Innovative medication packaging system

Abstract

The product is a medication packaging system, primarily designed for use in long-term care facilities, with a unique method of organizing and releasing pills that promotes correct medication administration, a natural wrist action, time savings, individual identification of medications, organization and quick release of patient medications according to time pass, and it meets requirements for compliance packaging in long-term care settings. It takes into consideration the differing needs of the pharmacy filling the prescriptions and, the caregiver administering the medications to the patient. The main design of the package consists of three parts:

Description

BACKGROUND OF THE INVENTION

[0001] This application claims the benefit of U.S. Provisional Application No. 60/440,168 filed Jan. 15, 2003.

[0002] Proper medication management is critical for patients in long-term care settings. Medication administration is a nursing function that is time-consuming, complicated, physically taxing, and if done improperly, it can cause injury or death to the patient and it can cost the nurse, facility, and pharmacy their licenses.

[0003] Most patients in long-term care settings cannot self-administer their own medications. They need nursing staff to keep track of ordering medications, storing the medications, and delivering medications to them. Pharmacies serving these patients and facilities need to use specialized packaging systems to comply with regulations and satisfy the needs and demands of the nursing staff.

[0004] As regulations increase and as the market for medication management in long-term care settings increases, nurses are demanding better tools for this vital function. According to the U.S. Census, the number of people over the age of 85 will double between 1990 and 2010, more than double in the following decade, and continue to rise. During this same time, the number of younger people who would traditionally care for the elderly and terminally ill is decreasing. Patients in long-term care settings take an average of eight prescriptions (and more with over-the-counter medications added to the mix). They may need to take several of these medications at the same time each day and different medications several times a day. Nursing teams are searching for ways of decreasing the time it takes to administer medications as well as methods that are less physically taxing on the staff. The pharmacy needs to fill prescriptions for these settings in packaging that will encourage the nursing staff/patient to select its pharmacy while keeping packaging and labor costs at a reasonable level.

[0005] A medication packaging system used in a long-term care setting must comply with federal guidelines for compliance packaging, it must appeal to the pharmacist filling prescriptions, and it must appeal to the end user (usually nursing staff). Compliance packaging helps ensure that the right medication is given to the right patient in the right dosage, form, and route, at the right time. It also helps ensure that the medication has not been tampered with and helps the caregiver document that the above has occurred.

[0006] Current systems being used in long-term care settings fall into four main categories: blister cards, pillow packs, cassettes, and vials (some with minor variations that combine features from two or more systems). There are serious disadvantages to each category, some of which include the following:

[0007] Blister cards (also called bubble packs and punch cards) are the most widely used system in long-term care and are produced by many manufacturers. A blister card is a plastic sheet molded with blisters (to hold pills) which is encased in a fold-over card cut with holes on each side (sealed with a heat-sealing machine or glued with a special “cold seal” glue). One side accommodates the blisters while the other side is backed with foil. The pill in the blister is released when the nurse pushes it through the foil backing. It is the easiest and most inexpensive system for the pharmacy and it is more tamper resistant than other systems, but most cards do not work with automated fill systems and the nurses complain of wrist injuries from having to push the pill out (an unnatural wrist and finger action). There are an increasing number of compensation claims and lawsuits filed by nursing staff against facilities using blister cards because of this unnatural wrist action. Blister cards are usually very time-consuming for the nurses since they must release the pill from one card, document, then go to the next card, document, and the next until they have released all of the pills a patient needs for that time pass (such as 8 am).

[0008] Pillow packs (which look like clear M&M packages with the prescription labeling printed on the clear plastic envelope) are expensive for the pharmacy, are prone to error, can be hard on the wrists when opening, make it difficult for nurses to identify each medication (and check orders), and it is usually necessary to destroy all medications in the pack when one order is changed (which is costly and time-consuming). Pillow packs are usually filled via automated systems.

