AU2005203414A1

AU2005203414A1 - A Method of Reducing Inadvertent Injection of Topical Drugs

Info

Publication number: AU2005203414A1
Application number: AU2005203414A
Authority: AU
Inventors: Malvin Leonard Eutick
Original assignee: MALVIN EUTICK
Current assignee: MALVIN EUTICK
Priority date: 2005-07-28
Filing date: 2005-07-28
Publication date: 2007-02-15

Description

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c'K A METHOD OF REDUCING INADVERTENT INJECTION OF TOPICAL

DRUGS

00 FIELD OF THE INVENTION The present invention is directed to methods of reducing inadvertent injection of drugs which are meant for topical application. The methods comprise the provision of

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distinctive markings on the vials containing topical drugs to easily distinguish them from O vials containing injectable drugs. The invention is also directed to a medical container 0 10 containing a topical composition and where the container has been modified in a particular manner to reduce the possibility of the composition being injected as opposed to being applied topically.

BACKGROUND ART Vials are commonly used to store liquid and solid medications. Historically, injectable medicaments were provided in sealed glass or at a later period plastic ampoules, which restricted access to the medicament to syringe needles. In this way, the vial could not be opened and the medicament mistakenly administered in another manner.

These ampoules were superseded in the early 1980s by small glass vials with a bottle-like shape. The vials are sealed with a rubber stopper pushed into, or placed over the opening of the vial. The stopper is held in place by an aluminium cap which covers the rubber stopper, and bends around the edges of the collar on the top of the vial, to create a sealed skirt around the top rim of the vial. In order to allow a syringe needle access to the medicament, the aluminium cap either has an annular circular portion absent to expose the centre of the rubber stopper, or has a perforated circular portion in the centre which can be easily removed to expose the centre of the rubber stopper.

More recently, a plastic cap has been added to the lid system of vials. The cap is used to indicate tampering with the vial and to assist in the removal of the perforated aluminium on the top of the vials. The cap covers the top of the vial sitting over the

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Cl aluminium seal, and, once removed, cannot be resealed. The plastic lids come in two 3 variants: the one variant comprising a cap which is totally removed from the vial upon 0 opening, leaving the aluminium covering in place but exposing the rubber stopper to allow needle access to the vial, and, in another version, a cap which retains an attachment to the aluminium skirt after opening. However, when the cap of the latter description is removed entirely, the aluminium cap and rubber stopper may also be removed, allowing n access to the drug for administration other than by injection.

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o The plastic cap with this 'flip/tear' functionality is used on vials for storage and supply of topical medicaments. It is also used for medicaments which have to be administered with a wide-bore needle, for example a long, wide-bore intrathecal needle which may not be able to be inserted through a rubber stopper of the more traditional vial top. Due to the fact that the plastic cap does not have to be removed entirely, and can be left open but attached to the aluminium rim, the flip/tear system could be used for any injectable medicament.

This duality of functionality becomes problematic when the vial contains a medicament intended solely for topical use and where this medicament may be dangerous or fatal if injected into a patient. An example of a medicament of this description is a topical preparation called "Laceraine", which is supplied in a glass vial to maintain stability of the medicament. Laceraine is indicated for stemming blood flow in deep skin wounds and simultaneously providing some local anaesthesia to allow stitching of the wound. Laceraine contains, inter alia, adrenalin, amethocaine and lignocaine. This mixture would cause a fatal heart attack if injected.

Previously, medicaments of the sort where the route of administration is critical have been marked with highly visible warnings on the label, which is adhered to the side of the vial. Additionally, the Product Information Sheets and/or Consumer Medical Information Sheets are attached to the side of the vial or supplied inside with the vial packets. The Information Sheets are also available electronically. Also, bright colours

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have been used for the caps to indicate different medicaments. US57730292 describes the use of colour-coded vial caps with tactile raised symbols thereon to distinguish six types 0 of insulin.

The advantage of the above warning systems is that they comply with the legal requirement for marking drug containers as prescribed by the Government Drug O Regulatory Authorities.

Bar coding is also available for marking vials, but requires a bar code reader to be on hand.

