Micro barcoded pill and identification/medical information retrieval system

[0002] The present invention relates to a pill on which is applied a micro barcode containing identification and/or medical information concerning the pill. Such identification and/or medical information is scanned and then either enunciated or displayed to a medical or health care professional handling the pill or to a patient planning to digest the pill.

[0003] Generic drugs in pill form become more common every day. The pills are in a variety of shapes and colors. Indeed, pills of one manufacturer containing one type of medication may have a confusingly similar color and shape of another containing a different medication. A mix-up between pills containing different medications is potentially dangerous for the patient relying on receiving the correct medication.

[0004] Standardizing the color and shape of every kind of pill containing the same medication may be one answer to resolving the mix-up problem, but is not commercially viable in a freely competitive marketplace, where pill manufacturers seek proprietary rights in the trade dress of their pills. Indeed, such a practice may do a disservice to the public, who may come to rely on the quality of pills from a particular manufacturer but, under standardization of shape and color, has no way of knowing whether the pill itself actually originated from that manufacturer or was substituted by a generic copy. So called tamperproof bottles help curtail unauthorized substitution of medication, but they are not completely reliable.

[0005] Even if the tamperproof bottles were to effectively prevent unauthorized pill substitution, a patient taking multiple medications, especially if the person is visually impaired or has trouble thinking clearly, may mix up the different medications and thereby take one type of medication at the wrong time. For instance, an elderly patient taking heart medicine may be trying to follow a prescribed treatment by taking various doses of medication throughout the day. Mixing one type of medication for another could prove fatal (e.g., a prescription could be: take exactly five tablets of pill X every 3 hours and take exactly two tablets of pill Y every 5 hours. Mistaking X for Y and vice versa could be disastrous).

[0006] Another problem is potency. Medication may lose its potency over time or when exposed to the elements such as sunlight. A patient may not be aware that the potency of a pill being taken is no longer viable, due to a long-shelf life in the store or in the home.

[0007] Pharmacists and other health care personnel responsible for providing the patient with medication will continue to find it increasingly difficult to distinguish one type of pill from another as pills of different sources appear similar in shape and color. Other than relying on what is printed on the bottle containing the pills, there is no way to verify that a pill's potency expiration date has not already expired, absent independent testing. With medication passing through many different distributors before reaching the patient, the unscrupulous practice of fraudulent switching of new medication for old may become increasingly the norm. Such switching may become particularly hazardous, not only because pills with diminished potency are unknowingly being taken by patients, but also if the unscrupulous merchant doing the switching mixes up one type of medication for another because of their similar shape and color.

[0008] In addition, health care professionals, such as nurses in hospitals, may be responsible each day for distributing medication to patients under their care. For convenience, they may sort the medication for the entire day as one of their first tasks in the morning. This task may be assigned to one or a few nurses on the floor to free the other nurses for other duties. If a mistake is made in sorting the medication, the mistake may not be noticed unless the nurse distributing the medication realizes upon close scrutiny that the medication is wrong. The potential for human error, therefore, is ever present.

[0009] It would therefore be desirable to provide a system to identify each individual pill before it is taken by a user as to its source, the type of medication it contains and the potency expiration date and thereby safeguard against unauthorized switching of medication or the taking of medication whose potency has lapsed.

[0010] Standard barcode typically found on packaging is too large to be imprinted on pills. It is therefore not feasible to use this technology in connection with labeling individual pills.

[0011] One aspect of the invention relates to a pill on which is applied a non-toxic, pharmaceutically inert (to the contents of the pill) label in micro barcode form. The micro barcode is coded with a pattern that, when read, is interpreted as identification and/or medical information pertaining to the pill. The identification may include information concerning the type of medication contained in the pill, the manufacturer or source identification such as the distributor and country of origin, and production lot number. The medical information may include information concerning frequency and quantity of dosages for different kinds of treatments, medically related warnings concerning the medication, and the potency expiration date.

