US 3503493 A
Description (OCR text may contain errors)
March 31, 1970. v ,J,NAG 3,503,493
MEDICAMENT PACKAGING DEVICE Filed Jan. 8, 1968 I 2 Sheets-Sheet 1 TRADE NAME DOSAGE CONTROL No.
TRADE NAME DOSAGE CONTROL No.
March 31, l970 J. J. NAGY 3,503,493
- MEDICAMENT PACKAGING DEVICE Filed Jan. 8, 1968 2 Sheets-Sheet z TRADE NAME TRADE NAME DOSAGE OSAGE mgmm. No. ONTROL No..
54 4 =J5B Q United States Patent US. Cl. 206-56 7 Claims ABSTRACT OF THE DISCLOSURE A unit dose package for dispensing of medicaments in cluding an identification means for record keeping and similar purposes. The identification means includes on one side preprinted indicia concerning the drug contained within the unit dose package and is removably secured to the main body of the unit dose package, which main body additionally includes preprinted indicia concerning the drug. At the other side of the identification means is a pressure-sensitive adhesive-coated surface substantially covered by a protective release strip arranged for ease of removal therefrom. The identification means when removed from the main body of the unit dose package and freed of the protective release strip may be readily adhered to a document surface. The unit dose package is also designed for facility of assembly in removably securing the identification means thereto and so that in manufacture a plurality of such unit dose packages may conveniently be detachably connected for ease of handling 0 This invention relates to packaging and is especially concerned with a new packaging arrangement concerning the medicinal dispensing of a unit dose of a drug.
In the area of administering drugs, there has been an increasing demand for unit dose dispensing packages particularly for use in hospitals and similar institutions. One of a number of motivations for this increasing demand is the desirability to trace and control the flow of a drug from an initial source, such as source of manufacture, through to ultimate consumption by the patient.
Other considerations forming a basis for this demand include the otherwise constant handling of drugs in the dispensary or at the nursing station in the drug transfer from large to individual receptacles which creates a distinct health risk. Further, a requisitioned drug for patient use involved in such a transfer creates a need for provid ing an additional label and data on the individual receptacle necessary to prevent any confusion or mixup of drugs insuring that a patient receives the particular drug prescribed by his physician and not a drug intended for another patient.
In addition to the problems noted above, the solution of which problems many believe may be realized by implementation of the unit dose dispensing package, there exists another serious problem in the area of administering drugs which to date has not been adequately accomplished. This problem concerns the generally cumbersome, present-day record keeping methods in hospitals relating to dispensing of unit doses of the drug to patients, which methods involve an enormous amount of routine paper work, consuming an immoderate amount of time of highly trained technical personnel. The imposition of the requirement for maintaining such record keeping data significantly shortens the period that the nurse or other technical personnel might otherwise devote to or be available for bedside or other type duties. Some factors which most certainly contribute to the amount of time expended in record keeping include those such as the amount of information which is required to be recorded as well as the number of times this particular information must be duplicated for efficiently maintaining the record keeping system. An example of the information normally recorded by a nurse in drug administration for a particular bookkeeping technique might include: the patients name, medication name and strength, control number, patients number and bed number, time of administration, etc. In the regular course of drug administration, such information would have to be completely filled out in at least five distinct forms, for purposes including: drug inventory to maintain a plentiful stock and an effective reorder operation, patient billing, patient monitoring, etc. It is also evident from the above, and especially in view of the busy atmosphere of a hospital, that the likelihood of mistakes in recording some of these data is of a high order.
To illustrate best the time consumption involving technical personnel in record keeping, a brief review of a typical procedure for dispensing of drugs in hospitals will be described. After the patient has been examined, the physician would prescribe a drug setting into motion a series of events generating a paperwork snowball that might be described as follows:
(a) The drug prescribed and other related data such as strength, frequency, and time of administration, etc., would be recorded on a patient order sheet.
(b) From the patient order sheet, the nurse would make several copies of a requisition form to be distributed to several hospital departments such as the dispensary, the billing office, and the nursing station at which the patients chart is kept.
(c) The nurse would additionally make out a card normally kept at the nurses station that would be the nurses permanent instruction document containing a permanent list of all medication and other pertinent data for a particular patient.
(d) From the card, the nurse would fill out a medication card on the daily nurses record which also becomes part of the patients chart, containing such information as a list of all medication and drugs needed for the current twenty-four hour period as well as a past record of medication administered.
