GB2264097A - Adhesive label - Google Patents

Abstract

A label 1, for clinical trials, having opposed adhesive and non-adhesive surfaces comprises a wide portion 3 and a narrow portion 5, the two portions being divided by a first fold-line 7, eg perforations, and the narrow portion 5 being further divided, by a second fold line 6, into two parts 12 & 13. The narrow portion 5 can be folded about fold line 6 so that the non- adhesive faces of parts 12 & 13 are brought into contact. Then portion 5 is folded about fold-line 7 so that the adhesive faces of part 13 and portion 3 are brought into contact. The wide portion 3 bears a public inscription and part 12 bears a secret inscription. Preferably, also provided is a tab 15, to facilitate opening, defined by a continuous cut 11, that extends into part 12, and perforated cuts 20. At least one detachable section 16 and panel 18, for easy disclosure, may be provided. <IMAGE>

Description

ADHESIVE LABEL The invention relates to adhesive labels, and in particular to adhesive labels for concealing inscriptions for use e.g. as clinical trial labels.

Such labels are used for clinical trials conducted by pharmaceutical companies in conjunction with doctors and voluntary patients. In these circumstances, samples of a drug under trial are administered along with placebos that act as controls.

It is important in such trials that neither the patient nor the doctor is aware of the identity of the substance administered (i.e. either drug or placebo), since such knowledge may affect both the patient's reaction to the substance administered and the doctor's interpretation of the results obtained. The labels affixed to the drug containing vials in such trials must therefore bear two classes of information; a "public" inscription (for example giving details of the patient subject to administration of the drug, dosage details etc.) and a "secret" inscription (giving details of the nature of the contents of the vial, e.g. whether drug or placebo).

The "secret" information is therefore sensitive information that must be concealed from both patient and doctor, and yet available for collation and interpretation of the results of the drug trial.

Moreover, in the event of a bad patient reaction, the identity of the contents of the vial needs to be quickly established.

The requirement for labels capable of fulfilling the above requirements has been met to a limited extent in the art by the provision of multilayer adhesive labels (e.g. the laminated label disclosed in US 4,674,771).

The effectiveness of such labels in concealing sensitive information depends entirely on patterned printed surfaces and the involvement of carbon paper or NCR paper in 2 or 3 layer laminates. Such labels suffer from the disadvantages that they are expensive to produce and can only receive inscriptions that are delivered by impact printing (such as typewriters, dotmatrix printers and direct manuscript application etc.).

Such methods of printing have lately been superseded by more modern and convenient vehicles suitable for electronic data printing, such as laser, ink-jet, thermal transfer or direct thermal imprinting.

Moreover, such prior art labels are difficult to apply to vials, and their complex laminate construction makes it difficult to disclose the sensitive "secret" information easily and quickly. This latter disadvantage is a particular drawback, since in the event of an emergency (such as a bad patient reaction), rapid disclosure of the concealed information is very important.

It is an object of the present invention to provide an adhesive label which obviates or mitigates the aforementioned problems and which is capable of securely bearing concealed inscriptions delivered by non-impact printing means such as laser, ink-jet, thermal transfer or direct thermal imprinting.

The invention provides an adhesive label (e.g. a clinical trials label) for bearing a concealed inscription, comprising opposed adhesive and nonadhesive surfaces, the non-adhesive surface being suitable for receiving inscriptions formed by non-impact printing means (such as a thermal printer, ink-jet printer or a laser printer), and at least a first and a second parallel fold-defining means across the width of the label. -The label further comprises a first portion and a second portion, the second portion being divided by the first fold-defining means into a first part and a second part, the first part being joined to the first portion at a junction, which junction comprises the second fold-defining means.In use, the second portion bears the concealed inscription and is folded about said second fold-defining means so that the adhesive surface of the first part thereof is in contact with the adhesive surface of a corresponding part of the first portion, and the second part of the second portion is folded about the first fold-defining means to bring the non-adhesive surface thereof into contact with a corresponding part of the non-adhesive surface of the first part of the second portion and so conceal the inscription. The first portion is thus in overlying and at least partially overlapping relationship with the folded second portion, so that the first portion can act to adhere the folded label to a substrate, such as a clinical trials vial.

