WO2008149349A2

WO2008149349A2 - Labelling system

Info

Publication number: WO2008149349A2
Application number: PCT/IL2008/000751
Authority: WO
Inventors: Zeev Avidov
Original assignee: Avidov Computing Solutions
Priority date: 2007-06-04
Filing date: 2008-06-03
Publication date: 2008-12-11

Description

LABELLING SYSTEM

FIELD

The invention relates to personal medical care.

BACKGROUND

The use of generic pharmaceutical consumables, commonly referred to as "generic drugs", has been steadily increasing worldwide, particularly in the United States (US), since the early 1980s. The enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 in the US, also known as the Hatch- Waxman Act, creating a shortened approval process for generic drugs while extending the patent lifetime of "brand-name" pharmaceutical consumables, commonly referred to as "brand name drugs" (drugs for which a patent has been issued), fueled a dramatic rise in sales in the US. The success of generic drugs may generally be attributed to two factors; first, that generic drugs are considered "bioequivalent" to brand- name drugs, and second, that generic drugs are less expensive to produce than brand-name drugs.

Generic drugs are pharmaceutical consumables which comprise the same active ingredients or combination of active ingredients as brand-name drug(s) but are marketed under a name other than the brand name. A generic drug is considered bioequivalent to a brand-name drug if it is similar in strength, dosage, safety, quality, method of taking, way of using, and way of working. Generic drugs typically look different than brand-name drugs, as they comprise inactive ingredients which help to physically differentiate them, such as, for example, through color and/or flavor. For convenience, generic drugs and brand-name drugs comprising the same active ingredients or combination of active ingredients may hereinafter be referred to as "drug group" or "group". A generic drag may generally be produced after the patent of a brand-name drag has expired. The cost of manufacturing the drag is usually much less than that of a brand-name drag as the costs incurred with research and development, obtaining regulatory approval and marketing are generally avoided. This manufacturing cost advantage allows for generic drags to be sold at prices which offer a consumer substantial savings compared to brand-name drags, in some cases up to 70 percent less than the brand-name drag.

Regulations for naming generic drags may vary from country to country. Typically, it is required from a generic drag manufacturer and/or generic drag supplier to include the generic name of a drag on a label generally attached to the drag's immediate container and optionally to the outside container or wrapper. The label, aside from including the generic name of the drag, typically may include such information as, for example, the active ingredients or combination of active ingredients, recommended dosage, method of taking and recommended way of using. The generic name is usually given by the manufacturer and/or supplier and includes a group of letters and/or a code, hereinafter referred to as "code", associating the generic drag with the drug group to which it belongs. Assignment of codes is generally done according to the regulations of the country where the generic drags are manufactured and/or marketed.

Generic names on the labels, however, may sometimes create confusion in the minds of consumers and may lead to possible drug misuse. One such case may be when the names of different groups resemble one another. The consumer may misread the label and may take a wrong drug. Another example case may occur when the names of different groups sound similar to one another. The consumer may ask for a drag and may be handed a wrong, similar sounding drug. Another case may be when the consumer is required to take several drags and the label on the drags makes it difficult to differentiate between different name generic drags belonging to the same group, or between a generic drag and its brand-name equivalent. As a result of the confusion the consumer may repeat doses by taking two (or more) generic drugs from the same group, or by taking a brand-name drug and also taking its generic equivalent. The problem is further exacerbated when drugs from different groups may have the same use, for example, Aspirin and Tylenol. Here again, the consumer may repeat dosages by taking two or more drugs which are intended for the same treatment. Drug misuse may create drug dependency in the consumer and/or may worsen his or her medical condition. Furthermore, in some cases drug misuse may affect the consumer's health to the extent where he or she may require hospitalization, and in some extreme cases may even cause death.

More information on generic drugs may be found in (www.fda.gov/cder/ogd/), Office of Generic Drugs, US Food & Drug Administration, in

(http://www.pueblo.gsa.gov/cic_text/health/testtube/generics.htm), Greater Access to Generic

Drugs, US Food & Drug Administration, and in (http://www.drugsafetyinstitute.com/), Drug

Safety Institute, all of which are incorporated herein by reference.

