A BLISTER PACK

FIELD OF THE INVENTION

This invention relates to a blister pack for storing medication units and to a method for monitoring the administration of medication. The invention also relates to a method of distributing medication.

BACKGROUND TO THE INVENTION

Various problems exist with current medication packaging systems and methods. Certain diseases or syndromes, notably tuberculosis and HIV/AIDS, are treated using combinations of drugs. For effective treatment, medication must be taken as prescribed by a health practitioner over an extensive time period, sometimes for the duration of the patient's life. Failure to correctly take the medication leads to drug resistance. In countries where many patients are illiterate or semi-literate, complicated drug regimens are not always correctly followed.

There are also diseases, such as cancer, which are treated with drugs having harsh side effects. Such drugs are commonly taken together with a second drug for treatment of the side effect. Again, where patients are illiterate, drug regimens are not always correctly followed.

A serious problem in countries having limited resources is theft of medication. Often such theft is opportunistic, carried out by health workers and others who have easy access to the medication. This problem is exacerbated when medication units are supplied in bulk or loose form, it is also exacerbated by inability of law enforcing authorities to trace stolen medication.

Another problem is known as round tripping. This is especially prevalent with HIV/AIDS medication which is often made available to resource limited countries at significantly discounted prices. A market emerges in which cheap medication from poorer countries is brought into wealthier countries where it is sold at a significant profit. Such a practice is not only damaging to pharmaceutical manufacturing companies but also to the population of

the country for whom the medication was originally intended. If authorities were able to trace medication, the round-tripping market could be more effectively controlled and possibly prevented.

Resource poor countries and certain wealthier countries also lack ineffective administrative systems. This has serious consequences. One consequence is lack of stock control. Due to poor administration, staff at hospitals and field clinics are often not aware of what drugs are in stock. If there is a change in staff, drugs may be ordered unnecessarily due to a poor understanding of pharmacological equivalence. Also, no attention is paid to the expiry dates of drugs kept at hospitals leading to wastage of resources. As a result of poor control, very little statistical data may be captured and such data would have use in epidemiological research and would allow the financial management of the hospital to be improved.

Another consequence of poor administration in hospitals and clinics is poor pharmacovigilance. Should one patient be treated by more than one health practitioner, such as two medical doctors, there is often no communication between the practitioners. One doctor may prescribe medication which interacts negatively with or diminishes the effect of another medication which has been prescribed by the second doctor.

OBJECT OF THE INVENTION

The object of this invention is to provide a solution, which at least partly alleviates the abovementioned problems.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a blister pack including a tray defining a plurality of recesses, each recess accommodating a unit of medication, and; a cover sheet, secured to the tray to enclose the units of medication accommodated in the recesses, characterized in that the recesses accommodate more than one type of medication.

The invention further provides for each recess to accommodate a single unit of medication.

The medication units on the blister pack may be associated with a single disease, for which treatment may be curative or prophylactic, or with more than one disease, such as HIV and an opportunistic disease, for example, tuberculosis. It may therefore include the treatment of secondary diseases and/or symptoms and/or the treatment of side effects of a primary medication. In particular if such a disease is a common disease for which the treatment with a combination of drugs is commonly prescribed, such as tuberculosis and HIV/AIDS, blister packs containing all drugs prescribed in combination can be manufactured efficiently in large series on a large scale, industrial basis.

The invention yet further provides for the recesses to arranged in sets of one or more recesses, each set accommodating one or more units of medication to be administered within a predetermined time frame. The blister sets may be arranged on the pack in groups and each group may consist of units of medication to be administered within a predetermined time frame.

The recess sets may further be arranged on the blister pack into groups, each group consisting of units to be taken during the course of one day. Each group may be arranged in a row on the pack and each row may further be grouped into a series. The series may represent a week or a month.

There is further provided for the cover sheet to have displayed thereon indicia associated with each set representative of a time of day when the medication of that set has to be taken. The time of day may be indicated by means of a symbol for day and night which may be a sun for day and a moon for night. The cover sheet may further include indicia associated with each group indicating the day of the week or of the month.

