NZ241492A - Medication system; blister packs and administration charts ring-bound in coded folder - Google Patents

Description

24149; 242062 Patents Form No. 5 COMPLETE AFTER PROVISIONAL NO. 241492 FILED 3 FEBRUARY 1992 NO. 242062 FILED 19 MARCH 1992 NEW ZEALAND PATENTS ACT 1953 COMPLETE SPECIFICATION FATE'ff CFFICE, N.2 >-j4-£iVED .T-firo -3FEB1993 •T-':Ct J by 'ChpcfcoV.by A DRUG PACKAGING, DISPENSING AND MANAGEMENT SYSTEM I, KENNETH CHO SZETO, a New Zealand citizen of 18 Pilmuir Street, Lower Hutt, New Zealand, do hereby declare the invention, for which I pray that a patent may be granted to me, and the method by which it is to be performed, to be particularly described in and by the following statement: se/specs/200157 2 24149 24206 1 This invention relates to a system which facilitates the supply, management and dispensing of drugs in residential care facilities, continuing care facilities, hospitals, community homes and the like. The system may also be used by individuals to manage drug administration to themselves. The invention also relates to packaging means for use in the system and to a method of managing and dispensing drugs using the system.

The administration of medication to patients has always been a problem; particularly in institutions such as hospitals. An early practice in these institutions was for a nursing sister to pre-pour medication in a medication room. Tablets were placed in special cups and placed on ice block trays. The trays were then taken through the wards and each item of medication was administered to the appropriate patient. This practice has many defects and is now illegal in many countries.

It is also common to use medication trolleys that have individual patient drawers. This system avoids pre-pouring of the medication but is extremely time consuming and labour intensive for nursing sisters. Each time medication is to be administered, the nursing sister is faced with the task of opening the drawer, removing the drug container, taking the lid off the container, administering the medication, placing the lid back on the container and then placing the container back in the drawer. To repeat this procedure for a large number of patients, each often taking more than one drug, often three times a day, is extremely time consuming and is not popular with nursing staff. Also mistakes can occur frequently.

An attempt to overcome these problems has been made by Manrex Australia Pty. Limited with a system called the Webstersystem (trade mark). This system requires nursing staff to supply the pharmacist with details of the medication required by each patient. Then, for each patient, the pharmacist prepares the medication that is to be administered se/specs/200157 24149JV 242062 at a set time by placing each day's dosage in the cavity of a blister pack. Usually the blister pack has 35 cavities and therefore can be used to administer drugs for 35 days.

A foil backing sheet is then heat sealed onto the blister pack to contain and protect the medication. The medication is removed from the blister pack by pushing it through the backing foil.

The blister pack is then placed in a folder that comprises two panels joined at a fold. Each panel has 35 apertures through it; the apertures of one panel being aligned with those of the other when the panels are folded together. The apertures also align with the blister cavities so that medication can be removed by pushing a finger through an aperture, breaking the backing foil, and pushing the medication out of the aligned aperture of the other panel.

The apertures through one of the panels are numbered to provide a convenient administration sequence guide. Also various areas are left open on the panel such that information labels can be adhered to it.

The panels also have a pair of punch holes through them such that the folder can be secured in a ring binder. In this way, all medication to be administered to all patients in the morning (for example) is secured in a particular ring binder. The nursing staff then dispenses the medication by placing all the ring binders on a trolley and pushing the trolley through the wards or rooms. The nursing sister then flicks to the folder containing a particular patient's medication, pushes the medication from the folder, and administers it to the patient. The appropriate folder is then selected for the next patient and the process repeated. se/specs/200157 < e i 0 ' 4 241492 242062 The folders are colour coded such that all folders for any particular administration time have a common colour. For example medication to be administered in the morning is placed in green folders, medication to be administered at lunch time is placed in pink folders, and so on. It will be appreciated that at least one ring binder is required for each standard administration time.