SUMMARY

An aspect of some embodiments of the invention relates to providing a method and a system for labeling generic pharmaceutical consumables, commonly known as "generic drugs", and brand-name pharmaceutical consumables, commonly known as "brand-name drugs", so that they may be easily identified by a consumer. Drugs comprising the same active ingredients or the same combination of active ingredients, but from different manufacturers and/or suppliers are generally labeled using different names. The use of different names may be confusing to a consumer and, when taking medication, the consumer may unknowingly repeat doses by taking drugs comprising the same active ingredients or combination of active ingredients, thereby exceeding a recommended or prescribed dosage. For convenience, generic drugs and brand-name drugs comprising the same active ingredients or combination of active ingredients may hereinafter be referred to as "drug group" or "group". Furthermore, different drug groups may sometimes use names which seemingly appear to be the same. The similarity in the names may be misleading and the consumer may end up taking the wrong drugs. The problem is further exacerbated when drugs from different groups may have the same use, for example, Aspirin and Tylenol. Here again, the consumer may repeat dosages by taking two or more drugs which are intended for the same treatment.

According to an aspect of some embodiments of the invention, a drug group is labeled so that a consumer may easily identify drugs belonging to the same group or to a different group having the same use. In accordance with an embodiment of the invention labeling comprising same or substantially similar markers is used to identify drugs which belong to the same group or to a different group having the same use. Labeling refers to a label which is attached to each drug's immediate container and optionally to the outside container or wrapper. Markers are symbols comprised in the label used to easily identify a group, and may include the use of colors, numerical characters, alphabetical characters, graphics, Braille, and/or any combination thereof. Furthermore, the markers may be generic, that is, the label of a group may include the same markers for all consumers, each group comprising one or more particular markers. Optionally, the markers may be unique to each consumer so that each group is labeled with one or more markers distinctly associated with each consumer (for the same group each consumer may use different markers).

In accordance with an embodiment of the invention, the markers may be stored electronically in a data processing device and/or data storage device, also referred to as "digital medium", for example a central computer, personal computer (PC), lap-top computer, smart card, flash card ("disc-on-key"), mobile phone, and/or other network devices and/or nonvolatile memory devices. Each consumer may then have stored in the digital medium the markers for each drug group he or she consumes, the information of which may be accessed by a drug provider which may be, for example, doctors, pharmacists, and/or over the counter (OTC) vendors. Optionally, in accordance with some embodiments of the invention the markers may be stored as "hard copy" on paper and/or on other non-electronic storage means such as, for example, medical necklaces, medical bracelets, and medical tags.

There is therefore provided, in accordance with an embodiment of the invention, a method of labeling a given pharmaceutical consumable, the method comprising assigning the same symbol to a group of given pharmaceutical consumables, and where the symbol is correlated to the pharmaceutical consumables and to a specific consumer.

In some embodiments of the invention each member of the group comprises the same active pharmaceutical ingredient or the same combination of active pharmaceutical ingredients. Optionally, each member of the group has the same dosage form and may, additionally or alternatively, have the same use for the consumer. Furthermore, each member of the group may comprise the same active pharmaceutical ingredient or the same combination of active pharmaceutical ingredients.

In accordance with some embodiments of the invention the group comprises the generic pharmaceutical consumable and may additionally comprise the brand-name pharmaceutical consumable.

Furthermore, in some embodiments of the invention the symbol is selected from a set of possible symbols associated with the consumable and by the consumer, where the symbols may be specific to a certain consumer. The consumer may generate the symbol and optionally, the provider of the given pharmaceutical consumable may assign the symbol. Additionally, a label comprising the symbol may be generated. In accordance with some embodiments of the invention the symbol is stored on a digital medium to which both the consumer and provider have access. Optionally, the digital medium may be a non-volatile memory device. Additionally or alternatively, the digital medium may be a network device.

There is further provided, in accordance with an embodiment of the invention, a user customized generic product label comprising a symbol correlated to a combination of a specific pharmaceutical consumable and a specific consumer.

There is further provided, in accordance with an embodiment of the invention, a product, such as a generic product, labeled with a user customized label comprising a symbol correlated to a combination of a specific pharmaceutical consumable and a specific consumer.

