand what they know about child poisonings and what they do to prevent it in their homes. The online survey revealed dangerous inconsistencies between what parents know about the dangers of accidental medicine poisonings and the actions they take to protect their children. While nine in ten parents agree it is important to store all medicine out of sight and up high after every use, nearly seven in ten report that, in reality, they often store medicine within a child’s sight - on a shelf or surface at or above counter height. The majority of parents report storing medicine in at least one location where it is unsafe - either within sight or within reach of young children.

Innovations in Abuse Deterrent Packaging to Reduce Scope of Opioid Epidemic

In 2016, the FDA developed an Opioid Action Plan to reduce the impact of opioids on the American public. FDA Commissioner Scott Gottlieb, M.D. has stated that one of his highest priorities is to take whatever steps necessary to reduce the scope and human tragedy created by the opioid epidemic, including supporting new innovations in opioid packaging and storage. According to the FDA, inappropriate or illicit use of opioids, such as sharing drugs with family and friends or using drugs stolen from home medicine cabinets account for some of the problem with prescription opioids. The FDA has stated that medication packaging and/or storage designs that limit access could help prevent use of the medication by someone for whom it was not prescribed, thereby, preventing accidental exposure (e.g., by a child or other household contact) or theft.

Abuse-deterrent packaging is a term that covers innovative new medication packaging and storage solutions meant to help prevent or deter misuse, abuse, or inappropriate access to prescription opioids. An expert panel at the Duke University, Robert J. Margolis, MD, Center for Health Policy convened in 2017 for a workshop entitled “Exploring Packaging, Storage, and Disposal Solutions to Enhance Opioid Safety.” The panel agreed that “Abuse-deterrent packaging can be an effective measure for reaching achievable goals, such as reducing accidental household exposure in young children and serving as a deterrent to teenagers in the home of patients.” The panel found that Locking cap technologies, such as Safer Lock, were considered to be effective in supporting safe storage for households with young children that might be at risk for accidental exposure or those with young adults that might be at risk for non-medical use of opioids found in the household.

How Safer Lock Works

The Safer Lock has a 4-digit combination locking cap that can be set to any combination. The 4-digit combination code offers 10,000 possible combinations, making unauthorized access very difficult.

When the correct combination is used on the Safer Lock cap, the cap will easily open and allow access to the prescription medications stored within. Under normal circumstances and when used correctly, a properly locked Safer Lock cap will not open without the correct combination.

The Safer Lock Story

Safer Lock was designed to keep curious toddlers and experimental teens from accessing opioids and other powerful prescription medications that can lead to poisoning, misuse, and overdose death.

Safer Lock was invented as a result of one family’s personal experience with teen opioid misuse and addiction. After a 2002 car accident left Safer Lock co-founder Deborah Simpson in a wheelchair for two years, doctors prescribed opioid painkillers to ease the pain of over 34 subsequent operations. One of Simpson’s two teenage sons, Steven, had access to the opioid painkillers Simpson kept in the home and in her purse, and, unbeknownst to her, began experimenting with her prescription drugs. His drug misuse became abuse and opioid addiction. Like many opioid abusers, Steven Simpson’s addiction to opioids lead him to seek out heroin, which became easier to obtain. Steven Simpson was lucky. He sought treatment and slowly beat his addiction.

Through the journey, Steven’s brother, Joseph, was angry and disappointed to discover that his brother’s story was not unique. He wanted to find an answer, to protect other families from the tragedy of teenage addiction. Joseph was inspired to create a locking prescription bottle that would help keep prescription medications away from unintended consumers, such as experimental teens and curious toddlers.

Joseph Simpson and fellow inventor Nathan Langley went through seven generations of prototypes to develop the Safer Lock.

Gatekeeper Innovation

Safer Lock is manufactured by California-based Gatekeeper Innovation, Inc. Gatekeeper Innovation, Inc. provides portable containers for securing prescription medications. It offers Safer Lock, a medicine bottle cap lock designed to prevent unauthorized access to prescription medication primarily from children and teens. The company provides single unit packing and pack case locking caps; single unit and pack case safer lockers; safer lockers for bottles; and medium and large replacement adapters. It offers its products online. The company is based in Sacramento, California.

The Gatekeeper team is lead by Kim Box, President and COO. Box previously served as Vice President at Hewlett-Packard, leading the global organization of over 10,000 HP employees and 5,000 contractors in more than 100 locations. Box has over 29 years experience in the high-tech industry.

References

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