GB2342203A - Drug packaging method - Google Patents
Drug packaging method Download PDFInfo
- Publication number
- GB2342203A GB2342203A GB9821016A GB9821016A GB2342203A GB 2342203 A GB2342203 A GB 2342203A GB 9821016 A GB9821016 A GB 9821016A GB 9821016 A GB9821016 A GB 9821016A GB 2342203 A GB2342203 A GB 2342203A
- Authority
- GB
- United Kingdom
- Prior art keywords
- container
- containers
- drug
- label
- filled
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000000034 method Methods 0.000 title claims abstract description 18
- 238000009512 pharmaceutical packaging Methods 0.000 title abstract description 4
- 239000003814 drug Substances 0.000 claims abstract description 35
- 229940079593 drug Drugs 0.000 claims abstract description 35
- 238000002372 labelling Methods 0.000 claims abstract description 14
- 238000004806 packaging method and process Methods 0.000 claims description 19
- 238000002360 preparation method Methods 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 5
- 239000000902 placebo Substances 0.000 description 3
- 229940068196 placebo Drugs 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000002547 new drug Substances 0.000 description 2
- 238000000275 quality assurance Methods 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 238000013480 data collection Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000010399 physical interaction Effects 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000009517 secondary packaging Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K17/00—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B57/00—Automatic control, checking, warning, or safety devices
- B65B57/10—Automatic control, checking, warning, or safety devices responsive to absence, presence, abnormal feed, or misplacement of articles or materials to be packaged
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
- B65B61/26—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for marking or coding completed packages
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01V—GEOPHYSICS; GRAVITATIONAL MEASUREMENTS; DETECTING MASSES OR OBJECTS; TAGS
- G01V15/00—Tags attached to, or associated with, an object, in order to enable detection of the object
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
Landscapes
- Engineering & Computer Science (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Theoretical Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Primary Health Care (AREA)
- Public Health (AREA)
- Mechanical Engineering (AREA)
- Geophysics (AREA)
- General Life Sciences & Earth Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Treatment And Welfare Office Work (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
A drug packaging method is particularly useful in the preparation of containers for use in clinical trials. Containers are produced each of which carries a unique remote-readable identifier in the form of for example an RFID tag. The containers are filled with a selected drug to be packaged and the identity of each filled container is determined from the remote-readable identifier. The identity of the container and of the drug are stored in a database with associated labelling data and the label is applied to the container, the label reproducing the labelling data associated in the database with the identified container.
Description
2342203 DRUG PACK-AGING METHOD The present invention relates to a drug
packaging method and in particular to such a method which has particular utility in the packaging of drugs used for clinical trials.
When new drugs are developed, it is necessary for the manufacturers to conduct extensive, time consuming and costly trials. Clinical trials generally occur in phases, that is by testing the drugs firstly on animals, then on terminally ill patients, then on healthy volunteers and so on. The trials can be conducted in different parts of the world where different languages are used, and the drugs can be delivered in various fon-nats, for example simple bottles, or blister packs in which each of a series of tablets is delivered to the user in a separate section of a flexible carrier from which tablets are removed by rupturing individual tablet compartments. In clinical trials, it is generally the case that the dr-ug under test is administered to a first group of patients, a placebo is administered to a second group, and the "best" equivalent to the drug under test is administered to a third group. It is of course crucial to identif7 which containers carry the drug under test, which containers carry the placebo, and which containers carry the currently available equivalent drug. It is essential that the information which can be read from the containers by a user does not indicate to which of these three categories the tablets carried by the container belongs. Neither the person taking the tablets nor the individuals responsible for packaging the tablets C> must know A,-hat each tablet contains. Labels applied to the tablets must carry instructions to the user, for example take one tablet on each of 28 consecutive days, and a record must be kept of the content of the container from which a particular user takes tablets. All relevant information must be returned to the company conducting the clinical trials so that the efficacy of the drug under test can be compared with the placebo and the equivalent drug. This requires a major effort in terms of establishing databases to ensure that data generated as the result of the trial is correctly correlated with the identity of the particular tablets taken by a particular patient to whom those tablets are administered.