(e) Upon completion of forms such as those noted above, either completely or with the preliminary necessary data, the nurse would then obtain the drug from the nurses supply cabinet or hospital pharmacy, whereby in each case, the drug is normally removed from a large receptacle to an individual receptacle such as a soufil cup that is positioned on the medication card indicating to which patient the drug is to be administered. A num ber of such drugs and medication cards would be positioned (one for each patient) on a cart enabling the nurse to make her rounds.
(f) Subsequent to the administration of the drug, a record is made in the daily nurses record as well as on a patients charge sheet noting this completed act of drug administration, which would additionally contain any other material or services rendered to a patient.
Thus, it can be readily appreciated that the time consumed and actual costs incurred in maintaining accurate records is no small factor contributing to the increasing budgets for running hospitals.
The purpose of the present invention is to provide a unit dose packaging arrangement that will serve to diminish the time expended for record keeping purposes, reduce the likelihood of mistake present in manual recording operations, contribute to the avoidance of medication error, and, in addition, further the ability to trace and control the flow of a drug. Simultaneously, it is a purpose of the present invention to provide a unit dose packaging arrangement that is inexpensive, simple in construction, and economical to manufacture. To attain this, the present invention contemplates combining a receptacle means and an identification means, the receptacle means having removably received therein a single dose of a drug. The identification means is removably secured to the receptacle means, one side of the identification means hearing preprinted indicia concerning the drug and its source while its other side is provided with a pressure-sensitive adhesive-coated surface, whereat the latter side is positioned a peel-ofl? protective strip having a surface opposing and releasably attached to the adhesive-coated surface. The present embodiment discloses the identification means to be divisible by way of a weakened severance line into two parts, each part of which bears corresponding preprinted data. Of course, the identification means could, if desired, be divisible into three or more parts, each part bearing corresponding preprinted data. The prepr'inted indicia referred to above might additionally include provisions for recording a patients name, time of drug administration, billing number, etc., or suitable space could be provided to record such latter-noted type of data. The identification means is flexible, and arranged so that when flexed will cause the peel-off protective strip to separate from the pressure-sensitive adhesive-coated surface. In addition, a pressure-sensitive adhesive-coated surface serves a dual function as a portion thereof is exposed and used as the vehicle for removably securing the identification means to the receptacle means. It is also desirable, of course, that the receptacle means itself be provided with preprinted data concerning the drug,
As a further feature, an arrangement and method are designed for packaging a plurality of the above type unit dose package subassemblies for ease of manufacture, storage and dispensing operations. In particular, a convenient technique of removably securing the identification means to complete a package assembly of unit dose package subassemblies is shown and described.
Other objects, advantages, and capabilities of the invention will become apparent from the following description, taken in conjunction with the accompanying drawings showing only a preferred embodiment of the invention.
In the drawings:
FIGURE 1 is an over-all perspective view of a unit dose package constructed in accordance with the present invention.
FIGURE 2 is a top plan view of the unit dose package.
FIGURE 3 is a somewhat enlarged front elevation view of the unit dose package.
FIGURE 4 is a bottom plan view of the unit dose package.
FIGURE 5 is an exploded isometric view of the unit dose package.
FIGURE 6 is a view of the backside of tag 32 shown in FIGURE 4 with a protective release strip partially extending thereover.
FIGURE 7 is a perspective view of a portion of tag 32 disclosing how the protective release strip can be separated therefrom.
FIGURE 8 is a top plan view illustrating one arrangement of packaging multiple unit dose subassemblies embodying the present invention.
FIGURE 9 is a somewhat enlarged side plan view of FIGURE 8.
FIGURE 10 is a partial bottom plan view of FIG- URE 8.
FIGURE 11 is a view of the backside of tag sheet 52 shown in FIGURE 11 with a protective release sheet extending thereover.
FIGURE 12 is a somewhat enlarged side elevation view of FIGURE 8.
Referring now to the drawings and more particularly to FIGURES 1 through 5, a unit dose package assembly designated generally as 21 includes a container sheet 22 often referred to as a blister, preferably of thermoplastic sheet material having a generally rectangular outline. Blister 22 is shown to comprise a depressed or concave portion 23 formed about its center with a planar rim or flange 24 extending about depressed portion 23. The blister depressed portion is conveniently designed to contain a drug 25 of capsule, tablet or like configuration, and is provided with a fiat upper surface. Blister 22 could be fabricated of a non-toxic relatively stiff material such as polystyrene, and in the present embodiment is depicted to be transparent affording visual observation of the contents embodying drug 25 contained therein.
