This series spotlights CSA members and, in this case, highlights entrepreneurial members. Dr. John Hsu is an anesthesiologist and pain management specialist who has practiced for 28 years. He is also the CEO of iPill Dispenser. Dr. Agarwal was intrigued by the concept of this potentially important advance in the safer use of opioids at home and thought that other CSA members might also be interested. This is not an endorsement by the CSA of this product. If you are an entrepreneur and CSA member, or know of someone whose work might be of interest to CSA members, please contact email@example.com.
RA: What lead to your concern regarding opioid use?
JH: Opioids have been around for thousands of years. There are 8,000 year old Sumerian clay-tablets which represent the earliest known prescriptions of opium. Ancient Greeks, Indians, Chinese, Egyptians, Romans, Arabs, people in the middle ages, Europeans from the Renaissance to the present, used opium and its derivatives as a panacea for many maladies. References in the Bible and ancient Greek text, as well as by famous persons such as Homer, Franklin, Napoleon, Coleridge, Poe, Shelly, and Quincy, have made its use appear more acceptable. Wounded soldiers from many wars have benefited from its use. However, by the 1830s one third of all lethal poisoning was due to opium.
In more recent events, including increased attention to pain management, the addition of pain as the “fifth vital sign,” and unscrupulous pharmaceutical companies marketing, have accelerated opioid use and misuse to the current opioid epidemic.
RA: What do you think the scope of the problem is?
JH: Opioids will always have a role in medicine. There is currently nothing better to treat acute pain as effectively and quickly as an opioid. There are short term side effects which are often treatable or resolve when opioids are stopped. Long term opioid side effects are dependency, misuse, and addiction are unfortunately, much more difficult, and expensive to treat. Addiction treatment can include Suboxone or methadone, plus inpatient treatment, or intensive outpatient therapy, all of which can add up to thousands of dollars a month. Each death is associated with 119 ER visits and 22 hospitalizations equivalent to $1.8 million.
Chronic opioid use can lead to dependency, misuse, addiction, accidental overdoses, and death or at least a lifetime of addiction treatment.
Hospitals, doctors, dentists, and pharmacies triple lock their opioids securely in DEA approved locations. Ironically, they are then given to patients who take them home where they are often freely accessible to anyone. According to a review of several studies, 42-71 percent of postop opioids go unused and it has been estimated that there may be 3.3 billion unused opioids entering our cities every year. 1 in 4 overdoses now involves children. A very telling study found that at Boston Medical Center only 1.3% of overdose victims had an opioid prescription .
Opioid misuse has occurred for centuries, however only in the past 20 years has the opioid overdose and death rate increase so dramatically.
RA: Are there other approaches to opioid misuse?
JH: Families and patients can be counseled to return their opioids. Voluntary return programs of opioids often don’t work because many pharmacies, physicians, and other health care providers don’t tell patients how to properly dispose of unused opioids. In addition, studies show that take-back events and permanent drug donation boxes for opioid return constituted a miniscule proportion of the number of prescriptions dispensed.
RA: I thought the FDA and DEA had other guidelines for safe disposal of opioids?
JH: There are Federal guidelines from the DEA, EPA, and FDA for disposal of household medications. While securely returning the medications to an authorized take back location is the preferred method, in situations where residents have no access to such a program the FDA and DEA recommend flushing opioids in the toilet. This of course, leads to the ocean contamination of Oysters in Chesapeake Bay and mussels in Puget Sound.
Early studies with various approaches to safe disposal have had mixed results, but will probably require a combination of education, easy to access disposal techniques, and reminder messages. Most however will simply save opioids for future use. Greater than 60 percent of Americans have unused opioids in their homes.
RA: What inspired you to create the iPill Dispenser?
JH: The DEA considers the pharmacy to be the end-user of opioids. All of our litigation, regulations, and guidelines for prescribing are directed upstream. There are no rules between the pharmacy and the patient.
Current attempts to resolve the problem are treatment based. Regulatory agencies (CURES) have limited prescriptions, limited pill volumes, created abuse deterrent formulations, and created slow release long-acting opioids, and none of these changes have had the expected results. Narcan can be used to treat patients who have intentionally or accidentally taken excessive doses. Suboxone, Methadone, and Naltrexone, may all be used to treat patients who have a confirmed opioid use disorder diagnosis and are seeking help.
There is an increased urgency in addressing these issues since the COVID-19 pandemic, as social distancing and quarantining has led to an increase in mental health issues, decrease in-person health care visits, and a subsequent rise in opioid use, misuse, and overdose deaths.
We wondered if a more effective solution may lie in technology where mental health treatment and active controlled dispensing could be used together. This is a new frontier: mental health treated and supported with telemedicine and mobile apps on smart phones. The results seem promising as mHealth and PearTherapeutics have recently obtained FDA approval as digital health platforms to treat opioid use disorder.
The second frontier: opioid dispensing under active control – also using smart phones. The goal was to create a system that ensured only the person prescribed the medication could access it, and that only the prescribed dose could be accessed. The dispenser would securely store the opioids so that they could not be diverted, and ideally, unused opioids would be destroyed so that they would not be sitting in a medicine cabinet.
Three devices are currently under development: MedicaSafe, TAD, and iPill dispenser. All three embed the prescription electronically into their circuit boards and only allow dispensing as indicated by the prescription schedule, but only the iPill uses 2-point biometrics, a DEA approved solution to destroy contained pills if the device is tampered with, and to safely dispose of unused pills at the end of 90 days. iPill also features the combination of mental health support and active controlled dispensing to combat opioid use disorder. Patients must use their own smartphone to dispense opioids from the secure dispenser. Clinical studies are currently being done with all three devices.
RA: Can you describe how the other two devices work?
JH: All the devices embed the prescription electronically into their circuit boards and only allow opioid dispensing as indicated by the prescription schedule. MedicaSafe and TAD allow patients to fill their own devices which while convenient, introduces an inherent risk for opioid diversion.
RA: Thank you for sharing your thoughts with us, any last words?
JH: Opioid abuse and addiction must be addressed from the perspective of patients, pills, and the human factor. After all, it is individual people who decide to take pills and if they take too many, and without proper medical supervision, the result is all too often tragic. Hopefully technology can make opioid use safer and more effective.
John Hsu, MD, has practiced anesthesia and pain management for 28 years. Combining his knowledge of anesthesia, software and hardware, his latest innovation is using remote monitoring technology to ensure opioid prescription adherence to reduce opioid abuse and diversion. His company, iPill dispenser has three granted patents to fight the opioid epidemic and is FDA registered. His other company, Quivivepharma is concerned with drug development. It is combining oral opioids with an oral respiratory stimulant to counteract opioid induced respiratory respiratory depression. It is fast-tracked by the FDA and has two granted patents. He is devoted to making a social impact with projects that can save lives, improve healthcare, and reduce medical expenses.