Clinical trials are a necessary precursor to commercial exploitation of new drugs and must not only satisfy the drug developer's research needs but also statutory z:1 Zl 2 requirements. Clinical trials by their very nature are of complex configuration predetermined by protocols established outside of the clinical trial departments of the pharmaceutical companies. These protocols will be issued as a Trial Instruction and will identify the drugs, pack information and style, the bottle or pack fill information, labels required, number of patients recruited, and the countries in which the trial is to be conducted, leading to the quantification of bottles or packs, outer car-tons and label requirements. Packs are usually filled and then returned after line clearance to a warehousing facility to be brought back in for labelling and then for pack assembly.
C C, Labels are printed in a separate environment and then brought together with the container for labelling and secondary packaging, then on to a despatch area. The traceability of drug batch number, the patient number, the label etc is a major problem that is continually addressed by various control systems. Studies are conducted "blind" and this aspect of a trial can be undermined by any use of visible coding or non functional packaging variations. The correctness of the packaging requirement is threatened by errors at labelling, assembly and distribution stages and as a result a great amount of resource is applied to quality control and assurance. This is time consuming and consequently can be expensive. A study may be made up of several different products, each product packed separately. with product doses arranged in a specific format in a patient pack. The patient packs may then be shipped using further outer labels to various sites through the world. As a result, the logistics of a trial are considerable, bearing in mind the number of patients who are randomised in patient numbers, the product variations, the label variations for different countries, the control of despatch etc.
By the standards of the pharmaceutical industry, clinical trials involve relatively small volumes of tablets and therefore the filling and labelling of containers used in clinical trials has been largely a manual operation. A container filling line is cleared of all drugs, a batch of tablets identified by the supplier as for example "tablet A" is delivered to the packaging line with a batch of labels appropriate to that particular tablet. Containers are then filled and the associated labels are applied to the containers. Once a first batch of tablets has been processed, the packaging line is cleared and a second batch is delivered to the line, for example "tablet B", with associated labels and the next batch of containers is filled and labelled. Typically 3 each label will incorporate a code number which identifies the particular batch of tablets which has beep used to fill a particular batch of containers. Meticulous care must be taken to ensure that no mistakes are made either with regard to filling containers or applying labels to the appropriate containers.
After a patient has taken a particular batch of tablets, data must be gathered as to the associated circumstance, for example to confirm that the patient does at least say that the tablets have been taken in accordance with the instructions set out on the label, the identity of the patient and the identity of the drug which has been taken. The drug identity may be determined by reading information off the label, and therefore if there is any mis-matching as between labels and containers this can invalidate and render a costly and time consuming trial worthless.
It is an object of the present invention to provide a drug packaging method which can simplify the process of accurately identifying the content of a particular drug container.
According to the present invention, there is provided a method for packaging a drug in which drug containers are produced each of which carries a unique remotereadable identifier, and the containers are filled with a selected drug to be packaged, wherein the identity of each container is determined, the identity of each container and the identity of the drug with which it is filled is stored in a database with associated labelling data, and a label is applied to the container, the label reproducing the labelling data being associated in the database with the identified container and the drug with which that container is filled.
As each container can be uniquely identified, and its content and the associated labelling data is determined at the time that the container is filled, a database can be established which directly associates the content of a container with the label which is applied to that container, the method being immune to errors assuming that the basic information identifying a particular batch of drugs which has c C1 been delivered for packaging and the associated label data has been correctly entered. There is no risk of mis-labelling as labels are generated at the point of packa ing directly from the database by reference to-the drug identifying data.
Each container may incorporate a radio frequency identification tag storing a unique identification code. For example individual tags can be incorporated into the 4 base of a tablet bottle or into a surface of a tablet blister pack. A radio frequency identification tag (RFD tag) can be fabricated in a relatively small rigid structure or incorporated into a flexible structure suitable for application to a blister pack.