The Webstersystem (trade mark) has greatly facilitated the administration of drugs to patients by nursing staff but requires a great amount of effort on the part of the pharmacist. The process of packaging the medication in the blister pack and heat sealing the backing foil is labour intensive. The pharmacist must by hand place each drug in a cavity until the blister sheet is full and then heat seal the sheet. Consequently each pharmacist can only service a relatively small number of institutions. Also the system is relatively expensive since the plastics folders are expensive. The process of flicking through the folders is also a problem since identification of any folder is not simple. Also overall management of the system is lacking.

Another form of the Webstersystem (trade mark) is available but this is even more troublesome for nursing staff. In this form, the blister pack has five columns of seven drugs each and each column is labelled for a particular administration time. Therefore any patient has only one folder but dispensing of drugs at any one time is made more difficult.

Accordingly it is an object of this invention to provide a system to facilitate packaging, management and dispensing of medication.

This invention provides a medication dispensing assemblage, suitable for a plurality of patients having potentially different medication requirements from each other, but who receive medication at substantially the same times as each other comprising: ^S^specs/2 0 015 7 folder means having identification means to identify a particular administration time, drug type or patient group, said folder having a binder means adapted to releasably hold a blister pack sheet containing a prescribed amount of drug, each sheet having identification means to relate it to a single patient and describing medication details; a plurality of individualised patient drug treatment charts containing identification means and medication information; and wherein each blister pack sheet has a cavity sheet made from a food grade plastic material, having a plurality of cavities formed therein, said cavities arranged in rows and clumps, and a backing sheet, the backing sheet having perforations alignable with respective cavities in the cavity sheet, and being a two part assembly, one part being a food grade plastics self adhesive sheet, the second a removable liner, perforated to provide on removal from the first sheet a series of retained segments of said liner which are not removed, but which adhere to the first sheet in a pattern registerable with the cavities of said cavity sheet on alignment therewith.

The invention also provides a method of assembling a medication dispensing assembly comprising: (i) forming a cavity sheet, being a series of cavities adapted to retain medication in a sheet of food grade plastic material; (ii) placing pre-determined amounts of selected drugs in said cavities; (iii) applying a liner to a self adhesive sheet of food grade plastic material, said liner having segments thereof perforated either before or after this application, in a perforation pattern capable of conforming with the cavities formed in a sheet of step (i) above; se/sp - 5a - >/?. (iv) removing sufficient of the liner to expose the adhesive of the self adhesive sheet, but retaining those segments which have been perforated; (v) aligning said liner with the cavity sheet of (i) above so as to align the perforated segments in the retained liner with the cavities in the cavity sheet to thus form a blister pack; (vi) releasably mounting the medicament containing sheets within a folder and; (vii) releasably mounting in said folder information sheets relating medicaments with intended recipients.

The invention also provides a method for the preparation and dispensation of medicaments comprising: (i) the preparation by a dispenser of medicaments of a Medicaments Schedule of patient identification, drug type and dosage regime; (ii) the transfer of this information to a drug treatment chart; : (iii) the preparation of a medication dispensing assemblage above containing designated medicaments in a or several blister pack sheets; (iv) the placement of the, or several, blister pack sheet(s) in folders by dosage time; (v) the manual breaking of the appropriate blister pack sheet(s) and dispensation to the patient.

The retained segments may have perforations through the liner but not through the plastics, defining a region of weakness for perforation and extraction of the contents of the cavity, iecs/200157 241492 242062 Preferably, the backing sheet is a heat shrunk thermoplastics sheet.

Preferably the blister pack has identification means to identify the administration time, the patient and/or the drug and dosage. The identification means may be in the form of labels adhered to the blister sheet.

The blister sheet may have printed indications or directions on it to provide guidance to the sequence in which the drugs in the cavities are to be taken. The blister sheet may have 31 recesses to provide 31 cavities in the blister pack. Therefore a drug can be packaged for each day of a month.

Preferably the blister pack is pre-prepared by a drug manufacturer or distributor and distributed to pharmacists; there being a different pack for each standard dosage of the drug. The pharmacist may then select the appropriate blister pack from a supply and adhere to it patient and administration identification labels. se/specs/200157 24149 242062 The drug treatment instruction sheet may also include information concerning drugs that cannot be packaged in a blister pack and drugs that are to be administered at irregular times.

