A team at Yale University has discovered a method for patients to self-administer oral opioid medication in a way that decreases consumption and depletes reserves in the community, thus slowing the epidemic.

Annually, 100 million surgeries take place in the United States. With most requiring postoperative pain medication, there are presently three main modalities available to the patient:

  1. Patient-controlled intravenous analgesia is invasive and eventually requires a transition to oral medication.
  2. Oral opioid pills are most common but can have obstacles due to workforce shortages and diversion.
  3. Oral pill dispensers have not yet gained traction due to issues with diversion.

It is a known fact that patient-controlled analgesia (PCA) offers better pain control with a lower-dose opioid requirement, but this type of medication is currently only available in the intravenous format. The pain management market has recently focused on self-administration of oral medication, but with most available in the pill form, leftover opioid pills in the community present an ongoing public health concern. In 2020 alone, 142 million opioid prescriptions were dispensed and over half were misused (asamonitor.pub/3M9ZDB8). For the past two years, the Yale team has been working on a solution to this problem.

Jinlei Li, MD, PhD, FASA, Associate Professor of Anesthesiology at Yale University and Director of Regional Anesthesia at Yale New Haven Hospital, noticed an issue while treating a postoperative patient in early 2022. She observed her patient struggling with poor pain control, as medications were not received on time, and sometimes not administered at the right dose, which could lead to side effects. This patient fell into a gap between someone with severe pain who qualified for an I.V. PCA and one who had manageable pain, and required pills on a frequent as-needed schedule. Following her assessment, Dr. Li wondered if there was a way to administer PCA opioids to the patient in the oral form. She then realized other patients could benefit from this, but there was no option available. After brainstorming more, Dr. Li set off to find a better way for patients to self-administer their pain medications. She next engaged the help of an OR colleague, Dr. Daniel Wiznia, Assistant Professor of Orthopaedics and Rehabilitation at Yale University and Director of Technology and Innovation. Dr. Wiznia also recognized the problem and confirmed the benefits of a liquid form of medication. This would not only allow for customized dosages versus taking a pill but also stronger control and oversight to help control diversion.

Additionally, the infrastructure was already in place to support liquid medication, given the number of medications already available in liquid formula. The team didn’t need to recreate the wheel by building out liquid oral pain medicine at the pharmacy and distributing it. In spring 2022, the two built prototypes and proof-of-concepts in the lab to demonstrate that it would work. A new hypothesis was born – the Patient-Controlled Dispenser and Deactivator (PCDD).

The PCDD allows patients to self-administer liquid oral pain medication, and the device destroys leftovers when the patient completes the treatment. It has inherent safety features to minimize overdose, limit diversion, and decrease nursing workload. The PCDD relies on the PCA pump to work, so the “brains” of the device are already in place with the PCA programming. Physicians and nurses are already familiar with how it works.

However, PCA pumps are designed to administer medicine in many nonoral routes such as intravenously, intrathecally, epidurally, or subcutaneously, but not orally yet, so the team specifically designed the PCDD as an accessory to couple with the PCA pump.

Dr. Wiznia and Dr. Li explained in detail how the PCDD operates. After surgery, the patient must be fully awake and oriented, able to eat, drink, and take oral solution. Once the PCA pump is customized with a dose specifically for that patient, the patient requests a dose from the PCDD pump by pressing a button. The pump will then distribute the dose into a secured medication cup, with limits, and the patient can receive the medication from the cup after entering a personal ID to open the valve. The patient is then able to drink the medication, and any leftover medication gets destroyed in a waste reservoir through the press of a button via activated charcoal at a timing determined by the patient. The benefits of the PCDD’s liquid format over pills include easier dose adjustment, lower risk of overdose, and safe disposal of waste to mitigate the risks of opioid diversion.

The PCDD is unique to other devices that deliver patient-controlled opioids, such as the traditional patient-controlled intravenous analgesia pump and oral pills, due to the attributes described below.

This allows for small doses to be administered at more frequent intervals for better therapeutic effects, resulting in fewer side effects and less risk of overdose.

The suction apparatus has dual safety requirements, which is safer than a traditional I.V. PCA, minimizing overdose potential, and only the specifically designed straw can interface with the medicine cup via a special connector.

This corresponds with the administered dosage and has an overflow drain to remove excess medication.

It allows excess fluid to automatically flow out of the medicine cup into the waste reservoir. An activated charcoal solution deactivates the medicine and hardens it with a solidifier so it can be disposed of as regular trash.

A digital keypad requires the patient to enter identifying information before any medication is dispensed.

The medication reservoir is tamper-proof and secured to the PCA pump. Additionally, the PCA pump is password protected and physically locked with a key. The PCA pump is programmed to only release a certain dose or allotted amount.

Chips in the PCDD allow short-distance communication between the device and the electronic medical record via a secure server.

The target audience for the PCDD is perioperative patients who require frequent oral opioids administration in the hospital, and likely long inpatient hospital stays. Most surgical specialties for this need include orthopedics, trauma, general surgery, gastroenterology, urology, neurosurgery, oncology, OB/GYN, cardiac, and others. The first-generation PCDD design, which is being built with the help of a contract manufacturing partner, is part of phase one and will focus on use in hospitals and ambulatory surgery centers. Eventually, a home version will launch in coordination with pharmacies, rehab and chronic pain centers, and more. The PCDD will be sold by a company called REALIEF.

Although not tested on patients yet, many have been interviewed, including clinicians, nurses, and clinical pharmacists, and feedback is being incorporated into the prototypes. The goal is to have 30 units ready by the end of 2023 for clinical trials in hospitals. The second phase will include launching the PCDD for home use, in about five years, with remote control through electronic devices and an app that will be monitored from the patient’s cell phone. Given the concern with liability when pharmacies and health centers send a patient home with opioids, the PCDD will provide insight about where and how the medicine is being used. Since its inception, the PCDD has gained traction as an award-winning device. Current accolades include:

  • Fall 2022: Yale New Haven Health System award to build a hospital-focused PCDD.
  • Winter 2022: Won a Foundation for Anesthesia Education and Research Swimming with Sharks first-place pitch demonstrating international support from pain management experts.
  • Two provisional patents filed in June and October 2022, which resulted in a utility patent filing in May 2023.
  • 2023 Yale School of Management Donor-Funded Fuad El-Hibri Entrepreneurial summer award.
  • The Fuad El-Hibri ’82 Entrepreneurial Award from the Yale University School of Management.
  • The Yale Angels Award from Accelerate Yale.
  • Yale New Haven Health System will serve as a clinical trial partner.