The label, which may be printed on or adhere to the outer surface of the cover sheet or be attached to the set of medication in another manner, may further include indicia identifying each set depicted thereon, each in association with the respective set, for instance each time in an area of the cover sheet close to the cavities containing the medication units of that set. Preferably, the indicia represent a code representing which blister pack the set is or was a member. Further preferably, the indicia represents the generic name of each medication unit in the set. Still further preferably, it represents the production batch of the set. Yet further preferably, it represents the expiry date of each set. The indicia may also

represent the date of production of the set, the name of the manufacturer, and a sequential tablet identifier.

There is yet further provided for the indicia to be in the form of a bar code, which may for instance be a single dimension or 2D bar code, associated with each set. The bar code may be included in addition to or instead of written information.

There is yet further provided for the medication unit identifiers to be contained in a radio frequency transmitter arranged for transmitting a code identifying at least the blister pack.

The invention extends to a method of monitoring the administration of medication from a pack containing more than one type of medication unit arranged on the pack in sets of one or more units, the pack having indicia representative of each set depicted thereon, each in association with the respective set. In this method, a medication set code represented by the indicia depicted in association with one of the sets of the medication is entered into an electronic communication device. In reacting to an observation that the set of the medication has been taken, the entered medication set code is sent to a data centre where a database is maintained including medication set codes of sets to be administered and associated time limits. Medication set codes in the database corresponding to the code received at the data centre as having been taken are marked accordingly and a warning signal is issued from the data centre to predetermined parties in response to expiration of a time limit, stored in the data centre, associated with a medication set code while the corresponding medication set code has not yet been received at the data centre.

Because the codes only need to be entered per occasion when a plurality of medication units is taken (the medication units may be taken briefly after each other, for instance because it is preferred to swallow one at a time), the effort and amount of communication required to monitor whether the drug regimen is correctly followed is substantially reduced.

The communication device may be a telephone. Telephones are compact, low-cost standard equipment and are widely available.

The telephone may be a mobile telephone incorporating a barcode reader in electronic communication with the data centre. Alternatively it may be a mobile telephone

incorporating a digital camera, the method further comprising capturing and storing an image including the indicia by the digital camera, determining a medication set code from the indicia contained in the image as medication set code to be sent to the data centre. Thus, the need of manually entering the medication set code is avoided and the image data (or the codes if the determination is made in the telephone before sending) can easily be transmitted to the data centre even from remote areas, without having to resort the use of specialized devices such as bar-code scanners and connections of such devices to communication equipment, although such devices are not excluded from the scope of this invention.

The communication device may also be a computer enabled with a modem.

If the data centre stores a communication device code identifying the communication device from which the medication set code is received, it can easily be verified if the medication set code is received from a person authorized to send the monitoring data.

Moreover, the warning signal can be sent to a communication device identified by a communication device code received in association with an earlier medication set code identifying a medication set of the same pack, so that it is ensured in a simple manner that the person involved in the implementation of the drug regimen for a given patient is warned if a time limit has been missed.

The time limits associated with the medication set codes assigned to medication sets of the same pack may be set in response to receiving a first one of the medication set codes assigned to medication sets of that pack, so that the time limits are automatically triggered with the start of the use of a medications from a pack.

The authenticity of a received medication set code may be checked against reference data and subsequently an authenticity message containing a result of the authenticity check may be returned in reply to the received medication set code. The authenticity message may contain a warning of non-authenticity or a confirmation of authenticity. Depending on requirements, only warnings or only confirmations may be sent.

