EP0554393A1

EP0554393A1 - Decoration, identification and differentiation closure system

Info

Publication number: EP0554393A1
Application number: EP92900073A
Authority: EP
Inventors: Charles Papciak
Original assignee: West Co Inc
Current assignee: West Pharmaceutical Services Inc
Priority date: 1990-10-30
Filing date: 1991-10-29
Publication date: 1993-08-11
Also published as: WO1992007769A1; EP0554393A4; CA2095032A1; AU9016991A; CA2034693A1

Abstract

L'invention se rapporte à un système d'emballage pour produits pharmaceutiques ayant une fonction d'identification et constitué par une fermeture (10) qui est placée sur un récipient contenant le produit pharmaceutique et qui se compose d'un capuchon scellé hermétiquement (11), lequel comprend une paroi annulaire solidaire et une face supérieure (13) tournée vers le haut. La fermeture et l'élément (17) recouvrant la capuchon comportent des repères d'identification pouvant se présenter sous la forme de couleurs et de mots qui ensemble fournissent à l'utilisateur du récipient d'emballage des informations sur le contenu.The invention relates to a packaging system for pharmaceutical products having an identification function consisting of a closure (10) which is placed on a container containing the pharmaceutical product and which consists of a hermetically sealed cap (11 ), which comprises an annular wall integral with an upper face (13) facing upwards. The closure and the element (17) covering the cap have identifying marks which may be in the form of colors and words which together provide the user of the packaging container with information on the contents.

Description

DECORATION, IDENTIFICATION AND

DIFFERENTIATION CLOSURE SYSTEM BACKGROUND ART

Pharmaceutical products are sold with extensive labeling. Packaging and containers are filled with instructions, warnings, and other information. Goods which can be packaged in vials, such as unit doses of medicaments, are packaged with written instructions inside the box or other package which contains the vial. These vials are intended for use with syringes and are to be applied to the patient at the bedside or other places of treatment.

Typically, nurses will be assigned to give medicines and the like to a number of patients at one period of time. Often times, the nurse administering the medicine will have an entire tray or even a cart full of medicines to be given to a part or all of a floor in a hospital. In order to understand the background of the present invention and the environment in which it is intended to be used, it is necessary to visualize a health care worker assembling medicine on a cart or tray for a visit to several patients. Typically, the nurse or health care worker will have individual instructions for each patient, and will place those instructions on separate locations on the tray or cart. Reading each set of instructions separately, the health care worker will then place the appropriate medicines from the pharmacy- department of the hospital on the respective instruction sheets or slips of paper.

When tablets or pills are given, they are often placed in disposable cups and one can be relatively certain that the correct patient will be given the correct medicine. Similarly, when medicines are to be given with a syringe, unit dose vials of the correct medicine in the correct amount can be placed on the patient's instruction list or chart and there is every expectation that the appropriate medicine will be delivered to the appropriate patient. In some instances, however, the medicine which is to be given to the patient will be mixed at the point of administration or use. For example, dilution instructions are often times provided for medicine which, if it is not diluted, can cause serious problems. This information is given with the instructions from the doctor or pharmacist in most cases. In addition, this information is often printed on the vial label or container itself. Every effort is made to insure that the instructions are followed at the point of administratio .

A problem arises when the health care worker relies upon information which is placed on the cap of the container, particularly in containers which have a removable protective cap. These caps are essential to maintain sterile conditions for the medicines, and are designed to be easily removed by a flipping motion of the thumb, while the vial is held in one hand. At that point, the nurse can then add the diluent or perform whatever additional steps are necessary as the medicine is transferred to a syringe and then to the patient. Occasionally, however, the health care worker will remove more than one cap, particularly if a number of treatments are all to be given at one time. Also, even when one medicine is being administered, if it is to be diluted and if the diluent is supplied separately, caps from many containers must be removed. If the container without the cap does not contain the appropriate instructions, or if there is some way for the container to be separated from the cap, thereby losing the instructions, an unnecessary risk is taken.

While every intention is to avoid confusion and haste, sometimes it is unavoidable that the health care worker will have too many patients to treat in too short of time, and the very real possibility exists that the medicine given to a particular patient may not be precisely the treatment which the doctor has prescribed. While sometimes too much or too little diluent may not cause a significant problem, the very real possibility exists that improper administration of medicine can cause serious harm to the patients being treated.

As simple as it sounds, there have been many tragic examples of mistakes being made by health care personnel. These mistakes have cost lives and have endangered the lives of many others. For example, many deaths occur nationally each year because of a mix-up of sodium chloride and potassium chloride the latter of which, if not diluted, can cause death. And yet, at the present time, there is no system for product identification of pharmaceutical products and the like which is designed specifically for point of application treatments. In many instances, where removable outer caps are used for protection of the patient and maintenance of sterile conditions, after removal the cap is placed near the vial to keep the instructions on the cap near the vial. Yet there is no real assurance that the cap and vial are properly matched at a later time when the busy health care worker picks up the medicine for a particular patient. If he or she glances at the wrong cap, a mistake of potentially fatal consequences can take place.

