Abstract:
A secure packaging unit utilizing an open top container that is filled and an intermediary section having an integral removable seal fixedly attached thereto after the open top container is filled thereby sealing the contents therein. A user is able to break out the removable seal and replace a standard lid upon the intermediary section/open top container combination thereby capping and containing the contents therein. Such a unit allows a pharmacist to fill a prescription in a manner that prevents third parties from tampering with the filled prescription between the time of filling and the time the customer removes the removable seal.

Description:
PRIORITY  
       [0001]     This application claims the priority date of the provisional application entitled SEALED SECURE PRESCRIPTION VIAL APPARATUS AND METHOD filed by Jonathan K. Reynolds, et al. on Sep. 19, 2003 with application serial number 60/504,287. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention.  
         [0003]     The present invention generally relates to packaging, and more particularly relates to the packaging of prescriptions.  
         [0004]     2. Background Information. We have an aging population hence a greater demand for medications. In 1998, pharmacists filled 2.8 billion outpatient prescriptions nationwide, a number expected to jump by nearly 40% to 4.0 billion by 2005. In 1998, there were 129,000 pharmacists to fill those billions of prescriptions and only 137,000 pharmacists are projected for 2005.  
         [0005]     In 2001, a report from the National Institute of Medicine estimated that mistakes are made on about 4.0% of the nation&#39;s prescriptions. That equates to 120 million errors per year. Many of these errors can be catastrophic, including wrongful death to patients. Estimates of the cost in the United States of America due to medication errors alone range from $76 billion to more than $177 billion a year. Adverse drug effects from improperly used prescription medications by the feeble, the misinformed, the malicious and the unlucky account for 15.0% of all hospital admissions and 100,000 deaths each year, at an annual cost estimated at $136 billion. These people could knowingly or unknowingly manage to alter the prescription that they received from the pharmacy and claim that an error on the part of the pharmacist resulted in a personal injury.  
         [0006]     The National Pharmacists Association recommends that for safety purposes, a pharmacist fill no more than 15 prescriptions per hour. Studies note that errors increase sharply when filling more than 24 prescriptions per hour. Many pharmacists fill nearer to 30 per hour. In response to the shortage, many pharmacies are now starting to automate, relying on computers to count pills instead of human hands. This is believed to yield a 33.0% time savings in a work shift. Pharmacists still must check every prescription filled by man or machine.  
         [0007]     Currently, pharmaceuticals are dispensed from a pharmacy in a disposable prescription vial, typically amber in color having a white lid. The prescription vial is a container designed to contain and protect the contents. Inert, waveband sensitive plastics protect the contents against damage by light radiation, and prevent the product from becoming contaminated by toxins, vapor or moisture. Elder friendly—child resistant closures help assure that access to the contents is easy for adults and difficult for children.  
         [0008]     Pharmacists labor in rapid paced, high stress conditions. Pharmacists attempt to secure, control and dispense a product that is often more valuable (ounce per ounce) than gold and life threatening when misused. Dispensing errors are common and pharmacists are sued for mistakes such as dispensing incorrect quantities, and filling prescriptions with the incorrect drug.  
         [0009]     However, once filled and checked by a pharmacist, filled prescriptions are no longer under the pharmacist&#39;s control. Liability for dispensing errors or theft and/or other fraudulent acts within the pharmacy is retained by the pharmacist regardless of who might have been involved in tampering either before or after the sale transaction.  
         [0010]     Pharmacists shoulder the liability of support staff such as pharmacy technicians and cashiers who may accidentally alter or even choose to alter filled prescriptions resulting in loss or harm to the end consumer.  
         [0011]     A subset of pharmaceuticals consumers commonly misuse, abuse and fraudulently administer the dispensed drugs. Correctly filled prescriptions that have left the pharmacy can become altered by the end consumer or others who have access to patient prescriptions. For instance, a person sent to the pharmacy to retrieve a prescription for someone else, may steal a few of the pills on the way home and blame the pharmacist for the missing pills. People can be harmed from these altered prescriptions and sue the pharmacist alleging that the prescriptions were incorrectly filled.  