The disadvantage of all of the above warning systems is that they are not efficient for or effective in emergency situations. Warnings adhered to the sides of vials are often concealed by the hand holding the vial. This becomes even more of an issue when the caregiver is under pressure, such as in an emergency ward where situations frequently require rapid response. Medical situations in low light are also problematic with these labelling systems, for example night time roadside incidents where lighting is usually poor and medical staff are pressurized to treat and/or stabilize the victim. There are many other trauma situations where rapid treatment of a patient is required under hazardous conditions of rain, mud, low light, wind, cold, precarious positions, obscured visibility and the like, and there is a possibility that a medical container containing a topical composition (for instance to reduce blood flow) will be mistaken for a container containing an injectable composition which can result in fatal outcomes.

The situation with Information Sheets attached to vials, often merely with a rubber band or placed in the vial container, is even worse than labels. In an emergency situation, the Information Sheet is likely to be removed and discarded in haste in order to have rapid access to the medicament, or the sheet is read by a first person and the vial is

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Sgiven to a second person to administer the medicament. Low light situations obviously lessen the likelihood of the medical personnel being able to read the information sheet.

00 Barcodes provide their own problems, presenting the necessity for permanent 5 access to a barcode reader, which is often not feasible. Additionally, barcodes could also present the problem that the barcode is read by a first person and the vial is then handed O to a second person to administer the medicament.

N With regard to coloured caps, there are so many colours available that it is not feasible to expect all medical personnel to be able to identify medicaments by colour of cap. This is more likely to cause confusion than solve the problem.

From the above, it is clear that is would be advantageous, if not medically crucial, to have an effective warning system on vials containing medicaments which are meant for topical application only.

SUMMARY OF THE INVENTION It is an object of the invention to provide a method of reducing inadvertent injection of topical drugs, which may overcome at least some of the above-mentioned disadvantages or provide a useful or commercial choice.

In one form, the invention resides in a method of reducing inadvertent injection of a drug which is meant for topical application, the method comprising providing the topical drug in liquid form in a vial, and providing a removable cap for the outlet of the vial, the cap being removable to enable the contents of the vial to be applied topically to a patient, wherein the cap is provided with a warning message that the contents of the vial are not to be injected.

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In this way, the last visual input a caregiver has before administration of the 00 medicament contained in the vial is the bold message on the top of the vial, right where the final act of cap removal takes place. The top of the vial is not obscured by fingers holding the vial and the message does not have to be sought. Even in emergency situations, any medical personnel will look at the cap portion on removal thereof. This ensures that the medical personnel are forced to take cognisance of the message

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emblazoned on the top area of the vial.

It is therefore considered that the concept of placing the warning message on the cap as opposed to the side wall, or a separate data sheet, contributes substantially to the working of the invention which is directed to a method of reducing inadvertent injection of a drug which is meant for topical application.

After much research and experimentation, it has been discovered that a doctor/paramedic/caregiver delivering the medicine in a vial will always pay particular attention to the top or cap the vial, inter alia to ensure that the top is sufficiently open, that there are no obstructions to prevent the medicine from being poured out of the vial et cetera. One form of the present invention takes advantage of this attention or focus on the top of the vial to provide a synergistic combination of a warning message to provide a "last line of defence" against inadvertent injection of the medicine that can cause fatal results.

In a second form, the invention resides in a method of reducing inadvertent injection of a drug which is meant for topical application, the method comprising providing the topical drug in liquid form in a vial, providing a removable cap for the outlet of the vial, the cap being removable to enable the contents of the vial to be applied topically to a patient, wherein the cap is provided with a warning message that the contents of the vial are not to be injected, and wherein the vial is coloured from at least the shoulder of the vial to the base of the vial.

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In another form, the invention resides in a vial containing a topical composition of 00 the type that would be hazardous if injected rather than applied topically, the vial having an outlet, and containing a removable cap for the outlet, the cap being removable to enable the contents of the vial to be applied topically to a patient, wherein the cap is provided with a warning message that the contents of the vial are not to be injected.

The vial used in the invention can be any vial known in the medical field, but is Opreferably the conventional vial used to store and supply injectable and some topical medicaments. The vial comprises a body of glass or plastic with a neck of diameterl3- 42mm. The sealing mechanism of the vial can be any mechanism appropriate for allowing access to the medicament, either by needle and/or for topical application. The vial is preferably sealed with a stopper in the outlet; the stopper being partially or completely covered by an aluminium covering which extends over the rim of the vial to create a skirt around the rim, and a plastic cap covering the aluminium covering.