The first portion is preferably at least partially wider than the second portion. Alternatively, or in addition, the first portion may further comprise a tab at the junction of the first portion and the first part of the second portion. The tab may be formed by a continuous cut extending from the first portion into the first part of the second portion, and the tab may then help to adhere the folded label to a substrate.

Preferably, the fold-defining means are perforations, though they may also be simply printed lines.

The adhesive labels according to the invention may be mounted on a substantially opaque backing sheet, so that the labels may be peeled off for use as required. The backing sheet may bear printed matter that contributes to the opacity of the sheet. When the labels are provided with a backing sheet, an arrangement is possible whereby a panel of the backing sheet, the extent of which is defined by a continuous cut in the backing sheet, underlies the second portion of the label and remains attached thereto when the label is peeled off the backing sheet. This panel may then contribute to the opacity of the label and help to conceal the sensitive information, besides simplifying handling of the label during application.

Also, with this end in mind, a part of the second portion not bearing the concealed inscription may bear printed matter that contributes to the opacity of that part of the second portion.

The label conveniently also includes a detachable slip that comprises a third portion removably attached to the label by a line of perforations. This slip may be used to separately store information relating to the content of the sensitive information for later collation.

An embodiment of the present invention will now be described by way of example with reference to the accompanying drawings in which: Figure 1 is an outline of a plurality of labels according to the invention mounted on backing material showing the cuts made to the labels themselves and to the backing material. Perforating cuts are indicated by dotted lines and continuous cuts by continuous lines.

Figure 2 shows the folding pattern required to conceal sensitive information.

Figure 1 shows four clinical trial labels arranged on a sheet of backing material 2, each individual label being separated from its neighbours by a perforating cut 14, The overall dimensions of this sheet are such that it may be easily fed through a laser printer (convenient sizes include the standard A4. Each label consists of two portions; a wide portion 3 and. a narrow portion 5, these portions being separated by a perforating cut 7 in the label. The narrow portion is divided into two halves by a second perforating cut 6.

One half 13 of the narrow portion is pre-printed with a dense pattern of characters to form a security pattern which confers greater opacity on this part of the label.

The sheet of labels 1 is fed through a laser printer programmed to print "secret" information (e.g.

relating to the contents of the container that will ultimately bear the label) onto the inner half of the narrow portion 12 of each label, as well as "public" information (e.g. relating to the identity of the doctor and patient, dosage details etc.) on the wide portion 3.

A detachable section 16 of the wide portion, which is separated from the rest of the label by a perforating cut 8 through the label and an adjacent continuous cut through the backing sheet, may be printed with information for records and thus stored and handled independently of the rest of the label. It may also be used as a convenient means of attaching the label to a batch of drugs after the labels are printed but before they are attached to vials. More than one detachable section 16 may be provided, if desired.

The narrow portion 5 of each label is equipped with a panel of the backing sheet that is defined by a continuous cut 9 in the backing sheet. These panels contribute to the opacity of the narrow portion and help conceal the secret information printed on the inner half 12 of this portion. To this end at least this portion of the backing material may bear a printed security pattern.

Also provided is a tab 15, the dimensions of which are defined by a continuous cut in the label 11 that extends into the inner half of the narrow portion 12. Along with parallel perforated cuts 20 extending from the second folding means into the first portion, this tab facilitates the ultimate opening of the label to reveal the "secret" information and also helps to securely adhere the folded label to a substrate..

Adhesion of a part 24 of the adhesive surface of the first portion to a part 25 of the non-adhesive portion of the second part of the second portion (because of the hole 22 left in the second portion) can render disclosure of the concealed inscription difficult. This problem can be overcome by providing a panel 18 of backing sheet under the first portion near the tab. Surprisingly, the panel has also been found to facilitate folding of the label.

After the labels have passed through the laser printer, they are ready for attachment to the corresponding drug/placebo-containing vials. A label is torn free of the rest on the sheet at the perforations 14 in the backing sheet, and is then folded as shown in Fig. 2. The backing material from the detachable section 16 may first be removed and the label attached thereby to a batch of drugs so that packaging and labelling can be better co-ordinated. In this case the rest of the label is first torn free at the perforations 8 to leave the detachable portion in situ on the batch of drugs. The rest of the label is then removed from the backing paper for application to a vial of glass or plastic containing a patient's dose.