         [0012]     Pharmacists need assurance through “proof of record” and “proof of product” that no one can tamper with filled prescriptions prior to reaching the end consumer without leaving evidence of tampering. Pharmacists also need a system to allow them to correctly take responsibility for any dispensing errors in which they might be involved. The currently available prescription vials are not tamper resistant and therefore do not assist in making the patient and pharmacist accountable for the contents. Some of these vials may have tamper resistant features available for optional use, but none of them have tamper resistance built into the vial such that packaging the product is impossible without first attaching the tamper resistant features.  
         [0013]     The known or potential problems with the current system include: a shortage of workforce in the pharmaceutical industry; errors at an unacceptable level that are expected to increase; unsecured access behind pharmacy counter—i.e. cashiers, technicians, vendors; hazardous human interface with pharmaceuticals behind counter; known high theft level by employees; many pharmaceuticals including narcotics which gram for gram are more valuable than gold (the street value for certain narcotics can reach $100/pill); unsecured bottles (technicians, cashiers and pharmacists can alter the count of pills intentionally before the sale, no proof of count and seal on the vial that cannot be altered prior to the point of sale, seals are replaceable); customers can alter the count of pills after the sale (seals are replaceable); once an order is ready, the pharmacist has his/her name on the contents verifying the type of medication and quantity and dosage and date (these can be altered including the content prior to the sale or post sale which potentially renders the pharmacist legally liable, claims are made for incorrect counts or incorrect drug); e-mailed prescriptions are not widely used; doctors handwrite all prescriptions (many are illegible with incorrect strengths or sizes that do not exist, signatures are unclear leaving the uncertainty of the prescribing doctor and patient); and frequently no validation of patient identification at the point of sale (no validation of courier in lieu of patients presence at the pharmacy counter).  
         [0014]     The current general prescription procedure is: (1) doctor writes a prescription on a legal prescription blank; (2) the prescription is sent to a pharmacy or the patient carries the prescription to the pharmacy; (3) the pharmacist will interpret the doctor&#39;s handwriting and enter the information into a computer system; (4) the prescription is screened for safety, contraindications and drug interactions; (5) the prescription information is sent to the insurance company for claim adjudication; (6) a label, a bill and important patient information is printed; (7) a stock bottle containing the correct pharmaceutical is chosen from the shelf and the correct amount is either measured or counted by the pharmacist (most pharmacists count prescriptions using a counting tray and a spatula, counting pills by 5, putting the desired number into the vial and return any remaining tablets to the stock bottle, the stock bottle being returned to the shelf); (8) the patent prescription vial is capped with a child-resistant closure; (9) the prescription vial is labeled and any necessary warning labels are also applied at this time; and (10) the capped prescription vial is then put in a sack and filed on a shelf under the patient&#39;s last name awaiting delivery to the patient/customer.  
         [0015]     Competitive Analysis. Currently no prescription vials are available to pharmacists that offer any built-in tamper resistant features. However, many methods are available that could be optionally employed on prescription vials to help secure filled prescriptions. (e.g. shrink-wrapping, induction seals and tamper resistant closures designed with sections that break off with the initial opening). None of these measures are intrinsic to the vials whose contents they protect. These offer only a small degree of security since enterprising individuals can also shrink-wrap, clean vials and replace induction seals. Tamper resistant lids can be removed and discarded and the vial re-capped to make them appear as if no tampering has occurred. No current method is secure against malicious or innocent misconduct by the pharmacist, the interns, the couriers, the patients, patient&#39;s family members or others with access to filled prescriptions.  