There is further provided, in accordance with an embodiment of the invention, a system for labeling a given pharmaceutical consumable comprising a controller adapted to assign a symbol to the given pharmaceutical consumable, and where the symbol is correlated to a combination of pharmaceutical consumable and consumer.

BRIEF DESCRIPTION OF FIGURES

Examples illustrative of embodiments of the invention are described below with reference to figures attached hereto. In the figures, identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral in all the figures in which they appear. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

Figure 1 schematically shows an exemplary label for a drug in accordance with an embodiment of the invention; Figure 2 schematically shows an exemplary label for another drug of the same group as that of Figure I₅ in accordance with an embodiment of the invention;

Figure 3 schematically shows an exemplary markers table in accordance with an embodiment of the invention; and,

Figure 4 schematically shows an exemplary block diagram of a system for labeling a pharmaceutical consumable.

DETAILED DESCRIPTION

Reference is made to Figure 1 which schematically shows an exemplary label 100 for a generic drug and/or brand-name drug in accordance with an embodiment of the invention. For convenience, a generic drug and/or brand-name drug will be referred to hereinafter as "drug". Label 100 is attached by the provider to the drug's immediate container and optionally to the outside container or wrapper, hereinafter referred to as "container". The label shall be of suitable dimensions, W 130 and L 132, to fit on any type of container adapted to hold drugs. Label 100 may be self-adhesive although in some embodiments of the invention label 100 may be attached to the container by applying an adhesive such as, for example, glue or paste, or by using an adhesive tape or other means of adhesion. Label 100 is shown as rectangular in shape although in accordance with other embodiments of the invention the label may have other geometrical shapes, for example, elliptical, rhomboid, or triangular. Additionally or alternatively, in some embodiments of the invention the label may comprise components used for electronic labeling and comprising labeling information, such as, for example bar code and/or electronic chip(s).

Label 100 comprises two types of fields, "title" fields and "variable" fields. The title fields are the same or substantially similar for all labels of all drug groups, while the variable fields comprise information generally input by the provider. The information in the variable fields is preferably input electronically although it may optionally be input manually or by some other means of input. In other embodiments of the invention the label may include other title and/or variable fields not shown in the referenced figure, while in some other embodiments of the invention the fields may be arranged in a manner differently to that shown in the reference figure.

Field 102 is a variable field located at the top of the label. Field 102 may comprise information related to the provider of the drug, for example, name of the provider, address and telephone. Optionally, variable field 102 may also comprise other useful information such as, for example, date of issue of the drug, drug expiration date, name of doctor prescribing the drug, or other useful data not covered by the other fields in the label. Field 104 located below field 102 is a title field comprising the word "Name". Adjacent to field 104 is variable field 112 wherein will be input the name of the consumer, for example, "Joe Smith" as shown. Below title field 104 is title field 106 comprising the word "Drug Name". Adjacent to field 106 and below variable field 112 is variable field 114 wherein will be input the name of the drug, for example, "Asperien" as shown. Below title field 106 is title field 108 comprising the word "Private ID".

Private ID is associated with markers selected by the provider to identify drugs of the same group and to distinguish them from drugs from other groups. Each drug group is identified by one or more markers specifically assigned to each group. The markers comprise symbols which are input in variable fields 116 and 118 adjacently located to field 108. These symbols may comprise colors, numerical characters, alphabetical characters, graphics, Braille, and/or any combination thereof. In the exemplary label 100, field 116 will be input a number, for example, "11" as shown. The number "11" is the symbol selected by the provider to identify all drugs belonging to the same group as "Asperien". In field 118, a color coded geometrical shape resembling an ellipse will be input, for example, the grey colored ellipse as shown. The provider has selected a grey colored ellipse to identify all drugs belonging to the same group as "Asperien". Instead of looking at the names of drugs, the consumer only has to refer to either one of the symbols, or optionally to both symbols, in the labels to corroborate that the drugs belong to the same group or to different groups. In accordance with some embodiments of the invention, the other symbols previously mentioned may be used, instead of numbers and colored geometric shapes, in fields 116 and 118. Furthermore, in accordance with other embodiments, of the invention additional variable fields may be included for the use of other symbols, for example, three fields, four fields, or even five fields may be used for the symbols.