[0009] Cassettes are reusable plastic containers that may contain one or more pills per cavity (filled manually by the pharmacist). Some comply with regulations for compliance packaging; others do not. The cassettes are reused, so there is a high risk of cross-contamination (from other pills that have been housed in the cavities on previous fills, but more significantly from the spread of illness and disease on the cassettes). They are more easily tampered with, increasing the chance of drug diversion/theft. Some have a more nurse-friendly way of releasing the pills, but these systems break open easily and discarded lids and plastic chards can create a hazardous mess. Cassettes are difficult and very costly for the pharmacy to use.

[0010] Vials are not considered compliance packaging and should not, and in most cases cannot, be used in long-term care settings.

SUMMARY OF THE INVENTION

[0011] A new packaging system creates a new category of compliance packaging: A front-release time pass system.

[0012] The inventor of this new system has been part of nursing teams who administer medications in long-term care settings, has been a long-term care facility administrator, works in a long-term care pharmacy, and is married to a leading geriatric consultant pharmacist. This new system answers the main concerns of the pharmacists and the nursing staffs regarding medication packaging. It releases pills in a manner unlike any other system on the market. It was developed with the intent to create a system that would be easier to open and more gentle on the nurses' wrists while being tamper-resistant and tamper-evident. Since nurses and pharmacists need to be able to identify each pill being administered to the patient and allow for changes to orders without having to destroy all of the patient's medications, each pill should be housed in a separate cavity or bubble. If the pills could be organized by time pass (such as all pills the patient needed to take at 8 am on Tuesday), and could be released with one action, it would save the nurse a great deal of time and create a system that would help ensure that medications were being administered as prescribed. The packaging should not be too costly for the pharmacist or the pharmacist would not purchase the cards (the product needs to be comparable to the most popular system—blister cards). It would also need to be able to be used with the expensive medication storage carts and heat sealing machines that a pharmacy already owns, so that changing to the new system would not be cost prohibitive due to the change needed for filling and storage equipment. It should be easy to use, requiring little training.

[0013] This new system answers all of those concerns with the front-release rows of bubbles, i.e., the lines of perforations and channels that allow a row of individual bubbles of pills to be released with one action.

[0014] Based on the facility needs, pharmacy needs, or manufacturer preferences, the systems can be modified while still maintaining the unique method of organizing and releasing pills. The cards can be different sizes and colors. The number of rows, columns, bubbles per row, or size of bubbles can vary. The tab at the beginning of the row can be created in the plastic or the cardboard: In the plastic with a tab extending beyond the card, in the plastic with a tab flush with the card and containing a notch that slightly lifts the plastic from the cardboard, or by creating a half-circle cut in the cardboard at the beginning of each row. The label can be attached to the top of the card, on the top and back of the card, or printed on the card under the bubbles. The card can be assembled using manual systems (cold sealing, heat sealing) or automated systems. The cardboard backing could be made of clear plastic. The card could also book around the unit, making it a contained system for patients who need to use it while traveling or for self-administration. The system could be used with a die-cut card lined with foil. The plastic bubbles and channels could be adhered to cardboard that has been perforated. There are many possible variations; however the innovation—the perforations and channels—remain the same. The key is in the manner in which the pills are organized and released from the front of the card due to the line of perforations and channels.

[0015] The following lists the packaging components illustrated on the diagrams and explains some of the features and benefits of these components.

THE DRAWINGS

[0016] A preferred embodiment of the invention is illustrated in the accompanying drawings in which:

[0017] EXHIBIT 1A: Completed Card, Front View, sized to fit equipment made for blister cards and some of the cassette systems: The clear plastic front of the card, the cardboard back, and the label; the card is disposable after all doses have been administered, reducing the risk of cross-contamination. The cost of the card will be comparable to the most frequently used system currently available and over time, it should cost less, because it uses less materials.

