Welcome to the iPill Dispenser a solution for opioids public policy

A digital health - Hardware Innovation to improve prescription adherence and safety by reducing opioid diversion and abuse

Get in Touch

Supporters

Ricky Russert has graciously allowed his short film SLLiP about opioid addiction to be placed here. He hopes that we can all gather together as friends to support prevention of opioid addiction. https://www.youtube.com/watch?v=dWobm0Ze-BM&t=2s

Steve Melen " I’d say that if I had a device like the ipill dispenser, I would have completely avoided the downward spiral that took place after leaving the hospital. Giving most people opiates for many days, then sending them free allowing to open a bottle of pills at their will is a recipe for a high probability for abuse. Innocent and well intentioned people who’ve never had a problem with pills before can easily fall to this. I would have saved a lot of heartache and pain having this device."

My website has the book that can be ordered along with a gallery of photos that some make enjoy. Also attached amazon link.

https://stevemelen.com/

https://www.healthcentral.com/article/fighting-opioid-dependency-stomach-cancer

https://www.amazon.com/Killer-Graces-power-breakthrough-living/dp/1735165719/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=&sr=

Security - Treat Underlying Causes

Secure storage of opioids

Control dispensing to only the person prescribed the opioids

Control dispensing so opioids can be accessed only as prescribed

Destruction of contained pills upon tampering

To reduce diversion

Safety - Harm Reduction

Security - Treat Underlying Causes

Patient prescribed cannot take more than prescribed

Only registered user can access pills from the iPill Dispenser, at the prescribed dose.

Destroys unused opioids to reduce to other patients, family, or friends
To reduce the 3.3 Billion unused opioids entering our communities every year

Serenity - Safely Treat Pain

Security - Treat Underlying Causes

Serenity - Safely Treat Pain

Knowledge you can take opioids safely and securely

A wellness app to offer alternatives to opioids
An anitanxity and anti-depression app support mental health

The Opioid Crisis

135 people die each day from an opioid overdose (2017 FDA)

1 in 5 people know someone who abuse drugs. We can prevent someone you know from dying of an opioid overdose
770,000 people have died of an opioid overdose since 1999
There are more donor hearts available because of opioid overdoses
The impact to the US economy is $635 Billion dollars per year in healthcare costs and loss of workers productivity

90% of opioid drugs are orally abused

135 people die each day from an opioid overdose (2017 FDA)

Getting a bottle of pills is like getting a handful of pills. Nothing prevents 1 pill or 10 pills from being taken
The Child-resistant cap was invented for child in 1967 by Dr. Herni Breault
Pain management, not elimination of opioids, will save lives
Passive Control like REMS, PMDP monitor pills don't work
Limit opioids and abusers will mov

Getting a bottle of pills is like getting a handful of pills. Nothing prevents 1 pill or 10 pills from being taken
The Child-resistant cap was invented for child in 1967 by Dr. Herni Breault
Pain management, not elimination of opioids, will save lives
Passive Control like REMS, PMDP monitor pills don't work
Limit opioids and abusers will move onto the next drug. 67% of opioid overdoses involve a "cocktail" of drugs

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The iPill App + iPill Dispenser

135 people die each day from an opioid overdose (2017 FDA)

The iPill App + iPill Dispenser

What it does:

Promotes safe pain management
Enforces prescription adherence
Prevents diversion
Safely stores unused opioids
Detects respiratory depression (and alerts emergency services)

Features:

2 point Biometric Authentication

(Class II Product)

BlockChain transaction records
EMR compatibility
Remote physician control
DeNovo Class 2 FDA approval pending

Problem

The DEA and FDA consider the end user of opioids to be the pharmacy. In hospitals and pharmacies opioids are triple locked in a secure location. Patients receive prescription opioid medications in unsecured bottles.

What prevents them from abusing their prescriptions? 73% of teens cite ease of access in family medicine cabinets as their reason for abusing prescription drugs. https://drugfree.org/wp-content/uploads/2014/07/PATS-2013-FULL-REPORT.pdf

ABSOLUTELY NOTHING.

The opioid crisis is 20 years old. Why isn't it getting better?

Fewer prescriptions are written but the overdose death rate continues to rise. We need to change what has been done because it is not working. We don't need to follow what has been done because it has failed. We need a new mindset and an innovation. The iPill is ready to change the future.

In 2 years, we've had traction:

*The iPill was one of eight company chosen by the FDA in the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm#background

* The FDA is focused on secure storage and safe disposal solutions

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm582954.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632067.htm

* The iPill was a winner of the 2018 FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm#background

* We won the 2018 UCLA Opioid Hack-A-Thon

https://predictiontechnology.ucla.edu/events/the-opioid-hackathon-2018/

* The FDA designated iPill as a “breakthrough” medical device for a Class II submission.