Immeriately beneath blister 22 is a blister cover or backing sheet 26 of flexible rupturable planar sheet material having a rectangular configuration similar to but with somewhat wider dimensions than blister 22. Blister cover 26 is preferably a paper-metallic foil laminate such as paper aluminum foil, the foil upper surface being coated with a film of thermoplastic material (not shown) such as polyethylene, polystyrene, or the like. Blister cover 26 also functions as a label as its paper or lower surface bears preprinted indicia concerning the drug, such as the drug generic and/or trade name, the drug manufacturer, the dosage value, a control number, etc. The lower surface of flange 24 is adhesively united in facing engagement with blister cover 26 as, in manufacture, with the application of heat and pressure, the paper foil lamination is fused with the planar flanged area 24 of blister 22 by way of the thermoplastic coating to define a hermetically sealed receptacle. Drug 25 contained within the receptacle is shown to be of capsule form, but, of course, might be a tablet or any suitable form for patient administrating purposes, and might even consist of plural units when a medical treatment might require simultaneous administration of two components of medication where the components for some reason are not combined in a single unit dosage form.
As may be best observed from FIGURES 1 and 2, the termination of flange 24 at each corner of the unit dose package assembly is cut short of blister cover 26 at edge 27 leaving exposed pie-shaped portions 28 at the corners of blister cover 26 functioning to provide readily accessible finger tabs or pulls for removing, by tearing, blister cover 26 from container sheet 22 to open the otherwise sealed receptacle.
Unit dose package assembly 21 is further depicted to have an identification means 31 secured in flap-like relationship to the receptacle defined by blister 22 and blister cover 26, as illustrated in FIGURES 1, 3, 4, 5, and 6. The identification means comprises a tag 32 hearing on one side thereof preprinted indicia 33 provided in addition to the preprinted indicia appearing on blister cover 26. Preprinted indicia 33 similarly concerns or relates to drug 25 contained within the receptacle, whereby data forming a basis for the indicia could include the drug generic and/or trade name, the manufacturer of the drug, the dosage, and a control number. In addition, space or indicia might be provided for listing a patients name, time of drug administration, patients billing number, etc. As may be observed from FIGURES 4 and 5, tag 32 is shown to include a weakened severance line 34 across its center, which in the present embodiment consists of a perforated score to facilitate division of the tag into two separate stub members 35 and 36, each bearing corresponding preprinted indicia.
The entire backside of tag 32 is covered by a pressuresensitive adhesive coating. Such pressure-sensitive adhesives are well known and need not be described in detail here. A protective release strip 37 having a treated surface lies in releasable engagement with substantially the entire adhesive-coated area. The release strip may be treated with wax or a like substance enabling the release strip to be separated from or be peeled off the adhesive coating upon a slight pull without affecting the adhesive character of the coating. Release strip 37 is also provided with a perforated score line 38 aligned with perforated score line 34 of tag 32. In addition to each side of line 38, release strip 37 is shown to be slit along a common line 39 perpendicular to perforated score line 38, forming at each side of line 38 a release strip 37' comprising two distinct but abutting members. Since tag 32 is formed of flexible material, when flexed by simple manipulation of the fingers into the curved configuration depicted in FIGURE 7, the two distinct abutting members will readily separate from the pressuresensitive adhesive coating about slit line 39 facilitating removal of the protective release strip therefrom, when desired.
As may be seen from FIGURES l and 6, release strip 37 does not extend over the entire rear surface of tag 32 as a narrow ribbon-like area 41 of the pressuresensitive adhesive is exposed, allowing identification means 31 to be removably secured to the receptacle in flaplike relationship at the underside of of the blister cover 26 along a corresponding ribbon-like area 40 as shown in FIGURE 1.
In use of the present unit dose package arrangement, when the need for a drug administration is dictated, identification means 31 is removed from the receptacle and, when convenient, separated simultaneously along perforated score lines 34 and 38 into two distinct tag stub members 35, 36, whereby upon peeling the release strip therefrom, each stub member may be individually adhered to any one of the hospital record keeping documents heretofore designated, such as the hospital dispensary, inventory control record and the patients chart. If desired, the identification tag could, of course, be formed to be divisible into three or more stub members, each bearing coresponding preprinted indicia. It may be advantageous to have only one identification tag member, in which case perforated score lines 34, 38, as well as the duplication of preprinted indicia, would be unnecessary.
Since the top of blister 23 is of a flat configuration, the blister lends itself to being used as a pedestal for supporting the unit dose package, the blister thus functioning as a stable pedestal or souffle cup for administering drug 24 to a patient subsequent to blister cover 22 being ripped away from the blister by way of taps 28. In addition, it enables the preprinted indicia on the underside of blister cover 26 and/or the identification means to be observed when the receptacle is so supported in storage or on a cart for delivery to a patient.