[0018] a. Perforations. A line of perforations is cut into the clear plastic on each side of the bubbles. The perforations are spaced to allow for easy release of the row of bubbles, while maintaining the integrity of the package before the pills need to be released. The line of perforations allow for a natural wrist action when the nursing staff is releasing the pills (rather than the unnatural action created when pushing each pill in the blister card through the foil backing). The packaging is tamper-resistant and tamper-evident, reducing the risk of drug diversion/theft.

[0019] b. Plastic Channels. The plastic is molded into ridges that create channels. These channels have several functions. They create a tunnel that directs the pills from the card into the medication cup in an easy, orderly manner (and helps keep the pills from rolling off the wrong edge of the card before rolling into the cup). The channels also help to protect the perforations and bubbles from being crushed or the card from being bent. It is recommended that the person releasing the pills put his/her index and middle fingers on the channels surrounding the med pod they are trying to release to better stabilize the card while breaking the perforations. The channels also allow for more space for the glue to adhere to the plastic, creating a more solid seal.

[0020] c. Med Pod for Time pass. The med pod is the strip of bubbles within the perforated area. When the perforations are broken, the pod lifts from the card, releasing the pills. The pills remain within the channel until the card is slightly tipped, allowing the pills to roll into a medication cup. The med pod is discarded after the pills within it are released. Having all of the pills for a time pass released in one action significantly reduces the time it takes to prepare the pills for each patient. It also reduces the chance of errors because the pharmacist organizes the time pass row. It also reduces errors that occur when a nurse is interrupted in the middle of preparing for a med pass. The pill release is quick and complete.

[0021] d. Plastic Bubbles to House Pills. The plastic is molded into bubbles large enough to hold individual pills. The bubbles are organized in rows and columns. Vertical columns contain the same pills (prescription #1, #2, #3, etc.), creating rows that contain all of the pills a patient may need at a certain time of day (such as 8 am on Thursday, 8 am on Friday, 8 am on Saturday, etc.). Nurses need to be able to identify each pill and document that they have administered the pill to the patient. The individual bubbles allow the nurse to identify each pill. The perforated rows (the med pod) allow for quick release of the pills. If the doctor changes or discontinues one of the medications, it can be removed without disturbing the other pills. There will not be residue from the discontinued medication on the other pills, so they can be administered as packed.

[0022] e. Tabs. In this card design, the tab is created in the cardboard, so the plastic is not cut into tabs. If it is easier for the manufacturer to cut the plastic rather than the cardboard, a circular tab can be cut into the plastic at the beginning of each row to assist the person releasing the pills to grab the plastic and break the perforations.

[0023] f. Day/Date Pass Identifiers. Many nurses like to have medications organized by the pharmacist by time pass (such as all 8 am medications together) and date pass (organized and labeled by day/date). The card can be imprinted with days, dates, or numbers to help nursing staff check if the medications were administered on the right day and time.

[0024] g. Labeling. The card can be imprinted with a place for the patient name and prescription information. Since medication on this card design is organized by medication columns and day/time pass rows, the card could identify which column is associated with which prescription. Most pharmacies will affix a label to the top and/or back of the card with prescription information and bar codes.

[0025] h. Cardboard Backing. The card may be colored to assist the nurse in identifying the time pass (such as 8 am medication on yellow cards). The portion of the card that is the size of the plastic front is coated with a food-grade glue (to adhere the plastic piece to the cardboard back). The top portion of the card is mechanically or physically labeled.

[0026] Exhibit 1B: Completed Card, Back View, sized to fit equipment made for blister cards and some of the cassette systems: The card back and label.

[0027] i. Tabs. In this card design, the tab is created in the cardboard, so the plastic is not cut into tabs. If it is easier for the manufacturer to cut the plastic rather than the cardboard, a circular tab can be cut into the plastic at the beginning of each row to assist the person releasing the pills to grab the plastic and break the perforations.

[0028] j. Label Area. It may be printed to allow for the pharmacist to hand label it or the pharmacy may adhere prescription label and bar code information.

