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INNOVATIVE NEW JERSEY COMPANY PATENTS “TALKING PILLS” AS A SOLUTION TO THE OPIOID EPIDMIC

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The U.S. Patent & Trademark Office (USPTO) on May 30, 2017 issued a patent on a potential breakthrough solution to the opioid epidemic. The patent is for both a drug delivery and abuse deterrence device that will be submitted to the U.S. Food & Drug Administration (FDA) for marketing clearance.

The FDA is very experienced when it comes to intelligent pill technologies, but not until the newly patented “Smart Pill Drug Delivery Device” was presented to the agency did they see a solution with potential to solve primary challenges with opioids. The FDA wants “smart pill” technology for opiates to be produced and submitted so it can be efficiently reviewed through every relevant FDA division. To that end, the FDA, in a pre-IND / pre-IDE meeting, provided Pop Test (PT) Abuse Deterrent Technologies with a roadmap of guidances to get there.  www.SmartPillsSaveLives.com

The Smart Pill Drug Delivery Device prevents overdoses on prescription opioids. It also prevents the ability to counterfeit opioids.  Finally, it prevents the ability to divert pills from their prescribed user to others. The “Smart Pills” communicate with each other and they “talk” to the dispensing pharmacist and sometimes to law enforcement, too. The Smart Pills know the prescribed dosage for a patient, and if exceeded, the Smart Pills warn each other to not open their capsule to release medicinal contents, and this action thereby prevents an overdose.   [Read more…]

Substance Abuse in Rural America

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I have always lived in rural America, even when working in a city. I prefer rural areas because of their friendly folks with core values and the landscape—open fields, woods, and livestock, mainly beef cattle!

Since April 2016, I’ve had a part-time job commanding the Brown County, Ohio, drug and major crimes taskforce, which needed to be reenergized and expanded. I live just 15 minutes away and was eager to assist. For the past 2 years, Brown County (population: 45,000) has led Ohio in unintentional overdose deaths per capita. With Ohio appearing to lead the country in the number of these deaths, Brown County is a top contending overall leader in this tragedy. At first, I found this almost unbelievable, but then I began to receive almost daily texts regarding overdoses and related deaths in the county. Life squads and emergency medical technicians seem to be constantly busy trying to save individuals with naloxone, whether it be 1 dose or multiple doses. [Read more…]

Doctors and the Rx Scandal Circa 1966

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This past August, I was walking through the commercial building of the Ohio State Fair in Columbus, and a copy of an old Life magazine caught my eye. It showed multicolored pharmaceuticals all over the cover, with the silhouette of someone drinking from a glass in the background. The headline read, “Doctors and the Rx Scandal,” followed by “How some MDs short-cut ethics and profit from their own prescriptions.” The most surprising part to me was that the issue was dated June 24, 1966—50 years ago, and a year before I graduated from high school!

The article begins by saying that more than 10,500 doctors “are employing doubtfully ethical means of making extra money out of the prescriptions they write for their patients.” It goes on to say that the estimate of more than 10,500 doctors is very conservative and that the problem is growing among the 225,000 physicians nationwide. [Read more…]

Counterfeit Pharmaceutical Dangers

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Lately, the number of counterfeit prescription drugs seems to have exploded in the United States. These drugs are nothing new, but the seemingly large increase in schedule II opiate medications is new.

Many years ago, when erectile dysfunction (ED) drugs such as Viagra and Cialis hit the US market, big money was made on counterfeit versions of them, and big money was spent by legitimate manufacturers to try to stop the counterfeiting. The counterfeit drugs were typically made overseas in unsanitary conditions, and the packaging was produced in China.

The indicia on the pharmaceuticals and the packaging were extremely difficult to detect as counterfeit. I attended training with security personnel from legitimate manufacturers in which we were asked to identify counterfeit pills and packaging when they were presented next to legitimate products. The only reason we occasionally chose correctly is that we had a 50/50 chance! Counterfeit products could be identified only by laboratory analysis. [Read more…]

Reducing the Number of Pills for Diversion While Effectively Managing Acute Pain?

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By John Burke

A few months ago, I was contacted by a local Cincinnati oral surgeon asking if we could meet. He wanted to share his ideas and efforts for reducing the prescribing of opiates. Over the years, I have become skeptical of these kinds of calls, as the proposed ideas usually turn out to be impractical and, frankly, a waste of time. However, this surgeon had previously met with a pharmacist of whom I think very highly, so I consented.

I soon learned from the surgeon that his idea was a seemingly well-tested, acute pain protocol—one that could change the role and priority of opiates for acute pain. Furthermore, he had partnered with a local orthopedic surgeon with whom he plans on issuing 32,000-plus fewer opiate dosage units in 2016 versus 2015. (The 2 surgeons indicate that 13 months of ongoing clinical trials demonstrate they have an opiate prescription issuance rate that is 70% less than that of their peers.) In addition to the surgeons indicating superior multimodal pain control by emphasizing ibuprofen and acetaminophen, their PainPack Protocol educates every patient about proper opiate disposal. Their goal is to provide effective multimodal acute pain control, presented in a way that patients can follow, and to reduce diversion by leaving patients with far fewer opiates in their medicine cabinets! [Read more…]

How BIG is the problem?

Year after year, state and local law enforcement statistics indicate that pharmaceuticals are almost 30% of the overall drug problem in the United States, running a close second only marijuana abuse. However, until recently, law enforcement, health care professionals, and the general public have placed little emphasis on this huge problem.

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Pharmaceutical Diversion Education (PDE) is designed to assist a wide range of the population in understanding the potential abuse and addiction that can be associated with prescription medication.

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