         [0016]     Vials currently available for prescription packaging are single open chambers with allowances for a child resistant closure. A variety of prescription vials with child resistant closures are available. Among these are: U.S. Pat. No. 4,091,948 (Northup), U.S. Pat. No. 4,128,184 (Northup) and U.S. Pat. No. 4,223,795 (Akers).  
         [0017]     A variety of methods of creating tamper resistant seals have been invented and many are available on the market. Among these are: U.S. Pat. No. 4,069,935 (Hampel), U.S. Pat. No. 4,436,213 (Paul, et al.), U.S. Pat. No. 4,747,499 (Gach et al.), U.S. Pat. No. 4,747,500 (Gach et al.), U.S. Pat. No. 5,092,477 (Johnson et al.), U.S. Pat. No. 5,265,744 (Duty et al.) and U.S. Pat. No. 5,400,915 (Kennedy).  
         [0018]     Another form of packaging that is effectively tamper resistant is the glass ampule that traditionally contains injectable medication. An example of such a glass ampule is found in U.S. Pat. No. 5,900,378 (Mayer, et al.). Once the glass on an ampule is broken it cannot be rejoined. In the case of a glass ampule containing medication, the container itself is broken to access the contents (medication).  
         [0019]     Other systems. Drug manufacturing and packaging companies have developed several anti-counterfeiting, anti-diversion and anti-tampering methods. These innovative packaging solutions have been invented and put in place to prevent the primary packager, the pharmaceutical manufacturer, from exposing themselves to the liability of product diversion. These methods include: (1) security holograms; (2) electronic article surveillance tags; (3) covert or overt printing methods on the labels; (4) near-infrared (NIR) inspection systems, which are typically used to verify tablet placement in blister packaging before package sealing; (5) bar coding systems; (6) radio-frequency identification systems—will find use in hospitals; (7) X-ray; (8) build tampering controls into the product itself; (9) lot numbers; (10) expiration dates; (11) tamper evident rings that tear off the bottom of the closure like on 1 quart plastic motor oil containers; (12) foil membranes like on yogurt containers; (13) tear top plastic like on some beverage containers; (14) shrink wrap, which is commonly used on over the counter products; (15) vacuum packing; (16) tear top lids; and (17) window caps, which is used seldom or never in the pharmaceutical industry, are also not original and home canners were applying them to Mason jars around 100 years ago. All vial closure designs that we know of that are currently patented to be tamper evident can be removed and replaced leaving no evidence behind that the vial was violated.  
         [0020]     Obviously, all of the prior art packaging methods and apparatuses discussed herein, while not in the preferred embodiment, contain portions, elements and components which could be used in conjunction with the present invention and therefore are envisioned as potential suitable portions of embodiments of the present invention. Discussion of their disadvantages is expressly not intended to disclaim inclusion of their subject matter within embodiments of the present invention.  
         [0021]     It is a first object of the present invention to provide a prescription vial with built in tamper resistant features.  
         [0022]     Additional objects, advantages and novel features of the invention will be set forth in part in the description which follows and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.  
       SUMMARY OF THE INVENTION  
       [0023]     The present invention is a secure packaging unit for holding a material to be stored. The unit comprising an open top container. The open top container is for holding the material that is to be stored. The open top container defining a container passageway therein and a seal portion. The seal portion is configured for fixed attachment to the container portion.  
         [0024]     The seal portion defines a seal portion passageway therethrough the seal portion in alignment with the container passageway when the seal portion is fixed to the open top container. The passageway has a first end extending to a second end. The second end attaches to the container portion. The seal portion further comprises a seal membrane between the first and second ends, thereby dividing the seal portion passageway. The seal membrane is configured for removal from the seal portion thereby allowing access through the seal portion passageway into the container passageway.  
         [0025]     It is preferred that the present invention be provided with a lid portion that is configured for removable attachment to the seal portion first end. Likewise, it is preferred that the open top container comprises a base, this base being generally clear in coloration for allowing an individual, camera or machine to more easily view the markings and to view and/or record the actual color of the material placed in the open top container passageway after the container is sealed.  