Containers can be produced each of which incorporates a remote-readable identifier pre-programmed with a unique identification code, the identification code of each container being read at the time of packaging either before or afler that container is filled with tablets. Alternatively, containers may be produced incorporating remote-readable identifiers which are programmable with a unique identification code at the time of packaging. the containers being programmed before or after they are filled and the remote identification code being read after the identifier has been programmed.
The containers themselves may be used in the data collection process which follows the administration of particular tablets to particular users. For example the container may be returned to a central point with a simple questionnaire indicating for example that all of the tablets have been taken in the manner instructed by, the label. The full identity of the tablets which had been contained within that container can then be determined simply by reading the remote-readable identifier.
An embodiment of the present invention will now be described, by way of example, with reference to the accompanying drawing.
Referring to the drawing, this is a simple flow diagram seeking to illustrate one embodiment of the invention. A drug in the form of a batch of tablets to be packaged is delivered to the packaging line which has been previousl., cleared of all other tablets. The packaging line is also supplied with containers each of which carries an RFID tag, but at this stage in the process the containers are in no way associated with any particular batch of tablets. The identity of the batch of drugs is entered into a computer system, converted into data identifying the particular drug, for example "drug batch A" and that data is stored in a database. Details of a label appropriate to that batch are also entered or looked up from a look-up table previously entered into the computer system so as to determine the appropriate label details. Label data representative of the determined label details is then generated and stored in the database. Containers are then filled with the tablets, the RFID tag of each filled container is read, and container identifying data is generated and stored in the 0 database. The database then produces an appropriate label which is applied to the identified container. A label may be produced in the form of an adhesive strip but preferably is directly printed onto the container itself so that no manual intervention associating a particular label with a particular container is required.
Alternative methods which differ from that described above are of course possible. For example, rather than simply relying upon the remote readable tag to identif), the container, the remote readable tag may also be written to so as to store within it for example the identity of the tablets with which the container has been filled, or any other production process or tablet identity details deemed appropriate by the organisation running the intended clinical trials.
The containers themselves may be used to assist in the generation of data of relevance to the overall clinical trial programme. For example, the containers may be issued to users with instructions that the containers be returned to a central collection point after the tablets have all been administered to a patient. The data stored on the tag incorporated in any one container can then be read to provide confirmation that the tablets sent out in that particular container have been administered to the patient to whorn the container was sent. Thus the present invention is relevant not only to addressing the issue of ensuring the appropriate identification and labelling of X:, t5 containers for use in clinical trials but may also assist in the collection of data with regard to the progress of the clinical trials.
W The particular embodiment of the invention described above makes use of an RFID tag but it will be appreciated that other remote-readable identifiers could be used, the only fundamental requirement of the remotereadable identifier being that it carries data which is unintelligible to an), one without an appropriate reader and that the data can be read without physical interaction with the container in which the tag or other identifier is incorporated.
In summary, the use of RFID tags or functional equivalents makes it possible to address the challenges presented in clinical trial packaging. Each tag may be uniquely, identified at manufacture and can be applied at the very earliest stages of packaging of a product e.g. to a bottle, a blister tray or a blister wallet, an ampoule or syringe etc. The opportunity to write to or read from a tag or its associated database, provides many opportunities in the areas of control and formal workflow at all stages
6 and makes it possible readily to record details and status of materials, assembly and storage, to interrogat(z and update the database or tag as required for planning and scheduling, material transfer from a warehouse, filling and labelling and package assembly. With the use of hand held readers essential data can be read off-site by clinicians, monitors or quality assurance staff. Probably of most importance is that the combination of the unique tag identification allied to a database enables specific "instructions" to be issued. For instance, at the appropriate point in the process a label can be printed, verified and applied in the secure knowledge that it is correct; the correct contents of a patient pack can be verified, not only for content but also for position in a sealed pack without the need to open the pack and check visibly. Again, despatch labels can be printed by accessing the database and verifying the data stored. Just in time packaging is a very real possibility, especially with the opportunity to rewrite (a change of address/label/patient etc) the tags in a controlled manner. The C' basis of a clinical trial packaging unit is to put the right drug in to the correct container, apply the correct label to the container and to pack these in the correct formation in a patient pack which must also be labelled correctly and despatched to the correct address. All of these areas can be controlled and verified with the use of RFID tags.
