Packaging is taking on a more prominent role in protecting opioids from abuse, misuse and theft, with innovative designs leading the way. One of these uses biometric (fingerprint) authorization to ensure that patients—and only patients—receive their prescribed doses of liquid opioid medications.
The tamperproof SmartBottle from Swiss-based Ethimedix, which holds up to one liter of medication in an internal cartridge, functions as a smart dispensing system. Prescriptions and the fingerprints of authorized users are programmed into the device’s chip to enable controlled access to the medication. If an unauthorized user tries to tamper with or force-dispense medication from the SmartBottle, the device immediately neutralizes the opioid.
Bicêtre Hospital in Paris has been testing the SmartBottle for more than 18 months. The device has not yet been approved for use in the United States.
Leila Smith, scientific and business consultant at Ethimedix, and Isabelle Nègre, M.D., anesthesiologist at Bicêtre Hospital and head of the Pain Relief Commission for Hôpitaux Universitaires Paris Sud, jointly answer Packaging Digest’s questions about the SmartBottle.
Is fingerprint authentication by both a recognized healthcare provider and a patient required to dispense a dose from the SmartBottle?
Smith: Yes and no. The patient’s fingerprints are absolutely and always required for dispensing each dose. In both situations—outpatient and hospital bedside—it is by swiping the patient’s finger over the detector that the patient receives his/her dose according to the prescription embedded on the device’s chip. For that, no healthcare provider or family member is required.
Additionally, if the patient is allowed an occasional “bolus” dose (that is, an extra pain-relief dose), it is with the extra swipe by either a healthcare provider or a family member, whose fingerprints are also captured on the device, that the patient can receive these additional doses, always according to the doctor’s prescription. This is a built-in way to ensure that the patient is able to receive this extra dose without risks, and that it doesn’t constitute an abuse or misuse, which can lead to addiction or additional health problems.
We also have a purely hospital (we call it Team) version. The healthcare providers within a ward who are authorized to give pain relief to their ward patients can safely leave their SmartBottle on the cart as they do their rounds, and swipe their own fingerprints to dispense a dose for their patients; they log the information, which allows for traceability and of course total safety, as the opioid cannot be stolen. The SmartBottle acts as a lockbox.
Having the pain medication at the healthcare providers’ fingertips allows them to provide relief to their patients in real time, without delay.
How is the SmartBottle used at Bicêtre Hospital?
Nègre: The pharmacy department of the hospital currently compounds the drug directly on-site by diluting an existing morphine solution, adding some preservative and dispensing it into the SmartBottle. The pharmacist locks the device, and it is then ready for use by any of our three wards: neurosurgery, orthopedic surgery and urology. Because we can have multiple fingerprints recorded onto one device, we can have multiple healthcare providers who can use it on a single ward. The device allows a decrease in pill/tablet inventory, which is safer and saves time.
Do healthcare providers and/or patients need much training or instruction to use the SmartBottle? Are there any instructions on the device?
Smith: The device itself is easy to use. Healthcare providers and patients need very little training, and we provide a manual that stays with the SmartBottle. Provided the users have detectable fingerprints, no reading or writing is required. The work of setting up the SmartBottle is in the hands of the pharmacist, who also enters the prescription in the SmartBottle’s processor—its brain—as well as the duration, possible bolus doses and fingerprints.
The pharmacy is responsible for tracking the use of liquid opioids and can download the usage log of the patient after the SmartBottle is returned. However, we have dedicated software and a user interface that simplify the pharmacist’s task of uploading all the information related to the opioid, including lot, shelf life, quantity, concentration, prescription, duration, patient—or healthcare provider—information and fingerprints.
How does the SmartBottle provide opioid traceability and trackability?
Smith: The pharmacy is responsible for entering and tracking the concentration, amount and lot number of the opioid used—just as it is for tracking dispensing of tablets and pills—before locking the device, and is also responsible for destroying the remaining solution upon return. The device keeps a log of all its uses, and users, which can be downloaded and exported, as needed. Both the software and the SmartBottle are password protected and have two levels of verification.
What is Bicêtre Hospital’s procedure for tracking opioids packaged in the SmartBottle? Is theft by staff members an issue?
Nègre: Unlike the United States, we do not currently have a crisis of similar proportions, and theft by healthcare providers is not considered to be a significant risk. However, the opioid is measured and tracked through a log book that indicates patient name, time and volume of delivery dose; it needs to match the SmartBottle’s own log and can be audited by the pharmacy before and after use.
Every morning, the healthcare-provider manager is asked to verify the concordance between administered doses to patients reported in the manual log book and the amount of delivered doses recorded by the SmartBottle.
Once tampered with, the SmartBottle no longer dispenses, and the ensuing neutralized solution cannot be used. It is discarded by the pharmacy—the only department that can open the SmartBottle and handle the opioid.
What are Ethimedix’s plans for bringing the SmartBottle to the United States?
Smith: It is a difficult question to answer precisely at this time, as we are proceeding step by step. We plan on working with the Food and Drug Administration (FDA) to find the fastest path for authorization to market in the USA.
Next steps include doing a real live test in the United States, and we have been approached by a few large medical centers that are interested in trying it with their outpatients who need pain relief and are currently managing it through pills/tablets—or for inpatients who are autonomous enough to manage their pain relief at their hospital bedside, and who do not need an IV.
Will Ethimedix be partnering with an approved prescription-drug manufacturer to run usability trials in the United States?
Smith: We are in discussions with potential vendors; trials could start before we have a final ready-made solution, provided that the hospital’s pharmacy has the ability to compound the opioid at the right concentration for our SmartBottle specifications.
Are liquid opioids commonly prescribed in the United States? If not, will this be a barrier to entry for the SmartBottle in this country?
Smith: In some situations, in pain-management centers or addiction-treatment centers, doctors and healthcare providers already provide methadone in liquid form. Concentrated drops of morphine can also be prescribed (Tramadol). However, it does constitute a change in practice for many doctors and patients who have become accustomed to prescribing and taking pills and/or tablets.
The advantage offered by using this liquid form of opioid through our device is that you can neutralize it instantly (as the neutralizing agent is immediately discharged into the solution) if anyone tries to tamper with the SmartBottle—something that is not feasible with pills or tablets.
This is a huge benefit to the entire community surrounding a patient needing pain relief: Our SmartBottle provides a dose to the patient only at allowed time intervals, and only for the duration prescribed. The drug cannot be accessed otherwise, so it protects both the patient and family/friends from possible misuse, over-use, abuse and theft. When a patient goes home with his or her prescription of pills/tablets, these can easily be taken in excess (accidentally or not) or taken by the wrong person.
If we look at the FDA’s own estimate on the number of deaths by overdose, we could potentially save more than 17,000 lives per year with our abuse-deterrent device. This is why we feel it is important to accelerate our presence in North America and provide relief from the current crisis.
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