Patent Application
20130325727
1. Field
This application relates generally to the field of waste disposal systems, and in particular to a system for sorting controlled substances and other pharmaceutical waste for disposal.
2. Description of the Related Art
The Environmental Protection Agency (EPA) enforces the Resource Conservation & Recovery Act (RCRA) which was enacted in 1976 in order to control the disposal of harmful or hazardous waste materials. There are currently over 100,000 drugs commercially available in the United States, of which about 14,000 are considered hazardous by RCRA requirements. A typical medium size hospital utilizes thousands of different drugs in a year many of which are considered hazardous. The EPA is increasingly enforcing hospitals' compliance with the RCRA requirements because it has been shown in several studies that millions of pounds of pharmaceutical waste generated each year by hospitals and individuals is contributing to the pollution of groundwater and endocrine system damage in humans and other species. In addition, many organizations including Hospital for a Healthy Environment (H2E), Joint Council for Accreditation of Healthcare Organizations (JCAHO) and others are pressing hospitals to be more environmentally friendly. In view of these changes, hospitals are increasing efforts to audit or otherwise regulate their own compliance with the applicable laws and regulations. As a result, these hospitals are becoming more aware of the difficulty of sorting the numerous pharmaceutical waste streams that the EPA, Department of Transportation (DOT), Drug Enforcement Administration (DEA), some states agencies and/or other organizations require.
For example, millions of tons of medical waste are generated by hospitals, medical clinics and pharmaceutical manufacturers each year. As much as half of this waste is considered infectious. Until the late 1990s, when the EPA began to enforce tough environmental emission laws most of the infectious waste was treated in thousands of incinerators located throughout the country. This effort has resulted in a significant reduction in the number of incinerators throughout the U.S. Presently, much of the infectious waste generated in the U.S. is treated by alternative technologies such as autoclaves and chemical processors. There is very little choice for hospitals because of the upfront cost and large footprint of the processing equipment. Although many companies have offered different kinds of equipment, the prices vary from a few hundred thousand dollars for smaller units to a few million for large units. Because of the long cycling times to decontaminate the waste, the equipment typically is very large in order to provide acceptable throughput. There are also several companies that provide a service to hospitals by utilizing chemical processors mounted on trucks. They go to a facility and decontaminate the infectious waste, allowing the treated waste to be hauled to a local landfill. There are concerns that this technology may not completely treat the waste in all circumstances and the chemical residue left after processing may remain an ecological issue.
Increasingly, hospitals are required to comply with the recent and projected enforcement of federal and state hazardous pharmaceutical waste regulations. Currently, clinicians must manually sort pharmaceutical waste streams into different colored containers for proper disposal of the separate waste streams. It is often not clear to a clinician which pharmaceuticals or waste materials are hazardous simply by looking at the container. Such confusion may lead to clinicians throwing hazardous drugs in non-hazardous containers such as sharps containers, infectious waste bags, non-hazardous pharmaceutical containers or simply down the drain.
Further, some pharmaceuticals, which are referred to as controlled substances, are further regulated by other laws and standards, such as, for example, the Controlled Substances Act of 1970 (CSA). In general, the CSA and similar laws were passed to control the manufacturing, distribution, dispensing and other aspects related to the handling of controlled substances in the United States. As such, it establishes requirements that form a closed system for legitimate handlers of controlled substances to prevent the diversion of the drugs into illicit markets. Among other things, the CSA separates controlled substances into 5 different groups or Schedules. The second of these, Schedule II (CII), includes substances which have accepted medical uses in the U.S, but have a high potential of abuse. The substances listed in CII have special disposal requirements that are different from substances categorized in some of the other CSA schedules (e.g., Schedule III, IV or and V).
The Drug Enforcement Administration (DEA) is the Federal law enforcement agency responsible for enforcing the CSA. Substances listed in Schedules III, IV and V can be disposed of following the rules from CFR Titles 40 and 29. CII substances, however, require special handling. The CSA allows CII controlled substances to be disposed of in several ways. For example, CII substances can be destroyed in the presence of a DEA agent or some other authorized person. Alternatively, a DEA Special Agent in Charge can make a determination on a particular disposal method so as to ensure that the CII substances do not become available to unauthorized persons.
Destruction methods currently involve collecting the wasted CII substances at hospitals, pharmacies and other facilities where they are generated, and transferring them to DEA-registered incinerators for final destruction. In order to prevent unwanted diversion of the CII substances, such methods typically require detailed tracking and accounting of the wasted substances. In current practice the tracking and accounting of the wasted CII substances tends to be performed manually, making it tedious, inefficient and generally inaccurate.
Currently, in order to avoid the tedious tracking and accounting of wasted CII substances, the DEA has deemed disposing of CII substances into sewer lines to be one preferred disposal method for hospitals, pharmacies and/or other facilities. However, this method generally conflicts with the EPA's mission of reducing or preventing water pollution. For example, current water treatment facilities that treat wastewater are generally not equipped to remove or destroy CII substances. Certain states, such as California, also have laws that make it illegal for hospitals to dump such drugs into the sewer system. In the face of this conflict, an easier, more efficient and more accurate CII waste disposal method is needed to satisfy both drug enforcement and environmental protection laws and regulations.
According to some embodiments, a method for tracking a controlled substance before and after such controlled substance is administered to a patient comprises obtaining information regarding a controlled substance to be administered to a patient and a corresponding residual volume of the controlled substance. The residual volume of the controlled substance can comprise an amount of the controlled substance that is not administered to the patient and that is designated for disposal. The method additionally comprises obtaining information from a spent drug container configured to receive the residual volume of the controlled substance. In one embodiment, the spent drug container comprises a closure member to secure the residual volume of the controlled substrate within the spent drug container.