7
Claims (5)
1. A method for packaging a drug in which drug containers are produced each of which carries a unique remote-readable identifier, and the containers are filled with a selected drug to be packaged, wherein the identity of each container is determined, the identity of each container and the identity of the drug with which it is filled is stored in a database with associated labelling data, and a label is applied to the container, the label reproducing the labelling data associated in the database with the identified container.
2. A method according to claim 1, wherein each container incorporates a radio frequency identification tag storing at least a unique identification code.
0
3. A method according to claim 1 or 2, wherein containers are produced incorporating remote-readable identifiers pre-programmed with a unique identification code, and the unique identification code is read before or after the container is filled.
4. A method according to claim 1 or 2, wherein containers are produced incorporating remote -readable identifiers which are programmable with at least a unique identification code, the containers being programmed before or after they are filled, and the identification code being read after the identifier has been programmed.
5. A method for packaging a drug substantially as hereinbefore described with tn reference to the accompanying drawing.
t
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9821016A GB2342203B (en) | 1998-09-29 | 1998-09-29 | Drug packaging method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9821016A GB2342203B (en) | 1998-09-29 | 1998-09-29 | Drug packaging method |
Publications (3)
Publication Number | Publication Date |
---|---|
GB9821016D0 GB9821016D0 (en) | 1998-11-18 |
GB2342203A true GB2342203A (en) | 2000-04-05 |
GB2342203B GB2342203B (en) | 2003-02-19 |
Family
ID=10839550
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GB9821016A Expired - Fee Related GB2342203B (en) | 1998-09-29 | 1998-09-29 | Drug packaging method |
Country Status (1)
Country | Link |
---|---|
GB (1) | GB2342203B (en) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003001429A2 (en) * | 2001-06-23 | 2003-01-03 | Smithkline Beecham P.L.C. | Monitoring drug packaging in clinical trial process |
US7757948B2 (en) | 2003-05-08 | 2010-07-20 | Aegate Limited | Authentication system |
GB2561347A (en) * | 2017-04-07 | 2018-10-17 | Medi Clear Ltd | Methods and apparatus for automatically filling dispensing containers |
EP3636240A1 (en) * | 2018-10-09 | 2020-04-15 | MEDI-Clear Ltd | Methods and apparatus for automatically filling dispensing containers |
US20200115074A1 (en) * | 2018-10-10 | 2020-04-16 | Medi-Clear Ltd | Methods and Apparatus for Automatically Filling Dispensing Containers |
WO2024073353A1 (en) * | 2022-09-29 | 2024-04-04 | R.P. Scherer Technologies, Llc | Systems and methods for aggregating supply orders for pharmaceutical trials |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3526773A (en) * | 1966-09-12 | 1970-09-01 | Gen Atronics Corp | Bar code applying and sensing method |
EP0271624A1 (en) * | 1986-12-17 | 1988-06-22 | André Tourette | Method for making a bill of sale for different products |
GB2275123A (en) * | 1993-01-27 | 1994-08-17 | Ian James Hossack | Drug dispensing system |
-
1998
- 1998-09-29 GB GB9821016A patent/GB2342203B/en not_active Expired - Fee Related
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3526773A (en) * | 1966-09-12 | 1970-09-01 | Gen Atronics Corp | Bar code applying and sensing method |
EP0271624A1 (en) * | 1986-12-17 | 1988-06-22 | André Tourette | Method for making a bill of sale for different products |
