U.S. patent number 3,593,443 [Application Number 04/858,669] was granted by the patent office on 1971-07-20 for label for use in blind clinical studies of a medicament.
This patent grant is currently assigned to Merck & Co., Inc.. Invention is credited to Julius Christ Demetrius, Jr., Wayne Martin Grim.
United States Patent |
3,593,443 |
Demetrius, Jr. , et
al. |
July 20, 1971 |
**Please see images for:
( Certificate of Correction ) ** |
LABEL FOR USE IN BLIND CLINICAL STUDIES OF A MEDICAMENT
Abstract
A label to be used in the clinical studies of the effects of a
particular medicant and comprises two separable parts, one part of
which is secured to the container while the other goes into a file
and with both sections having visible thereon the necessary patient
and study numbers but not the nature of the medicant nor the
dosage. This information is on the file section of the label but is
normally hidden by a removable cover.
Inventors: |
Demetrius, Jr.; Julius Christ
(Lansdale, PA), Grim; Wayne Martin (Chalfont, PA) |
Assignee: |
Merck & Co., Inc. (Rahway,
NJ)
|
Family
ID: |
25328858 |
Appl.
No.: |
04/858,669 |
Filed: |
September 17, 1969 |
Current U.S.
Class: |
40/638; 283/105;
40/672; 40/674; 283/81; 283/900 |
Current CPC
Class: |
G09F
3/00 (20130101); G09F 3/0288 (20130101); Y10S
283/90 (20130101) |
Current International
Class: |
G09F
3/02 (20060101); G09F 3/00 (20060101); A44c
003/00 () |
Field of
Search: |
;40/2,310,312 ;35/17
;206/42 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Michell; Robert W.
Assistant Examiner: Contreras; Wendeslao J.
Claims
We claim:
1. A label, for use in blind clinical studies of a medicament:
formed from a blank having a succession of at least three adjoining
panels which are folded along the panel junction lines so that the
first panel overlays the second panel and the third panel underlays
the second panel;
medicament-identifying indicia on the original front side of the
second panel and substantially solid ink on the original front side
of the first and third panels so that when the first and third
panels are folded to overlay and underlay, respectively, the second
panel, the medicament identifying indicia on the second panel not
only is covered and so rendered invisible, but also is not readable
by holding the folded label against a light;
other indicia, representative of the single patient being
administered the medicament with which the label has been
associated, and not of a character to identify the medicament to
the clinician, either on the original back side of the first panel
or on the original front side of the fourth panel adjoining the
third panel, the fourth panel, when present, being folded over the
original back side of the first panel when the latter is folded
over the second panel, in either case the other indicia being the
indicia exposed on the front of the folded label; and
means adhesively securing said panels in folded position while
maintaining free from adhesive the portion of the original front
side of the second panel on which the medicament identifying
indicia is printed, so that the clinician may, if necessary, cut
along the junction line between the first and second panels and
readily pull forward the second panel from the first panel to
expose the medicament identifying indicia for the single patient
being administered the medicament associated with the label.
2. An assembled label as set forth in claim 1 in which the blank
has an additional panel adjoining the side of the second panel, the
original front side of the additional panel having thereon indicia
substantially corresponding to the other indicia, the original back
side of the additional panel being adhesively secured to the
container containing the medicament to be clinically tested and the
additional panel having a tear line at or near the junction line
between the additional panel and the second panel, at which tear
line the remaining portion of the assembled label may be separated
from the portion of the label secured to the container so that the
separated portion may be readily kept with the medical records for
the specific patient identified by the other indicia.
3. A label, for use in blind clinical studies of a medicament,
formed from a blank having a succession at at least four adjoining
panels which are folded along the panel junction lines so that the
first panel overlays the second panel, the third panel underlays
the second panel, and the fourth panel overlays the first and
second panels together, the blank also having an additional panel
adjoining the side of the second panel;
medicament-identifying indicia printed on the original front side
of the second panel and substantially solid ink printed on the
original front side of the first and third panels so that when the
first and third panels are folded to overlay and underlay,
respectively, the second panel, the medicament identifying indicia
on the second panel not only is covered and so rendered invisible,
but also is not readable by holding the folded label against a
light and also is protected from examination of the original back
side of the second panel for any deformation of the label stock
caused by printing the medicament identifying indicia on the
original front side thereof;
other indicia representative of the single patient to be
administered the medicament with which the label is associated, and
not of a character to identify the medicament to the clinician,
printed on the original front side of the fourth panel and on the
original front side of the additional panel, this other indicia
thus being the indicia exposed to the clinician after the label is
fully folded;
means adhesively securing the succession of panels in folded
position while maintaining free from adhesive the portion of the
original front side of the second panel on which the medicament
identifying indicia is printed; adhesive securing the original back
side of the additional panel to the container containing the
medicament to be clinically tested; and
the additional panel having a tear line at or near the junction
line between the additional panel and the second panel, at which
tear line the remaining portion of the assembled label may be
separated from the portion of the label secured to the container so
that the separated portion may be readily kept with the medical
records for the specific patient identified by the other
indicia;
this separated portion, after being cut by the clinician, when
necessary to do so, along the junction line between the first and
second panels, enabling the clinician to readily pull forward the
second panel from the first panel to expose the
medicament-identifying indicia printed on the second panel for the
single patient being administered the medicament in the associated
container, without exposing to the clinician the
medicament-identifying indicia for any other patient in the same
blind clinical study.