         [0026]     In use, after the material is placed into the open top container passageway and the seal portion is fixed to the open top container thereby sealing the material within the passageway until the seal membrane is removed.  
         [0027]     The purpose of the foregoing abstract is to enable the United States Patent and Trademark Office and the public generally, and especially the scientists, engineers, and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.  
         [0028]     Still other objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description wherein we have shown and described only the preferred embodiment of the invention, simply by way of illustration of the best mode contemplated by carrying out the invention. As will be realized, the invention is capable of modification in various obvious respects all without departing from the invention. Accordingly, the drawings and description of the preferred embodiment are to be regarded as illustrative in nature, and not as restrictive in nature. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]      FIG. 1  shows a side, cross-sectional view of a first embodiment of the present invention.  
         [0030]      FIG. 2  shows a side, cross-sectional view of a second embodiment of the present invention.  
         [0031]      FIG. 3  shows a perspective exploded view of a third embodiment of the present invention, along with a cap.  
         [0032]      FIG. 4  shows a perspective exploded view of a fourth embodiment of the present invention.  
         [0033]      FIG. 5  shows a perspective view of a fifth embodiment of the present invention with a human hand in place to remove the seal portion.  
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]     While the invention is susceptible of various modifications and alternative constructions, certain illustrated embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the invention to the specific form disclosed, but, on the contrary, the invention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined in the claims.  
         [0035]     The present invention is a secure packaging unit. Referring initially to  FIG. 1 , shown is the secure packaging unit  10  of the present invention. In the preferred embodiment, this secure packaging unit comprises a pharmaceutical pill bottle. While this is the preferred embodiment, the present invention and components of the present invention can be utilized in other applications and therefore the discussion of the present invention directed towards the pharmaceutical pill bottle embodiment is not intended to be a limitation.  
         [0036]     The invented secure packaging unit  10  comprising an open top container  30  having a seal portion  60 . While the preferred embodiment utilizes an open top container in the sense of a vial, other types and configurations of open top containers are likewise envisioned.  
         [0037]     The open top container  30  having a side wall or side walls  36  which cooperate with a base  34  to define a container passageway  32  therein. In the preferred embodiment, the base  34  is a separate component, which is affixed to the second end  40  of the open top container  30 . This can be done through any manner, including but not limited to adhesives, plastic welds, etc. One reason for this separate base is for allowing the base to be of a different material or coloration than the body of the container  30  itself. For instance, the base could be clear thereby allowing a pharmacist or patient to clearly view the accurate color of the contents of the vial through looking through the bottom of the vial, while the remainder of the container  30  could be the traditional amber color. However, in some embodiments, the base could be molded as an integral portion of the container itself rather than being a separate component. The base thus can serve as a security view window, allowing the contents of the container to be verified according to size, shape and color. The base preferably has no wrinkles, embossing or markings that might obstruct the view into the container.  
         [0038]     The open top container  30  having at least one first end  38  extending to at least one second end  40 . The second end  40  being provided with a base attachment  42 , and the second  38  being provided with a seal portion attachment  44 . While the embodiment shown in the Figures shows an open top container comprising a side wall body attaching to a base, it is expressly envisioned that embodiments of the present invention could utilize open top containers having integral bases, such as injection molded or blow molded open top containers, etc. In being so affixed to the container, the site of welding or adhesion cannot be used twice thereby preventing the new container body from being applied to a previously used base or vice versa.  
         [0039]     The seal portion  60  of the present invention comprises a seal portion passageway  62  extending therethrough, defined by a side wall  63 , this passageway having a first end  64  extending to a second end  66 . In the embodiment shown, the sidewall is generally cylindrical tubular in shape. Other shapes are likewise envisioned, including, but not limited to triangular tubes, rectangular tubes and other shapes.  