According to some embodiments, the method further comprises electronically accessing a database of a waste sorting system, wherein the database comprises waste item classification information. In some embodiments, the waste sorting system comprises a plurality of waste container compartments, each of the waste container compartments being configured to receive a removable waste container. In some embodiments, a movable lid is coupled to at least one removable waste container of the waste sorting system. In one embodiment, each of the removable waste containers is associated with at least one of a plurality of waste categories, wherein each of the movable lids is configured to be selectively moved between an open position and a closed position. In some embodiments, the movable lids are configured to selectively expose an opening in the corresponding removable waste containers when in an open position. In one embodiment, at least one of the removable waste containers of the waste sorting system is configured to receive controlled substances and/or any other regulated substance.
According to some embodiments, the method further comprises electronically assigning the spent drug container comprising the residual volume of the controlled substance to at least one waste category based at least in part on the obtained information and the waste item classification information and providing access to an interior of the removable waste container associated with said waste category to permit disposal of the spent drug container and the controlled substance positioned therein. In some embodiments, the method comprises prompting a user to enter information regarding the quantity of the residual controlled substance and comparing the quantity of the residual volume of the controlled substance within the spent drug container with a quantity of the controlled substance prior to administration to the patient and a quantity of the controlled substance intended to be administered to the patient, thereby tracking the controlled substance before and after administration to the patient.
According to several embodiments of the invention, a system and method to efficiently and effectively track and sort controlled substances (e.g., a narcotic or other CII substances) are provided. Drugs that can be accommodated according to several embodiments herein include, but are not limited to, opium, morphine, codeine, hydromorphone, methadone, meperidine, cocaine, oxycodone, anileridine, phenylacetone, oxymorphine, amphetamine, methamphetamine, phenmetrazine, methylphenidate, amobarbital, pentobarbital, secobarbital; fentanyl, etorphine hydrochloride, and phencyclidine. The drugs can be in solid, liquid, gaseous or gelatinous form.
In one embodiment, the invention comprises a method for sorting and tracking a controlled substance before and after administration to a patient. In one embodiment, the method comprises providing a spent drug container for receiving a residual controlled substance, wherein the residual controlled substance is the amount of controlled substance that is designated for disposal; obtaining information regarding the quantity of the controlled substance to be administered to a patient; providing a medical waste sorting system comprising a plurality of waste container compartments for housing a plurality of removable waste containers, providing an automatically movable lid coupled with each of the removable waste containers; wherein each of the removable waste containers is associated with at least one of a plurality of waste categories, wherein the movable lid is movable to an open position and a closed position; obtaining information from the spent drug container; electronically accessing a database comprising waste item classification information; electronically assigning the spent drug container to at least one waste category based at least in part on the obtained information and the waste item classification information; automatically opening the lid coupled to the removable container associated with the waste category to permit disposal of the spent drug container; automatically locking the lid coupled to the removable container in the closed position after disposal of the spent drug container; prompting a user to enter information regarding the quantity of the residual controlled substance; and electronically comparing the quantity of the residual controlled substance with the quantity of controlled substance prior to administration to the patient, thereby tracking the controlled substance before and after administration to the patient. The steps identified in any of the methods described herein are performed by a machine (e.g., the control system, processor, barcode readers, key readers, electronic components, etc.) in several embodiments.
In another embodiment, the invention comprises a sorting system for sorting and tracking a controlled substance before and after administration to a patient. In one embodiment, the system comprises: a plurality of waste container compartments for housing a plurality of removable waste containers, wherein each of the removable waste containers comprises an opening; at least one automatically movable lid coupled with each of the removable waste containers; wherein each of the removable waste containers is associated with at least one of a plurality of waste categories, wherein the movable lid is movable to an open position and a closed position; an input device configured to receive information associated with a spent drug container, wherein the spent drug container comprises a residual controlled substance, wherein the residual controlled substance is the amount of controlled substance that is designated for disposal; an input device configured to obtain information regarding the quantity of the residual controlled substance, a control system, wherein the control system is configured to compare the quantity of the residual controlled substance with a quantity of the controlled substance prior to administration to the patient, thereby tracking the controlled substance before and after administration to the patient; wherein the control system is further configured to assign the residual controlled substance to at least one waste category based at least in part on the inputted information and a waste item classification information contained in a database and automatically open the lid coupled to the removable container associated with the waste category; and wherein the control system is further configured to lock the lid coupled to the removable container associated with the waste category after the spent drug container is disposed. A sorting system according to any one of the preceding claims, further comprising an input device configured to obtain information regarding the quantity of the drug to be administered to a patient.
In one embodiment, the input device configured to obtain information regarding the quantity of the spent drug comprises a touch screen or keyboard, wherein the information can be entered by a user upon a prompt or query. In one embodiment, the input device configured to receive information associated with a spent drug container can include a touch screen or keyboard, wherein the information can be entered by a user upon a prompt or query. In one embodiment, the input device configured to receive information associated with a spent drug container comprises a barcode reader configured to read a barcode on the spend drug container.
In any of the embodiments described herein, the spent drug container comprises a vessel, such as a cup. The vessel can have graduations to facilitate measurement. In one embodiment, the cup serves as a vessel for receiving the residual controlled substance which was previously contained, for example, in a vial, bottle or syringe. In some embodiments, the spent drug container comprises a vial, bottle, a syringe, or an intravenous (IV) bag.
In one embodiment, obtaining information from a spent drug container comprises scanning a barcode associated with the spent drug container via a barcode reader.
In one embodiment, obtaining information from a spent drug container comprises prompting a user to input data regarding the controlled substance and/or spent drug container.
In one embodiment, obtaining information from a spent drug container comprises prompting a user to input data regarding the controlled substance and/or spent drug container via a touch screen or keyboard.