4. The label as set forth in claim 3 in which the blank has a fifth
panel in the succession of panels and a stub panel positioned along
the side of the second panel opposite the side along which the
additional panel is positioned;
the stub panel being folded forward over the original back side of
the first panel after the latter is folded forward to overlay the
second panel, and the fifth panel being folded back to underlay the
third panel after the fourth panel is folded forward to overlay the
second and first panels together; and
the adhesive of the adhesive means for securing the panels in
folded position being applied along the side of the original front
side of the first panel nearest the additional panel, over the
original front side of the stub panel, along the sides of the
original back side of the third and fourth panels, and over the
original back side of the fifth panel.
5. The label as set forth in claim 3 in which the adhesive means
includes a heat sensitive coating on the back side of the blank
that can be activated upon the application of heat and pressure to
the folded succession of panels to secure them in their folded
positions, the first panel being slightly smaller than the second
panel so that the original back side of the fourth panel is
adhesively secured to the original front side of the second panel
around the perimeter of the second panel not covered by the first
panel when folded to overlay the second panel.
6. A plurality of labels, one for each container of material to be
administered to patients in a blind clinical study of a medicament,
wherein the clinician is not to be advised which containers contain
the medicament in a certain amount, which containers contain a
placebo, and also, if desired, which containers contain the
medicament in another amount, each such label having a package
portion secured to the associated container and a separable file
portion for inclusion with the medical records of the specific
patient being administered the contents of the container to which
was secured the corresponding package portion of the label, the
file portion of each such label bearing, in a concealed manner, the
identification of the contents of the container to which was
secured the corresponding package portion of the label, so that the
clinician may, when medically necessary for a specific patient,
ascertain by appropriate mutilation of the file portion of the
label for that patient, the identity and amount of the material
being administered to that patient, without ascertaining the
identity and amount of the material being administered to any other
patient in the blind clinical study; characterized in that:
each label is formed from a flat blank having a printable front
side and a heat sensitive coating on its back side that can be
activated upon the application of heat and pressure thereto;
the blank having a succession of four substantially rectangular
panels adjoining one another along their long sides and having a
fifth substantially rectangular panel with one of its short sides
adjoining one of the short sides of the second panel, the second,
third and fourth panels being of substantially equal size and the
first panel being slightly smaller than the second panel, and the
fifth panel being separable from the second panel along a tear line
at or near the junction line between the fifth and second
panels;
medicament-identifying indicia being printed on the printable side
of the second panel;
other indicia representative of the single patient to be
administered the medicament with which the label is associated, and
not of a character to identify the medicament to the clinician,
being printed on the printable side of the fourth panel and on the
printable side of the fifth panel;
substantially solid ink printed on the printable side of the first
and third panels;
the first panel being folded forward along its junction line with
the second panel to overlay the second panel, the third and fourth
panels being folded rearward along the junction line of the third
panel with the second panel so that the third panel underlays the
second panel, and the fourth panel being then folded forward along
its junction line with the third panel to overlay the first and
second panels together;
the first four panels of the label being adhesively secured in
folded, assembled portion by activation of the heat sensitive
coating on the original back sides of those panels and constituting
the file portion of the label; and
the fifth panel being adhesively secured to the appropriate
container by activation of the heat sensitive coating on the
original back side of that panel, so that the fifth panel
constitutes the package portion of the label.
Description
SUMMARY OF THE INVENTION
The assembled label has two joined portions; a package portion
which is secured to and remains with the medicament container, and
a file portion which is detachable from the package portion for
inclusion with the records of the patient receiving the tablets or
capsules in the container. The information visible on the two
portions does not reveal to the clinician the product information
for a particular patient, i.e., whether or not the tablets or
capsules (in that particular container) that are being administered
to that particular patient, contain the medicament being clinically
tested, and if so, in what amount. This nondisclosure to the
clinician is necessary for a valid, blind clinical study of the
medicament.
However, the file portion of the label has a concealed panel
bearing this product information regarding the tablets being
administered to the associated patient, so that, if medically
necessary for a particular patient, the file portion of the label
for that patient may be opened to reveal this information to the
clinician, without revealing this product information for any of
the other patients involved in the same blind clinical study, and
thus without invalidating the study as to the remaining
patients.
In preparing such a label, the blank used has at least three
four-sided panels joined successively on opposite sides, with
another four-sided panel joined to the side of the second panel.
The product information is printed on the front of the second
panel, while most of the front of the first and third panels are
printed solid with dark ink. General information, not of product
information character, is printed on the front of the panel to the
side of the second panel, and also on either the back of the first
panel, or preferably on the front of a fourth four-sided panel
joined to the bottom of the third panel and extending below it.
The finished label is assembled by folding the first panel over the
second, and by folding the third panel under the second, and
securing them in that position, so that not only is the product
information that is printed on the second panel obscured by the
first panel, but also that product information cannot be read by
holding the folded label against a light, as the solid ink printing
on the first and third panels prevent the passage of light through
at least the portion of the second panel that contains the product
information printed thereon.