From the foregoing, it is seen that the pressure-sensitive adhesive coating at the backside of tag 32 serves two distinct purposes, as not only it is employed for attaching the tag or a portion thereof to one or more record keeping documents, but in addition, it is used to removably secure the identification means to the blister cover or backing member in flap-like relationship.
Another feature of the present invention may be viewed in FIGURES 8 to 11 wherein there is illustrated an assembly and method for packaging a plurality of unit dosage package subassemblies, each subassembly being of the unit dose package type disclosed in FIGURES l to 7. As may be observed with specific reference to FIGURES 8 and 9, there is shown an elongate package 42 containing a plurality of connected unit dose package subassemblies 21, which package arrangement in the preferred embodiment is shown to comprise of two columns of five unit dose assemblies each; however, it is quite evident that variance of the particular number of unit dose assemblies in each row or coulrnn is, of course, obvious to those skilled in the art and within the scope of the instant invention.
Package 42 includes an elongate backing sheet 43 of flexible material the same as that described with reference to blister cover 26 in FIGURES 1 to 7. A plurality of blister pairs 44 are arranged in spaced relation longitudinally of sheet 43 whereas each individual blister pair is disposed laterally relative to sheet 43. As may be observed, each blister pair 44 comprises a pair of blisters 23 of the type shown in FIGURES 1 to 7, and in a similar manner blister pairs 44 are adhesively united to sheet 43 by a heat sealing operation. Extending transversely of sheet 43 are weakened severence lines 45, one lying Within the spaced area between adjoining blister pairs 44, whereby each severance line comprises alternately spaced perforation scores 46 and slits 47, as depicted. Longitudinally of sheet 43, extending perpendicular to weakened severance lines 45 and midway between the two defined columns is a singular weakened severance line 48 comprising a slit 49 interrupted by a pair of tie tabs 51 at each blister pair row. As illustrated, the weakened severance lines 45 and 48 together clearly define a plurality of unit dose package subassemblies.
The identification means forming a part of package 42 may best be described with reference to FIGURES 10 and 11 wherein there is shown an elongate tag sheet 52 and protective release sheet 53, respectively similar to tag 32 and protective release strip 37 described in FIG- URES 1 through 7 whereby each of sheets 52, 53 generally corresponds in area to backing sheet 43. Release sheet 53 having a treated surface lies in releasing en- I gagement with substantially the entire adhesive-coated area of tag sheet 52 except along a columnar strip 54 to expose adhesive coating 55 at each side of the longitudinal midline of tag sheet 52. Tag sheet 52 is also provided with weakened severance lines extending longitudinally thereof, comprising slits 49 and tabs 51 similar to and coextensive with those on the backing sheet, and in fact, in manufacture, would most likely be formed during the same die-cut operation on backing sheet 43 and blister pairs 44. Running transverse of tag sheet 52 and aligned with weakened severance lines 45 are a plurality of parallel weakened severance lines 56 comprising slits 57 and tie tabs 58. The remaining structure of each unit dose package subassembly 21 has been explained in detail with reference to FIGURES 1 to 7.
It may be seen from FIGURE 12 that the exposed adhesive-coated surface 55 of tag sheet 52 is the vehicle by which the identification means or tag sheet 52 is removably secured to backing band 43 in flap-like relationship. In manufacture of the packaging assembly, columnar band 54 of tag sheet 52 would initially be covered with the protective release type material forming a part of release sheet 53. However, the release sheet in a die-cutting operation would be severed along lines 59 forming a ribbon strip 61 enabling the same to easily be removed from tag sheet 52 thereby exposing pressuresensitive adhesive coating 55 adapting tag sheet 52 for securement to backing sheet 43 with the application of pressure. Thus, a simple package assembly is formed where any one of the disclosed subassemblies may be readily removed by a tearing operation to provide a unit close package for convenient administration of a drug to a patient where each unit dose package is supplied with an identification means separable therefrom and adapted to be adhesively secured to one or more record keeping documents obviating the need for extensive record keeping steps otherwise necessary to maintaining an eflicient record keeping system of the type heretofore described.
Obviously, the type and/or dimensions of the weakened severance lines made mention to throughout the specification may be varied and will be controlled by a number of factors, such as the desirability to provide ease of separation by a user yet simultaneously to provide sufficient strength for avoiding accidental separation under conventional handling conditions.
Although the present invention has been shown and described with reference to a particular embodiment, it is understood that the invention is not limited thereto but that changes and modifications may be made within the scope of the invention.