In any of the embodiments described herein, one or more (or all) of the removable waste containers comprises an opening and a machine readable identification key. In one embodiment, the machine readable identification key is read to determine the waste category associated with the container via a key reader.
In any of the embodiments described herein, the quantity of the controlled substance that should have been administered to the patient is calculated by comparing the quantity of the residual drug with the quantity of the dispensed drug.
In any of the embodiments described herein, the quantity of the controlled substance that should have been administered to the patient is reported to a user.
In any of the embodiments described herein, the quantity of the controlled substance that should have been administered to the patient is compared to a quantity that was actually administered to the patient.
In any of the embodiments described herein, a manifest is generated containing information regarding the quantity of the residual controlled substance. The manifest can be printed or generated in an electronic form.
In any of the embodiments described herein, the waste item classification information comprises classification information based on environmental or drug enforcement regulations contained in a database.
In any of the embodiments described herein, at least one of the moveable lids is configured to be manually closed upon disposal of the waste item.
In any of the embodiments described herein, at least one of the moveable lids is configured to be automatically closed upon disposal of the waste item.
In yet another embodiment, the invention comprises a method of sorting controlled substances. In one embodiment, the method comprises scanning a bar-coded drug container, wherein the bar-coded drug container comprises a drug waste; accessing a database to assign the drug waste to a waste category; identifying the drug waste as a controlled substance based on the waste category; prompting a user to enter the user's identification (or otherwise obtaining a user's identification information); prompting a witness to enter the witness's identification (or otherwise obtaining a witness's identification information); scanning a bar-coded vessel, wherein the vessel is configured to receive a residual portion of the controlled substance from the bar-coded drug container, wherein the residual controlled substance is the amount of controlled substance that is designated for disposal; prompting the user to enter the quantity of the residual controlled substance placed in the vessel (or that should be placed in the vessel) after the user has transferred the controlled substance from the drug container to the vessel; and prompting the user to dispose of the vessel in the appropriate waste container. A lid coupled to the appropriate waste container is automatically opened to permit disposal and automatically locked after disposal. Because controlled substances are disposed, many of the containers are restricted access containers. Obtaining a user's (or witness's) identification includes scanning of a badge or biometrics scanning. A user's identity and/or location can be determined in some embodiments.
Use of vessels (such as cups) is particularly advantageous in certain embodiments because it prevents co-mingling of drugs in a waste container. Thus, for example, opium and morphine can be discarded into single waste container because they are each self-contained in their own individual vessels (e.g., cups). Thus, systems and methods of self-containing drugs to minimize co-mingling are provided in several embodiments herein.
These and other features, aspects and advantages of the present disclosure are described herein in connection with certain preferred embodiments, in reference to the accompanying drawings. The illustrated embodiments, however, are merely examples and are not intended to limit the disclosure presented herein. The drawings include the following figures.
There remains a need for a system that allows clinicians to more easily sort medical waste items, including controlled substances (e.g., CII pharmaceuticals) and other regulated waste for appropriate disposal. There also remains a need for an automated system of waste disposal that encourages and facilitates hospital compliance with the relevant federal (e.g., EPA, DEA, etc.), state and/or other types of waste disposal and handling rules and regulations.
For any of the embodiments disclosed herein, or equivalents thereof, the corresponding waste sorting and disposal devices, systems and methods can be configured to receive, sort, handle and track the disposal of highly regulated materials, such as, for example, CII pharmaceuticals and/or other DEA-regulated substances, other materials susceptible to theft or misuse and/or the like. As a result, any of the waste sorting stations, other devices, systems and/or methods discussed or illustrated herein can be modified in accordance with the following disclosure to adequately, accurately, efficiently and/or safely handle the disposal of such controlled or other regulated substances.
As discussed in greater detail below, a waste sorting and disposal device or system can be at least partially automated. In some embodiments, such sorting systems comprise a plurality of individual sorting and disposal stations connected or otherwise operatively coupled to one another via a centralized or de-centralized network. Alternatively, a medical waste sorting system can comprise one or more stand-alone sorting and disposal stations configured to operate independently of one or more other devices. Although some of the embodiments disclosed herein are described in the context of individual stand-alone stations, such individual stations can be connected or otherwise operatively coupled to each other in a networked system to provide additional functionality and/or to improve efficiency. Conversely, some embodiments disclosed herein are described in the context of networked systems, certain features and advantages of which can be readily applied to individual stand-alone systems. As used herein, the term “sorting” is a broad term and shall be given its ordinary meaning and generally refers to the distribution of one or more waste items into one or more appropriate waste receptacles. As used herein, the term “disposing” is also a broad term and shall be given its ordinary meaning and shall, in some embodiments, generally refer to the discarding or “throwing out” of one or more items of waste into an appropriate receptacle. As used herein, the terms receptacle and container are broad terms that can be used interchangeably.
According to certain embodiments, a waste sorting and disposal station comprises a sorting station or machine, which includes a series of container positions or compartments. Each compartment can be configured to receive a removable container for collecting waste belonging to a particular category or classification. Further, each container can be configured to receive a liner that is removably positioned therein. Some embodiments of a sorting station comprise a waste-identifying device, a processor configured to carry out a waste-sorting algorithm, a waste-sorting mechanism and/or other components, devices and features. As used herein, the term “removable” shall be given its ordinary meaning, and is used to describe items (e.g., containers, liners, etc.) that are disposable and/or reusable.
In some embodiments, a sorting machine comprises one or more sensors for determining the presence of a container, a type of container, a volume, weight or fill level of a container and/or any other property or characteristic of a container. In some embodiments, the vessel comprises or is operatively coupled to one or more sensors. In some embodiments, a sorting machine/station includes and/or is coupled to one or more computer peripherals, such as, for example, automatic or manual user input devices (e.g., barcode scanners, radio frequency identification (RFID) devices, other types of scanners or readers, touchscreens, keyboards, keyboards, pointer devices, etc.), display devices, sound-producing devices (e.g., speakers or buzzers), other peripheral device.