If the label blank has the fourth panel described (as it is
preferred), it is then folded forward over the top of the first
panel and secured in that position, so that the general information
printed on the fourth panel is visible and is adjacent to the
general information printed on the panel to the side of the second
panel.
The panel to the side of the second panel becomes the package
portion of the assembled label, while the remainder of the
assembled label serves as the file portion of the assembled label.
This file portion the clinician may open, when medically necessary,
by cutting the file portion along its lower edge, and removing the
covering panel or panels, thereby exposing the product information
printed on the second panel.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of an assembled label of the present
invention prior to separation of the file portion of the label from
the package portion of the label;
FIG. 2 is a front view of the flat, die-cut and printed blank from
which the label of FIG. 1 is assembled;
FIG. 3 is a rear view of the same;
FIG. 4 through FIG. 9 are views, in perspective, showing the
sequence by which the various panels of the flat, printed label
blank of FIGS. 2 and 3 are folded and adhesively secured to produce
the assembled label of FIG. 1;
FIG. 10 is a perspective view of the assembled label of FIG. 1 as
it is being separated into its two parts, i.e., the package portion
and the file portion;
FIG. 11 is a perspective view of the file portion of the label of
FIG. 1, as it is being opened to gain access to the concealed
information contained therein;
FIG. 12 is a front view of the opened file portion of the label of
FIG. 1;
FIG. 13 is a front view of the flat, die-cut and printed blank for
a modification of the label of FIG. 1;
FIG. 14 is a rear view of the same;
FIGS. 15 and 16 are views, in perspective, showing the sequence by
which the various panels of the flat, printed label blank of FIGS.
13 and 14 are folded and adhesively secured to produce the
assembled label;
FIG. 17 is a perspective view of the rear of the assembled label of
FIGS. 12--15;
FIG. 18 is a front view of the flat, die-cut and printed blank for
another modification of the label of FIG. 1;
FIGS. 19 through 21 are views, in perspective, showing the sequence
by which the various panels of the flat, printed blank of FIG. 18
are folded to produce the assembled label;
FIG. 22 is a schematic diagram showing the folded label of FIG. 21
being treated with heat and pressure to secure the panels in their
positions as shown in FIG. 21 (the material of which the labels are
made having a heat-sensitive coating on its back which, upon the
application of heat and pressure, activates and adheres to an
adjoining surface);
FIG. 23 is a perspective view of the assembled label from the blank
of FIG. 18 as it is being separated into its two parts, i.e., the
package portion and the file portion;
FIG. 24 is an enlarged vertical section of the file portion of the
label of FIG. 23 along the line 24-24 of FIG. 23;
FIG. 25 is an enlarged vertical end view of the file portion of the
label of FIG. 23 as indicated by the line 25-25 of FIG. 23; and
FIG. 26 is a perspective view of the file portion of the label of
FIG. 23 as it is being opened to gain access to the concealed
information contained therein.
DESCRIPTION OF EMBODIMENT SHOWN IN FIGURES 1--12
Referring to FIG. 1, the assembled label, generally designated 21,
has two principal portions, the package portion 22 shown at the
left, and the file portion 23 shown at the right, the two portions
being initially joined along a perforation line 24.
The back of the package portion 22 is adhesively secured to the
container (not shown), such as a bottle, in which the medicament is
contained. The back of the file portion 23 is not secured to the
container.
The package portion 22 of the label has certain information printed
thereon, such as the name of the company distributing the
medicament, an identification number (such as 17) identifying the
clinical study for which the medicament was prepared, and a patient
identification number (such as 19) by means of which the
distributing company is able to ascertain whether the tablets or
capsules in the container to which the label 22 is secured (i)
contain the medically active ingredient that is being clinically
tested, or (ii) are merely placebo tablets that only simulate the
appearance of such medically active tablets or capsules.
The file portion 23 of the label also has printed thereon the same
study identification number (such as 17) and the same patient
identification number (such as 19) that appear on the package
portion 22 of the label.
It is to be noted that on neither the package portion 22 nor the
file portion 23 of the label, in the assembled condition of the
label as shown in FIG. 1, does the name of the medically active
ingredient appear, nor whether the tablets or capsules in the
associated container are medically active tablets or placebo
tablets.
In use, the company sends to the clinician a specially prepared
supply of containers, some of which contain medically active
tablets or capsules and the rest of which contain placebo tablets
or capsules. Each such container is labeled with a label as shown
in FIG. 1, except that the labels bear different patient numbers,
generally in a numerical sequence. The company's record of these
patient numbers also indicates those patients, by patient number,
who are to receive medically active tablets or capsules and those
patients, by patient number, who are to receive placebo tablets or
capsules. This company record is generally referred to as the
"code" or "allocation schedule."
When the clinician assigns a particular container to a specific
patient, the patient's name is written on both the package portion
22 and the file portion 23 and of the label 21. Then the file
portion 23 is separated from the package portion along the
perforation line 24, as shown in FIG. 10, and the file portion 23
is put with the medical records for that specific patient.