The narrow portion is first folded in half at the perforations 6, so that the non-adhesive faces of each are brought into contact to conceal the "secret" information on the inner half 12. Since the panel of backing material 9 will have remained attached to the label when it was peeled off the backing material, this panel will contribute to the opacity of the folded narrow portion and help conceal the secret information.

The folded narrow portion is then folded at the perforations 7, so that the adhesive face of the inner half of the narrow portion is brought into adhesive contact with a corresponding part of the adhesive underside of the wide portion 3. This folding pattern is shown in Fig. 2. It can readily be appreciated that additional folds may be made along further perforation so that the second portion becomes concertinaed behind the first portion. This may allow use of a larger second portion which can bear more information.

The thus folded label is then attached to the drug-containing vial, the adhesive parts of the wide portion that overlap the underlying narrow portion acting to anchor the label to the vial. The tab 15 also adheres to the vial and contributes to a tamper-evident seal, since attempts e.g. with a fingernail to break its adhesive contact with the substrate are likely to result in marking or creasing of the tab.

When the results of the trial need to be assessed, or in the event of a bad patient reaction, the secret information printed on the inner half of the narrow portion must be revealed. This is done by simply tearing the perforations 7 at the tab 15 and then opening out the folded narrow portion by pulling back that part of the wide portion that overlaps the narrow portion by tearing along the perforated cuts 20.

In a modified embodiment black adhesive may be used instead of or in addition to the security pattern on the backing material beneath the portion 5 of the label.

Claims (12)

CLAIMS:

1. An adhesive label (e.g. a clinical trials label) adapted for use in bearing a concealed inscription, comprising opposed adhesive and nonadhesive surfaces, the non-adhesive surface being suitable for receiving inscriptions formed by nonimpact printing means, and at least a first and a second parallel fold-defining means across the width of the label; the label further comprising a first portion and a second portion, the second portion being divided by the first fold-defining means into a first part and a second part, the first part being joined to the first portion at a junction, which junction comprises the second fold-defining means; whereby in use, the second portion bears the concealed inscription and is folded about said second fold-defining means so that the adhesive surface of the first part thereof is in contact with the adhesive surface of a corresponding part of the first portion, and the second part of the second portion is folded about the first fold-defining means to bring the non-adhesive surface thereof into contact with a corresponding part of the non-adhesive surface of the first part of the second portion and so conceal the inscription; the first portion being in overlying and at least partially overlapping relationship with the folded second portion, so that the first portion can act to adhere the folded label to a substrate.

2. An adhesive label according to claim 1 in which the label is mounted on a substantially opaque backing sheet from which it may be peeled off.

3. An adhesive label according to claim 1 or claim 2 in which the first portion is at least partially wider that the second portion.

4. An adhesive label according to any one of the preceding claims in which the first portion further comprises a tab at the junction of the first portion and the first part of the second portion, which tab is formed by a continuous cut extending from the first portion into the first part of the second portion, wherein in use the tab acts to adhere the folded label to a substrate.

5. An adhesive label according to claim 4 as dependent on any one of claims 2 to 3 in which a panel of the backing sheet, the extent of which is defined by a continuous cut in the backing sheet, underlies the first portion at a location that is adjacent to the tab and remains attached thereto when the label is peeled off the backing sheet, such that in use the panel reduces the area of contact between the adhesive surface of the tab and the underlying non-adhesive surface of the second part of the second portion.

6. An adhesive label according to any one of the preceding claims in which parallel perforated cuts extend from the second folding means into the first portion to facilitate disclosure of the concealed inscription.

7. An adhesive label according to any one of the preceding claims in which the fold-defining means are perforations.

8. An adhesive label according to any one of the preceding claims in which the fold-defining means are printed lines.

9. An adhesive label according to any one of claims 2 to 8 in which a panel of the backing sheet, the extent of which is defined by a continuous cut in the backing sheet, underlies the second portion and remains attached thereto when the label is peeled off the backing sheet.

10. An adhesive label according to any one of the preceding claims in which a part of the second portion not bearing the concealed inscription bears printed matter that contributes to the opacity of that part of the second portion.

11. An adhesive label according to any one of the preceding claims, in which the label further comprises a third portion removably attached to the label by a line of perforations.

12. An adhesive label substantially as hereinbefore described with reference to and as shown in the accompanying drawings.