The invention still further extends to a system for distributing medication stored in blister

packs in a hospital, each blister pack including a tray defining a plurality of recesses, each accommodating a medication unit, and a cover sheet secured to the tray to enclose the units in the recesses, the recesses accommodating more than one type of medication and being arranged on the tray in sets of one or more recesses, the cover sheet having a label including indicia representing a medication set code associated with each set, the system comprising a storage space for storing blister packs, the storage space having an electronic communication device associated therewith operable to read the set code; and an administration centre including a database for storing information relating to each medication set; the communication device being operable to transmit the reading to the administration centre.

The stored information may include a batch number, active ingredients and expiry date. It may also include a manufacturer identifier.

The invention further provides for the system to include a plurality of electronic communication devices for predetermined health practitioners to transmit a reading to the administration centre and to receive a signal from the administration centre in response to the reading. Each device for the predetermined health practitioners may have an identifier and the administration centre may have a means for detecting the identifier.

The administration centre may be operable to verify the authority of the health practitioner by receiving a password from the health practitioner's electronic communication device and then verifying that the password corresponds to the identifier detected.

There is yet further provided for the system to include a plurality of patient identifiers, each carried by a patient, and for the data centre to have a database for storing each patient's code, diagnosis and treatment regimen. The electronic communication devices may then be operable to read a patient's identifier and to transmit the reading to the administration centre.

The electronic communication devices may be a mobile telephone incorporating a digital camera or a barcode scanner.

The administration centre may be operable to receive prescription information from the health practitioner's communication device. Preferably, the administration centre is also operable to verify that the medication included in the patient's prescription is compatible with any other medication, which is recorded in the patient's treatment regimen in the database, and to transmit a warning signal to the electronic communication device in response to the reading. Further preferably, the administration centre is operable to verify that the prescribed medication is compatible with any pre-existing medical condition stored in the database. Then, the administration centre may be operable to transmit a warning signal to the health practitioner's communication device in the event of incompatibility.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described, by way of example only, with reference to the drawings in which:

Figure 1 is a perspective view of the front side of a blister pack in accordance with the invention;

Figure 2 is a perspective view of the reverse side of a blister pack in accordance with the invention;

Figure 3 is an overview of an example of an implementation of a method according to the invention;

Figure 4 is a table representing some features of an example of a database to be used in combination in a method according to the invention; and

Figure 5 is a schematic representation of a system for distributing medication in accordance with this invention.

DETAILED DESCRIPTION OF THE INVENTION

A blister pack 1 is shown in Figures 1 and 2 and includes a transparent tray 3 defining a plurality of recesses 5, each accommodating a medication unit 7, and a cover sheet 9, typically an aluminium or other frangible foil sheet, secured on the tray 3 to enclose the units 7 in the recesses 5 in any conventional manner.

As can be seen in Figure 2, the recesses 5 are shaped and dimensioned to accommodate more than one type of medication unit 7 and are arranged on the sheet 3 in seven groups 13 or rows 13, each row 13 being associated with a week day. Each row 13 is arranged into two sets 15, the first set 17 including two medication units 7.1 and 7.2 to be taken during the morning, typically with breakfast, and the second set 19 including three medication units 7.3, 7.4 and 7.5 to be taken in the evenings.

As can be seen in Figure 1 , there is further provided for the cover sheet 9 to have a label 21 associated with each set 15 indicating prescribing information. The prescribing information includes a sun 23, symbolizing day, and a crescent moon 25, symbolizing night. The cover sheet also includes a numeral 27 between one and seven associated with each row 13 indicating the day of the week. It will be readily appreciated that no literacy is required to understand at which time of day each set of medication is to be taken. If it is wished to indicate whether or not the medication is to be taken together or not with a meal, the set may have a spoon or a crossed out spoon associated therewith depicted on the label.

The name 29 of each medication unit 7 is also labelled on the cover sheet 9 and is positioned thereon so that it is associated with the relevant medication unit 7. In the drawings, this is depicted generically using the terms "DRUG 1", "DRUG 2" and the like. A batch number 31 and an expiry date 33, associated with each group 13, are also depicted on the cover sheet 9. The cover sheet 9 has a bar code 35 depicted thereon associated with each set 15. The information contained in the barcode 35 includes the expiry date, active ingredient, and batch number of the set 15. It may optionally include the manufacturer's name. Instead, the barcode 35 may contain a coded reference to the expiry date, active ingredient and batch number, the code and the information to which it corresponds being stored in a database.