GB2275123A (en) * | 1993-01-27 | 1994-08-17 | Ian James Hossack | Drug dispensing system |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003001429A2 (en) * | 2001-06-23 | 2003-01-03 | Smithkline Beecham P.L.C. | Monitoring drug packaging in clinical trial process |
WO2003001429A3 (en) * | 2001-06-23 | 2003-11-27 | Glaxo Group Ltd | Monitoring drug packaging in clinical trial process |
US20040243620A1 (en) * | 2001-06-23 | 2004-12-02 | Carter Paul Laurence | Process |
US8165892B2 (en) | 2001-06-23 | 2012-04-24 | SmithKline Beeacham P.L.C. | Monitoring drug packaging in clinical trial process |
US7757948B2 (en) | 2003-05-08 | 2010-07-20 | Aegate Limited | Authentication system |
GB2561347A (en) * | 2017-04-07 | 2018-10-17 | Medi Clear Ltd | Methods and apparatus for automatically filling dispensing containers |
EP3636240A1 (en) * | 2018-10-09 | 2020-04-15 | MEDI-Clear Ltd | Methods and apparatus for automatically filling dispensing containers |
US20200115074A1 (en) * | 2018-10-10 | 2020-04-16 | Medi-Clear Ltd | Methods and Apparatus for Automatically Filling Dispensing Containers |
WO2024073353A1 (en) * | 2022-09-29 | 2024-04-04 | R.P. Scherer Technologies, Llc | Systems and methods for aggregating supply orders for pharmaceutical trials |
Also Published As
Publication number | Publication date |
---|---|
GB9821016D0 (en) | 1998-11-18 |
GB2342203B (en) | 2003-02-19 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
AU2007100687A4 (en) | Drug Dispense, Identification, Labelling and the System of Inspection | |
US5046609A (en) | Kit for distributing pharmaceutical products | |
US6976628B2 (en) | System and method for ensuring the proper dispensation of pharmaceuticals | |
US5048870A (en) | Multipart flag label for pharmaceutical products | |
US4976351A (en) | Kit for distributing pharmaceutical products | |
US5752234A (en) | Method and apparatus for managing disposable medical supplies appropriate for a single patient visit | |
US10290368B2 (en) | Bulk encoding medical items with wireless identification | |
US20050096941A1 (en) | Method for saving medication costs by redistributing unused medications | |
US20090134211A1 (en) | Method | |
CN206672118U (en) | For indicating the device of medical substance with label | |
CN101221632A (en) | Medicine dispensation checking system and method thereof | |
US3358824A (en) | Dispensing of pharmaceuticals | |
JP2004532491A (en) | Method | |
JP2017182599A (en) | Order placing/receiving management system of pharmaceutical, order placing/receiving management system of radiopharmaceutical, and order receiving management system of radiopharmaceutical | |
Meyer et al. | Use of bar codes in inpatient drug distribution | |
GB2342203A (en) | Drug packaging method | |
US20140114470A1 (en) | Methods and systems for improving efficiency of pharmacy practice and reducing the incidence of medication errors | |
US20140350946A1 (en) | Methods for Tracking Workflow in Pharmacies Involving Compound Operations | |
Okeke et al. | Revised USP standards for product dating, packaging, and temperature monitoring | |
US11200972B2 (en) | System, apparatus, and method for dispensary management | |
Ting et al. | AN RFID-BASED DRUG MANAGEMENT SYSTEM-A case in Medical Organization | |
EP3246862A1 (en) | Dispensing process of medical products in a healthcare facility | |
Bunn | Packaging and labeling control | |
JP6932826B2 (en) | Radiopharmaceutical order management system | |
Hug et al. | Logistics |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
732E | Amendments to the register in respect of changes of name or changes affecting rights (sect. 32/1977) | ||
PCNP | Patent ceased through non-payment of renewal fee |
Effective date: 20050929 |