         [0040]     The seal portion  60  further comprises a removable seal membrane  68  located between the first end  64  and the second end  66 . This seal membrane  68  divides the seal portion passageway  62  into two chambers, namely an inner chamber  76  and an outer chamber  78 . This seal membrane  68  is configured for easy removal from the seal portion passageway. In the preferred embodiment, the seal membrane  68  is plastic. Preferably, the seal membrane is a continuous piece of plastic along with the rest of the seal portion  60 , so that the seal portion  60  and the seal membrane  68  are not two pieces of plastic that were molded and subsequently attached, but rather the seal portion  60  and seal membrane  68  together are one piece of plastic that were molded at once. Separating the seal membrane  68  from the seal portion  60  requires breaking the plastic. Such a fracture in the plastic prevents the seal membrane  68 , or a piece similar to the seal membrane  68 , from ever being reapplied after the separation. Suitable seal membranes include, but are not limited to: foil, plastic, foil backed plastic, perforated plastic and metal and pull-tabs. The seal portion  60  provides a seal that is able to be removed by the end user after purchase, this seal portion sealing the contents of the open top container (or “vial) within the container passageway (when the seal portion has been connected to the open top container after the open top container has been filled with the material to be stored  2 . The seal membrane  68  can be flat, convex ( FIG. 2 ) or concave ( FIG. 1 ).  
         [0041]     The seal membrane  68  can be removed from the seal portion  60  any number of ways. In example, as shown in  FIGS. 3 and 5 , the user could push his or her finger down on the seal membrane  68 , thereby causing the seal membrane, or a portion of the seal membrane, to break away from the rest of the seal portion  60  around the perimeter of the seal portion, the seal membrane being then removed from the container and discarded. Alternatively, as shown in  FIG. 4 , the seal membrane  68  could haven an integral ring or handle  80  allowing a user to pull the handle thereby breaking the seal membrane  68  out of the seal portion. Additionally, the seal membrane could be pried upward or torn from its location, or the container/vial could be squeezed resulting in breaking the seal membrane. Other methods of removing the seal are envisioned.  
         [0042]     The seal portion second end  66  is configured for connecting to the open top container  30  through use of an open top container attachment  70  for cooperating with and rigidly attaching to the seal portion attachment  44  of the open top container first end  38 . Manners of attaching these two components together include, but are not limited to spin weld seals, ultra-sonic seals, heat stake, ultraviolet light welds, laser welds or other fastening techniques for creating a plastic weld or a permanent hermetic adhesion and adhesives. These welds or adhesions are preferably to minimally exceed 94.0% of mechanical strength of that of the surrounding plastics when plastics are the manner of construction. Tampering with the weld or adhesions will damage surrounding plastics and will be visibly detectible. It is the intent that the connection between the two components will be permanent, requiring the destruction of one or both of the components if the two components are to be separated from one another.  
         [0043]     The external surface of the seal portion  60  comprises a lid portion attachment  72 . In the embodiment shown, this lid portion attachment  72  comprises a plurality of threaded lugs, such as those typically used with prescription pill vials. While this is described as present in the embodiment shown, other lid portion attachments are likewise envisioned.  
         [0044]     The present invention preferably being provided with a separate lid portion  90 . The unit configured for sealing by said lid portion. The lid portion  90  further comprising a seal portion attachment  92 , such as integral threads, for allowing said lid portion  90  to attach to the seal portion  60 , preferably at a lid portion attachment  72 , such as the external threads shown in  FIG. 1 . While it is preferred that the present invention be provided with said lid portion, the lid portion is not necessary to the operation or utilization of the present invention. It is preferred that the lid portion  90  comprise a standard stock pharmaceutical pill bottle lid with standard child resistant/elderly friendly features, and lids that are not child resistant. The lid portion  90  (child-resistant or not) may be screwed onto or otherwise attached to the top of the assembled container thereby covering the seal membrane and protecting it against accidental damage. The lid portion must then be removed before the seal membrane can be removed in order to access the contents of the vial/container. The lid can be repeatedly applied and removed regardless of the presence of the seal membrane.  