The stopper can be any material suitable for penetration by a needle, but is preferably rubber. The covering on the stopper can be any suitable material, but is preferably aluminium as aluminium is easily tearable for rapid removal of the sealing system in emergency situations.

The aluminium covering can cover the stopper completely, but have a perforated section in the centre of the opening of the vial to enable easy removal of the section. This allows access to the stopper for the needle. Alternatively, the centre section is absent in the aluminium covering.

The plastic cap can be opaque or transparent, coloured or colourless. The warning message on the top of the vial can be in any form. The message can be engraved, embossed or printed onto the aluminium cap when the plastic cap is transparent. The

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Cl message can also be engraved, embossed or printed onto the plastic cap. The text of the message can be in any colour, but is preferably in a bold colour, in sharp contrast to the 0 colour of the cap, for example a white cap with red text thereon. Other examples of colour combinations which naturally indicate warnings or danger and would be appropriate in this instance are red text on a yellow cap, or black text on a red cap.

O In the second form of the invention, in addition to the message on the top of the ivial, the body of the vial is coloured a bold colour to immediately attract the attention of 0 O the medical personnel, and alert them to the fact that the vial contains a medicament which must be used with caution. They will then be prompted to establish the preferred method of administration of the medicament. The vial can be any colour which will immediately attract the attention of the user, but is preferably red or yellow, being colours which naturally indicate warnings or danger.

The colour can be applied to the vial in any appropriate way, for example the glass itself can be coloured. The preferred method of colouring the vial is to apply a plastic coating to the outside of the vial, the plastic being capable of withstanding the temperatures of steam sterilization necessary in the production of sterilized vials. In addition to the visual stimulation that a coloured vial would provide, the tactile nature of the plastic coating would also alert the medical personnel to the fact that there is something unusual about the particular vial, and they would then be even more receptive to the message emblazoned on the cap of the vial. The warning colours on the coating may be of a very visible mono colour or multiple colours including using multiple colours in designs such as blocks, spots or vertical or horizontal stripes.

The warning message on the cap may comprise warning text, warning letters, warning symbols, or any combination thereof In one form, the may prominently contain the warning text "DO NOT INJECT". However, it is not considered that the invention should be limited to this particular exemplification of the warning message.

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N In order that the invention may be more readily understood and put into practice, one or more preferred embodiments thereof will now be described.

00 BRIEF DESCRIPTION OF THE DRAWING CFig. I is a top view of a vial of the invention.

~5 ~Fig. 1 is a tperspective view of a vial of the invention.

5 "Fig. 2 is a perspective view of a vial of the invention.

Fig.s 3 to 6 illustrate progressive removal of the sealing elements of a vial of the N invention.

oDETAILED DESCRIPTION OF PREFERRED EMBODIMENT The preferred form of the invention comprises a method of reducing inadvertent injection of drugs which are meant for topical application. The method comprises the provision of distinctive markings on the vials containing topical drugs to easily distinguish them from vials containing injectable drugs.

The vials of the preferred form are conventional drug-containing vials having a neck diameter from 1342mm. An example of such a vial is shown in Figs 1-6. The vials are sealed at the top with a rubber stopper which is held in place by an aluminium coating which at least partially covers the stopper and extends over the rim of the vial to form an external skirt around the top of the vial. The aluminium coating is covered by a plastic cap which is not resealable after opening. The plastic cap can be partially removed from the vial to expose the stopper or aluminium coating (Fig. or totally removed to expose the contents of the vial (Fig. To enable the latter function, the plastic cap is attached at least at one point to the aluminium skirt.

In order to ensure that the person administering the topical medicament in the vial does not inject the medicament, the plastic cap is provided with a warning, preferably embossed on the cap itself. The preferred form of the message is embossed red text "DO NOT INJECT" on a white cap.

Additionally, the preferred form of the invention provides a coloured vial to 00 enhance the warning message. The preferred method of colouring the vial is to coat the body of the vial with red or yellow or red and yellow striped steam sterilization-resistant plastic.