According to some embodiments, several container types are provided in a sorting device or system, such that each type of container is associated with one or more categories or classifications of pharmaceutical and/or other waste that is generated at a hospital, clinic, pharmacy and/or similar facility. For example, a single container can be associated with a single waste category. In other embodiments, a single container is associated with multiple (e.g., two, three, more than three, etc.) waste categories. As discussed in greater detail herein, a waste sorting and disposal station or system can include one or more containers that are configured to receive controlled substances (e.g., CII pharmaceuticals) and/or other regulated materials. The containers can include liners and/or other protective members which protect the containers. Such liner and/or other members can be configured to be removably positioned within the containers. In some embodiments, a controlled substance container is incorporated into the structure of a single waste sorting and disposal device (e.g., cart-on-wheels, wall or floor mounted unit, etc.). Alternatively, however, a controlled substance container can be provided as a separate item that can be physically and/or operatively connected to one or more waste sorting and disposal stations. In arrangements where the controlled substance container is separate from the waste sorting station, such a controlled substance container can be selectively attached (e.g., removably, permanently, etc.) to one or more waste sorting and disposal stations, as desired or required.
In some embodiments, container types can include controlled substance containers (e.g., configured to receive CII or other DEA-regulated pharmaceuticals or substances, other regulated materials and/or the like), sharps containers, chemotherapy agent containers, infectious waste containers, ignitable waste containers, hazardous P-list waste containers, hazardous U-list waste containers, toxic pharmaceutical waste containers, non-toxic pharmaceutical waste containers, chemotherapy sharps containers, corrosive waste containers, or reactive waste containers. Additional container types can also be used as desired. In one embodiment, the container types are pre-designated by the container provider. Further, the container types can be assigned by the hospital so that the hospital can selectively and uniquely customize its waste sorting system(s). For example, some hospitals may wish to define their own waste categories in order to comply with internal goals, targeted rules and/or regulations and/or the like. Accordingly, user-defined container types can be provided either in addition to or in lieu of standard or typical container types.
Any of the waste sorting and disposal devices, systems and methods disclosed herein can comprise one or more waste identifying devices or mechanisms. In several embodiments, the waste identifying mechanism is configured to identify a particular item of waste. Identification of a waste item can be accomplished prior to depositing such waste item into the appropriate container. Identification of the waste item can be accomplished by scanning a barcode, reading a label (e.g., using an optical scanner and Optical Character Recognition software), reading a Radio Frequency identification (RFID) tag, chemical sensors, spectroscopic analyzers, measuring or evaluating any other qualitative parameter of the waste item presented for identification and/or any other device or method. In other embodiments, an item of waste is identified by the manual input of information by a nurse, physician, other clinician or any other user discarding a particular waste item. Such information can include, without limitation, a National Drug Code (NDC), a generic name, a chemical name, an abbreviated name of the drug (or mnemonic), other data associated with a particular item of waste and/or the like. In one embodiment, a user can simply read a waste identifier (e.g., alphanumeric code, graphical pattern, etc.) from an item of medical waste and enter such identifier into the system via a keyboard, touch screen or other user input device.
Once an item of waste has been automatically or manually identified, a sorting algorithm within or operatively coupled to the waste sorting system can accurately determine to which of a plurality of waste categories that particular waste item belongs. The station can be configured to indicate the proper container for disposal of the waste item to the user. For example, in some embodiments, the station indicates a correct container by opening a door, lid, cover, hatch or the like or otherwise providing access to the desired waste container. Alternatively, such an indication can be provided by illuminating a light, displaying a name or number of a container on a display device, providing an audible or other perceivable message and/or otherwise identifying the proper container.
In some embodiments, the waste sorting device or system comprises a plurality of openings that provide access to corresponding containers. For example, each of the containers can be configured to interface with an automatically operable lid, door, cover or other closure member to identify the container opening to the user. Alternatively, the sorting device can be configured to provide access to an appropriate container in other ways, such as, for example, by moving a container relative to the machine in order to present a container opening to a user. Further, the sorting mechanism can include a series of lights or other indicators configured to alert the user of the correct container into which a particular item of waste is to be deposited. Alternatively, the sorting mechanism can include an apparatus configured to receive an item of waste from a user and physically convey the item to the appropriate container.
One embodiment of a waste sorting and disposal station 10 is illustrated in
With continued reference to
Another embodiment of a waste sorting and disposal station 10A is illustrated in
As discussed herein, waste items comprising one or more controlled substances (e.g., CII pharmaceuticals, other DEA-regulated materials, etc.) can be received within one or more containers of a main sorting and disposal station, such as those illustrated in
With continued reference to
In other arrangements, a controlled substance container 80″ is separate from the main sorting and disposal station. As illustrated in
Any of the embodiments of a waste container or receptacle disclosed herein, including but not limited to those that are configured to be positioned within a main sorting station (e.g.,
According to certain embodiments, a waste item (e.g., a CII pharmaceutical or other regulated waste) can be deposited directly into a controlled substance container or receptacle 80′, 80″, regardless of its exact size, shape, state (e.g., liquid, solid, etc.), the manner in which it is contained, if at all (e.g., vial, ampoule, syringe, loose form, etc.) and/or any other details related to the waste item. For example, according to some embodiments, a controlled substance container 80′, 80″ or receptacle is adapted to accept both solid and liquid forms of a regulated drug waste. In some embodiments, the containers or receptacles 80′, 80″ comprise one or more solidifying agents and/or other substances that help solidify, neutralize, deactivate and/or otherwise treat liquid forms of a regulated drug waste. In some embodiments, the solidifying agent includes materials capable of absorbing at least a portion of a liquid. For example, such absorbent materials can include ceramic materials, sponge materials, powders, other porous materials and/or the like. In other arrangements, a controlled substances container or receptacle is configured to render waste items non-recoverable by providing a substance that can react chemically with waste items.