[0029] k. Cardboard Backing. The card may be colored to assist the nurse in identifying the time pass.

[0030] EXHIBIT 2A and 3A: Completed Card, Small Size, Front View (different designs): The card can be configured to match the equipment that the facility or pharmacy is currently using. The innovative features are still applied Oust the size and organization of rows and columns change).

[0031] l. Perforations. A line of perforations is cut into the clear plastic on each side of the bubbles. The perforations are spaced to allow for easy release of the column of bubbles, while maintaining the integrity of the package before the pills need to be released. The line of perforations allows for a natural wrist action when the nursing staff is releasing the pills (rather than the unnatural action created when pushing the pill in the blister card through the foil backing). The packaging is tamper-resistant and tamper-evident, reducing the risk of drug diversion/theft.

[0032] m. Plastic Channels. The plastic is molded into ridges that create channels. These channels have several functions. They create a tunnel that channels the pills from the card into a medication cup in an easy, orderly manner (and helps keep the pills from rolling off the wrong edge of the card before rolling into the cup). The channels also help to protect the perforations and the bubbles from being crushed or the card from being bent. The channels also allow for more space for the glue to adhere to the plastic, creating a more solid seal.

[0033] n. Med Pod for Time pass. The med pod is the strip of bubbles within the perforated area. When the perforations are broken, the pod lifts from the card, releasing the pills. The pills remain within the channel until the card is slightly tipped, allowing the pills to roll into a medication cup. The med pod is discarded after the pills within it are released. Having all of the pills for a time pass released in one action significantly reduces the time it takes to prepare the pills for each patient. It also reduces the chance of errors because the pharmacist organizes the time pass column. It also reduces errors that occur when a nurse is interrupted in the middle of preparing for a med pass. The pill release is quick and complete.

[0034] o. Plastic Bubbles to House Pills. The plastic is molded into bubbles large enough to hold individual pills. The bubbles are organized in rows and columns. Rows contain the same pills (prescription #1, #2, #3), creating columns that contain all of the pills a patient may need at a certain time of day (such as 8 am on Thursday, 8 am on Friday, 8 am on Saturday, etc.). Nurses need to be able to identify each pill and document that they have administered them to the patient. The individual bubbles allow the nurse to identify each pill. The perforated columns allow for quick release of the pills. If the doctor changes or discontinues one of the medications, it can be removed without disturbing the other pills. There will not be residue from the discontinued medication on the other pills, so they can be administered as packed.

[0035] p. Tabs. In EXHIBIT 2, the tab is created in the cardboard, so the plastic is not cut into tabs. If it is easier for the manufacturer to cut the plastic rather than the cardboard, a circular tab can be cut into the plastic at the beginning of each column (EXHIBIT 3) to assist the person releasing the pills to grab the plastic and break the perforations.

[0036] q. Day/Date Pass Identifiers. Many nurses like to have medications organized by the pharmacist by time pass (such as all 8 am medications together) and date pass (organized and labeled by day/date). The card can be imprinted with days, dates, or numbers to help nursing staff check if the medications were administered on the right day.

[0037] r. Labeling. The card can be imprinted with a place for the patient name and prescription information. Since medications on this card are organized by medication rows and day/time pass columns, the card could identify which row is associated with which prescription. Most pharmacies would affix a label to the top and/or back of the card with prescription information and bar codes.

[0038] s. Cardboard Backing. The card may be color coded to assist the nurse in identifying the time pass (such as 8 am medication on yellow cards). The portion of the card that is the size of the plastic front is coated with a food-grade glue (to adhere the plastic piece to the cardboard back). The top portion of the card is labeled or used for adhesive labeling.

[0039] EXHIBIT 2B and 3B: Completed Card, Small Size, Back View, sized to fit equipment made some of the cassette systems (different designs): The card back and label.