* 3 granted patent. USPTO no. 10,426,707, 10588824, 10709643

* November 21, 2019

We were chosen as a winner of the 2019 Hartford Insurtech Hub competition where we will build a financial reimbursement model and apply for a HHS HCPCS/CPT code to make the iPill a reimbursable medical device.

https://www.insurancejournal.com/news/east/2019/11/15/548572.htm

* June 16, 2020

iPill named a winner of the 2020 American College of Cardiology Digital Health Innovation Award in association with AngelMD

* June 25, 2020

iPill receives its first purchase order from a Connecticut Addiction Rehab Treatment center pill dispensers opioids public policy automatic pill dispenser

* September 9, 2020

iPill receives a second purchase order from a behavioral treatment center in 3 different states.

Find out more

Solution

In the hospital, opioids are stored under lock and key and dispensed by trained healthcare providers. Patients who receive opioids at the hospital are closely monitored for side effects. There is no similar regulation or monitoring at a patient's home. Patient safety should be equal from the hospital to the home. The relapse rate has been reported to be 91% in transition from inpatient to outpatient therapy. The study also found that at least 59% of those who had an opiate relapse would do so within the first week of sobriety, and 80% would relapse within a month after discharging from a detox program/

2. Smyth, B. P., Barry, J., Keenan, E. & Ducray, K. (2010). Lapse and relapse following inpatient treatment of opiate dependence. Irish Medical Journal. 103(6),176–179.

The iPill App and iPill Dispenser provides a solution:

To enforce prescription adherence to prevent overconsumption
To reduce diversion of by using fast 2-point biometric authentication
To provide a safe tamper-resistant storage solution
To provide safe disposal of unused pills

If you are interested, please contact us.

Fact Check

Attitudes on youth addiction

https://www.centeronaddiction.org/addiction-research/reports/teen-insights-drugs-alcohol-and-nicotine-national-survey-adolescent

Opioid Overdose deaths by type of opioid

https://www.kff.org/other/state-indicator/opioid-overdose-deaths-by-type-of-opioid/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

Drug and Opioid-Involved Overdose Deaths — United States, 2013–2017

https://www.cdc.gov/mmwr/volumes/67/wr/mm675152e1.htm?s_cid=mm675152e1_w

1,313,958 patients over study period of 2002 to 2011 and 9,458 patients died of a postop OD.

11,313,958 total patients divided by 9 years divided by 9,458 OD Patients = patient and this represents 20% of US admissions so 132 patients divided by 20% = 664 patients.

https://www.ncbi.nlm.nih.gov/pubmed/28267693

NCBI

Ann Surg. 2017 Apr;265(4):702-708. doi: 10.1097/SLA.0000000000001945.

Predictors of In-hospital Postoperative Opioid Overdose After Major Elective Operations: A Nationally Representative Cohort Study.

Cauley CE1, Anderson G, Haynes AB, Menendez M, Bateman BT, Ladha K.

The death rate may actually be underestimated because as people overdose they aspirated on their own vomit. County coroners did not have the right CPT codes to classify death due to aspiration pneumonia secondary to opioids.

https://www.dea.gov/sites/default/files/2018-11/DIR-032-18%202018%20NDTA%20final%20low%20resolution.pdf

https://www.ajmc.com/newsroom/opioidrelated-deaths-underestimated-because-of-incomplete-reporting-study-says

Pitt study_ 70K opioid overdose deaths went unreported on death certificates _ TribLIVE.pdf

https://www.upmc.com/media/news/062718-buchanich-death-certs

The Effect of Incomplete Death Certificates on Estimates of Unintentional Opioid-Related Overdose Deaths in the United States, 1999-2015 - Jeanine M. Buchanich, Lauren C. Balmert, Karl E. Williams, Donald S. Burke, 2018.pdf

https://journals.sagepub.com/doi/10.1177/0033354918774330

The Number of Opioid Overdose Deaths May Be Underestimated

https://www.ajmc.com/newsroom/opioidrelated-deaths-underestimated-because-of-incomplete-reporting-study-says

Undercount Seen in Opioid Deaths _ Medpage Today

https://www.medpagetoday.com/neurology/opioids/73735

Most people use a cocktail of drugs

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5769014/

https://www.doh.wa.gov/Portals/1/Documents/2300/2017/AnnalsInternalMed.pdf

https://www.newsweek.com/study-finds-less-2-percent-overdose-victims-prescriptions-opioids-1467035

Prescription drug use is a risk factor for Heroin use

https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroin-abuse/prescription-opioid-use-risk-factor-heroin-use

90% with a substance abuse problem began as youth with prescription opioids