The folder means may have bound in it a plurality of blister packs; one for each drug that is to be administered to the patient.

The folder means may have bound in it a drug instruction sheet containing information concerning drugs that are to be administered over a short period.

Preferably the identification means on the folder means to identify the administration time is a colour; the folder means being coloured in the colour. The identification label on the blister sheet is preferably the same colour.

A cassette case containing a video-cassette giving instructions to visually impaired people may be secured to the inside of the cover of the folder means. Similarly, additional information may be provided by way of video-cassette or compact disc, and these may be secured within the folder also.

The invention also provides a drug dispensing and management system for a patient that comprises a plurality of folder packages as described above; each folder package being clearly distinguishable from any other and each folder package containing drugs to be administered at a particular time or containing particular drugs.

The invention also provides a method of storing and managing drugs to be administered to a patient; the method comprising: se/specs/200157 24149; 242062 forwarding to a pharmacist facility a drug treatment instruction sheet that identifies a patient, a drug, a dosage and an administration time; at the pharmacist facility, selecting a blister pack that has a plurality of sealed cavities each containing the drug in the appropriate dosage, the blister pack comprising a blister sheet having a tearable backing sheet adhered to it; and releasably binding the blister pack and the drug instruction sheet in a folder means that has identification means to identify the patient and administration time or drug type.

Preferably a plurality of drug treatment instruction sheets are forwarded to the pharmacist facility and a folder means for each administration time is prepared.

Embodiments of the invention are now described, by way of example only, with reference to the drawings in which: Figure 1 illustrates, in schematic form, one embodiment of a folder means; Figure 2 is plan view of the folder means; and Figure 3 illustrates a drug treatment chart for use in the system.

Referring to Figures 1, 2 and 3, the folder means 10 comprises a ring file 12 that has a ring binder 14 attached to its rear panel 16. The ring file 12 is a standard ring rile comprising a rear panel 16, a spine panel 19 and a front panel 20. The ring file 12 is plastics coated and coloured.

A second ring binder 18 is attached to the front panel 20 of the ring file 12 adjacent its upper edge 22. The ring file 12 forms a means by which all medication to be administered to se/specs/200157 242062 a patient at a particular time can be stored. Also, for particular types of medication that must be administered separately, the ring file 12 forms a means in which to store the medication for a patient.

In a further preferred embodiment (not shown) a 4-ring binder is employed.

A medication blister sheet 24 is releasably secured in the ring file 12 on the ring binder 14. The blister sheet 24 is a clear sheet made of plastics and has a plurality of blister cavities 26 vacuum formed in it. The blister cavities 26 are arranged in rows and columns. Each cavity 26 has a number above it to provide guidance on the sequence in which drugs contained in the cavities are to administered. The blister sheet 24 illustrated in Figure 1 has 31 cavities.

The cavities 26 are illustrated to be circular in cross-section but they can be any suitable shape. For example, if the drugs are rectangular, the cavities 26 can be rectangular.

A pair of apertures 30 are formed through the sheet 24 adjacent the inner edge 28 of the blister sheet 24. The apertures 30 are spaced from one another to align with the spikes 32 of the ring binder 14. The blister sheet 24 has a label field 34 adjacent its upper edge 36. A label indicating the time of day or the medication to be administered is adhered in the label field 34. Further label fields 38 are provided adjacent the lower edge 40 of the blister sheet 24 so that labels containing further information can be adhered to the blister sheet 24.

For use with the 4-ring binder, 4 apertures 30 are punched in the sheet 24. se/specs/200157 241492 242062 A thermoplastic sheet 42 is adhered to the back of the blister sheet 24 to hold the medication in the blister cavities 26. The thermoplastic sheet 42 is made of a heat sensitive plastics material that shrinks onto the blister sheet 24 when heat is applied. In this way the sheet 42 seals the blister cavities 26. The sheet 42 has perforations 44 in one of its faces; the perforations not extending completely through the sheet 42. These perforations 44 are arranged in a pattern so that they align with the blister cavities 26 when the sheet 42 is heat shrunk on the blister sheet 24. In this condition/ the perforations 44 face the exterior of the blister cavities 26. Tablets, pills or capsules contained in the blister cavities 26 can be removed by pushing them through the thermoplastics sheet 42; the perforations 44 facilitating tearing of the thermoplastics sheet 42.