In some embodiments, it may not be possible or desirable to combine waste items that comprise different types of controlled substances (e.g., a CII pharmaceutical) and/or another regulated materials in a single container or receptacle. For example, some waste haulers and treatment facilities of waste comprising controlled substances and/or other regulated waste are not willing and/or able to accept commingled waste. Accordingly, as discussed in greater detail herein, an item that includes such regulated waste may need to be initially transferred to a controlled substance (CS) vessel (e.g. a cup or other enclosure) before being deposited into a common container or receptacle 80′, 80″. As used herein, vessels and cups are broad terms that include any type of container capable of receiving waste or a waste item. The terms vessel and cup may be used interchangeably. Accordingly, the term vessel shall be given its ordinary meaning and shall include containers, receptacles, packaging, holders and, without limitation, any enclosure configured to receive liquids, solids and/or any other materials. Vessels can comprise one or more suitable materials, such as, for example, plastics, elastomers, glass, or paper-based or wood-based materials, metals, alloys and/or any other natural and/or synthetic material. Vessels can be biodegradable or non-biodegradable, as desired or required. The capacity of a vessel can range from about 0.1 ml to about 1 L (e.g., approximately 0.1 ml, 0.5 ml, 1 ml, 5 ml, 10 ml, 50 ml, 100 ml, 200 ml, 300 ml, 400 ml, 500 ml, 600 ml, 700 ml, 800 ml, 900 ml, 1 L, volume between the foregoing values, etc.). In other arrangements, the capacity of a vessel can be less than about 0.1 ml or greater than about 1 L, as desired or required. In one embodiment, vessels comprise graduated vessels or containers (e.g., graduated cylinders) that can hold, for example, about 0.1 ml, 0.5 ml, 1 ml, 5 ml, 10 ml, 25 ml, 50 ml, 100 ml, 500 ml or 1 L of liquid waste and/or other type of waste.
Use of vessels (such as cups) can be particularly advantageous in certain embodiments, because it reduces or minimizes the co-mingling of drugs in a waste container. Thus, for example, opium, morphine and/or other narcotics and/or other highly-regulated pharmaceuticals can be discarded into single waste container as they are each self-contained in their own individual vessels (e.g., cups).
One embodiment of a vessel or cup 100 is illustrated in
Although the CS vessel or cup 100 illustrated in
With continued reference to
Another embodiment a CS vessel or cup 100′ configured to receive controlled substances or other regulated materials is illustrated in
With continued reference to
According to certain embodiments, as illustrated in
According to some embodiments, vessels or cups can be color-coded or otherwise distinguished from each other depending on the specific type of controlled substances, other regulated materials and/or other waste materials they are configured to receive. For example, a pharmacy, hospital or other facility can require waste items comprising a CII narcotic (e.g., opium, morphine, codeine, methadone, meperidine, cocaine, oxycodone, etc.) to be deposited in a CS vessel or cup 100 having a first color (e.g., red). Further, waste items comprising a CII stimulant (e.g., amphetamine, methamphetamine, phenmetrazine, etc.) can be deposited in a CS vessel or cup having a second color (e.g., blue), while waste items comprising a CII depressant (e.g., amobarbital, pentobarbital, secobarbital; etorphine hydrochloride, phencyclidine, etc.) can be deposited in a CS vessel or cup having third color (e.g., yellow). A hospital, pharmacy or other facility that disposes of controlled substances and other regulated waste can include more or fewer (or different) categories, as desired or required. Alternatively, vessels or cups 100 can include some other distinctive marking or configuration, such as, for example, other color scheme, a unique pattern, shape, size, label and/or the like, to distinguish between the various waste items that are to be discarded therein.
Accordingly, in some embodiments, when a nurse, other clinician or other user wishes to discard a controlled substance or other regulated waste, he or she selects an unused, sterile vessel or cup 100 that is specifically associated with the substance or item to be wasted. In some embodiments, the vial, ampoule, syringe, packet, capsule and/or other container in which a substance or other item is located can be adapted to indicate a general category with which the substance or item is associated. Further, such containers can include information that associates the substance or item contained therein with a specific type of vessel or cup. For example, a vial, ampoule, syringe or other container can include a color or some other distinguishing graphic, scheme, other marking, shape, size or the like that helps the user associate the materials contained within the ampoule to a specific CS vessel or cup. Thus, in one embodiment, if the ampoule includes a red marking (e.g., dot), a user is alerted that any waste originating from the ampoule should be deposited into a red vessel or cup 100.
In other embodiments, other than the unique identifier 120 (e.g., alphanumeric 122, barcode 124, RFID, etc.), vessels, cups or other containers 100 are configured to have approximately the same size, shape, color and/or other properties and characteristics. In some embodiments, vessels or cups are identical or substantially identical to each other and are supplied without any identifiers. Additional details regarding the various vessel or cup embodiments and the related methods by which such vessels or cups are handled and disposed are provided below.
With reference to
As illustrated in
In some embodiments, the need for a printed label is eliminated, as each vessel or cup is provided with a unique identifier (e.g., barcode, alphanumeric text, graphical pattern, color scheme, RFID, etc.). Thus, a user may be required to identify both the controlled substance being discarded (e.g., by scanning a barcode or other identifier of the vial, ampoule or other enclosure that houses the substance, by manually entering information regarding the waste, etc.) and the vessel or cup 100 into which the waste controlled substance will be placed (e.g., by scanning a barcode or other identifier of the cup, by manually entering information regarding the vessel or cup, etc.). As a result, the substance, material and/or other item to be wasted can be accurately linked to or otherwise associated with a specific vessel or cup 100.