As previously stated, and as evident from FIGS. 1 and 10, neither
the name of the medicament, nor the quantity thereof contained in
each tablet or capsule being administered to a specific patient, is
visible on either portion 22 or 23 of the completely assembled
label 21. Hence, neither the doctor nor the nurse handling the
medicament container can tell, from the package portion 22 of the
label, whether the tablets or capsules within the container contain
the medically active ingredient that is being clinically tested, or
are merely placebos simulating the appearance of such tablets or
capsules. Likewise, neither the doctor nor the nurse who examines
the file of the patient to whom the tablets or capsules are being
administered, and who, in such examination, see merely the exterior
of the file portion 23 of the label 21 of this invention, can tell
from the exterior of such file portion, whether the patient is
receiving tablets or capsules containing the medically active
ingredient, or is receiving a placebo, or can tell the amount of
the medically active ingredient being administered, if any is being
administered at all.
In this manner, the clinical study of the effect of the medically
active ingredient is not subconsciously influenced by any knowledge
the doctor, nurse, or patient may have as to whether the medically
active ingredient being clinically studied is actually being
administered to a specific patient, and as to whether the amount
being administered is large or small.
At the end of the clinical study, the clinician reports his results
to the company, using the patient numbers appearing on the file
portion 23 of the label. The company then interprets these results
by the use of the "code" which it has retained, and makes a
statistical analysis of those decoded results.
A statistical analysis of the clinical results of the testing of a
medically active material on a number of patients in this blind
manner, is thus an unbiased and reliable analysis.
It is desirable for safety purposes, in case a specific patient who
is involved in such a blind clinical study develops an unexpected
reaction that must be treated promptly, that the doctor or nurse
know immediately whether or not that specific patient has actually
been receiving the medicament under study and, if so, in what
amount.
The delay entailed in communicating with company to ascertain this
fact is usually unacceptable to the clinician and the company, as
the delay might be injurious to the patient.
If the company sends to the clinician, along with the carefully
prepared supply of containers for the clinical study, a copy of its
patient code for the containers, but in a sealed envelope, with
instructions to open the envelope only when necessary to "break the
code" for a specific patient, and the clinician does have to open
the sealed envelope to determine what was being administered to a
specific patient, the statistician is inclined to treat the entire
study as unreliable. His reason for this is that there is no way of
knowing how much more information the clinician has accidentally,
or otherwise, obtained from examining the code, and how much such
additional information may have influenced the clinician's report
of the clinical results with the other patients.
It is to meet this dilemma in a simple and economical manner that
the label of this invention has been devised.
Referring now to FIG. 2, the label blank generally designated 30
from which the label 21 is prepared is a flat die-cut sheet having
four generally rectangular panels 31, 32, 33 and 34 of equal size
and shape adjoining one another successively on their long
sides.
A fifth generally rectangular panel 35 preferably adjoins the
fourth panel 34, with the long side of the fifth panel 35 adjoining
the long side of panel 34 opposite the long side that is joined to
panel 33. The short side of this fifth panel 35 is shorter than the
short sides of panels 31--34.
Adjoining the second panel 32 on one of its short sides is a sixth
panel 36 which is generally rectangular and which has the
perforations 24 therein from one long side to the other long side
near where the short side of this sixth panel 36 joins the short
side of the second panel 32.
Adjoining the second panel 32 on its other short side is a small,
seventh panel 37 which is a generally rectangular panel, the long
side of which is the short side of the second panel 32.
After the label blank 30 is cut to provide the panels described
above, the blank is printed on the top side shown in FIG. 2. The
printing of label information is on the second, forth and sixth
panels 32, 34 and 36, respectively. The printing on the first and
third panels 31 and 33 is solid and unbroken and preferably done
with a dark ink as indicated by the shading 31a and 33a
representing blue color. This conveniently is the same type and
color of ink used for printing the remainder of the blank, i.e.,
panels 32, 34 and 36. Preferably a small part 31b and 33b, of the
panels 31 and 33, respectively, is left uninked, these parts 31b
and 33b being at the left of the panels as they are viewed in FIG.
2. The left-hand portion 31b of the first panel 31 and the seventh
panel 37, are shown in FIG. 2 with mottled shading to indicate
adhesive, which is applied thereto after the label blank 30 is
die-cut and printed and is about to be assembled.
The label information printed on the sixth panel 36 is that which
appears on the package portion 22 of the assembled label, as shown
in FIG. 1. The label information printed on the fourth panel 34 is
that which appears on the file portion 23 of the assembled label,
as shown in FIG. 1.
The label information printed on the second panel 32 includes the
name of the product and the quantity of such product per unit dose
in the container, such as tablet or capsule. In the assembled label
as shown in FIG. 1, this second panel 32 is part of the file
portion 23 of the label but is not visible or accessible without
mutilation of the file portion of the label, as will be evident as
the description proceeds.
Referring now to FIG. 3, which shows the back side of the die-cut
and printed label blank, it is to be noted that there is no
printing thereon. In other words, in preparing the label of the
preferred form of this invention, the die-cut label blank 30 is
printed on one side only. The mottled shading shown along the short
sides of the third and fourth panels 33 and 34, and over the fifth
panel 35, indicates adhesive which is applied after the label blank
30 is die cut and printed.
The folding and securing of the various panels of the die-cut and
printed label blank 30 of FIGS. 2 and 3 to produce the assembled
label of FIG. 1, is shown, in sequence, in FIGS. 4--9,
inclusive.