1. In a unit dose package for medicinal use,
container means having an opening and adapted to contain a drug of tablet or capsule form;
cover means positioned over said opening and united to said container means;
means for removably securing the tag means to said cover means;
said tag means bearing pre-printed indicia on one side thereof concerning said drug and comprising a pressure-sensitive adhesive-coated surface at the other side thereof;
a protective release strip having a surface opposing and releasably attached to the adhesive-coated surface;
said means for removably securing the tag means to said cover sheet including an exposed portion of the pressure-sensitive adhesive-coated surface; and
said tag means including a weakened severance line to present a pair of connected stub members each bearing corresponding pre-printed indicia.
2. Apparatus according to claim 1 wherein said tag means is flexible; and
said peel-off protective strip includes a weakened severance line adjacent the line where said two stub members are connected to present a pair of protective release strips one of said release strips being associated with each stub member.
3. Apparatus according to claim 2 wherein each of said protective release strips is slit scored to form two distinct abutting strip members adapted to be partially separated at the abutting area from its associated stub member when flexed, enabling the protective strip to be readily manipulated for removal.
4. A package arrangement comprising a plurality of unit dose package subassemblies;
an elongate cover sheet;
a plurality of containers of flexible plastic material,
each container including symmetrically spaced blisters formed therein, each blister being adapted to contain a drug;
each of said containers extending transversely of said elongate cover sheet, the containers jointly defining a number of blister columns extending longitudinally of the cover sheet;
said containers being arranged at uniform spaced intervals along said longitudinal direction;
means for adhesively uniting said containers to said cover sheet;
an identifying sheet corresponding in area to said cover sheet;
means for removable securing the identifying sheet to said cover sheet;
transversely spaced weakened severance lines aligned on said cover sheet at said spaced intervals and on the identifying sheet;
longitudinal weakened severance lines running midway of said symmetrically spaced blisters aligned on said containers, cover sheet and identifying sheet;
said longitudinal and transverse weakened severance lines jointly defining a plurality of equal compartments each containing but a single blister and defining a unit does package subassembly;
an area of the cover sheet and identifying sheet corresponding to each compartment bearing preprinted indicia relating to said drug;
assembly bearing preprinted indicia on one side thereof concerning said drug and comprising a pressure sensitive adhesive-coated surface at the other side thereof; and a separate peel-off protective sheet at each unit dose package subassembly having a surface opposing and releasably engaging the adhesive-coated surface; said means for removably securing the identifying sheet to said cover sheet includes an exposed portion of the pressure-sensitive adhesive-coated surface formed by the absence of said peel-off protective sheet along a columnar area aligned with the longitudinal midline of said cover sheet.
5. Apparatus according to claim 4 whereby means for dividing the identifying sheet and peel-off protective sheet corresponding to a unit dose package subassembly to form a pair of identifying sheet stubs each bearing corresponding preprinted indicia. 6. In the method of packaging, the steps which comprise:
providing an elongate cover sheet of relatively flexible material; adhesively uniting to said cover sheet a plurality of uniformly spaced containers of relatively stiff material, each container defining symmetrically spaced blisters containing a drug, where each receptacle pair runs transversely of the elongate cover sheet; providing identifying means corresponding in area to said cover means, the identifying means including a pressure-sensitive adhesive-coated surface covered by a protective release paper; removably securing the identifying means to the cover sheet by the application of pressure; and providing weakened severance lines running transverse of and longitudinal of said elongate cover sheet to form a plurality of equal and separable compartments, each containing but a single blister and defining a unit dose package sub-assembly. 7. In the method according to claim 6 including the step of:
removing a strip of release paper from said identifying means to expose an adhesive surface prior to and for the purpose of removably securing said identifying means to the cover sheet.
References Cited UNITED STATES PATENTS MARTHA L. RICE, Primary Examiner U.S. Cl. X.R.
.* g;;g UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No.l,50},493 Dated March 51, 1970 Inventor(s) Julius Joseph Nag ppears in the above-identified patent It is certified that error a hereby corrected as shown below:
and that said Letters Patent are Column 5, line 34, "coresponding" should read corresponding (line 19 page 12 of specification) line 43, "24" should read --25-- (line 27 page 12 of specification) Column 7, line 64, "does' should read dose-- (line 25 page 3)of our amendment filed January 3, 1969 SIGNED AND SEALED JUL 2 81970 6EAL) .Attest: I
Edward M. Fletcher, If; 71mm 3 5m mm m Offi Commissioner of Patents