Regardless of how a vessel or cup 100 is linked or otherwise associated with a waste item that is or will be deposited therein, a handheld device 73 (
One embodiment of a method 200 for sorting and disposing pharmaceutical and other waste items is schematically illustrated by the flowchart of
Once the necessary identifying information has been received by the sorting and disposal system, the system can compare 214 such information with waste item classification information from a database. Based on such a comparison, the waste item can be assigned 218 to one or more waste categories. In some embodiments, if the waste category is one that does not include a controlled substance or another highly regulated material, a container of the waste sorting and disposal station automatically opens 222, prompting the user to dispose 226 the waste item therein. For example, with reference to the sorting and disposal stations illustrated in
According to some embodiments, if the sorting and disposal system determines, after comparing the information regarding the waste item to the database, that the waste item includes a controlled substance (e.g., a CII pharmaceutical, another DEA-regulated material, etc.) or some other highly regulated material, a different protocol 240 is followed.
The flowchart 300 of
According to some embodiments, a user provides 318 the requested information about his or her identity to the sorting system in one of several ways. For example, the user can scan his or her identification card or other identifying device through or near a corresponding identification device. In some embodiments, this involves passing a magnetic strip of the identification card through a card reader, passing a barcode of the identification card across a barcode reader, placing the identification card having a RFID device is proximity to a RFID reader, placing a thumb and/or other finger on a fingerprint reader, positioning his or her face in front of a retina or biometrics scanner and/or the like. Alternatively, the user can manually enter his or her name, a username, a password and/or any other information that is required using a touchscreen, keypad, keyboard or any other data entry device. As discussed in greater detail herein with reference to the identification of waste items, such scanners, readers, data entry devices and/or the like can be positioned on or near a sorting station, handheld, vessel, cup dispensing system and/or any other component or location.
In some embodiments, the disposal of a controlled substance or other regulated material necessitates the presence of one or more qualified witnesses to confirm the transfer of such materials into a vessel or cup, to confirm the accuracy of the any information entered into the sorting and disposal system (e.g., the identity of the material, the identity of the user, the volume, weight, mass, quantity or other amount of waste being discarded, the patient in connection with which the controlled substance was used and/or the like). Thus, the sorting and disposal system can be configured to prompt 322 one or more witnesses to provide their identity. As discussed above with reference to the identity of the user, such witnesses can provide 326 their identifying information to the system manually and/or automatically (e.g., using a magnetic strip, barcode, RFID or other identifying features on the identification card, fingerprint, retina or biometrics scanning, manual entry using a touchscreen or other data entry device, etc.).
The user and/or any required witnesses can alternatively identify themselves at an earlier or later stage of the sorting and disposal process. For example, in one embodiment, such individuals provide their identity information to the system at the beginning of the procedure, immediately before the vessel or cup containing the waste is scanned and deposited into a container or receptacle and/or at any other time, as desired or required by a particular rule, regulation or protocol.
As discussed herein with reference to
As discussed in greater detail above, the vessels or cups 100 can be supplied or otherwise provided with a barcode, RFID or other unique identifier. In such embodiments, the sorting and disposal system prompts 330 the user to scan the barcode, RFID or other identifier of a cup or vessel or to otherwise identify the vessel or cup into which the controlled substance will be transferred. For example, a user can manually enter a unique alphanumeric code 122 (
Once the user has identified 334 the vessel or cup to the sorting system, he or she can transfer 338 the waste into the vessel or cup and properly secure the cap or other closure thereto. As discussed above, the lid 130 or other closure can be configured to create a generally water-tight, air-right, leak-proof and/or other type of seal, thereby helping to prevent or reduce the likelihood that any waste positioned within the vessel or cup will leak, evaporate or otherwise escape during any of the sorting, disposal, handling, collection, transfer and/or other steps that follow. According to some arrangements, depositing 338 the waste into the vessel or cup comprises emptying the contents of a vial, ampoule, syringe or other container therein. The controlled substance can include liquids, solids (e.g., granulated, powder or other loose forms, tablets, capsules, etc.), patches, bandages, gels, crèmes, lotions and/or the like. In embodiments where it is generally difficult or impossible to physically separate the controlled substance from its container (e.g., vial, ampoule, covering, sac, packaging, etc.), the controlled substance can be transferred into a vessel or cup along with its container.
The system can be configured to request 342 additional information from a user regarding the waste transferred into a vessel or cup. For example, the system can prompt the user to enter the volume, weight, mass, quantity, size or other measurement related to the amount of waste transferred into the vessel or cup. Relatedly, the system can prompt the user to enter the volume or other amount of controlled substance that is initially included in the vial, ampoule or other container and/or the volume of other amount of controlled substance that is to be immediately used (e.g., administered to a patient). As discussed with reference to
In other embodiments, a nurse or other user enters the anticipated volume or other amount of controlled substance to be wasted (e.g., residual) before transferring such residual volume into the vessel or cup. For example, if a syringe comprises 10 ml of a controlled substance, but only 8 ml is to be injected into a patient, a nurse can indicate to the system that 2 ml of the controlled substance will be wasted.
After a nurse, other clinician or other user has entered the requested information regarding the waste, the system can be configured to associate a particular vessel or cup with such waste and its various characteristics. Accordingly, when the user scans 350 a barcode of the vessel or cup or otherwise identifies the vessel or cup to a waste sorting and disposal system (e.g., using a RFID device and reader, by manually entering a code, etc.), the system can ascertain the internal contents of the vessel or cup. As a result, the system can be configured to compare this information to the proper database in order to determine the proper container or receptacle into which a vessel or cup should be disposed 354. Alternatively, the vessel or cup can be placed into a receptacle or other container that has been specifically designated to receive controlled substances, without the need to scan the vessel or cup.