The first panel 31, after having adhesive applied to its unprinted
left-hand portion 31b, is folded forward, as shown in FIG. 4, along
the junction between the first and second panels 31 and 32, so that
the first panel 31 overlays the second panel 32. The panels are
secured in that position by the adhesive along the left side of
these panels. The solid ink printing 31a on this first panel 31
thus is positioned on top of, and covers, the product information
printed on the second panel 32.
The next two steps, shown in FIGS. 5 and 6, can be performed in
that sequence or in the reverse sequence. In the sequence shown,
adhesive is applied to the back of the third and fourth panels 33
and 34 near the short sides thereof, and to the back of the fifth
panel 35. The three panels 33, 34 and 35 are then folded as a unit
along the junction between the long sides of panels 32 and 33, so
that the third panel 33 underlays the second panel 32. The panels
are secured in that position by the adhesive along the short sides
of panel 33. The partially assembled label is then as shown in FIG.
5. In this position of panel 33 the solid ink printing 33a is
positioned underneath the product information printed on the second
panel 32.
The small, seventh panel 37 is then folded along the junction line
between the short side of panel 32 and the adjacent (long) side of
panel 37, so that the seventh panel 37 overlays the back of the
first panel 31. The panels are secured in that position by the
adhesive on the front of the seventh panel 37.
In the next step, shown in FIG. 7, the fourth and fifth panels 34
and 35 are folded as a unit along the junction line between the
third and fourth panels 33 and 34, so that the fourth panel 34
overlays the back of the first panel 31 and the back of the seventh
panel 37. The panels are secured in this position by the adhesive
applied to the short sides of panel 34. In this position the front
of the fourth panel 34 is over the second panel 32, with the
printing on the front of the sixth panel 36. The printing on the
front of the second panel 32 is not visible, as that second panel
32 is covered by the first and fourth panels 31 and 34.
In the final step of assembling the label of this form of this
invention, the fifth panel 35 is folded along the junction line
between the fourth and fifth panels 34 and 35, as shown in FIG. 8,
so that the fifth panel 35 engages the back of the third panel 33
(this third panel 33 underlaying the back of the second panel 32).
The fifth panel 35 is secured in its folded position by the
adhesive applied to the back of this fifth panel 35.
The fully assembled label, when viewed from the rear, is shown in
FIG. 9. The first and second panels 31 and 32 are inside the
enclosure formed by the fourth panel 34 on the front, and by third
and fifth panels 33 and 35 on the back.
After the label has been fully assembled, as shown in FIGS. 1 and
9, after the package portion 22 of the label has been secured to
the container containing the material which the clinician is to
test in patients, and after the clinician receives such container
and assigns it for use with a specific patient, the clinician, or
his nurse, separates the file portion 24 of the assembled label
from the container portion 22, as shown in FIG. 10, tearing the two
portions apart along the perforation line 24 near the short side of
panel 36 adjacent to the file portion 23. The file portion 23 is
then placed with, and kept with, the medical records of that
specific patient.
It is to be noted at this point that in fully assembled form, the
label information printed on the second panel 32, containing the
name of the product and the quantity of such product per unit dose
in the associated container, is obscured by having the first panel
31 and the fourth panel 34 folded over the front of such second
panel 32 and secured in that position. In addition, the label
information printed on the second panel 32 is not readable by
holding the assembled label 21 (or the file portion 23 of such
label, if such file portion has been detached from the package
portion 22) against the light, for the solid ink 31a and 33a on the
first and third panels 31 and 33, respectively, that overlay and
underlay, respectively, the second panel 32, prevent the passage of
sufficient light through the file portion 23 of the assembled label
to enable the printing on the second panel 32 to be read by the
naked eye when the label is so held against the light.
Also, the printing on the second panel 32 is not readable by
lifting an edge of a covering panel, for there is no edge of a
covering panel that can be lifted without first tearing some part
of the assembled label or separating some adhesively secured
portion of the assembled label.
If a specific patient in a group of the clinician's patients being
administered the contents of the specially prepared supply of
containers, develops an unexpected reaction, and for this reason,
or some other medically appropriate reason, the clinician wants to
know immediately whether that specific patient has actually been
receiving the medicament under study and, if so, in what amount,
the clinician removes the file portion 23 of the label of this
invention from the patient's medical records and cuts or tears the
label along the top edge, as shown at 39 in FIG. 11. He then pulls
the panels which cover the second panel 32 forward away from the
second panel, as indicated in FIG. 11, at the same time breaking
the adhesive bond between the part 31b of the first panel 31 and
the opposite part of the second panel 32, and also tearing or
cutting the junction between the second panel 32 and the seventh
panel 37. The file portion 23 of the label is then opened up, and
in this opened position it appears as shown in FIG. 12.
In so doing, the clinician has broken the "code" as to this
specific patient only. He has not broken the "code" as to any of
the other patients in the study. Hence, the study can continue and
be treated as reliable as to all the remaining patients. A
significant saving in clinical time and effort is thus achieved by
the label of this invention, while providing the desired safety for
the patient and clinician in enabling the clinician to quickly
determine, when essential, whether a specific patient is actually
being administered the medicament under test, and in what
amount.