While not wishing to be bound by theory, preliminary indications show that O placement of a particular type of warning message do not inject or similar) in a iparticular place on a vial on the cap), provides a remarkable and unexpected 0 O reduction in inadvertent injection of medicines of the type that could be harmful or fatal if injected rather than applied topically or by other means. It seems that the present invention takes advantage of the fact that the cap area of the vial is always visible and unobstructed during use because of the need to remove the cap. The present invention also takes advantage of the fact that a caregiver will look closely at the top area of the vial when removing the cap in order to make sure that the contents of the vial can be properly accessed, and that the vial will not spill etc, and having the warning message precisely in this particular area, provides a substantial safety advantage and contribution in reducing inadvertent injection of medicines.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the present invention without departing from the spirit or scope of the invention as broadly described. The above examples are therefore to be considered in all respects illustrative and not restrictive.

Claims

2. The method of claim I wherein the vial has a sealing means at the outlet of the vial, O and an external skirt around the neck of the vial.
3. The method of claim 2 wherein the sealing means comprises a stopper for covering the outlet of the vial.
4. The method of claim 3 wherein the external skirt is part of an aluminium covering which at least partially covers the stopper and extends over the top rim of the vial. The method of claim 4 wherein the removable cap extends over the sealing means, at least partially over the external skirt, and is attached to the aluminium covering whereby removal of the cap results in simultaneous removal of the covering and stopper.
6. The method of claim 5 wherein the cap is transparent and the message is underneath the cap.
7. The method of claim 6 wherein the message is indelibly applied to the aluminium covering.
8. The method of claim 6 wherein the message is indelibly applied to the cap.
9. The method of any one of claims 5-8 wherein the drug in the vial is under inert atmosphere. A method of reducing inadvertent injection of a drug which is meant for topical application, the method comprising providing the topical drug in liquid form in a vial, providing a removable cap for the outlet of the vial, the cap being removable to enable the contents of the vial to be applied topically to a patient, wherein the cap is provided with a warning message that the contents of the vial are not to be injected, and wherein the vial is coloured from at least the shoulder of the vial to the base of the vial. O O
11. The method of claim 10 wherein the vial is coloured by means of a plastic coating Sapplied to the exterior surface of the vial. 00 12. The method of claim 11 wherein the plastic is capable of withstanding the heat of steam sterilization.
13. The method of claim 12 wherein the plastic is coloured red or yellow.
14. The method of claim 13 wherein the plastic may be coloured with stripes, spots or o other designs such as blocks of colour. O 15. The method of claim 10 wherein the vial has a sealing means at the outlet of the vial, and an external skirt around the neck of the vial.
16. The method of claim 14 wherein the sealing means comprises a stopper for covering the outlet of the vial.
17. The method of claim 15 wherein the external skirt is part of an aluminium covering which at least partially covers the stopper and extends over the top rim of the vial.
18. The method of claim 16 wherein the removable cap extends over the sealing means, at least partially over the external skirt, and is attached to the aluminium covering whereby removal of the cap results in simultaneous removal of the covering and stopper.
19. The method of claim 17 wherein the cap is transparent and the message is underneath the cap. The method of claim 18 wherein the message is indelibly applied to the aluminium covering.
21. The method of claim 19 wherein the message is indelibly applied to the cap.
22. The method of claim 20 wherein the drug in the vial is under inert atmosphere.
23. A method of reducing inadvertent injection of a drug which is meant for topical application, the method comprising providing the drug in liquid form in a vial, providing a sealing means in the outlet of the vial, providing an external skirt around the neck of the vial, and providing a removable cap that extends over the sealing means and at least partially over the external skirt, the cap being removable to enable the contents of the vial tfl IL 0 0 C to be applied topically to a patient, wherein the cap is provided with a warning message that the contents of the vial are not to be injected. 00 24. The method as claimed in any one of the preceding claims, wherein the warning message comprises the words DO NOT INJECT.
25. A vial containing a topical composition of the type that would be hazardous if injected rather than applied topically, the vial having an outlet, and containing a O removable cap for the outlet, the cap being removable to enable the contents of the vial to f be applied topically to a patient, wherein the cap is provided with a warning message that Othe contents of the vial are not to be injected.
26. The method as claimed in any one of the preceding claims substantially as hereinbefore described.
27. The vial as claimed in claim 24 substantially as hereinbefore described. Dated this 28 th day of July 2005 Malvin Leonard Eutick By his Patent Attorneys CULLEN CO.