In a further preferred embodiment the backing sheet is made up from a plastic sheet and a liner. The plastic sheet is self adhesive, or heat sealable, or a combination thereof. It seals the cavity, with a food grade plastic. It can be translucent, clear to permit visual identification or confirmation of the drug contents, or opaque to prevent damage by ultra violet light, as the user may elect.

It is backed by a liner, which can helpfully be of contrasting colour, and which has an exterior perforation line defining a segment, and one or several interior perforations providing a weak point to facilitate tearing of and then opening of the blister pack cavity.

The thermoplastic sheet 42 has a pair of apertures 46 through it adjacent its inner edge 48. The apertures 46 align with the apertures 30 of the blister sheet 34. In use lines of adhesive 47 are placed on the face of the thermoplastic sheet 42 adjacent three of the edges. The thermoplastic sheet 42 is then adhered to the blister sheet 24 after a drug has been se/specs/200157 -.10 - 24149^ 242062 / placed in each cavity 26. Hot air is then blown onto the thermoplastic sheet, 42 to cause heat shrinking so that the blister cavities 26 can be sealed and so that the thermoplastics sheet 42 adheres to the blister sheet 24. The adhesive 47 prevents slippage of the thermoplastics sheet 42 while it is being heat shrunk.

The blister packs are conveniently made up by the pharmaceutical company or a drug distributor in a variety of standard doses. In this way, a pharmacist need not make up the pack. It will be appreciated that pharmaceutical companies package many drugs in this form (for example headache tablets, contraceptives, anti-allergy tablets and the like) and therefore it will not be a problem to extend the range.

A drug treatment chart 50 (best illustrated in Figure 3) is positioned in a clear plastics sheet envelope 52. The sheet envelope 52 has a pair of apertures 54 through it adjacent its inner edge 56. The apertures 54 are spaced apart to align with the spikes 32 of the ring binder 14. The sheet envelope 52 is conventional.

For use with the 4-ring binder, 4 apertures 54 are provided.

The drug treatment chart 50 is a paper or cardboard sheet that forms a patient and medication reference chart to assist in packaging of medication and administration of the medication. The upper portion 60 of the chart includes fields for patient and doctor identification. For example, the patient's photograph, name, ward and bed number, sensitivities and the doctor's name can be entered here. Also any pertinent notes and the date the request is forwarded to the pharmacist can be entered.

The chart 50 also has an information area 62 containing fields for information concerning medication to be administered se/specs/200157 from the blister sheet 24 in regular doses. This information area 62 forms the instructions to the pharmacist on what to package in a blister sheet 24 for each administration time for the patient.

The information area 62 has a date started field 64 and a date discontinued field 66. Also included are fields for identification of the drug, the dosage amount and the administration time. The sheet 50 illustrated has an administration time field for each of a number of times.

The drug treatment chart 50 also has a further information area 68 containing fields for information concerning medication that is administered regularly but the medication not being in a blister pack. This information area 68 is substantially identical to the information area 62 and provides instructions to the pharmacist to make up medication which is not suitable for packing in a blister sheet.

The rear (not shown) of the drug treatment chart 50 may include further fields to provide information concerning medication that is not administered regularly. The pharmacist again makes up this medication in accordance with the instructions.

An intermittent drug treatment chart (not shown) may be clipped to the ring binder 18. This chart lists information concerning medication for short term therapy. These medications can also be packaged in blister sheets 24.

The outside (not shown) of the spine panel 19 has a clear plastics sleeve adjacent its lower edge. An information insert that identifies the patient can be inserted into the sleeve.