In addition, the preparation of the label with which this result is
achieved is simple and rapid. Printing is required on one side only
of the label blank, and after that side has been printed and dried,
no further processing effort and time is required, as is necessary
with some forms of labels heretofore prepared for use in blind
studies.
In one such form heretofore used, the file portion of the label,
after having been printed with the product information, is further
processed as follows:
i. by varnishing at least the area containing the product
information;
ii. by drying the varnished area
iii. by revarnishing the varnished area;
iv. by drying the revarnished area;
v. by overprinting the product information with a solid bar of dark
ink;
vi. by drying this overprinting;
vii. by overprinting the product information a second time with a
solid bar of the same dark ink used in the first overprinting (in
an attempt to make the product information more completely
invisible and unreadable in any manner);
viii. by drying this second overprinting;
ix. by turning the label over and printing on the back of the label
a solid bar of dark ink over the area where the product information
is printed on the front side of the label; and
x. by drying this backside solid bar printing.
To break the code of such prior label, the solid ink overprinting
over the top of the label is rubbed or scratched off, which, when
done with care, can be done without penetrating the double varnish
layer and so without impairing the legibility of the product
information printed on the label.
The saving in production time and labor in making the label of this
invention, as compared with that required to make such prior label,
is manifest. The saving in the time and effort required of the
clinician to break the code of the label of this invention, as
compared with that required to break the code of such prior label,
is also manifest.
Furthermore, the label of this invention does not require that
unusual care be taken to insure that, in printing the product
information on the label, the pressure of the type on the label
does not deform the paper or other stock of which the label is
made. With such prior label, such unusual care must be taken, or
else the product information can be readily determined by examining
the deformations which are present on the back of the printed
label. In the label of this invention, if any such deformations are
created in printing the product information on the second panel 32,
then such deformations are not ascertainable in the fully assembled
form of the label, for there is a smooth-surfaced panel 33 folded
and secured against the back of the printed second panel 32 which
prevents any such paper deformations in panel 32 from being readily
ascertained.
DESCRIPTION OF MODIFIED EMBODIMENT (FIGURES 13--17)
FIGS. 13 through 17 show a modified label that embodies some, but
not all, of the features of the label heretofore described.
Referring to FIG. 13, the die-cut and printed label blank 50 of
such modified label 41 has three generally rectangular panels 51,
52, and 53 of equal size adjoining one another successively on
their long sides.
Adjoining the second panel 52 on one of its short sides is a fourth
panel 54 which is generally rectangular and which has perforations
44 therein from one long side to the other long side near where the
short side of this fourth panel 54 joins the short side of the
second panel 52.
After the label blank 50 is cut to provide the panels described
above, the blank is printed on the top side shown in FIG. 13. The
printing of label information is on the second and fourth panels 52
and 54, respectively. The printing on the first and third panels 51
and 53 is solid and unbroken, and preferably done with a dark ink
as indicated by the shading 51a and 53a representing blue color.
This conveniently is the same type and color of ink used for
printing the front of the other panels 52 and 54. Preferably three
small parts 51b, 51c and 51d of the first panel 51 are left
uninked, parts 51b and 51d being along the short sides of that
panel, and part 51c being along the long side of that panel that is
not adjoining panel 52. These uninked areas 51b, 51c and 51d are
shown in FIG. 13 with mottled shading, to indicate adhesive which
is applied thereto after the label blank 50 is die cut and printed
and is about to be assembled.
The label information printed on the second panel 52 of label blank
50 corresponds to that printed on the second panel 32 of label
blank 30. The label information printed on the fourth panel 54 of
label blank 50 corresponds to that printed on the sixth panel 36 of
label blank 30.
The label blank 50, after the printing described above has dried,
is turned over and printed on the back side, as shown in FIG. 14.
This consists of printing on the back of the first panel 51 label
information corresponding to that printed on the front of the
fourth panel 34 of label blank 30.
The areas 53b, 53c and 53d on the back of the third panel 53 shown
in FIG. 13 with mottled shading, indicate adhesive which is applied
to those areas (along the short sides of panel 53 and along the
long side of panel 53 that is not adjoining panel 52) after the
label blank is die cut, fully printed, and is about to be
assembled.
The folding and securing of the various panels of the die-cut and
printed label blank 50 of FIGS. 13 and 14 to produce the assembled
label is shown in sequence in FIGS. 15 and 16.
The first panel 51, after having adhesive applied around its free
edges 51b, 51c and 51d, is folded forward, as shown in FIG. 15,
along the junction between the first and second panels 51 and 52,
so that the first panel 51 overlays the second panel 52. The panels
are secured in this position by the adhesive along the edge areas
51b, 51c and 51d of panel 51. The solid ink printing 51a on this
first panel 51 thus is positioned on top of, and covers, the
product information printed on the second panel 52. The label
information printed on the back of the first panel 51 now appears
on the front of the label, over the area of the second panel
52.
In the next step, shown in FIG. 16, the third panel 53 is folded
along the junction between the second and third panels so that the
third panel 53 underlays the second panel 52. In this position the
solid ink printing 53a on this third panel 53 covers the back of
the label information printed on the front of second panel 52. The
panels 52 and 53 are secured in that position by the adhesive along
the edge areas 53b, 53c and 53d of panel 53.