         [0045]     Thus, in one embodiment, the present invention comprises a sealed prescription vial that essentially offers a contract between a pharmacist and a patient. It is designed to safely package the product and also increase the level of confidence that both patients and pharmacists have in the contents of the vial. The patient is assured that the contents have not been altered after the pharmacist filled it and is also assured that the pharmacist takes responsibility for the contents whether it was correctly filled or not. In such a configuration it is impossible to access the contents of a filled container without destroying the seal membrane or the vial with destruction of the seal membrane being permanent and unable to be covered up or disguised.  
         [0046]     Optionally, a pharmacist could photographically record the contents of a vial/container of the present invention&#39;s structure, thereby authenticating the type, quantity, time, patient and proof of security of the contents at any time. Therefore, the pharmacist is assured that any alteration of the contents of the vial while in possession of the patient cannot be blamed on the pharmacist. To package a product in the invented vial one has no choice but to initially seal the contents.  
         [0047]     The person who packages the contents into one of the present invention containers may rest assured that the contents may not be accessed without breaking into the container through the seal membrane, thereby doing the container irreparable harm and creating clearly visible evidence that unauthorized entry into the vial/container has been accomplished. The only way to seal the contents again is to package and seal them in a brand new container.  
         [0048]     The present invention can be used on prescription vials designed to hold tablets, boxes (such as a box containing an inhaler, other vials (such as vials of eye drops)), or liquids. It could also be used on ointment jars and ointment tubes.  
         [0049]     All current technology for making containers/vials tamper resistant could be used on containers of the present invention in addition to the novel system of the present invention (i.e., induction seals with holographs can still be applied to the top of the vial (over the top of the seal membrane)), tamper resistant lids that separate off a piece while the initial opening could still be used to cap the vial/container, shrink-wrap could still be applied over the top of the lid and vial, etc.  
         [0050]     The present invention allows pharmaceutical and other packaging security to rise to a new level. Once the vial is sealed and indelibly marked, the contents cannot be accessed or altered without leaving a trace. Since the contents are secure, the vials together with their contents may be weighed, photographed, bar-coded, signed, laser marked or thumb printed to record the contents at the time of sale or at the time the pharmacist seals the vials (prior to the customer breaking the seal). Should the contents ever be returned to the person who sealed it containing substances other than what the weight, photos and other evidence show, then the packager can be sure that the contents were altered after the sale.  
         [0051]     This invention succeeds in looking beyond the traditional approach of consumer protection and innovates toward provider protection as well. By applying the present invention, pharmacists are improving the security of their inventories, protecting their employees and hosts, reducing liability risks for insurance providers and eliminating the costs of fraudulent consumer claims of under-counting and mis-filling by pharmacies.  
         [0052]     No other vial is able to provide this level of protection. This technology will begin the process of helping to reduce the costly attrition of pharmacists from this highly stressful working environment.  
         [0053]     This technology also allows the industry sufficient proof of product that fully automated-unmanned (including ATM style) pharmacies may be considered.  
         [0054]     The present invention is intended principally for pharmacists who are involved in secondary packaging of prescription products. However, the technology has other applications as well. Primary packagers may have interest in the product. Others who are not in the pharmaceutical industry but who may wish to secure items such as keys, groceries, cosmetics, cosmeceuticals, hardware, toxins, chemicals, lab samples, microchips, small parts for production, money, precise measurements of valuable materials such as gold or other items for which they might find this secure package to be useful.  
         [0055]     While there is shown and described the present preferred embodiment of the invention, it is to be distinctly understood that this invention is not limited thereto but may be variously embodied to practice within the scope of the following claims. From the foregoing description, it will be apparent that various changes may be made without departing from the spirit and scope of the invention as defined by the following claims.