In some embodiments, as illustrated in
The waste sorting and disposal method for waste comprising controlled substances has been described herein in reference to one particular embodiment. However, one or more aspects of the method and associated devices and systems can be varied, as desired or required. For example, the steps can be re-sequenced. In alternative embodiments, a method can include fewer, additional and/or different steps in accordance with a desired or required procedure or protocol.
A waste sorting and disposal system configured to receive controlled substances, in accordance with the various embodiments disclosed herein, can be used at a pharmacy, hospital, physician's office or other facility as part of a take back program. As a result, information regarding unused controlled substances can be accurately obtained and provided to haulers, treatment facilities and/or the like.
For instance, according to some embodiments, the CS vessels or cups are provided without a barcode or other unique identifier. Thus, a label may need to be added to the outside of a vessel or cup, as discussed with reference to
Further, in any of the embodiments disclosed herein, the waste sorting and disposal system can be relatively simplified. For example, the need for a nurse or other user to enter his or her identity or other personal information, the need to enter the volume, weight and/or other information about the waste item being discarded and/or other tasks can be eliminated or modified, in accordance with specific needs and requirements of the waste generator (e.g., hospital, pharmacy, other facility, etc.), the waste collector, the waste treatment facility, regulatory and/or enforcement agencies (e.g., EPA, DEA, etc.) and/or the like.
In other arrangements, waste items comprising controlled substances (e.g., CII pharmaceuticals) and/or other regulated materials can be directly deposited into a corresponding container or receptacle 80′, 80″ (
A container or receptacle configured to accept controlled substances can be emptied according to a predetermined time schedule and/or when a particular level within the container or receptacle has been attained. As discussed, such a container or receptacle can include a removable liner. Thus, the following discussion regarding change out procedures is equally applicable to both receptacles and any liners that may be removably placed therein.
According to some embodiments, a special key or code is required to access an interior of the controlled substance container or receptacle, as only certain authorized personnel may be given access to the sensitive materials contained therein. Once a receptacle or liner containing controlled substance waste has been removed, it can be transported and to a secure area. The removed receptacles or liners can be stored in such secure areas until a DEA Registrant hauler or other authorized party or entity arrives to verify their contents and remove them from the hospital, pharmacy, other medical facility and/or other waste generation location. In some embodiments, the liners and/or receptacles comprise barcodes, RFID devices and/or other identifying features so that they can be conveniently tracked and manifested as they are moved through various procedures, including collection, handling, storage, transportation, treatment and/or the like.
In some arrangements, a DEA Registrant hauler or other inspector verifies the contents of the liner or receptacle by scanning or otherwise retrieving data related to one or more CS vessels or cups discarded therein. For example, the DEA Registrant hauler can confirm the accuracy of the type and amount (e.g., volume, weight, quantity, etc.) of waste contained in one or more vessels or cups. According to certain arrangements, one or more vessels or cups are randomly selected and subjected to additional scrutiny to protect against errors, intentional or unintentional diversion and/or the like. For instance, the contents of such random vessel or cup samples can be tested using photospectroscopy and/or any other protocol to confirm the chemical composition, concentration, strength and/or other properties of the waste deposited therein. Accordingly, in one embodiment, the vessels or cups are sized, shaped and otherwise configured for placement into a spectrophotometer or other testing device. In other arrangements, a dipstick or other testing methods can be used to perform the necessary testing or verification. In some embodiments, the vessel or cup comprises a tapered portion, such as a tapered end.
In other embodiments, a DEA Registrant hauler is required to document each and every vessel or cup that contains a controlled substance. Thus, the use of the various devices, systems and methods disclosed herein can facilitate the collection of the necessary information (e.g., type and concentration of waste, volume or amount, etc.) and the generation of any required reports or forms. For example, by scanning the barcodes, reading the RFID devices and/or making use of any identifier associated with the vessels or cups, a DEA Registrant hauler can quickly and accurately obtain detailed information regarding the controlled substances collected from a particular pharmacy, hospital or other waste generation facility.
In one embodiment, once the accuracy of the receptacle or liner contents (e.g., vessels or cups) has been confirmed, one or more regulatory forms, manifests and/or the like can be completed. For example, in order to satisfy federal regulations in the U.S., Form B40 and/or Form 222 can be completed and submitted to the proper governmental agency or authority (e.g., DEA, EPA, appropriate state or local agency, etc.). Advantageously, in embodiments where data and other information regarding the controlled substance waste vessels or cups have been entered and collected during the sorting and disposal methods (as described in greater detail herein), such manifests, other forms and/or other documentation can be automatically completed by communicating with the system's processor or network. As with users that generate and dispose of waste items that comprise controlled substances, inspectors, haulers, treatment personnel and/or other parties that may handle or otherwise come in contact with such waste may also be required to identify themselves and/or provide additional information to further ensure proper custody of the waste and to provide an accurate record of its handling from cradle to grave.
The various waste sorting and disposal devices, systems and methods according to several embodiments disclosed herein can help reduce or eliminate the diversion of controlled substances (e.g., narcotics, other CII pharmaceuticals, other regulated materials, etc.), as the movement of such substances and materials is more accurately tracked within a particular facility (e.g., hospital, pharmacy, clinic, etc.). As a result, the proportion of pharmaceuticals and/or other controlled substances that is wasted (e.g., not used) or otherwise unaccounted can be accurately determined. This can help reduce waste (e.g., by providing valuable insight to hospital, pharmacy or other facility administrators), discourage the theft or unintentional diversion of controlled substances, discourage counterfeiting of pharmaceuticals (e.g., filling of empty vials with placebos, saline, etc.) and/or provide additional benefits. This may be particularly important for experimental controlled substances and other materials that tend to be very expensive.