The resulting assembled label 41 is shown in FIG. 17, as viewed
from the rear, similarly as for the assembled label 21 shown in
FIG. 9. The use of the assembled label 41 is the same as described
for the assembled label 21, and so is not repeated. The opening of
the file portion 43 of the assembled label 41 is substantially the
same as shown in FIGS. 11 and 12 for the file portion 23 of the
assembled label 21. The top long edge of the file portion 43 is
cut, and the covering panel 51 which overlays the product
information bearing panel 52 is peeled off to expose the printing
on the product information bearing panel 52.
DESCRIPTION OF ANOTHER MODIFIED EMBODIMENT (FIGURES 18--26)
In lieu of using a tacky, pressure-sensitive adhesive as described
in connection with FIGS. 1--17, the labels may be made using
material having a heat-sensitive adhesive coating on the back of
the label blank, so that, upon the application of heat and pressure
to the label after its panels are folded into assembled position,
the adhesive is activated so that it adheres to the adjoining
surface which is pressed against the adhesive-bearing surface,
thereby securing the label in its assembled position.
FIGS. 18 through 26 show one mode of making a label of this
invention using material having such a heat-sensitive coating on
one of its sides.
The label blank generally designated 70 from which the label 61 is
prepared is a flat, die-cut sheet having a printable surface on its
front side and having, on its back side, a heat-sensitive coating
of the type referred to above. A satisfactory sheet of this
character in white "Kromekote" cast coated paper, which is coated
on one side and sold by Champion Papers, a division of U.S.
Plywood-Champion Papers Inc. of Hamilton, Ohio, the sheets having
subsequently been coated on their other side by the Nashua
Corporation of Nashua, N.H. with a delayed action heat sealing
adhesive sold under the name "Pervenac" BM-3.
The label blank 70 has four generally rectangular panels 71, 72, 73
and 74 adjoining one another on their long sides. Panels 72, 73 and
74 are substantially of the same size. Panel 71 is somewhat smaller
in length and height, with the panel substantially centered in
relation to the adjoining panel 72.
A fifth generally rectangular panel 75 adjoins the second panel 72
on one of its short sides, and has perforations 64 therein from one
long side to the other long side near where the short side of this
fifth panel 75 joins the short side of the second panel 72.
After the label blank 70 is cut to provide the panels just
described, the blank is printed on the top side, as shown in FIG.
18. This printing includes label information on the second, fourth
and fifth panels 72, 74 and 75, and solid or substantially solid
ink over all, or substantially all, of the first and third panels
71 and 73. This solid ink printing is indicated by the shading 71a
and 73a on these panels 71 and 73, respectively, the shading
representing blue color. This solid ink printing is conveniently of
the same type and color of ink that is used for printing the
remainder of the blank, i.e., panels 72, 74 and 75.
The label information printed on the fifth panel 75 is that which
appears on the package portion 62 of the assembled label, as shown
in FIG. 23. The label information printed on the fourth panel 74 is
that which appears on the file portion 63 of the assembled label,
as shown in FIG. 23.
The label information printed on the second panel 72 includes the
name of the product and the quantity of such product per unit dose
in the container, such as tablet or capsule. In the assembled label
as shown in FIG. 23, this second panel 72 is part of the file
portion 63 of the label but is not visible or accessible without
mutilation of the file portion of the label.
The folding of the various panels of the label blank 70 is shown in
sequence in FIGS. 19, 20 and 21. The first panel 71 is folded
forward, as shown in FIG. 19, along the junction between the first
and second panels 71 and 72, so that the first panel 71 overlays
the second panel 72. The solid ink printing 71a on this first panel
71 thus is positioned on top of, and covers, the product
information printed on the second panel 72. Because the first panel
71 is smaller in length than the second panel 72, and is centered
with respect thereto, there is a small strip 72a along each short
side of the second panel 72 (see FIG. 20) that is not covered by
the first panel 71. Likewise, because the first panel 71 is smaller
in height than the second panel 72, there is a small strip 72b
along the lower long side of the second panel 72 (see FIG. 20) that
is not covered by the first panel 71.
The third and fourth panels 73 and 74 are then folded backward as a
unit, as shown in FIG. 20, along the junction between the long
sides of panels 72 and 73, so that the third panel 73 underlays the
second panel 72. In this position the solid ink printing 73a on the
third panel 73 is positioned underneath the product information
printed on the second panel 72.
Finally, the fourth panel 74 is folded forward, as shown in FIG.
21, along the junction between the long sides of panels 73 and 74,
so that the fourth panel 74 overlays the first panel 71 and the
second panel 72.
If desired, the sequence of folding these panels may be slightly
varied, as follows: the third and fourth panels 73 and 74 are
folded backward as a unit, as shown in FIG. 20, and then the fourth
panel 74 and the first panel 71 are together folded forward,
similarly as shown in FIG. 21.
The label as thus folded, whether by the sequence first described
or by the alternate sequence described in the preceding paragraph,
is then secured in its folded position by subjecting the folded, or
file portion 63, of the label to heat and pressure, as
schematically shown in FIG. 22. The label is placed upon a support
plate 78 and a heated plate 79 is then moved down against the
support plate 78 (or the support plate 78 is moved up against the
heated plate 79). The heat activates the coating on the back of the
material of which the label is made, and causes the coating to
adhere to the adjoining surface against which it is pressed thereby
securing the label in its assembled position.