In use a drug treatment chart 50 is completed for a particular patient and signed by a doctor. Drugs that can be se/specs/200157 -•12 2 24; 4. administered in blister packs are identified in the information area 62 and those that are not suitable for packaging in blister packs are identified in the information area 68. Also the dosages required and the administration times required are indicated. A separate drug treatment chart 50 is filled out for each administration time and for each patient. The drug treatment charts 50 are then supplied to a pharmacist who then makes up the medication that is not to be packed in a blister pack. If available, the pharmacist then selects the appropriate pre-packed blister pack containing the required medication in the correct dosage. These blister sheets 24 can be conveniently made up by the drug company supplying the drug or the company's wholesaler or distributor. Plainly the blister sheets 24 will contain the drug in a standard dosage of which there may be any number.

The pharmacist then attaches an appropriate administration time label in the field 34 and attaches labels giving administration instructions in the fields 38. The blister pack is then slipped into a ring folder 12 that is colour coded for the particular administration time or a particular drug. The drug treatment chart 50 for that administration time or drug is then also placed in the ring file 12.

If more than one drug is to be administered, a blister pack for each drug is placed in the ring file 12.

Alternatively, if certain drugs are usually administered together, the pharmaceutical manufacturer or distributor may pre-package these drugs together in a blister pack 52 in standard dosages.

Each patient may have a separate ring file 12 for each administration time and, in some instances, for a particular drug (for example, antibiotics must be administered separately). However, it is practical to place blister packs se/specs/200157 -• 13 2414 24 20 for multiple patients within the one folder. Thus, all patients requiring medication at say, lunchtime, may have the appropriate blister packed dosages with identifying information within one or a small number of folders.

Therefore when the nursing staff do their rounds, all the folders for a particular administration time or drug can be placed on a suitable trolley. When the appropriate patient is reached, the appropriate ring file 12 is removed and the drug or drugs administered. The medication that cannot be blister packed, will also be carried on the trolley and administered at that time; the drug treatment chart 50 indicating to the nursing staff what needs to be administered.

In certain cases the drugs will be such that they are not convenient to be pre-packed by the pharmaceutical manufacturer or distributor. This might occur when these drugs are not administered in standard dosages. In these cases the pharmacist can prepare the blister packs by placing a required dosage in each cavity 26 of a blister sheet 24, adhering a backing sheet 42 to it and heat shrinking the backing sheet 42. However a large majority of the drugs can be pre-packed by the manufacturers or distributors. In this way a large portion of the labour intensive component of the Webstersystem (trade mark) is done away with. Also storage, management and dispensing of the drugs by the nursing staff is greatly facilitated since each patient's drugs are stored separately in a folder for each administration time.

Although tablets, pills and capsules are most suitable for use in the system, drugs in other forms can be stored in blister packs. For example drugs in the form of suppositories creams and lotions can be stored in blister packs. However drugs in liquid form would require some adjustment to the standard blister; for example the use of small containers in the blister pack. se/specs/200157 241492 242062 This system is particularly suited for use in homes for the aged where patients are resident for long periods of time and are administered certain drugs daily. However the system can also be used in hospitals and the like where patients will remain for short periods and the drugs and dosages would be more varied. The system can also be used by patients at home who are required to undergo a drug treatment programme.

It will appreciated that the system provides a neat and convenient storage, management and dispensing system. The folders can be neatly stored in shelving and rapidly located.

Also dispensing of the drugs by the nursing staff is greatly facilitated. Apart from the initial outlay for the ring files, the cost of the system is relatively low.

It is to be understood that the invention is not limited to the bodiment described in the specification and numerous modifications can be made without departing from the scope of the invention as defined in the following claims. se/specs/200157

Claims (18)

WHAT I CLAIM IS:

1. A medication dispensing assemblage, suitable for a plurality of patients having potentially different medication requirements from each other, but who receive medication at substantially the same times as each other comprising: folder means having identification means to identify a particular administration time, drug type or patient group, said folder having a binder means adapted to releasably hold a blister pack sheet containing a prescribed amount of drug, each sheet having identification means to relate it to a single patient and describing medication details; a plurality of individualised patient drug treatment charts containing identification means and medication information; and wherein each blister pack sheet has.a cavity sheet made from a food grade plastic material, having a plurality of cavities formed therein, said cavities arranged in rows and clumps, and a backing sheet, the backing sheet having perforations alignable with respective cavities in the cavity sheet, and being a two part assembly, one part being a food grade plastics self adhesive sheet, the second a removable liner, perforated to provide on removal from the first sheet a series of retained segments of said liner which are not removed, but which adhere to the first sheet in a pattern registerable with the cavities of said cavity sheet on alignment therewith.