Several modifications to this embodiment are possible without departing from the scope of the invention, which will be readily envisaged by a person skilled in the art. For example, the medication unit identifiers may be contained in a radio frequency transmitter instead of or in addition to the barcode.

In Figure 3, a pack 1 as shown in Figure 1 is shown in the context of means for monitoring adherence to a drug regimen. In the example shown, a communication device 40 in the form of a mobile telephone is used for inputting a medication set code represented by the indicia 35 into the telephone 40. The indicia 35 are provided in the form of a bar code that is depicted on the back of the set 17 of the medications.

The mobile telephone 40 may incorporate a barcode reader. Instead, the mobile telephone 40 may incorporate a digital camera with a lens 41. An image including the indicia 35 is then projected via the lens 41 on an imaging chip (not shown). The image is converted into image data representing the projected image by the digital camera. The medication set code is read by a suitable reader remote from the telephone 40 from the indicia contained in the image data. The indicia may also be provided in another form, for instance in the form of humanly readable characters, if optical character recognition software is available for determining the code therefrom.

If it has been ascertained, for instance by a supervisor, that a set of medications has to be taken by a patient, the medication set code that has been captured is sent to a data centre 42.

The first time a medication set code belonging to a pack 1 is sent, the supervisor also needs to provide a code identifying the patient for whom the medications in the pack 1 are intended. In response to receiving a first one of the medication set codes 46 assigned to medication sets 19 of a pack 1 in combination with the patient code 51 , the medication set codes 46 of the sets 19 of that pack 1 are associated to that patient code. The time limits 47 for administering successive dosage sets 19 associated to that patient are then also associated to the set codes 46. This provides the advantage, that the patient code 51 associated to a blister pack needs to be registered only once for each pack 1. When next medication set codes of medication sets that are members of the same pack 1 are received, it is then automatically known to which patient and time limit the received

medication set codes belong.

The medication set code as sent may be in the form of the image data containing the indicia (the determination of the medication set code is then made after transmission of the image data) or in the form of data representing the medication set code as such, which have been determined from the image data before sending. According to the present example, the transmission of the medication set code involves sending a message to a cellular network station 43 via wireless communication represented by arrow 44 and transmission of the message via a Public Switch Telephone Network 44 to the data centre 42. This transmission may involve the use of SMS servers or other communication equipment known per se.

At the data centre, a database 45 is maintained including medication set codes 46 of sets to be administered, associated time limits 47 and data 48 indicating whether a medication set represented by a medication set code is marked as having been taken.

In the present case, the medication set code 7385-01 has been received from the telephone 40, and in reaction thereto, the medication set code 7385-01 in the database 45 is marked as having been taken by a "1", the other medication set codes of the group 7385 still being marked with a "0" to indicate that those sets still have to be taken.

A warning signal is issued from the data centre 44 in response to expiration of a time limit (in this example 30 July, 8:00 PM) associated to a medication set code while the corresponding medication set code 7385-02 has not yet been received at the data centre 42. In the present example, the warning signal is sent to the mobile telephone 40 of supervisor 138, which has been registered as sender of a previous medication set code of the group 7385 of medication sets packed in the blister pack 1 in a data subset 49. The transmission is again sent via the Public Switch Telephone Network 44, cellular network station 43 and via wireless communication represented by arrow 50.

A received medication set code may also be checked against reference data, which may also include a list of senders authorized to make an authenticity check, for medication set codes from a list, and subsequently an authenticity message containing a result of the authenticity check may be sent in response to the received medication set code. Particularly

in hospitals where many health practitioners may work with one individual patient, this method provides the advantage in that the monitoring of the administration of the medication takes place at one centre.