Below title field 108 is title field 110 comprising the word "Instruction". Adjacent to field 108 and below variable fields 116 and 118 is variable field 120 wherein instructions related to the drug are input.

Reference is made to Figure 2 which schematically shows an exemplary label 200 for a drug from a different group as that of Figure 1 and with a different name, but having the same use, in accordance with an embodiment of the invention. Label 200 is attached by the provider to the drugs immediate container and optionally to the outside container or wrapper, hereinafter referred to as "container". The label shall be of suitable dimensions, W 230 and L 232, to fit on any type of container. Label 200 may be self-adhesive although in some embodiments of the invention label 200 may be attached to the container by applying an adhesive such as, for example, glue or paste, or by using an adhesive tape or other means of adhesion. Label 200 is shown as rectangular in shape although in accordance with other embodiments of the invention the label may have other geometrical shapes, for example, elliptical, rhomboid, or triangular. Additionally or alternatively, in some embodiments of the invention the label may comprise components used for electronic labeling and comprising labeling information, such as, for example bar code and/or electronic chip(s).

Label 200 comprises two types of fields, "title" fields and "variable" fields. The title fields are the same or substantially similar for all labels of all drug groups, while the variable fields comprise information generally input by the provider. The information in the variable fields is preferably input electronically although it may optionally be input manually or by some other means of input. In other embodiments of the invention, the label may include other title and/or variable fields not shown in the referenced figure, while in some other embodiments of the invention the fields may be arranged in a manner differently to that shown in the reference figure.

Label 200 comprises title field 202, title field 204, variable field 212, title field 206, title field 208, variable fields 216 and 218, title field 210, and variable field 220, all of which are the same or substantially similar to that shown in Figure 1 at 102, 104, 112, 106, 114, 108,

116, 118, 110, and 120, respectively. Label 200 further comprises variable field 214 wherein will be input the name of the drug, for example, "Tylenol" as shown.

Reference is made to Figure 1 and Figure 2. The symbols assigned by the provider to variable field 116 and variable field 216 are the same or substantially similar. Additionally, the symbols assigned by the provider to variable field 118 and variable field 218 are also the same or substantially similar. Although the drug identified in variable field 114 has a name of "Asperien" while that in field 214 has a different name of "Tylenol", the use of the same or substantially similar symbols indicates that the two drugs belong to the same group or belong to different groups but have the same use.

In accordance with an embodiment of the invention, the markers may be generic, that is, the label of a group may comprise the same markers for all consumers, each group having its own particular markers. For example, the symbols used in fields 116, 118, 216 and 218 may apply for all consumers provided with drugs belonging to the same groups, or to different groups having the same use, as "Asperien" and "Tylenol". In accordance with some embodiments of the invention, the markers may be unique to each consumer so that each group is labeled with markers distinctly associated with each consumer. For example, the symbols used in fields 116, 118, 216 and 218 apply for "Joe Smith" when provided with drugs belonging to the same groups or different groups having the same use as "Asperien" and "Tylenol", but may correspond to a different drug group for a consumer other than "Joe Smith".

Reference is made to Figure 3 which schematically shows an exemplary markers table 300 in accordance with an embodiment of the invention. Reference is also made to Figures 1 and 2. Markers table 300 comprises a list of each drug provided to a consumer by a provider and the respective markings associating the drug to a particular drug. The marker table is adapted to allow the provider, and optionally the consumer, to identify drugs which may belong to the same drug group, or to different groups but have the same use, and to effectively track which drugs have been provided to the consumer. The table is generally updated by the provider, and optionally by the consumer, every time a drug not previously listed is provided to the consumer.

Markers table 300 is arranged in tabular form and comprises the information found in the variable fields of the labels, for example, the labels of Figures 1 and 2. Nevertheless, in other embodiments of the invention the table may be arranged in any manner, according to the data storage medium, which facilitates entry and processing of the information contained in the variable fields.