Accordingly, it is an object of this invention to provide additional safety at the point of use of medicines.

It is a specific object of this invention to provide a system for pharmaceutical product identification which can be used at the point of application to insure the proper identification and other information be communicated to the nurse or other health care personnel. Other objects will appear hereinafter. DISCLOSURE OF THE INVENTION

It has now been discovered that the above and other objects of the present invention may be accomplished in the following manner. Specifically, a new system for pharmaceutical product identification has been developed. The system includes a closure on a pharmaceutical container, including an aluminum cap seal which has a first identifying indicia. Also provided is a removable overcap protecting the closure and having a second identifying indicia. The first and second indicia cooperatively convey information to the user of the container. Information is conveyed both before and after the overcap is removed.

Examples of information which is conveyed by the first and second indicia are safety messages, identity messages, dosage messages, restriction on use warnings, color codings and other instructions. In addition, the indicia may convey contents, brand names, dosage strengths and other information.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects of the present invention and the various features and details of the operation and construction thereof are hereinafter more fully set forth with reference to the accompanying drawings, where:

Fig. 1 is an enlarged elevational view of one embodiment shown is section illustrating the attachment of a removable overcap onto a closure seal.

Figs. 2 - 5 are perspective, exploded views of different embodiments of the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION

As shown in Fig. 1, the system of the present invention includes a device, shown generally by the reference numeral 10, which includes, among other parts of the closure system, a cap seal 11 which is normally made from aluminum. The cap seal includes a top 13, on which a first identifying indicia may be placed. The top terminates inwardly at the center hole 15 which is designed to accept the overcap 17. Overcap 17, shown in Fig. 1, is typically a plastic button like member which has been formed or molded from plastic and which contains a second identifying indicia. The annular dependent ring 19 is sized to fit hole 15 and, during assembly, is formed outward, shown at 19a as the dot and dash view of cap 17a fits on top 13. This entire assembly is then placed on a rubber stopper or other closure. When the cap 17a is desired to be removed, the health care worker merely presses upward against the cap 17a, fracturing frangible portions and exposing the top 13.

Shown in Fig. 2 is a pharmaceutical product identification system in which the cap 21 is plain and the top 23 has been colored. Overcap 27 is clear, thereby allowing the information contained on the top to be seen both before and after removal of cap 27. This ensures that the health care worker using this system will have whatever . information is desired by the pharmacist, drug manufacturer, or physician, as need be, before and after the cap is removed.

Similarly, in Fig. 3, the plain cap 31 has printed information such as advertising or instruction such as "must Be diluted" for potassium chloride. This information is placed on top 33 which is visible through clear cap 37, both before and after the cap 37 has been removed. In this case, whether color coding or information is important for the user, that information can be relayed without any possibility of the information being thrown away with the cap.

In Fig. 4, a plain cap 41 with a plain top 43 include a printed cap 47 which is primarily for advertising purposes in this example.

In Fig. 5, a colored cap 51 and colored shoulder 53 are matched with a similarly colored cap 57. In this case, the information is contained on cap 57, but the similarity of color coding allows the health worker to match the cap to the appropriate vial or container, even after the cap 57 has been removed. Of course, the vials, not shown, to which the seal and cap are added may be clear or the same or different colors from the seal and/or cap.

In each case, the information conveyed by the first identifying indicia on the cap seal is cooperatively combined with the information conveyed by the indicia on the removable overcap, to provide a fail-safe redundancy of information at the point of use of the container to which they are applied.

As has been noted, safety messages such as the appropriate material for dilution or the quantity of dilution can be conveyed with both the first and second indicia, either duplicating the information or combining to convey that information. Extra assurances are given when the same message is on both the cap and the top of the container seal. Similarly, restrictions on use or other warnings can be used. For example, the cap may state that dilution is required while the seal top may state that the contents cannot be used without dilution. One particular example of the present invention which illustrates the important contribution made toward safety is the use of identical indicia, such as black coloring or warnings that the contents must be diluted before use, on both the closure and the overcap. Thus, if the over cap is removed by a nurse prior to the time when the contents are to be diluted, there is less likelihood that the instructions will be ignored because the same instructions are contained on the closure itself. If the overcap is misplaced or becomes mixed up with other overcaps, the safety alert is still present on the closure. Prior to removal of the overcap, when the nurse is selecting medicines to take to the patient, she can rely on the overcap before it has been removed to convey the same necessary information. As she takes the steps to properly prepare the medicine cart or the like, removal of the cap will not cause the necessary information to be separated from the pharmaceutical container.