[0012] Another aspect of the invention relates to a scanner of micro barcode that preferably is equipped with a computer program that indicates the information contained in the micro barcode to the patient or other viewer of the information. Preferably, the computer program has an internal clock and is programmed to keep track of when medications should be taken and the proper dosages.

[0013] A micro barcode is about one-tenth the size of a standard barcode. The micro barcode was developed by Neorex, which is a Nagoya, Japan-based company. The scanner for reading the micro barcode has a specially developed lens that reads the micro barcode even if the lines are blurred.

[0014] Since the pill is digested, the micro barcode applied to a pill should be made from a non-toxic material (at least for the sake of good public relations), even though only trace amounts would be swallowed. Further, the micro barcode material should be pharmaceutically inert with respect to the active ingredients of the pill itself to avoid interfering with the administration of the proper dosage of medication. Some pills commercially available are imprinted with the tradename; the same type of printing dye may be used to form the micro barcode.

[0015] After imprinting the micro barcode on the pill, the pill may be coated with a transparent film to protect the micro barcode from smudging during handling. However, such coating may be dispensed with because the handling, if any, will be minimal and because the barcode reader can tolerate some blurriness in the micro barcode and still take an accurate reading.

[0016] A patient seeking to identify a pill before swallowing it, would simply place it in the scanner and allow the scanner to read the micro barcode; the scanner is connected to a system that indicates to the user in an understandable manner the information encoded in the micro barcode. This may be done by enunciating or displaying the identification information. Medical information, such as that pertaining to proper dosage amount and frequency of taking the medication, may be accessed in a like manner from data bases and then enunciated or displayed as well. The technique for enunciating or displaying the information may be done in the same manner as is done conventionally with respect to standard barcode reading.

[0017] To make an analysis, the micro barcode as read is compared with codes stored in memory to find a match. Information corresponding to the matched code may then be retrieved for display, enunciation or some other form of processing. To minimize the amount of memory required, the invention may access other data bases already containing the same information and employ the same codes. For instance, the pharmacist may already have a data base containing inventory information of medications, each being assigned a corresponding inventory code number. It then becomes a simple matter for the micro barcode to be matched up with the inventory code number to retrieve the associated information. Alternatively, a central data base may be created and accessed over phone lines that contains all the necessary information to be retrieved based on the micro barcode.

[0018] Preferably, the patient's scanner has a programmable computer with memory and is programmed with the recommended treatment schedule for medication; the program thus has an internal clock. The scanner may signal or indicate (such as by sounding an alarm) at the time when a dosage of medication should be taken. Further, it may keep track of when the medication is presumably taken, i.e., at about the time the patient places the pill within the scanner for analysis prior to digesting it. The analysis may be printed out in a conventional manner. The time during which the analysis is made also represents the approximate time the pill, if it passes the analysis as acceptable, will be swallowed.

[0019] In addition, a conveyor may be provided to convey in succession the pills individually to the scanner. The pills are then conveyed away from the scanner after analysis and sorted in dependence upon what was read by the scanner. For instance, the pills may be sorted by expiration date or by type of medication.

[0020] No system is failsafe. Even with the system of the present invention in place, an unscrupulous merchant could go through the trouble of removing the micro barcode and replacing it with a new one. However, it seems that the added layer of security afforded by imprinting a micro barcode on the medication renders its removal and replacement highly unlikely to be cost-effective. Removing the micro barcode is not a simple matter; washing or etching the barcode off may destroy the integrity of the outer coating of the medication as well. Further, criminal laws could be passed making the mere possession of a micro barcode imprinting device a crime by those involved in the medication distribution network, not unlike the criminal laws against possessing counterfeit currency equipment.

[0021] Nevertheless, if such tampering becomes widespread, the medication manufacturer could incorporate into the micro barcode a validity code that is difficult to reproduce. The validity code must be detected by the scanner before it will indicate to the patient that taking the medication is safe. For instance, the validity code may become visible to the scanner for reading only when exposed to ultraviolet light.

[0022] By referring to pills in the present application, it is intended to encompass tablets, capsules and any other orally administered form of medication in solid form.