Because the volume or other amount of a wasted pharmaceutical is measured and recorded by the sorting and disposal system, the portion (e.g., volume) of such a pharmaceutical that is actually administered to a patient can be accurately or approximately calculated. Thus, the detailed information that is collected regarding the handling and use of controlled and/or other regulated substances within a hospital, other healthcare facility, pharmacy and/or the like, including both the tracking of the actual substances and the tracking of nurses, technicians, doctors and other personnel that have access to such substances, can help make such personnel more accountable for intentional and unintentional diversions.
In addition, such enhanced sorting and disposal devices, systems and methods can help satisfy the various environmental, drug-enforcement and other regulatory laws, regulations, goals and other requirements which currently exist and which are likely to be implemented in the future. For example, the various embodiments disclosed herein help improve the accuracy of cradle-to-grave tracking of controlled substances and/or other regulated materials. This can assist in advantageously reducing waste and promoting resource conversation.
The following non-limiting examples illustrate embodiments of the disclosure presented herein and are not intended in any way to limit the disclosure provided herein.
In one embodiment, a nurse obtains a syringe or other container having a controlled substance (e.g., morphine) that will be injected into a patient. In order to obtain information regarding the controlled substance (e.g., name, concentration, batch number, etc.), the nurse can use a scanner (e.g., located on a sorting and disposal station, a handheld or any other location) to scan the barcode of the syringe. Once the sorting and disposal system recognizes that the syringe comprises a controlled substance, it can prompt the nurse to enter certain identifying information, such as, for example, his or her name. In some embodiments, the nurse slides his or her identification card through a reader, passes his or her card in the vicinity of a RFID reader or performs any other action that allows the system to automatically recognize his or her identity. In addition, the system can optionally require that one or more authorized persons witness the nurse while he or she administers the controlled substance and/or wastes a particular volume of the controlled substance. Thus, the witnesses identify themselves to the system either automatically or manually.
For purposes of this example, the syringe contains 10 ml of the controlled substance. However, the patient is set to receive only 8 ml of the controlled substance. Accordingly, the residual 2 ml of the controlled substance will need to be wasted. According to one embodiment, the nurse obtains a sterilized bar-coded vial or cup, deposits the residual 2 ml of the controlled substance into it and injects 8 ml into the patient. Further, the nurse seals the vessel or cup, which now should contain 2 ml of the controlled substance, using a lid or other closure. Next, the nurse scans the barcode or other identifier placed on the vessel or cup using a scanner of the sorting and disposal system. The system receives the information and, in response, prompts the nurse to enter the volume, weight, quantity or other amount of the controlled substance that has been placed into the vessel or cup. Alternatively, the system may have required the nurse to enter the anticipated amount of residual volume prior to the nurse placing the 2 ml into the vessel or cup. After the nurse enters the volume of residual controlled substance that has been placed into the vessel, he or she disposes the vessel into a container or receptacle of the waste sorting and disposal station that is configured to receive controlled substance waste.
An authorized hauler can then access the vessels that have been deposited into the interior of the controlled substance container or receptacle. The hauler can scan each vessel to accurately determine the types, concentrations, volumes or other amounts and/or other details regarding the various controlled substances present within the controlled substances container or receptacle. In order to ensure the accuracy of the information entered by the nurse and other personnel, random vessels can be selected for testing.
In some embodiments, a nurse obtains a vial having a controlled substance (e.g., morphine) that will be injected into a patient. The nurse manually enters the information about the controlled substance contained with the vial into the sorting and disposal system using a touchscreen or some other data input device. Once the sorting and disposal system recognizes that the syringe comprises a controlled substance, it will prompt the nurse to enter certain identifying information, such as, for example, his or her name. The nurse manually enters the requested identifying information. In addition, the system optionally requires that an authorized person witness the nurse while he or she administers the controlled substance and/or wastes a particular volume of the controlled substance in accordance with the prescribed treatment. Thus, the witness automatically or manually identifies himself or herself to the system.
For purposes of this example, the syringe contains 10 ml of the controlled substance. However, the patient is set to receive only 5 ml of the controlled substance. Accordingly, the residual 5 ml of the controlled substance will need to be wasted. According to one embodiment, the nurse obtains a sterilized vial or cup that does not include a barcode or other identifying information. The nurse then transfers 5 ml of the controlled substance into the vessel or cup, and administers the remaining 5 ml to the patient. After the nurse has sealed the vessel or cup using a lid or other closure, he or she can enter the volume or other amount of the controlled substance that was wasted into the sorting and disposal system (e.g., using a touchscreen or other data entry device). The system receives the information and prints a customized label that is to be placed on the vial or cup. The nurse then deposits the labeled vial or cup into a container or receptacle of the waste sorting and disposal station that is configured to receive controlled substance waste.
Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments. Additionally, it will be recognized that the methods described herein may be practiced using any device suitable for performing the recited steps. Moreover, the methods steps need not be practiced in any given order in some embodiments. Such alternative embodiments and/or uses of the methods and devices described above and obvious modifications and equivalents thereof are intended to be within the scope of the present disclosure. Thus, it is intended that the scope of the present inventions should not be limited by the particular embodiments described above, but should be determined by a fair reading of the claims that follow.
This application claims the priority benefit of U.S. Provisional Application No. 61/317,143, filed Mar. 24, 2010, the entirety of which is hereby incorporated by reference herein.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US11/29275 | 3/21/2011 | WO | 00 | 3/1/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61317143 | Mar 2010 | US |