The administration monitoring means which has been described until now may be readily applied in clinical trials where it is essential, for the success of the trial, that the medication be taken as prescribed and for accurate and precise record keeping to be kept.

Referring to Figure 5, a medication distribution system 50 is shown and includes a central storage space 52 in a hospital for storing medication units packaged in blister packs as described above. The storage space 52 is equipped with a bar code reader 54 which is in electronic communication with a central administrator 56 in the hospital. The administrator 56 has a processing unit 58 and a database 60 which is operable to store information relating to the medication in the storage space 52.

The system 50 includes a medication transportation means 62, typically a truck 62, also equipped with a barcode reader 64 in electronic wireless communication with a supplier database (not shown) on a supplier's processing unit (not shown). Medication which is loaded onto the truck 62 is barcoded. For bulk transportation, the blister packs are stored in boxes (not shown) of, for example, 100 packs. The boxes are then clustered in containers of, for example 10 boxes. The boxes and containers are barcoded with information of each blister pack contained thereinside.

Each barcode is read by the truck's barcode reader 64 when loaded on the truck 62 and the reading is transmitted to the supplier processing unit. The database stores the details of each container. When the truck 62 arrives at the point of delivery, the barcode is again scanned by the barcode reader 64 on the truck 62 and the data is transferred to the processing unit and stored in the supplier database as a function of the date and time of delivery. Each pack delivered is marked on the database as having been delivered. Should the entire truck load not be discharged at the point of delivery, a warning signal may be issued to predetermined parties alerting them to the fact that certain units were removed from the truck during transit.

Once the medication is loaded onto the hospital storage space 52, the expiry dates of each

medication are stored as this is indicated on the barcode. Also indicated is the active ingredient and the batch number.

It will be readily appreciated that, should the hospital staff be changed, a newcomer may readily ascertain what medication is available in stock and what is its active ingredient. Should two pharmaceutical equivalent products be available, this will appear on the central administrator.

A health practitioner 66, such as a medical doctor or a dentist, who examines a patient 68 may carry with him a mobile telephone 70, as described above, or a portable computer 72 in electronic communication with the central processing unit 58. Each practitioner who has capacity to prescribe medication in the hospital is given a practitioner identifier code which may be contained in barcode depicted on a wrist band, for example. Instead, it may be an alphanumeric password which may be transmitted to the central processing unit using any of a number of electronic communications means. Upon receiving the code, the processing unit is operable to verify the identity of the practitioner. Once the identity has been verified, the practitioner may prescribe medication to the patient.

To prescribe the relevant information, the practitioner 66 enters the patient's identifying code on the computer 72 or the telephone 70 and then the prescription including method of administration. The code and the prescription details are then sent to the central administrator 56 where they are captured in the database 60 against the patient's details. If the patient 68 is already on another medication, the operating system is operable to check the compatibility of it with the newly prescribed medication. If there is any incompatibility, a warning message is transmitted to the practitioner's communication device 70 or 72.

Upon reading the prescription, a nurse or other assistant then obtains the relevant medication from the storage space 52 and scans it against the barcode reader 54 at the storage space. The reading is transmitted to the administrator 56 and stored in the central database 60 where the relevant blister pack is marked as "out of storage". The nurse then administers the medication to the patient as described above.

Should the blister pack indicate that the medication has passed its expiry date, then the operating unit is operable to transmit a warning signal to a communication device carried by

the nurse, such as a mobile telephone or pager.

It will be readily appreciated that this invention provides a simple yet effective blister pack, which facilitates the taking of medication, by illiterate or semiliterate people. The blister pack also facilitates the tracing of medication units in the event of theft. By providing several different medication units in a pack, the likelihood of theft is also diminished.

The method of administering medication increases pharmacovigilance in hospitals. The capturing of data also permits useful statistics relating to the administration of hospitals is kept. This permits for more accurate budgeting and monitoring. Also, the information may be useful for purposes of epidemiological research.