2. A medication dispensing assemblage as claimed in claim 1, in which the retained segments have perforations through se/specs/200157 the said liner, but not through said plastic, defining a region of weakness for perforation and extraction of the contents of said cavity.

3. A medication dispensing assemblage as claimed in claim 1, having a second binding means to retain sheets other than the blister pack sheets.

4. A medication dispensing assemblage as claimed in claim 3 in which said sheets are therapy charts for the prescription of intermittently dispensed drugs.

5. A medication dispensing assemblage as claimed in claim 1, having an alternative binding means adapted to retain any one or more of a video cassette, an audio cassette or a compact disc containing patient and/or drug dosage information.

6. A medication dispensing assemblage as claimed in any one of claims 1 to 5 substantially as herein described, with reference to any one of the accompanying drawings.

7. A method of assembling a medication dispensing assembly comprising: (i) forming a cavity sheet, being a series of cavities adapted to retain medication in a sheet of food grade plastic material; (ii) placing pre-determined amounts of selected drugs in said cavities; (iii) applying a liner to a self adhesive sheet of food grade plastic material, said liner having segments thereof perforated either before or after this se/specs/200157 241492 17 242062 application, in a perforation pattern capable of conforming with the cavities formed in a sheet of step (i) above; (iv) removing sufficient of the liner to expose the adhesive of the self adhesive sheet, but retaining those segments which have been perforated; (v) aligning said liner with the cavity sheet of (i) above so as to align the perforated segments in the retained liner with the cavities in the cavity sheet to thus form a blister pack; (vi) releasably mounting the medicament containing sheets within a folder and; (vii) releasably mounting in said folder information sheets relating medicaments with intended recipients.

8. A method as claimed in claim 7 in which the perforations provide a series of segments which are retained and which provide a close register with the cavity with which they are aligned.

9. A method as claimed in claim 7 or 8 in which human or machine readable indicia are printed onto the blister pack.

10. A method as claimed in claim 7 having the additional step of mounting intermittent drug therapy charts within the folder.

11. A method as claimed in any one of claims 7 to 10 having the additional step of mounting any one or more of a video cassette, audio cassette or a compact disc within the folder. X 5 o/5!%s.se/specs/200157 , g A"

12. A method as claimed in any one of claims 7 to 11 in which the blister pack or packs selected for each patient are selected from pre-packaged stock of such blister packs.

13. A method as claimed in any one of claims 7 to 12 substantially as herein described with reference to any one of the accompanying drawings.

14. A method for the preparation and dispensation of medicaments comprising: (i) the preparation by a dispenser of medicaments of a Medicaments Schedule of patient identification, drug type and dosage regime; (ii) the transfer of this information to a drug treatment chart; (iii) the preparation of a medication dispensing assemblage as claimed in claim 1, containing designated medicaments in a or several blister pack sheets; (iv) the placement of the, or several, blister pack sheet(s) in folders by dosage time; (v) the manual breaking of the appropriate blister pack sheet(s) and dispensation to the patient.

15. A method as claimed in claim 14, in which step (iii) is substituted for by the selection of a stock of pre-prepared blister pack sheets.

16. A method as claimed in either claim 14 or 15, in which all medication for patients for dispensation at the same time is grouped together with identifying information in a folder identified by indicia as to that time. se/spec§ 19

17. A method as claimed in claim 16, in which the indicia is the colour of the folder.

18. A method as claimed in any one of claims 14 to 17 herein, substantially as herein described, with reference to the accompanying drawings. By His Attorneys BALDWIN SON & CARET