[0040] t. Tabs. In EXHIBIT 2, the tab is created in the cardboard, so the plastic is not cut into tabs. If it is easier for the manufacturer to cut the plastic rather than the cardboard, a circular tab can be cut into the plastic at the beginning of each column (EXHIBIT 3) to assist the person releasing the pills to grab the plastic and break the perforations.

[0041] u. Label Area. It may be printed to allow for the pharmacist to hand label or the pharmacy may adhere prescription label and bar code information.

[0042] v. Cardboard Backing. The card may be colored to assist the nurse in identifying the time pass.

DETAILED DESCRIPTION OF THE INVENTION: HOW IT WORKS

[0043] The innovative medication packaging system works with the heat seal machines, stays secure, and releases pills as planned, saving an average of 72% of the time it took to prepare the medications for administration (over the blister card and system). The number of cards used is comparable to the blister card and cassette systems (since the prototype uses seven-day cards containing up to six medications rather than the blister card with a thirty-day supply of one medication).

[0044] The following details use of the packaging system for a new patient in a long term care facility:

[0045] Step 1: The pharmacist receives a list of the current medications for the patient, and organizes them according to time pass (such as five-morning medications, three-noon medications, and four-evening medications).

[0046] Step 2: The pharmacist completes the computer file for the patient, prints the labels, gathers the medications, and puts the pills in the bubbles in the plastic piece (each medication its own column, which forms day/time pass rows).

[0047] Step 3: The plastic piece is placed in a wooden paddle, which is topped by the cardboard backing, and the unit is put into the heat sealer.

[0048] Step 4: The unit is removed from the heat sealer, removed from the paddle, and the label is affixed to the top of the package.

[0049] Step 5: All of the medications for the patient are packaged, double checked by the pharmacist, and placed in the patient's bin, which is delivered to the facility.

[0050] Step 6: The nurse receives the medications for the patient, checks the medications against the medication administration record, and places the bin in the medication cart.

[0051] Step 7: At the time of the med pass, the nurse removes the card for the patient and checks it against the medication record.

[0052] Step 8: The nurse places the medication card on a level surface, along with a medication cup. She places her fingers on the channels surrounding the med pod strip and pulls the tab, breaking the perforations until the pod is released from the package (she discards the med pod strip of bubbles). She tips the card slightly toward the medication cup until the pills roll through the channel area into the cup.

[0053] Step 9: The nurse hands the cup to the patient, who takes the medication.

[0054] Step 10: The nurse records the successful med pass and replaces the card in the bin.

[0055] The key element, the perforations on the front of the card, allows the nurse to release the pills for an entire time pass in one easy action. This innovation allows the nurse to identify individual pills, but release them all with one action. It allows for a more natural wrist action, reducing the chance of wrist fatigue and injury. It saves valuable time. With the pharmacy organizing the pills by time pass and the nurse checking the medications against the medication administration record, it also creates a safer method, with less risk of medication error. The construction of the card, channels, and perforations allow for these benefits while still being cost-effective and labor-effective for the pharmacy.

[0056] There is no medication packaging system for long-term care like this one. It makes significant improvements over prior art and will improve the way medications are administered in long term care settings.

[0057] While this invention has been described and illustrated herein with respect to preferred embodiments, it is understood that alternative embodiments and substantial equivalents are included within the scope of the invention as defined by the appended claims.

Claims

1. A package for containing and dispensing medicines in pill form, comprising:

a cardboard backing member;

a plasticized cover attached to one side of said cardboard backing member, said cover having a plurality of bubbles arranged in elongate rows therein for containing pills; and

a series of perforations and elongate channels in said cover to provide for individual release of each of the pills from the bubbles in the cover.

2. A package as set forth in claim 1, wherein said cardboard backing member is non-perforated.

3. A package as set forth in claim 1, wherein the bubbles are arranged for the release of multiple pills at one time.

4. A package as set forth in claim 1, wherein said row of bubbles has a tab at an end thereof to provide for easy access to the pills.