Markers table 300 comprises a "Name" column 302, "Drug Name" column 304, "Private ID" column 306, and an "Instruction" column 308. The column headers correspond to the title fields in the labels, for example, title fields 104, 106, 108 and 110 shown in Figure 1. A row in marker table 300 comprises the information contained in the variable fields of a label. Reference is made to line 310 of marker table 300. Under "Name" column 302 is listed the name of the consumer as appears in variable field 112 of label 100. Under "Drug Name" column 304 is listed the name of the drug as appear in field 114 of label 100. Under "Private ID" column 306 are listed the symbols as they appear in fields 116 and 118, respectively, of label 100. Under "Instruction" column 308 are listed the instructions as they appear in field 120 of label 100. Reference is made to line 312 of marker table 300. Under "Name" column 302 is listed the name of the consumer as appears in variable field 212 of label 200. Under "Drug Name" column 304 is listed the name of the drug as appear in field 214 of label 200. Under "Private ID" column 306 are listed the symbols as they appear in fields 216 and 218, respectively, of label 200. Under "Instruction" column 308 are listed the instructions as they appear in field 220 of label 100.

Reference is made to Figure 4 which schematically shows an exemplary block diagram of a system 400 for labeling a pharmaceutical consumable in accordance with an embodiment of the invention. A controller 401 comprises circuitry adapted for storing electronically the marker table in a digital medium 402. Digital medium 402 comprises a data processing device and/or data storage device, such as for example a central computer, personal computer (PC), lap-top computer, smart card, flash card ("disc-on-key"), mobile phone, CDs, DVDs, and/or other network devices and/or nonvolatile memory devices. Optionally, controller 401 is adapted to store the marker table in a hard copy storage means 404, such as for example paper.

Additionally or alternatively, controller 401 is optionally adapted to store the marker table in non-electronic storage means 403 such as, for example, necklaces, bracelets, tags, and watches. In the description and claims of embodiments of the present invention, each of the words, "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

The invention has been described using various detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments may comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described, and embodiments of the invention comprising different combinations of features noted in the described embodiments, will occur to persons with skill in the art. The scope of the invention is limited only by the claims.

Claims

CLAIMSWhat we claim is:

1. A method of labeling a given pharmaceutical consumable, said method comprising:

assigning the same symbol to a group of given pharmaceutical consumables, wherein the symbol is correlated to the pharmaceutical consumables and to a specific consumer.

2. The method according to claim 1, wherein each member of the group comprises the same active pharmaceutical ingredient or the same combination of active pharmaceutical ingredients.

3. The method according to claim 1, wherein each member of the group has the same dosage form.

4. The method according to claim 1, wherein each member of the group has the same use for the consumer.

5. The method according to claim 1, wherein each member of the group comprises the same active pharmaceutical ingredient or the same combination of active pharmaceutical ingredients.

6. The method according to claim 1, wherein the group comprises the generic pharmaceutical consumables.

7. The method according to claim 6, wherein the group further comprises the brand-name pharmaceutical consumable.

8. The method according to claim 1, wherein the symbol is selected from a set of possible symbols associated with the consumable and by the consumer.

9. The method according to claim 1, wherein the symbols are specific to a certain consumer.

10. The method according to claim 1, wherein the consumer generates the symbol.

11. The method according to claim 1, wherein a provider of the given pharmaceutical consumable assigns the symbol.

12. The method according to claim I₅ further comprising generating a label comprising the symbol.

13. The method according to claim 1, wherein the symbol is stored on a digital medium to which both the consumer and provider have access.

14. The method according to claim 13, wherein the digital medium is a non- volatile memory device.

15. The method according to claim 13 wherein the digital medium is a network device.

16. A user customized generic product label comprising a symbol correlated to a combination of a specific pharmaceutical consumable and a specific consumer.

17. A generic product labeled with a user customized label comprising a symbol correlated to a combination of a specific pharmaceutical consumable and a specific consumer.

18. A system for labeling a given pharmaceutical consumable comprising:

a controller adapted to assign a symbol to the given pharmaceutical consumable, wherein the symbol is correlated to a combination of pharmaceutical consumable and consumer.