The assembled, and thermoplastically secured, label 61 is shown in
FIG. 23, as it is being separated along the perforation line 64
into its two parts, i.e., the package portion 62 and the file
portion 63. As evident from this figure, and from the enlarged
sectional and end views FIGS. 24 and 25 of the file portion 63 of
this label, in conjunction with FIGS. 19, 20 and 21, the fourth
panel 74 is secured to the second panel 72 by the action of the
thermoplastic coating on the back of the fourth panel 74 in
adhering to the areas 72a and 72b around three sides of the second
panel 72. The remainder of the fourth panel 74 is secured to the
first panel 71 by the thermoplastic coating on the backs of the two
panels which engage each other. The third panel 73 is secured to
the second panel 72 by the thermoplastic coating on the backs of
these two panels which engage each other.
In the fully assembled form of this embodiment of the label of this
invention, the label information printed on the second panel 72,
containing the name of the product and the quantity of such product
per unit dose in the associated container, is obscured by having
the first panel 71 folded over the front of such second panel 72
and secured in that position by the fourth panel 74. In addition,
the label information printed on the second panel 72 is not
readable by holding the label against the light, for the solid ink
printing 71a and 73a on the first and third panels 71 and 73,
respectively, that overlay and underlay, respectively, the second
panel 72, prevent the passage of sufficient light through the file
portion 63 of the assembled label to enable the printing on the
second panel 72 to be read by the naked eye when the label is so
held against the light.
Also, the printing on the second panel 72 is not readable by
lifting an edge of a covering panel, for all such edges (i.e., the
edges of the fourth panel 74) are adhesively secured to the second
panel 72.
Finally, the printing on the second panel 72 cannot be read by
examining the deformations which such printing may create on the
back of the panel 72, for there is a smooth-surfaced panel (i.e.,
the third panel 73) positioned over the back of the second panel 72
and secured in that position. This prevents any such paper
deformations in panel 72 from being readily ascertained.
As with the embodiments of this label previously described, the
package portion 62 of the label 61 is secured to the container
containing the material which the clinician is to test in a
patient, and the file portion 63 is separated from the package
portion 62 by the clinician, or his nurse, by tearing the two
portions apart along the perforation line 64. The file portion 63
is then placed with, and kept with, the medical records of the
patient receiving the contents of the associated container.
If it becomes necessary for the clinician to know quickly what a
specific patient has actually been receiving, and in what amount,
the clinician removes the file portion 63 of the label from that
patient's medical records and cuts off the top edge of the label,
as indicated by the line 80 in FIG. 23. He then slightly pushes
together the two side edges of the label, which then opens up along
the top edge, as shown in FIG. 26. The clinician can then pull the
front part of the label down, tearing the side edges of the panel
74 or pulling those edges away from the side edges 72a of the
second panel 72, to expose the label information printed on the
second panel 72. In doing this, the clinician does not "break the
code" for any other patient in this blind study, so that the study
continues, as to the remaining patients involved in that study, as
an unbiased and reliable clinical test of the material being
tested.
Another embodiment of the invention which is so similar to the
embodiment of FIGS. 18--26 that it is not separately shown, is to
use heat-sealable sheet material similar to that described in
connection with FIGS. 18--26, but with the first panel
corresponding to panel 71 having the same height as the second
panel corresponding to panel 72. (In other words, there is no area
corresponding to area 71b when the first panel is folded forward
over the second panel.) However, there is an additional panel below
the fourth panel corresponding to panel 74. This additional panel,
after the fourth panel is folded over the front of the label (i.e.,
over the back of the first panel corresponding to panel 71), is
folded rearward over the back of the label. Thus this additional
panel, after the folded label is subjected to heat and pressure,
serves to secure the bottom of the first panel, corresponding to
panel 71, in position over the panel on which the label information
is printed (i.e., the second panel corresponding to panel 72). This
embodiment of the invention is less efficient in the use of label
material, as it employs one more panel than does the embodiment of
FIGS. 18--26.
Still another embodiment of the invention which is so similar to
the embodiment of FIGS. 18--26 that it also is not separately
shown, is to position the fourth panel, corresponding to panel 74,
to the right side (as viewed in FIGS. 18--20) of the third panel,
corresponding to panel 73. In such case the first panel,
corresponding to panel 71, need not have its right side (as viewed
in FIGS. 18--20) cut away to produce an uncovered strip
corresponding to strip 72a when the first panel is folded forward
over the second panel. In assembling this label, the fourth panel
is thus folded forward from the side over the second panel and over
the already-folded-forward first panel. When the label, as thus
constructed and folded, is subjected to heat and pressure, the
original back side of the fourth panel is adhesively secured to the
original front side of the second panel along a strip at the bottom
corresponding to strip 72b, and along a strip at the left side
corresponding to strip 72a. The folding along the junction line
between the side of the fourth panel and the side of the second
panel enables the adhesive bond between the second panel and the
fourth panel along the strip corresponding to strip 72a at the
right side of the second panel, to be dispensed with, without
impairing the integrity of the assembled label.
* * * * *