Unit dose packaging means that one dose of a medication is packaged individually rather than contained together in a bottle for example. This form of packaging is common in hospitals that incorporate (externally affixed) barcoded medication administration systems. It is also used in common OTC-as-needed medications to allow the consumer to travel with a single dose rather than a bottle.
In this application of the technology, a machine-readable data label is incorporated into this unit dose packaging in such a way that it may only be scanned once the packaging has been opened. Blister packs and UDP have substantial advantages when incorporated with the present technology. It is not financially feasible to apply digital sensors to blister packs and unit dose packaging. While digital bottles and sensors can detect when a medication bottle was opened, QR code utilization produces the same data and similar end results at a fraction of the cost and is not limited exclusively to bottles.
In the UDP and blister pack application, another step in the medication taking process has been proven. In the medication bottle application, the patient must go to their bottle, open it, scan the QR code to mark a dose as taken. In the UDP and blister pack application, the patient still takes the previous steps, but now when they open the container, their exact dose is accessible and cannot be returned to the container. The end result is the patient having their exact prescribed dose on hand and documented.
Our technology provides a blister pack for unit-dose packaging. The blister pack has a front surface with a plurality of cavities in which individual doses of product are placed. The doses typically are tablets or capsules. The doses may be a single dose or multiple doses. A rear surface over which a lidding seal encloses the cavities. For each individual dose of product, a front-surface facing machine-readable code associated with the product is imprinted onto or affixed to the lidding seal in alignment with each individual dose of product. In this way, the machine-readable code is occluded until the lidding seal is opened to access the individual dose of product.
A machine-readable code encodes a common GUID associated with the product contained in all individual doses. For example, a GUID of c8b6ca6c-167b-4636-b534-3e33acbba5e9 is encoded into a QR-code that is displayed open opening each lidding seal of each cavity.
In another embodiment of the technology, the machine-readable code encodes unique GUIDs for each individual dose. This permits more precise tracking of dosages.
This is particularly useful if a bolus is given upon the start of a course of medication. Accordingly, the bolus makes the dosages asymmetrical and a unique GUID for the bolus dose allows patients and providers to track and confirm the correct order of dosing is followed. In yet another embodiment of the invention, an additional identifier is included with the common GUID, the additional identifier associated with each individual dose within the blister packet. The common GUID as a machine-readable code may be used only for registration of the medication and/or schedule of dosages before any individual cavity is opened. Then, the common GUID is combined or appended into encoded machine-readable codes associated with each dosage cavity. In a simple example, an incrementing integer may be appended to the common GUID effectively serializing the doses:
|Dose||GUID encoded into QR-Code|
Opioid Use Monitoring
In 2019, the FDA considered requiring fixed-quantity blister packaging for certain opioid pain medicines in order to decrease unnecessary exposure to opioids. In a study of patients with rheumatoid arthritis, it was found that screw on caps and blister packs were the easiest to open. Lisberg RB, Higham C, Jayson MI. Problems for rheumatic patients in opening dispensed drug containers. Br J Rheumatol. 1983 May;22(2):95-8. doi: 10.1093/rheumatology/22.2.95. PMID: 6850197. Because these are considered easy to open for the majority of patients, this packaging may be applied to all opioids. Utilizing the blister pack embodiment, each pill pouch has an associated QR code. In order to document a dose as taken, the patient must scan the interior QR code via the app. This helps them safely space out doses and raise red flags if doses are missing that have not been taken. Additionally, it may be required that opioids be kept in this original packaging to reduce the likelihood of abuse and accidental overdose. In the case of acute illness or surgery, the patient may be required to return unused opioids after a certain time period has passed, preventing them from saving them.