In the preferred embodiment, cap 17 may be manufactured from plastic such as polypropylene or other similar plastics. The specific material is not critical, as long as other functional requirements are met. The plastic should be suitable for receiving printing or other information after formation, and such be susceptible to being colored prior to manufacture. Similarly, the seal can be made from a number of materials, although aluminum is the preferred material since it is suitable for application of colors through dies and lacquers, and since it is receptive to printing.

It is particularly important that the product be immediately and visually identified. Messages, instructions or. warnings must be highly visible and for that reason the printing process must be sufficient to clearly define the color and/or information which is intended to be placed on either the cap, under seal, or both. The colors should be easily duplicated, particularly since the cap and seal are often made at different points in the manufacturing process. The products should be autoclavable, and thus would stand temperatures in excess of 121°C for sufficient time to sterilize the products. It should be noted that the information added to the products by the present invention is on the exterior and is never in contact with the contents of the vial. Accordingly, there is no reason for expensive qualification testing and the like.

In a preferred embodiment, the system of this invention contemplates the use of a color indicia and instructive words on both the pharmaceutical container closure and the removable overcap. The color indicia of the closure and the overcap cooperatively convey information to the user of the container. The instructive words also cooperatively convey information to the user.

For example, a black closure and a black overcap together tell the user that the two were originally together and should be kept together, as well as telling the user that the contents must be diluted. The instructive words also tell the user that the contents must be diluted prior to administration to the patient. Separation of the overcap from the closure also conveys information to the user.

While particular embodiments of the present invention have been illustrated and described herein, it is not intended to limit the invention. Changes and modifications may be made therein within the scope of the following claims.

Claims

CLAIMSWhat is claimed is:

1. A system for pharmaceutical product identification, comprising; a closure on a pharmaceutical container, including a cap seal having a dependent skirt and an upwardly facing top with a color indicia and an instructive indicia; and a removable overcap having a color indicia and an instructive word indicia; said color indicia of said closure and overcap cooperatively conveying information to the user of said container and said instructive word indicia also conveying information to the user of said container, whereby separation of said overcap from said cap seal also conveys information to said user.

2. The system of Claim 1, wherein said color indicia convey safety messages.

3. The system of Claim 1, wherein said instructive word indicia convey safety messages.

4. A system for pharmaceutical product identification, comprising: a closure for a pharmaceutical container, including a cap having a top and a dependent skirt, said cap having a first identifying indicia; and a removable overcap. covering said first indicia connected to said cap by a frangible attachment, said overcap having a second identifying indicia thereon; said first and second indicia cooperatively conveying information to a user.

5. The system of Claim 4, wherein said first and second indicia^' convey safety messages.

6. The system of claim 4, wherein said first and second indicia convey the same message.

7. The system of Claim 4, wherein the first and second indicia convey dosage information.

8. The system of Claim 4, wherein said first and second indicia convey restriction on use information.

9. The system of Claim 4, wherein said indicia convey information using color coding.

10. The system of Claim 4, wherein said removable overcap is clear.

11. The system of Claim 4, wherein said first and second indicia convey source of goods information.

12. A system for pharmaceutical product identification, comprising: a container having a pharmaceutical product therein; a closure on said pharmaceutical container, including a cap having a top and a dependent skirt, said cap having a first identifying indicia; and a removable overcap connected to said cap by a frangible attachment, said overcap having a second identifying indicia thereon, said first and second indicia cooperatively conveying information to a user.

13. The system of Claim 12, wherein said first and second indicia convey safety messages.

14. The system of Claim 12, wherein said first and second indicia convey the same message.

15. The system of Claim 12, wherein the first and second indicia convey dosage information.

16. The system of Claim 12, wherein said first and second indicia convey restriction on use information.

17. The system of Claim 12, wherein said indicia convey information using color coding.

18. The system of Claim 12, wherein said removable overcap is clear.

19. The system of Claim 12, wherein said first and second indicia convey source of goods information.

20. A system for pharmaceutical product identification, comprising: a container having a pharmaceutical product therein; a closure on said pharmaceutical container, including a cap having a top and a dependent skirt, said cap having a first identifying indicia; and a removable overcap connected to said cap by a detachable attachment, said overcap having a second identifying indicia thereon, said first and second indicia cooperatively conveying information to a user.

21. A system for pharmaceutical product identification, comprising:

a closure on a pharmaceutical container,, including a cap seal having a dependent skirt and an upwardly facing top with a first color indicia and a first instructive indicia in the.form of words; and

a removable overcap having a second color indicia and a second instructive indicia in the form of words; said first and second color indicia cooperatively conveying information to the user of said container and said first and second instructive indicia conveying information to the user of said container, whereby separation of said overcap from said cap seal also conveys information to said user.